analytical paper

Analytical Paper

Analysis of the EU requirements concerningsanitary and phytosanitary measures and their

implementation in Ukraine

UKRAINIAN-EUROPEAN POLICY AND LEGAL ADVICE CENTRE (UEPLAC) - PHASE V

УКРАЇНСЬКО-ЄВРОПЕЙСЬКИЙ ДОРАДЧИЙ ЦЕНТР З ПИТАНЬ ЗАКОНОДАВСТВА (UEPLAC) - ЕТАП V

The Project is fundedby the European Union

The Project is implemented by UPMFin consortium with PAI, FIIAPP,Louis Berger SAS, KLC and HRTA

102-104, Antonovycha Street 03150, Kyiv, Ukraine

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E-mail: [email protected]://www.ueplac.kiev.ua

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The Project is implemented by the UPMF, PAI, FIIAPP, Louis Berger SAS, KLC and HRTA consortium Ukrainian-European Policy and Legal Advice Centre – Phase V

EuropeAid/127777/C/SER/UA

The Project is funded by the European Union

Analytical Paper

Analysis of the EU requirements concerning sanitary and phytosanitary measures and their

implementation in Ukraine

December 2009


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The Project is implemented by the UPMF, PAI, FIIAPP, Louis Berger SAS, KLC and HRTA consortium Ukrainian-European Policy and Legal Advice Centre – Phase V

EuropeAid/127777/C/SER/UA

The Project is funded by the European Union

This Analitycal Paper was prepared by the experts of Ukrainian-European Policy and Legal Advice Centre (UEPLAC) Phase V Sanra Smulko, UEPLAC Non-Key Expert Sergey Nerpii, UEPLAC Non-Key Expert The views expressed in this paper do not necessary reflect the views of the European Delegation


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Table of Contents

ACRONYMS.................................................................................................................5 1. FOREWORD............................................................................................................7 2. EU FTA AND THE ECONOMIC AND LEGAL FRAMEWORK OF THE SANITARY AND PHYTOSANITARY MEASURES..............................................8

2.1. EU LEGISLATIVE FRAMEWORK OF FOOD HYGIENE AND FOOD SAFETY, ANIMAL HEALTH...............................................................................82.2. EU LEGISLATIVE FRAMEWORK OF PLANT HEALTH AND WOOD PACKAGING MATERIAL..................................................................................142.3. EU LEGISLATIVE FRAMEWORK ON IMPORT CONTROLS............152.4. EU IMPORT CONTROL PROCEDURES..................................................16

2.4.1. Import control procedures on animals and animal origin products ...........17 2.4.2. Import control procedures on plants and plant products............................18 2.4.3. Import control procedures on non- animal origin products .......................20

3. ANALYSIS OFTHE SELECTED EU FTA ANALYSIS IN FORCE, NEMELY OF THEIR PROVISIONS ON SPS TERMSIN THE RELEVANT MARKET ACCESS accessMECHANISMS APPLIED.......................................21

3.1. General rules on sanitary and phytosanitary measures .....................................21 3.2. EFTA-EU FTA and SPS provisions .................................................................23

SPS provisions in terms of the relevant market access mechanisms applied ......24 3.3. EU-CHILE FTA and SPS provisions ...............................................................263.4. EU-SWITZERLAND FTA and SPS provisions...............................................28

4. LEGALFRAMEWORK, REGULATORY STRUCTURE AND CONSTARINSCONCERNING SPS CONTROL SYSTEM IN UKRAINE........30 5.RECOMENDATIONS ...........................................................................................36 ANNEX I EU Legislative references, Directives, Decisions, Useful websites ...........38 ANNEX II Current sanitary and phytosanitary control rules in EU............................43 ANNEX III Table on special import conditions……………………………………..43 ANNEX IV EU Hygiene package legislation summary……………………………..45 ANNEX V Standart layut on SPS agreements.............................................................74 ANEEX VI EU-CHILE Agreemnt Annex IV on Sanitary measures applicable to trade in animals and animal products, plants, plant products and other goods……….........89


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ACRONYMS

AA Association Agreement AGCI Governmental Agency for International Co-operation (in Chile) FTA Free Trade Agreement ALADI All South American countries along with Mexico and Cuba CAP Common Agricultural Policy CEN European Committee for Standardisation CED Common Entry Document ( for non animal origin products) CENELEC European Committee for Electro-technical Standardisation CFIA Canadian Food Inspection Agency CODEX CODEX Alimentarius (standard-setting body for food safety) CVED Common Veterinary Entry Document DCI Instrument for Development Cooperation EA MLA European Cooperation for Accreditation Multilateral Agreemen ECAs Economic Complementation Agreements EEA European Free Trade Association EA MLA European Cooperation for Accreditation Multilateral Agreemen EFSA European Food Safety Authority EFTA European Free Trade Association ENP European Neighbourhood PolicyEPPO European and Mediterranean Plant Protection Organisation EU European Union FAO Food and Agriculture Organization of the United Nations FVO Food and Veterinary Office for European Commision GATS General Agreement on Trade in Services GATT General Agreement on Tariffs and Trade GDP Gross domestic Product GI Geographical Indication GPT General Preferential Tariff HACCP Hazard Analysis Critical Control Point regulations HS Harmonized Commodity Description and Coding System IAF International Accreditation Forum ILAC International Laboratory Accreditation Cooperation IP Intellectual Property


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IPPC International Plant Protection Convention

ISO International Organisation for Standartization

ISPM 15 International Standard for Phytosanitary Measures No.15 MEPNR Ministry of Environmental Protection and Natural Resources of Ukraine

MERCOSUR "Common Market of the South “ Chile, Bolivia, Colombia, Ecuador, and Peru

MRL Maximum Residue Level NAAU National Accreditation Agency of Ukraine NAFTA North American Free Trade Agreement NPPA National Plant Protection Authority OIE World Organization for Animal Health POAO Products of Animal Origin PCA Partnership and Co-operation Agreement RASFF Rapid Alert System for Food and Feed R&D Research and Development RPPO Regional Plant Protection Organizations RTA Regional Trading Agreement S&DT Special and Differential Treatment SME Small and Medium-Sized Enterprise SPS Sanitary and Phytosanitary Measures TBT Technical Barriers to Trade TRACES Trade Control and Expert System TRIMs Agreement on Trade-Related Investment Measures TRIPs Agreement on Trade-Related Aspects of Intellectual Property Rights TRQs Tariff Rate Quotas TRTA Trade Related Technical Assistance UEPLAC Ukrainian-European Policy and Legal Advice Centre UR Uruguay Round WHO World Health Organization WTO World Trade Organization


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1. FOREWORD

This Analytycal paper entitled „Analysis of the EU requirements concerning sanitary and phytosanitary measures and their implementation in Ukraine” has been written by the joint effort of the experts of the Ukrainian-European Policy and Legal Advice Centre per request of Ukrainian partners as part of the Project „Ukrainian-European Policy and Legal Advice Center-PHASE V”. It was prepared to serve as an information source on the legal framework of current sanitary and phystosanitary measures in EU applicable to trade in animals and animal products, plants and plant products and other goods. In practical terms, the information provides the analytical support to the Cabinet of Ministers and the Ministry of Economy of Ukraine in capacity building of management of SPS requirements that can serve as a basis for policymaking, priority setting, and regulatory approximation in order to be in line with WTO Sanitary and phytosanitary Agrement and what is more important of the EU Legislation. This Paper is divided into four main sections. The first three subsequent chapters deal with the following analyses: European Union Free Trade Agreements and legal framework of the sanitary and phyto-sanitary measures, notably: the legislative framework of food hygiene and food safety, animal health; plant health and wood packaging material; legislative framework on import controls and EU import control procedures on animals and products of animal origin, plants and plant products and non- animal origin products; desription on general rules on Sanitary and phytosanitary measures in accordance with WTO and analysis of EU FTA in force, namely EFTA-EU, EU-CHILE and EU- SWITZERLAND Agreements SPS provisions; analysis on legal framework, regulatory structure and constrains concerning SPS Control system in Ukraine. The last section contains recommendations and finally Annexes contains list of useful references whith more detailed information on the issues, the Glossary of terms, the summary of Special Import conditions, as well as a practical example with EU-Chile SPS agreement and other useful documents. However, the main focus is on legal and institutional implications which are likely to arise from implementation of particular commitments by Ukraine in the future Association Agreement and deep Free Trade Area as its core part. The present document aims to assist all players in the food chain to better understand and to apply correctly and in a uniform way the SPS legislation. It should also be remembered that this survey was drawn up in a rather short period of time in order to respond to the request of the Ministry of Economy of Ukraine. We nevertheless hope that it will serve its purpose well.


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2. EU FTA AND THE ECONOMIC AND LEGAL FRAMEWORK OF THE SANITARY AND PHYTOSANITARY MEASURES

2.1. EU LEGISLATIVE FRAMEWORK OF FOOD HYGIENE AND FOOD SAFETY, ANIMAL HEALTH

The EU integrated approach to food safety aims to assure a high level of food safety, animal health, animal welfare and plant health within the European Union through coherent farm-to-table measures and adequate monitoring, while ensuring the effective functioning of the internal market.

The implementation of this approach involves the development of legislative and other actions:

� To assure effective control systems and evaluate compliance with the EU standards in the food safety and quality, animal health, animal welfare, animal nutrition and plant health sectors within the EU and in third countries in relation to their exports to the EU;

� To manage international relations with third countries and international organisations concerning food safety, animal health, animal welfare, animal nutrition and plant health;

� To manage relations with the European Food Safety Authority and ensure science-based risk management;

� The majority of provisions in the EU feed and food legislation, animal health and animal welfare rules are based on provisions of the WTO Agreement on the Application of the SPS Agreement. Para 2 of Art.2 declares: “Members shall ensure that any sanitary or phytosanitary measure is applied only to the extent necessary to protect human, animal or plant life or health, is based on scientific principles and is not maintained without sufficient scientific evidence.” In other words it means that EU Member States have no right to maintain SPS Measures without sufficient scientific evidence.

The general principles are laid down in the so called general food law, i.e. Regulation (EC) No 178/20021 Hygiene and official control rules are then set in the following regulations:

- Regulation (EC) No 852/2004 2- Hygiene of foodstuffs - Regulation (EC) No 853/20043- Specific hygiene rules for food of animal

origin

1 Regulation EC/178/2002 of the European Parliament and of the Council of 28th January 2002 laying down the

principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety. Official Journal of the European Communities, Series L, issue 31, 1.2.2002, pages 1-24

2 Corrigendum to Regulation EC/852/2004 of the European Parliament and of the Council of 29th April 2004 on the hygiene of foodstuffs. Official Journal of the European Union, Series L, issue 226, 25.6.2004, pages 3-21

3 Corrigendum to Regulation EC/853/2004 of the European Parliament and of the Council of 29th April 2004 laying down specific hygiene rules for food of animal origin. Official Journal of the European Union, Series L, issue 226, 25.6.2004, pages 22-82

4 Corrigendum to Regulation EC/882/2004 of the European Parliament and of the Council of 29th April 2004 on

official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules. Official Journal of the European Union, Series L, issue 191, 28.5.2004, pages1-52.


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- Regulation (EC) No 882/20044 - Official Feed & Food Controls - Regulation (EC) No 854/20045 - Official controls on products of animal origin

intended for human consumption

Implementing rules and guidance documents have been adopted to complement these regulations. This is summarized in the chart below:

� Key Principles

The general food law introduces key principles: scientific basis and risk analysis, precautionary principle, protection of consumers' interest. The Regulation (EC) No 178/2002 sets general requirements regarding food safety requirements, the presentation of products, the responsibility of the different actors and the procedures to follow. The principle of scientific basis is reflected in the setting up of the European Food Safety Authority.

� Responsibilities of feed and food business operators according to the

Artt.17-20 of Regulation (EC) No 178/2002

According to the EU food law, the primary responsibility for food safety lies with feed and food operators. In particular, each feed and food business operator:

- is responsible for food safety of every food imported, produced, processed and placed on the market at his level;

5 Corrigendum to Regulation EC/854/2004 of the European Parliament and of the Council of 29th April 2004

laying down specific rules for the organisation of official controls on products of animal origin intended for human consumption. Official Journal of the European Union, Series L, issue 226, 25.6.2004, pages 83-127


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- has to identify hazards at every stage of the food chain, to prevent, to eliminate or to reduce such hazard at acceptable levels before products become available to consumers. Acceptable levels of hazards mens that such hazards have not potential to cause and adverse health effect;

- has to withdraw non-compliant food from the market and to inform consumers accordingly on its own expenses.

EU Member States ensure the surveillance and the control of these operators. Finally, the European Commission tests the performance of Member States' control capacities and capabilities through audits and inspections.

� Traceability principle

Regulation (EC) No 178/2002 introduces the obligation to ensure traceability, i.e. the ability to “trace and follow the route” of food, feed, food-producing animals and any other substance incorporated into food trough all stage of production, processing and distribution. This traceability principle implies the registration of all food business operators, including in the primary sectors, and the maintenance of adequate records.

� Risk analysis

Regulation (EC) No 178/2002 confirms the basis for the Rapid Alert System for Food and Feed, through which observed non compliance and food safety risks are communicated to competent authorities of the EU and to concerned third countries. Procedures to withdraw food from the market are also in place. If a food/feed business operator considers or has reason to believe that a food/feed which it has imported, produced, processed, manufactured or distributed does not satisfy the food/feed safety requirements, it shall immediately:

- initiate procedures to withdraw the feed/food in question from the market and inform the competent authorities thereof;

- in thesee circumstances, where the batch, lot or consignment does notsatisfy the food/feed safety requirements, that food/feed shall be destroyed, unless the competent authority is satisfied;

- effectively and accurately inform users of the reason for its withdrawal, and if necessary;

- recall from them products already supplied when other measures are not sufficient to achieve a high level of health protection.

Regulation (EC) No 178/2002 establishes in the EU law that the three inter-related components of risk analysis (risk assessment6, risk management7 and risk

6 Risk assessment means a scientifically based process consisting of four steps: hazard identification, hazard

characterisation, exposure assessment, risk characterisation. Risk assessment shall be based on the available scientific evidence and undertaken in an independent, objective and transparent manner.

7 Risk management means the process, distinct from risk assessment, of weighing policy alternatives in consultation with interested parties, considering risk assessment and other legitimate factors, and, if need be, selecting appropriate prevention and control options;


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communication8) provide the basis for food law as appropriate to the measure under consideration.

� Hygiene rules

The hygiene rules addressed to food business operators Regulation (EC) No 852/2004 and Regulation (EC) No 853/2004), include general hygiene requirements, notably:

- requirements for the primary production and associated operations, e.g. protection against contamination, animal health and animal welfare rules, facilities, cleanliness of animals, cleaning and disinfection, water supply, pest control, waste handling, feedstuffs, record-keeping;

- hygiene requirements for food premises, equipment, cleaning and disinfection, pest control programme, handling of waste, safe water supply, personal hygiene, raw materials, handling of food, wrapping and packaging of food, heat treatment, storage and transport requirements, training;

- compliance with microbiological criteria; - compliance with temperature control requirements for foodstuffs; - maintenance of cold chain; - sampling and analysis.

� Hazard Analysis and Critical Control Points

Food business operators must also implement procedures based on HACCP. HACCP procedures imply the identification, evaluation and control of hazards that are significant to food safety, in 7 steps that are conform to CODEX standards for HACCP:

- identification of hazards; - identification of critical control points that are essential to prevent of eliminate

a hazard or to reduce it to acceptable levels; - establishment of critical limits that separate acceptability from unacceptability;

for example Regulation (EC) No 2073/20059 Microbiological criteria lays down clear separation between acceptance and non-acceptance ;

- implementation of monitoring procedures at critical control points; - implementation of corrective actions when critical limits are reached; - establishment of procedures to verify that the above mentioned measures are

working effectively; - establishment of documents and records.

� Official controls

Rules on official feed and food controls, addressed to competent authorities (Regulation (EC) No 854/2004 and Regulation (EC) No 882/2004), set the framework for the official verification of compliance with feed and food law, animal health and

8 Risk communication means the interactive exchange of information and opinions throughout the risk analysis

process as regards hazards and risks, risk-related factors and risk perceptions, among risk assessors, risk managers, consumers, feed and food businesses, the academic community and other interested parties, including the explanation of risk assessment findings and the basis of risk management decisions.

9Commission Regulation EC/2073/2005 of 15th November 2005 on microbiological criteria for foodstuffs. Official Journal of the European Union, Series L, issue 338, 22.12.2005, pages 1-26.


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animal welfare, and lay down the principles for ensuring that official controls are objective and efficient. These rules notably deal with:

- auditing and inspection tasks of the official veterinarian (i.e.: ante and post mortem inspection, food chain information, animal welfare, laboratory testing);

- health marking; - frequency of controls; - professional qualification of official veterinarians and official auxiliaries.

� Microbiological criteria

Within the implementing rules, Regulation (EC) No 2073/2005 on microbiological criteria should be flagged out. This regulation sets harmonized microbiological criteria, process hygiene criteria as well as food safety criteria.

Process hygiene criteria indicate the acceptable functioning of the production process. When analyses show results that are not in line with process hygiene criteria, corrective actions must be defined by the operator in the HACCP programme, so as to improve production hygiene.

Food safety criteria define the acceptability of the products/batch placed on the market. When analyses show results that are not in line with food safety criteria, the products concerned must be withdrawn from the market or recalled, and corrective actions must be taken based on the HACCP programme.

� Principle of mutual recognition

The main principle of the single market concept is the “principle of mutual recognition” to ensure that all food products, whether produced in the EU or imported from a third country, can move freely throughout the EU if they comply with the requirements. There is one exception to this principle: certain directives allow Member States to make exceptions e.g. in cases where a country can prove public safety, health or environmental concerns about a product intended for import.

� Animal health rules

As regards to animal health rules, Council Directive 2002/99/EC10 laying down the animal health rules governing the production, processing, distribution and introduction of products of animal origin for human consumption has been applicable since 1 January2005, while Council Directive 2004/68/EC11 laying down animal health rules for the importation into and transit through the Community of certain live ungulate animals has been applied since 20 November 2005.

10 Council Directive 2002/99/EC of 16th December 2002 laying down the animal health rules governing the

production, processing, distribution and introduction of products of animal origin for human consumption. Official Journal of the European Communities, Series L, issue 18, 23.1.2003, pages 11-20.

11 Corrigendum to Council Directive 2004/68/EC of 26 April 2004 laying down animal health rules for the

importation into and transit through the Community of certain live ungulate animals, amending Directives 90/426/EEC and 92/65/EEC and repealing Directive 72/462/EEC Official Journal of the European Communities, Series L, issue139, 30.4.2004, p. 128–143


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� Third country approval procedure

The following sequence is generally followed (although it may vary according to the animal/product concerned):

1) The national authority submits a formal request for approval to the Commission services. This should include at least the following information:

a) Type of animal/product for which approval is sought. Full details of all

animal-origin products should be given; b) Anticipated volume of trade and main importing EU countries; c) Class of animals (e.g. breeding, fattening, slaughter) involved; d) Description of minimum treatment (heat, maturation, acidification etc.

applied to the products; e) Number and type of establishments considered to meet the EU

requirements12;2) Commission acknowledges request and sends the relevant pre-mission

questionnaire. 3) National authority submits completed questionnaire, with the proposed

residues monitoring programme for approval, and with copies of the national legislation applicable to the animals/products concerned (if English or French translations are provided this will speed up the processing of the dossiers).

4) Bilateral contacts between the national authorities and the Commission to resolve outstanding issues.

5) If the Commission is satisfied with the information provided, an on-the-spot inspection is (in most cases) organised by the FVO.

6) Following completion of the FVO inspection, a copy of its report is sent to the national authorities, the relevant Commission services, the European Parliament and the Member States. Reports of theFVO are also published on the website of DG SANCO http://ec.europa/eu/food/fvo/index_en.htm

7) If the outcome of the mission is satisfactory, and any other outstanding issues have been resolved, the Commission prepares draft legislation: a) to add the third country to the list of third countries from which imports of

the animal/product are approved; b) to draw up if necessary animal health certification based on the country or

part of the country’s health situation to accompany imports, (a number of model health certificates are already laid down in Community legislation);

c) to approve the residues monitoring programme;to set up an initial list of approved establishments13.

12 It should also include confirmation that all proposed establishments satisfy the EU requirements. References to the appropriate EU legislation must be given.

13 It must be noted however that the approval of residue programs, the adding a country on a list for animal health

purposes, the requirements for public health purposes and the listing of the approved establishments are done by different Commission services and often under different legal acts. Appearance in one of them is not a precondition for the inclusion on another list. For example the inclusion on the residue list does not affect in any way the possible inclusion on the animal health list. In this regard the third country can choose its approach as to how and in what order to launch applications for approval, some of their elements can be done parallel.


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8) The proposed legislative texts are adopted by the Commission, and published in the Official Journal, after a favourable opinion of the Standing Committee on the Food Chain and Animal Health has been received.

9) If an implementation date is not specified in the legislative text then it will be the date of official notification of the text by the Commission to Member States.

Generally it is advised to start with the animal health listing because usually this may be the most difficult to comply with, and it would not be cost effective to build a slaughterhouse and then discover that export of meat cannot be authorised for animal health reasons. 2.2. EU LEGISLATIVE FRAMEWORK OF PLANT HEALTH AND WOOD

PACKAGING MATERIAL

EU plant health legislation regulates the trade of plants and plant products within the EU as well as imports from the rest of the world in accordance with international plant health standards and obligations. A new Community plant health strategy is being developed. The first step is the launching of an evaluation of the current Community plant health regime (June 2009 - June 2010).

� Plant health regime

The Community plant health regime is established by Council Directive 2000/29/EC14.

The general principles are based upon provisions laid down in the International Plant Protection Convention concluded at the United Nation Food and Agriculture Organisation and, in the World Trade Organisation Agreement on Sanitary and Phytosanitary Measures.

� Obligations are placed upon third countries which want to export plants or plant products to the Community, notably:

EU requires all countries wishing to export to member states that they have a competent National Plant Protection authority (NPPA) capable of conducting phytosanitary inspection and certification prior to export.

� Phytosanitary certificate

Before they can be introduced into the Community, certain plants, plant products and other objects (listed in Part B of Annex V to Directive 2000/29/EC) must be accompanied by a phytosanitary certificate, issued by the National Plant Protection Organisation of the exporting country.

14 Council Directive 2000/29/EC of 8th May 2000 on protective measures against the introduction into the community of organisms harmful to plants or plant products and against their spread within the community. Official Journal of the European Communities, Series L, issue 169, 10.7.2000, pages 1-112


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Phytosanitary certificates should be issued conforming to the models set out under the International Plant Protection Convention, certifying that the plants, plant products or other objects:

− Have been subject to the appropriate inspections; − Are considered to be free from quarantine harmful organisms, and practically

free from other harmful organisms; − Are considered to conform to the phytosanitary regulations of the importing

country.

� Legislative Framework for wood packaging material

Commision Directive 2004/102/EC15 align Community measures with the FAO ISPM No 15 on "Guidelines for regulating wood packaging material in international trade" which was adopted in March 2002.

This Standard provides for the wood packaging material to be treated and to be marked.

� Technical requirements for wood packaging material

The technical requirements for wood packaging material include:

− a heat treatment or fumigation with methyl bromide ; − be made from debarked wood; − be marked with 3 codes (country, producer and measure applied) and the IPPC

logo.

2.3. EU LEGISLATIVE FRAMEWORK ON IMPORT CONTROLS

Sanitary and phytosanitary measures are "border control measures necessary to protect human, health, animal or plant life or health. Popularly they are often called

quarantine measures"16.

� The main the EU legislation on border import controls concerning public and animal health are Council Directives 91/496/EEC17 and 97/78/EC18. These two Directives set out the veterinary procedures to be followed in order to import

15 Commission Directive 2004/102/EC of 5 October 2004 amending Annexes II, III, IV and V to Council

Directive 2000/29/EC on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community Official Journal of the European Union, Series L, issue309, 6.10.2004, p. 9–25

16 Dictionary of Trade Policy Terms, Walter Goode, Centre for International Economic Studies University of Adelaide, 1998

17 Council Directive 91/496/EEC of 15 July 1991 laying down the principles governing the organisation of veterinary checks on animals entering the Community from third countries and amending Directives 89/662/EEC, 90/425/EEC and 90/675/EEC, Official Journal of the European Union, Series L, issue 268, 24.9.1991,

p 56

18 Council Directive 97/78/EC laying down principles governing the organisation of veterinary checks on products entering the Community from third countries, Official Journal of the European Union, Series L, issue 24, 30.01.1998, p 9


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into or transit through the EU commercial consignments of live animals and products of animal origin;

� In relation to animal health requirements, Council Directive 2002/99/EC19 requires that product consignments intended for human consumption and Regulation (EC) No 1774/200220 requires that product consignments not for human consumption have to fulfil animal health requirements;

All consignments of live animals and products of animal origin introduced into the territory of the EU must be presented at an EU approved border inspection post (BIP) to undergo mandatory veterinary checks. 2.4. EU IMPORT CONTROL PROCEDURES

In the EU the food hygiene import systems for food of animal origin (such as meat, fish and dairy products) are not entirely the same as for food of non-animal origin (such as fruit, vegetables) or as for food containing both ingredients of animal origin and plant origin etc.

This section aims to clarify in general procedures and with regard to food hygiene, the import systems for different food commodities, and in particular for:

- food of animal origin - food of non-animal origin.

Also system on import controls of plants and plant products and plant health is desribed. The detailed summary on current sanitary and phytosanitary import control rules on health inspections of animals and animal products, plants and plant products and non-animal products are listed in the Annex II. The main differencie between these commodities are the following:

- with regard to food of animal origin only a third country that appears on list established by the Community can export to the EU,

- with regard to food of non-animal origin, third countries do not need to appear on a list for being eligible for export.

The procedural aspects of the entry of consignments of live animals and animal origin products are mainly the responsibility of the importer or as it is often the case, shared between importer, exporter and transporter including perhaps other agents, it must be mentioned that live animal consignments need to be pre-notified to the BIP 24 hours before arrival and product consignments before arrival in the BIP with the first part of the so-called common veterinary entry documents filled in as appropriate as presribed in the Commission Regulationc (EC) No 136/200421 and 282/200422.

19 Council Directive 2002/99/EC of 16 December 2002 laying down the animal health rules governing the production, processing, distribution and introduction of products of animal origin for human consumption, Official Journal of the European Union, Series L, issue 18, 23.01.2003, p 11

20 Regulation (EC) No 1774/2002 of the European Parliament and of the Council of 3 October 2002 laying down health rules concerning animal by-products not intended for human consumption, Official Journal of the European Union, Series L, issue 273, 10.10.2002, p 1

21 Commission Regulation (EC) No 136/2004 of 22 January 2004 laying down procedures for veterinary checks at Community border inspection posts on products imported from third countries, Official Journal of the European Union, Series L, issue 21, 28.1.2004, p. 11–23


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2.4.1. Import control procedures on animals and animal origin products

� List of products to be subjected to veterinary checks

Commission Decission 2007/275/EC23 lays down rules regarding the animals and products to be subjected to veterinary checks at border inspection posts on introduction into the Community, in accordance with Directives 91/496/EEC 24and 97/78/EC.

� Border inspection facilities

The facilities and equipment at the BIP have to meet very precise hygiene and ergonomic criteria for the handling of animals and products, as laid down in Commission Decision 2001/812/EC.25 BIPs are placed under the authority of official veterinarians, who are effectively responsible for health checks on incoming consignments.

� Documentary, identity and physical checks

The health requirements are defined by Community rules which are described in Chapter I and Annex IV Table on hygiene package legislation summary for each sector of animal production; establish lists of approved third countries, lists of approved establishments and specimen official health certificates. All consignments are subject to a documentary and identity checks, i.e. 100 % of consignments imported are inspected at their first point of entry to the Community. A physical check including laboratory analyses may be carried out at a frequency determined by Community rules: checks may be reduced or increased, on the basis of the health information distributed in the European Union.

� Reduced physical checks regime

In addition physical checks are carried out, the percentage of which is depending on the harmonisation status of the third country of origin as specified in Commission Decision 94/360/EC26. The physical check cannot be reduced for products originating 22 Commission Regulation (EC) No 282/2004 of 18 February 2004 introducing a document for the declaration of,

and veterinary checks on, animals from third countries entering the Community, Official Journal of the European Union, Series L 49, 19.2.2004, p. 11–24

23 2007/275/EC: Commission Decision of 17 April 2007 concerning lists of animals and products to be subject to controls at border inspection posts under Council Directives 91/496/EEC and 97/78/EC, Official Journal of the European Union, Series L 116, 4.5.2007, p. 9–33

24 Corrigendum to Council Directive 91/496/EEC of 15 July 1991 laying down the principles governing the organization of veterinary checks on animals entering the Community from third countries and amending Directives 89/662/EEC, 90/425/EEC and 90/675/EEC Official Journal of the European Union, Series L 141, 31.5.2008, p. 22–22

25 2001/812/EC: Commission Decision of 21 November 2001 laying down the requirements for the approval of border inspection posts responsible for veterinary checks on products introduced into the Community from third countries Official Journal of the European Union, Series L 306, 23.11.2001, p. 28–33

26 Commission Decision 94/360/EC of 20 May 1994 on the reduced frequency of physical checks of consignments of certain products to be implemented from third countries, under Council Directive 90/675/EEC, Official Journal of the European Union, Series L issue 158, 25.06.1994, p 41

22 Council Directive 96/23/EC of 29 April 1996 on measures to monitor certain substances and residues thereof in live animals and animal products and repealing Directives 85/358/EEC and 86/469/EEC and Decisions 89/187/EEC and 91/664/EEC, Official Journal of the European Union, Series L , issue 125, 23.5.1996, p. 10–32


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from third countries with specific risks (Annex III Table on Special Import conditions), for which a safe guard Decision is in place or for products for which a RASFF message has been sent; in these cases the consignment has to be stay in the BIP until the results of the physical checks including laboratory tests are available.

� Reinforced physical checks regime

Reinforced control testing rules are laid down in the Directive 97/78/EC and Decision 94/360/EC. According to Article 29.3 of the Directive 96/23/EC27, import controls are a means to verify the implementation of the residue monitoring plans of third countries. Annex III Table listing the current Special Import Conditions for the importation of products of animal origin into the European Union. As part of the physical check, a laboratory test may be carried out in accordance with the national monitoring plans of each MS to verify that the product does not contain any residues, contaminants, pathogens or other substances dangerous for animal and public health.

� Decision on consignment compliance with the EU import requirement

Inspections result either in a favorable decision on consignments admission to Community territory for free circulation, for transit to third countries or storage in specific approved warehouses or an unfavorable decision of return to the country of origin or destruction.

� Inspection certificate

At the end of the inspection, CVED is issued by the BIP and must be presented to the customs service when clearing customs. This final verification serves as a check that the consignment has been subjected to veterinary import control. 2.4.2. Import control procedures on plants and plant products

� List of plants and plant products which are to be subjected for phytosanitary control

Commission Decission 2000/29/EC Annex V part B lays down list of products which are to be subjected for phytosanitary control.

� Border inspection point facilities

As for animals and animal products, consignments of imported plants and plant products subject to phytosanitary inspection (for organisms which are harmful to plants) must all be presented at the first point of entry to the Community. Directive 98/22/EC28 laying down the minimum conditions for carrying out plant health checks

28 Commission Directive 98/22/EC of 15 April 1998 laying down the minimum conditions for carrying out plant health checks in the Community, at inspection posts other than those at the place of destination, of plants, plant products or other objects coming from third countries, Official Journal of the European Union, Series L, issue 126, 28.4.1998, p. 26–28


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in the Community of of plants, plant products or other objects coming from third countries.

� Lists of prohibited plants and products for compulsory check on import

Community rules, notably Commission Decission 2000/29/EC Annex III determine the list of plants whose import is prohibited, the list of plants and plant products subject to a compulsory check on import, as well as the harmful organisms which must be absent and the phytosanitary requirements which must be complied with. In certain cases rules, notably Commission Decission 2000/29/EC Annex IV lay down compulsory wording which must appear on the phytosanitary certificates of origin which accompany the consignment, and thus provide the guarantee that the phytosanitary requirements have been complied with.

� Documentary, identity and phytosanitary checks

All consignments of products which are subject to controls are subject to a documentary, identity and phytosanitary check at their first point of entry to the Community. The Commission Decission 2000/29/EC provide for the possibility of carrying out identity and physical checks at the destination, when the place of destination has approval from the services responsible for plant protection and the customs services.

� Sampling regime

The physical check may include the taking of samples for laboratory analysis at the border to send for laboratory investigations and may be carried out at a set frequency. This mechanism to reduce the frequency of inspections is optional for the Member States: the sectors (product/origin) and the percentage of frequency reduction are determined annually at Community level.

� Inspection certificate

Inspections result either in a favorable decision on admission to Community territory, or an unfavorable decision of return to the country of origin or destruction. At the end of the inspection, national rules provide for the issue of a phytosanitary laissez-passer by the Community point of entry which must be presented to the customs service.

� Measures of non compliance

In case of non compliance at import, one or several of the following measures shall be taken immediately:

• Refusal of entry into the Community of all or part of the consignments; • Movement, under official supervision, in accordance with the appropriate

customs procedure, during their movement within the Community, to a destination outside the Community;

• Removal of infected/infested produce from the consignments; • Destruction,


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• Imposition of a quarantine period until the results of the examinations or official tests are available;

• exceptionally and only in specific circumstances, appropriate treatment where it is considered by the responsible official body of the Member State that, as a result of the treatment, the conditions will be fulfilled and the risk of spreading harmful organisms is obviated; the measure of appropriate treatment may also be taken in respect of harmful organisms not listed in Annex I or Annex II of Council Directive 2000/29/EC.

Member States must notify the Community and the other Member States of any such consignments and the measures taken.

2.4.3. Import control procedures on non- animal origin products or food

Food is defined in Article 2 of Regulation (EC) No 178/2002. ‘Food’ means any substance or product, whether processed, partially processed or unprocessed, intended to be, or reasonably expected to be ingested by humans. ‘Food’ includes drink, chewing gum and any substance, including water, intentionally incorporated into the food during its manufacture, preparation or treatment. It includes water after the point of compliance as defined in Article 6 of Directive 98/83/EC29 and without prejudice to the requirements of Directives 80/778/EE30C and 98/83/EC. 2.4.3.1. Intended for human consumption

Food of non-animal origin includes items such as fruits, vegetables, cereals, tubers, drinks, (apart from drinks prepared from products of animal origin such as milk and certain milk based drinks), food of mineral origin (such as salt), spices, condiments etc.

� Control system

The physical and documentary checks carried out pursuant to Article 15 of Regulation (EC) No 882/2004 on non-animal foodstuffs are generally carried out on a random basis on the internal market at all points in the food chain.

� Increased control system

Increased controls are currently carried out pursuant to specific Community decisions and are not systematically subject to the establishment of inspection certificates (this is, however, the case for the increased controls on aflatoxins pursuant to Decision (EC) No 2006/504/EC 31

� Arrangements for increased level of control

29 Corrigendum to Council Directive 98/83/EC of 3 November 1998 on the quality of water intended for human consumption, Official Journal of the European Union, Series L, issue 111, 20.4.2001, p. 31–31

25 CORRIGENDUM TO: 80/778/EEC: Council Directive of 15 July 1980 relating to the quality of water intended for human consumption Official Journal of the European Union, Series L, issue 224, 3.9.1993, p. 35–35

31 On special conditions governing certain foodstuffs imported from certain third countries due to contamination

risks of these products by aflatoxins


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The arrangements for increased controls will be harmonised by the Commission Regulation (EC) No 669/2009 32 in the following way: mandatory pre-notification, application of a control frequency, issuing of an inspection certificate CED. That regulation will be applicable from 15 January 2010. The checks could be split between the first Community point of entry (documentary check) and a consignment site within the territory (identity and physical check).

� List of sensitive products

The Regulation establishes a list of products which, on the basis of information available (RASFF notifications, reports by the Commission's FVO, information provided by Member States, by third countries, by the EFSA) are to be submitted to such increased level of controls by the Member States' competent authorities when entering the Community.

It is to be noted that the list of products will be regularly reviewed (quarterly) and updated as appropriate. 2.4.3.2. Intended as animal feed Under Directive 95/53/EC 33, controls in the Member State of introduction with the issuing of an Annex A document (to certify that the control has been carried out) are mandatory only where the consignment is intended to be placed on the market in another Member State. 3. ANALYSIS OF THE EU SELECTED FTA AGREMENTS IN FORCE, NAMELY OF THEIR PROVISIONS ON SPS TERMS IN THE RELEVANT MARKET ACCESS MECHANISMS APPLIED

3.1. General rules on sanitary and phytosanitary measures

Sanitary and phytosanitary measures are any measure applied: − to protect animal or plant life or health within the territory of a country from

risks arising from the entry, establishment or spread of pests, diseases, disease-carrying organisms or disease-causing organisms;

− to protect human or animal life or health within the territory of a country from risks arising from additives, contaminants, toxins or disease-causing organisms in foods, beverages or Feedstuffs;

− to protect human life or health within the territory of a country from risks arising from diseases carried by animals, plants or products thereof, or from the entry, establishment or spread of pests; or

− to prevent or limit other damage within the territory of a country from the entry, establishment or spread of pests.

32 Commission Regulation (EC) No 669/2009 of 24 July 2009 implementing Regulation (EC) No 882/2004 of

the European Parliament and of the Council as regards the increased level of official controls on imports of certain feed and food of non-animal origin and amending Decision 2006/504/EC OJ L 194, 25.7.2009, p. 11–21

33 The provisions of which are still in force pending the new measures for implementing Regulation (EC) No 882/2004.


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Sanitary or phytosanitary measures include all relevant laws, decrees, regulations, requirements and procedures including, inter alia, end product criteria; processes and production methods; testing, inspection, certification and approval procedures; quarantine treatments including relevant requirements associated with the transport of animals or plants, or with the materials necessary for their survival during transport; provisions on relevant statistical methods, sampling procedures and methods of risk assessment; and packaging and labeling requirements directly related to food safety. Sanitary and phyto-sanitary standards are drawing increasingly more attention within the framework of international trade. SPS control measures are designed to prevent any harm imports could cause to consumer health and safety. At the same time, restrictions imposed in order to achieve national safety standards could be abused as a means of protectionism. The WTO primarily concerns itself with tariffs, which serve as traditional instruments of protectionism. However, international agreements on SPS are aimed at finding a balance between national standards for product safety and fair market access.

� The WTO agreement on SPS contains a set of key provisions for more details see Annex V

− First, member countries are free to choose the level of protection they find appropriate and also to set out measures to achieve a target level of protection;

− Second, the agreement’s harmonization requirement envisages that national standards be based on standards approved and recommended by international organizations. Any stricter measure has to be grounded on scientific risk assessment;

− Third, an equivalence principle34 is recommended for various measures that achieve a similar protection level. An exporting country must demonstrate that its measures are equivalent to those in the importing country:

- Other important provisions of WTO SPS agreemnt refer to a regionalization concept envisaging that safety identification must take note of regional peculiarities, particularly regional diseases, or control programs set up in certain regions.(This concept is especially crucial for Ukraine in the aftermath of the Chornobyl disaster.) Finally, procedural provisions deal with transparency issues, particularly requirements envisaging the introduction of ways to formulate inquiries and informing.

Bilateral agreements are for the most part focused on procedural issues, whereas the WTO establishes the basis for stipulating norms and standards. Free trade agreements with the EU usually foresee provisions designated to make the introduction of WTO provisions on SPS easier. These can be done through:

1) the step-by-step introduction of SPS measures foreseen by the WTO; 2) harmonization, which means compliance with WTO standards and mutual recognitions of provisions.

Provisions on SPS usually cover the following aspects in free trade agreements: 34 Bilateral and multilateral agreements known as “equivalence agreements” or “mutual recognition agreements”

provide institutional frameworks for equivalence. Such agreements offer a basis for the interchange of information on standards, certification recognition, and provisions on repeated testing, appeal and the return of rejected products


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• recognition of agreements on SPS with the WTO; • cooperation on SPS issues; • harmonization of standards as an ultimate aim; and • clear provisions on technical assistance on SPS issues.

Beyond WTO provisions, free trade agreements may, for instance, refer to such aspects as:

• provisions or amendments on particular products; • establishment of a joint management committee; • a process of equivalence recognition worked out in detail; • methodology for verification, import checks and certification; • a timetable and provisions on internal accountability and consultations; • requirements on data exchange; • provisions recognizing specific establishments without prior inspection.

� EU Legal basis as regard of the SPS Agreement

The legal basis is double: - The first is Article 133 of the EC treaty that confers on the Commission, on

mandate from the Council, the powers to implement the Common commercial policy, including International Treaties;

- The second is Decision 94/800/EC of the Council that approved, on behalf of the European Community The Final Act of the Uruguay Round of Multilateral Trade Negotiations.This act includes the “Agreement on the Application of Sanitary and Phytosanitary Measures” also known as the SPS Agreement.

In accordance with WTO Agreement on the application of SPS Measures the standard agreement layout consists from 14 articles and three annexes. The detailed text is available on Aneex V 3.2. EFTA-EU FTA and its SPS provisions

Background information

� EFTA

The European Free Trade Association was founded in 1960 for the promotion of free trade and economic integration to the benefit of its four Member States: Iceland, Liechtenstein, Norway and Switzerland. http://www.efta.int/content/eea/EURelations/EEAInfo

The Associatoon is responsible for the management of:

• The EFTA Convention, which forms the legal basis of the organisation and governs free trade relations between the EFTA States;

• EFTA’s worldwide network of free trade and partnership agreements; • The European Economic Area Agreement, which enables three of the four

EFTA Member States (Iceland, Liechtenstein and Norway) to participate in the EU’s Internal Market.

� EEA Agreement


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The Agreement on the European Economic Area, which entered into force on 1 January 1994, brings together the 27 EU Members and the EFTA countries in a single internal market, referred to as the “Internal Market”. Switzerland is not part of the EEA Agreement, but has a bilateral agreement with the EU.

Full text with EEA agreement is possible to find http://www.efta.int/content/legal-texts/eea

� The structure of the EEA Agreement

The EEA Agreement is made up of 129 articles as well as 22 annexes and 49 protocols. The annexes refer to the acquis communautaire applicable in the EEA. The protocols include provisions on specific areas such as rules on the origin of goods, transition periods for the EEA EFTA States in certain fields, and simplified customs procedures.

� What is in an EFTA Free Trade Agreement?

All EFTA FTAs cover trade in industrial products, including fish, and processed agricultural products. They include trade disciplines as well as rules on competition, protection of intellectual property and payments and transfers. Bilateral arrangements between the individual EFTA countries and the respective partner countries cover trade in basic agricultural products. Since 2000, EFTA FTAs with a number of partners also contain substantive rules liberalising trade in services, investments and public procurement.

� Different Levels of Economic Development

EFTA FTAs take into account the partner countries’ different levels of economic development, sometimes leading to an asymmetrical approach. While the EFTA States normally abolish all tariffs and other restrictions on industrial products at entry into force of the agreement, less economically developed partner countries may benefit from transition periods. These periods are intended to provide the partners with the necessary time to adapt their economies to free trade conditions.

� EFTAs Joint Declarations on Co-operation

In addition to the Free Trade Agreements, the EFTA States have concluded several Joint Declarations on Co-operation. These agreements can be the first step towards free trade relations between the partners concerned. EFTA has Joint Declarations on Co-operation with the following countries: Albania, Algeria, Mauritus, MERCOSUR, Mongolia, Peru, Serbia, and Ukraine.

SPS provisions in terms of the relevant market access mechanisms applied

Products covered by the EEA-Agreement are e.g.: seeds, feeding stuffs, animals and animal products, aquaculture animals and products thereof. The EEA -Agreement is the basis for import from third countries to the EEA/EFTA States in the covered areas. However there is a difference in the application of the EEA/EFTA Member States in this area.


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� Import of products of animal origin

The general principle is that authorised third countries and third country establishments must comply with the EU rules based on :

- the animal health situation; residue, contaminants and additives controls; food safety standards in processing establishments; BSE-related import controls ; national authority standards; animal welfare provisions; health certification; border controls upon entry to the EU.

� The phytosanitary field

Not full harmonization since plant health is not part of the EEA Agreement. However the legislation is for the major part consistent with the EU legislation.

Since Iceland, Norway and the EU are parties to the IPPC, the legislative requirements are subject to the international standards spelled out the Convention.

Norway Norway is fully harmonized in the fields covered by the EEA Agreement. This includes that Norway can:

- Participate in Committees – Working Groups and Standing Committees (”SCFCAH”);

- Has right to speak – but not to vote; - Common legal situation ; - No border controls; - Common external border vs. 3. countries

Norway is fully harmonized with the EU which means that they apply all the same legislation as the EU when it comes to food law, food safety in this case Regulation (EC) 178/2002. Followed up with Regulation (EC) 882/2004 which concerns official control performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules. Also in this regard the so called hygene package.

• Requirements regarding Salmonella

As part of the EEA agreement Norway has the same legislation as Sweden and Finland regarding specific and all imported consignments must have special Salmonella certificate. Liechtenstein Liechtenstein is not fully harmonized for products of animal origin and for plants/seeds. Chapter I, "Veterinary issues" in the EEA Agreement shall not apply to Liechtenstein. For products covered by Chapter II, Feedingstuffs, and Chapter III of Annex I, Phytosanitary matters, Liechtenstein may apply Swiss legislation deriving from its


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regional union with Switzerland on the Liechtenstein market in parallel with the legislation implementing the acts referred to in those Chapters. Iceland Iceland is only partly harmonized for products of animal origin – Iceland makes therefor its own risk assessment for the products concerned. Island have a different sanitary status due to long time isolation of the. Import requirements for meat and meat products, eggs, dairy products and other products carried out by the Agricultural Authority of Iceland.

The Island has never experienced food and mouth disease, BSE, Newcastle disease, avian influenza etc.

- The Food and Veterinary Authority of Iceland Regulation 509/2004 Article 5 Specify the raw material imports, notably which are listed under HS numbers: 0202, 0203, 0204, 0207, 0208, 0210 and 1602 and which have not received satisfactory heat treatment shall be accompanied by the following certificates:

- official certificate of origin and health; - official certificate certifying that the source animals of the products have not

been given growth-promoting substances during their breeding period; - official certificate certifying that the products have been stored at a

temperature of at least –18° C for one month prior to customs clearance; - official certificate certifying that the source animals of the products were

slaughtered in slaughterhouses and the products processed in processing plants authorized by the European Communities, Member States of the European Economic Area or authorities of the United States for export and/or sales within the respective association of states;

- official certificate certifying that the products are free of salmonella bacteria; - animal meat and by-products, dairy products and eggs shall conform to the

appropriate provisions of current regulations on food contaminants; - the product shall be labelled in conformity with the current Regulation on the

Labelling, Advertising and Promotion of Foodstuffs. 3.3. EU-CHILE FTA and its SPS provisions

� Background information

The Association Agreement between the European Community and its Member States, of the one part, and the Republic of Chile, of the other part, was signed in Brussels on 18 November 2002. The Agreement entered into force on 1 March 2005, although some parts, namely the provisions on trade in goods, had been applied on a provisional basis since 1 February 2003.35 The services aspects of the Agreement were notified under GATS Article

35 At the time of entry into force, ten new countries had joined the Agreement, as new members of the European

Communities. These countries are: Cyprus, the Czech Republic, Estonia, Hungary, Latvia, Lithuania, Malta, Poland, the Slovak Republic and Slovenia. On 1 January 2007, Bulgaria and Romania also acceded the Agreement as new members of the European Communities. In light of the accession of Bulgaria and Romania


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V:7(a) on 28 October 2005 as an agreement providing for the liberalization of trade in services within the meaning of Article V of the GATS (S/C/N/360).36 The Council for Trade in Services referred the Agreement for examination in the CRTA on 9 February 2006 (S/C/M/81).37

Though this Association Agreement (please see goes beyond trade to cover political dialogue and cooperation, its trade provisions stand out as the most advanced in EU bilateral agreements to date. SPS provisions in terms of the relevant market access mechanisms applied

� Annexes

- The Association Agreement contains comprehensive annexes, of which Annex IV covers SPS measures applicable to trade in animals and animal products, plants, plant products and other goods, along with animal welfare;

- Annex V covers trade in wine. Both annexes reaffirm an overall commitment to WTO rules (Annex IV, Art. 42k and Annex V, Art. 26).

The substantive provisions on norms and standards follow those of the WTO. However, several procedural rules make this agreement different and more detailed than the other FTAs. For more detailed information please see Annex VI.

� Technical assistance

Technical assistance is specified for SPS-related matters and is included within the provisions on support for the agricultural and rural sectors (Art. 24.2g). Another aspect that makes the agreement unique compared with the others is the comprehensive provisions on equivalence integrated into Annex IV.

� Joint Management Committee

As in the Global Agreement, a joint committee, called the Joint Management Committee, is responsible for monitoring and control of the implementation of the agreement (Art. 16). Flexibility is provided by additional ad hoc groups that deliberate on SPS-related issues. These groups are made up of expert representatives of the parties or external experts.

� Information Exchange

As for information exchange, the agreement details specific information requirements for verification procedures, import checks and relevant scientific opinions (Art. 12). Further, detailed provisions ensure transparency by defining strict time schedules (Art. 8) and deadlines for the submission of required information. The agreement also

to the EU, an additional Protocol was signed on 24 July 2007 in Brussels. 36 The text of the services aspects of the Agreement was circulated as document WT/REG164/1/Add.1 and it is

also available at the Parties' official websites (URL addresses: http://www.direcon.cl/frame/acuerdos_internacionales/f_bilaterales.htm and http://ec.europa.eu/trade/issues/bilateral/countries/chile/euchlagr_en.htm). The Parties had previously notified the entire text of the Agreement on 3 February 2004 (WT/REG164/1).

37 The factual examination of the goods part of the Agreement was conducted in the CRTA; it concluded on 13 October 2006, after three rounds of examination (WT/REG164/M/1-3).


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foresees concrete steps for consultation when a party fails to comply with notification requirements (Art. 8.3).

� A safeguard clause

A safeguard clause reiterates WTO rules on implementing transitional SPS measures when scientifc evidence is insufficient (Art. 14). Acomprehensive article in Annex IV covers the determination and suspension of equivalence and considers time schedules for the consultation process between the parties (Art. 7). The provisions are supplemented by appendices with procedural details on the consultation process, the priority sectors concerned, and conditions for provisional approval of establishments (e.g. slaughter houses or processing establishments) without prior inspection by the importing party (appendices V and VI).

� Procedural relevance

Other appendices of procedural relevance provide guidelines for conducting verifications for import checks and inspection fees and for certification (appendices VII–IX). Also, the competent authorities are defined with regard to the implementation of the agreement (Appendix II). Besides these institutional provisions, the scope of SPS objectives is extended by a special focus on animal welfare standards concerning the stunning and slaughter of animals (Art. 2 and 3 and Appendix 1c). This follows the current policy of the OIE).

� Legal security for exporters

SPS provisions are more directly operational than those in the other agreements. Being an integral part of the FTA, they provide more legal security for exporters. 3.4. EU-SWITZERLAND FTA and its SPS provisions

� Background information

Key data: Date of signing: 21 June 1999 (in the framework of Bilaterals I) Approval by the electorate: 21 May 2000 (in the framework of Bilaterals I) Date effective: 1 June 2002.

The Agreement consists from 17 Articles and11 Annexes, notably the Annex 11 on animal health and zootechnical measures applicable to trade in live animals and animal products forms SPS measures applicable in EU-Switzerland FTA. Appendix 6 explains the rules for Border checks and Inspections fees. It is important to underline that Switzerland and the European Union have been

negotiating in the areas of agriculture, food-stuffs and health since November 2008. The aim is to open their respective markets to the en-tire agro food product chain as well as to improve cooperation in the areas of food safety, product safety and health protection. There have been three comprehensive negotiation rounds so far.


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SPS provisions in terms of the relevant market access mechanisms applied

� Annex 11, Appendix 6 Border checks and Inspections fees

The veterinary annex ensures that the legal requirements of the EU and Switzerland for the control of animal diseases are essentially consistent with each other and produce the same results. This then gives rise to comparable trading conditions between Switzerland and the EU Member States. With Decision 1/2008, the Veterinary Annex has been amended as follows:

• The border veterinary inspections in trade with the EU Member States has been abolished

• For imports from third countries, a Border inspection post (BIP) in conformity with the EU has been set up both at Zurich airport and at Geneva airport.

• Importation of hormone treated meat remains possible. • Animal transits through Switzerland remain banned • As from 1 January 2007, Swiss / EU harmonisation is applicable for all foods

of animal origin. Before this has already been the case for milk, milk products and also for animal by-products.

• The situation is monitored by the Joint Veterinary Committee to make sure the veterinary annex is properly implemented. As a rule, the committee meets once a year.

� Change in border inspections according to veterinary law

The border inspections enshrined in veterinary law were abolished on 1 January 2009 for trade between Switzerland and the EU. All tariff regulations and species conservation controls remain in force. Consignments from non-EU Member States are inspected on their first entry into the veterinary area of Switzerland and the EU and can be moved around freely thereafter. In Switzerland, appropriate facilities have been set up at the airports of Geneva and Zurich. At these inspection posts, Switzerland carries out an inspection for all goods according to the EU regulations. By the same token, the EU inspects consignments destined for Switzerland when they first enter an the EU Member State.

� Reduced level of physical checks

The European Commission is negotiating equivalence agreements with major trading partners. Once in place these are expected to reduce the level of checks on animal products from those countries, to below those set by 94/360/EC. EU currently have such agreements with Canada, Chile, New Zealand, Switzerland and USA. The agreements still require documentary checks on all consignments.The New Zealand agreement merges the identity and physical checks and substantially reduces the number of checks. The Canadian agreement requires 100% identity checks but reduces the level of physical checks below the levels in Commission Decision


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94/360/EC. Chile and USA are still on the 94/360 level of checks. Levels of checks for equivalence countries are laid down 97/78/EC Article 4(3). The Canadian Equivalence Agreement states that in the event of a frontier check revealing non-conformity with the relevant import requirements, importation will be based on an assessment of the risk involved.

4. LEGAL FRAMEWORK, REGULATORY STRUCTURE AND CONSTRAINS CONCERNING SPS CONTROL SYSTEM IN UKRAINE

4.1. Introduction/Legislative Framework The field of SPS measures covers rules of trade in animals and animal products, animal welfare; trade in plants and plant products, and food safety. Ukraine had consolidated all existing SPS provisions into three separate framework laws, i.e., a Law on Veterinary Medicine, a Law on Safety and Quality of Food Products, and a Law on Plant Quarantine, which are aimed to be the only laws governing SPS matters. The Law of Ukraine “On Quality and Safety of Food Products №771/97-ВР from December 23, 1997 as amended by Ukrainian Law on Changing the Law of Ukraine on the Safety and Quality of Food Products No 2809-IV on September 6, 2005, is a key legal act that regulates sanitary measure in Ukraine. The state veterinary and sanitary surveillance and control over economic agents’ activities related to slaughter of animals, processing, storage, transportation and distribution of animal products (raw materials, raw food and products, foodstuffs included) are implemented in accordance with the following Laws of Ukraine: “On Veterinary Medicine” No. 361-V of 16.11.2006 (with amendments); “On Liability of Enterprises, Institutions and Organizations for the Breach of Veterinary Medicine Legislation”; “On Quality and Safety of Foodstuffs”; “On Withdrawal from Circulation, Processing, Recycling, Disposal or Further Use of Defective and Dangerous Products”; also with rules, instructions, decrees and orders of the Chief State Veterinarian of Ukraine and with other legal regulations.

� The Law of Ukraine “On Veterinary Medicine” establishes the general framework for the operation of veterinary medicine and veterinary and sanitary quality and safety requirements to animal, or — in the case of products sold at public markets — also of plant products. The Law also provides for legal approximation with the EU legislation in the field of veterinary medicine and for unification of preventive, anti-epizootic measures and methods of animal disease detection.

� Phytosanitary measures implemented in Ukraine are regulated by: the Law of Ukraine “On Quarantine of Plants” No. 3349-XII of 30.06.1993 (as last amended by the Law of Ukraine N 3369-IV of 19.01.06); Statute of the State Phytosanitary Service of Ukraine, as approved by the Ministry of Agrarian Policy of Ukraine No. 310 of 08.05.07; Rules of Phytosanitary Border Control in Ukraine, and other regulations. The Main State Phytosanitary Inspection (UkrGolovDerzhKarantin) of the Ministry of Agricultural Policy of Ukraine


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has been assigned by the Government of Ukraine the competent state body in charge of phytosanitary regulation.

� Issues of protecting agricultural crops, other plants and vegetable products from pests, diseases and weeds are regulated by the Law of Ukraine “On Plant Protection” No. 180-XIV of 14.10.1998. The Law of Ukraine “On Pesticides and Agricultural Chemical Products” No. 87/95-BP of 02.03.1995 establishes the fundamental principles of the state policy on pesticides and agricultural chemical products. The priority of human health and environment protection over the economic effect of the pesticides and agricultural chemical products’ application is one of the principles. This Law accounts for principal provisions of the International Plant Protection Convention.

The Law of “On Quality and Safety of Foodstuffs” of 23.12.1997 is a key legal act, which establishes general requirements on quality and safety of foodstuffs and raw food products. 4.2. Regulatory structure Government agencies responsible for food safety, plant and animal health included, each within its own sphere of competence is:

- Ministry of Agrarian Policy (i.e., the State Service of Veterinary Medicine of Ukraine and the State Service of Plant Quarantine of Ukraine);

- Ministry of Health (i.e., the State Sanitary-Epidemiological Service of Ukraine);

- State Committee of Ukraine for Technical Regulation ad Consumer Policy; - Ministry of Environmental Protection and Natural Resources; - State Customs Service of Ukraine; - National Accreditation Agency; - National Commission of Ukraine of the Codex Alimentarius; - Food Safety Audit Agencies; - State Testing Laboratories.

4.2.1. Food Safety Sanitary Measures

At the present time, within the sanitary service, the administration of sanitary measures assuring the safety of foods for human consumption as well as control over facilities of their manufacture and circulation is within the State Sanitary and Epidemiological Service of Ukraine under the Ministry of Health.

Presently, mandatory food safety requirements of all imported/exported food products for human consumption and food raw materials are being reviewed to determine the degree of compliance or the need for further harmonization with the international food standards of the Codex Alimentarius Commission.

In addition, under the current legislation there are provisions for sanitary and veterinary inspectors to implement and exercise state supervision over the introduction of HACCP-based systems by food manufacturers. However, a move from the current inspection model based primarily on end-product testing towards a


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more audit-based approach raises a number of concerns given the lack of awareness of HACCP principles in the country, both among officials and private sector.

4.2.2. Animal Health

Under Ukrainian legislation, the state veterinary and sanitary control and surveillance are executed by the public administration authorities, namely by the State Departments for Veterinary and Sanitary Medicine of the Ministry of Agricultural Policy of Ukraine and local units thereof:

- the Veterinary and Sanitary Departments in the Autonomous Republic of Crimea,

- regions of Ukraine, - in the cities of Kyiv and Sevastopol, - regional centres, districts, and by specially appointed veterinarian officers

acting under authority of the State Department for Veterinary and Sanitary Medicine.

The State Department of Veterinary Medicine of the Ministry of Agricultural Policy of Ukraine has as long history of dedication to the protection of animal health and life in Ukraine. Traditionally, the animal health standards of the OIE are followed; specifically the OIE Terrestrial and Aquatic Animal Health Codes which give guidelines for all control measures that are adopted by OIE member countries.

The recent revision of import requirements for animals and animal products has brought animal health measures closer to full compliance with the SPS Agreement. Refinements to the import requirements will continue in order to account for the animal health status of Ukraine compared to its trading partners.

4.2.3. Phytosanitary Measures

The State Plant Quarantine Service develops, formulates and implements quarantine measures for protection of the Ukrainian territory from penetration and spread of dangerous harmful organisms on the basis of international phytosanitary standards and data from FAO international data bank.

- Items subject to quarantine may be imported into Ukraine provided the phytosanitary certificate issued by the state phytosanitary and plant protection authorities according to the international standard form established by the FAO;

- Importation of items subject to quarantine without such phytosanitary certificate from countries which have no state phytosanitary and plant protection authorities of their own may be allowed with preliminary issuance of import quarantine permit by the State Plant Quarantine Service.

Ukraine commenced the harmonization process for its phytosanitary measures with international standards, guidelines and recommendations of the IPPC and the relevant RPPO. Ukraine is a member of the IPPC and a member of EPPO. Harmonization of Ukrainian phytosanitary measures with standards, guidelines and recommendations of the IPPC and the RPPO commenced.


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Starting from 27 January 1994, the Main State Phytosanitary Inspection of Ukraine is a member of the EPPO, which unites more than 40 countries, EU Member States included. Phytosanitary measures taken in the member states of these international organisations are based on the EPPO international standards. The membership in this organisation provides Ukraine with a real possibility of obtaining up-to-date information on emergence and spread of new pests and other harmful organisms in countries of the European region and on changes and plant quarantine rules in EPPO member states.

- The phytosanitary certificate of export of items subject to quarantine outside Ukraine is issued according to the international standard form, as established by the EPPO;

- The list of harmful organisms subject to quarantine has been compiled based

on the relevant list prepared by the European Phytosanitary Organisation. Ukraine confirmed that, upon accession to the WTO, Ukraine would base all of its SPS measures on the Codex Alimentarius, OIE and IPPC standards, guidelines and recommendations in accordance with the requirements of the SPS Agreement. Other Regulatory State Structure related to the SPS 4.2.4. State Committee of Ukraine for Technical Regulation ad Consumer Policy The State Committee of Ukraine for Technical Regulation and Consumer Policy (Committee hereafter) – Derzhspozhyvstandart – is responsible simultaneously for development and approval of standards, including food standards, issuing certificates, conducting inspections of producers, and ensuring market surveillance and protection of consumer rights. The Committee is a member of the international organisations ISO (since 1993), IEC (since 1993), has an observer status in the CEN, and affiliate status at the CENELEC. According to the Decree of Cabinet of Ministers, assessment of

- products conformity with voluntary technical norms is delegated to non-state bodies

- while assessment of conformity with mandatory norms must be implemented exclusively through state agencies.

Currently the assessment is done through the UkrSEPRO state certification system covering about 120 bodies throughout Ukraine. The Commitee system includes three research and scientific centres, 28 regional centres for standardization, metrology and certification, and 27 territorial departments for consumer rights protection. The Committee has a network of 107 accredited product certifying bodies and six accredited certifying bodies for quality management systems, as well as 780 testing laboratories throughout Ukraine. 4.2.5. Ministry of Environmental Protection and Natural Resources The MEPNR through the State Ecological Inspection is responsible for radiological and environmental control. The environmental protection functions are executed by national, regional and local agencies. The main duty of MEPNR is to conduct


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environmental control at customs entry points in accordance with Ukrainian Legislation. 4.2.6. State Customs Service of Ukraine The State Customs Service of Ukraine is not a food safety regulatory agency. The main tasks of the State Customs Service are: support of implementation of the state policy in the customs sector; protection of economic interests of Ukraine; control over adherence of the Ukrainian customs legislation; using means of tariff and non-tariff regulation. Food and agricultural products can be imported or exported only through designated border points where appropriate control agencies have their officers, there is an approved the list of border crossing points for food and agricultural products. 4.2.7. National Accreditation Agency;

A Law of Ukraine “On accreditation of conformity assessment bodies” was ratified in 2001, thus established legislative, organizational and economical measures for accreditation of conformity assessment bodies in Ukraine.

In conformity with this Law, the Ministry of Economy of Ukraine created the National Accreditation Agency of Ukraine in 2001. Besides this, Accreditation Council, Technical committee for accreditation and Appeal’s Commission were created. The main functions of the National Accreditation Agency of Ukraine are accreditation of conformity assessment bodies and further control over conformance of accredited bodies to the accreditation requirements.

NAAU is set to play a major role in ensuring that Ukraine’s laboratories and certification agencies are recognized abroad by the EU and other countries; however NAAU is not a member of the EA MLA. This implies that certification, testing, and inspections of products by bodies accredited in Ukraine are not accepted abroad, requiring the re-examination of these goods by a foreign laboratory or certification body. Moreover, Ukraine is not a member of the IAF or a full member of the ILAC – it became only Affiliate but not full member in September 2004, the two principal international organizations for accreditation. Membership in these organizations enhances an accreditation body’s prospect for gaining international credibility. To join the IAF or ILAC, accreditation bodies must demonstrate that they operate at high international standards in areas covering operations, quality management systems, personnel, and equipment. 4.2.8. National Commission of Ukraine of the Codex Alimentarius

Ukraine joined FAO and Codex Alimentarius Commission. In particular, the National Commission on Codex Alimentarius was established in 1999. It is supposed to fulfil coordinating functions in the area of norm setting, regulation and standardisation of foodstuffs by their quality and safety indicators, as well as regarding fulfilment of FAO/WHO membership commitments of Ukraine. The Ministries of Public Health and Foreign Affairs have been included into the list of the central executive authorities responsible for fulfilment of commitments from Ukraine’s membership in international organizations, by the Resolution of the Cabinet of Ministers of Ukraine (CMU) No.1145 of 24 July 2003. These ministries are responsible for the issue of fulfilment of the Codex Alimentarius Commission


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membership commitments of Ukraine. At the same time, there are some important issues within the competence of the Commission, which are also dealt with by.13 the Ministry of Agricultural Policy and State Committee for Technical Regulation and Consumer Policy. Therefore, there are grounds to expect that the problem of delimitation of powers will be settled soon. 4.2.9. Food Safety Audit Agencies Unfortunately HACCP is just begging to be developed and implemented in Ukraine. There less than 2 percent of food industry enterprises are HACCP certified. All organizations that provide HACCP implementation and audit services in Ukraine can be divided into three groups:

- prominent international companies that offer full-scale services including consulting, training, testing, risk management, inspections, and certification according to international standards, that is highly credible within the EU and other developed economies;

- domestic private consulting companies; - DSSU certification bodies, which offer HACCP in its own version adopted as

DSTU 4661 national standard, sometimes using official status of the standard and various ways of influence producers as “competitive advantage” to other service providers.

4.2.10. State Testing Laboratories Ukraine has an extensive number of official food testing laboratories throughout Ukraine (about 2600). Due to the poor funding, planning and coordination their overall effectiveness and credibility is low as they are poorly equipped and staffed with under-qualified personnel in the majority of cases. The waste majority of Ukrainian testing laboratories are not internationally recognized by international trading partners and Ukrainian businesses that are exporting have to test their products again in the importing country. Due to this enormous number different Government laboratories of Ministry of Agrarian Policy, Ministry of Health Care, State Committee of Veterinary Medicine and DSSU are conducting tests by the very same laboratories which in most of the cases repeat the same test for all the different ministries/agencies to which they are accountable. Out of the total number of laboratories only 38 are accredited in accordance to ISO 17025 (as of October 12, 2007) which constitutes only 1.5 percent of the total number. 4.2.11. Some of the shortcomings and issues of the existing system

- Of the major issue that is related to the food safety and its implementation is the duplication of supervisory and controlling functions between the sanitary service, veterinary service and the State Standards Committee. Ukrainian food legislation does not set up clear distribution of responsibility. State bears the main responsibility for ensuring food safety;


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- Duplication of supervisory and controlling functions between the sanitary service, veterinary service, and the State Standards Committee persisted. Importers of food products continued to be required by Ukrainian authorities to complete multiple testing procedures in order to establish compliance with overlapping regulations of the veterinary service and the State Standards Committee. Further, the list of imported food products subject to mandatory certification by the State Standards Committee had not been eliminated despite Ukraine's assurances that it would be;

- Ukrainian food legislation applies a general intent principle vesting state controls bodies’ officials with an authority to decide whether an enterprise is an infringer and also to impose a fine upon this enterprise or apply other types of punishment;

- There are discrepancies between standard provisions, misunderstandings in jurisdiction, and, as a consequence, inefficient performance and gaps in control over food products;

- There is a very poor coordination at the national level as well as at the level of individual agencies monitoring food policy and controlling food safety:

- Laboratory testing. According to the Food Law, only accredited laboratories may conduct laboratory tests and studies of food products for evaluating their safety and quality. According to the information of the National Agency on Accreditation of Ukraine published on its official web-site, there are 37 accredited laboratories testing food products in Ukraine nowadays: 31 of them being laboratories of different State bodies and only 6 independent or companies’ accredited laboratories. There is a need of developing a wide range of independent laboratories as well as consensus at the level of Government to recognize equally the test results.

5. RECOMMENDATIONS

Approximation of Ukraine’s legislation with the EU SPS Directive and Regulations, implementation practice, and enforcement of such legislation in compliance with the acquis in the field of food safety will create a good basis for potential development and growth of the agricultural sector. It would require sustained political support to undertake significant structural reforms in the legislative, regulatory, institutional, and infrastructural spheres. Here are highlighted possible focus areas to continue and downstream the reform process:

- The biggest challenge for Ukraine is to make the step changes that are necessary to put in place a legislative basis for food safety that places primary responsibility for safety on business operators, and to move away from state control through technical standards and end-product testing;

- Ukrainian officials will need to conduct and overview the legal gap analysis consists of reviewing existing laws and regulations of Ukraine and identifying the provisions that must be amended in order to conform with the EU Directives and implementing measures, as well as areas not covered under the laws and regulations of Ukraine and where new laws and regulations must be prepared;


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- The process of Approximation with the EU Directives should continue and be supported in the framework of multi-year twinning programs between officials of Ukraine and the EU. These twinning programs could be followed-up and supported by other Donor and Financial organisation (USAID, World Bank and other countries);

- For Mutual Recognition of Ukrainian SPS Authorities with their Counterparts in the EU Member States it will need to enforce the EU Directives, as well need to achieve compliance with the EU standards of regulation and supervision. Compliance with the EU principles will be a sine qua non to achieve mutual recognition with counterpart regulatory agencies in the EU Member States that is required (http://ec.europa.eu/food/animal/bips/legis_en.htm)

- However, putting the legislative basis in place is one of the first steps. An implementation and enforcement strategy is also essential in order to create the environment in which Ukraine’s consumers and trading partners increase their confidence in the safety of Ukrainian products.


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ANNEX I

REFERENCES EU Regulations Commission Regulation EC/2076/2005 of 5th December 2005 laying down transitional arrangements for the implementation of regulations EC/853/2004, EC/854/2004 and EC/882/2004 of the European Parliament and of the Council and amending regulations EC/853/2004 and EC/854/2004. Official Journal of the European Union, Series L, issue 338, 22.12.2005, pages 1-26. Commission Regulation EC/2073/2005 of 15th November 2005 on microbiological criteria for foodstuffs. Official Journal of the European Union, Series L, issue 338, 22.12.2005, pages 1-26. Regulation EC/396/2005 of the European Parliament and of the Council of 23rd February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC. Official Journal of the European Union, Series L, issue 70, 16.3.2005, pages 1-16. Regulation EC/183/2005 of the European Parliament and of the Council of 12th January 2005 laying down requirements for feed hygiene. Official Journal of the European Union, Series L, issue 35, 8.2.2005, pages 1-22. Corrigendum to Regulation EC/854/2004 of the European Parliament and of the Council of 29th April 2004 laying down specific rules for the organisation of official controls on products of animal origin intended for human consumption. Official Journal of the European Union, Series L, issue 226, 25.6.2004, pages 83-127. Corrigendum to Regulation EC/853/2004 of the European Parliament and of the Council of 29th April 2004 laying down specific hygiene rules for food of animal origin. Official Journal of the European Union, Series L, issue 226, 25.6.2004, pages 22-82. Corrigendum to Regulation EC/852/2004 of the European Parliament and of the Council of 29th April 2004 on the hygiene of foodstuffs. Official Journal of the European Union, Series L, issue 226, 25.6.2004, pages 3-21. Corrigendum to Regulation EC/882/2004 of the European Parliament and of the Council of 29th April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules. Official Journal of the European Union, Series L, issue 191, 28.5.2004, pages 1-52. Regulation EC/178/2002 of the European Parliament and of the Council of 28th January 2002 laying down the principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of foosafety. Official Journal of the European Communities, Series L, issue 31, 1.2.2002, pages 1-24.


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Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC. Official Journal of the E uropean Communities, Series L, issue 309, 24.11.2009, pages 1-50.

Commission Regulation (EC) No 136/2004 of 22 January 2004 laying dowprocedures for veterinary checks at Community border inspection posts on products imported from third countries, Official Journal of the European Union, Series L, issue 21,28.1.2004, p. 11–23 Commission Regulation (EC) No 282/2004 of 18 February 2004 introducing a document for the declaration of, and veterinary checks on, animals from third countries entering the Community, Official Journal of the European Union, Series L 49, 19.2.2004, p. 11–24

EU Directives Commission Directive 2006/14/EC of 6th February 2006 amending annex IV to Council Directive 2000/29/EC on protective measures against the introduction into the community of organisms harmful to plants or plant products and against their spread within the community. Official Journal of the European Union, Series L, issue 34, 7.2.2006, pages 24-25. Commission Directive 2004/102/EC of 5th October 2004 amending annexes II, III, IV and V to Council Directive 2000/29/EC on protective measures against the introduction into the community of organisms harmful to plants or plant products and against their spread within the community. Official Journal of the European Union, Series L, issue 309, 6.10.2004, pages 9-25. Corrigendum to Directive 2004/41/EC of the European Parliament and of the Council of 21st April 2004 repealing certain directives concerning food hygiene and health conditions for the production and placing on the market of certain products of animal origin intended for human consumption and amending Council Directives 89/662/EEC and 92/118/EEC and Council Decision 95/408/EC. Official Journal of the European Union, Series L, issue 195, 2.6.2004, pages 12-15. Council Directive 2002/99/EC of 16th December 2002 laying down the animal health rules governing the production, processing, distribution and introduction of products of animal origin for human consumption. Official Journal of the European Communities, Series L, issue 18, 23.1.2003, pages 11-20. Council Directive 2000/29/EC of 8th May 2000 on protective measures against the introduction into the community of organisms harmful to plants or plant products and against their spread within the community. Official Journal of the European Communities, Series L, issue 169, 10.7.2000, pages 1-112. Corrigendum to Council Directive 2004/68/EC of 26 April 2004 laying down animal health rules for the importation into and transit through the Community of certain live ungulate animals, amending Directives 90/426/EEC and


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92/65/EEC and repealing Directive 72/462/EEC, Official Journal of the European Communities, Series L, issue 226, 25.6.2004, p. 128–143

Council Directive 91/414/EEC of 15th July 1991 concerning the placing of plant protection products on the market. Official Journal of the European Communities, Series L, issue 230, 19.8.1991, pages 1-194. Council Directive 79/117/EEC of 21st December 1978 prohibiting the placing on the market and use of plant protection products containing certain active substances. Official Journal of the European Communities, Series L, issue 033, 8.2.1979, pages 36-39. EU Commission Decisions Commission Decision 2005/85/EC of 26th January 2005 imposing special conditions on the import of pistachios and certain products derived from pistachios originating in, or consigned from Iran. Official Journal of the European Union, Series L, issue 30, 3.2.2005, pages 12-18. 2001/812/EC: Commission Decision of 21 November 2001 laying down the requirements for the approval of border inspection posts responsible for veterinary checks on products introduced into the Community from third countries Official Journal of the European Union, Series L 306, 23.11.2001, p. 28–33

Commission Decision 2005/85/EC of 26th January 2005 imposing special conditions on the import of pistachios and certain products derived from pistachios originating in, or consigned from Iran. Official Journal of the European Union, Series L, issue 30, 3.2.2005, pages 12-18. EU Commission Communications & White Papers COM (2000) 1 final Communication from the Commission on the precautionary principle. Commission of the European Communities, Brussels, 2.2.2000, pages 1- 28. COM (1999) 719 final. White paper on food safety. Commission of the European Communities, Brussels, 12.1.2000, pages 1-52. Guidance on the interpretation of EU food law Health and Consumer Protection Directorate General (2006) Guidance document on certain key questions relating to import requirements and the new rules on food hygiene and on official food controls. European Commission, Brussels, 5.1.2006, pages 1-28. Health and Consumer Protection Directorate General (2005) Guidance document on the implementation of certain provisions of Regulation EC/852/2004 on the hygiene of foodstuffs. European Commission, Brussels, 21.12.2005, pages 1-16. Health and Consumer Protection Directorate General (2005) Guidance document on the implementation of procedures based on the HACCP principles and on the facilitation of the implementation of the HACCP principles in certain food businesses. European Commission, Brussels, 16.11.2005, pages 1-27. Health and Consumer Protection Directorate General (2005) Guidance on the


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implementation of articles 11, 12, 16, 17, 18, 19 and 20 of regulation EC/178/2002 on general food law. European Commission, Brussels, 20.12.2004, pages 1-30. USEFUL WEBSITES Eur-lex: http://europa.eu.int/eur-lex/lex/RECH_menu.do?ihmlang=en official website offering plain text searches of the Official Journal, Legislation in force, Consolidated legislation, Community preparatory acts and treaties, documents can also be searched for by number within the sections. Official Journal: http://europa.eu.int/eur-lex/lex/JOIndex.do?ihmlang=en Official Journal series “L” for legislation and “C” for information and notices, document searches are most readily carried out by entering the regulation or directive reference number such as EC/852/2004. Legislation in force: http://europa.eu.int/eur-lex/lex/en/repert/index.htm organised into 20 chapters, 03 deals with agriculture (agriculture, biotechnology, organic farming, foodstuffs etc), chapter 15 covers environment, consumers and health protection. Consolidated texts: http://europa.eu.int/eur-lex/en/consleg/index.html Consolidated texts are useful because they present the text of the law with all amendments added thus saving a lot of time on cross-referencing. SCADPlus: http://europa.eu.int/scadplus/leg/en/s84000htm provides official EU summaries of legislation, sections include, controls and food hygiene rules, imports from third countries, specific provisions (all meat related) and production and placing on the market of foodstuffs. http://europa.eu/legislation_summaries/food_safety/index_en.htm EU Guidance documents: http://europa.eu.int/comm/food/food/foodlaw/guidance/index.htm Official guidance documents on food law, clarifying the requirements for food businesses. Health and Consumer Protection Directorate General (DGSANCO): http://europa.eu.int/comm/dgs/health_consumer/index_en.htm

DG SANCO is responsible for food safety and hygiene within the EU, and this website offers excellent coverage of food safety issues and global listings of EU approved countries, establishments and laboratories. EU MRL: Useful websites on pesticides – A selection of websites offering access to EU MRL’s, pesticide safety data and government testing programmes with results published on a quarterly basis. http://europa.eu.int/comm/food/plant/protection/pesticides/index_en.htm

Codex Alimentarius Commission: www.codexalimentarius.net provides access to electronic copies of all of the Codex Alimentarius Commission international


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standards, guidance documents and manuals consisting of combined texts developed jointly by the 154 member states of the Codex Alimentarius Commission. Codex maximum residue limits for pesticides and veterinary drugs are provided via user friendly databases that can be searched by commodity or compound. The Codex documents are the official reference texts for the WTO administered SPS and TBT agreements that set the framework for regulation of international trade. FAO International Portal on Food Safety, Animal and Plant Health (IPFSAP): www.ipfsaph.org/En/default.jsp The IPFSAP offers an alternative route for accessing Codex documents, but more importantly the portal has a searchable database of official documents (downloadable as PDF files) on SPS issues submitted by signatories to the WTO administered SPS and TBT agreements. These documentscan be invaluable for checking national regulatory requirements either within theproducer country or for checking the regulatory requirements for access to a newexport market

World Trade Organisation: www.wto.org provides access to copies of the SPS and TBT agreements that form the basis for harmonisation of international regulation of food safety, quality, and animal and plant health in global trade. WTO quarterly reports are also accessible covering trade and regulatory issues and disputes between members of the WTO

Import into the EFTA States

• Switzerland http://www.eda.admin.ch/eda/en/home.html• Iceland http://www.utn.stjr.is/• Norwayhttp://www.regjeringen.no/en/dep/ud.html?id=833• Liechtenstein

http://www.liechtenstein.li/en/eliechtenstein_main_sites/portal_fuerstentum_liechtenstein/home.htm

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ANNEX II

Current sanitary and phytosanitary control rules in EU

Health inspection of non-animal products

For human consumption

Health inspection of animals andanimal products

Plant health inspection of plants andplant products

For animal feedstandard inspection increased level of inspection

Regular bases Dir. 91/496 and 97/78 Dir. 2000/29 Reg. 882/2004, Article 15 Reg. 882/2004, Article 15 Reg. 882/2004, Article 15(5)Standard frequency systematic prior to customs clearance systematic prior to customs clearance

for plants, plant products and otheritems subject to checking (list)

by sample by sample At the frequency laid downby the Reg. EC 669/2009

Inspection carriedout

at first point of entry to EU at first point of entry to EU+ possibility of performing part of thecheck at destination

at all points in the food chain at all points in the foodchain

at first point of entry to EU

Declaration prior toarrival

compulsory compulsory non-compulsory non-compulsory compulsory

Inspection facilities border inspection post (BIP)conditions Dir. 91/496 and Dec.2001/812Community approval

point of entry to Community (PEC)conditions Dir. 98/22national approval

non-compulsorydesignated entry point (DEP)national approval

No Yes –point of entry (in thecase of professionals)

Standard doc.check

100% 100% 100% by sample At the frequency laid downby the Reg.669/2009

Standard identitycheck

100% 100% by sample by sample At the frequency laid downby the Reg.669/2009

Standard physicalcheck

variable, in accordance with ill-adapted rules Dec. 94/360

100% of consignments by sample by sample At the frequency laid downby the Reg.

Increased level ofinspection

Community rulesDir. 97/78

Community rules in draft form Yes

Inspectioncertificate

CVED in Reg. 136/2004 and Reg.282/2004

Plant health laissez-passer Annex A to Dir. 98/68 non-compulsory DCE

Fee Yes Yes No No YesImport monitoringplan

Yes Yes Yes Yes Yes

Information system Traces Europhyt

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Annex IIIList of Special Import Conditions for the importation of products of animal origin into the European Union:

Chemical risks

Country Issue Product Action Entryintoforce

Legal Reference

Albania Histamine Fishery products 100% testing of each import consignment by theMember States for histamine if those consignments arenot accompanied by a test certificate indicating that theycomply with Community levels for histamine.

4October

2007

CommissionDecision2007/642/EC

Bangladesh Residues ofveterinarymedicines

Crustaceous importedand intended for humanconsumption

Results of an analytical test carried out at origin, inparticular for the presence of chloramphenicol,metabolites of nitrofurans tetracycline, malachite greenand crystal violet in conformity with CouncilRegulation (EEC) No 2377/90 and CommissionDecision2002/657/EC

24 July2008


China Residues ofveterinarydrugs,pesticidescontaminantsand,prohibitedsubstances

Aquaculture fish andshrimps; crayfishRabbit meatPoultrymeat productsEggs and egg productsHoney and Royal JellyCasings

Pre-export testing and certification by the Chineseauthorities for chemical tests for chloramphenicol andnitrofuranes and its metabolites, additional foraquaculture fish products for malachite green, crystalviolet and their metabolites;

26 July2005

CommissionDecision2002/994/ECas amended

Gabon Heavy metalsandsulphites

Fishery products 100 % testing of import consignments by MS for heavymetals (as in Commission Regulations (EC) No1881/2006 and 333/2007) and for sulphites ( as inCouncil Directive 95/2/EC)

3 July2008

CommissionRegulation (EC)No 601/2008

India Residues ofveterinarymedicines

Crustacea ofaquaculture origin forhuman consumption

Pre-export testing and certification, in particular, with aview to detecting the presence of nitrofurans or theirmetabolites in conformity with Decision 2002/657/EC


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and animal feed respecting the Community Minimum RequiredPerformance Limit (MRPL) of 1 .g/kg

Indonesia Histamine andheavymetals

Fishery products – notfor aquacultureproducts

100% testing of each import consignment by theMember States for heavy metals, and, for theappropriate species, histamine.

21March2006

CommissionDecision2006/236/EC asamended

Mexico Residues ofveterinarymedicines

Horse meat and meatproducts

100% testing of each import consignment by theMember States for residues of hormonesand beta-agonists

16January

2006


Myanmar(no longer

listed in theannex to

2004/432/EC

Residues ofveterinarymedicines

Shrimps and fisheryproducts

100% testing of each import consignment of shrimps bythe Member States for residues of chloramphenicolCAVE: aquacultural shrimps prohibited as no residuecontrol plan

27March2002

CommissionDecision2002/249/E

Ukraine Residues ofveterinarymedicines

Milk powder orartificial milk replacermade from milkpowder, intendedfor animal nutrition

100 % testing of each import consignment of milkpowder or artificial milk replacer made from milkpowder, for residues, in particular for the presence ofchloramphenicol.

15October

2002



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ANNEX IV FOOD HYGIENE LEGISLATION SUMMARY

. FOOD HYGIENE PACKAGE AND ASSOCIATED LEGISLATION

Hygiene rules for businesses making or handling food of animal origin changed on the 1st January 2006. The new rules consolidated the sector specific requirements, with the output being that there is now a set of general hygiene regulations with which all business must comply and some specific requirements that vary depending on the type of product. Some foods that were previously subject to specific requirements for foods of animal origin are now only subject only to the more general requirements of the regulations. These are foods containing both products of plant origin and processed products of animal origin. It is no longer are requirement for premises that make such foods to be approved, or to put an identification mark on these foods. This is change is affecting the import requirements Many of the detailed import requirements were contained in the sector specific requirements, where these have been consolidated and decisions repealed.


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FOOD HYGIENE PACKAGE AND ASSOCIATED LEGISLATION

Commission Decision 2002/99/EC -Animal health rules Covers animal health rules for EU production and third country imports of POAOs for human consumption COMMISSION REGULATION (EC) NO 178/2002 -GENERAL PRINCIPLES OF FOOD AND FEED LAW

Lays down general rules governing food and feed especially. food and feed safety, establishes European Food Safety Authority. Covers all stages of production, processing and distribution including primary production (farm to fork) I. COMMISSION REGULATION (EC) NO 852/2004 - HYGIENE OF FOOD

Lays down general rules for food business operators on the hygiene of foodstuffs. Applies to all stages of production, processing and distribution of food II. REGULATION (EC) NO 882/2004 – OFFICIAL CONTROLS TO VERIFY

COMPLIANCE WITH FOOD AND FEED LAW, ANIMAL HEALTH RULES, ANIMAL WELFARE RULES

Lays down general rules for the performance of official controls to verify compliance with rules aiming to: • prevent, eliminate of reduce to acceptable levels risks to humans or animals either directly or

through the environment • guarantee fair practices in feed and food trade and protecting consumer interests, including feed

and food labelling and other forms of consumer information DIRECTIVE 2004/41 - REPEALS OLD PRODUCT-SPECIFIC DIRECTIVES

COMMISSION REGULATION (EC) NO 853/2004 –SPECIFIC HYGIENE RULES FOR

PRODUCTS OF ANIMAL ORIGIN

1. Lays down specific hygiene rules on POAOs for human consumption for food business operators, supplements Regulation (EC) No 852/2004. Does not apply to food containing processed POAOs and plant products; does not apply to retail

2. Commission Regulation (EC) No 854/2004 Organisation of official controls for the specific hygiene requirements covered by Regulation (No) 853/2004 (POAOs for human consumption)


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III. COMMISSION REGULATION (EC) NO 2073/2005 - MICROBIOLOGICAL CRITERIA AND IMPLEMENTING RULES. THESE APPLY AT POINT OF PRODUCTION, NOT AT POINT OF IMPORT

IV.

V. COMMISSION REGULATION (EC) NO 2074/2005 - (AMENDS REGS 852, 853, 854, 882/2004)

VI.

VII. COMMISSION REGULATION (EC) NO 2075/2005 - TRICHINELLA IN MEAT

VIII.

IX. COMMISSION REGULATION (EC) NO 2076/2005 – TRANSITIONAL ARRANGEMENTS

X. REGULATION OF EUROPEAN PARLIAMENT AND COUNCIL (EC) NO 183/2005

– FEED HYGIENE REQUIREMENTS


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Food hygiene legislation: How it works

Products of animal origin: Products of animal origin listed in Commission Decision 2007/275/EC of 17 April 2007 to be subject to controls at border inspection posts under Council Directives 91/496/EEC and 97/78/ EC Animal health requirements Council Directive 2002/99/EC of 16 December 2002 applies to all products of animal origin governing production, processing, distribution and introduction of products of animal origin for human consumption Public health requirements:Unprocessed POAOs and 100% processed POAOs subject to:

General Food Hygiene controls – Regulations (EC) No. 178/2002, 852/2004 and specific Food Hygiene controls – Regulation (EC) No. 853/2004

Processed POAOs mixed with plant products subject to: General Food Hygiene controls – Regulations (EC) No. 178/2002, 852/2004 only

Other import requirementsOther existing import legislation e.g. country-specific fish legislation, 79/542 (red meat), 2005/432 (meat products) continue to apply.

Summary of Hygiene Legislation Council Directive 2002/99/EE -Animal health rules

Reg 2073/2005:Microbiological

Criteria

REG 2074/2005:

IMPLEMENTATION

Reg 2075/2005 Trichinella in meat

Reg 2076/2005: Transition Rules

General Hygiene: A. REGULATION (EC)NO

852/2004

Specific Hygiene Law: B. REGULATION (EC) NO

853/2004

General Control Law: Regulation (EC) No 882/2004

Specific Control Law: Regulation (EC) No 854/2004

Food and Feed Safety Law Regulation (EC) No. 178/2002

Food of animal origin


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Animal health rules Entries in blue are those thought to be of interest or relevance to border control. COUNCIL DIRECTIVE 2002/99/EC -ANIMAL HEALTH RULES

Article 1: Scope - covers animal health rules for EU production and third country imports of POAOs for human consumption Article 2: Definitions: Products of animal origin = products obtained from animals and products obtained there from for human consumption incl. live animals CHAPTER I: Animal health requirements for production processing and distribution of POAOs in EU Articles 3 to 6 CHAPTER II: Imports from third countries Article 7: Import requirements must be equivalent to those for intercommunity production Article 8: – Imports must come from approved third countries. – Lists of third countries from which specific POAOs permitted to be established. – Criteria for approving third countries Article 9: Imports of POAOs must be accompanied by a veterinary certificate certifying relevant animal health conditions Article 10: Community inspections and audits in third countries CHAPTER III: Final provisions (Articles 11 to 16) ANNEXES: Annex I: List of control measures in EU for various animal diseases in Annex II: Special identification mark to be used for meat from affected areas in EU (health mark with X on it) Annex III: Treatments required eliminating the disease risk Annex IV: Principles of certification Annex V: Withdrawn legislation


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REGULATION (EC) NO 178/2002 - GENERAL PRINCIPLES OF FOOD AND FEED LAW

Covers products of animal origin and non-animal origin CHAPTER I: Scope and definitions

Article 1: Aim and scope: Lays down general rules governing food and feed esp. food and feed safety, establishes European Food Safety Authority; covers all stages of production, processing and distribution including primary production (farm to fork). Article 2: Definition of food – any substance or product intended or reasonably expected to be ingested by humans except feed, live animals (unless marketed for human consumption), plants prior to harvesting, medicinal products, cosmetics, tobacco, narcotics, contaminants and residues Article 3: Other definitions – feed (= feeding stuff), – risk analysis = risk assessment + risk management + risk communication (all defined); – food and feed business operators, includes transport and storage – retail – includes catering and wholesale outlets – placing on the market – holding for sale, distribution or any other form of transfer whether free

of charge or not – traceability – ability to trace food/feed/food-producing animal/substance intended to be

incorporated into food or feed through all stages of production, processing and distribution 1. CHAPTER II General Food Law

Article 4: Scope (i) Section 1: General principles of Food Law

Article 5: General Objectives: Food law to protect human health and protect consumer interest including fair practices in food trade Article 6: Risk analysis – food law to be risk-based Article 7: Precautionary principle to be used where risk assessment not possible. To be proportionate. Article 8: Food law to protect consumers interest (no fraud / deception / adulteration / other practices which may mislead the consumer) Section 2: Principle of transparency

Article 9: Open and transparent public consultation in formulation of food law Article 10: Where reasonable grounds to suspect food / feed may present a risk to human or animal health, public authorities to inform public on nature of risk, food/feed affected, measures takenSection 3: general obligations on food trade Article 11: Food & Feed imported into the community shall comply with the relevant requirements of food law or conditions recognised by the Community as equivalent.


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Article 12: Food exported or re-exported from EU shall comply with relevant food law unless otherwise requested by the authority of the exporting country Article 13: Community and MS to contribute to and promote international food and feed standards Section 4: General requirements of food law

Article 14: Food safety requirements: Food shall not be placed on the market if unsafe = considered ‘injurious to health or ‘unfit for human consumption’. Unsafe – take into consideration normal conditions of use and any labelling info. Injurious to health – consider short term, long term effects on consumer & subsequent generations; cumulative effects, health sensitivities of category of consumer intended for. Unfit for human consumption – consider intended use, contamination, putrefaction, deterioration, decay Presumption that all of a lot of batch is unsafe unless detailed assessment shows otherwise Article 15: Feed safety requirements Feed shall not be placed on the market or fed to a food-producing animal if unsafe Unsafe if considered to: • have an adverse effect on human or animal health • make food derived from food-producing animals unsafe for human consumption Presumption that all of a lot of batch is unsafe unless detailed assessment shows otherwise Article 16: Labelling, presentation, advertising shall not mislead consumers Article 17: – Food and feed business operators to ensure food or feed under their control meets food law

requirements and must verify requirements met. – MS to monitor this is done and measures and penalties to be applied if it isn’t – measures to be

effective, proportionate and dissuasive Article 18: – Traceability of food, feed, food producing animals, any substance intended for incorporation

into food or feed, shall be established at all stages of production, processing, distribution – Food & Feed business operators required to be able to identify people who have supplied them

and businesses they have supplied, details to be available to CA on demand. – Food or feed placed on the market to be labelled or identified to facilitate traceability Articles 19, 20: Product recalls

CHAPTER III: European Food Safety Authority

Articles 22 to 49: Establishment of European Food Safety Agency – to provide scientific and technical support and advice for the Community CHAPTER IV: Rapid alerts system, crisis management, emergencies

Articles 50 to 52: Rapid alert system – serious risk to human health to be reported, Commission to forward, confidentiality rules


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Articles 53, 54: Emergency measures where food or feed likely to constitute a serious risk to human health, animal health of environment, Commission powers to suspend imports or lay down special conditions e.g. controls on aflatoxins. Once reported MS can implement national rules until Commission acts Articles 55 to 57: Plan for management of crises to be developed

CHAPTER V: Final provisions

2. Articles 58 to 65


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REGULATION 852/2004 - HYGIENE OF FOOD – PRODUCTS OF ANIMAL ORIGINA AND NOM-ANIMAL ORIGIN

CHAPTER I: General provisions

Article 1: Scope Lays down general rules for food business operators on the hygiene of foodstuffs, principles include: – primary responsibility for food safety rests with the food business operator; – safety throughout the food chain to be ensured, starting with primary production; – cold chain to be maintained for food that cannot be stored safely at ambient temperatures; – general implementation of procedures based on the HACCP principles, together with the

application of good hygiene practice, should reinforce food business operators’ responsibility; – imported foods to be of at least the same hygiene standard as food produced in the Community,

or an equivalent standard. Applies to all stages of production, processing and distribution of food and without prejudice to more specific requirements relating to food hygiene. Does not apply to: (a) primary production for private domestic use; (b) the domestic preparation, handling or storage of food for private domestic consumption; (c) the direct supply, by the producer, of small quantities of primary products to the final consumer or to local retail establishments directly supplying the final consumer; (d) collection centres and tanneries which fall within the definition of food business only because they handle raw material for the production of gelatine or collagen. Article 2: Definitions

‘Establishment’ means any unit of a food business (includes approved establishment + all other food businesses –not just those with approval numbers); ‘wrapping’ means the placing of a foodstuff in a wrapper or container in direct contact with the foodstuff concerned, and the wrapper or container itself; ‘packaging’ means the placing of one or more wrapped foodstuffs in a second container, and the latter container itself; ‘processing’ means any action that substantially alters the initial product, including heating, smoking, curing, maturing, drying, marinating, extraction, extrusion or a combination of those processes; ‘unprocessed products’ means foodstuffs that have not undergone processing, and includes products that have been divided, parted, severed, sliced, boned, minced, skinned, ground, cut, cleaned, trimmed, husked, milled, chilled, frozen, deep-frozen or thawed; ‘processed products’ means foodstuffs resulting from the processing of unprocessed products. These products may contain ingredients that are necessary for their manufacture or to give them specific characteristics. Definitions in Regulation (EC) No178/2002 also apply.

CHAPTER II: Food business operators obligations


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Article 3: General obligation Food business operators shall ensure that all stages of production, processing and distribution of food under their control satisfy the relevant hygiene requirements laid down in this Regulation. Article 4: General and specific hygiene requirements 1. Food business operators carrying out primary production must comply with the general hygiene provisions in Annex I and any specific requirements in 853/2004. 2. Food business operators carrying out any stage of production, processing and distribution of food after those stages to which paragraph 1 applies shall comply with the general hygiene requirements laid down in Annex II and any specific requirements in 853/2004. 3. Food business operators shall, as appropriate, adopt the following specific hygiene measures: (a) Compliance with microbiological criteria for foodstuffs; (c) Compliance with temperature control requirements for foodstuffs; (d) Maintenance of the cold chain. Article 5: Hazard analysis and critical control points 1. Food business operators shall put in place, implement and maintain a permanent procedure or procedures based on the HACCP principles. 2. The HACCP principles consist of: (a) identifying any hazards that must be prevented, eliminated or reduced to acceptable levels;

(b) identifying the critical control points at the step or steps at which control is essential to prevent or eliminate a hazard or to reduce it to acceptable levels;

(c) establishing critical limits at critical control points which separate acceptability from unacceptability for the prevention, elimination or reduction of identified hazards; (d) establishing and implementing effective monitoring procedures at critical control points(e) establishing corrective actions when monitoring indicates that a critical control point is not under control; (f) establishing procedures, which shall be carried out regularly, to verify that the measures outlined in subparagraphs (a) to (e) are working effectively; and (g) establishing documents and records commensurate with the nature and size of the food business to demonstrate the effective application of the measures outlined in subparagraphs (a) to (f). When any modification is made in the product, process, or any step, food business operators shall review the procedure and make the necessary changes to it. Article 6: Official controls, registration and approval Every food business operator shall notify the appropriate competent authority of each establishment under its control that carries out any of the stages of production, processing and distribution of food, with a view to the registration of each such establishment.

Establishments must additionally be approved where required by Regulation (EC) No 853/2004 or national law. CHAPTER III: Guides to Good Practice

Articles 7 to 9: Provision for development of national and Community guides CHAPTER IV: Imports and Exports

Article 10: Imports


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Imported food to meet requirements laid down in Articles 3 to 6. Article 11: Exports Exported or re-exported food to meet requirements laid down in Articles 3 to 6. CHAPTER V: Final provisions

Articles 12 to 18 ANNEXES:

Annex I: Primary production – General hygiene provisions for primary production, record keeping Annex II: General hygiene requirements (after primary production): Chapter 1: Food premises - General requirements Chapter 2: Rooms where food prepared / treated / processed – specific requirements Chapter 3: Temporary premises Chapter 4: Transport requirements – containers to be kept clean and maintained in good repair Chapter 5: Equipment requirements Chapter 6: Food waste Chapter 7: Water supply Chapter 8: Personal hygiene Chapter 9: Provisions applicable to foodstuffs – not to use contaminated or unfit food, must be stored to prevent contamination / deterioration, pest control, temperature control. Chapter 10: Wrapping and packaging Chapter 11: Heat treatment of food in hermetically sealed containers Chapter 12: Training


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COMMISSION REGULATION (EC) NO 882/2004 – OFFICIAL CONTROLS TO ENSURE THE VERIFICATION OF COMPLIANCE WITH FOOD AND FEED LAW, ANIMAL HEALTH RULES, ANIMAL WELFARE RULES

TITLE I: CHAPTER I: General obligations

Article 1: Scope: Lays down general rules for the performance of official controls to verify compliance with rules aiming to: − prevent, eliminate of reduce to acceptable levels risks to humans or animals either directly or

through the environment; − guarantee fair practices in feed and food trade and protecting consumer interests, including feed

and food labelling and other forms of consumer information. Article 2: Definitions Article 3: Organisation of official controls – regular and risk-based CHAPTER II: Competent authorities

Article 4: Designation of competent authorities and operational criteria Article 5: Possibility of delegation of tasks to a ‘control body’ i.e. an organisation other than the CA Article 6: Staff performing official controls

– To be trained – Training to be updated – Have aptitude for multidisciplinary co-operation

Article 7: Transparency and confidentiality

− Public shall have access to control activities of CA and their effectiveness − Where animal or public health risk, public to be informed or nature of risk, food/feed

affected the risk and control measures Matters not to be disclosed – personal data, preliminary investigations for legal proceedings and others Article 8: CA to carry out controls in accordance with documented procedures, verify effectiveness of controls, can issue guidelines Article 9: CA to produce report on controls carried out Article 10: Control activities – methods and techniques CHAPTER III: Sampling and Analysis

Article 11: Sampling methods to comply with relevant Community rules or if none, internationally recognised rules or if none, a method fit for purpose


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CA to establish procedures so feed / food business operator can apply for a supplementary expert opinion and to be able to take samples Article 12: Official laboratories – Competent authorities to designate laboratories, must operate, be assessed and accredited by EN ISO/IEC 17025. EN45002, EN45003 CHAPTER IV: Crisis management

Article 13: Contingency plans. CA to have a contingency plan for when food or feed poses a serious risk to humans or animals directly or through the environment CHAPTER V: Official controls on feed and food from third countries

Article 14: Official controls on imports The Competent authority designated under Directive 97/78/EC to also verify compliance with food law not covered by Directive 97/78/EC. Article 15 – 17: Controls on food and feed of non-animal origin. Article 18: In case of suspicion, competent authority to detain consignment and carry out controls. Article 19: Action following official control: − Food and feed not complying with food/feed law to be detained. − After hearing the food business operator:

− Order destruction / re-export / special treatment (see article 20); − Order product recall; − Ensure no risk while stored.

− If consignment injurious to human or animal health, competent authority to place under detention pending destruction or any other appropriate measure necessary to protect human and animal health;

− When food / feed refused, competent authority to notify Commission, MS’s and Customs services of identification of the product, findings and final destination of the product.

Article 20: ‘Special treatment’ Includes − treatment or processing in establishments under competent authority control to bring into

compliance, including decontamination but not dilution, − processing for use other than human or animal consumption. Article 21: Re-dispatch only if: − Destination agreed with food/feed business operator, and − Feed / food business operator has first informed competent authority of country of destination

of reasons why refused; − If country of destination not country of origin, competent authority of country of destination

must notify competent authority that prepared to accept. − Re-dispatch within 60 days unless justified delay − Consignment to be under detention pending re-dispatch − competent authority to notify Commission, MS and Customs − competent authorities to ensure that not possible to re-introduce rejected consignments Article 22: Food/Feed business operator responsible for costs Article 23: Allows for possibility of pre-export checks by competent authority of exporting country and consequent reduced checks (documentary, identity or physical)


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Article 24: Customs and CA to co-operate Customs not to allow entry of products of animal origin or high risk non-animal origin products into free warehouse or free zones without agreement of competent authority Where samples are taken, Customs and food/feed business operator to be notified whether goods can be released before results known provided traceability is ensured. Competent authorities and Customs services to work together in accordance with Regulation (EC) No. 93/339 (which puts various obligations on Customs not to release where serious risk to health and safety or product not accompanied by a document or not marked in accordance with Community rules on product safety). Article 25: Provision for more-detailed rules CHAPTER VI: Financing of official controls

Article 26: MS to ensure adequate finance for staff and resources for official controls through general taxation or charges Article 27: For POAO imports, minimum charges as laid down in Annex V required, commence 1/1/07 for POAO imports. Costs above minimum charges can be levied but not to be higher than actual costs incurred. Article 28: Expenses arising from additional controls can be charged to food/feed business operator. Article 29: Additional expenses to be in accordance with Article 27. Article 30: Official certification – allows for official certification to be introduced as necessary. Article 31: Registration/approval of establishments. Competent authorities to maintain up-to-date lists of registered food/feed businesses and approved establishments. TITLE III: Reference labs TITLE IV: Co-operation between MS TITLE V: National control plans TITLE VI: Controls Community controls (audits) in MS Community controls (audits) in third countries Import conditions – Commission to seek information from third countries exporting to EU about their health controls. Specific import requirements may be laid down. Equivalence Training of control staff – Commission may organise Third country controls in MS – Commission to be informed and may assist TITLE VII: Enforcement measures – National and Community TITLE VIII: Adaptation of community legislation: Amendments to Directives 96/23/EC, 97/78/EC, Regulation (EC) No 854/2004 TITLE IX: General provisions TITLE X: Final provision (implementation dates)


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DIRECTIVE 2004/41/EC - REPEALS OLD PRODUCT-SPECIFIC DIRECTIVES

Article 1: Commencement date Article 2: Repeals 64/433 Red meat 71/118 Poultry meat 72/462 As regards meat (continues to apply only to live animals) (ref article 5) 77/96 Trichinella examinations 77/99 Meat products and OPOAs 89/437 Egg products 91/492 Live bivalve molluscs 91/493 Fishery products 91/494 Poultry imports AH conditions 91/495 Rabbit and farmed game 92/45 Wild game 92/46 Milk products 92/48 Fishery products on vessels 94/65 Minced meat and meat preps Article 3: 92/118 - Annex II (the specific public health conditions for white meat products, eggs, snails, frog’s legs, raw material for gelatine / collagen, gelatine, collagen) repealed. References to ‘Annexes I and II’ replaced by ‘Annex I’. Article 4: References to the repealed directives shall be construed as being references to Regulations (EC) No 853/2004, 854/2004 or Directive 2002/99/EC as appropriate. Pending adoption of microbiological criteria and temperature control requirements of Regulation (EC) No 852/2004 any such criteria laid down in directives referred to in Article 2, Annex II to 92/118 or their implementing rules continue to apply. (Microbiological criteria now laid down in Regulation (EC) No 2005/2073). Pending adoption of provisions in Regulations (EC) No 852/2004, 853/2004, 854/2004, Directive 2002/99/EC, provisional lists of 3rd countries drawn up in accordance with 95/408 continue to apply Article 5: Directive 72/462/EC now applies only to live animals Article 6: Amends Directive 89/662/EC Annex A – old directives removed, Annex now Directive 2002/99/EC, Regulations (EC) No 853/2004, 1774/2002 and Directive 92/118/EC, only.


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B. REGULATION (EC) NO 853/2004 – PRODUCTS OF ANIMAL ORIGIN FOR HUMAN CONSUMPTION -SPECIFIC HYGIENE REQUIREMENTS

CHAPTER I: General provisions Article 1 Scope Lays down specific hygiene rules on POAOs for human consumption for food business operators, supplements Regulation (EC) No 852/2004, applies to processed and unprocessed (see Regulation (EC) No 852/2004 for definitions) Does not apply to food containing processed POAOs and plant products, however processed POAOs in the food have to have been handled in accordance with this Regulation, i.e. once ‘processed’ as defined in Regulation (EC) No 852/2004 and mixed with plant product, food is no longer covered by this Reg. but remains covered by Regulation (EC) No 852/2004 as for general foodstuffs Also does not apply to: a) primary production for private domestic use; b) the domestic preparation, handling or storage of food for private domestic consumption; c) the direct supply, by the producer, of small quantities of primary products to the final consumer or to local retail establishments directly supplying the final consumer

(d) the direct supply, by the producer, of small quantities of meat from poultry and lagomorphs slaughtered on the farm to the final consumer or to local retail establishments directly supplying such meat to the final consumer as fresh meat; (e) hunters who supply small quantities of wild game or wild game meat directly to the final consumer or to local retail establishments directly supplying the final consumer. Does not apply to retail (as defined in Regulation (EC) No 178/2002) except when operations are carried out with a view to the supply of food of animal origin to another establishment, unless: the operations consist only of storage or transport, in which case the specific temperature requirements laid down in Annex III apply;

the supply of food of animal origin from the retail establishment is to other retail establishments only and, in accordance with national law, is a marginal, localised and restricted activity. Article 2 Definitions The following definitions apply for the purposes of this Regulation: 1. the definitions laid down in Regulation (EC) No 178/2002; 2. the definitions laid down in Regulation (EC) No 852/2004; 3. the definitions in Annex I; 4. definitions in Annexes II and III. CHAPTER II: Food business operators obligations

Article 3 General obligations: Food business operators must comply with relevant provisions of: Annex II Identification marking – when applied, format of mark, method of marking Annex III Product specific requirements Only potable water to be used for cleaning POAOs except where Regulation (EC) No 882/2004 allows otherwise. Article 4 Registration and approval of establishments


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POAOs for HC must be produced only in establishments meeting general requirements in Regulation (EC) No 882/2004 and specific requirements in Annexes II and III. Where establishments undertaking any of the activities listed in Annex III they must be approved except if: • Carrying out only primary production • Transport • Ambient storage • Retail operations If not approved, cannot operate Article 5: Health and identification marking Where required by Regulation Regulation (EC) No 854/2004 POAOs must be health marked (i.e. carcases). Otherwise must have identification mark as Annex II - meat in cartons has an identification mark on the carton which must be destroyed on opening. Identification mark can be applied only if product manufactured in accordance with this Regulation in an establishment meeting requirements of article 4. Article 6: POAO Imports Paragraph 1: Food business operators may import POAOs for HC only if: – From approved third country for the product concerned; – From approved establishment for the product concerned; – Meets requirements of Regulations (EC) No 852/2004 (general hygiene requirements ) and this

Regulation (specific hygiene requirements); – Meat, meat preps, minced meat, meat products - the meat must be from approved

slaughterhouses and cutting plants; – Live bivalve molluscs, echinoderms, tunicates, marine gastropods - must be from approved

production areas; – The product is health marked / has an identity mark in accordance with Article 5; – Meets other Community import legislation requirements including requirements of Article 14

of Regulation (EC) No 854/2004 i.e. a certificate issued by the competent authority of the exporting country confirming products meet requirements in Regulation (EC) No Regulations 852/2004 and 853/2004 or equivalent and any special import conditions.

Paragraph 2: (Applies to direct landings from fishing, factory or freezer vessels with 3rd country flag – details in Regulation (EC) No 854/2004 article 15). Paragraph 3: Products must be declared for veterinary checks. Products must meet the animal health requirements laid down in Directive 2002/99/EC. Paragraph 4. Food business operators importing food containing both products of plant origin and processed products of animal origin shall ensure that the processed products of animal origin contained in such food satisfy the requirements of paragraphs 1 to 3. They must be able to demonstrate that they have done so (for example, through appropriate documentation or certification).


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Note: Such imports to comply with harmonised community, or national, rules which existed before 1/1/06 ref. Article 7 of Regulation (EC) No 2076/2005

CHAPTER III Trade

Article 7: Documents. Documents to accompany consignments. Article 8: Special conditions for meat from bovine, porcine, poultry and eggs destined for Finland and Sweden, in respect of Salmonella. CHAPTER IV: Final provisions

Articles 9 to 15 ANNEX I – Definitions Various definitions covering the following categories: - Meat

Meat preparations = fresh meat which has had foodstuffs, seasonings or additives added to it or has undergone processes insufficient to modify the internal muscle structure of the meat and thus to eliminate the characteristics of fresh meat

- Live bivalve molluscs - Fishery products

Fishery products = all seawater or freshwater animals (except live bivalve molluscs,

echinoderms, tunicates, marine gastropods, mammals reptiles frogs) whether wild or farmed and

including all edible forms parts and products of such animals)

Prepared fishery products = unprocessed fishery products that have undergone an operation affecting their anatomical wholeness, such as gutting, heading, slicing, filleting, chopping

- Milk - Eggs - Frogs legs and snails - Processed products – ‘meat products’, ‘dairy products’, ‘egg products’, ‘processed fishery

products’ etc. - Product of animal origin - Wholesale market – food business where food sold to food business operators ANNEX II – Requirements concerning several products of animal origin

Section I: Identification marking Application of the mark:

- before leaves establishment; - new mark not required if packaging / wrapping not removed; - not required for eggs covered by 1990/1907; - food business operators must be able to show who they have received; POAOs from and

delivered them to (traceability). Form of the mark:

- must be legible, indelible, clearly displayed for competent authorities;


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- must show name of country of ISO code and approval number; - same identification mark can be used on non-animal origin products; - only has to be oval if EU production.

Method of marking: - Applied to product, wrapping or packaging either directly or by label; - For cut meat and offal must be on a label on the packaging which must be destroyed on

opening unless package is destroyed by opening. May be on wrapping if wrapping provides same protection as packaging.

- Products of animal origin large packages for further handling/processing/wrapping/packaging in another establishment mark needs only to be on the outside of the packaging;

- (reference to fishery and other products carried in bulk); - if in retail pack, mark can be just on outside of retail package; - if applied direct to product, only authorised colours to be used.

Section II: Objectives of HACCP-based procedures for slaughterhouses Section III: Food chain information for slaughterhouses ANNEX III – Specific requirements (by product type)

SECTION 1: MEAT OF DOMESTIC UNGULATES

Chapter 1: Transport of animals to slaughterhouse Chapter 2: Requirements for slaughterhouses Chapter 3: Requirements for cutting plants Chapter 4: Slaughter hygiene Contact between outside of hides / skins with carcase must be prevented

Complete skinning except porcine

Carcases must not have visible faecal contamination Chapter 5: Cutting hygiene Chapter 6: Emergency slaughter Chapter 7: Storage and transport Chilled meat must be 7C or less, offal 3C of less

Meat for freezing to be frozen without undue delay C.

SECTION 2: MEAT FROM POULTRY AND RABBITS

Chapter 1: Transport of animals to slaughterhouse Chapter 2: Requirements for slaughterhouses Chapter 3: Requirements for cutting plants Chapter 4: Slaughter hygiene Immersion chilling is allowed

Meat to be chilled and maintained at 4C or below

Chapter 5: Cutting hygiene Chapter 6: On farm slaughter Chapter 7: Storage and transport Chilled meat must be 7C or less, offal 3C of less

Meat for freezing to be frozen without undue delay


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SECTION 3: MEAT OF FARMED GAME

Provisions of sections 1 or 2 apply as appropriate SECTION 4: WILD GAME MEAT

Chapter 1: Training of hunters in health and hygiene Chapter 2: Handling of large wild game

Must be skinned and chilled to 7C or below

Chapter 3: Handling of small wild game Must be chilled to 4C or below

SECTION 5: Minced meat, meat preparations and mechanically separated meat (MSM) Chapter 1: Requirements for production establishments Chapter 2: Requirements for raw material All must meet requirements for fresh meat

Minced meat: Must be skeletal muscle and adherent fatty tissue only. Cannot include scraps and trimmings, MSM, meat containing fragments of bone or skin, head meat except masseters, non-muscular part of linea alba, meat from carpus/tarsus, bone scrapings, diaphragm unless serosa removed.

Meat preparations: Same as minced meat but can include scraps and trimming and MSM if clearly intended to be heat-treated before consumption D.

MSM

Must not include: Poultry: feet, neck skin, head. Other animals: bones of head, feet, tail, femur, tibia, fibula, humerus, radius, ulna. Chapter 3: Hygiene during and after production MSM must be 2C or below. Frozen minced meat, meat preparations and MSM must be –18C or colde.

SECTION 6: MEAT PRODUCTS

Must not include: - genital organs except testicles, - urinary organs except kidney and bladder, - cartilage of larynx, trachea, extralobular bronchi, - eyes and eyelids, - external auditory meatus, - horn tissue,


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- poultry oesophagus, crop, intestines, genital organs, head (other than comb, wattles, caruncles).

SECTION 7: LIVE BIVALVE MOLLUSCS

Chapter 1: General requirements for placing on the market Chapter 2: Hygiene requirements for production and harvesting Part A: Requirements for production areas

Only from areas classified A, B, C as Regulation (EC) No 854/2004 Part B: Requirements for harvesting and subsequent handling Part C: Requirements for relaying bivalve molluscs Chapter 3: Structural requirements for dispatch and purification centres Chapter 4: Hygiene requirements for dispatch and purification centres Chapter 5: Health standards for live bivalve molluscs Organoleptic characteristics must indicate fresh and alive (i) Marine toxin levels below specified maxima

Chapter 6: Wrapping and packaging Chapter 7: Identification Standard identification mark plus common and scientific name plus day and month of packaging Chapter 8: Other requirements Chapter 9: Specific requirements for pectinidae harvested outside production areas

SECTION 8: FISHERY PRODUCTS

Excludes live bivalve molluscs, echinoderms, tunicates, marine gastropods Regulation (EC) No 852/2004 also applies Chapter 1: Requirements for vessels

Fishery products must be handled and stored to prevent bruising Chapter II: Requirements during and after landing Chapter III: Requirements for establishments handling fishery products

- Fresh fishery products - Frozen fishery products - Mechanically separated fishery products - Requirements concerning parasites for fish to be eaten raw or cold-smoked

Chapter IV: Requirements for processed fishery products (cooked shellfish) Chapter V: Health standards for fishery products

- Microbiological criteria to be met - Freshness criteria - Histamine - TVN in unprocessed fishery products - Parasites – fish obviously contaminated with parasites not to be marketed - Toxins harmful to health:

- Poisonous fish (Tetraodontidae, Molidae, Diodontidae, Canthigasteridae) not to be marketed

- Fishery products containing biotoxins not to be marketed Chapter VI: Wrapping and packaging

- Frozen blocks prepared on vessels must be adequately wrapped before landing


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Chapter VII: Storage of fishery products - Below -18C

Chapter VIII: Transport of fishery products - “During transport frozen fish must be maintained at an even temperature of not more

than –18C in all parts possibly with short upward fluctuations of not more than 3C”. There is an exception for short journeys where Competent authority permits

SECTION 9: Raw milk and dairy products Chapter I: Raw milk –primary production

Cannot be placed on the market if contains antibiotic residues in excess of maximum permitted by Regulation (EC) No 2377/90

Chapter II: Requirements concerning dairy products - Temperature requirements for raw milk in processing establishments; - Heat treatment – to be in accordance with Regulation (EC) No 852/2004 Annex II,

Chapter IX (includes requirement for heat treatment to conform to internationally recognised standard e.g. pasteurisation, UHT, sterilisation;

- Criteria for raw cows milk. Chapter III: Wrapping and packaging (refers to liquid products) Chapter IV: Labelling (where made with raw milk to be labelled ‘raw milk’ or ‘made with raw milk’) Chapter V: Identification marking (establishment number can be elsewhere on packaging provided identification mark indicates where)

SECTION 10: Eggs and Egg products CHAPTER 1: EGGS

- Must be clean, dry, free from odour, protected from shock and out of direct sunshine; - Stored and transported at a preferably constant temperature; - Delivered to consumer within 21 days of laying.

Chapter II: Egg products Requirements for establishments

- Raw materials for manufacture of egg products; - Cracked eggs permissible if go direct to processing establishment.

Special hygiene requirements for the manufacture of egg products - Liquid egg to be frozen; - Egg products not ambient stable to be frozen.

Analytical specifications - 3-OH-butyric acid not to exceed 10mg/kg dry matter; - Egg shell and membrane remains must not exceed 100mg/kg of egg product.

Labelling and identification marking If for further manufacture must have a label giving temperature at which egg products must be maintained and the period during which conservation is assured.

SECTION 11: FROGS LEGS AND SNAILS

SECTION 12: Rendered animal fats and greaves Chapter I: Requirements applicable to establishments collecting or processing raw materials.


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Chapter II: Hygiene requirements for the preparation of rendered animal fat and greaves - Must be from animals slaughtered in a slaughterhouse etc; - TABLE for FFA, Peroxide, Total insoluble impurities, odour / colour / taste; - Temperature storage requirements.

SECTION 13: Treated stomachs, bladders and intestines

- Must be from animals slaughtered in a slaughterhouse etc; - Must be salted, heated or dried; - Effective measures taken to prevent recontamination; - If cannot be stored ambient then must be below –3C.

SECTION 14: GELATINE

Chapter I: Requirements for raw materials - Hides and skins which have undergone any tanning process not permitted; - Raw materials from animals slaughtered in slaughterhouse and passed for human

consumption; - Raw materials to come from establishment registered under Regulation (EC) No

852/2004. Chapter II: Transport and storage of raw materials

- No need for identification mark if accompanied by document indicating origin and as per annex;

- Must be stored chilled or frozen except for degreased and dried bones or ossein, salted, dried or limed hides, hides treated with alkali or acid.

-Chapter III: Requirements for the manufacture of gelatine

- Required treatment if from low BSE-risk countries; - Required treatment if from other countries.

Chapter IV: Requirements for finished products - As, PB, Cd, Hg, Cr, Cu, SO2, H2O2

SECTION 15: Collagen Chapter I: Requirements for raw materials

- Hides and skins which have undergone any tanning process not permitted; - Raw materials from animals slaughtered in slaughterhouse and passed for human

consumption; - Raw materials to come from establishment registered under Regulation (EC) No

852/2004. Chapter II: Transport and storage of raw materials

- No need for identification mark if accompanied by document indicating origin and as per annex;

- Must be stored chilled or frozen except for degreased and dried bones or ossein, salted, dried or limed hides, hides treated with alkali or acid.

Chapter III: Requirements for the manufacture of collagen Chapter IV: Requirements for finished products

- As, PB, Cd, Hg, Cr, Cu, SO2, H2O2. Chapter V: Wrapping and packaging must bear words “Collagen fit for human consumption’ and indicate date of preparation”.


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ANNEX III - APPENDIX

EU model document for transport of raw material for gelatine or collagen REGULATION (EC) NO 854/2004 ORGANISATION OF OFFICIAL CONTROLS ON PRODUCTS OF ANIMAL ORIGIN FOR HUMAN CONSUMPTION

Chapter I: General

Article 1: Applies only to the specific hygiene controls mentioned in Regulation (EC) No 853/2004. Article 2: Definitions – Definitions in Regulation (EC) No 178/2002, 1774/2002, 852/2004, 853/2004 also apply. Chapter II: Official control on EU establishments Chapter III: Imports Article 11: Third country lists – products of animal origin only from countries on relevant third country list; criteria for inclusion on lists Article 12: Establishment lists − Only required where Regulation (EC) No 853/2004 lays down requirements - transport and

ambient storage exempted; − Meat, meat preps, meat products must come from approved slaughterhouses and cutting plants

as well; − Relevant POAOs to come only from approved establishments. Criteria for listing − 3rd countries to guarantee that lists up to date and advise Commission of changes; − Commission send details of changes to MS. 20 days to object; − New list published, imports authorised 10 days later. Article 13: Live bivalve molluscs, echinoderms, tunicates and marine gastropods to come from approved production areas; does not apply to pectinidae. Article14. Document to accompany imports of products of animal origin Article 15: Official controls on direct landings of fish. Chapter IV: Final provisions ANNEX 1: FRESH MEAT

Tasks of the official veterinarian Chapter I: Auditing tasks Chapter II: Inspection tasks Chapter III: Health marking – Details health marks size and shape of mark and lettering Chapter IV: Animal Welfare Chapter V: Reasons for unfitness Section III Responsibilities and frequencies of controls Section IV Specific requirements Chapter IX: Specific hazards – Cysticercosis (cold treatment allowed), Trichinosis – unfit, Glanders, TB, Brucellosis


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ANNEX II LIVE BIVALVE MOLLUSCS

Chapter I: Scope includes live echinoderms, tunicates, marine gastropods Chapter II: Production areas. Chapter III: Pectinidae from outside production areas ANNEX III FISHERY PRODUCTS

Chapter I: Vessels and establishments Chapter II: Official controls to include:

A. Organoleptic B. TVB-N, TMA-N C. Histamine D. Residues and contaminants E. Microbiological F. Parasites G. Poisonous fish

Chapter III: Reasons for unfitness – Organoleptic, chemical, physical, microbiological, parasite checks failures – Contaminants or residues in edible parts exceed EU permitted maxima – Poisonous fish or biotoxins – Risk to animal or public health or any other reason –ANNEX IV: Raw milk and dairy products Chapter I: Control of milk production holdings Chapter II: Collection of raw milk ANNEX V Third country establishments exempt from listing – Primary production establishments – Where Annex III of Regulation (EC) No 853/2004 does not lay down requirements – Ambient storage operations – Transport operations

ANNEX VI Requirements for certificates accompanying imports Each sheet to be signed and stamped by competent authority Factory vessel captain or other ships officer can issue certificate if competent authority authorises Original to accompany consignments Pages to be marked 1of 2, 2 of 2 etc. Unique reference number, to be on each page To be issued before consignment leaves control of 3rd country of dispatch COMMISSION REGULATION (EC) NO 2073/2005 MICROBIOLOGICAL CRITERIA AND IMPLEMENTING RULES

There are two sets of requirements in the regulation, process hygiene criteria and food safety criteria. The process hygiene criteria are not applicable at import. Food Safety criteria have been established for certain products and contaminants and are applicable at import. This list is not exhaustive and risk based testing for other contaminants are recommended.


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COMMISSION REGULATION (EC) NO 2074/2005 (AMENDMENTS TO REGULATIONS (EC) NO 852, 853, 854, 882/2004)

Articles refer to annexes Annex I: Details of food chain information to accompany animals to slaughterhouses. Annex II: Fishery products Section 1: Visual inspection for parasites

− Definitions of visible parasites, visual inspection, candling; − Visual inspection – to be carried out at time of gutting.

Section 2: TVB-N limits for certain species and method of analysis Annex III: Marine biotoxin testing methods Annex IV: Calcium content of MSM Annex V: List of approved food establishments in EU to be made; format of the listings Annex VI: Model health certificates for: Frogs legs and snails (raw and cooked); Gelatine;

Collagen;

COMMISSION REGULATION (EC) NO 2075/2005 - TRICHINELLA IN MEAT

CHAPTER I: General provisions CHAPTER II: Obligations of CA and Food business operator CHAPTER III: Imports Article 13: Meat of susceptible species must be examined for trichinella before import Article 14: Derogations from article 13 − Pigmeat from holding in a third country recognised by the Community as free from Trichinella; − Pigmeat that has undergone required freezing as per Annex II; − Health certificate accompanying import to confirm meat has been examined or appropriate

derogation applies. CHAPTER IV Final provisions ANNEX I: Detection methods ANNEX II: Freezing treatments – in locked room, time and temperatures stated (vary with thickness of meat) ANNEX III: Examination of animals other than swine – horses, wild boar, all meat of game animals’ carnivorous mammals’ inc. marine mammals and reptiles. Includes walrus, crocodiles, and birds.


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COMMISSION REGULATION (EC) NO 2076/2005 – TRANSITIONAL ARRANGEMENTS

CHAPTER I: General provision Article 1: Transitional period to 31/12/09 CHAPTER II: Transitional arrangements for Regulation (EC) No 853/2004 Article 2: Food can be placed on market if marked under old Regulations. Article 3: Direct supply of small quantities of poultry or lagomorphs by producer to final consumer or local retailers exempt from Regulation (EC) No 853/2004 controls. Article 4: Placing of food of animal origin on the national market pending approval of establishments. Food business operators allowed to place food on national market (only) before 1/1/06 can continue to do so providing they use a special mark until competent authorities approves them. Article 5: Pre-printed packaging and labels obtained before 1/1/06 can be used to 31/12/07. Article 6: Existing marking equipment can be used to end of 2009 Article 7: − Unharmonised POAOs can be imported under existing national rules; − Foods containing both processed POAOs and plant products can continue to be imported under

previous harmonised rules or if unharmonised, national rules, pending development of harmonised import conditions.

Article 8: Food chain information for slaughterhouses – derogations. Article 9: Meat of farmed non-domestic ungulates. Article 10: Composition criteria and labelling of minced meat – various derogations. Article 11: Continued use of clean water (as opposed to potable) for ice for fishery products. Article 12: Raw milk and dairy products – plate count applies only where raw milk intended to be heat-treated but isn’t within permitted time Article 13: Eggs and egg products − Existing national storage and transport temperatures can continue − Cracked eggs can be used to produce liquid egg provided delivered direct to establishment CHAPTER III: Transitional arrangements for Regulation (EC) No 854/2004 Article 14: Training of slaughterhouse staff assisting with official controls – reduced training requirement. Article 15: Certification of establishments using staff assisting with official controls in slaughterhouses – exemption from requirement for certificate while pursues one. Article 16: Model certificate for meat of farmed, non-domestic ungulates as per 91/495 can continue to be used. CHAPTER IV: Transitional arrangements for Regulation (EC) No 882/2004 Article 17: Competent authorities can designate laboratories without accreditation provided seeking it and provides competent authorities with satisfactory guarantees re existing analyses. CHAPTER V: Final provisions Articles 18 to 22


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REGULATION OF EUROPEAN PARLIAMENT AND COUNCIL (EC) NO 183/2005 – REQUIREMENTS FOR FEED HYGIENE

CHAPTER I: Subject matter, scope and definitions Article 1: Regulation lies down − General rules on feed hygiene; − Traceability of feed; − Conditions and arrangements for registration and approval of establishments. Article 2: Scope Covers primary production to placing on market. Excludes feed for animals for domestic private consumption and non-food producing animals. Article 3: Definitions Establishment = any unit of a feed business CHAPTER II Article 4 General obligation son feed business operators; Article 5: Specific obligations on feed business operators; Article 6: HACCP required – includes details of HACCP principles; Article 7: Documentation of HACCP required; Article 8: Provision for financial guarantees to cover liabilities from feed ; Article 9: Feed businesses to notify competent authority and competent authority to register them and keep a list; Article 10: Approval required if manufacturing or marketing feed additives, premixes or feed containing them (only); Article 11: Feed business operators shall not operate without registration / approval; Articles 12 to 19: Further details on registration and approval – if approved, to have an approval number; competent authority to keep list. CHAPTER III Articles 20 to 22 National and Community guides to be encouraged CHAPTER IV: Imports and exports Article 23: Feed business operators to import only from permitted third countries and establishments and feed must meet EU requirements CHAPTER V: Final provisions Articles 26 to 33. Rapid alert system to be used ANNEX I: Primary production Hygiene Provisions; Record keeping ; Areas to be covered by guides. ANNEX II: Operations after primary production Premises and equipment; Personnel (suitably skilled / qualified); Production requirements;


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Quality control. Storage and transport: − Processed feed to be kept separate from unprocessed feed and additives; − To be easily identifiable; − Containers and equipment to be clean; − Spoilage to be minimised; − Temperatures controlled to avoid condensation and spoilage. Record keeping Complaints and product recalls ANNEX III: Good animal feeding practice Pasture grazing – to avoid physical, biological or chemical hazards; Rest period to avoid cross-contamination from manure and respect withholding periods for agricultural chemicals. Requirements for stable and feeding equipment − Cleanable; − Cleaned; − Pest control; − Feed and bedding changed and not allowed to become mouldy. Feeding − Storage; − Distribution. Feed and Water Personnel ANNEX IV: List of feed additives ANNEX V: Layout of Competent authorities list of approved feed businesses; Format of approval number.


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ANNEX V Standart layout on SPS agreement AGREEMENT ON THE APPLICATION OF SANITARY AND PHYTOSANITARY MEASURES

Members,

Reaffirming that no Member should be prevented from adopting or enforcing measures necessary to protect human, animal or plant life or health, subject to the requirement that these measures are not applied in a manner which would constitute a means of arbitrary or unjustifiable discrimination between Members where the same conditions prevail or a disguised restriction on international trade; Desiring to improve the human health, animal health and phytosanitary situation in all Members;

Noting that sanitary and phytosanitary measures are often applied on the basis of bilateral agreements or protocols;

Desiring the establishment of a multilateral framework of rules and disciplines to guide the development, adoption and enforcement of sanitary and phytosanitary measures in order to minimize their negative effects on trade;

Recognizing the important contribution that international standards, guidelines and recommendations can make in this regard;

Desiring to further the use of harmonized sanitary and phytosanitary measures between Members, on the basis of international standards, guidelines and recommendations developed by the relevant international organizations, including the Codex Alimentarius Commission, the International Office of Epizootics, and the relevant international and regional organizations operating within the framework of the International Plant Protection Convention, without requiring Members to change their appropriate level of protection of human, animal or plant life or health;

Recognizing that developing country Members may encounter special difficulties in complying with the sanitary or phytosanitary measures of importing Members, and as a consequence in access to markets, and also in the formulation and application of sanitary or phytosanitary measures in their own territories, and desiring to assist them in their endeavours in this regard;

Desiring therefore to elaborate rules for the application of the provisions of GATT 1994

which relate to the use of sanitary or phytosanitary measures, in particular the provisions of Article XX(b)38;

38 In this Agreement, reference to Article XX(b) includes also the chapeau of that Article.


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Hereby agree as follows: Article 1

General Provisions

1. This Agreement applies to all sanitary and phytosanitary measures which may, directly or indirectly, affect international trade. Such measures shall be developed and applied in accordance with the provisions of this Agreement. 2. For the purposes of this Agreement, the definitions provided in Annex A shall apply. 3. The annexes are an integral part of this Agreement. 4. Nothing in this Agreement shall affect the rights of Members under the Agreement on Technical Barriers to Trade with respect to measures not within the scope of this Agreement. Article 2

Basic Rights and Obligations

1. Members have the right to take sanitary and phytosanitary measures necessary for the protection of human, animal or plant life or health, provided that such measures are not inconsistent with the provisions of this Agreement. 2. Members shall ensure that any sanitary or phytosanitary measure is applied only to the extent necessary to protect human, animal or plant life or health, is based on scientific principles and is not maintained without sufficient scientific evidence, except as provided for in paragraph 7 of Article 5. 3. Members shall ensure that their sanitary and phytosanitary measures do not arbitrarily or unjustifiably discriminate between Members where identical or similar conditions prevail, including between their own territory and that of other Members. Sanitary and phytosanitary measures shall not be applied in a manner which would constitute a disguised restriction on international trade. 4. Sanitary or phytosanitary measures which conform to the relevant provisions of this Agreement shall be presumed to be in accordance with the obligations of the Members under the provisions of GATT 1994 which relate to the use of sanitary or phytosanitary measures, in particular the provisions of Article XX(b). Article 3

Harmonization

1. To harmonize sanitary and phytosanitary measures on as wide a basis as possible, Members shall base their sanitary or phytosanitary measures on international standards, guidelines or recommendations, where they exist, except as otherwise provided for in this Agreement, and in particular in paragraph 3.


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2. Sanitary or phytosanitary measures which conform to international standards, guidelines or recommendations shall be deemed to be necessary to protect human, animal or plant life or health, and presumed to be consistent with the relevant provisions of this Agreement and of GATT 1994. 3. Members may introduce or maintain sanitary or phytosanitary measures which result in a higher level of sanitary or phytosanitary protection than would be achieved by measures based on the relevant international standards, guidelines or recommendations, if there is a scientific justification, or as a consequence of the level of sanitary or phytosanitary protection a Member determines to be appropriate in accordance with the relevant provisions of paragraphs 1 through 8 of Article 5.39 Notwithstanding the above, all measures which result in a level of sanitary or phytosanitary protection different from that which would be achieved by measures based on international standards, guidelines or recommendations shall not be inconsistent with any other provision of this Agreement. 4. Members shall play a full part, within the limits of their resources, in the relevant international organizations and their subsidiary bodies, in particular the Codex Alimentarius Commission, the International Office of Epizootics, and the international and regional organizations operating within the framework of the International Plant Protection Convention, to promote within these organizations the development and periodic review of standards, guidelines and recommendations with respect to all aspects of sanitary and phytosanitary measures. 5. The Committee on Sanitary and Phytosanitary Measures provided for in paragraphs 1 and 4 of Article 12 (referred to in this Agreement as the "Committee") shall develop a procedure to monitor the process of international harmonization and coordinate efforts in this regard with the relevant international organizations. Article 4

Equivalence

1. Members shall accept the sanitary or phytosanitary measures of other Members as equivalent, even if these measures differ from their own or from those used by other Members trading in the same product, if the exporting Member objectively demonstrates to the importing Member that its measures achieve the importing Member's appropriate level of sanitary or phytosanitary protection. For this purpose, reasonable access shall be given, upon request, to the importing Member for inspection, testing and other relevant procedures. 2. Members shall, upon request, enter into consultations with the aim of achieving bilateral and multilateral agreements on recognition of the equivalence of specified sanitary or phytosanitary measures. Article 5

39 For the purposes of paragraph 3 of Article 3, there is a scientific justification if, on the basis of an examination and evaluation of available scientific information in conformity with the relevant provisions of this Agreement, a Member determines that the relevant international standards, guidelines or recommendations are not sufficient to achieve its appropriate level of sanitary or phytosanitary protection.


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Assessment of Risk and Determination of the Appropriate Level of Sanitary or Phytosanitary Protection

1. Members shall ensure that their sanitary or phytosanitary measures are based on an assessment, as appropriate to the circumstances, of the risks to human, animal or plant life or health, taking into account risk assessment techniques developed by the relevant international organizations. 2. In the assessment of risks, Members shall take into account available scientific evidence; relevant processes and production methods; relevant inspection, sampling and testing methods; prevalence of specific diseases or pests; existence of pest- or disease-free areas; relevant ecological and environmental conditions; and quarantine or other treatment. 3. In assessing the risk to animal or plant life or health and determining the measure to be applied for achieving the appropriate level of sanitary or phytosanitary protection from such risk, Members shall take into account as relevant economic factors: the potential damage in terms of loss of production or sales in the event of the entry, establishment or spread of a pest or disease; the costs of control or eradication in the territory of the importing Member; and the relative cost-effectiveness of alternative approaches to limiting risks. 4. Members should, when determining the appropriate level of sanitary or phytosanitary protection, take into account the objective of minimizing negative trade effects. 5. With the objective of achieving consistency in the application of the concept of appropriate level of sanitary or phytosanitary protection against risks to human life or health, or to animal and plant life or health, each Member shall avoid arbitrary or unjustifiable distinctions in the levels it considers to be appropriate in different situations, if such distinctions result in discrimination or a disguised restriction on international trade. Members shall cooperate in the Committee, in accordance with paragraphs 1, 2 and 3 of Article 12, to develop guidelines to further the practical implementation of this provision. In developing the guidelines, the Committee shall take into account all relevant factors, including the exceptional character of human health risks to which people voluntarily expose them selves. 6. Without prejudice to paragraph 2 of Article 3, when establishing or maintaining sanitary or phytosanitary measures to achieve the appropriate level of sanitary or phytosanitary protection, Members shall ensure that such measures are not more trade-restrictive than required to achieve their appropriate level of sanitary or phytosanitary protection, taking into account technical and economic feasibility.40

7. In cases where relevant scientific evidence is insufficient, a Member may provisionally adopt sanitary or phytosanitary measures on the basis of available pertinent information, including that from the relevant international organizations as well as from sanitary or phytosanitary measures applied by other Members. In such circumstances, Members shall seek to obtain the

40 For purposes of paragraph 6 of Article 5, a measure is not more trade-restrictive than required

unless there is another measure, reasonably available taking into account technical and economic feasibility, that achieves the appropriate level of sanitary or phytosanitary protection and is significantly less restrictive to trade.


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additional information necessary for a more objective assessment of risk and review the sanitary or phytosanitary measure accordingly within a reasonable period of time. 8. When a Member has reason to believe that a specific sanitary or phytosanitary measure introduced or maintained by another Member is constraining, or has the potential to constrain, its exports and the measure is not based on the relevant international standards, guidelines or recommendations, or such standards, guidelines or recommendations do not exist, an explanation of the reasons for such sanitary or phytosanitary measure may be requested and shall be provided by the Member maintaining the measure. Article 6

Adaptation to Regional Conditions, Including Pest- or Disease-Free Areas and Areas of Low Pest or Disease Prevalence

1. Members shall ensure that their sanitary or phytosanitary measures are adapted to the sanitary or phytosanitary characteristics of the area - whether all of a country, part of a country, or all or parts of several countries - from which the product originated and to which the product is destined. In assessing the sanitary or phytosanitary characteristics of a region, Members shall take into account, inter alia, the level of prevalence of specific diseases or pests, the existence of eradication or control programmes, and appropriate criteria or guidelines which may be developed by the relevant international organizations. 2. Members shall, in particular, recognize the concepts of pest- or disease-free areas and areas of low pest or disease prevalence. Determination of such areas shall be based on factors such as geography, ecosystems, epidemiological surveillance, and the effectiveness of sanitary or phytosanitary controls. 3. Exporting Members claiming that areas within their territories are pest- or disease-free areas or areas of low pest or disease prevalence shall provide the necessary evidence thereof in order to objectively demonstrate to the importing Member that such areas are, and are likely to remain, pest- or disease-free areas or areas of low pest or disease prevalence, respectively. For this purpose, reasonable access shall be given, upon request, to the importing Member for inspection, testing and other relevant procedures. Article 7

Transparency

Members shall notify changes in their sanitary or phytosanitary measures and shall provide information on their sanitary or phytosanitary measures in accordance with the provisions of Annex B. Article 8

Control, Inspection and Approval Procedures

Members shall observe the provisions of Annex C in the operation of control, inspection and approval procedures, including national systems for approving the use of additives or for


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establishing tolerances for contaminants in foods, beverages or feedstuffs, and otherwise ensure that their procedures are not inconsistent with the provisions of this Agreement. Article 9

Technical Assistance

1. Members agree to facilitate the provision of technical assistance to other Members, especially developing country Members, either bilaterally or through the appropriate international organizations. Such assistance may be, inter alia, in the areas of processing technologies, research and infrastructure, including in the establishment of national regulatory bodies, and may take the form of advice, credits, donations and grants, including for the purpose of seeking technical expertise, training and equipment to allow such countries to adjust to, and comply with, sanitary or phytosanitary measures necessary to achieve the appropriate level of sanitary or phytosanitary protection in their export markets. 2. Where substantial investments are required in order for an exporting developing country Member to fulfil the sanitary or phytosanitary requirements of an importing Member, the latter shall consider providing such technical assistance as will permit the developing country Member to maintain and expand its market access opportunities for the product involved. Article 10

Special and Differential Treatment

1. In the preparation and application of sanitary or phytosanitary measures, Members shall take account of the special needs of developing country Members, and in particular of the least-developed country Members. 2. Where the appropriate level of sanitary or phytosanitary protection allows scope for the phased introduction of new sanitary or phytosanitary measures, longer time-frames for compliance should be accorded on products of interest to developing country Members so as to maintain opportunities for their exports. 3. With a view to ensuring that developing country Members are able to comply with the provisions of this Agreement, the Committee is enabled to grant to such countries, upon request, specified, time-limited exceptions in whole or in part from obligations under this Agreement, taking into account their financial, trade and development needs. 4. Members should encourage and facilitate the active participation of developing country Members in the relevant international organizations. Article 11

Consultations and Dispute Settlement

1. The provisions of Articles XXII and XXIII of GATT 1994 as elaborated and applied by the Dispute Settlement Understanding shall apply to consultations and the settlement of disputes under this Agreement, except as otherwise specifically provided herein.


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2. In a dispute under this Agreement involving scientific or technical issues, a panel should seek advice from experts chosen by the panel in consultation with the parties to the dispute. To this end, the panel may, when it deems it appropriate, establish an advisory technical experts group, or consult the relevant international organizations, at the request of either party to the dispute or on its own initiative. 3. Nothing in this Agreement shall impair the rights of Members under other international agreements, including the right to resort to the good offices or dispute settlement mechanisms of other international organizations or established under any international agreement. Article 12

Administration

1. A Committee on Sanitary and Phytosanitary Measures is hereby established to provide a regular forum for consultations. It shall carry out the functions necessary to implement the provisions of this Agreement and the furtherance of its objectives, in particular with respect to harmonization. The Committee shall reach its decisions by consensus. 2. The Committee shall encourage and facilitate ad hoc consultations or negotiations among Members on specific sanitary or phytosanitary issues. The Committee shall encourage the use of international standards, guidelines or recommendations by all Members and, in this regard, shall sponsor technical consultation and study with the objective of increasing coordination and integration between international and national systems and approaches for approving the use of food additives or for establishing tolerances for contaminants in foods, beverages or feedstuffs. 3. The Committee shall maintain close contact with the relevant international organizations in the field of sanitary and phytosanitary protection, especially with the Codex Alimentarius Commission, the International Office of Epizootics, and the Secretariat of the International Plant Protection Convention, with the objective of securing the best available scientific and technical advice for the administration of this Agreement and in order to ensure that unnecessary duplication of effort is avoided. 4. The Committee shall develop a procedure to monitor the process of international harmonization and the use of international standards, guidelines or recommendations. For this purpose, the Committee should, in conjunction with the relevant international organizations, establish a list of international standards, guidelines or recommendations relating to sanitary or phytosanitary measures which the Committee determines to have a major trade impact. The list should include an indication by Members of those international standards, guidelines or recommendations which they apply as conditions for import or on the basis of which imported products conforming to these standards can enjoy access to their markets. For those cases in which a Member does not apply an international standard, guideline or recommendation as a condition for import, the Member should provide an indication of the reason therefor, and, in particular, whether it considers that the standard is not stringent enough to provide the appropriate level of sanitary or phytosanitary protection. If a Member revises its position, following its indication of the use of a standard, guideline or recommendation as a condition for import, it should provide an explanation for its change and so inform the Secretariat as well as the relevant international organizations, unless such notification and explanation is given according to the procedures of Annex B.


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5. In order to avoid unnecessary duplication, the Committee may decide, as appropriate, to use the information generated by the procedures, particularly for notification, which are in operation in the relevant international organizations. 6. The Committee may, on the basis of an initiative from one of the Members, through appropriate channels invite the relevant international organizations or their subsidiary bodies to examine specific matters with respect to a particular standard, guideline or recommendation, including the basis of explanations for non-use given according to paragraph 4. 7. The Committee shall review the operation and implementation of this Agreement three years after the date of entry into force of the WTO Agreement, and thereafter as the need arises. Where appropriate, the Committee may submit to the Council for Trade in Goods proposals to amend the text of this Agreement having regarded, inter alia, to the experience gained in its implementation. Article 13

Implementation

Members are fully responsible under this Agreement for the observance of all obligations set forth herein. Members shall formulate and implement positive measures and mechanisms in support of the observance of the provisions of this Agreement by other than central government bodies. Members shall take such reasonable measures as may be available to them to ensure that non-governmental entities within their territories, as well as regional bodies in which relevant entities within their territories are members, comply with the relevant provisions of this Agreement. In addition, Members shall not take measures which have the effect of, directly or indirectly, requiring or encouraging such regional or non-governmental entities, or local governmental bodies, to act in a manner inconsistent with the provisions of this Agreement. Members shall ensure that they rely on the services of non-governmental entities for implementing sanitary or phytosanitary measures only if these entities comply with the provisions of this Agreement. Article 14

Final Provisions

The least-developed country Members may delay application of the provisions of this Agreement for a period of five years following the date of entry into force of the WTO Agreement with respect to their sanitary or phytosanitary measures affecting importation or imported products. Other developing country Members may delay application of the provisions of this Agreement, other than paragraph 8 of Article 5 and Article 7, for two years following the date of entry into force of the WTO Agreement with respect to their existing sanitary or phytosanitary measures affecting importation or imported products, where such application is prevented by a lack of technical expertise, technical infrastructure or resources.


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ANNEX A DEFINITIONS41

1. Sanitary or phytosanitary measure - Any measure applied:

(a) to protect animal or plant life or health within the territory of the Member from risks arising from the entry, establishment or spread of pests, diseases, disease-carrying organisms or disease-causing organisms;

(b) to protect human or animal life or health within the territory of the Member from

risks arising from additives, contaminants, toxins or disease-causing organisms in foods, beverages or feedstuffs;

(c) to protect human life or health within the territory of the Member from risks arising

from diseases carried by animals, plants or products thereof, or from the entry, establishment or spread of pests; or

(d) to prevent or limit other damage within the territory of the Member from the entry,

establishment or spread of pests. Sanitary or phytosanitary measures include all relevant laws, decrees, regulations, requirements and procedures including, inter alia, end product criteria; processes and production methods; testing, inspection, certification and approval procedures; quarantine treatments including relevant requirements associated with the transport of animals or plants, or with the materials necessary for their survival during transport; provisions on relevant statistical methods, sampling procedures and methods of risk assessment; and packaging and labelling requirements directly related to food safety. 2. Harmonization - The establishment, recognition and application of common sanitary and phytosanitary measures by different Members. 3. International standards, guidelines and recommendations

(a) for food safety, the standards, guidelines and recommendations established by the Codex Alimentarius Commission relating to food additives, veterinary drug and pesticide residues, contaminants, methods of analysis and sampling, and codes and guidelines of hygienic practice;

(b) for animal health and zoonoses, the standards, guidelines and recommendations

developed under the auspices of the International Office of Epizootics;

(c) for plant health, the international standards, guidelines and recommendations developed under the auspices of the Secretariat of the International Plant Protection Convention in cooperation with regional organizations operating within the framework of the International Plant Protection Convention; and

41 For the purpose of these definitions, "animal" includes fish and wild fauna; "plant" includes

forests and wild flora; "pests" include weeds; and "contaminants" include pesticide and veterinary drug residues and extraneous matter.


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(d) for matters not covered by the above organizations, appropriate standards, guidelines and recommendations promulgated by other relevant international organizations open for membership to all Members, as identified by the Committee.

4. Risk assessment - The evaluation of the likelihood of entry, establishment or spread of a pest or disease within the territory of an importing Member according to the sanitary or phytosanitary measures which might be applied, and of the associated potential biological and economic consequences; or the evaluation of the potential for adverse effects on human or animal health arising from the presence of additives, contaminants, toxins or disease-causing organisms in food, beverages or feedstuffs. 5. Appropriate level of sanitary or phytosanitary protection - The level of protection deemed appropriate by the Member establishing a sanitary or phytosanitary measure to protect human, animal or plant life or health within its territory. NOTE: Many Members otherwise refer to this concept as the "acceptable level of risk". 6. Pest- or disease-free area - An area, whether all of a country, part of a country, or all or parts of several countries, as identified by the competent authorities, in which a specific pest or disease does not occur. NOTE: A pest- or disease-free area may surround, be surrounded by, or be adjacent to an area - whether within part of a country or in a geographic region which includes parts of or all of several countries -in which a specific pest or disease is known to occur but is subject to regional control measures such as the establishment of protection, surveillance and buffer zones which will confine or eradicate the pest or disease in question. 7. Area of low pest or disease prevalence - An area, whether all of a country, part of a country, or all or parts of several countries, as identified by the competent authorities, in which a specific pest or disease occurs at low levels and which is subject to effective surveillance, control or eradication measures.


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ANNEX B TRANSPARENCY OF SANITARY AND PHYTOSANITARY REGULATIONS

Publication of regulations

1. Members shall ensure that all sanitary and phytosanitary regulations42 which have been adopted are published promptly in such a manner as to enable interested Members to become acquainted with them. 2. Except in urgent circumstances, Members shall allow a reasonable interval between the publication of a sanitary or phytosanitary regulation and its entry into force in order to allow time for producers in exporting Members, and particularly in developing country Members, to adapt their products and methods of production to the requirements of the importing Member. Enquiry points

3. Each Member shall ensure that one enquiry point exists which is responsible for the provision of answers to all reasonable questions from interested Members as well as for the provision of relevant documents regarding:

(a) any sanitary or phytosanitary regulations adopted or proposed within its territory;

(b) any control and inspection procedures, production and quarantine treatment, pesticide tolerance and food additive approval procedures, which are operated within its territory;

(c) risk assessment procedures, factors taken into consideration, as well as the determination of the appropriate level of sanitary or phytosanitary protection;

(d) the membership and participation of the Member, or of relevant bodies within its

territory, in international and regional sanitary and phytosanitary organizations and systems, as well as in bilateral and multilateral agreements and arrangements within the scope of this Agreement, and the texts of such agreements and arrangements.

4. Members shall ensure that where copies of documents are requested by interested Members, they are supplied at the same price (if any), apart from the cost of delivery, as to the nationals43 of the Member concerned. Notification procedures

42 Sanitary and phytosanitary measures such as laws, decrees or ordinances which are applicable generally.

43 When "nationals" are referred to in this Agreement, the term shall be deemed, in the case of a separate customs territory Member of the WTO, to mean persons, natural or legal, who are domiciled or who have a real and effective industrial or commercial establishment in that customs territory.


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5. Whenever an international standard, guideline or recommendation does not exist or the content of a proposed sanitary or phytosanitary regulation is not substantially the same as the content of an international standard, guideline or recommendation, and if the regulation may have a significant effect on trade of other Members, Members shall:

(a) publish a notice at an early stage in such a manner as to enable interested Members to become acquainted with the proposal to introduce a particular regulation;

(b) notify other Members, through the Secretariat, of the products to be covered by the

regulation together with a brief indication of the objective and rationale of the proposed regulation. Such notifications shall take place at an early stage, when amendments can still be introduced and comments taken into account;

(c) provide upon request to other Members copies of the proposed regulation and,

whenever possible, identify the parts which in substance deviate from international standards, guidelines or recommendations;

(d) without discrimination, allow reasonable time for other Members to make comments

in writing, discuss these comments upon request, and take the comments and the results of the discussions into account.

6. However, where urgent problems of health protection arise or threaten to arise for a Member, that Member may omit such of the steps enumerated in paragraph 5 of this Annex as it finds necessary, provided that the Member:

(a) immediately notifies other Members, through the Secretariat, of the particular regulation and the products covered, with a brief indication of the objective and the rationale of the regulation, including the nature of the urgent problem(s);

(b) provides, upon request, copies of the regulation to other Members;

(c) allows other Members to make comments in writing, discusses these comments upon

request, and takes the comments and the results of the discussions into account. 7. Notifications to the Secretariat shall be in English, French or Spanish. 8. Developed country Members shall, if requested by other Members, provide copies of the documents or, in case of voluminous documents, summaries of the documents covered by a specific notification in English, French or Spanish. 9. The Secretariat shall promptly circulate copies of the notification to all Members and interested international organizations and draw the attention of developing country Members to any notifications relating to products of particular interest to them. 10. Members shall designate a single central government authority as responsible for the implementation, on the national level, of the provisions concerning notification procedures according to paragraphs 5, 6, 7 and 8 of this Annex. General reservations


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11. Nothing in this Agreement shall be construed as requiring:

(a) the provision of particulars or copies of drafts or the publication of texts other than in the language of the Member except as stated in paragraph 8 of this Annex; or

(b) Members to disclose confidential information which would impede enforcement of

sanitary or phytosanitary legislation or which would prejudice the legitimate commercial interests of particular enterprises.


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ANNEX C CONTROL, INSPECTION AND APPROVAL PROCEDURES44

1. Members shall ensure, with respect to any procedure to check and ensure the fulfilment of sanitary or phytosanitary measures, that:

(a) such procedures are undertaken and completed without undue delay and in no less favourable manner for imported products than for like domestic products;

(b) the standard processing period of each procedure is published or that the anticipated processing period is communicated to the applicant upon request; when receiving an application, the competent body promptly examines the completeness of the documentation and informs the applicant in a precise and complete manner of all deficiencies; the competent body transmits as soon as possible the results of the procedure in a precise and complete manner to the applicant so that corrective action may be taken if necessary; even when the application has deficiencies, the competent body proceeds as far as practicable with the procedure if the applicant so requests; and that upon request, the applicant is informed of the stage of the procedure, with any delay being explained;

(c) information requirements are limited to what is necessary for appropriate control,

inspection and approval procedures, including for approval of the use of additives or for the establishment of tolerances for contaminants in food, beverages or feedstuffs;

(d) the confidentiality of information about imported products arising from or supplied in connection with control, inspection and approval is respected in a way no less favourable than for domestic products and in such a manner that legitimate commercial interests are protected;

(e) any requirements for control, inspection and approval of individual specimens of a

product are limited to what is reasonable and necessary;

(f) any fees imposed for the procedures on imported products are equitable in relation to any fees charged on like domestic products or products originating in any other Member and should be no higher than the actual cost of the service;

(g) the same criteria should be used in the siting of facilities used in the procedures and

the selection of samples of imported products as for domestic products so as to minimize the inconvenience to applicants, importers, exporters or their agents;

(h) whenever specifications of a product are changed subsequent to its control and

inspection in light of the applicable regulations, the procedure for the modified product is limited to what is necessary to determine whether adequate confidence exists that the product still meets the regulations concerned; and

44 Control, inspection and approval procedures include, inter alia, procedures for sampling, testing and certification.


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(i) a procedure exists to review complaints concerning the operation of such procedures and to take corrective action when a complaint is justified.

Where an importing Member operates a system for the approval of the use of food additives or for the establishment of tolerances for contaminants in food, beverages or feedstuffs which prohibits or restricts access to its domestic markets for products based on the absence of an approval, the importing Member shall consider the use of a relevant international standard as the basis for access until a final determination is made. 2. Where a sanitary or phytosanitary measure specifies control at the level of production, the Member in whose territory the production takes place shall provide the necessary assistance to facilitate such control and the work of the controlling authorities. 3. Nothing in this Agreement shall prevent Members from carrying out reasonable inspection within their own territories.


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ANNEX VI EU-CHILE Agreemnt Annex IV on Sanitary measures ANNEX IV AGREEMENT ON SANITARY AND PHYTOSANITARY MEASURES APPLICABLE TO TRADE IN ANIMALS AND ANIMAL PRODUCTS, PLANTS, PLANT PRODUCTS AND OTHER GOODS AND ANIMAL WELFARE (Referred to in Article 89 (2) of th e Association Agreement)

AGREEMENT ON SANITARY AND PHYTOSANITARY MEASURES APPLICABLE TO TRADE IN ANIMALSAND ANIMAL PRODUCTS, PLANTS, PLANT PRODUCTS AND OTHER GOODS AND ANIMAL WELFARE THE PARTIES, as defined in Article 197 of the Association Agreement: DESIRING to facilitate trade between the Community and Chile in animals and animal products, plants, plant products and other goods, whilst safeguarding public, animal and plant health; CONSIDERING that the implementation of this Agreement is to take place in accordance with the internal procedures and legislative processes of the Parties; CONSIDERING that recognition of equivalence will be gradual and progressive and should apply to priority sectors; CONSIDERING that one of the objectives of Part IV, Title I of the Association Agreement is to liberalise trade in goods in accordance with the GATT 1994 progressively and reciprocally; REAFFIRMING their rights and obligations under the WTO Agreement and its Annexes and in particular the SPS Agreement; DESIRING to ensure full transparency as regards sanitary, phytosanitary measures applicable to trade, to have a common understanding of the WTO SPS Agreement and to implement its principles and provisions; RESOLVED to take the fullest account of the risk of spread of animal infections, diseases and pests and of the measures put in place to control and eradicate such infections, diseases and pests, to protect public, animal and plant health while avoiding unnecessary disruptions to trade; WHEREAS, given the importance of animal welfare, with the aim of developing animal welfare standards and given its relation with veterinary matters, it is appropriate to include this issue in this Agreement and to examine animal welfare standards taking into account the development in the competent international standards organisations. HAVE AGREED AS FOLLOWS: Article 1 Objective


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1. The objective of this Agreement is to facilitate trade in animals and animal products, plants, plant products and other goods between the Parties, whilst safeguarding public, animal and plant health, by:

a) ensuring full transparency as regards sanitary and phytosanitary measures applicable to trade;

b) establishing a mechanism for the recognition of equivalence of such measures maintained

by a Party consistent with the protection of public, animal and plant health; c) recognition of the health status of the Parties and applying the principle of regionalisation; d) further implementing the principles of the WTO SPS Agreement; e) establishing mechanisms and procedures for trade facilitation; and f) improving communication and Cooperation between the Parties on sanitary and

phytosanitary measures.

2. Furthermore, this Agreement aims at reaching a commonunderstanding between the Parties concerning animal welfare standards. Article 2 Multilateral obligations The Parties reaffirm their rights and obligations under the WTO Agreement and, in particular, the WTO SPS Agreement. These rights and obligations shall underline the activities of the Parties under this Agreement. Article 3 Scope 1. This Agreement shall apply to the following measures in so far as they affect trade between the Parties:

a) sanitary measures applied by either Party to animals and animal products listed in Appendix I.A; and

b) phytosanitary measures applied by either Party to plants and plant products and other

goods listed in Appendix I.B. 2. Additionally, this Agreement shall apply to the development of animal welfare standards as listed in Appendix I.C. 3. Without prejudice to paragraph 4, this Agreement shall initially not apply to matters listed in Appendix I.D.


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4. The Committee mentioned in Article 16 may modify thisAgreement by means of a decision to extend the scope to other sanitary and phytosanitary measures affecting trade between the Parties. 5. The Committee mentioned in Article 16 may modify this Agreement by means of a decision to extend the scope to other animal welfare standards. Article 4 Definitions For the purposes of this Agreement the following definitions shall apply:

a) animals and animal products means live animals, including live fish and bivalve molluscs, semen, ova, embryos and eggs for incubation and products of animal origin including fish products, as defined in the International Animal Health Code and the International Aquatic Health Code of the .Office International des Epizooties (OIE.);

b) plants means living plants and living parts thereof, including seeds, as set out in Appendix

I.B. Living parts of plants shall be considered to include: (i) fruits, in the botanical sense, other than those preserved by deep freezing; (ii) vegetables, other than those preserved by deep freezing; (iii) tubers, corms, bulbs, rhizomes; (iv) cut flowers; (v) branches with foliage; (vi) cut trees retaining foliage; and (vii) plant tissue cultures.

c) plant products means products of plant origin, unprocessed or having undergone simple preparation in so far as these are not plants set out in Appendix I.B.; d) seeds means seeds in the botanical sense, intended for planting; e) other goods means packaging, conveyance, container, used agricultural machinery, soil, growing mediums and any other organism, object or material capable of harbouring or spreading pests as set out in Appendix I.B.;

f) pests means any species, strain or biotype of plant, animal or pathogenic agent injurious to plants or plant products; g) animal disease means a clinical or pathological manifestation in animals of an infection; h) fish diseasemeans clinical or non-clinical infection with one or more of the aetiological agents of the diseases affecting aquatic animals; i) infection in animals means the situation where animals maintain an infectious agent with or without presence of clinical or pathological manifestation of an infection; j) sanitary and phytosanitary measures. means measures as defined in paragraph 1 of Annex A to the WTO SPS Agreement, falling within the scope of this Agreement;


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k) animal welfare standards. means standards for the protection of animals as developed and applied by the Parties and, as appropriate, in compliance with the OIE standards and falling within the scope of this Agreement; l) appropriate level of sanitary and phytosanitary protection means the appropriate level of sanitary and phytosanitary protection as defined in paragraph 5 of Annex A to the WTO SPS Agreement; m) region means:

(i) as regards animal health, zones or regions as defined in the Animal Health Code of the OIE, and for aquaculture as defined in the International Aquatic Animal Health Code of the OIE, on the understanding that as regards the territory of the Community its specificity shall be taken into account recognising the Community as an entity; (ii) as regards plant health, an area referred to in the FAO International Standard for Phytosanitary Measures Glossary of Phytosanitary terms., i.e. an officially defined part or all parts of any of the Parties the status of which is recognised in accordance with Article6(6)(a), as regards the distribution of a said pest; (n) regionalisation. means the concept of regionalisation as described in Article 6 of the WTO SPS Agreement; (o) consignment means a quantity of products of the same type, covered by the same certificate or document, conveyed by the same means of transport, consigned by a single consignee and originating in the same exporting country or part of such country. A consignment may be composed of one or more lots; (p) equivalence for trade purposes. (herein referred to as equivalence) means the state wherein measures applied in the exporting Party, whether or not different from the measures applied in the importing Party, objectively achieve the importing Party's appropriate level of protection or acceptable level of risk; (q) sector means the production and trade structure for aproduct or category of products in a Party; (r) sub-sector means a well-defined and controlled part of a sector; (s) commodities. means animals and plants, or categories thereof, or specific products, including other goods, referred to in paragraphs (a), (b), (c) and (d); (t) specific import authorisation. means a formal prior authorisation by the competent authorities of the importing Party addressed to an individual importer as a condition for import of a single consignment or multiple consignments of a commodity from the exporting Party, within the scope of this Agreement; (u)measures. includes any law, regulation, procedure, requirement or practice; (v) working days. means working days for the authorities which must take the required action;


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(w) Agreement. means the entire text of this Agreement and all its Appendices; and (x) Association Agreement. means the Agreement establishing an Association between the Parties, to which this Agreement is annexed.

Article 5 Competent authorities 1. The competent authorities of the Parties are the authorities competent for the implementation of the measures referred to in this Agreement, as provided for in Appendix II. 2. In accordance with Article 12, the Parties shall inform each other of any significant changes in the structure, organisation and division of competency of their competent authorities. Article 6 Recognition for trade of animal health and pest status and regional conditions A. Recognition of status for animal diseases, infections in animals or pests 1. As regards animal diseases and infections in animals (including zoonoses), the following shall apply:

(a) The importing Party shall recognise for trade the animal health status of the exporting Party or its regions as determined by the exporting Party in accordance with Appendix IV.A., with respect to animal diseases specified in Appendix III.A. (b) Where a Party considers that it has, for its territory or a region, a special status with respect to a specific animal disease other than that in Appendix III.A., it may request recognition of this status in accordance with the criteria set out in Appendix IV.C. The importing Party may request guarantees in respect of imports of live animals and animal products, which are appropriate to the agreed status of the Parties.

(c) The status of the territories or regions, or the status in a sector or sub-sector of the Parties related to the prevalence or incidence of an animal disease other than those in Appendix III.A. or infections in animals, and/or theassociated risk, as appropriate, as defined by the international standard setting organisations recognised by the WTO SPS Agreement, is recognised by the Parties as the basis for trade between them. The importing Party may request guarantees in respect of imports of live animals and animal products, which are appropriate to the defined status in accordance with the recommendations of the standard setting organisations, as appropriate. (d) Without prejudice to Articles 8 and 14, and unless the importing Party raises an explicit objection and requests supportive or additional information or consultations and/or verification, each Party shall take without undue delay the necessary legislative and administrative measures to allow trade on the basis of the provisions of subparagraphs (a), (b) and (c).

2. As regards pests, the following shall apply:


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(a) The Parties recognise for trade their pest status in respect to pests specified in Appendix III B. (b) Without prejudice to Articles 8 and 14, and unless the importing Party raises an explicit objection and requestssupportive or additional information or consultations and/or verification, each Party shall take without undue delay the necessary legislative and administrative measures to allow trade on the basis of the provision ofsubparagraph (a).

B. Recognition of regionalisation 3. The Parties recognise the concept of regionalisation, which they agree to apply to trade between them. 4. The Parties agree that regionalisation decisions for animal and fish diseases listed in Appendix III.A. and for pests listed in Appendix III.B. must be taken in accordance with the provisions of Appendix IV.A. and Appendix IV.B., respectively. 5. (a) As regards animal diseases and in accordance with the provisions of Article 13, the

exporting Party seeking recognition of its regionalisation decision by the importing Party shall notify its measures with full explanation and supporting data for its determinations and decisions. Without prejudice to Article 14, and unless the importing Party raises an explicit objection and requests additional information or consultations and/or verification within 15 working days following receipt of the notification, the regionalisation decision so notified shall be construed as accepted.

(b) Consultations referred to in subparagraph (a) shall take place in accordance with Article 13(3). The importing Party shall assess the additional information within 15 working days following receipt of the additional information. The verification referred to insubparagraph (a) shall be carried out in accordance with Article 10 and within 25 working days following receipt of the request for verification.

6. (a) As regards pests, each Party shall ensure that trade in plants, plant products and other goods

takes account of the pest status in a region recognised by the other Party. A Party seeking recognition of its regionalisation decision by the other Party shall notify its measures with full explanation and supporting data for its determinations and decisions, as guided by the relevant FAO International Standards for Phytosanitary Measures, including No 4 .Requirements for the establishment of Pest Free Areas., No 8 .Determination of Pest Status in an area., and other International Standards for Phytosanitary Measures as the Parties deem appropriate. Without prejudice to Article 14, and unless a Party raises an explicit objection and requests additional information or consultations and/or verification within three months following the notification, the regionalisation decision so notified shall be construedas accepted.

(b) Consultations referred to in subparagraph (a) shall take place in accordance with Article 13(3). The importing Party shall assess the additional information within three months following receipt of the additional information. The verification referred to in subparagraph (a) shall be carried out in accordancewith Article 10 and within 12 months following receipt of the request for verification, taking into account the biology of the pest and the crop concerned.


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7. After finalisation of the procedures of paragraph 4, 5 and6, and without prejudice to Article 14, each Party shall take, without undue delay, the necessary legislative and administrative measures to allow trade on that basis. Article 7 Determination of equivalence 1. Equivalence may be recognised in relation to an individual measure and/or groups of measures and/or systems applicable to a sector or sub-sector. 2. In the determination of equivalence, the Parties shall follow the consultation process of paragraph 3. This process shall include the objective demonstration of equivalence by the exporting Party and the objective assessment of this demonstration by the importing Party with a view to possibly recognising equivalence by the latter. 3. Upon request of the exporting Party concerning a measure or measures affecting one or more sector(s) or sub-sector(s), the Parties shall, within three months after receipt by the importing Party of such request, initiate the consultation process which includes the steps set out in Appendix VI. However, in case of multiple requests from the exporting Party, the Parties, on request of the importing Party, shall agree within the Committee referred to in Article 16 on a time schedule in which they shall initiate the process referred to in this paragraph. 4. Unless otherwise mutually agreed, the importing Party shall finalise the assessment of equivalence within 180 days after having received from the exporting Party its demonstration of equivalence, except for seasonal crops when it is justifiable to delay the assessment to permit verification of phytosanitary measures during a suitable period of growth of a crop. The sectors or sub-sectors of priority of each Party for which this process may be initiated, are to be set out, where appropriate, in order of priority in Appendix V.A. The Committee referred to in Article 16 may amend, by means of decision, this list, including its order of priority. 5. The importing Party may withdraw or suspend equivalence on the basis of any amendment by one of the Parties of measures affecting equivalence, provided that the following procedures are followed:

(a) In accordance with the provisions of Article 12, the exporting Party shall inform the importing Party of any proposal for amendment of its measures for which equivalence of measures is recognised and the likely effect of the proposed measures on the equivalence which has been recognised. Within 30 working days of receipt of this information, the importing Party shall inform the exporting Party whether or not equivalence would continue to be recognised on basis of the proposed measures. (b) In accordance with the provisions of Article 12, the importing Party shall inform the exporting Party of any proposal for amendment of its measures on which recognition of equivalence has been based and the likely effect of the proposed measures on the equivalence which has been recognised. Should the importing Party not continue to recognise equivalence, the Parties may agree on the conditions to re-initiate the process referred to in paragraph 3 on the basis of the proposed measures.

6. Without prejudice to Article 14, the importing Party may not withdraw or suspend equivalence before the proposed new measures of either Party enter into force.


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7. The recognition or withdrawal or suspension of equivalence rests solely with the importing Party acting in accordance with its administrative and legislative framework including, as regards plants, plant products and other goods, appropriate communications in accordance with FAO International Standard for Phytosanitary Measures No 13 Guidelines for the notification of non-compliances and emergency action and other International Standards for Phytosanitary Measures, as appropriate. That Party shall provide to the exporting Party in writing full explanation and supporting data used for the determinations and decisions covered by this Article. In case of non-recognition, withdrawal or suspension of equivalence, the importing Party shall indicate to the exporting Party the required conditions on which the process referred to in paragraph 3 may be reinitiated. When necessary, the importing Party may provide technical assistance to the exporting Party in accordance with the provisions of Article24 of the Association Agreement. Article 8 Transparency and trade conditions 1. For commodities referred to in Appendices I.A. and I.B., the Parties agree to apply general import conditions. Without prejudice to the decisions taken in accordance with Article 6, the import conditions of the importing Party shall be applicable to the total territory of the exporting Party. Upon entry into force of this Agreement and in accordance with the provisions of Article 12, the importing Party shall inform the exporting Party of its sanitary and phytosanitary import requirements for commodities referred to in Appendices I.A and I.B. This information shall include, as appropriate, the models for the official certificates or attestations, as prescribed by the importing Party. 2. (a) For the notification by the Parties of amendments or proposed amendments of the

conditions referred to in paragraph 1, they shall comply with the provisions of the SPS Agreement and subsequent decisions, as regards notification of measures. Without prejudice of the provisions of Article 14, the importing Party shall take into account the transport time between the Parties to establish the date of entering into force of the amended conditions referred to in paragraph 1.

(b) If the importing Party fails to comply with thesenotification requirements, it shall continue to accept the certificate or attestation guaranteeing the previously applicable conditions until 30 days after entering into force of the amended import conditions.

3. (a) Within 90 days after recognition of equivalence, the Parties shall take the necessary legislative and administrative measures to implement the recognition of equivalence in order to allow on that basis trade between them of commodities referred to in Appendices I.A. and I.B. in sectors and sub-sectors, for which all respective sanitary and phytosanitary measures of the exporting Party are recognised as equivalent by the importing Party. For these commodities, the model for the official certificate or official document required by the importing Party may, then, be replaced by a certificate drawn up as provided for in Appendix IX.B.

(b) For commodities in sectors or sub-sectors for which one or some but not all measures are recognised as equivalent, trade shall continue on the basis of compliance with the conditions


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referred to in paragraph 1. Upon request of the exporting Party, the provisions of paragraph 5 shall apply.

4. For the commodities referred to Appendices I.A. and I.B., import shall not be subject to specific import authorisations. 5. For conditions affecting trade of the commodities referred to in paragraph 1, upon request of the exporting Party, the Parties shall enter into consultations in accordance with the provisions of Article 16, in order to agree on alternative or additional import conditions of the importing Party. Such alternative or additional import conditions may, when appropriate, be based on measures of the exporting Party recognised as equivalent by the importing Party. If agreed, the importing Party shall take the necessary legislative and/or administrative measures to allow import on that basis, within 90 days. 6. (a) For the import of animal products referred to in Appendix I.A., upon request of the exporting Party accompanied by the appropriate guarantees, the importing Party shall provisionally approve processing establishments referred to in Appendix V.B.(2) which are situated on the territory of the exporting Party, without prior inspection of individual establishments. Such approval shall be consistent with the conditions and provisions set out in Appendix V.B. Unless additional information is requested, the importing Party shall take the necessary legislative and/or administrative measures to allow import on that basis within 30 working days after the importing Party has received the request and guarantees. The initial list of establishments shall be approved in accordance with the provisions of Appendix V.B.

(b) For the import of animal products referred to in paragraph 3(a), the exporting Party shall inform the importing Party of its list of establishments’ meetingthe exporting Party's requirements. 7. Upon request of a Party, the other Party shall provide full explanation and supporting data for the determinations and decisions covered by this Article. Article 9 Certification procedures 1. For purposes of certification procedures, the Parties shall comply with the principles and criteria set out in Appendix IX.A. 2. Certificates or official documents referred to in Article 8(1) and (3) shall be issued as set out in Appendix IX.C. 3. The Committee referred to in Article 16 may agree on rules to be followed in case of electronic certification, withdrawal or replacement of certificates. Article 10 Verification 1. In order to maintain confidence in the effective implementation of the provisions of this Agreement, each Party, within the scope of this Agreement, shall have the right:


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a) to carry out, in accordance with the guidelines of Appendix VII, verification of all or part of the other Party's authorities' total control programme. The expenses of such verification shall be borne by the Party carrying out the verification;

b) from a date to be determined by the Parties, to receive on its request from the other Party

submission of all or part of that Party's total control programme and a report concerning the results of the controls carried out under that programme;

c) that, for laboratory tests related to commodities of Appendix I.A., on request of one Party,

the other Party shall participate in the periodical inter-comparative test programme for specific tests organised by the reference laboratory of the requesting Party. Such participation shall be borne by the participating Party.

2. Either Party may share the results and conclusions of its verifications with third countries, and make them publicly available. 3. The Committee referred to in Article 16 may modify, by means of a decision, Appendix VII, taking due account of relevant work carried out by international organisations. 4. The results of verification may contribute to measures by the Parties or one of the Parties referred to in Articles 6, 7, 8 and 11. Article 11 Import checks and inspection fees 1. The Parties agree that import checks on importation by the importing Party of consignments from the exporting Party shall respect the principles set out in Appendix VIII.A. The results of these checks may contribute to the verification process referred to in Article 10. 2. The frequencies of physical import checks applied by each Party are set out in Appendix VIII.B. A Party may amend these frequencies within its competences and in accordance with its internal legislation, as a result of progress made in accordance with Articles 7 and 8, or as a result of verifications, consultations or other measures provided for in this Agreement. The Committee referred to in Article 16 shall by decision modify Appendix VIII.B. accordingly. 3. Inspection fees may only cover the costs incurred in by the competent authority for performing import checks. They shall be equitable in relation to fees charged for the inspection of similar domestic products. 4. The importing Party shall inform the exporting Party of any amendment, including the reasons for these amendments concerning the measures affecting import checks and inspection fees and of any significant changes in the administrative conduct for such checks. 5. For the commodities referred to in Article 8(3) (a), the Parties may agree to reduce reciprocally the frequency of physical import checks. 6. From a date to be determined by the Committee referred to in Article 16, the Parties may agree on the conditions to approve each other's controls referred to in Article 10(b), with a view to adapt the frequency of import checks or replace import checks.


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These conditions shall be included in Appendix VII by a decision of the Committee referred to in Article 16. From that date, the Parties may reciprocally approve each other's controls for certain commodities and, consequently reduce or replace the import checks for these commodities. Article 12 Information Exchange 1. The Parties shall exchange information which is relevant for the implementation of this Agreement on a systematic basis, for developing standards, for providing assurance, for engendering mutual confidence and for demonstrating the efficacy of the programmes controlled. Where appropriate, this exchange of information may include exchanges of officials. 2. The Parties shall also exchange information on other relevant topics including:

a) significant events concerning commodities covered by this Agreement, including information exchange provided for in Articles 7 and 8;

b) the results of verification procedures provided for in Article 10; c) the results of import checks provided for in Article 11 in the case of rejected or non-

compliant consignments of animals and animal products; d) scientific opinions, relevant to this Agreement and produced under the responsibility of a

Party;

e) the progress on developing animal welfare standards; and f) rapid alerts relevant to trade within the scope of this Agreement.

3. The Parties shall provide for the submission of scientific papers or data to the relevant scientific fora to substantiate anyviews or claims made in respect of a matter arising under this Agreement. Such information shall be evaluated by the relevant scientific fora in a timely manner, and the results of that examination shall be made available to both Parties. 4. When the information referred to in this Article has been made available by notification to the WTO in accordance with the relevant rules or when the above information has been made available on the official, publicly accessible and fee-free web-sites of the Parties, the addresses of which are set out in Appendix XI.B., the information exchange shall be considered to have taken place. In addition, for pests of known and immediate danger to the other Party, direct communication to the relevant Party shall be sent by mail or e-mail. The guidance provided by FAO International Standard for Phytosanitary Measures No 17 Pest reporting shall be followed. 5. The contact points for the information exchange referred to in this Article are set out in Appendix XI.A. Information shall be sent by post, fax or e-mail. Information by e-mail shall be signed electronically and shall only be sent between the contact points.


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Article 13 Notification and consultation 1. Each Party shall notify the other Party in writing within two working days of any serious or significant public, animal or plant health risk, including any food control emergencies or situations where there is a clearly identified risk of serious health effects associated with the consumption of animal or plant products and in particular concerning:

a) any measures affecting regionalisation decisions referred to in Article 6; b) the presence or evolution of any animal disease or pests listed in Appendix III.A. and III.B.;

c) indings of epidemiological importance or important associated risks with respect to animal

diseases and pests which are not in Appendix III.A. and III.B. or which are new animal diseases or pests; and

d)any additional measures beyond the basic requirements of their respective measures taken to

control or eradicate animal diseases or pests or protect public health and any changes in prophylactic policies, including vaccination policies.

2. (a) Notifications shall be made to the contact points set out in Appendix XI.A.

(b) Written notification means notification by mail, fax or e-mail. Notifications by e-mail shall be signed electronically and shall only be sent between the contact points set out in Appendix XI.A.

3. Where a Party has serious concerns regarding a risk to public, animal or plant health, consultations regarding the situation shall, on request, take place as soon as possible and, in any case, within 13 working days. Each Party shall endeavour in such situations to provide all the information necessary to avoid a disruption in trade, and to reach a mutually acceptable solution consistent with the protection of public, animal or plant health. 4. Upon request of a Party, consultations regarding animal welfare shall take place as soon as possible and, in any case, within 20 working days. Each Party shall endeavour, in such situations, to provide all the requested information. 5. Upon request of a Party, consultations referred to in paragraphs 3 and 4 shall be held by video or audio conference. The requesting Party shall ensure the preparation of the minutes of the consultation, which shall be formally approved by the Parties. For purposes of this approval, the provisions of Article 12(5) shall apply. Article 14 Safeguard clause 1. Should the exporting Party take domestic measures to control any cause likely to constitute a serious hazard to human, animal and plant health, the exporting Party, without prejudice to the provisions of paragraph 2, shall take equivalent measures to prevent introduction of the hazard into the territory of the importing Party.


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2. The importing Party may, on serious public, animal or plant health grounds, take provisional transitional measures necessary for the protection of public, animal or plant health. For consignments in transport between the Parties, the importing Party shall consider the most suitable and proportional solution in order to avoid unnecessary disruptions to trade. 3. The Party taking the measures shall notify the other Partythereof within one working day of the decision to implement them. Upon request of either Party, and in accordance with the provisions of Article 13(3), the Parties shall hold consultations regarding the situation within 12 working days of the notification. The Parties shall take due account of any information provided through such consultations and shall endeavour to avoid unnecessary disruption to trade, taking into account, where applicable, the outcome of the provisions of Article 13(3). Article 15 Outstanding issues The principles of this Agreement shall be applied to address outstanding issues falling within its scope, to be listed in Appendix X. The Committee referred to in Article 16 may modify, by means of a decision, Appendix X, and, as appropriate, the other Appendices, to take account of progress made and of new issues identified. Article 16 Joint Management Committee 1. The Joint Management Committee, hereafter called the Committee, established in Article 89(3) of the Association Agreement shall meet within the first year, after the entry into force of this Agreement, and on request of either Party thereafter, not exceeding however a frequency in principle of one meeting a year. If agreed by the Parties, a meeting of the Committee may be held by video or audio-conference. The Committee may also address issues out of session, by correspondence. 2. The Committee shall have the following functions:

a) to monitor the implementation of this Agreement and consider any matter relating to this Agreement, and examine all matters which may arise in relation to its implementation;

b) to review the Appendices to this Agreement, notably in the light of progress made under the

consultations and procedures provided for under this Agreement;

c) in the light of the review provided for in paragraph (b) or as provided in this Agreement, to modify by means of a decision, Appendices I to XII; and

d) in the light of the review provided for in paragraph (b), to make recommendations for

modifications to this Agreement.


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3. The Parties agree to establish technical working groups, when appropriate, consisting of expert-level representatives of the Parties, which shall identify and address technical and scientific issues arising from the application of this Agreement. When additional expertise is required, the Parties may establish ad hoc groups, including scientific groups. Membership of such ad hoc groups need not be restricted to representatives of the Parties. 4. The Committee shall report to the Association Councilestablished under Article 3 of the Association Agreement. 5. The Committee shall adopt at its first meeting its working procedures. Article 17 Facilitation of communication Without prejudice of the provisions of Articles 12, 13, 14 and16, the Committee referred to in Article 16 may agree on an arrangement to facilitate correspondence, exchange of information and associated documents and procedures and operation of the Committee. Article 18 Territorial application This Agreement shall apply, on the one hand, as regardsanimals and animal products, plants and plant products and other goods to the territories of Member States of the Community and, on the other hand to the territory of the Republic of Chile, as laid down in Appendix XII.


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Appendix I COVERAGE Appendix IA ANIMALS AND ANIMAL PRODUCTS 1. MAIN LIVE ANIMAL CATEGORIES I. Equidae (1)

II. Bovine animals (including Bubalus bubalis and Bison) III. Ovine and caprine animals IV. Porcine animals V. Poultry (2)

VI. Live fish VII. Crustaceans VIII. Molluscs IX. Eggs and gametes of live fish X. Hatching eggs XI. Semen-ova-embryos XII. Other mammals XIII. Other birds XIV. Reptiles XV. Amphibians XVI. Other vertebrates XVII. Bees 2. PRODUCTS OF ANIMAL ORIGIN Main product categories I. Fresh meat of domestic species (3) and game (4), including offal and blood for human consumption II. Meat products prepared from meat as defined under I and other products of animal origin for human consumption (minced meat, meat preparations, casings)


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III. Liquid milk and powdered milk for human and not for human consumption IV. Milk products for human and not for human consumption (including colostrum) V. Fishery products for human consumption, including bivalve molluscs and crustaceans VI. Eggs for human consumption, egg products VII. Products produced by bees VIII. Snails and frogs' legs for human consumption IX. Hides or skins of ungulates, wool, hair, bristles, feathers, down, or parts of feathers, game trophies X. Bones, horns, hooves and their by-products other than meals XI. Gelatine for human consumption, raw material for the production of gelatine for human consumption XII. Processed animal proteins (meals and greaves), lard and rendered fats, including fishmeal and fish oil XIII. Blood and blood products of ungulates and poultry (including serum of equidae), amniotic fluid for use in the pharmaceutical industry or for technical use other than in animal feeding stuffs XIV. Pathogenic agents XV. Other animal waste: low-risk raw materials for the pharmaceutical industry or technical use or for use in feeding stuffs (including pet food) XVI. Pet food XVII. Processed and unprocessed manure

______________________________________________________ (1) equidae (including zebras) or asinine species or the offspring of crossings of those species (2) fowl, turkeys, guinea fowl, ducks, geese (3) bovine, porcine, equine, caprine, ovine, poultry (4) farmed game, wild game of the categories leporidae, ungulates, feathered game, other mammals

Appendix IB


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Plants and plant products which are potential carriers of pests Packaging, conveyances, containers, soil and growing mediums and any other organisms, object or material capable of harbouring or spreading pests Appendix IC (1) Animal welfare standards Standards concerning stunning and slaughter of animals Appendix ID Matters to which this Agreement initially does not apply Sanitary measures related to: 1. Food additives (all food additives and colours) 2. Processing aids (1) The Committee referred to in Article 16 shall adopt a working plan, within one year of the entry into force of this Agreement, on the development of other animal welfare standards which are of importance for the Parties. 3. Flavours 4. Irradiation (ionisation) 5. Chemicals originating from the migration of substances from packaging materiāls 6. Labelling of foodstuffs 7. Nutritional labelling 8. Feed additives 9. Animal feeding stuffs 10. Medicated feeds and premixes 11. Genetically Modified Organisms (GMO's) Appendix II COMPETENT AUTHORITIES A. Competent authorities of the Community Control is shared between the national services of the Member States and the European Commission. In this respect the following applies:


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As regards exports to Chile, the Member States are responsible for control of the production circumstances and requirements, including statutory inspections and issuing health (or animal welfare) certifications attesting to the agreed standards and requirements. As regards imports from Chile, the Member States are responsible for control of the compliance of the imports with the Community's import conditions. The European Commission is responsible for overall co-ordination, inspection/audits of inspection systems and the necessary legislative action to ensure uniform application of standards and requirements within the Internal European Market. B. Competent authorities of Chile The Ministry of Agriculture, through the Servicio Agrícola y Ganadero. is the competent authority to administrate all the requirements dealing with: sanitary (animal health) and phytosanitary (plant health) measures applied to the import and export of animal, plants and their products; sanitary and phytosanitary measures issued to reduce the risk for entrance of animal diseases, plant pest, and to control its erradication or spread; and the issuing of the sanitary and phytosanitary export certificates for animal and plant products. The Ministry of Health is the competent authority for the sanitary control of all the foods, of national production and of import, dedicated to human consumption and of the sanitary certification of elaborated nutritious products for export, except for the hidrobiological products. The Servicio Nacional de Pesca dependent of the Ministry of Economy is the competent authority for controlling the sanitary quality of seafood products for export and for issuing the corresponding official certificates. It is also responsible for protecting the health status of aquatic animals, the sanitary certification of aquatic animals for export, and the control of imports of aquatic animals, bait and food used in aquaculture. Appendix III LISTS OF NOTIFIABLE DISEASES AND PESTS FOR WHICH REGIONAL FREEDOM CAN BE RECOGNISED Appendix IIIA Animal and fish diseases subject to notification, for which the status of the Parties is recognised and for which regionalisation decisions may be taken

Chile legal basis Diseases Community legal basis General Specifics


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Foot-and-mouth disease

Directives 85/511, 64/432, 82/894

1) Decreto Ley No 176/24 2) Decreto Supremo del Ministerio Agricultura, Industria y Colonización No 318/25 3) Decreto con Fuerza de Ley Reglamento Reforma Agraria del Ministerio de Hacienda No 16/63 4) Decreto Supremo del Ministerio de Agricultura No 46/78 5) Resolución del Servicio Agrícola y Ganadero, SAG, No 1254/91 6) Resolución del Servicio Agrícola y Ganadero, SAG, No 3138/ 99 7) Resolución del Servicio Agrícola y Ganadero No 1150/2000

Resoluciones del Servicio Agrícola y Ganadero: No 1487/92, 1692/92, 2404/96, 1447/95, 1042/99, 2738/99, 2405/96, 624/99, 1483/92, 1260/96, 1995/97, 487/00, 1446/95, 685/94, 1994/94, 1066/97, 937/95, 431/98, 2935/98, 938/91

Swine vesicular disease

Directives 92/119, 64/432, 82/894

1) Decreto Ley No 176/24 2) Decreto Supremo del Ministerio Agricultura, Industria y Colonización No 318/25 3) Decreto con Fuerza de Ley Reglamento Reforma Agraria del Ministerio de Hacienda No 16/63 5) Resolución del Servicio Agrícola y Ganadero, SAG, No 1254/91 6) Resolución del Servicio Agrícola y Ganadero, SAG, No 3138/99 7) Resolución del Servicio Agrícola y Ganadero No 1150/2000

Resoluciones del Servicio Agrícola y Ganadero No 685/94, 1066/97, 25/00, 3397/98, 2379/97, 24/00


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Vesicular stomatitis

Directives 92/119, 82/894


Resoluciones del Servicio Agrícola y Ganadero No: 1487/92, 1692/92, 2404/96, 1447/95, 1042/99, 2738/99, 2405/96, 624/99, 1483/92, 1260/96, 1995/97, 487/00, 1446/95, 685/94, 1994/94, 1066/97, 937/95, 431/98, 2935/98, 938/91

African horse sickness

Directives 90/426, 92/35, 82/894


Resoluciones del Servicio Agrícola y Ganadero: No 1486/92, 1258/96, 1808/90, 3274/94, 2854/95, 3393/96, 2496/94, 1806/90, 431/98

African swine fever


1) Decreto Ley No 176/24 2) Decreto Supremo del Ministerio Colonización Agricultura, Industria y No 318/25 3) Decreto con Fuerza de Ley Reglamento Reforma Agraria del Ministerio de Hacienda No 16/63 5) Resolución del Servicio Agrícola y Ganadero, SAG, No 1254/91 6) Resolución del Servicio

Resoluciones del Servicio Agrícola y Ganadero No :685/94, 1066/97, 25/00, 3397/98, 2379/97, 24/00


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Agrícola y Ganadero, SAG, No 3138/99 7) Resolución del Servicio Agrícola y Ganadero No 1150/2000

Bluetongue Directives 92/119, 82/894

1) Decreto Ley No 176/24 2) Decreto Supremo del Ministerio Colonización Agricultura, Industria y No 318/25 3) Decreto con Fuerza de Ley Reglamento Reforma Agraria del Ministerio de Hacienda No 16/63 5) Resolución del Servicio Agrícola y Ganadero, SAG, No 1254/91 6) Resolución del Servicio Agrícola y Ganadero, SAG, No 3138/99 7) Resolución del Servicio Agrícola y Ganadero No 1150/2000


Highly pathogenic Avian influenza

Directives 92/40, 90/539, 82/894


Resoluciones del Servicio Agrícola y Ganadero: No 4019/97, 1550/98, 2809/96, 3601/96, 1654/95, 685/93, 1597/97, 431/98


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Newcastle disease (NCD)

Directives 92/66, 90/539, 82/894


Resoluciones del Servicio Agrícola y Ganadero: No 4019/97, 1550/98, 2809/96, 3601/96, 1654/95, 685/93, 1597/97, 431/98

Peste des petits ruminants

Directive 92/11


Resoluciones del Servicio Agrícola y Ganadero: No 1483/92, 1260/96, 1995/97, 1446/95, 35/01, 55/9, 1725/90

Rinderpest Directives 92/119, 64/432, 82/894

1) Decreto Ley No 176/24 2) Decreto Supremo del Ministerio Colonización Agricultura, Industria y No 318/25 3) Decreto con Fuerza de Ley Reglamento Reforma Agraria del Ministerio de Hacienda No 16/63 5) Resolución del Servicio Agrícola y Ganadero, SAG, No 1254/91 6) Resolución del Servicio Agrícola y Ganadero,



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SAG, No 3138/99 7) Resolución del Servicio Agrícola y Ganadero No 1150/2000

Classical swine fever

Directives 80/217, 82/894, 64/432, 2001/89


Resoluciones del Servicio Agrícola y Ganadero No 685/94, 1066/97, 25/00, 3397/98, 2379/97, 24/00

Contagious bovine pleuro-pneumonia



Resoluciones del Servicio Agrícola y Ganadero: No 1487/92, 1692/92, 2404/96, 1447/95, 2738/99, 2405/96, 624/99, 2374/97, 1259/96, 1720/95, 1688/92, 1465/95, 2434/94

Sheep and goat pox


1) Decreto Ley No 176/24 2) Decreto Supremo del Ministerio Colonización Agricultura, Industria y No 318/25 3) Decreto con Fuerza de Ley Reglamento Reforma Agraria del Ministerio de Hacienda No 16/63 5) Resolución del Servicio

Resoluciones del Servicio Agrícola y Ganadero: No 1483/92, 1260/96, 1446/95, 1995/97, 35/01, 55/99


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Agrícola y Ganadero, SAG, No 1254/91 6) Resolución del Servicio Agrícola y Ganadero, SAG, No 3138/99 7) Resolución del Servicio Agrícola y Ganadero No 1150/2000

Rift Valley fever Directives 92/119, 82/894


Resoluciones del Servicio Agrícola y Ganadero: No 1487/92, 1692/92, 2404/96, 1447/95, 2738/99, 2405/96, 624/99, 1483/92, 1260/96, 1995/97, 1446/95, 2374/97, 1259/96, 1720/95, 1688/92, 1465/95, 2434/94

Lumpy skin disease





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Venezuelan equine encephalomyelitis

Directive 90/426


Resoluciones del Servicio Agrícola y Ganadero: No 1486/92, 1258/96, 1808/90, 3274/94, 2854/95, 3393/96, 2496/94

Glanders Directive 90/426


Resoluciones del Servicio Agrícola y Ganadero:No 1486/92, 1258/96, 1808/90, 3274/94, 2854/95, 3393/96, 2496/94, 1806/90, 431/98

Dourine Directive 90/426

1) Decreto Ley No 176/24 2) Decreto Supremo del Ministerio Colonización Agricultura, Industria y No 318/25 3) Decreto con Fuerza de Ley Reglamento Reforma Agraria del Ministerio de Hacienda No 16/63 5) Resolución del Servicio Agrícola y Ganadero, SAG, No 1254/91 6) Resolución del Servicio Agrícola y Ganadero,

Resoluciones del Servicio Agrícola y Ganadero:No 1486/92, 1258/96, 1808/90, 3274/94, 2854/95, 3393/96, 2496/94, 1806/90, 431/98


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SAG, No 3138/99 7) Resolución del Servicio Agrícola y Ganadero No 1150/2000

Enterovirus encephalomyelitis

Directive 82/894


Resoluciones del Servicio Agrícola y Ganadero: No 685/94, 1066/97, 25/00, 3397/98, 2379/97, 24/00

Infectious haematopoietic necrosis (IHN)



Decreto Supremo del Ministerio de Economía No 430/91

Viral haemorrhagic septicaemia (VHS)

Directive 91/67


Infectious Salmon Anaemia (ISA)




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Bonamia ostreae Directives 91/67 and 95/70


Morteilla refringens

Directives 91/67 and 95/70


Appendix III B Pests subject to notification, for which the status of the Parties is recognised and for which regionalisation decisions may be taken (1) As regards the situation in Chile: 1. Pests not known to occur in any part of Chile. 2. Pests known to occur in Chile and under official control. 3. Pest known to occur in Chile, under official control and for which pest free areas are established. As regards the situation in the European Community: 1. Pests not known to occur in any part of the Community and relevant for the entire Community, or for part of it. 2. Pests known to occur in the Community and relevant for the entire Community. 3. Pests known to occur in the Community and for which pest free areas are established. (1) The Committee referred to in Article 16 shall complete these lists by means of a decision.

Appendix IV REGIONALISATION AND ZONING A. Animal and fish diseases 1. Animal diseases The basis for recognition of the animal disease status of a Party or a region thereof shall be the International Animal Health Code of the OIE:”Recognition of the disease/infection free status of a country or a zone and epidemiological surveillance systems”. The basis for regionalisation decisions for an animal disease shall be the International Animal Health Code of the OIE: „Zoning and regionalisation”. 2. Aquaculture diseases The basis for regionalisation decisions for aquaculture diseases shall be the International Aquatic Health Code of the OIE.


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B. Pests The criteria for the establishment of a region free from certain pests shall comply with the provisions of either:

− the FAO International Standard for Phytosanitary Measures No 4 on Requirements for the establishment of pest free areas and the relevant definitions of the FAO International Standard for Phytosanitary Measures No 5 on Glossary of phytosanitary terms.;

− or Article 2(1)(h) of Council Directive 2000/29/EC.

C. Criteria for the recognition of the special status for animal diseases of the territory or a region of a Party 1. Where the importing Party considers that its territory or part of its territory is free from an animal disease other than those listed in Appendix III A, it shall present to the exporting Party appropriate supporting documentation, setting out in particular the following criteria:

− the nature of the disease and the history of its occurrence in its territory;

− the results of surveillance testing based on serological, microbiological, pathological or epidemiological investigation and on the fact that the disease must by law be notified to the competent authorities;

− the period over which the surveillance was carried out; − where applicable, the period during which vaccination against the disease has been prohibited

and the geographical area concerned by the prohibition; − the arrangements for verifying the absence of the disease.

2. The additional guarantees, general or specific, which may be required by the importing Party must not exceed those, which the importing Party implements nationally. 3. The Parties shall notify each other of any change in the criteria specified in paragraph 1 which relate to the disease. The additional guarantees defined in accordance with paragraph 2 may, in the light of such notification, be amended or withdrawn by the Committee referred to in Article 16 of this Agreement. Appendix V PRIORITY SECTORS OR SUB-SECTORS FOR WHICH EQUIVALENCE MAY BE RECOGNISED AND CONDITIONS AND PROVISIONS FOR PROVISIONAL APPROVAL OF ESTABLISHMENTS A. Priority sectors or sub-sectors in order of priority for which equivalence may be recognised List of priorities referred to in Article 7(4), to be completed by the Committee referred to in Article 16. B. Conditions and provisions for provisional approval of establishments


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1. Provisional approval of establishments means that the importing Party for the purpose of import approves provisionally the establishments in the exporting Party on the basis of the appropriate guarantees provided by that Party without prior inspection by the importing Party of the individual establishments in accordance with the provisions of paragraph 4. With the same procedure and under the same conditions, the Parties shall modify or complete the lists provided for in paragraph 2 to take account of new applications and guarantees received. Only as regards the initial list of establishments verification may be part of the procedure in accordance with the provisions of paragraph 4(d). The provisional approval shall initially be limited to the following categories of establishments. 2. The provisional approval shall initially be limited to the following categories of establishments: Slaughter houses for fresh meat of domestic species (Appendix IA.2.I); All establishments except slaughterhouses for fresh meat of domestic species; All establishments for fresh meat of wild and farmed game; All establishments for poultry meat; All establishments for meat products of all species; All establishments for other products of animal origin for human consumption (e.g. casings, meat preparations, minced meat); All establishments for milk and milk products for human consumption; Processing establishments and factory vessels for fishery products for human consumption including bivalve molluscs and crustaceans; Processing establishments for fish meal and fish oil; Processing establishments for gelatine; All establishments for eggs and ovo products. 3. The importing Party shall draw up lists of provisionally approved establishments and shall make these lists publicly available. 4. Conditions and procedures for provisional approval:

a) If import of the animal product concerned from the exporting Party has been authorised by the importing Party and the relevant import conditions and certification requirements for the products concerned have been established.

b) If the competent authority of the exporting Party has provided the importing Party with

satisfactory guarantees that the establishments appearing on its list or lists meet the relevant health requirements of the importing Party and have officially approved the establishment appearing on the lists for exportation to the importing Party.


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c) The competent authority of the exporting Party must have a real power to suspend the activities for exportation to the importing Party from an establishment for which that authority has provided guarantees, in the event of non-compliance with the said guarantees.

d) Verification in accordance with the provisions of Article 10 of the Agreement by the

importing Party may be part of the provisional approval procedure. This verification concerns the structure and organisation of the competent authority responsible for the approval of the establishment as well as the powers available to that competent authority and the guarantees that it can provide in regard to the implementation of importing Party's rules. These checks may include on the spot inspection of a certain representative number of establishments appearing on the list or lists provided by the exporting Party. Taking into account the specific structure and division of competence within the Community, such verification in the Community may concern individual Member States.

e) Based on the results of the verification provided for in (d), the importing Party may amend the existing list of establishments.

Appendix VI PROCESS OF DETERMINATION OF EQUIVALENCE 1. Principles

a) Equivalence can be determined for an individual measure and/or groups of measures and/or systems related to a certain commodity or categories of commodities.

b) The consideration of equivalence by the importing Party of a request by the exporting Party

for recognition ofits measures with regards to a specific commodity shall not be a reason to disru pt trade or suspend on-going imports from the exporting party of the commodity in question.

c) Determination of equivalence of measures is an interactive process between the exporting

Party and the importing Party. The process consists of an objective demonstration of equivalence of individual measures by the exporting Party and the objective assessment of this demonstration with a view to the possible recognition of equivalence by the importing Party.

d) The final recognition of equivalence of the relevant measures of the exporting Party rests

solely with the importing Party. 2. Preconditions

a) The exporting Party can only initiate the process of determination of equivalence when the importing Party has recognised the exporting Party for import of the commodity for which equivalence is sought in its agreed country list. The listing depends on the health or pest status, the legislation and the effectiveness of the inspection and control system related to the commodity in the exporting Party. To this end the legislation in the sector concerned shall be taken into account, as well as the structure of the competent authority of the


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exporting Party, its command chain, its authority, its operational procedures and resources, and the performance of thecompetent authorities as regards inspection and control system s, including its level of enforcement related to the commodity and the regularity and rapidity of information to the importing Party in case of identified hazards. This recognition may be supported by documentation, verification and earlier documented experience.

b) The Parties shall initiate the process of determination of equivalence based upon the

priorities established in Appendix V.A. c) The exporting Party shall only initiate the process when no safeguard measures imposed by

the importing Party apply to the exporting Party as regards the commodity.

3. The process

a) The exporting Party initiates the process by submitting to the importing Party a request for recognition of equivalence of an individual measure and/or groups of measures and/or systems for a commodity or a category of commodities in a sector or sub-sector.

b) When appropriate, this request includes also the request and required documentation for

approval by the importing Party on the basis of equivalence of any programme or plan of the exporting Party required by the importing Party as a condition for allowing import of that commodity (e.g. residue plan).

c) With this request, the exporting Party:

(i) explains the importance for trade of that commodity; (ii) identifies the individual measure(s) with which it can comply with out of the total of the measures expressed in the import conditions of the importing Party applicable to that commodity; (iii) identifies the individual measure(s) for which it seeks equivalence out of the total of the measures expressed in the import conditions of the importing Party, applicable to that commodity;

d) In reply to this request the importing Party explains the overall and individual objective and the rationale behind its measure(s), including the identification of the risk.

e) With this explanation, the importing Party informs the exporting Party on the relationship of its domestic measures and the import conditions for that commodity. f) The exporting Party objectively demonstrates to the importing Party that the measures that it has identified are equivalent to the import conditions for that commodity. g) The importing Party objectively assesses the demonstration of equivalence by the exporting party. h) The importing Party concludes whether equivalence is achieved or not.


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i) The importing Party provides to the exporting Party full explanation and supporting data for its determination and decision if so required by the exporting Party.

4. Demonstration of equivalence of measures by the exporting party and assessment of this demonstration by the importing Party

a) The exporting Party shall objectively demonstrate equivalence for each of the identified measures of the importing Party expressed in its import conditions. When appropriate, equivalence shall objectively be demonstrated for any plan or programme required by the importing Party as a condition to allow import (e.g. residue plan, etc).

b) Objective demonstration and assessment in this context should be based, as far as possible,

on: − internationally recognised standards; and/or − standards based on proper scientific evidence; and/or

− risk assessment; and/or

− objective earlier documented experience; and

− legal status or level of administrative status of the measures; and

− level of implementation and enforcement on the basis of in particular:

− corresponding results of surveillance and monitoring programmes;

− inspection results by the exporting Party;

− results of analysis with recognised analysis methods;

− verification and import check results by the importing Party;

− the performance of the competent authorities of the exporting Party; and

− earlier experiences.

5. Judgement by the importing Party In case the importing Party arrives at a negative conclusion, it shall provide the exporting Party with an explanation.


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Appendix VII GUIDELINES FOR CONDUCTING VERIFICATIONS Verifications may be carried out on the basis of or audits and/or on the spot checks. For the purposes of this Appendix:

a) the auditee is the Party subject to the verification;

b) the auditor is the Party that carries out the verification. 1. General principles of verification 1.1. Verifications should be made in Cooperation between the auditor and the auditee in accordance with the provisions set out in this Appendix. 1.2. Verifications should be designed to check the effectiveness of the controls of the auditee rather than to reject individual animals, groups of animals, consignments of food establishments or individual lots of plants or plant products. Where verification reveals a serious risk to animal, plant or human health, the auditee shall take immediate corrective action. The process may include study of the relevant regulations, method of implementation, assessment of the end result, level of compliance and subsequent corrective actions. 1.3. The frequency of verifications should be based on performance. A low level of performance should result in an increased frequency of verifications; unsatisfactory performance must be corrected by the auditee to the auditor's satisfaction. 1.4. Verifications, and the decisions based on them, shall be made in a transparent and consistent manner. 2. Principles relating to the auditor The auditors should prepare a plan, preferably in accordance with recognised international standards, that covers the following points: 2.1. the subject, depth and scope of the verification; 2.2. the date and place of the verification, along with a timetable up to and including the issue of the final report; 2.3. the language or languages in which the verification will be conducted and the report written; 2.4. the identity of the auditors including, if a team approach is used, the leader. Specialised professional skills may be required to carry out verification of specialised systems and programmes; 2.5. a schedule of meetings with officials and visits to establishments or facilities, as appropriate. The identity of establishments or facilities to be visited need not be stated in advance;


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2.6. subject to provisions on freedom of information, respect of commercial confidentiality shall be observed by the auditor. Conflicts of interest must be avoided; 2.7. respect of the rules governing occupational health and safety, and the rights of the operator. This plan should be reviewed in advance with representatives of the auditee. 3. Principles relating to the auditee The following principles apply to actions taken by the auditee, in order to facilitate verification: 3.1. The auditee must Cooperate fully with the auditor and should nominate personnel responsible for this task. Cooperation may include, for example:

− access to all relevant regulations and standards, − access to compliance programmes and appropriate records and documents, − access to audit and inspection reports, − documentation concerning corrective actions and sanctions, − facilitating entry to establishments.

3.2. The auditee must operate a documented programme to demonstrate to the auditor that standards are being met on a consistent and uniform basis. 4. Procedures 4.1. Opening meeting An opening meeting should be held between representatives of the Parties. At this meeting the auditor will be responsible for reviewing the verification plan and confirming that adequate resources, documentation, and any other necessary facilities are available for conducting the verification. 4.2. Document review The document review may consist of a review of the documents and records referred to in paragraph 3.1, the structures and powers of the auditee, and any relevant changes to inspection and certification systems since the entry into force of this Agreement or since the previous verification, with emphasis on the implementation of elements of the system of inspection and certification for animals, animal products plants or plant products of interest. This may include an examination of relevant inspection and certification records and documents. 4.3. On the spot checks 4.3.1. The decision to include this step should be based on a risk assessment, taking into account factors such as the animals, animal products, plants or plant products concerned, the history of conformity with requirements bythe industry sector or exporting country, the volume of product produced and imported or exported, changes in infrastructure and the national inspection and certification systems.


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4.3.2. On the spot checks may involve visits to production and manufacturing facilities, food-handling or storage areas and control laboratories to check on compliance with the information contained in the documentary material referred to in 4.2. 4.4. Follow-up verification Where a follow-up verification is being conducted in order to verify the correction of deficiencies, it may be sufficient to examine only those points which have been found to require correction. 5. Working documents Forms for reporting audit findings and conclusions should be standardised as much as possible in order to make the approach to verification more uniform, transparent and efficient. The working documents may include any checklists of elements to evaluate. Such checklists may cover:

− legislation; − structure and operations of inspection and certification services; − establishment details and working procedures, - health statistics, sampling plans

and results; − compliance action and procedures; − reporting and complaint procedures; and − training programmes.

6. Closing meeting A closing meeting shall be held between representatives of the Parties, including, where appropriate, officials responsible for the national inspection and certification programs. At this meeting the auditor shall present the findings of the verification. The information shall be presented in a clear, concise manner so that the conclusions of the audit are clearly understood. An action plan for correction of any deficiencies noted shall be drawn up by the auditee, preferably with target dates for completion. 7. Report The draft report of verification shall be forwarded to the auditee within 20 working days. The auditee shall have 25 working days to comment on the draft report. Comments made by the auditee shall be attached to and, where appropriate included in the final report. However, where a significant public, animal or plant health risk has been identified during the verification, the auditee shall be informed as quickly as possible and in any case within 10 working days following the end of the verification.


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Appendix VIII IMPORT CHECKS AND INSPECTION FEES A. Principles of import checks Import checks consist of documentary checks, identity checks and physical checks As regards animals and animal products, the physical checks and its frequency applied shall be based on the risk associated with such imports. In carrying out the checks for plant health purposes, the importing Party shall ensure that the plants, plant products and other goods and their packaging shall be meticulously inspected on an official basis, either in theirentirety or by representative sample, and that if necessary the vehicles transporting them shall be inspected meticulously on an official basis in order to make sure, as far as can be determined, that they are not contaminated by pests. In the event that the checks reveal non-conformity with the relevant standards and/or requirements, the importing Party shall take official measures proportionate to the risk involved. Wherever possible, the importer or his representative shall be given access to the consignment and the opportunity to contribute any relevant information to assist the importing Party in taking a final decision concerning the consignment. Such decision shall be proportional to the risk. B. Frequencies of physical checks B.1. Animals and animal products (a) Import into the Community Type of frontier check Frequency Rate 1. Documentary checks 100 % 2. Identity checks 100 % 3. Physical checks

Live animals 100 % Category I products Fresh meat including offal, and products of the bovine, ovine, caprine, porcine and equine species defined in Council Directive 92/5/EEC. Fish products in hermetically sealed containers intended to render them stable at ambient temperatures, fresh and frozen fish and dry and/or salted fisheries products Whole eggs Lard and rendered fats Animal casings Hatching eggs

20 %

Category II products Poultry meat and poultry meat products Rabbit meat, game meat (wild/farmed) and products thereof Milk and milk products for human consumption

50 %


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Egg products Processed animal protein for human consumption Other fisheries products than those mentioned under 20 % Bivalve molluscs Honey Category III products Semen Embryos Manure Milk and milk products (not for human consumption) Gelatin Semen Embryos Manure Milk and milk products (not for human consumption) Gelatin Frog's legs and snails Bones and bone products Hides and skins Bristles, wool, hair and feathers Horns, horn products, hooves and hoof products Apiculture products Game trophies Processed petfood Raw material for the manufacture of petfood Raw material, blood, blood products, glands and organs for pharmaceutical or technical use Hay and straw Pathogens Processed animal protein (packaged)

Minimum of 1 % Maximum of 10 %

Processed animal protein not for human consumption (bulked)

100 % for the first six consignments (Council Directive 92/118/EEC), then 20 %

(b) Import into Chile Type of frontier check Frequency Rate 1. Documentary checks Inspection of all the documents related with the shipment, including the certification which guarantees the compliance of the sanitary requirements.

Sanitary Inspection Inspection of livestock, products of animal origin and products for animal consumption. It involves all the actions aimed to assess thesanitary status of animals and animal products and verify that the same have been processed for the compliance of the sanitary requirements.


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Live animals Documentary checks 100 % Sanitary inspection 100 %

Semen and embryo Documentary checks 100 % Sanitary inspection 100 %

Animal products for human consumption Documentary checks 100 % Sanitary inspection 100 %

Animal products not for human consumption Documentary checks 100 % Sanitary inspection 100 %

Processed animal proteins not for human consumption Documentary checks 100 % Sanitary inspection 100 %

Food used in aquaculture Documentary check 100 % Identity check 5 % Physical check 0 %

Aquatic animals Documentary check 100 % Identity check 20 % Physical check: According to the country of origin (Decree No 626, 2001); 100 % official authority not recognised (quarantine); 0 % official authority recognised

Raw materials for reprocessing Documentary check 100 % Identity check 10 % Physical check 100 % marine toxins for shellfish and other susceptible species.

Bait Documentary check 100 % Identity check 10 % Physical check 0 %


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B.2. Plants and plant products (a) Import into the Community For plants, plant products and other goods listed in Annex V, Part B to Council Directive 2000/29/EC: Type of frontier check Frequency rate 1. Documentary checks The documentary checks shall be carried out for 100%

2. Identity checks The identity checks shall be carried out for 100 % 3. Physical checks The plants, plant products and other goods, and their

packaging shall be meticulously inspected on an official basis, either in their entirety or by representative sample, and that if necessary the vehicles transporting them shall also be inspected meticulously on an official basis in order to make sure, as far as can be determined, that they are not contaminated by pests

For plants, plant products and other goods not listed in Annex V, Part B to Council Directive 2000/29/EC: The importing party may, on a variable basis, carry physical checks in order to make sure, as far as can be determined, that they are not contaminated by pests. (b) Import into Chile Type of frontier checks Documentary checks concerns inspection of all the documents related with every consignment for determine compliance with phytosanitary certification. Verification concerns inspection of consignments for determines the degree of industrialisation or transformation (for instance verify if a product is frozen, or dried, toasted, etc). Phytosanitary inspection is a set of actions for determine the compliance of phytosanitary requirements. Reception concerns international conveyances for the determination of the phytosanitary status Plants, plants products and other goods that represent a phytosanitary risk

Type of frontier check Rate

Seeds, plants and parts of plants whose intended use is propagation, reproduction or to be planted

Documentary checks Phytosanitary inspection

100 % 100 %

Organism and microrganism used in Biological Control, polinisers, producers of certain substances or investigation


100 % 100 %

Plants products


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Plant material whose matter was submitted to one or more process of elaboration or industrialisation, that implies a transformation of the original characteristics, and as a consequence can not be affected directly by pest but can transport it or suffer infestation by the store conditions

Documentary checks Verification

100 % variable % (< 100 %)

Plant material whose matter despite being submitted to a process or industrialisation, can be affected by pest or harbouring pest

Documentary checks Verification

100 % 100 %

Fresh plants products whose intended use is consumption, by direct use or transformation, can be affected by pest or harbouring pest


100 % 100 %

Other goods that represent a phytosanitary risk:

Growing medias Documentary checks Phytosanitary inspection

100 % 100 %

Biofertilisers Documentary checks Phytosanitary inspection

100 % 100 %

Conveyances Reception 100 % Wood packaging materials Phytosanitary inspection Variable

percentage Containers Phytosanitary inspection Variable

percentage Used agricultural machine Phytosanitary inspection 100 %

Appendix IX CERTIFICATION A. Principles of certification Plants and plant products and other goods: In respect of certification of plants and plant products and other goods, the competent authorities shall apply the principles laid down in the FAO International Standards for Phytosanitary Measures No 7 Export Certification System and No 12 .Guidelines for Phytosanitary Certificates.

Animals and animal products: 1. The competent authorities of the Parties shall ensure that certifying officers have a satisfactory knowledge of the veterinary legislation as regards the animals or animal products to be certified and, in general, are informed as to the rules to be followed for drawing up and issuing the certificates and if necessary as to the nature and extent of the enquiries, tests or examinations which should be carried out before certification.


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2. Certifying officers must not certify data of which they have no personal knowledge or which cannot beascertained by them. 3. Certifying officers must not sign blank or incomplete certificates, or certificates relating to animals or animal products, which they have not inspected or which have passed out of their control. Where a certificate is signed on the basis of another certificate or attestation, the certifying officer shall be in possession of that document before signing. 4. A certifying officer may certify data which have been:

a) ascertained on the basis of paragraphs 1 to 3 by another person so authorised by the competent authority and acting under the control of that authority, provided that certifying authority can verify the accuracy of the data; or

b)obtained, within the context of monitoring programmes, by reference to officially recognised

quality assurance schemes or by means of epidemiological surveillance system where this is authorised under veterinary legislation.

5. The competent authorities of the Parties shall take all necessary steps to ensure the integrity of certification. In particular they shall ensure that certifying officers designated by them:

a) have a status which ensures their impartiality and have no direct commercial interest in the animals or products being certified or in the holdings or establishments in which they originate; and

b)are fully aware of the significance of the contents of each certificate which they sign.

6. Certificates shall be drawn up as to ensure a link between the certificate and the consignment, at least in a language understood by the certifying officer and at least in one of the official languages of the importing Party as set out in C. 7. Each competent authority shall be in a position to link certificates with the relevant certifying officer and ensure that a copy of all certificates issued is available for a period to be determined by it. 8. Each Party shall introduce such checks and have such control measures taken as are necessary to prevent the issuing of false or misleading certification and the fraudulent production or use of certificates purported to be issued for the purposes of veterinary legislation. 9. Without prejudice to any legal proceedings or penalties, the competent authorities shall carry out investigations or checks and take appropriate measures to penalise any instances of false or misleading certification, which are brought to their attention. Such measures may include the temporary suspension of the certifying officers from their duties until the investigation is over. In particular:

a) if it is found in the course of the checks that a certifying officer has knowingly issued a fraudulent certificate, the competent authority shall take all necessary steps to ensure, as far as is possible, that the person concerned cannot repeat the offence;


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b) if it is found in the course of the checks that an individual or an undertaking has made fraudulent use of or has altered an official certificate, the competent authority shall take all necessary measures to ensure, as far as possible, that the individual or undertaking cannot repeat the offence. Such measures may include a refusal subsequently to issue an official certificate to the person or undertaking concerned.

B. Certificate referred to in Article 8(3) The health attestation in the certificate reflects the status of equivalence of the commodity concerned. The health attestation states compliance with the production standards of the exporting Party recognised equivalent by the importing Party. C. Official languages for certification Import into Community Plants, plant products and other goods: The certificate must be drawn up in at least one of the official languages of the Community and preferably in one of the official languages of the Member State of destination. Animals and animal products: The health certificate must be drawn up in at least one of the official languages of the Member State of destination and in one of those of the Member State in which the import checks provided for in Article 11 are carried out. Import into Chile The health certificate must be drawn up in Spanish or another language, in which case a translation into Spanish must be provided. Appendix X OUTSTANDING ISSUES To be considered by the Committee referred to in Article 16 for completion. Appendix XI CONTACT POINTS AND WEB-SITES A. Contact points For Chile: Departamento Acceso a Mercados Dirección General de Relaciones Económicas Internacionales (DIRECON) Ministerio de Relaciones Exteriores Teatinos 20, piso 2 Santiago


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Chile Tel: (56-2) 5 65 90 09 Fax: (56-2) 6 96 06 39 Other important contacts: Departamento de Asuntos Económicos con Europa Dirección General de Relaciones Económicas Internacionales (DIRECON) Ministerio de Relaciones Exteriores Teatinos 20, piso 3 Santiago Chile Tel: (56-2) 5 65 93 67 Fax: (56-2) 5 65 93 66 Jefe Departamento de Protección Pecuaria Servicio Agrícola y Ganadero (SAG) Ministerio de Agricultura Av. Bulnes 140, piso 7 Santiago Chile Tel: (56-2) 6 88 61 83 Fax: (56-2) 6 71 61 84 Jefe Departamento de Protección Agrícola Servicio Agrícola y Ganadero (SAG) Ministerio de Agricultura Av. Bulnes 140, piso 3 Santiago Chile Tel: (56-2) 6 96 85 00 Fax: (56-2) 6 96 64 80 Departamento Asuntos Internacionales Servicio Agrícola y Ganadero (SAG) Ministerio de Agricultura Av. Bulnes 140, piso 6 Santiago Chile Tel: (56-2) 6 88 38 11 Fax: (56-2) 6 71 74 19 Jefe Departamento Sanidad Pesquera Servicio Nacional de Pesca (SERNAPESCA) Ministerio de Economía Victoria 2832 Valparaiso Chile Tel: (56-32) 81 92 03 Fax: (56-32) 81 92 00


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Jefe División de Rectoría y Regulación Sanitaria Ministerio de Salud Estado 360 piso 8 Santiago Chile Tel: (56-2) 6 30 04 88 . 6 30 04 89 Fax: (56-2) 6 38 35 62 For the Community: The Director DG SANCO Directorate E Food safety: plant health, animal health and welfare, International questions European Commission Mail: Rue de la Loi 200 B-1049 Brussels Belgium Office: Rue Froissart 101 B-1040 Brussels Belgium Tel: (32) 22 96 33 14 Fax: (32) 22 96 42 86 Other important contacts: The Director DG SANCO Directorate D Food safety: production and distribution chain European Commission Mail: Rue de la Loi 200 B-1049 Brussels Belgium Office: Rue Belliard 232 B-1040 Brussels Belgium Tel: (32) 22 95 34 30 Fax: (32) 22 95 02 85 The Director DG SANCO Directorate F Food and Veterinary Office Grange Dunsany Co Meath Ireland Tel: (353) 4 66 17 58 Fax: (353) 4 66 18 97 B. Contact points for e-mail For Chile: [email protected] For the Community: [email protected]

C. Fee free web-sites


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For Chile: http://www.sernapesca.cl/Sanidad/Pagina_del_departamento.htm http://www.sag.gob.cl http://www.direcon.cl For the Community: http://europa.eu.int/comm/dgs/health_consumer/index_en.htm Appendix XII TERRITORIAL APPLICATION For the Community The territories of Member States of the Community as laid down in Annex I to Council Directive 97/78/EC and as regards plants, plant products and other goods in Article 1 of Council Directive2000/29/EC. For Chile As provided for in Article 204 of the Association Agreement

analytical paper

Documents

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european unionthe project

legal framework

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vthe project

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