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EU REQUIREMENTS FOR THIRD COUNTRIES

EXPORTING FOOD TO THE EU

CTA Briefing on Food Safety Standards

Brussels 11/05/2009Jacky Le Goslès

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Scope of presentation

SPS agreement and equivalence

Requirements for third countries exporting food to the EU

Key components for a residue control system

Import controls

FVO inspections

BTFS programme

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The European Union is the world’s largest importer of agricultural and fishery products

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Sanitary & Phytosanitary Agreement

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SPS Agreement

Art. 2.2.measures taken to protect public health…should be Science based and appropriate. Art. 2.3. … should not be an unjustified barrier to trade.Art. 3.1. … based on international standards, guidelines or recommendations, where they exist.Art 3.2. ..higher level of SPS protection possible if there is scientific justification

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SPS - equivalence

Art. 4.1. Members shall accept SPS measures of other Members as equivalent... if the exporting Member objectively demonstrates … that its measures achieve the importing Member's appropriate level of SPS protection.

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EU Food Law (Regulation (EC) No 178/2002)

Equivalence enshrined in Community Food LawArticles 11 and 12: Food and feed imported to the Community shall comply with the relevant requirements of food law or conditions recognised by the Community to be at least equivalent with requirements contained therein

Food shall not be placed on the market if it is unsafe

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Requirements for third countries exporting food of animal origin to the EU

Every country wishing to export food of animal origin (FAO) to the EU must satisfy certain animal health, public health, veterinary

certification and residues requirements. Appear on ‘lists of authorised third countries’

Entire country or regionAuthorised commoditiesApproved establishments

Use of model certificates Food produced in accordance with EU rules

NOT ON RESIDUES LIST = NO EXPORTS

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Import of FAO From Third Countries

specific requirements (e.g. control plan)

control missions

(FVO)

Specific listing

Import control of products

(BIP)

import

country establishmentVessel ZV/FV

Listing

general import & control legislation+

product specific legislation

general listing

Directive 97/78/EC imposes a veterinary control of food and feed products coming from third countries.

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Decision No 4List of establishments

Decision No 2:Specific requirements

Decision No 3:Health certificates (AH and PH)

Request from the third Country

Technical Documentatio

n

Decision No 1:Addition to the list of third countries Standing Committee on

the Food Chain and animal health

Adoption by college of Commissioners

Import FAO From Third Countries

Official Journal

LISTING

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Why does the EU require residues controls in FAO both from Member States and trading partners?

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BECAUSEBECAUSE

Legislative requirement in EU

Public health - food safety

To detect and prevent abuse of drugs

To facilitate trade in animals and animal products

Equivalent standards expected from the EU’s trading partners: Art. 11, Directive 96/22/EC and Art. 29, Directive 96/23/EC)

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Elements of a residue control system

Control systemR

esid

ue t

estin

g La

bora

torie

s

Res

idue

S

urve

illan

ce

(Mon

itorin

g P

lan)

Bor

der

insp

ectio

n po

sts

in t

he E

U

Mem

ber

Sta

tes

Lice

nsin

g an

d co

ntro

ls o

n us

e of

ve

terin

ary

med

icin

esFVO scrutiny

On-the-spot

Desk study

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An approved residue plan is a prerequisite for export of food of animal origin to the EU.

Approved countries are listed in Commission Decision 2004/432/EC

Plans must be submitted to the Commission and approved annually

For third countries

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What food is tested for residues?

Food of animal originLaid down in Community law

Council Directive 96/23/ECMember States test domestic and imported

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Commission Decision 2004/432/EC revised twice in 2007 and twice in 2008

In 2008

10 countries delisted for total of 15 commodities

8 countries were newly listed or relisted for a total of 13 commodities

83 countries now listed

Improved understanding by third countries of EU

requirements

Residue monitoring plan evaluation - outcome

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IMPORT CONTROLS IN EU BORDER INSPECTION POSTS (BIP)

BIPs are approved by the European Commission

BIPs are run by Member States

3 fold control, identification (i), documentary (d) and physical (p)

All consignments should be (i) and (d) controlled.

For most of the authorised TC only for 20% of the consignments are submitted to (p) control

Samples are taken and relevant analyses carried out only randomly (consignments kept until analyses results)

Positive results :rejection or destruction and RASF information

Protective measures (e.g. Histamine analyses on 100% of tuna swordfish consignments)

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http://ec.europa.eu/food/international/trade/guide_thirdcountries2006_en.pdf

All relevant Community legislation may be obtained from:

http://europa.eu.int/eur-lex/lex/en/index.htm

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FVO MISSION INSPECTION/AUDIT METHODS

METHOD: EVALUATION OF THE EFFECTIVENESS OF THE OFFICIAL CONTROL SYSTEM OF FAO EXPORTED TO THE EU (documented system ensuring the 2 above mentioned objectives)

EVALUATION OF THE CA CONTROL ACTIVITY IN ITS OFFICE, files of at least the visited farms, vessels and establishments

SAMPLE OF FARMS/VESSELS/ESTABLISHMENTS IN ORDER TO VERIFY CA CONTROL ACTIVITIES

SOME CHOSEN BY THE CA

SOME CHOSEN BY THE FVO: RASFF, FOLLOW UP OF A PREVIOUS MISSION OR TARGETTED MISSION

VERIFICATION IN SITU (FARMS/VESSELS, ESTABLISHMENTS)

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E.G. MAIN FINDINGS RELATING TO FISHERY PRODUCTS EXPORTED TO THE EU

KNOWLEDGE, IMPLEMENTATION, CONTROL, ENFORCEMENT OF COMMUNITY REQUIREMENTS

CA EFFICIENCY, i.e. inspection frequency, scope, depth, follow-up, enforcement

BUDGET for CONTROLS/ANALYSES

LAB CAPACITIES/QUALITY OF ANALYSES

RESIDUE MONITORING PLAN FOR EXPORTED AQUACULTURE PRODUCTS

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E.G. MAIN FINDINGS RELATING TO FISHERY PRODUCTS EXPORTED TO THE EU (cont.)

RUNNING/POTABLE/CLEAN WATER (ICE)

FRESHNESS OF FISH LANDED

HYGIENE OF OPERATIONS

COLD CHAIN

HYPER-CHLORINATED WATER USE

FP TRACEABILITY:

• FROM VESSELS TO PLANTS

• WITHIN PLANTS

• RAW MATERIAL IMPORTED OR COMING FROM NON « EU APPROVED » VESSELS OR ESTABLISHMENTS

HACCP Plan inappropriate, inadequate/insufficient documentation

NUMBER OF OWN-CHECK ANALYSES AND OFFICIAL ANALYSES

ADDITIVES (crustaceans)

HEALTH STATUS OF STAFF

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FOOD of VEGETAL ORIGIN

Principal results from reports

General Lack of control by CA

Dependance on private standards

Poor performance in laboratories

No/poor controls at export

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Principal Results Pesticides

High frequency of use

Lack of control on GAP or on registered users

Lack of control in application or follow up

Variable MRLs

Poor equipment/analytical capability and poor quality control in laboratories

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Phytosanitary Controls

Problems with understanding of community regulations

Monitoring and official controls limited

Lack of documentation/ tracability

Principal Results

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HOW TO IMPROVE THE SITUATION

Pressure on TC: pre-listing on hold, appropriate and proportionate protective measures, action plans and follow-up (on-desk exercise and FVO missions)CA official training: SANCO programmes, « Better Training for Safer Food » (Indonesia, Colombia and Senegal in 2006, Morocco, Mauritius, UAE, Chile and Viet Nam in 2007, Philippines and Jamaica in 2008)technical assistance provided by Commission services (DEV, AIDCO, TRADE, SANCO) following TC requests

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Import From Third Countries

Import Control: reinforced measures

Test on each arrival/lot Additional costs supported by importers

Listing of • countries• establishments

Results significantly not conformand/ornegative report from FVO

De-listing

Results significantly not conform

Legislation and controls guarantee that exported products comply with EU legislation and consequently that their safety is not compromised

Safegardclause

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BTFS programmeThe programme started in 2005-2006. Commission Communication COM (2006) 519 has identified a long-term steady state of 6,000 participants and budget of €15million annually (around 2011-2012)

0

500

1000

1500

2000

2500

3000

3500

4000

4500

5000

5500

6000

6500

7000

2005 2006 2007 2008 2009 2010 2011 201.

Estimated trend of participants

Starting-up phase

Steady state

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2006 2007 2008

budget Number of training activities training days Number of participants

7.0 M€

3.5 M€

41255

1.400 71

615

2.900

110

800

4.000

9 M€

BTFSEvolution 2006-2008

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BTFS

Food hygiene and controls

3 modules of 5 five-day courses on:

Meat and meat products

Milk and dairy products

Fishery productsFishery products

25 participants per workshop

Theoretical sessions, practical exercises, site visits, discussion as appropriate

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BTFS

Hygiene and controls of fishery products (main subjects)

Organisation of official controls

Live Bivalve Molluscs: controls and applicable legislation

Controls of marine bio-toxins

Primary production

Hygiene requirements in freezers, vessels, processing establishments, fish farms and cold storage

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Africa-EU Joint Strategy

Capacity building activities in the SPS field in Africa

2009-2010 (€10M)

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Activity 1 (OIE)Evaluation of Performance of Veterinary Services + follow-ups

Activity 2 (OIE)Improvement of national / regional legal framework

Activity 3 (OIE)Laboratory capacity (twinning)

Activity 4 (OIE)Training of CVOs / National Focal Points

Activity 5 (AESA Cons.)-12 five-day Regional ‘training of trainers’ workshops:

-2 one-day (opening and closing) conferencesActivity 6 (AESA Cons.)

Sustained missions and ad hoc assistance (e.g. SMEs):1,560 days / 12 experts / 6 Regions (~ 26 countries)

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EU SPS rules for import of food

of animal origin from Third Countries to the EU

SUMMARY

CTA Briefing on Food Safety Standards

Brussels 11/05/2009J. Le Gosles Adviser DG SANCO

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Main Points to keep in mind

Food safety has become more important in the EU

EU first food importer in the world, e.g. More than 50% of fish consumed in EU are imported from TC/DC

Increase of establishments approved for export to the EU ( including freezer and factory vessels in TC)

More added value processed products imported

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Main Points to keep in mind

EU rules based on SPS Agreement principles

Art. 2.2.measures taken to protect public health… should be Science based and appropriate.

Art. 2.3. … should not be an unjustified barrier to trade.

Art. 3.1. … based on international standards, guidelines or recommendations, where they exist.

Art 3.2. ..higher level of SPS protection possible if there is scientific justification

Art. 4.1. : Members shall accept SPS measures of other Members as equivalent... if the exporting Member objectively demonstrates … that its measures achieve the importing Member's appropriate level of SPS protection.

EU and EQUIVALENCEEquivalence enshrined in Community Food Law (Regulation (EC) No 178/2002)

Articles 11 and 12: Food and feed imported to the Community shall comply with the relevant requirements of food law or conditions recognised by the Community to be at least equivalent with requirements contained therein

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Main Points to keep in mind

Import of FAO From Third Countries

specific requirements (e.g. residue monitoring programme)

control missions

(FVO)

Specific listing

Import control of products (BIP)

import

country establishmentVessel ZV/FV

Listingcontrol

missions(FVO)

general import & control legislation+

product specific legislation

general listing

Directive 97/78/EC imposes a veterinary control of food and feed products coming from third countries.

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Decision No 4List of establishments

Decision No 2:Specific requirements

Decision No 3:Health certificates (AH and PH)

Request from the third Country

Technical Documentatio

n

Decision No 1:Addition to the list of third countries Standing Committee on

the Food Chain and animal health

Adoption by college of Commissioners

Main Points to keep in mind

Import of FAO From Third Countries

Official Journal

LISTING

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Main Points to keep in mind

A Competent Authority (or more but need for a very good cooperation/coordination) and laboratory capacities;

Official (documented) controls all along the FAO production chain, including primary production and sampling/analyses

Residue and environmental contaminant monitoring programme;

FBO Establishments

: Structures and equipment requirements, Good Hygiene Practices (SSOPs) and HACCP system in place

Ensuring the eligibility of the FAO exported to the EU (« sanitary » traceability) from primary production to exported consignments;

Better Training for Safer Food (BTFS) programme and Technical Assistance (TA )