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RS Standards Ltd

Benchmark Assessment of

The CHILEAN PAC Standard against the IFIS Standard

At

Corpesca S.A.

Iquique

Chile

By

RS Standards Ltd

CLIENT REPORT

Assessment Date: 27th and 28th August 2014

Assessor: Mike Platt

RS Standards Ltd

Contents

1. Background and Purpose 3

2. Background to RS Standards Ltd 3

3. Benchmark Assessment Analysis and Overview 4

4. PAC Certification Protocol Review 12

5. Discuss points and Concluding Comments to Review 14

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1- Background and Purpose

RS Standards Ltd was commissioned by the Chilean Fishmeal Producers to design and conduct a Benchmark Assessment of their CHILEAN PAC (PAC) Good Manufacturing Standard, to establish if this standard is an equivalence to the International Feed Safety Assurance IFIS (International Feed Ingredient Standard) which is a prerequisite requirement of the IFFO RS programme. RS Standards conducted a full desk top review of PAC Standard against the 2007 version of the IFIS standard prior to an on-site assessment of the standard implementation and certification requirements at one of the Corpesca S.A. sites in Iquique Chile. From this review RS Standards developed a check list to test and verify that the systems in place within the Corpesca site were of suitable credibility to ensure that this PAC Standard was a credible equivalence to the IFIS requirements. The main standards reviewed were

IFIS Standard

Femas Standard

GMP+ Standard In addition, RS Standards was asked to review the certification protocols for the PAC standard to see if credible assurance could be given to meet the stipulated ISO guide 65 soon to be ISO 17065 accreditation requirements. The following report has been produced from the site assessment using this bespoke checklist conducted at the Corpesca S.A. Iquique Site Chile on the 27th and 28th August 2014. The main purpose of this report is to give the IFFO RS Governance Board assurance that the PAC Standard is an equivalence in content and certification to the IFIS prerequisite requirement needed for certification to the IFFO RS Standard.

2- Background to RS Standards Ltd

RS Standards Ltd is a dedicated consultancy business, based out of the EU that operates internationally across all sectors of the supply chain from the point of source to the point of purchase. RS Standards Ltd operates projects and programmes in all Seafood, Agri-food and General Merchandising sectors throughout all parts of the world stretching from Alaska to Australia.

The work of RS Standards Ltd is designed to enhance a client’s economic efficiency, international competitiveness and will contribute to their demand for a sustainable operation.

RS Standards Ltd offers a comprehensive Benchmarking service that will allow companies and organisations to expertly analyse strengths and weaknesses in products, processes and systems such as traceability or allergens, allowing them to confidently take steps to meet expectations and make statements of assurance to stakeholders, business partners and customers.

RS Standards Ltd are an elite team of standards and certification experts that were previously directors and leaders within Global Trust and SAI Global. We have unrivalled experience in Seafood standards and years of experience in the seafood sector.

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3- Benchmark Assessment Overview

The PAC standard is a voluntary Fishmeal and Fish Oil manufacturing assurance programme that has been designed by the Chilean Government National Service for Fisheries and Aquaculture SERNAPESCA.

SERNAPESCA is the competent authority and valid interlocutor with the European Community (EC),

and these EC regulations underpin the standards that govern the Quality Assurance Programme

(PAC) of the plants producing meal and oil fish in Chile. The PAC standard has 21 control forms that

must be complied with, the key ones have been highlighted below.

The PAC programme is F actory HACCP and Chilean National Standards:

PAC/MP1 Administrative Procedure to participate in the Program of securing of Quality.

PAC/MP3 Administrative and Requisite Procedures for actory courses HACCP and POS.

PAC/NT1 Guidebook of work for the elaboration of Programs of Securing of Quality in fishing plants

and boats factories.

Specific Requirement PAC/NT2 to consider in the design of a Program of Securing of Quality,

according to fish resources used and the requirenets of the end market.

PAC/NT3 Requirement programs for the implementation of the standard for Fishing boats and the

factories used to make fishmeal and oil to ensure that the Quality is maintained.

PAC/NT4 Operational Procedures for Cleaning the actory

Requisite HDP/NT1 is for the Infrastructures and sanitary handling requirements for establishments

exporting fish oil and fishmeal not destined for direct human consumption

HDP/NT2 Guidebook of the Programs required to ensure the quality of the fishmeal and fish oil.

Manual HDP/MP1 of Procedures

Norms Certifications required

Norms Crtitical Control Points for heat treatments

HPB Rating of plants.

These regulations are constantly updated according to new guidelines issued by the EC.

A full benchmark verification audit was under taken by the auditor from RS Standards Ltd. to the IFIS standard and has concluded that this PAC standard was equivalent to the KEY requirements of this standard and since the initial benchmark analysis conducted in 2010 the PAC Standard has now incorporated more specific HACCP and Product Recall requirements.

(Note- English versions of the entire PAC standard can now be located on the Sernapesca website http://www.sernapesca.cl/index.php?option=com_remository&Itemid=246&func=select&id=76 )

http://www.sernapesca.cl/index.php?option=com_remository&Itemid=246&func=select&id=76

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Corpesca S. A. Site Assessment Findings

Corpesca Personnel Interviewed Andres Montalva Director of Sites Miriam Rojas Quality Assurance and PAC Manager Mario Nuñez Head of Sites Operations

Sernapesca Personnel Interviewed Horacio Opitz Operations Manager

Auditor Personnel Interviewed via Skype 10th Oct 2014 Tania Sanchez University of Chile Auditor

IFIS Benchmarking Analysis with Programa de Aseguramiento de la Calidad (PAC) (June 2014) Good Manufacturing Practice in the animal feed industry

IFIS Standard Requirements

PAC GMP in the animal feed industry

Section 2

Quality Management system

Equivalent to IFIS

2.1 General Requirements

Covered under the requirements and Guidance given in the PAC/MP1/Junio 2014 Document Manual de Procedimientos Sección 1: in subsection 2 of the referenced document which states that a Quality Management System (QMS) that incorporates the PAC standard must be put in place by the fishmeal plants that wish to be certified to the PAC standard. In addition, further requirements on what each QMS should include are in the reference document PAC/NT6/enero 2012 Norma Técnica Sección 6 under subsection 1 Finally a very detailed HACCP study requirement is laid out in document PAC/NT5/enero 2012 Norma Técnica Sección 5

2.2 Management Responsibilities

The PAC requires that the fishmeal plant must have a person or persons responsible for the continual checking of the PAC

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standards on the Sernapesca Website to ensure that all changes to the said standard are incorporated into the factory operations. Adherence to these fundamental requirements is checked on audit by the independent University auditor in section 2 of their assessment named “Implementation of Programme”. The document that covers this area in more detail is the PAC/NT6/enero 2012 Norma Técnica Sección 6. In addition extra reference to these requirements are made in PAC/NT5/enero 2012 Norma Tecnia Sección 5 subsection VI. Finally More clauses are stated in document PAC/NT5/enero 2012 Norma Técnica Sección 5

2.3 Quality Management structure

The PAC requires that the fishmeal plant must have a person responsible for the implementation of the PAC standards on the Sernapesca Website to ensure that all changes to the said standard are incorporated into the factory operations. Adherence to these fundamental requirements is checked on audit by the independent University auditor in section 2 of their assessment named “Implementation of Programme”. The document that covers this area in more detail is the PAC/NT6/enero 2012 Norma Técnica Sección 6.

2.4 Documentation requirements

The document that covers this area in more detail is the PAC/NT6/enero 2012 Norma Técnica Sección 6. The PAC standard now has 21 Control Forms that each fishmeal plant wishing to be certified to it must be in full compliance with. This is an additional 2 control forms that have been incorporated into the programme since the first benchmark study back in 2010.

2.5 Record Keeping

The programme states that all records shall be kept for 2 years which is in compliance with other IFIS standards

2.6 Information management relating to safety

The PAC standard now has 21 Control Forms that each fishmeal plant wishing to be certified to it must be in full compliance with. The PAC is amended every time China or EU or any other foreign nation changes its requirements for fishmeal. As stated previously the PAC states that all factories wishing to be certified must have a person in place to ensure that all amends to the PAC standard are incorporated into their QMS system and that will be checked by the independent auditors to ensure compliance. The section in the PAC that references this requirements is PAC/MP1/Junio 2014 Manual De Procedimientos Sección 1 Subsection Modificaciones Del PAC VII

Section 3

Resources and Good Hygienic Practices

Equivalent to IFIS

3.1 General requirements

The PAC standard states in detail the requirements that each participating fishmeal plant will need to comply with to meet the

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requirements of the PAC, these are covered in detail by the following documents HDP/NT1/Junio 2013 Norma Técnica Sección 1 and PAC/NT7/Junio 2010 Norma Técnica Sección 7. No change on the requirements that were required in the benchmark study conducted in 2010 and are still in full compliance with European Feed Manufacturers Guide (EFMC) ver1 2007 and IFSA Feed Ingredient Standard (IFIS) International Feed Safety Alliance Sept 2005 Finally the Chilean authorities insist that all fishmeal factory’s if they are permitted to trade must comply with the basic resource and good hygiene practices that are stated in HDP/NT1/Junio 2013 Norma Técnica Sección 1 and this document covers in detail the following requirements stated in this following section of the IFIS standard

3.2 Personnel

Covered by the Chilean Authority Compulsory Requirements in HDP/NT1/Junio 2013 Technica Sección 1 subsections C2,D1-6,E1-3 Plus requirements covered by PAC standard HDP/NT1/Junio 2013 Norma Técnica Sección 1

3.3 Production/Processing Facilities & Equipment

Covered by the Chilean Authority Compulsory Requirements in HDP/NT1/Junio 2013 Technica Sección 1 subsections B. Plus requirements covered by PAC standard HDP/NT1/Junio 2013 Norma Técnica Sección 1

3.4 Storage Facilities

Covered by the Chilean Authority Compulsory Requirements in HDP/NT1/Junio 2013 Technica Sección 1 subsections C 11, G1,2,7,13

3.5 Intake and loading facilities

Covered by the Chilean Authority Compulsory Requirements in HDP/NT1/Junio 2013 Technica Sección 1 subsections B7 and C1

3.6 Planned Maintenance

Additional requirements covered by PAC standard PAC/NT7/Junio 2010 Norma Técnica Sección 7

3.7 Driers/Drying

Covered by the Chilean Authority Compulsory Requirements in HDP/NT1/Junio 2013 Technica Sección 1 subsections B4

3.8 Cross-Contamination

Covered by the Chilean Authority Compulsory Requirements in HDP/NT1/Junio 2013 Technica Sección 1 subsections B6 Additional requirements covered by PAC standard PAC/NT7/Junio 2010 Norma Técnica Sección 7

3.9 PACkaging and Pallets


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3.10 Pest Control

Covered by the Chilean Authority Compulsory Requirements in HDP/NT1/Junio 2013 Technica Sección 1 subsections C5 Additional requirements covered by PAC standard PAC/NT7/Junio 2010 Norma Técnica Sección 7

3.11 Cleaning

Covered by the Chilean Authority Compulsory Requirements in HDP/NT1/Junio 2013 Technica Sección 1 subsections B8, C2,C8,G4 Additional requirements covered by PAC standard PAC/NT7/Junio 2010 Norma Técnica Sección 7 Plus requirements covered by PAC standard HDP/NT1/Junio 2013 Norma Técnica Sección 1

3.12 Waste Management

Covered by the Chilean Authority Compulsory Requirements in HDP/NT1/Junio 2013 Technica Sección 1 subsections C7 Additional requirements covered by PAC standard PAC/NT7/Junio 2010 Norma Técnica Sección 7

3.13 Dust Control


3.14 Air Movement


3.15 Process water and used water for cleaning purposes

Covered by the Chilean Authority Compulsory Requirements in HDP/NT1/Junio 2013 Technica Sección 1 subsections C4

3.16 Control of Contaminants

Covered by the Chilean Authority Compulsory Requirements in HDP/NT1/Junio 2013 Technica Sección 1 subsections G4 Additional requirements covered by PAC standard PAC/NT7/Junio 2010 Norma Técnica Sección 7 Plus requirements covered by PAC standard HDP/NT1/Junio 2013 Norma Técnica Sección 1

3.17 Sieves, Screens, Filters& Separators, Magnets and Detectors

Covered by the Chilean Authority Compulsory Requirements in HDP/NT1/Junio 2013 Technica Sección 1 subsections B11 Additional requirements covered by PAC standard PAC/NT7/Junio 2010 Norma Técnica Sección 7

3.18 Glass and Brittle Materials Procedure


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Section 4

Transport Requirements

Equivalent to IFIS

4.1 General Requirements

The PAC standard states in detail the requirements that each participating fishmeal plant will need to comply with to meet the requirements of the PAC these are covered in detail by the following document HDP/NT1/Junio 2013 Norma Técnica Sección 1.No change on the requirements that were required in the benchmark study conducted in 2010 and are still in full compliance with European Feed Manufacturers Guide (EFMC) ver1 2007 and IFSA Feed Ingredient Standard (IFIS) International Feed Safety Alliance Sept 2005 which ensures that NO Land Animal Based Protein is transported with or by the same vehicles etc. that transport Fishmeal or Fish Oil Finally the Chilean authorities insist that all fishmeal factory’s if they are permitted to trade must comply with the basic resource and good hygiene practices that are stated in HDP/NT1/Junio 2013 Norma Técnica Sección 1 and this document covers in detail the following requirements stated in this following section of the IFIS standard

4.2 Owned & Contracted Land Transport

Covered by the Chilean Authority Compulsory Requirements in HDP/NT1/Junio 2013 Technica Sección 1 subsections G 14 , 15 Plus requirements covered by PAC standard HDP/NT1/Junio 2013 Norma Técnica Sección 1

4.3 Water Borne Transport

Covered by the Chilean Authority Compulsory Requirements in HDP/NT1/Junio 2013 Technica Sección 1 subsections G 14 , 15 Plus requirements covered by PAC standard HDP/NT1/Junio 2013 Norma Técnica Sección 1

Section 5

Product Safety Management

Equivalent to IFIS

The PAC standard states in detail the requirements that each participating fishmeal plant will need to comply with to meet the requirements of the PAC these are covered in detail by the following document PAC/NT5/enero 2012 Norma Técnica Sección 5. This is a MAJOR inclusion since the benchmark study conducted in 2010 and is now in full compliance with European Feed Manufacturers Guide (EFMC) ver1 2007 and IFSA Feed Ingredient Standard (IFIS) International Feed Safety Alliance Sept 2005, which ensures that fully documented Product safety management system

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is now stipulated for all fishmeal plants that wish to be certified to the PAC standard and export their product. In addition, a further PAC standard PAC/NT2/Marzo 2014 Norma Técnica Sección 2 is constantly updated to take into account the requirements of all the Chilean fishmeal plant export markets and as stated previously it is a requirement of PAC that all certified fishmeal plant constantly update these requirements if they are to remain in compliance with this PAC standard. Finally the Chilean authorities insist that all fishmeal factory’s if they are permitted to trade must comply with the basic resource and good hygiene practices that are stated in HDP/NT1/Junio 2013 Norma Técnica Sección 1 and this document covers in detail the following requirements stated in this following section of the IFIS standard

5.1 HACCP

Covered in detail by the following document PAC/NT5/enero 2012 Norma Técnica Sección 5.

5.2 Raw Materials

Covered by the Chilean Authority Compulsory Requirements in HDP/NT1/Junio 2013 Technica Sección 1 subsections G 16 , 17,18 and H1

5.3 Buying-in of Feed Ingredients

N/A This programme only covers the production of fishmeal and fish oil from fish products that are landed into Chile

5.4 Assessment of Suppliers

Covered by the Chilean Authority Compulsory Requirements in HDP/NT1/Junio 2013 Technica Sección 1 subsections H2

5.5 Sales Contracts

Covered by the additional PAC standard PAC/NT2/Marzo 2014 Norma Técnica Sección 2 is constantly updated to take into account the requirements of all the Chilean fishmeal plant export markets

5.6 Process Control

Covered by the Chilean Authority Compulsory Requirements in HDP/NT1/Junio 2013 Technica Sección 1 subsections F6 and G10 . Plus covered in detail by the following document PAC/NT5/enero 2012 Norma Técnica Sección 5.

5.7 Control of Monitoring and Measuring Devices

Covered by the Chilean Authority Compulsory Requirements in HDP/NT1/Junio 2013 Technica Sección 1 subsections B4 and C10. Plus covered in detail by the following document PAC/NT5/enero 2012 Norma Técnica Sección 5.

5.8 Preservation of Microbiological Status

Covered by the Chilean Authority Compulsory Requirements in HDP/NT1/Junio 2013 Technica Sección 1 subsections B8 . Plus covered in detail by the following document PAC/NT5/enero

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2012 Norma Técnica Sección 5. Additionally this is stated in the requirements for each country that the product is exported to in PAC/NT2/Marzo 2014 Norma Técnica Sección 2.

5.9 Technological Additives

Covered in detail by the following document PAC/NT5/enero 2012 Norma Técnica Sección 5. Additionally this is stated in the requirements for each country that the product is exported to in PAC/NT2/Marzo 2014 Norma Técnica Sección 2.

5.10 Feed Ingredients delivery Documents and labels.

Plus covered in detail by the following document PAC/NT5/enero 2012 Norma Técnica Sección 5. Additionally this is stated in the requirements for each country that the product is exported to in PAC/NT2/Marzo 2014 Norma Técnica Sección 2.

5.11 Identification of products not intended for feed use


5.12 Certificates of Conformity & Analysis


5.13 Inspection, Sampling and Analysis

Covered by the Chilean Authority Compulsory Requirements in HDP/NT1/Junio 2013 Technica Sección 1 subsections B10 , F1,2,3,4,5, H3. Plus covered in detail by the following document PAC/NT5/enero 2012 Norma Técnica Sección 5.

5. 14 Traceability

Covered by the Chilean Authority Compulsory Requirements in HDP/NT1/Junio 2013 Technica Sección 1 subsections G9 and G11 Plus additional requirements are stated in the document TPP/NT1/Marzo 2012 Norma Técnica Sección 1 to cover all the required for traceability that are stipulated in the EU regulation no 178/2002

5.15 Non-Conforming Products

Covered by the Chilean Authority Compulsory Requirements in HDP/NT1/Junio 2013 Technica Sección 1 subsections G12 Plus covered in detail by the following document PAC/NT5/enero 2012 Norma Técnica Sección 5.

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5. 16 Complaints Procedure

Covered by the document PAC/NT6/enero 2012 and these are new requirements for the PAC standard since the last benchmark study in 2010 and are in full compliance with the IFIS requirements

5.17 Recall Procedure

Covered by the document PAC/NT6/enero 2012 and these are new requirements for the PAC standard since the last benchmark study in 2010 and are in full compliance with the IFIS requirements

5.18 Internal Audits

Covered by the Chilean Authority Compulsory Requirements in HDP/NT1/Junio 2013 Technica Sección 1 subsections C9 Plus covered in detail by the following document PAC/NT5/enero 2012 Norma Técnica Sección 5.

4- Certification Protocols for the PAC Standard

The fishmeal and fish oil manufacturers that export to countries outside of Chile must have a valid PAC certificate before they will be granted an export licence by Sernapesca. The following section will describe the certification process and is based on the following documents: Programa De Certificación- Manual de Procedimientos Sección 1 – CER/MP1/Agosto 2014 Programa De Certificación- Norma Técnica Sección 3 – CER/NT3/Agosto 2014 Programa De Certificación- Norma Técnica Sección 2 – CER/NT2/Marzo 2014 In addition to direct interviews with representatives from Sernapesca and the University of Chile.

PAC Audits

Sernapesca is the authority that audits and verifies that plants adopting the assurance programme, meet with the infrastructure facilities and documentation requirements outlined in the PAC programme. To ensure that the assessment is transparent, Sernapesca engages the services of a third party auditing service which is independant of Sernapesca. This service is provided by the University of Chile. In the 2010 assessment the auditor was unable to verifiy the full independance of this audit as nobody from the university was avialable for interview. In 2014 assessment this was made a priority and the following evidence was obtained directly from the auditor who conducts the PAC assessment of the Corpesca Site.

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University of Chile Auditor Interview The independent University auditor Tania Sanchez was interviewed by Skype on the 10th October

2014 to gain an understanding of the role of these auditors in the assessment of factories to the PAC

standard. The following statements were given in Spanish and interpreted as follows.

The Audit and Certification Process

The University of Chile has a contract with Sernapesca to provide auditors to assess fishmeal

factories that seek certification to the PAC standard, which is required if these factories wish to

export their fishmeal and fish oil outside Chile. The university auditors are contracted to undertake

an audit of each factory wishing to have the PAC standard every two years.

The Auditor is contacted by Sernapesca when a date for an audit has been confirmed with the

fishmeal factory. The main reason is that the factory must be in operation if a full and detail PAC

audit is to conducted. Once the date is set the auditor is contracted by Sernapesca to conduct the

PAC audit at this time.

The audit lasts for a minimum of 3 days and the auditor will be shadowed in part or in full by a

Sernapesca representation. The auditor will assess the factory to each part of the PAC standard and

how it is implemented in the factory and will make a report on any areas of non-compliance. The

areas of non-compliance ranged from Critical to Major to Minor, examples of each are stated in the

PAC standard. The auditor will send this report to Sernapesca’s head office and they will send this

report with conditions attached of what the factory must do to ensure they are in compliance with

the PAC standard. The factory will then have 30 days to close off these non-compliances. If the

factory already has the PAC certificate they will keep this status for 30 days to allow them time to

close off the observed non compliances. However if the non-compliance is classified as a Critical

non-compliance the factory’s certified status will be rescinded immediately, until they have put the

necessary actions in place to close off this critical non-compliance.

To close of the non-compliances, if this is a structural issue this will be closed off by re-inspection by

Sernapesca representatives when they next visit the site. The auditor informed that Sernapesca

representatives will visit each factory every three months as part of their routine audits programme.

To close of a procedural non-compliance the action plan will be sent to Sernapesca who will then

send this on to the University auditor to VERIFY that they are happy with the proposed plans. The

auditor will then inform Sernapesca if they are happy to close off the non-compliance or not as the

case maybe in the form of another report.

Sernapesca will then make the final decision to award the certificate to the factory or not. If

awarded the certificate lasts for 2 years and is subject to quarterly surveillance audits that are

conducted by Sernapesca. At each of these audits a section of the PAC standard will be retested and

if any areas of non-compliance are observed the factory will, depending on the nature of the non-

compliance, have a period of 15-45 days to rectify. If a critical non-compliance is observed at this

stage the factory’s certificate will be suspended, which will mean that the factory will NOT be able to

export any of its fishmeal or fish oil.

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The auditor competency and training

The main qualification that is required by the university and Sernapesca is that a potential auditor

must have experience within the fishmeal industry, so that they can fully understand how the

requirements of the PAC standard shall be implemented. The potential auditor if they can provide

evidence of this fundamental requirement will then be placed on a training programme which will

ensure that they fully understand each aspect of the PAC standard. The auditor will conduct a PAC

audit that is shadowed by a qualified auditor. The qualified auditor will then write a report on the

performance of the potential auditor, which is submitted to Sernapesca to make the final decision

on if this potential auditor can be approved. Currently there are only 4 PAC auditors approved by

Sernaspesca to cover the entire fishmeal and fish oil industry in Chile.

Once approved all PAC standard auditors employed by the University will be subject to a number of

consistency checks to ensure that all factories certified to the PAC are audited in a consistent

manner and these include:

Sernapesca shadow audits- this will entail a Sernapesca representative from a different part

of Chile assessing the competency of a PAC auditor to ensure that they audit in a consistent

manner in all parts of the country.

The PAC auditors hold regular meeting to discuss audits and any non-compliances raised to

ensure that they all agree with each other’s findings.

Sernapesca will at their head offices cross-check all the PAC audit reports to ensure each

auditor is picking up the non-compliances in a consistent manner.

Any changes to the PAC standard will be communicated to the PAC auditors first to a) ensure

they understand the change and b) to gather any feedback from the auditors that they may

have on the proposed changes.

Sernapesca Interview dated 27/08/2014 All factories in Chile must comply with the compulsory good manufacturing standards stated in the “Programa De Harina De Pescado” HDP/NT1/Junio 2013 – Norma Técnica Sección 1, these requirements are checked by Sernapesca to ensure compliance before the factory is allowed to legally operate within Chile. For Factories that wish to export they must comply with the PAC Standard details of which can be found on the Sernapesca Website. This standard is based on the IFAS IFIS standard and all the export requirements from the countries that will accept the fishmeal and oil, notably the EU and China. The PAC Standard will be updated on a regular basis to take into account any changes in export country legislation, and it is the requirement of the certified factories to constantly review this website to ensure that they are completely in compliance with the latest version of the PAC Standard. The PAC standard will also be reviewed and amended every 2 years to ensure that its operational requirements are still fit for purpose to assist in the continual development and improvement of the Chilean Fishmeal Manufacturers industry.

Required Steps to Chilean Certification

1. Factory must first meet “Programa De Harina De Pescado” HDP/NT1/Junio 2013 – Norma Técnica Sección 1 requirements

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2. The factory will apply to Sernapesca for an export licence and will provide evidence to them

that they have met the pre-requisite requirements of the PAC standard as stated in the “ Programa De Aseguramiento De Calidad”- Norma Técnica Sección 6 – PAC/NT6/enero 2012

3. The University of Chile auditor validates the information in the field and issues a report stating the compliance of the factory to the PAC Standard. From information received the university auditor will rate any areas as of non-compliance as Critical, Major or Minor and will give 1 month to close out before the factory can be certified. The report is Split into 4 main areas – Technical Documents, Implementation of the PAC, Programme, Hygiene Standards, and Structural Condition. The length of the assessment is set to a minimum of 3 days. Sernapesca shadow every audit to ensure that the university auditor is consistent and does not deviate from the requirements of the PAC Standard.

4. The Report is submitted to Sernapesca who will complete a full technical review to ensure that all aspects of the PAC standard have been fully assessed and when satisfied will call a meeting of the Factory and the Auditor to decide if the Factory should be certified to the PAC standard. At this stage the Factory will also have completed their own internal audit on the auditor’s findings to show Sernpesca that the required actions for compliance to the standard have been adopted or are being implemented.

5. Sernapesca will make the final decison on whether to grant the PAC certificate to the Factory.

6. Factories that have been given certification will be issued with a certificate that lasts 2 years and are placed on public view on Sernapesca’a website : www.sernapesca.cl

7. In addition to these bi-annual audits Sernapesca visit each factory unanounced to ensure that the PAC standards are being maintained. If they are not, they will issue a non-compliance which must be acted upon, if the factory PAC certification status is to be maintained. These audits are carried out every 3months or sooner if a previous visit highlighted any serious or critical non-compliances to the standard.

The certification process does not fully comply with ISO guide 65 (17065) as the final decision for certification does not lie with the auditor but with Sernapesca - the Standard holder. However the programme does use independent auditors from the University of Chile and they do conduct the assessment independently from Sernapesca, who will not change the findings made by the auditor. The Sernapesca representative stated that they had to make this final decision as the PAC standard was a legal requirement if an export licence/certificate is to be granted and under Chilean Law they were the only organisation that was allowed to issue this licence/certificate. However, they were fully aware of ISO guide 65 requirements and this was being investigated further in their department but would not be fully implemented this year.

http://www.sernapesca.cl/

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5- Concluding Comments RS Standards concludes that the requirements of the PAC standard are robust and will provide assurance to the IFFO RS Governance Board that as prerequisite GMP standard that it is equivalent to the IFIS requirements for the IFFO RS Standard. However, the certification process to this standard is not fully third party and does not in its current operation fully meet the requirements of ISO guide 65, but will provide in its current format a good level of certification assurance and this was confirmed following the interview with the University PAC auditor. However, if this standard programme is still to be considered equivalent to the other recognised IFIS standards, The IFFO RS Governance Board will have to decide if they will accept the level of assurance described in this report and if yes this will entail that the following IFFO RS Standard clauses- 3.1.1 Applicants must demonstrate Responsible Manufacturing Practices by achieving certification to the International Feed Safety Alliance (IFSA) Feed Ingredient Standard (IFIS) Standard. And 3.1.2 Certification must be administered by an ISO 65 accredited certification body and the IFSA programme included in the scope by a member of the IAF Multilateral Agreement (MLA). will need to be amended accordingly. Possible suggestions to be considered could be- 3.1.1 Applicants must demonstrate Responsible Manufacturing Practices by achieving certification to the International Feed Safety Alliance (IFSA) Feed Ingredient Standard (IFIS) Standard or an approved equivalent GMP standard. And 3.1.2 Certification must be administered by either an ISO 65 accredited certification body and the IFSA programme included in the scope by a member of the IAF Multilateral Agreement (MLA) or can provide assurance that the standard assessed to is to an approved level of transparency and independence.