PAC Guidance on Application of ISO/IEC 17065:2012 to Organic Certification under the EU Legislation on Organic Farming
Proposed Draft Version 2015
May 2015
Introduction to PAC Guidance on Application of ISO/IEC 17065:2012 to Organic Certification under the EU Legislation on Organic Farming
ISO/IEC 17065:2012 is an International standard which sets out criteria for bodies operating certification of products and processes. One of the important certifications in this area is certification of organic products. In many countries organic farming and production is generally governed by the relevant regulations. The compliance to the regulation is generally verified through conformity assessment activities carriedby the certification bodies accredited to ISO/IEC 17065:2012. Since there is an increasing demand for organic products in many developed markets, there is also a greater demand for certification of organic products by the accredited certification bodies operating in the respective countries.
Access to the European Union market for organic products
The European Union is one such important market and access to this market is regulated under regulation (EC) 834/2007 and various implementing rules. These rules establish two mechanisms for access which require equivalence of the system in the export country to that within the EU; country to country equivalence (for further details the EU regulation may be referred) e and a list of recognized control bodies. A list of equivalent control bodies or certification bodies(CBs) is already established as Annex IV to Regulation EU-No. 1235/2008. Control bodies have to fulfill requirements stated in the EU-No. 1235/2008which accreditation body’s shall assess. Therefore special guidance is necessary for application by CBs and for assessment by accreditation bodies.
Purpose of this document
If such CBs are to be accredited in a worldwide harmonized manner as complying with ISO/IEC 17065: 2012, some Guidance to that document is necessary, especially since there are many specific requirements pertaining to organic farming and consequently requirements with respect to certification of such products and processes. This document intends to provide such guidance and has three main purposes:
- to enable accreditation bodies to harmonize their application of the standards against which they are required to assess the certification bodies.
- Tofacilitate mutual recognition of accreditation process, especially to facilitate the recognition of different organic certification schemes for mutual acceptance.
- Toassist certification bodies themselves and to those, whose decisions are guided by their certificates.
For the convenience of usage this document has been structured on the same lines as ISO/IEC 17065:2012 and the headings from that document are first printed in bold; Guidance where it is offered is, for ease of reference, identified with the letter “G”.
This Guidance forms the basis for assessment of organic certification bodies by the accreditation bodies and will become essential for the consistentapplication of ISO/IEC 17065:2012. This may also be used as the basis for assessment of AB’s applying for ISO 17065:2012 MLA for organic productsfor import into the European Union as all of this Guidance is expected to be adopted by certification bodies and verified by accreditation bodies engaged in the accreditation of CB’s operating organic certification.
This document was prepared through the contribution of the participants of the three stage training &workshops for assessors of accreditation bodies on organic agriculture (Annex 1). The training was organized by PAC and PTB. The program was attended by the accreditation body personnel from different Asian economies.
Definitions
Since this document is intended specifically for accreditation of CBs for them to provide access to the EU market, the definitions of regulations (EC)834/2007 and its implementing regulations (see references below) should apply. To provide clarity of understanding various terms used under these regulations are explained and linked to the terms in ISO 17065 as follows:
The EU-Legislation on Organic Farming uses the term “control body” meanwhile the ISO/IEC 17065:2012 uses the term “certification body”
The EU-Legislation on Organic Farming uses the term “control measures” meanwhile the ISO/IEC 17065:2012 uses the term “certification requirements”
The EU-Legislation on Organic Farming uses the term “production rules” meanwhile the ISO/IEC 17065:2012 uses the term “product requirements (clause 3.8).
Application for recognition
Regulation 1235/2008 sets out the need for control bodies to make an application to the Directorate General for Agriculture and Rural Development (DG AGRI) of the European Commission and, once recognized as equivalent, provide annual reports. The application is performed through the DG AGRI web portal at using the assessment reports provided by the accreditation body. The procedure is described in Regulation 1235/2008 Article 11. To access this portal it is necessary to apply for a password through the mail ere is an application deadline of September 30 every year.
The scope of the production rules applied by the CB for the purpose of access to the EU must conform to those described under regulation 1235 /2008 Annex IV.
References
COUNCIL REGULATION No (EC) 834/2007 of 28 June 2007 on organic production and labelling and repealing Regulation (EEC) 2092/91
COMMISSION REGULATION (EC) No 889/2008 of 5 September 2008 laying down detailed rules for the implementation of Council Regulation (EC) No 834/2007 on organic production and labelling of organic products with regard to organic production, labelling and control (as amended)
COMMISSION REGULATION (EC) No 1235/2008 of 8 December 2008 laying down detailed rules for implementation of Council Regulation (EC) No 834/2007 as regards the arrangements for imports of organic products from third countries (as amended)
Guidelines on imports of organic products into the European Union December 15, 2008
Useful addresses
European Commission
Directorate General for Agriculture and Rural Development
H3 OrganicFarming
Rue de la Loi
1049 Brussels
BELGIUM
E:
W:
4 General Requirements
4.1 Legal and Contractual Matters
4.1.1 Legal Responsibility
4.1.2 Certification Agreement
G.4.1.2.1 The certification system shall be based on written agreements, with clear responsibilities of all parties involved in the chain of operations for production of an organic certified produce/product.The certified operators shall sign contracts/agreements requiring them to:
- Follow the production standards/regulations and other published requirements for certification.
- Not to use any prohibited items in its production of organic produce and product.
- Accept inspections.
- Supply accurate information.
- Notify the certification program of any changes.
- Inform the certification body of complaints by the operator’s customers as well as consumers of the product as received by the certified operators/organizations.
G.4.1.2.2 The certification body shall ensure that its certification agreement requires that its clients for organic certification comply with the following organic certification specific requirements:
a)The certified operator shall provide access to the inspectors/evaluators of the certification body, to all relevant facilities of organic production / farm unit, including accounts and sales related records and other relevant documentation to provide adequate audit trails and traceability of organic certified produce and products.
b)The certified operator shall provide access to its record keeping system adapted to the type of production that enables the certification body to retrieve necessary information and to seek verification of the production, storage, processing, purchase and sale.
c)The certified operator shall provide access to non-organic production units or units associated by ownership or management to the applicant/certified organic operator.
d)The certified operator shall provide the certification body, updated information on the scheme of inspection and testing, which the certified operator maintains or intends to maintain for ensuring organic integrity
4.1.3 Use of Licenses, Certificates and Marks of Conformity
G.4.1.3.1 Certification mark with indication referring to organic nature shall not be used on non-organic products.
G.4.1.3.2 For the organic certification scheme requiring market surveillance,conformity of the certified product shall be monitored in accordance with the requirements stated in the certification scheme.
4.2 Management of Impartiality
G.4.2.1 The certification bodies that are administered by membership organizations or are owned by the membership organization or organic producer organizations, shall ensure clear separation of activities and all requirements with respect to impartiality in decision making and other activities shall be ensured by the certification body.
G.4.2.2 The certification body shall not offer any services that question its objectivity and impartiality. Such services may include marketing and promotion activities for organic products, consultancy services for clients and applicants.
4.3 Liability and Financing
Nil
4.4 Non-discriminatory Conditions
Nil
4.5 Confidentiality
G.4.5.1 Whilst maintaining confidentiality of information, the certification body shall have provision for exchange of information as necessary. For example, when laboratory tests showed that pesticides were found in organic products, the certification body shall notify any other certification body concerned, say certifier for manufacturer of organic products using as raw material the organic agricultural products found to contain the pesticides. It shall also inform, where relevant, also the competent authorities, any other relevant stake holders, etc.
4.6 Publicly Available Information
G.4.6.1The certification body operating the organic certification scheme shall have processes for informing all concerned including the prospective and present certified operators about the applicable standards for the different organic product categories and the program changes including updates of procedures and standards.
G.4.6.2The organic certification body shall identify clearly the standards and requirements used for the different product categories. These shall be available to the applicant and publicly accessible through its website.
G.4.6.3The detailed information regarding organic production/farming related regulations and standards against which the products will be certified and the certification processes, as well as a fee table shall be made available through publications and electronic media, and shall be available on the CB website from July 1, 2015.
5 Structural Requirements
5.1 Organizational Structure and Top Management
Nil
5.2 Mechanism for Safeguarding Impartiality
Nil
6 Resources Requirements
6.1 Certification Body Personnel
G.6.1.1 The certification body shall ensure that its personnel have sufficient knowledge on organic agriculture and regulatory requirements relevant to organic certification.
G.6.1.2 Qualification Criteria
G.6.1.2.1 The following criteria shall be applied for control and certification staff, in organic certification, which shall include but is not limited to, as appropriate the contract review personnel, inspection and evaluation personnel, technical reviewers and decision makers. The staff shall have:
a.Sufficient background and knowledge in agriculture and/or food science, food technology. The requirements may vary based on the functions undertaken by the personnel. Knowledge may be gained typically through educational qualification and/or experience, adequate to provide knowledge of organic products and processes. Personnel shall be qualified on the basis of use of appropriate evaluation methods.
Note: A number of evaluation methods like review of records; feedback; interviews; observations/witness; examination can be used to evaluate knowledge and skills.
b.Received appropriate training in respect to organic agriculture, food and feed processing, trade, specific production areas (e.g. aquaculture) and organic regulations and standards.
c.Gained experience for each scope by participation in a minimum of 10 certification audits or at least 6 days. The criteria stated above are specifically applicable for personnel involved in inspection and evaluation activities.
G.6.1.2.2 Competence of decision maker – Decisions on certification shall be taken by a competent person or group fulfilling the same criteria as stated in G.6.1.2.1.
G.6.1.3The certification body shall actively identify training at entry level as well as based on needs identified through systematic performance reviews and provide, as necessary, training to its staff on the requirements of the standards, the certification program and relevant methodologies. Adequacy of such training plans, training and evaluation records, and the associate materials shall be maintained.
G.6.1.4Depending upon the initial qualification and experience of individuals, qualification process may include just an evaluation of knowledge and skills, an induction period or a supervised working period with experienced auditors/inspectors or a combination of these measures.
G.6.1.5The performance monitoring for each evaluator/inspector should include observation in on-site audit/inspection, normally not longer than every three years, unless there is sufficient supporting evidence that the auditor is continuing to perform competently.
6.2 Resources for Evaluation
6.2.1 Internal Resources – Covered in clauses G.6.1.1 to G.6.1.5 above.
6.2.2 External Resources
G.6.2.2.1 Subcontracting of testing – subcontracting of testing (of input materials organic certified products, etc. for residue, genetically modified organism and others) shall be carried out on a risk based assessment by the certification body.The certification body shall ensure that the testing activities are subcontracted to competent laboratories as demonstrated either by the sub-contracted laboratory having accreditation to ISO/IEC 17025 for the relevant tests and providing endorsed (Logo) reports or the certification body itself assessing the competence of the sub-contracted laboratory to the requirements of ISO/IEC 17025. Where the assessment of the sub-contractor is carried out by the certification body, it should be able to demonstrate that the assessment team is technically competent and knowledgeable in the application of ISO/IEC 17025 for the relevant fields of testing.
7 Process Requirements
7.1 General
G.7.1.1 The requirements and procedures set up by the CB shall take into account the requirements with respect to organic farming as stated in the EU-Legislation on Organic Farming. These also include any other supporting requirements as prescribed by the importing countries. For example, for export to countries with in EU, all applicable requirements prescribed in the EU-guidelines on Imports shall also be covered.
G.7.1.2 Any organic certification program followed by the CB shall have defined requirements for certification body’s functioning as well as certification process requirements. CB requirements covering organic certification shall primarily be based on ISO/IEC 17065:2012 and the certification process requirements shall primarily be based on equivalent standards to the EU-legislation on Organic Farming which appear in Titles II, III and IV of Regulation 889/2008.. In case these requirements specific to organic certification have been documented by the Control Body / Regulator / Accreditation Body / scheme owner then the certification body can directly base its certification system on the prescribed requirements. However in absence of these it becomes incumbent upon the CB to describe the certification system related requirements (e.g. reduction of conversion period, exceptional permission of conventional seeds etc.), covering CB requirements (based on ISO/IEC 17065:2012) and certification process requirements (based on relevant regulations). In such cases the accreditation body will need to evaluate the equivalence of the certification process as part of its accreditation process.[1]
G.7.1.3In respect of requirements based on EU Legislation on Organic Farming, if the certification body uses an EU-equivalent certification program, the accreditation body shall conduct an equivalence assessment between this certification program and the EU-legislation on Organic Farming. The result of this assessment shall include an explicit confirmation of the result of the equivalence assessment. The result will be made available by the accreditation certificate to the public.
G.7.1.4 The certification program shall take into consideration explicitly the following aspects as applicable: retroactive recognition of conversion period, separation and inspection of conventional production units, parallel /split production, group certification and wild collection.
G.7.1.5The certification body shall have available and implemented policies for: risk based inspections, management of deviations, non-conformities and corrective actions, exchange of information with other control bodies and competent authorities and a policy for the annual report for the EU-Commission.
G.7.1.6The certification body shall have documented policies and procedures on residue testing, testing of genetically modified organism, input materials and others as relevant to establish organic integrity. These should generally include the following:
a)System for identification of cases in which samples shall be taken for analysis where, use of a substance prohibited by the standards, is suspected.
b)A procedure on how to take samples and send them to the laboratory.
c)The number of samples taken per annum must represent 5% of the operators under the scheme.
7.2 Application
G.7.2.1 The certification program shall not allow operators to switch in and out of the certification system. While accepting an application for change of certification body the certification body receiving such applications shall ensure availability of all the background information in respect of the applicant organic farm / production unit, and whether another certification body had denied certification to the applicant organic operator.Certification body shall also have a documented system for corroborating the information received from the certification body who had previously certified the operator.
G.7.2.2Pre-requisite for application – The applicant shall comply with and confirm at the time of application to the following. The certification body shall have appropriate provisions in its system for application to ensure receipt of relevant information from the applicant operator. :
a)The certification body and its auditors/inspectors shall have access to all relevant facilities of organic production / farm unit, including accounts and sales related records and other relevant documentation to provide adequate audit trails and traceability of organic certified produce and products.
b)The certified operator shall have a record keeping system adapted to the type of production that enables the certification body to retrieve necessary information and to seek verification of the production, storage, processing, purchase and sales.
c)The certification body shall have access to and inspect non-organic production units or units associated by ownership or management to the applicant/certified organic operator. Inspection stages should include review of such units when there is sufficient reason for doing so, such as production of the same kind of products, etc. The operator shall provide complete and accurate information in respect of the above.
G.7.2.3The applicant shall also inform in detail any scheme of inspection and testing, which the applicant maintains or intends to maintain for ensuring organic integrity.
7.3 Application review
Nil
7.4 Evaluation
G.7.4.1 Preparation for evaluation