Audit of the control body through the monitoring of compliance with control plan. Measures for the irregularities

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1 Workshop on verification of compliance with product specification for PDO, PGI and TSG Audit of the control body through the monitoring of compliance with control plan Measures for the irregularities Viktorija Belšak Zagreb, 12th December 2014

2 Responsibilities of involved institutions in Slovenia MINISTRY Administration for Food Safety, Veterinary Sector and Plant Protection Proceedure for protection and transitional national protection of products Submission of application to EC, collaboration with EC and MS and other institutions Preparation of legislation on technical and organisational conditions for designated control and certification bodies Nomination of designated control and certification bodies: - application decision - contract - offical control of work of designated control and certification bodies - cancellation of nomination Control of use of protected designated names of products on the market CONTROL BODIES application with evidences public appointment control of compliance with product specification issue of certificates

3 LEGISLATION Regulation (EC) No 882/2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules Regulation (EU) No 1151/2012 on quality schemes for agricultural products and foodstuffs

4 THE LEGAL BASIS FOR THE NOMINATION OF CONTROL BODY Regulation (EU) No 1151/2012 on quality schemes for agricultural products and foodstuffs Article 36 Designation of competent authority 1. In accordance with Regulation (EC) No 882/2004, Member States shall designate the competent authority or authorities responsible for official controls carried out to verify compliance with the legal requirements related to the quality schemes established by this Regulation. Procedures and requirements of Regulation (EC) No 882/2004 shall apply mutatis mutandis to the official controls carried out to verify compliance with the legal requirement related to the quality schemes for all products covered by Annex I to this Regulation. 2. The competent authorities to verify compliance with the legal requirements related to the quality schemes shall offer adequate guarantees of objectivity and impartiality, and shall have at their disposal the qualified staff and resources necessary to carry out their functions.

5 THE LEGAL BASIS FOR THE NOMINATION OF CONTROL BODY Regulation (EU) No 1151/2012 on quality schemes for agricultural products and foodstuffs Article 36 Designation of competent authority 3. Official controls shall cover: (a) verification that a product complies with the corresponding product specification; and (b) monitoring of the use of registered names to describe product placed on the market, in conformity with Article 13 for names registered under Title II and in conformity with Article 24 for names registered under Title III.

6 THE LEGAL BASIS FOR THE NOMINATION OF CONTROL BODY Regulation (EU) No 1151/2012 on quality schemes for agricultural products and foodstuffs Article 37 Verification of compliance with product specification 1. In respect of protected designations of origin, protected geographical indications and traditional specialities guaranteed that designate products originating within the Union, verification of compliance with the product specification, before placing the product on the market, shall be carried out by: (a) one or more of the competent authorities as referred to in Article 36 of this Regulation; and/or (b) one or more of the control bodies within the meaning of point (5) of Article 2 of Regulation (EC) No 882/2004 operating as a product certification body.

7 THE LEGAL BASIS FOR THE NOMINATION OF CONTROL BODY Regulation (EU) No 1151/2012 on quality schemes for agricultural products and foodstuffs Article 39 Delegation by competent authorities to control bodies 1. Competent authorities may delegate, in accordance with Article 5 of Regulation (EC) No 882/2004, specific tasks related to official controls of the quality schemes to one or more control bodies. 2. Such control bodies shall be accredited in accordance with European Standard EN or ISO/IEC Guide 65 (General requirements for bodies operating product certification systems). Now Standard SIST EN ISO/IEC

8 THE LEGAL BASIS FOR THE NOMINATION OF CONTROL BODY Regulation (EC) No 882/2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules Article 2 Definitions 5. control body means an independent third party to which the competent authority has delegated certain control tasks;

9 THE LEGAL BASIS FOR THE NOMINATION OF CONTROL BODY Regulation (EC) No 882/2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules Article 5 Delegation of specific tasks related to official controls 1. The competent authority may delegate specific tasks related to official controls to one or more control bodies in accordance with paragraphs 2 to 4.

10 THE LEGAL BASIS FOR THE NOMINATION OF CONTROL BODY Regulation (EC) No 882/2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules Article 5 2. The competent authority may delegate specific tasks to a particular control body only if: (a) there is an accurate description of the tasks that the control body may carry out and of the conditions under which it may carry them out; (b) there is proof that the control body: (i) has the expertise, equipment and infrastructure required to carry out the tasks delegated to it; (ii) has a sufficient number of suitably qualified and experienced staff; (iii) is impartial and free from any conflict of interest as regards the exercise of the tasks delegated to it;

11 THE LEGAL BASIS FOR THE NOMINATION OF CONTROL BODY Regulation (EC) No 882/2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules Article 5 (c) the control body works and is accredited in accordance with European Standard EN General criteria for the operation of various types of bodies performing inspection and/or another standard if more relevant to the delegated tasks in question (Standard SIST EN ISO/IEC 17065);

12 THE LEGAL BASIS FOR THE NOMINATION OF CONTROL BODY Regulation (EC) No 882/2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules Article 5 (e) the control body communicates the results of the controls carried out to the competent authority on a regular basis and whenever the competent authority so requests. If the results of the controls indicate non-compliance or point to the likelihood of non- compliance, the control body shall immediately inform the competent authority; (f) there is efficient and effective coordination between the delegating competent authority and the control body.

13 THE LEGAL BASIS FOR THE NOMINATION OF CONTROL BODY Regulation (EC) No 882/2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules Article 5 3. Competent authorities delegating specific tasks to control bodies shall organise audits or inspections of control bodies as necessary. If, as a result of an audit or an inspection, it appears that such bodies are failing to carry out properly the tasks delegated to them, the delegating competent authority may withdraw the delegation. It shall withdraw it without delay if the control body fails to take appropriate and timely remedial action.

14 THE LEGAL BASIS FOR THE NOMINATION OF CONTROL BODY Regulation (EC) No 882/2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules Article 5 4. Any Member State wishing to delegate a specific control task to a control body shall notify the Commission. This notification shall provide a detailed description of: (a) the competent authority that would delegate the task; (b) the task that it would delegate; (c) the control body to which it would delegate the task.

15 CONTROL PRIOR TO MARKETING - CERTIFICATION - The competence of designated control and certification bodies - Their work is under control of Competent Authority for official controls Documentary check including all proceedures at central level of organisation including existance of accrediation list according to ISO/IEC witness control or control of certified client/fbo after the control (post control)

16 CONTROL PLAN - CA The task Personnel Frequency 1) Control of certification proceedures performed by designated control bodies: - At central level control of documentation and proceedures, - At procucer groups (if existing), if they perform internal control for purpose of certification, -at producer s level (sample of them). Trained inspectors. 1) Each control body inspected at least 1x a year for all schemed for which it obtains the nominations.

17 TRAINING BTSF Instructions for controls of protected designated products Internal training for the inspectors - Central level - Regional level

18 TECHNICAL AND ORGANIZATIONAL CONDITIONS THE EU REGULATIONS STIPULATE THE CONDITIONS: There is proof that the control body: 1) has the expertise, equipment and infrastructure required to carry out the tasks delegated to it; 2) has a sufficient number of suitably qualified and experienced staff; 3) is impartial and free from any conflict of interest as regards the exercise of the tasks delegated to it 4) is accredited in accordance with Standard SIST EN ISO/IEC NATIONAL REGULATIONS MAY STIPULATE OTHER CONDITIONS: - Quality Manual - Rules of the rotation for the controlers - Sample of the contract with certificate holders - Sample of the minutes for the performance of controls - Sample of the certificate - Price list of services - Contracts with laboratories

19 CARRYING OUT THE OFFICIAL CONTROL Phase I At the headquarters of the control body: - verifying the technical and organizational conditions. In this review the documentation and procedures for each of the requirements are checked to prove the existence of the system and maintenance of documentation. - checking the suitability of the content of the documents and compliance with the regulation when carrying out controls and certification. - checking the accreditation. The official control may take several days (2-3) and has the form of audit. Report of the performed official control/audit.

20 CARRYING OUT THE OFFICIAL CONTROL Phase II Control of the work of controller during the performance of control witness control, or after the certification post control. Inspection is carried out at the premises of the producers of protected products, on a sample of producers. Party in the procedure is control body.

21 CARRYING OUT THE OFFICIAL CONTROL Phase II - implementation Competent authority for official control: 1) Ask the control body for the documentation for the selected producers/producer groups of the protected products for the last year. 2) Check the documentation 3) Check at the producers the correct finding of facts Party in the procedure is control body. The control body deals with non-compliance found at the producers in their procedures.

22 MEASURES Control body by the public appointment part of the official control system Official inspection by competent authority Reports Non-compliance decision with the measures to correct the non-compliance within a specified deadline Non-compliances not corrected within a deadline withdrawal of public appointment Significant non-compliance withdrawal of public appointment THE FINE????

23 OFFICIAL INSPECTION <-> ACCREDITATION ACCREDITATION OF THE CONTROL BODY - The existence of the system and documentation in accordance with Standard SIST EN ISO/IEC 17065: The use of the written procedures and documentation when performing the control and certification OFFICIAL INSPECTION OF THE CONTROL BODY - fulfill the prescribed conditions - comply with regulations - controls are fully implemented - facts properly found.

24 Thank you for your attention!

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