Official Controls Legislative Framework Hazard Classification

1. Implementation of Ukraine’s Commitments under WTO and ENP Frameworks in the Rural Sector (Sector-wide approach) Official Controls Legislative Framework Hazard Classification

2. Implementation of Ukraine’s Commitments under WTO and ENP Frameworks in the Rural Sector (Sector-wide approach) Introduction Tony Wheale

3. SWAP-RURAL Project Assist Ukraine to achieve greater EU integration and harmonisation with closer compliance with WTO requirements. Project objectives Project Purpose • Support the application of a Sector Wide Approach (SWAP) for agriculture and rural development within the context of WTO accession and the ENP Action Plan

4. Food Safety Component We are presenting a series of mass seminars in each of the pilot regions to which will be invited: Representatives of the food industry Representatives of regional departments of veterinary services and laboratories Representatives of regional offices of the Agency for the identification and registration Representatives of regional departments of the Sanitary-Epidemiological Service We also plan to present more detailed and in-depth seminars on “An introduction to the HACCP system and pre-requisites”. Activities in the pilot regions - Seminars Slide 4

5. Food Safety Component We also work with enterprises in the pilot regions to help develop and implement HACCP, traceability and pre-requisite systems Each of the pilot regions is scheduled to select companies for implementation of the HACCP system and pre-requisites Preliminary assessment of each enterprise under agreed criteria Training of responsible personnel at enterprises on HACCP and pre-requisite systems Providing advice on implementation of these systems Assisting enterprises to prepare for EU approval inspections by inspectors of the EU Food and Veterinary Office (FVO) Activities in the pilot regions - HACCP Slide 5

6. Implementation of Ukraine’s Commitments under WTO and ENP Frameworks in the Rural Sector (Sector-wide approach) Thank you for your attention

7. Implementation of Ukraine’s Commitments under WTO and ENP Frameworks in the Rural Sector (Sector-wide approach) Legislative Framework Yana Dobidovska Slide 7

8. EU Food Safety Legislation • Framework that defines obligations for food and feed business operators • Defines official controls to be carried out by EU Member States • Requires EU Member States to have effective sanctions and penalties • Enables free trade within the EU • Non-EU countries must have similar systems to be able to trade with the EU Slide 8 Slide 8

9. EU Food Safety Legislation • Compare with owning and driving a car • Obligations on car driver – pass driving test, good state of health, keep car in safe condition, drive responsibly • Powers of police – check speed, check condition of vehicle, stop a car on the road, examine documents • Contravene the law – administrative fine, criminal prosecution, confiscation of car Slide 9 Slide 9

10. EU Food Safety Legislation EU Regulations that define obligations for Food & Feed Business Operators include: Regulation 178/2002 (General Food Law) 852/2004 (General Food Hygiene Rules) 853/2004 (Additional Hygiene Rules for Food of Animal Origin) 1935/2004 (Food Contact Materials) 183/2005 (Feed Hygiene Rules) 2073/2005 (Microbiological Criteria). Slide 10

11. Example: Regulation 178/2002 • Not to place unsafe food on the market • Ensure the safety of the food and feed they produce • Ensure traceability of all materials at least one step forward / one step back • Withdraw unsafe food from the market • Identify Critical Control Points (CCPs) and apply appropriate controls • Cooperate with Competent Authorities Slide 11 Slide 11

12. Implementation of Ukraine’s Commitments under WTO and ENP Frameworks in the Rural Sector (Sector-wide approach) Thank you for your attention

13. Implementation of Ukraine’s Commitments under WTO and ENP Frameworks in the Rural Sector (Sector-wide approach) Official Controls Tony Wheale Slide 13

14. Regulation (EC) No. 882/2004 Official Controls: Checks carried out by competent authorities … to monitor compliance by business operators with legislation. Checks include inspections, audits, monitoring, surveillance, sampling and analysis. The objective of the Regulation is to improve the consistency and effectiveness of controls … and raise standards of food safety and consumer protection.

15. Regulation (EC) No. 882/2004 Official Controls: Must be carried out regularly;. Must be risk-based; Must be without prior notice; Must cover all stages of the food chain “from farm to fork”; Must cover food and animal feed produced within the country, imported into the country, and intended for export from the country.

16. Regulation (EC) No. 882/2004 Planning of official controls – take into account: Risks associated with animals, animal feed, food, processes, materials, substances, activities or operations that may affect the safety of animal feed or food; The business operators' past record of compliance with legislation and with animal health and animal welfare rules; and Other information that might indicate non-compliance.

17. Regulation (EC) No. 882/2004 Competent Authorities Each country has one central competent authority. The central competent authority is usually a ministry or an “independent” agency. For example: Danish Veterinary and Food Administration; Food Safety Authority of Ireland; Food Standards Agency (UK); Countries may devolve authority, e.g. to Oblast or Rayon administrations, but these must be supervised by the central competent authority.

18. Regulation (EC) No. 854/2004 Competent authorities must ensure: The effectiveness of official controls; Impartiality and accountability; Provision of suitable laboratories; Legal powers to enforce legislation; Contingency planning; Supervision of Oblast and Rayon administrations; Monitoring, surveillance and audit; Training of control officials.

19. Regulation (EC) No. 882/2004 Sampling and analysis Procedures and methods must comply with internationally recognised rules; If there are no international rules, then there must be national rules that are objective and based on scientific evidence; Annual official monitoring and surveillance programs for planned and coordinated sampling.

20. Regulation (EC) No. 882/2004 Official Laboratories Competent authorities designate official laboratories, which must be accredited in accordance with: (a) EN ISO/IEC 17025 on "General requirements for the competence of testing and calibration laboratories"; (b)EN 45002 on "General criteria for the assessment of testing laboratories"; (c) EN 45003 on "Calibration and testing laboratory accreditation system-General requirements for operation and recognition”.

21. Regulation (EC) No. 882/2004 Controls on imports from third countries Veterinary checks on products of animal origin are unaffected by Regulation 882/2004; Competent authorities carry out risk-based official controls onimports of animal feed and food of non-animal origin from third countries; Ports, airports and land border crossings for entry of imports of products of animal origin must be specified; An importer must give the competent authority advance notice of every consignment.

22. Regulation (EC) No. 882/2004 Controls on imports from third countries Consignments that do not meet the rules may be returned to their country of origin; The rules for allowing consignments to be returned to the country of origin must be set out in detail; The costs of returning a consignment to another country are paid by the importer.

23. Regulation (EC) No. 882/2004 Controls on imports from third countries Competent authorities and national customs services must co-operate closely. Customs services must not release food or animal feed unless they have the approval of the competent authority.

24. Regulation (EC) No. 882/2004 EU official controls in third countries EU experts carry out official controls in third countries to verify equivalence of the third country’s legislation and official control systems with EU animal feed, food, and animal health legislation; These official controls are carried out by experts from the EU’s Food and Veterinary Office (FVO); Recent FVO visits to Ukraine have looked at the production of fishery products, residue control and monitoring, sunflower oil, milk and dairy products, poultry meat and red meat production, egg production, and Ukraine’s official control systems in these sectors.

25. Regulation (EC) No. 854/2004 Official Controls Products of animal origin: Regulation 854/2004 sets out specific rules for official controls on products of animal origin intended for human consumption. Official veterinarians must carry out audits and inspections of slaughterhouses, game handling establishments and meat cutting plants The central competent authority should decide who are the most appropriate staff to audit and inspect other types of establishment.

26. Regulation (EC) No. 854/2004 Official Controls Products of animal origin: Establishments in the EU and imports from third countries are subject to similar controls; Competent authorities approve establishments that comply with EU legislation. Approved establishments are given a unique approval code; Approval may be suspended or withdrawn if the competent authority identifies serious deficiency.

27. Regulation (EC) No. 854/2004 Official Controls Products of animal origin: • Business operators must give competent authorities all the assistance they need to carry out official controls (e.g. access to premises, documents, records); • Official controls include: • audits of good hygiene practice and HACCP; • specific controls that are relevant to the specific food industry sector (e.g. fresh meat, fishery products, milk and dairy products). Slide 27

28. Regulation (EC) No. 854/2004 Official veterinarian Appointed and authorised by the competent authority; Professionally qualified; Has passed a special test; Responsible for auditing and inspecting good hygiene practice (maintenance of plant structure and equipment, plant hygiene, staff hygiene, training, processing of animal by-products not intended for human consumption, etc.); Responsible for auditing the HACCP system in relation to compliance of products of animal origin with microbiological criteria, and absence of excessive quantities of prohibited substances, contaminants or chemical residues, etc. Slide 28

29. Regulation (EC) No. 854/2004 Official veterinarian’s responsibilities: Traceability records; Ante-mortem inspections; Animal welfare during transport and slaughter; Post-mortem inspections Specified Risk Material (TSE controls); Other animal waste and by-products; Laboratory testing (zoonoses, TSE, other diseases) Health and identification marks; Official veterinarians may be assisted by veterinary auxilliaries. Slide 29

30. Implementation of Ukraine’s Commitments under WTO and ENP Frameworks in the Rural Sector (Sector-wide approach) Responsibilities of FBOs, and Responsibilities of the State Yana Dobidovska Slide 30

31. Conclusions FBO and OFFICIAL CONTROL RESPONSIBILITY All foodstuffs Food of animal origin Feed for animals Regulation 2073/2005 Microbiological criteria for foodstuffs Obligations of food/feed business operators Regulation 183/2005 Regulation [x] 852/2004 Regulation [x] 853/2004 Regulation 882/2004 Regulation [x] 854/2004 Official controls General Food Law (Regulation 178/2002)

32. Hartig Responsibilities of FBO • Reg 178/2002 Article 17: Food and feed business operators at all stages of production, processing and distribution within the businesses under their control shall ensure that foods or feeds satisfy the requirements of food law which are relevant to their activities and shall verify that such requirements are met.

33. Hartig Responsibilities of FBO Reg 178/2002 Article 17: • If a food business operator considers or has reason to believe that a food which it has imported, produced, processed, manufactured or distributed is not in compliance with the food safety requirements, it shall immediately initiate procedures to withdraw the food in question from the market where the food has left the immediate control of that initial food business operator and inform the competent authorities thereof. Where the product may have reached the consumer, the operator shall effectively and accurately inform the consumers of the reason for its withdrawal, and if necessary, recall from consumers products already supplied to them when other measures are not sufficient to achieve a high level of health protection.

34. Responsibilities of FBO Reg 178/2002 Article 17: 2. A food business operator responsible for retail or distribution activities which do not affect the packaging, labelling, safety or integrity of the food shall, within the limits of its respective activities, initiate procedures to withdraw from the market products not in compliance with the food-safety requirements and shall participate in contributing to the safety of the food by passing on relevant information necessary to trace a food, cooperating in the action taken by producers, processors, manufacturers and/or the competent authorities.

35. Responsibilities of FBO Reg 178/2002 Article 17: 3. A food business operator shall immediately inform the competent authorities if it considers or has reason to believe that a food which it has placed on the market may be injurious to human health. Operators shall inform the competent authorities of the action taken to prevent risks to the final consumer and shall not prevent or discourage any person from cooperating, in accordance with national law and legal practice, with the competent authorities, where this may prevent, reduce or eliminate a risk arising from a food. 4. Food business operators shall collaborate with the competent authorities on action taken to avoid or reduce risks posed by a food which they supply or have supplied.

36. Responsibilities of States Articel 17: Responsibilities (2) • Member States shall enforce food law, and monitor and verify that the relevant requirements of food law are fulfilled by food and feed business operators at all stages of production, processing and distribution. • For that purpose, they shall maintain a system of official controls and other activities as appropriate to the circumstances, including public communication on food and feed safety and risk, food and feed safety surveillance and other monitoring activities covering all stages of production, processing and distribution. • Member States shall also lay down the rules on measures and penalties applicable to infringements of food and feed law. The measures and penalties provided for shall be effective, proportionate and dissuasive.

37. COMPETENT AUTHORIT(Y)IES • Reg. 852/2004 • ‘competent authority’ means the central authority of a Member State competent to ensure compliance with the requirements of this Regulation or any other authority to which that central authority has delegated that competence; it shall also include, where appropriate, the corresponding authority of a third country; • Reg. 882/2004 • ‘competent authority’ means the central authority of a Member State competent for the organisation of official controls or any other authority to which that competence has been conferred; it shall also include, where appropriate, the corresponding authority of a third country; • Reg. 854/2004 • ‘competent authority’ means the central authority of a Member State competent to carry out veterinary checks or any authority to which it has delegated that competence;

38. COMPETENT AUTHORITIES • Designation of competent authorities and operational criteria (Art. 4) • Member States shall designate the competent authorities responsible for the purposes and official controls set out in this Regulation. • The competent authorities shall ensure: - the effectiveness and appropriateness of official controls on live animals, feed and food at all stages of production, processing and distribution, and on the use of feed; - that staff carrying out official controls are free from any conflict of interest;

39. COMPETENT AUTHORITIES • The competent authorities shall ensure - that they have, or have access to, an adequate laboratory capacity for testing and a sufficient number of suitably qualified and experienced staff so that official controls and control duties can be carried out efficiently and effectively - that they have appropriate and properly maintained facilities - and equipment to ensure that staff can perform official controls efficiently and effectively; - that they have the legal powers to carry out official controls and to take the measures provided for in this Regulation; - that they have contingency plans in place, - that the feed and food business operators are obliged to undergo any inspection carried out in accordance with this Regulation and to assist staff of the competent authority in the accomplishment of their tasks.

40. COMPETENT AUTHORITIES • The competent authorities shall ensure: - when, within a competent authority, more than one unit is competent to carry out official controls, efficient and effective coordination and cooperation shall be ensured between the different units. - Competent authorities shall carry out internal audits or may have external audits carried out,

41. COMPETENT AUTHORITIES • Delegation of specific tasks related to official controls • The competent authority may delegate specific tasks related to official controls to one or more control bodies in accordance with paragraphs 2 to 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; • and (c) the control body to which it would delegate the task.

42. Implementation of Ukraine’s Commitments under WTO and ENP Frameworks in the Rural Sector (Sector-wide approach) Criteria of FBO evaluation. Experience of EU countries. Yuriy Ohlashennyy Slide 42

43. Criteria of FBO evaluation • Each country has own system of FBO evaluation, but these systems are based on risk assessment. The risk can be considered as: - high - medium - low and/or very low Depending on adverse effect on human health

44. Criteria of FBO evaluation, example FBO structure and equipment Buildings and facilities for processing, storage and marketing of food products of animal origin must be constructed and comply with relevant EU regulations (852, 853). • Evaluation of risk. Depends on the year of construction, premises and equipment condition, layout, routine maintenace of equipment and premises.

45. Criteria of FBO evaluation, example Capacity of the sites • Each establishment is designed in a way that allows processing and production of a certain amount of raw materials and foods on the base of hour’s capacity, daily capacity or weekly capacity and also allows their efficient storage. In determining the frequency of verification inspectors should also take into account seasonal factors. • Evaluation of risk. Higher capacity leads in the case of deviation to increase of quantity of dangerous products and risk growth.

46. Criteria of FBO evaluation, example Range of products • Establishments that produce a range of products will have different documentation relevant to each product. As such they are complicated and will have additional challenges in terms of meeting the food safety requirements. • Evaluation of risk. Wide range of products, various structure and different technology treatment cause higher risk.

47. Criteria of FBO evaluation, example Technology (type of products) • Different food products of animal origin undergo a diverse range of technological processes, each of which is associated with differing hazards and risks.. • Evaluation of risk. Evaluation of the risk depends on the process technology criteria in terms of compliance with process parameters (time, temperature, pressure, etc.) in the product process documentation.

48. Criteria of FBO evaluation, example Origin and quality of raw materials The raw materials used by FBO’s for processing, production, storage and marketing of food of animal origin are particularly important criterion for evaluation of the risk in the production and marketing of a certain product. Evaluation of risk. Improper supplier evaluation, use of raw material of inappropriate origin, etc., lead to risk increase.

49. Criteria of FBO evaluation, example Water supply The water used for processing, production, storage and marketing is a very important factor with regard to the safety of food products. Each food processing establishment is unique in terms of the water used for different production processes. Evaluation of risk. Depends on: • the type of used water sources (public or own water sours) • the condition of plumbing • the quantity of incorporated in the product water • flow of the water in the enterprise • differences in the composition of the water in the regions(e.g. in some regions the level • of heavy metals, or salt or calcium etc. could be higher) • control over implementation of monitoring programs for water safety in accordance of legislation

50. Criteria of FBO evaluation, example Systems of self-control In accordance with the European and national legislations the establishment for processing, production, storage and marketing of food of animal origin should have developed and implemented food control systems (good manufacturing practices and HACCP). Each company has individual characteristics that must be taken into consideration when the self control systems are assessed (scope and stage of application) Evaluaton of risk. Self-control system shall be developed, fully implemented, validated, based on relevant legislation and shall cover whole product range.