ACCESS TO EC MARKET REQUIREMENTS TO FACILITIES BLATERAL NEGOTIATIONS ON ISSUES OF SANITARY AND PHYTO-SANITARY MEASURES

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1 ACCESS TO EC MARKET REQUIREMENTS TO FACILITIES BLATERAL NEGOTIATIONS ON ISSUES OF SANITARY AND PHYTO-SANITARY MEASURES BASHINSKY VITALY BISHKEK 2016 WHY COUNTRIES APPLY RESTRICTIVE AND PROTECTION MEASURES? RISK ASSESSMENTOFIMPORTS OBJECTS OF CONTROL CAN BE PRODUCTS OF ANIMAL OR VEGETABLE ORIGIN, LIVING ORGANISMS, RARELY, OTHER OBJECTS. FOR CERTAIN MICROBIOLOGICAL AND CHEMICAL HAZARDS IT IS REASONABLE TO CONSIDER THE PROXIMITY OF THE LOCATION OF THE COUNTRY. THE SCOPE OF COVERAGE SHOULD TAKE INTO ACCOUNT ALL POSSIBLE CHANNELS FOR HAZARDS IMPORTATION FROM A NEIGHBORING COUNTRY, AT THE SAME TIME IT IS NECESSARY TO TAKE INTO CONSIDERATION LEGAL AND ILLEGAL TRADE IN CERTAIN CATEGORIES OF GOODS, OTHER ASPECTS, SUCH AS THE CONTAMINATION BY AIR, WATER OR PRECIPITATION. HAZARDOUS FACTORS ARE MICROBIOLOGICAL PATHOGENS OR CHEMICAL CONTAMINANTS THAT CONSTITUTE A RISK TO HUMAN OR ANIMAL HEALTH AS THE RESULT OF THEIR CONSUMPTION OR CONTACT WITH THEM. FIRST STEP ON IDENTIFYING THE HAZARD, AS A RULE, IS PERFORMED SEPARATELY FROM RISK ASSESSMENT. THE RISK ASSESSMENT STEPS ARE: ESTIMATION OF EMISSION; EXPOSURE ASSESSMENT (SPREAD AMONG LIVESTOCK OR OTHER ANIMALS); IMPACT ASSESSMENT AND CALCULATION (DETERMINATION) OF THE RISK 1

2 GROUPS OF GOODS BY RISK LEVEL ACCORDING TO TRASBOUNDARY MOVEMENT ризик тваринного походження ДСЛ побічні тваринного пох. НДСЛ рослинного походження ДСЛ рослинного пох. НДСЛ CRITERIA OF TRANSBOUNDARY RISKS ASSESSMENT. 1. TRANSBOUNDARY MOVEMENT OF HUMAN AND ANIMAL PATHOGENS 2. CROSS-BORDER MOVEMENT OF AGENTS PATHOGENIC FOR PLANTS 3. THE LIKELY NEGATIVE IMPACT ON HUMAN AND ANIMAL HEALTH 4. THERE IS NO SINGLE METHOD OF RISK ASSESSMENT, SELECTION DEPENDS ON THE CIRCUMSTANCES THEREFORE FOR RISK ASSESSMENT: IT IS NECESSARY TO HAVE IN PLACE SPECIALLY TRAINED, RELIABLE AND TESTED IN PRACTICAL ASSIGMENTS PERSONNEL. 2

3 RISK ANALYSIS EC REQUIREMENTS FOR ADMISSION OF ANIMAL PRODUCTS BEGINNING - INITIATION OF THE PROCESS - THE STUDY AND EXECUTION OF EXTERNAL REQUIREMENTS. 1. MONITORING PLAN OF RESIDUES IS DEVELOPED BY THE COMPETENT AUTHORITY AND SENT TO THE SERVICE ON FOOD AND VETERINARY (FVO) FOR ASSESSMENT 2. IN THE CASE OF A POSITIVE ASSESSMENT THE COUNTRY IS INCLUDED IN THE RELEVANT LIST 3. THE RESIDUE CONTROL PLAN IS CARRIED OUT BY THE COMPETENT AUTHORITY AND IS REGULARLY CHECKED DURING THE AUDIT, WHICH IS CONDUCTED IN CONJUNCTION WITH THE FVO 4. INSPECTORS OF THE MISSIONS CARRIED OUT CONFIRMATION OF THE ABILITY TO CARRY OUT MONITORING EVERY 4-5 YEARS. 3

4 PROCEDURE FOR ADMITTING PRODUCTS OF ANIMAL ORIGIN Official country's application to the European Commission (EC) with request about the documentation necessary to enter the EU market for individual product of animal origin EC response with the questionnaire regarding the export opportunities to the EU of such products of animal origin (Up to 6 months) Response of the country to the questionnaire of EC (Up to 2 months) Providing additional materials upon request from EC о требованию ЕС (Up to 2 months) PROCEDURE FOR ADMITTING PRODUCTS OF ANIMAL ORIGIN The trip experts of the EC and the FVO to a potential exporter to certify companies - potential exporters (The verification visit) (Up to 6 months) In the case of positive findings of experts, the European Commission takes a decision on the inclusion of the country in the list of countries that are allowed to export to the EU single animal products (Up to 6 months) Approval of enterprises, filling out the application form and submitting it to EC (Up to 1 month) Enterprises may start exporting to the EU corresponding products of animal origin 4

5 VERIFICATION MISSION OF THE FOOD AND VETERINARY OFFICE COORDINATION OF THE VISIT MATCHING VISIT A VISIT TO THE COMPETENT AUTHORITY (TO) VISIT TO THE FARM A VISIT TO THE TERRITORIAL BODY OF THE COMPETENT AUTHORITY, AUTHORIZED BY THE COMPETENT AUTHORITY LABORATORY A VISIT TO A PROCESSING ENTERPRISE WHAT IS ASSESSEDBY THE EXPERTS OF THE FVO? NATIONAL LEGISLATION AND ITS COMPLIANCE WITH THE EUROPEAN LEGISLATION IN PARTICULAR: ANIMAL HEALTH (FOOT AND MOUTH DISEASE, RINDERPEST (PEST BOVINE), TUBERCULOSIS, BRUCELLOSIS, AND OVER 50 DISEASES MANDATORY FOR REPORTING BETWEEN MEMBERS OF THE OIE). FOOD SAFETY HACCP, TRACEABLITY THE EFFECTIVENESS OF OFFICIAL CONTROL AND ITS COMPLIANCE WITH THE INTERNATIONAL PRACTICE EXISTING CERTIFICATION RULES THE LEGISLATION AND THE ACTUAL USE OF THE FOOD AND FEED SUPPLEMENTS, LABELING, ETC. 5

6 HOW IS THE SYSTEM OF CONTROL ASSESSED BY THE FVO EXPERTS? VERIFICATION IS PRIMARILY RELEVANT FOR THE STATE BODY WHICH GENERATES AND IMPLEMENTS THE STATE POLICY IN THE FIELD OF VETERINARY MEDICINE AND EXECUTION OF SANITARY LEGISLATION. IF THE RESULTS OF FVO AUDIT IN THE COUNTRY ARE POSITIVE, THE COUNTRY IS INCLUDED IN THE LIST OF COUNTRIES APPROVED FOR EXPORT, BUT ONLY IN CASE OF SUPPLYING CREDIBLE EVIDENCE OF FULFILLMENT OF CERTAIN CONDITIONS WITH RESPECT TO ANIMAL HEALTH, FOOD SAFETY AND VETERINARY CERTIFICATION. IN THE CASE OF CRITICISM (RULE ) VERIFICATION VISIT IS PLANNED AGAIN AFTER THE COMMENTS ARE FULFILLED IN FULL. ENTERING OF NEW ENTERPRISES IN THE EU LIST AFTER ENTERING THE UKRAINE AS A STATE IN THE LIST OF COUNTRIES FOR WHICH IMPORT INTO THE EU IS PERMITTED THE COMPETENT AUTHORITY OF UKRAINE HAS THE RIGHT TO PROPOSE THE INCLUSION OF THE COMPANY IN THE LIST OF ENTERPRISES AUTHORIZED TO EXPORT THEIR PRODUCTS TO THE EU SOLELY ON THE BASIS OF ASSURANCES OF CONFORMITY DETERMINED IN THE COURSE OF INTERNAL AUDITS FOR COMPLIANCE WITH THE REQUIREMENT OF IMPORTING COUNTRY. 6

7 CONFORMATION BY THE COMPETENT AUTHORITY A PLANT, A PROCESSING ENTERPRISE MUST COMPLY WITH THE REQUIREMENTS SET OUT IN THE REGULATION (EC) 852/2004 AND 853/2004, OR BE EQUIVALENT THERETO.. SELF-CONTROL SYSTEM BASED ON THE PRINCIPLES OF HACCP AND TRACEABILITY MUST BE INTRODUCED CONFORMITY AT THE LEVEL OF THE COMMODITY SECTOR MUST BE PROVEN, FOR EXAMPLE, DAIRY PRODUCTS ARE PRODUCED FROM RAW MILK THAT MEETS THE REQUIREMENTS OF THE EU: THE NUMBER OF SOMATIC CELLS ACCORDING TO THE REGULATIONS 853 \ 2004 TOTAL NUMBER OF BACTERIA THE TEMPERATURE OF RAW MILK AVAILABILITY AND PARALLEL PRODUCTION AND STATE CONTROL ON INHIBITORS GUARATEES OF CONFORMITY PROVIDED TO THE COMPETENT AUTHORITY OF UKRAINE REGULAR LABORATORY TESTS OF WATER, FOOD PRODUCTS, RAW MATERIALS AND, WHERE APPROPRIATE, THE PRODUCTS IN THE PRODUCTION PROCESS, AT THE SAME TIME LOGICAL, RISK-BASED APPROACH TO PLANNING OF INSPECTIONS AND INTERPRETATION OF THE RESULTS IS TAKEN INTO ACCOUNT IT IS CONCLUSIVELY PROVED THAT RESPONSIBLE STAFF IN THE COMPANY KNOWS AND OBSERVES NATIONAL LEGISLATION AND EU REQUIREMENTS TO ENABLE THE ENTERPRISE BE INCLUDED IN THE EU LIST, ALL THE REQUIREMENTS AND CONDITIONS REFERRED TO ABOVE SHOULD BE ASSESSED BY THE COMPETENT AUTHORITY SHOULD BE ESTABLISHED THEIR CONFORMITY COMPETENCE AND ACTIONS OF THE COMPETENT AUTHORITY ARE CHECKED DURING REGULAR AUDITS BY FVO A GOOD RESULT FOR THE COUNTRY AND ENTERPRISES CAN ONLY BE ACHIEVED IF THERE IS GOOD COOPERATION, UNDERSTANDING, TRUST AND RAPID EXCHANGE OF INFORMATION BETWEEN THE COMPETENT AUTHORITIES, ENTERPRISE AND FARM, SUPPLYING RAW MATERIALS. 7

8 THE SYSTEM OF URGENT NOTIFICATION AND THE REPUTATION OF THE COUNTRY, THE ENTERPRISE, THE COMPETENT AUTHORITY. (ПОРТАЛ RASFF) EUROPEAN COMMUNITY LEGISLATION WITH REGARDS TO FOOD SAFETY REGULATION (EC) 178/2002, GFL REGULATION (EC) 882/2004: OFFICIAL CONTROLS REGULATION (EC) 852/2004: HYGIENE OF FOODSTUFFS REGULATION (EC) 853/2004: HYGIENE OF FOOD OF ANIMAL ORIGIN REGULATION (EC) 854/2004: OFFICIAL CONTROL OF PRODUCTS OF ANIMAL ORIGIN 8

9 CONTAMINANTS, AND RESIDUES OF CONTAMINANTS REGULATION (EC) 1881/2006: THE MAXIMUM PERMITTED LEVELS OF CONTAMINANTS IN FOOD REGULATION (EEC) 2377/90: MAXIMUM PERMITTED LEVELS OF VETERINARY DRUGS DIRECTIVE 96/22 / EC: PROHIBITION OF CERTAIN SUBSTANCES DIRECTIVE 96/23 / EC: MONITORING OF SUBSTANCES AND RESIDUES DIRECTIVE 91/414 / EC: PESTICIDES REGULATION (EC) 396/2005: THE MAXIMUM PERMITTED LEVELS OF PESTICIDES. INTRODUCTION OF A PACKAGE OF DOCUMENTS ON HYGIENE REGULATION (EC) 2073/2005: MICROBIOLOGICAL CRITERIA REGULATION (EC) 2074/2005: MEASURES FOR INTRODUCTION REGULATION (EC) 2075/2005: STUDIES OF TRICHINELLA SPIRALIS REGULATION (EC) 2076/2005: TRANSITIONAL MEASURES 9

10 LABELING, CONTACT MATERIALS, SUPPLEMENTS DIRECTIVE 2000/13 / EC: FOOD LABELING DIRECTIVE 90/496 / EEC: LABELING OF FEED REGULATION (EC) 1935/2004: CONTACT MATERIALS FOR FOODSTUFFS REGULATION (EC) 258/97: "NEW" FOODS REG. (EC) 1333/2008: FOOD SUPPLEMENTS REG. (EC) 1332/2008: FOOD ENZYMES REG. (EC) 1334/2008: FOOD SEASONINGS CONDUCTING NEGOTIATIONS 1. INITIATION OF NEGOTIATIONS ON THE OFFICIAL LEVEL. TO DO THIS, YOU MUST JUSTIFY THE REQUEST OR SELECT AN EXISTING COMMON PROBLEM, TOPIC, ETC. 2. NEGOTIATIONS HAVE TO BE MUTUALLY NECESSARY, OTHERWISE THEY WILL BE BROUGHT TO A FORMAL EXCHANGE OF VIEWS WITH THE SIDE TO WHICH THESE NEGOTIATIONS "ARE NOT INTERESTING". 3. THE INITIATING PARTY CAN AFFORD TO RAISE THE LEVEL OF THE REPRESENTATIVE DURING THE NEGOTIATIONS, BUT NOT VICE VERSA. 4. REPRESENTATIVES SHOULD BE ABLE TO GUARANTEE THE DECLARATIONS THE LEVEL OF GUARANTEES, RATHER THAN OPPORTUNITIES. 5. NEGOTIATIONS MAY BE INITIATED ONLY WHEN THE PARTIES HAVE A NUMBER OF CONSOLIDATED SOLUTIONS AND CLEARLY DEFINED BOUNDARIES OF ACCEPTABLE AND UNACCEPTABLE LIMITS. 10

11 FOUNDATION FOR NEGOTIATIONS INTERNATIONAL NEGOTIATIONS ARE ALWAYS PROGRESS. NEGOTIATIONS, THE ACTUAL JUSTIFICATIONS AND EVIDENCE ARE BASED SOLELY ON INTERNATIONAL NORMS. WHEN REFERRING TO NATIONAL LEGISLATION, IT IS NECESSARY TO BE GUIDED BY THE MANIFESTATIONS THAT ARE THE MOST TRANSPARENT AND MOST DEMOCRATICALLY PROTECT THE CONSUMER. ACTIVELY USE OFFICIAL STATUS PROVIDED BY INTERNATIONAL ORGANIZATIONS - IT IS ALWAYS EFFECTIVE. NEGOTIATIONS SHOULD CONCERN THE TOPICS UNDERSTANDABLE TO BOTH SIDES. MULTILATERAL NEGOTIATIONS ARE TYPICALLY EXPLORATORY IN NATURE AND RARELY END WITH A UNANIMOUS DECISION OR A JOINT COMPROMISE. (EXCEPT ARBITRAGE). NEGOTIATIONS ON SANITARY AND PHYTOSANITARY MEASURES NEGOTIATIONS MAY BE THE MOST PRODUCTIVE IN TERMS OF SANITARY AND PHYTOSANITARY MEASURES: IN CASE OF FORMATION OF MUTUALLY BENEFICIAL TRADE MEASURES, OR THE FORMATION OF MUTUALLY BENEFICIAL TRADE RELATIONS... NEGOTIATIONS SHOULD BE BASED ON GLOBAL RULES TO PROTECT AREAS FROM CONTAMINANTS AND TO FIT WITHIN THE MAXIMUM PREFERENTIAL MODE FOR FREE TRADE. USE OF THE RULES OF THE WORLD TRADE ORGANIZATION (SPS SECTION), TERRESTRIAL ANIMAL HEALTH CODE AND CODEX ALIMENTARIUS WILL GREATLY SIMPLIFY ANY EVIDENTIARY BASIS. 11

12 THANK YOU FOR YOUR ATTENTION! 12