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ACCESS TO EC MARKETREQUIREMENTS 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

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GROUPS OF GOODS BY RISK LEVEL ACCORDING TO TRASBOUNDARY MOVEMENT

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ризик

тваринного походження ДСЛ рослинного походження ДСЛ

побічні тваринного пох. НДСЛ 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.

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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.

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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

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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.

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HOW IS THE SYSTEM OF CONTROL ASSESSED BY THEFVO 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 20-20-20) 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.

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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.

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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

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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

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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.

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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.

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THANK YOU FOR YOUR ATTENTION!