French-German WorskshopBeijing, China, 06/11/2015

Jacky Le Goslès, Direction G AdviserDirectorate General Health and Food Safety/European Commission

European Union

food safety experience

The European Union:

28 Member States

500 million consumers

Biggestworld importer of food

STEPS AND TRIGGERS OF THE EC/EU SPS ACTIONS

Intra-Community trade and Community Agriculture Policy (1960/90)

– Article 36 of the EC treaty (avoiding unilateral use of sanitary safeguard

clause)

– Self - sufficiency

– Export

– Live Animals: set of control/eradication disease Directives (forming the

Community Animal health policy) and trade Directives

– Food of animal origin trade Directives by commodity

Single Market (1990/95); (European Unique Act) 1st January 1993

Fair Trade

– End of intra-community sanitary controls

– Total harmonisation (including food of non-animal origin and retail)

STEPS AND TRIGGERS OF THE EC/EU ACTIONS

• 1995 onwards

– SPS Agreement (reduction of barriers to trade/science based FS legislation)

– BSE and Dioxins crises

– Animal health crises (FMD, CSF)

– Avian Flu/globalisation (human and goods movements)/Possible

pandemia of human flu

– Emerging diseases ( Blue Tongue)

– Science and uncertainties (pesticides, growing factors, GMO,..)

– Other legitimate factors : "societal concerns": animal welfare, GMO,

fair trade, environment friendly

– Climate changes: sustainable agriculture/aquaculture

– Complete revision of the food safety EU legislation (2002-2004)

– Proposal of a new EU new AH law (on going)

EU Food safety legislation

• GOALS

o HIGH LEVEL OF CONSUMER HEALTH PROTECTION

o ALLOWING AN HARMONISED SINGLE MARKET

o PREVENTING PRODUCER/FOOD SECTOR ECONOMIC LOSES AND REDUCING HEALTH CARE COSTS DUE TO UNSAFE FOOD

• PRINCIPLES

o FOOD SAFETY BASED ON THE CONTROL OF THE FOOD PRODUCTION CHAIN « FARM TO FORK APPROACH » versus CONTROL ON END-PRODUCTS

o FOOD BUSINESS OPERATORS (FBO) MUST NOT PUT UNSAFE FOOD ON THE MARKET (injurious to health or unfit for human consumption); FBO liability.

o FBO IS RESPONSIBLE TO IMPLEMENT EU HARMONISED FOOD SAFETY LEGISLATION, INCLUDING "SANITARY"TRACEABILITY (one stepbackward/one step forward)

o MEMBER STATE COMPETENT AUTHORITY (CA) HAVE TO CONTROL AND INFORCE THE EU FOOD SAFETY LAW BY FBOs

o NO DISCRIMINATION BETWEEN NON-EU COUNTRIES EXPORTING TO THE EU (based on SPS principle)

EU FOOD SAFETY LEGISLATION PRINCIPLES based on Sanitary and Phyto-Sanitary Agreement

Measures taken to protect public health:

– Science based and appropriate.

– No unjustified barrier to trade.

– Based on international standards, guidelines or

recommendations(CA).

– SPS measures of other Members as equivalent shall be accepted... if the exporting Member objectively demonstrates … that its measures achieve the importing Member's appropriate level of SPS protection.

EU food import principle: Food imported into the EU shall comply with the

relevant requirements of food law or conditions recognised by the EU to be

at least equivalent with requirements contained therein (Articles 11 and 12

of Regulation (EC) No 178/2002)

Framework of the new legislation

It addresses all the food chain from primary production (animals and plants) tothe consumer, and covers the industry, catering, transport and distribution: “FromFarm to Fork approach”.

Tools of the new legislation

Import rules in 2004 Regs: 852 Art.10, 853 Art.6, 854 Art.10 to 15, 882/Art.14 to 25

Regulation EC N°178/2002

General food law

Regulation EC N°852/2004

General Hygiene rules

Regulation EC N°853/2004

Specific hygiene rules for food of A.O.

Regulation EC N°183/2005

Feed Hygiene

Regulation EC N°854/2004

Official control rules for food of A.O.

Regulation EC N°882/2004

General food and feed official controls

Regulatory Framework

EU Legislation

Regulation EC N°178/2002 (General Food Law)

Aim: high level of human life + health protection

Main provisions

Protection of consumer interests,

Fair trade practices

Free movement of food in the Community

Science based rules/Risk analysis

International standards to be taken into consideration except different level of

protection or Scientific justification

Traceability

Precautionary principle: where scientific uncertainty persists: other legitimate factors

(Societal, economic, traditional, ethical, environmental factors and/or feasibility of controls

Import principles

FBO liability and Competent Authority/Commission responsibilities

RASFF (Rapid Alert System for Food & Feed)

EFSA (European Food Safety Authority)

EU Legislation for FBO

PRE-REQUISITES

(structure, organisation, equipment, material)

EU LEGISLATION CONTROLS

•4 levels of controls:

–Food Business Operators working towards compliance.

–Competent Authority (CA) to control FBOs and to proceed to

specific official controls/analyses on products throughout the

production chain to ensure compliance or equivalence with food

safety legislation.

–EU Controls in Border Inspection Posts

–Food & Veterinary Office (FVO) evaluates CA official control

system performance through audits (EU member states and

countries out of the EU)

11

Reg. 852/2004

Hygiene of FOODSTUFFS

Reg. 853/2004

Hygiene of food ofANIMAL ORIGIN

EU Legislation for FBO

Annex III,Sec. IX

Raw Milk and

Dairy products

EU Legislation for CA

12

Reg. 882/2004Official controls on FOOD, FEED, ANIMAL

HEALTH/WELFAREMULTI‐ANNUAL NATIONAL CONTROL PLAN

Reg. 854/2004

Official controls on PRODUCTS OF ANIMAL

ORIGIN

Annex IV

Official controls on raw milk and

Dairy PRODUCTS

To verify compliance of FBO with:

Objectives, prioritization, resources

Risk categorization

Competent authorities and their tasks

Organization and management

Documented procedures

Staff trainingDelegation of tasks

MethodsContingency plans

Annual reports

Actions in case of non compliance

Official laboratories

Internal audits

ADDITIONAL EU LEGISLATION ON SPECIFIC HAZARDS

Microbiological criteria (food safety criteria and process hygiene criteria)

Control of Salmonella and other zoonotic agents present in the foodchain

Surveillance of Zoonoses and zoonotic agents

Spongiform Encephalopathy control measures (SRM withdrawal,

detection, control measures)

Animal By-Product regulation

Meat and Bone meal use

Control measures regarding certain substances and their residuesin live animals and food thereof (e.g. Veterinary Medical Products)

FVO MISSION OBJECTIVES

OBJECTIVES: TO VERIFY THAT THE CA IS CAPABLE :

– FOR MS TO ENSURE COMPLIANCE WITH SPECIFIC REQUIREMENTS OF EU 2004 REG. 852/853/854/882

– FOR NON-EU COUNTRIES:

- TO CONTROL AND CERTIFY EXPORTED FOOD OF ANIMAL ORIGIN TO THE EU (e.g. amended Reg (EC) 605/2010 AH/PH combined requirements for import of raw milk and dairy products)

- TO DEMONSTRATE ITS RELIABILITY IN ORDER TO MAINTAIN THE PRE-LISTING PROCEDURE

FVO MISSION INSPECTION/AUDIT METHODS

METHOD: EVALUATION OF THE EFFECTIVENESS OF THE OFFICIAL

CONTROL SYSTEM OF FP EXPORTED TO THE EU (documented system):

– EVALUATION OF THE CA CONTROL ACTIVITY IN ITS OFFICE, files of at least the visited vessels and establishments

– SAMPLE OF FARMS/VESSELS/ESTABLISHMENTS IN ORDER TO VERIFY CA CONTROL ACTIVITIES

- SOME CHOSEN BY THE CA

- SOME CHOSEN BY THE FVO RE. RASFF, FOLLOW UP OF A PREVIOUS MISSION OR TARGETED MISSION

FVO CRITERIA FOR CA EVALUATION

• CA ORGANISATION

• COOORDINATION/COOPERATION BETWEEN CAs in order to cover the food chain and to

avoid gaps and overlap (national control programmes) e.g. poultry meat production feed, VMP, farms, SH and further processing plants including cold stores, AM and PM inspection and feed back to farms

• STAFF (QUANTITY; QUALITY; TRAINING)

• CA CONTROL PLAN AND CONTROL ACTIVITY DOCUMENTATION

• EVALUATION OF CA/OPERATOR KNOWLEDGE OF THE EU REQUIREMENTS (NON EU COUNTRIES)

• IMPLEMENTATION BY THE CA OF CONTROL ACTIVITIES & PROCEDURES, in particular

APPROVAL PROCEDURE, HACCP BASED FOOD SAFETY MANGEMENT SYSTEM EVALUATION, OFFICIAL CONTROLS ON FOOD WHERE REQUIRED (Reg. 852/2004, 853/2004 and 854/2004)

• «SANITARY TRACEABILITY» THROUGHOUT THE ENTIRE PRODUCTION CHAIN

• OFFICIAL LABORATORIES DESIGNATED BY CA and ACCREDITED (Reg. 882/2004, Article 12)

• CAPACITIES AND QUALITY OF THE LABS TO CARRY OUT OFFICIAL ANALYSES AND OWN-CHECK ANALYSES (ACCREDITATION, QUALITY SYSTEMS, PROFICIENCY TESTS, METHODS

USED)

The Process of Exporting of FoAO to EU

Application from

NCA to the EU

The NCA receivesa pre-mission questionaire to fill in

FVO inspection

The EU lists the Country as authorised to export FoAO

The NCA lists approved processing establishments /vessels to export in EU

Prepare products in approvedvessels/establishments

Require Health Certificate from Competent Authority

Border Inspection at entrance to EU

Allowed for distribution in the EU Member States or rejected

EU LEGISLATION CONTROLS ON IMPORTED FOAO4 levels of controls

Food & Veterinary OfficeCommission Inspectorate Direction

Export Country Competent Authorities

(plant approval, AH/PH certificate)

Food Business Operators

BIPs

4EU LEGISLATION CONTROLS ON IMPORTED FONAO

Various levels of controls

CA (certificate, approval if required)

Food Business Operators(exporters/importers)

DEPs

Control points

Basic rules:article 15 of REG 882/2004 OFFC

Increased level of official controls on certain FoNAO: Commission Regulation(CE) No 669/2009 du 24 juillet 2009 (Art. 15.5)

SPECIFIC REQUIREMENTS

FOR SPROUTS AND SEEDS INTENDED FOR

THE PRODUCTION OF SPROUTS (SHIGA

TOXIN-PRODUCING/E. COLI OUTBREAK

POSSIBLE ACTIONS in case ofUNFAVOURABLE AUDITS or REPEATED NON COMPLIANCES in BIPs

A) NO IMMEDIATE OR SERIOUS RISKS FOR CONSUMER HEALTH

NO ACTION NEDED BY THE COMMISSION SERVICES

EXCEPT, IN SOME CASES, PRE-LISTING PROCEDURE ON HOLD, DELISTING OF SOME

ESTABLISHMENTS, TILL RECEPTION OF GARANTIES or ACTION PLAN REQUIRED

FOLLOWING THE DRAFT REPORT, AND ITS EVALUATION,

B) SERIOUS OR IMMEDIATE RISKS FOR CONSUMER HEALTH

ACTION BY COMMISSION SERVICES NEEDED

APPROPRIATE AND PROPORTIONATE PROTECTIVE MEASURE(S)

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HOW TO IMPROVE THE SITUATION ?

– Pressure on MS:

• request for action plans

• tight follow-up (on-desk exercise and FVO missions)

– CA official training: SANCO programme « Better Training for Safer Food » for better harmonisation regarding control and enforcement

– Feedback on Community legislation implementation for possible revision

HOW TO IMPROVE THE SITUATION?

–Pressure on non-EU countries: pre-listing on hold, appropriate and proportionate protective measures, action plans and follow-up (on-desk exercise and FVO missions)

–CA official training: DG SANTE/DG DEVCO programme: « Better Training for Safer Food WORLD»

–Technical assistance provided by Commission services (DEVCO,SANTE,TRADE; following non-EU country requests)

THANK YOU