Dr Stuart A. Slorach

Dr Stuart A. Slorach Deputy Director-General of the Swedish National Food Administration, 1991-2005 Chairman, Management Board of the European Food Safety Authority, 2002-2006 Chairperson of the Codex Alimentarius Commission 2003-2005 Please note that the views expressed in this presentation are the author s own and not necessarily those of the Swedish National Food Administration, the Swedish Government, the European Commission or any other organisation Conference on Reforming Food Safety Regulations in Ukraine, Kiev, 18 May 2009 1

Some important principles of EU food law Policy underpinned by a sound scientific basis. Based on risk analysis, with a functional separation of risk assessment and risk management. Precautionary principle EU-wide free movement of human food and animal feed Integrated approach covering all aspects of the food production chain: primary production, processing, transport and distribution. Applies to all foods. Tackle problems at source, if possible Responsibility for ensuring the safety of foodstuffs clarified Openness and transparency Conference on Reforming Food Safety Regulations in Ukraine, Kiev, 18 May 2009 2

Some important triggers of the process Desire for free movement of foods and feed within the EU Need to restore confidence of consumers, trading partners, etc. in the safety of the EU food supply and EU food safety system following BSE crisis, dioxin incident in Belgium, etc. Need to comply with the requirements of SPS Agreement and have a risk-based system with a whole food chain approach Need to clarify responsibilities of food business operators and the authorities Need to simplify and update the system and incorporate flexibility to deal with differing conditions in Member States Import control moving offshore Conference on Reforming Food Safety Regulations in Ukraine, Kiev, 18 May 2009 3

Important EU food safety legislation EC Regulations 178/2002: general food law, European Food Safety Authority (EFSA),etc. 882/2004: official controls 852/2004: the hygiene of foodstuffs 853/2004: the hygiene of foods of animal origin 854/2004: official controls on products of animal origin 1881/2006: maximum levels for contaminants in foodstuffs 2377/90: maximum residue levels for veterinary medicines 396/2005: maximum residue levels for pesticides 258/97: novel food 1333/2008: food additives EC Directives 96/22: prohibition on certain substances; 96/23: monitoring of substances and residues; 97/78 veterinary checks on imported animal products Conference on Reforming Food Safety Regulations in Ukraine, Kiev, 18 May 2009 4

Reg. (EC)178/2002:General food law (1) Covers all stages of production, processing and distribution Risk analysis Precautionary Principle: provisional risk management measures may be taken when a risk assessment points to the likelihood of harmful health effects and there is a lack of scientific certainty Protection of consumers interests Transparency: public consultation, public information General obligations of food trade: food and feed imported into the Community, food and feed exported from the community International standards: contribute to development, consistency between international technical standards and food law Conference on Reforming Food Safety Regulations in Ukraine, Kiev, 18 May 2009 5

Reg. (EC)178/2002:General food law (2) Responsibilities: Food & feed business operators at all stages of production, processing and distribution shall ensure that foods/feeds satisfy the legal requirements and verify that requirements are met. Member States shall enforce food law, and monitor and verify that relevant requirements are fulfilled. The traceability of food, feed and food-producing animals and all substances incorporated into foodstuffs must be established at all stages of production, processing and distribution. Responsibility of operators - one step forward, one step back Responsibility of operators to act and report when they have reason to believe that food is not in compliance with food safety requirements Conference on Reforming Food Safety Regulations in Ukraine, Kiev, 18 May 2009 6

Regulation (EC) 178/2002: EFSA European Food Safety Authority (EFSA) Risk assessment and risk communication (not risk management, which is the responsibility of the Commission, Parliament, Council and Member States) Provides the scientific basis for Community legislation and scientific and technical support to the Commission Management Board, Advisory Forum, Executive Director and staff (400+), Scientific Committee and 10 Scientific Panels Strong emphasis on independence, competence and openness and transparency Website: www.efsa.europa.eu Conference on Reforming Food Safety Regulations in Ukraine, Kiev, 18 May 2009 7

Risk analysis in EU food safety system Review Monitoring Preliminary activities EC+EFSA+MS RISK COMMUNICATION = Info Exchange EC+EP+MS RISK MANAGEMENT COM = Policy Implementation EFSA RISK ASSESSMENT = Science Options selection Options identification 8

EFSA organisation www.efsa.europa.eu 9

EFSA s Scientific Committee & Panels Mainly generic opinions Mainly opinions on applications 1. Panel on plant health (PLH) 2. Panel on plant protection products and their residues (PPR) 3. Panel on biological hazards (BIOHAZ) 4. Panel on animal health and welfare (AHAW) 5. Panel on contaminants in the food chain (CONTAM) 6. Panel on Genetically Modified Organisms (GMO) 7. Panel on additives and products or substances used in animal feed (FEEDAP) 8. Panel on food contact materials, enzymes, flavorings and processing aids (CEF) 9. Panel on food additives and nutrient sources added to food (ANS) 10. Panel on dietetic products, nutrition and allergies (NDA) Scientific Committee 10

Scientific opinions of EFSA Risk assessment Risk management EFSA Secretariat EFSA Panel Question Opinion European Commission European Parliament Member States Panel Working Group Risk communication 11

Reg. (EC) 178/2002:Rapid Alert System Rapid Alert System for Food & Feed (RASFF) - System by which Member States are linked via the Commission to provide rapid information exchange on serious food safety problems. Obligation on Member States to notify Commission of food safety problems. Contact Point in each Member State. - Example: Dioxins in Irish pork in December 2008. Emergency preparation Crisis management Conference on Reforming Food Safety Regulations in Ukraine, Kiev, 18 May 2009 12

Reg.(EC) 882/2004: Official controls Risk-based official controls of all food, feed and live animals National competent authorities control the correct implementation of legislation by operators The Commission s Food and Veterinary Office (FVO) controls verify the correct implementation of EU legislation in Member States. FVO also inspects establishments in countries exporting products to EU. Principles and general requirements: documented procedures, training, enforcement Conference on Reforming Food Safety Regulations in Ukraine, Kiev, 18 May 2009 13

Reg. (EC) 852/2004: Hygiene Regulation Hygiene requirements for all food, including primary production general and specific hygiene requirements, microbiological criteria, temperature control requirements, cold chain, sampling and analysis. Annex I for primary production, Annex II for other stages Food business operators shall put in place, implement and maintain a permanent procedure(s) based on Hazard Analysis and Critical Control Point (HACCP) principles. (Does not apply to primary production) Registration of all food businesses National and Community guides to good practice Conference on Reforming Food Safety Regulations in Ukraine, Kiev, 18 May 2009 14

Reg. (EC) 853/2004: Hygiene rules for foods of animal origin Directed to food business operators Approval or registration of establishments Identification mark required Health mark only on carcases HACCP-based systems Detailed rules in guidelines Possibility for national measures traditional methods, remote areas For import from countries outside EU products must come from establishments approved and listed and must fulfil requirements of the Regulation Conference on Reforming Food Safety Regulations in Ukraine, Kiev, 18 May 2009 15

Regulation (EC) 854/2004. Official controls on products of animal origin Responsibilities of competent authorities Approval of establishments Meat inspection: ante- and post mortem Health mark for red meat, large wild and farmed game meat Implementation of hygiene package Reg. (EC) No 2073/2005: microbiological criteria Reg. (EC) No 2074/2005: implementing measures Reg. (EC) No 2075/2005: Trichinella testing Reg. (EC) No 2076/2005: transitional measures Directive 96/23/EC: measures to monitor certain substances and residues in live animals and animal products Conference on Reforming Food Safety Regulations in Ukraine, Kiev, 18 May 2009 16

Swedish National Food Administration The National Food Administration (NFA), an autonomous government agency under the Ministry of Agriculture, Food and Fisheries is the central administrative authority for matters concerning all types of food, including drinking water. In the interests of consumers, the NFA is working towards three goals safe foods, fair practices in the food trade and healthy eating habits. The NFA issues food standards and other food regulations, leads and coordinates food control in Sweden, assists the Government with and participates in EU work and other international activities in the food area. Conference on Reforming Food Safety Regulations in Ukraine, Kiev, 18 May 2009 17

Organisation of the Swedish National Food Administration Board DG DDG Office of the DG Communications division R&D Department Food Standards Department Food Control Department Nutrition Department Administration Department Divisions: Chemistry 1 Chemistry 2 Microbiology Toxicology Divisions: Inspection International Trade Local Authority Support Control Programme Meat Inspection Divisions: Finance IT Personnel Service Conference on Reforming Food Safety Regulations in Ukraine, Kiev, 18 May 2009 18

Food legislation in Sweden Sweden has been a member of the EU since 1995 and its food legislation is harmonised with that of the EU NFA takes an active part in the development of new legislation in cooperation with other EU Member States & Commission The Food Act (made by the Swedish Parliament) complements EC Regulations. It also designates the authorities responsible for food control and contains provisions on penalties & appeals EC Directives are transposed into NFA regulations and published in the NFA s own Code of Statutes. The authority of the NFA to issue legislation is primarily laid down in the Food Act and the Food Decree (made by the Government) Conference on Reforming Food Safety Regulations in Ukraine, Kiev, 18 May 2009 19

Food control in Sweden (1) The NFA is responsible at the national level, the County Administrative Boards (CABs) at the regional level and the municipal Environment and Health Protection Committees at the local level. NFA provides advice to the regional and local control bodies NFA inspects slaughterhouses, cutting establishments, dairies, egg product establishments, export-controlled establishments & other very large food-producing establishments (ca. 650 in all) NFA organises control of residues of pesticides and veterinary drugs in various foods and is the RASFF Contact Point. NFA is responsible for import control at Border Inspection Posts and has overall responsibility for export control Conference on Reforming Food Safety Regulations in Ukraine, Kiev, 18 May 2009 20

Food control in Sweden (2) 21 County Administrative Boards (CABs) responsible for coordinating food control at the regional level and for controls of food in primary production. 290 Municipal Environment & Health Protection Committees carry out food control at all food handling establishments except those under the supervision of the NFA or CABs, including food production establishments, wholesalers, retailers, catering establishments and waterworks, altogether some 65000 establishments. Food samples collected by the food control authorities are analysed by accredited, mainly private, laboratories Annual and multi-annual food control programmes developed Conference on Reforming Food Safety Regulations in Ukraine, Kiev, 18 May 2009 21

Food control in Sweden (3) The work of the NFA is financed mainly by annual government appropriation (180 MSEK) and by fees paid by food business operators (FBOs) (185 MSEK). NFAs meat inspection and inspection of other establishments is financed entirely by fees collected from FBOs. All CAB activities are financed by annual government appropriation. Municipal control is financed by fees collected from FBOs. Fees are based on control needs, assessed risk and compliance history. The NFA participates actively in the training of food inspectors, including training in HACCP principles, and of veterinarians. NFA s laboratories develop methods for food control, in particular methods for chemical and microbiological analysis. Conference on Reforming Food Safety Regulations in Ukraine, Kiev, 18 May 2009 22

Structure of Swedish food control NFA legislation, support coordination, audit, control (500-600 establishments), National Ref Lab, R&D, etc. CABs (21) Coordination, support, audit, etc. From 2009, control in primary production (80 000 establishments) Municipalities (290) Control (65 000 establishments Control staff 500 fte.) Conference on Reforming Food Safety Regulations in Ukraine, Kiev, 18 May 2009 23

Cooperation with other govt. agencies On food safety issues the NFA cooperates closely with a large number of other government agencies in Sweden, including: Board of Agriculture (primary production, animal feed, animal health and welfare) National Veterinary Institute (zoonoses, animal feed, laboratories) Institute for Infectious Disease Control (zoonoses) National Chemicals Inspectorate (pesticides, etc.) Medical Products Agency (veterinary drugs, etc.) Environmental Protection Agency (environmental pollution, water) National Board of Health & Welfare (health services and statistics) Board for Accreditation and Conformity Assessment (accreditation) Conference on Reforming Food Safety Regulations in Ukraine, Kiev, 18 May 2009 24

NFA s international contact network The NFA is the Swedish Codex Contact Point Swedish Focal Point for EFSA Swedish Contact Point for RASFF main Swedish contact with FAO and WHO on food safety issues The NFA has an extensive network of international contacts, established through its work in the EU, Codex, FAO/WHO, etc., with authorities, research institutes, laboratories, scientists, etc in the Nordic countries, Europe and other parts of the world Conference on Reforming Food Safety Regulations in Ukraine, Kiev, 18 May 2009 25

Reform of the Swedish system A report in February 2009 proposed that the National Food Administration, the National Veterinary Institute and part of the National Board of Agriculture be amalgamated to form a single Food Safety Authority, responsible for the whole food chain. Proposal currently out for comment and may well result in the formation of a new authority next year. That would make organisation more in line with organisation at the Commission. A weakness of current Swedish system is that some of the 290 local authorities have very small resources and coordinating such a large number of independent organisations is difficult. Better to have a central authority with regional/local offices. Conference on Reforming Food Safety Regulations in Ukraine, Kiev, 18 May 2009 26

Changes in Sweden following EU membership Legislation now developed together with Commission, the other 26 EU Member States, European Parliament. Some food-producing establishments had to be upgraded to meet EU requirements Sweden now more reliant on the food control carried out in other EU Member States, including control of foods coming from third countries. Salmonella guarantees instead of Swedish border control. Operation of Swedish food control system subject to regular inspection by Commission s Food and Veterinary Office Annual and multi-annual control programmes now developed Farm-to-table control principle emphasised Some more restrictive Swedish regulations were withdrawn Improved scientific and other cooperation and coordination with other EU Member States via EFSA, EU research projects, etc. Conference on Reforming Food Safety Regulations in Ukraine, Kiev, 18 May 2009 27

Advantages of the EU food safety system Modern approach applying Codex risk analysis principles, with a clear functional separation of risk assessment (EFSA) and risk management (Commission, Parliament, Council/Member States), covering all foods and the whole of the food chain. Risk-based control system based on HACCP principles Clear assignment of responsibilities for food safety Strong scientific base provided by EFSA s independent Scientific Committee/Panels. Improved scientific cooperation between MS. Combining the resources of the Member States, Commission, etc. enables development of food safety legislation, etc. that would be very difficult/impossible for a single country to achieve and strengthens position in dealing with food, chemical, etc. industries. Conference on Reforming Food Safety Regulations in Ukraine, Kiev, 18 May 2009 28

Advantages of the EU food safety system Food & Veterinary Office (FVO) inspections provide external audit of the operation of food safety controls in all EU Member States and in countries exporting to the EU and inspection results are available on the FVO website EU-wide rapid alert system and emergency planning in place Coordination of EU position at meetings of international organisations (e.g. Codex Alimentarius Commission, OIE, SPS Committee) gives added weight to EU Member States views. Free circulation within EU means domestic food producers have direct access to a market of ca. 500 million consumers, but are also more exposed to competition from producers in other EU Member States Open and transparent system Conference on Reforming Food Safety Regulations in Ukraine, Kiev, 18 May 2009 29

Disadvantages of the EU food safety system Process to develop and adopt new/amended food safety legislation is complicated and often slow, since it involves 27 Member States (Council), the European Commission and the European Parliament. Need to compromise to reach agreement. Free circulation of foodstuffs within the EU, without border controls between Member States, means that countries are dependent on the correct functioning of the food control system in all Member States, including controls carried out on foods from third countries at Border Inspection Posts (system is only as strong as the weakest link) Conference on Reforming Food Safety Regulations in Ukraine, Kiev, 18 May 2009 30