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In the aftermath of the BSE crisis and several other food scandals, the EU published its White Paper on Food Safety setting out a legislative action plan for a pro-active new food policy. Key elements in the new approach were the establishment of a framework regulation, the establishment of an independent body providing scientific advise to the legislators, the development of specific food and feed safety legislation including a major overhaul of the existing hygiene legislation, and the creation of a framework for harmonized food controls. The EU developed a “Farm to Fork” approach covering all sectors of the food and feed chain, with traceability as basic concept. The application of the “precautionary principle” as described in the February 2000 Commission Communication on the Precautionary Principle is also an important concept in the EU’s approach.
Framework Regulation 178/2002
In January 2002, the EU adopted the framework regulation EC/178/2002 laying down the general principles and requirements of EU food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety. The regulation takes account of the “precautionary principle” and sets out general provisions for imposing traceability (applicable from January 1, 2005) of food and feed. With the establishment of the Rapid Alert System for Food and Feed (RASFF), the existing notification system was expanded to include feed. Commission Decision 2004/478/EC (corrected version published in Official Journal L 212) establishes a general plan for food and feed crisis management.
European Food Safety Authority (EFSA)
The main responsibility of EFSA is to provide independent scientific advice for EU legislation and policies in all fields that have an impact on food and feed safety and communicate on risks in the food chain to the general public. EFSA is primarily a scientific risk assessment body while risk management and decision-making remains the domain of the EU’s institutions: the European Commission, the Council and the European Parliament. Enforcement of rules, including recalls is still in the member states’ hands.
Further information can be found on the EFSA website.
The White Paper outlined a radical revision of the EU’s food hygiene rules. The “hygiene package” aims to merge, harmonize and simplify very detailed and complex hygiene requirements currently scattered over 17 directives. The overall aim is to create a single hygiene regime covering food and food operators in all sectors, together with effective instruments to manage food safety and any possible food crises, throughout the food chain. Food producers will bear primary responsibility for the safety of food through the use of a “Hazard Analysis and Critical Control Points” system (HACCP). Certain food establishments will need to be registered or to be approved by the competent authorities. Competent authorities should have control systems in place in order to verify with food law in general and with food hygiene in particular.
The hygiene package includes the following regulations/directives:
Hygiene 1: European Parliament and Council Regulation 852/2004 on the hygiene of foodstuffs - general requirements primary production, technical requirements, HACCP, registrations/approval of food businesses, national guides to good practice - enters into force on January 1, 2006
Hygiene 2: European Parliament and Council Regulation 853/2004 laying down specific hygiene rules - specific hygiene rules for food of animal origin (approval of establishments, health and identification marking, imports, food chain information) - enters into force on January 1, 2006
Hygiene 3: European Parliament and Council Regulation 854/2004 laying down specific rules for the organization of official controls on products of animal origin intended for human consumption - detailed rules for the organization of official controls on products of animal origin (methods to verify compliance with Hygiene 1 & 2 and animal by-products regulation 1774/2002) - enters into force on January 1, 2006
Hygiene 4: Council Directive 2002/99/EC laying down health rules governing the production, processing, distribution and importation of products of animal origin - veterinary certification, compliance with EU rules - enters into force on January 1, 2005. For more information on "Hygiene 4" see GAIN Report E34015 "General requirements for veterinary certificates".
Hygiene 5: European Parliament and Council Directive 2004/41/EC repealing 17 existing Directives (corrigendum published in Official Journal L 195) - enters into force on January 1, 2006
Subsequent Regulations Providing Additional Details
The initial food hygiene package, however, does not cover all detailed aspects related to food hygiene. Since the adoption of the basic package, a number of additional measures have been adopted by the Member States representatives in the Standing Committee on the Food Chain and Animal Health.
Microbiological Criteria for Foodstuffs
Microbiological criteria are an essential element of the Commission’s food hygiene rules. They were published in a separate regulation (Commission Regulation (EC) No 2073/2005, updated by Commission Regulation 1441/2007). A number of existing Community microbiological criteria for foodstuffs have been revised and certain important new criteria have also been laid down. The Commission Regulation on microbiological criteria for foodstuffs, lays down food safety criteria for certain important foodborne bacteria, their toxins and metabolites, such as salmonella, listeria, Enterobacter sakazakii, staphylococcal enterotoxins and histamine in specific foodstuffs. These criteria are applicable to products placed on the market during their entire shelf-life. In addition, the Regulation sets down certain process hygiene criteria to indicate the correct functioning of the production process.
The implementing rules for the hygiene package includes provisions for food chain information, specific testing methods for marine biotoxins, lists of approved establishments, model health certificates for certain products, derogations for traditional foods and specific rules for the control of the parasite Trichinella in certain types of meat. (Commission Regulation (EC) 2074/2005 and Commission Regulation (EC) 2075/2005). Transitional arrangements until 31 December 2009 are also laid down for some of the new hygiene provisions, to allow a gradual change-over from the current to the new regime (Commission Regulation (EC) 2076/2005).
It is expected that additional implementing regulations will be developed over the next few years, providing further details to the provisions agreed upon in the basic package. Such additional implementing regulations could e.g. concern the authorization of antimicrobial substances for the decontamination of meat.
What Does it Mean For Countries Exporting to the EU ?
The Commission developed a guidance document addressing the key questions related to EU import requirements. The most recent version dates from Jan 23, 2006. It covers a series of important questions related to the difference in import regimes for food of animal and non-animal origin and on requirements for food business operators in third countries.
Although mainly addressed at a Member State audience, additional information is also provided in the following guidance documents:
The objective of European Parliament and Council Regulation 183/2005 laying down requirements for feed hygiene, is to ensure feed safety at all stages that may have an impact on feed and food safety, including primary production. Traceability is an essential component in ensuring feed safety. The legislation introduces compulsory registration of all feed business operators by the competent authority, while feed businesses dealing with more sensitive substances continue to require approval . Feed can only be imported from operators included in the yet to be established list of EU approved third countries. The feed hygiene legislation introduces HACCP principles for the feed business operators other than at the level of primary production. It also provides for a European Union framework for guides to good practice in feed. The new feed hygiene regulation became applicable on January 1, 2006. However, in the absence of specific implementing rules concerning third countries, the existing rules on EU imports continue to apply.
European Parliament and Council Regulation 882/2004 on official controls to ensure compliance with food and feed laws is one of the measures announced in the White Paper. It establishes an EU framework for a harmonized food and feed control system in which the respective responsibilities of the member states’ competent authorities and the Commission are set out. The new regulation replaces the existing EU rules which were adopted separately for the animal feed sector, the food sector and the veterinary sector. The new regulation covers the entire range of activities covered by food and feed law and provides a common approach with regard to controls on imports of food and feed from third countries. Official controls will verify compliance of all food and feed (including pet food), with food and feed law, rules on animal health, animal welfare and certain aspects of plant health. The sections relevant to third countries do not include animal welfare controls except where there are explicit animal welfare provisions in EU-third country bilateral agreements which is not the case for the U.S. The regulation applies from January 1, 2006 onwards.