July 2004
New food safety regime agreed

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EHJ July 2004, pages 226-227

It's not often you get a revolution in food safety. Tina Garrity outlines how new EU regulations are set to become the cornerstones of a new Europe-wide food safety regime

It was at the 11th hour that the Commission's dream of a new, modernised food safety regime applying across the EU was finally realised. It looked touch and go for a while that any agreement could be reached between the Council, the Parliament and the Commission before last month's EU elections. But, at the last minute, a package of measures were agreed providing a new framework for the way in which food safety is practised and enforced over the coming years. Not everyone is happy about the compromise texts, which have been adopted. But most agree that compromise was preferable to scrapping the whole deal.

Outlined below are the key new regulations.

HYGIENE OF FOODSTUFFS

The new food hygiene regulation (852/2004), similar to the old 1993 directive, outlines basic rules that all food businesses must follow with specific rules set out in a technical annex. What is new this time around is the emphasis placed on primary producers who, with a new annex devoted entirely to them, are for the first time included under the food hygiene regulations.

The big change, however, is under the rules on hazard analysis. All businesses, except primary producers, must now "put in place, implement and maintain a permanent procedure or procedures based on the Haccp principles." There are seven principles laid out in the regulation. These include verifying that Haccp is working properly and being able to produce documents "commensurate with nature and size of the food business" to prove it.

Businesses will also be expected to provide the competent authority with satisfactory evidence that they are complying with the new rules. All documents describing the procedures must be up-to-date with supporting documents and records being kept for the appropriate period. Guides to good hygiene practice will continue to be drawn up along with new guides covering the application of Haccp principles.

Hopes that the final regulation would introduce EU-wide prior approval of food businesses have been dashed. Businesses will have to register with the competent authority, but approval will only be required in limited situations. For example, where it is required by regulation on products of animal origin or under national law.

As regards to the training of food handlers, the old rule remains firmly in place, namely businesses must ensure that "food handlers are supervised and instructed and/or trained in food hygiene matters commensurate with their work activity." Anyone responsible for Haccp procedures or for the operation of the relevant guides must have received proper training in the principles of Haccp.

FOOD OF ANIMAL ORIGIN

Regulation 853/2004 covering specific hygiene rules for food of animal origin updates and brings together in one place various pieces of legislation. The first part of the regulation sets out the general obligations on all businesses and lists that are exempt. These include anyone producing for private domestic use, producers directly supplying small quantities to the final consumer or local retailers who supply directly to the final consumer. It also sets out the rules on the registration and approval of establishments and health marking. Identification and documentation systems to be applied across the EU are laid down along with rules on imports from outside the Community of food of animal origin.

Annex I defines different foodstuff sectors. Annex II identifies which marking systems are to be used, outlines what Haccp-based procedures in slaughterhouses are supposed to achieve and considers food chain information. Annex III lays down the precise requirements to be met in 15 different foodstuff sectors. This includes what rules must be followed by slaughterhouses, cutting plants, meat production establishments and game handlers. They include hunters, as well as bivalve mollusc producers and those involved with fishery products, raw milk and dairy products, and eggs and egg products. Also covered are businesses dealing with gelatine, collagen, rendered animal fats and greaves, treated stomachs, bladders and intestines, frogs' legs and snails.

OFFICIAL CONTROLS

Regulation 854/20041 covers rules on official controls on products of animal origin and requires all competent authorities to ensure compliance with the two food hygiene regulations and the general food law regulation. Under its terms food businesses must cooperate in making sure these controls can be performed effectively. In particular, they must allow inspectors access to all areas, provide all the necessary documentation required by the regulation plus any additional paperwork deemed necessary by the competent authority.

As well as conducting audits of good hygiene practice and Haccp-based procedures, the competent authorities must perform controls set out in the annexes to the regulation. These cover meat, bivalve molluscs, fishery products, raw milk and dairy products. The elements to be verified by the audits are laid down in the regulation, as is the action to be taken in the case of non-compliance, as well as procedures governing imports.

With regards to slaughterhouses, the regulation defines what the official veterinarian can do and what tasks the official auxiliaries may perform. Member states must use a risk-based approach in calculating the number of official staff needed to be present on the slaughter line in any given slaughterhouse. The controversial policy of allowing slaughterhouse staff to assist with official controls while being supervised by the official veterinarian in plants producing poultry and lagomorphs can be found in the final text. However, there are constraints. Staff must be qualified and trained, according to parameters set out in an annex, that must act independently from production staff and they must report any deficiency to the official veterinarian.

The training and qualifications required for official veterinarians and auxiliaries are also set out in an annex. Auxiliaries must have received at least 500 hours of theoretical training and at least 400 hours of practical training covering key areas specified in the regulation.

They must also have had sufficient training to enable them to undertake their duties competently. Practical training must occur in slaughterhouses and cutting plants under the supervision of an official veterinarian and on holdings and other relevant establishments. Training tests should relate to red meat or poultry, but where auxiliaries pass the test for one, they need only receive abridged training for the other. Training and tests should cover game and lagomorphs, where appropriate.

COMPLIANCE

Regulation 882/20042 covers official controls to ensure the verification of compliance with food and feed law, animal health and animal welfare rules. Under the new regime all member states will by law have to regularly carry out risk-based official controls on food and feed to ensure compliance with EU legislation. These controls must be conducted on a regular basis and without prior warning, except when they are part of an audit programme requiring prior notification of the business. Appropriate action, laid out in the regulation, must be taken if a company fails to comply.

Control staff must be properly trained according to standards set out in an annex. They must keep up-to-date in their area of competence and must be capable of following documented procedures, including those designed to verify the effectiveness of their controls. They must also ensure that mistakes are corrected and that all documentation is up-to-date.

Reports on controls must be drawn up and given to the business concerned, especially where non-compliance is found. The types of controls envisaged under the regulation are set out including controls on feed and food imports of non-animal origin.

Member states must also, in compliance with European standards, designate laboratories to analyse samples and draft contingency plans in case of a food and feed emergency. Governments must ensure that enough money and resources are available to their control authorities. Costs can be covered by charging fees, subject to certain considerations such as the type or throughput of the business concerned. When action must be taken in more than one member state the competent authorities must provide each other with administrative assistance. Member states must set up liaison bodies to achieve this.

To do all of this, each member state must prepare a single integrated national control plan, the details of which must be laid down. The regulation also sets down import conditions for third countries and empowers the Commission to adopt safeguard measures where it has evidence of a serious failure in a member state's control systems.

References

  1. OJ L 139. 30 April 2004. http://europa.eu.int/eur-lex/en/archive/2004/l_13920040430en.html
  2. OJ L 165 30 April 2004 http://europa.eu.int/eur-lex/en/refdoc/L_165/L_2004165EN_0.pdf