EHJ July 2002, pages 214-215 Two years ago, proposals were put forward for four new food safety regulations, designed to consolidate the existing legal requirements. Tina Garrity reports on the latest updates

Almost two years after it was published, the Commission's draft food hygiene regulation has been given its first reading, along with the draft regulation laying down specific hygiene rules for foods of animal origin and the two draft regulations on the control and monitoring of zoonoses, published in August last year.

MEPs made a number of changes to the text, including an amendment to the rule on training to require annual training by experts. They have extended the Haccp requirement to include primary producers but have made the rules on documentation less stringent. The rules on registration of businesses remain largely unchanged. A number of technical changes to the text were made to take account of the new regulation laying down the general principles and requirements of food law.

BACKGROUND
In July 2000, the Commission published proposals for four new food safety regulations, designed to consolidate all the existing legal requirements on food safety. One of the proposed new regulations is a replacement for the existing food hygiene directive.

Although similar in its requirements and its layout to the existing directive, the new regulation would be extended to cover primary producers and would have some additional features such as the registration of food businesses and a requirement for documented Haccp for all non-primary producers.

The CIEH in its response to the proposal has welcomed the requirement for documented Haccp, but has called for a flexible approach to take account of the needs of small businesses. It has also called for Haccp to be extended to primary producers and for all food businesses to be licensed subject to prior approval. It would also like to see a number of improvements made to the regulation's technical annexes.

In September 2001, the CIEH was invited to submit comments to the European Parliament's Trade and Industry Committee, which was feeding its views into the Environment, Public Health and Consumer Policy Committee; which is leading on the draft regulation in the parliament. The rapporteur for the proposal is German Conservative MEP, Horst Schnellhardt, who is by profession a veterinary surgeon. His report, containing all the relevant committees' comments and proposed amendments was presented to the plenary session of the parliament on 15/16 May 2002.

SCOPE OF THE REGULATION
Among the amendments agreed at the plenary session was an exemption from the regulation for those directly supplying small quantities of primary products to the final consumer or to the local retail trade. The Commission's proposed derogations for traditional and locally produced foods were welcomed and were amended to make the rules more flexible. MEPs extended the scope of regulation so that it also applies to foodstuffs produced for export to third countries.

REGISTRATION OF THE BUSINESS
The CIEH had urged MEPs to make licensing with prior approval compulsory for all food businesses, but this was not taken up. Instead, parliament reworded the Commission's requirement slightly to require food business operators to declare their existence to the competent authority which must then allocate a registration number (using, if they wish, registrations already issued for other purposes.)

It retained the Commission's requirement that prior approval need only apply in certain cases. In the parliament's view, prior approval should only apply to plants referred to in the specific hygiene rules or where the competent authority considers it necessary.

Though a clause allowing the Commission to propose a decision requiring prior approval at a later date was added. The requirement for all businesses, except retail business, to mark their foodstuffs with their registration number was deleted. A requirement for them to identify their products to permit traceability and to identify the foodstuffs' origin was substituted instead. The CIEH has called for the retail exemption to be removed.

HYGIENE PROCEDURES
The requirement for food businesses to conduct operations in a hygienic way was expanded to require them to inform the competent authorities of any actual or suspected hygiene breaches during production and of the action taken. Businesses would be required to adopt specific hygiene measures such as: maintenance of the cold chain; compliance with microbiological criteria for foodstuffs; sampling and analysis; and the setting of targets and performance standards. This is in addition to observing the rules set out in the regulation's technical annex. Usage of guides to good practice would remain voluntary - the CIEH had argued for usage to become compulsory. Existing guides would remain in force under the parliament's text, if they are consistent with the new regulation. Any Community guides produced would have to be reviewed at least every five years to take account of technological and scientific developments.

HACCP
Under the Commission's proposal, primary producers were exempt from Haccp. The CIEH argued that there was no reason for this, a view shared by MEPs who have removed the exemption in their text. Regarding the contentious requirement for documented Haccp procedures to be applied by all businesses, parliament amended the text so that documentation is only required where the nature and size of the business so necessitates.

Data on products with a shelf life would have to be kept for six months following expiry. For products without a shelf life, a time limit of five years, corresponding to the time limit on civil liability, would apply. Concerned about the role of Haccp in food safety, MEPs have written into the text the following clause: "Application of the Haccp rules shall be considered to be no more than an additional food hygiene-related safety measure. The Haccp rules may under no circumstances take the place of official controls."

TECHNICAL ANNEXES
A number of changes were made to annex I laying down the rules on primary production to make them more comprehensive. Numerous changes, some of them minor, were also made to the hygiene rules for all premises laid out in annex II. For example, MEPs inserted a rule that:

• sanitary conveniences should not have any direct access to production areas;
• cleaning agents and disinfectants must be stored away from production areas;
• the hygiene rules on ceilings and overhead fixtures should instead cover ceilings, overhead structures and the inner surfaces of roofs;
• surfaces in food areas must be corrosion-resistant;
• adequate facilities must be provided for the storage of work utensils and equipment;
• sinks provided for washing food must be capable of disinfection where required;
• articles, fittings and equipment in contact with food must not merely minimise risk of food contamination but must preclude it; and
• food waste and refuse must not merely be prevented from accumulating, it must be removed from food premises as quickly as possible.

The requirement for persons with certain sicknesses and symptoms to inform their employer was extended to require them to undergo appropriate medical examination.

A significant change was made to the rule on training. The parliament has amended the Commission's text so that it now reads as follows: "Food business operators shall ensure that food handlers are regularly supervised and annually undergo appropriate training by experts concerning aspects of food hygiene, as well as general legislation on protection of health and prevention of infection." The Commission has welcomed the parliament's text in principle and is now considering which of the many amendments can be accepted.

A copy of the parliament's amended text adopted on 16 May 2002, along with the amended texts on specific hygiene rules for foods of animal origin and the control and monitoring of zoonoses, can be found at: www.europarl.eu.int/plenary/default_en.htm