The European Commission has finally revealed its proposal for new, overarching, food hygiene legislation. Tina Garrity reports

At long last the Commission has presented its proposal for new food hygiene legislation. Seventeen existing directives, including the 1993 food hygiene directive, would be replaced with just four key regulations intended to cover the whole food chain from farm to fork.
The four new regulations would cover the following topics:

• a general regulation setting out the key principles applicable to the food industry, with a special annex for primary producers
• a regulation setting out the specific additional hygiene rules for food of animal origin
• a regulation setting out the obligations of the official control authorities
• a regulation consolidating and updating existing animal health controls, currently spread across seven directives.

This month's EU news looks at the general hygiene proposal.

Draft regulation
Although the new food hygiene package as a whole is intended to simplify existing legislation and place more emphasis on operator controls and on the achievement of food safety objectives, in practice the proposal for a new food hygiene regulation does not differ radically from the existing directive. The basic structure of the text, setting out the scope, the definitions used, some general principles and then detailed technical annexes is retained. A comparison of the old and the new reveal the following main changes:

Scope: The new regulation would extend the scope of the old one to cover primary production. Primary producers would get their own annex setting out general requirements for all products with specific ones for products of animal origin and for products of plant origin. A new provision would allow member states to adapt the rules for businesses in regions suffering from special geographical constraints or affected by supply difficulties, which serve local markets, or to take account of traditional methods of production, providing the objectives of food hygiene were not compromised.

Definitions: The old definition of food hygiene reads: "all measures necessary to ensure the safety and wholesomeness of foodstuffs". The proposed new definition reads: "the measures and conditions necessary to control hazards and ensure fitness for human consumption of a foodstuff taking into account its intended use". There is a separate definition for food safety which reads: "the assurance that food will not cause adverse health effects to the final consumer when it is prepared and eaten taking into account its intended use".

A whole host of new definitions are included, covering terms such as contamination, hazard, processed product, hermetically sealed and so on. An attempt is made to define more closely terms such as "where necessary/appropriate/sufficient" by saying these apply after hazard analysis in the context of the Haccp system.

HACCP
The following requirement is proposed:
Food business operators other than at the level of primary production shall put in place, implement and maintain a permanent procedure developed in accordance with the following principles of the system of hazard analysis and critical control points (Haccp):
a) identify any hazards that must be prevented, eliminated or reduced to acceptable levels
b) identify the critical control points at the step or steps at which control is essential to prevent or eliminate a hazard or reduce it to acceptable levels
c) establish critical limits at critical control points which separate acceptability from unacceptability for the prevention, elimination or reduction of identified hazards
d) establish and implement effective monitoring procedures at critical control points
e) establish corrective actions when monitoring indicates that a critical control point is not under control.
Operators would have to establish and undertake regular verification procedures and establish documents and records commensurate to the nature and size of their business to demonstrate compliance and facilitate official controls. These would have to be retained for at least the shelf life of the product.

Guides to good practice
The old provision for member states to encourage the development of guides to good practice is retained but is given slightly more urgency by a requirement for member states to submit annual reports to the Commission on the steps taken to achieve this. The proposed new rule mentions specifically that guides should contain advice on complying with Haccp where it is required.
The provision for Community guides to be drafted, where requested, remains, but there is still no obligation on the Commission to produce them. The existing requirement for member states, if they consider it appropriate, to recommend operators to apply the EN2900 standards, is removed.

Registration of premises
The new regulation would require food business operators to notify the competent authority of their existence, giving the nature of the business and the name and addresses of premises used. The competent authority would then issue a registration number and keep an up-to-date list thereof.
Non-retail businesses would have to ensure foodstuffs produced by them were identified with this number. It is left to member states to decide whether registration should follow prior approval. The regulation would allow them to introduce it where they considered it necessary to ensure compliance with the regulation.
Withdrawal of products
A new article is added requiring operators to establish and operate adequate procedures for the withdrawal of food presenting a serious health risk. Where such withdrawal occurred, operators would have to inform the competent authority immediately. Adequate supplier records would have to be kept to facilitate traceability.

Official controls
The existing article on official controls is removed and relocated in amended form to the regulation on official controls. The new article would require operators to give all assistance needed to ensure official controls can be performed efficiently. This includes granting access to premises and making available any documentation required under the regulation or considered necessary by the competent authority to judge the situation.

Imports/exports
A brief article requires imports from third countries and exports out of the EU to comply with certain parts of the regulation. These are specified in the text. The old article on the procedures to be followed in case of health risk in third countries is removed.

Annexes
There are two annexes, one for primary producers and one for all businesses.

Primary producers: The general rules proposed for primary products are that they must be produced under appropriate hygienic conditions; measures regarding environmental hazards must be adopted; pests, contaminants, diseases and infections must be controlled and the competent authority must be informed if any human health problem is suspected.
The animal product rules cover issues such as cleaning and disinfection procedures for animal housing, transport etc; precautions to be taken when introducing new animals; proper use of veterinary medicinal products and feed additives; proper disposal of waste including dead animals; cleanliness of slaughter animals and so on.
Various records would have to be kept by farmers, eg, the nature and origin of the feedstuffs, their use of veterinary medicinal products, occurrences of diseases affecting food safety etc.
They would be able to demand assistance from those responsible for animals at the farm such as vets, farm technicians and so on. Information relevant to food safety would have to accompany slaughter animals to the abattoir and animal products to the processing facilities. The rules proposed for plant origin products cover issues such as correct application of pesticides and fertilisers, hygienic use of water and organic waste, adequate cleaning and disinfection and the avoidance of contamination.

Non primary producers: The rules here are similar to the existing ones and the annex contains more or less the same chapters as the existing directive. The general premises requirements mention the need to avoid or minimise airborne contamination and the drainage requirement is expanded to require drainage away from contaminated areas where drainage channels are open. Temperature controlled storage systems would have to be designed to permit the monitoring and recording of temperatures.
The chapter on food waste contains a new requirement for wastewater to be eliminated in a hygienic and environmentally friendly way. The rules about infected food handlers remain the same except that the prohibition on such persons working in a food handling area is extended to read "entering" a food handling area. A new provision requires infected persons to report the illness or symptoms to the operator.
The foodstuffs temperature control rule is extended to say that businesses manufacturing, handling and wrapping processed foodstuffs must have suitable rooms large enough for the separate storage of raw materials from processed material, with sufficient separate refrigerated storage to prevent contamination. A new provision on the thawing of foodstuffs is introduced. Essentially, it requires thawing to be done safely. Dangerous run-off liquid must be adequately drained.
The annex then introduces two new chapters, one on the wrapping and packaging of foodstuffs and one on special conditions for certain processing operations. The former contains various provisions relating to preventing contamination. The second sets out rules for heat treatment, smoking (including prohibition on the combustion of treated wood) and salting (prevention of contamination and re-use of salt only where Haccp demonstrates no contamination risk.) Finally... training. There is no change in the wording but those responsible for the Haccp system must have received adequate training in the principles of Haccp.
The application date for the new regulation, if adopted, would be 1 January 2004.

COM (2000) 438. final. Brussels, 14 July 2000.
http://europa.eu.int/eur-lex/en/com/pdf/2000/com2000_0438en01.pdf