EHJ March 2003, pages 92-93 Tina Garrity looks at the amendments to the draft food hygiene regulation

Around two thirds of all the amendments tabled to the draft regulation on food hygiene by Members of the European Parliament (MEPs) last May have been accepted by the Commission. A revised version of the proposal was published in late January. Unsurprisingly, the controversial amendment requiring food hygiene training to be conducted annually by experts was not accepted. Most of the amendments adopted are designed to clarify or tighten up the proposed new provisions.

REGISTRATION OF FOOD BUSINESSES

Hopes that the proposal might be amended to require prior approval of all food businesses have not been met. The registration requirement remains essentially unchanged but is clarified to stress that it covers all new activities, all new establishments and the closure of any existing establishments. Member states may still introduce prior approval at national level, however. Where they do so, establishments would only be able operate after an on-the-spot check by inspectors to confirm they were complying with the hygiene regulations. The previous requirement for foodstuffs to be marked with the establishment’s registration number has been deleted since this is now covered by the General Food Law Regulation (178/2002).

HACCP

Both the CIEH and MEPs had called for flexibility in the proposed requirement for the hazard analysis system to be documented. The new wording reflects this, saying that operators must provide evidence to the competent authority that they are complying with the requirements for hazard analysis but only where the nature and size of the food business so necessitates, must this evidence include documentation.

Where businesses use guides to good practice to assist them in the hazard analysis process, the text stresses that this is on a voluntary basis. MEPs had called for hazard analysis to be extended to primary production, something supported by the CIEH. The Commission feels, however, that this is too ambitious and that hazards in this sector can be controlled by the use of guides to good farming practice.

GUIDES TO GOOD PRACTICE

At present guides to good practice are developed by the food business sectors and by representatives of other interested parties such as the appropriate authorities and consumer groups. This requirement was retained in the proposed new regulation but has now been changed to say that they will be developed by the food business sectors in consultation with these parties. Guides to good practice developed under the current food hygiene directive will, however, remain valid where compatible with the new regulation.

SCOPE AND DEFINITIONS

The direct supply by the producer of small quantities of primary products to the final consumer or to local shops and restaurants would now be exempt from the regulation and be subject to national rules instead. The provision for member states to adapt the rules to take account of traditional methods of production is extended to cover the use of raw materials which are, according to scientific findings, established practice or tradition, characteristic of the production process. Where this occurs, the Commission and the other member states must be given a list of the products and regions concerned, as well as the adaptations made.

GENERAL AND SPECIFIC HYGIENE REGULATIONS

This section is expanded to spell out the key tasks that businesses must take to operate hygienically, namely:

• comply with temperature criteria for foodstuffs and ensure the cold chain is maintained;
• comply with microbiological criteria;
• take measures or adopt procedures necessary to meet targets and performance standards set out to achieve the objectives of the regulation; and
• use appropriate methods of sampling and analysis.

The elements of c) and d) are to be developed in due course. In the meantime, those set out in existing legislation are to be followed.

ANNEX 1 – HYGIENE RULES FOR PRIMARY PRODUCTION

Annex 1 has been significantly reworded. It now covers not just production but also any associated operations such as the transport, storage and handling of products at the place of production. The previous clause requiring producers to follow good practice, monitor hazards and eliminate or reduce hazards to an acceptable level has been replaced with a clause to the effect that they must comply with appropriate EU and national legislation on hazard control in primary production. This includes two specific elements. First, they must take measures to control contamination from the air, soil, water, feed, fertilisers, veterinary medicinal products, plant protection agents and biocides, and the storage, handling and disposal of waste. Second, they must take measures relating to animal health and welfare and plant health that have implications for human health, including programmes for zoonotic monitoring and control.

With respect to products of animal origin, businesses rearing, harvesting or hunting animals or producing primary products of animal origin would now be required to keep all facilities connected with production, including feed areas, clean and, where necessary disinfected. The same applies to equipment, containers, crates, vehicles and vessels. In the plant production section, an additional requirement for pest control has been added.

Examples of the elements to be included in any guides to good hygiene practice in the sector are given.

ANNEX II – GENERAL HYGIENE REGULATIONS

Chapter I – general requirements for all food businesses: This chapter remains largely untouched. The reference to “cross-contamination” (as something, which must be protected against) has been to altered to “contamination”. The requirement for staff changing facilities to be provided where necessary “for the purposes of hygiene” has had the hygiene caveat dropped. An additional clause requires that cleaning agents and disinfectants must not be stored in food handling areas.

Chapter II – specific requirements in food handling rooms: This chapter will now apply to compartments in vehicles, unless covered by the chapter on moveable and/or temporary food premises. The reference to ceilings and overhead fixtures is reworded to read “ceilings, overhead structures and the inner surfaces of roofs.” Materials used for surfaces in food handling areas would have to be corrosion-resistant, as well as smooth, washable and non-toxic. Sinks for the washing of food would, where necessary, have to be disinfected.

Other chapters: In the chapter on moveable and/or temporary premises the reference to protection from contamination by pests is extended to include animals. The equipment chapter now requires equipment to be kept in such a way that contamination risk is avoided, as opposed to minimised, as at present. The chapter on food waste and other refuse previously required that food waste must not be allowed to accumulate unavoidably. It now says that waste must be removed as quickly as possible. The scope of the chapter is extended to cover non-edible by-products. Adequate provision must be made not just for the removal of waste but for its disposal. Refuse stores must be free from pests and animals. The requirement for wastewater to be eliminated hygienically is extended to include all waste, whether liquid, solid or gaseous and the word eliminated is changed to “disposed of”.

The chapter on water supply is extended to require that any water used for the heat treatment or later cooling of hermetically sealed containers is not a source of contamination. In the wrapping and packaging chapter the existing requirement for materials to be protected from the risk of contamination is clarified to say that this refers to contamination which might be detrimental to food safety. Packaging must be clean when brought into the packaging area. The training requirement remains the same as at present but the clause on Haccp training is extended to require training not just for those responsible for the development and maintenance of the Haccp system but also for those introducing the guides referred to in the regulation. In rejecting the call for annual training by experts, the Commission says it felt that this would present difficulties for very small enterprises.

COM (2003) 33 final. Amended proposal for a regulation of the European Parliament and of the Council on the hygiene of foodstuffs. Brussels 27.01.03
http://europa.eu.int/eur-lex/en/com/pdf/2003/com2003_0033en01.pdf