Select Committee on European Scrutiny Third Report


The European Scrutiny Committee has made further progress in the matter referred to it and has agreed to the following Report:—


COM(00) 438

Draft Council Regulation on the hygiene of foodstuffs.

Draft Council Regulation laying down specific hygiene
rules for food of animal origin.

Draft Council Regulation laying down detailed rules for
the organisation of official controls on products of animal
origin intended for human consumption.

Draft Council Regulation laying down the animal health rules
governing the production, placing on the market and
importation of products of animal origin intended for human

Draft Council Directive repealing certain Directives on the
hygiene of foodstuffs and the health conditions for the production
and placing on the market of certain products of animal origin
intended for human consumption, and amending Directives
89/662/EEC and 91/67/EEC.

Legal base: (a) Articles 95 and 152(4)(b) EC; co-decision; qualified majority voting
(b) and (c) Article 152(4)(b) EC; co-decision; qualified majority voting
(d) Article 37 EC; consultation; qualified majority voting
(e) Articles 37, 95 and 152(4)(b) EC; codecision; qualified majority voting 
Documents originated: 14 July 2000
Forwarded to the Council: 14 July 2000
Deposited in Parliament: 8 August 2000
Department: (a)-(c) and (e) Health
(d) Agriculture, Fisheries and Food
Basis of consideration: (a)-(c) and (e) EM of 29 September 2000
(d) EM of 21 September 2000
Previous Committee Report: None
To be discussed in Council: Following receipt of European Parliament opinion
Committee's assessment: Legally and politically important
Committee's decision: For debate in European Standing Committee C


  1.1  According to the Commission, there are at present 17 Directives dealing in one way or another with food hygiene, which were gradually developed since 1964 in response to the needs of the internal market, but which take into account also the need for a high level of consumer protection. The Commission considers that this multiplicity of measures, the inclusion of provisions covering not only hygiene but also animal health and official controls, and the existence of different hygiene regimes for products of animal origin and other products, has led to considerable confusion. Consequently, as foreshadowed in the White Paper[9] it produced at the beginning of last year, it is proposing to recast the existing requirements, and, in the process, to separate aspects of food hygiene from animal health and control issues.

The current proposals

  1.2  The Commission is proposing that the existing Directives should be repealed and replaced by four new Regulations, dealing separately with food hygiene, animal health and control issues, as follows:

    (1)  on the hygiene of all foodstuffs;

    (2)  laying down specific hygiene rules for food of animal origin;

    (3)  laying down detailed rules for the organisation of official controls on products of animal origin intended for human consumption; and

    (4)  laying down the animal health rules governing the production, placing on the market and importation of products of animal origin intended for human consumption.

These are dealt with in turn in paragraphs 1.3-1.11 below. The remaining measure would simply bring about the repeal of the existing Directives.

(a) Hygiene of all foodstuffs

  1.3  At present, the principal measure, setting out hygiene rules applicable to all food, is Directive 93/43/EEC, which the Commission says is based on the following principles:

  • the paramount concern to protect human health;

  • the use of hazard analysis, risk assessment and other techniques to identify, control and monitor critical points in food businesses;

  • the adoption of microbiological criteria and temperature control measures;

  • the development of codes of good hygiene practice;

  • monitoring of food hygiene by the Member States; and

  • the obligation of food businesses to ensure that only foodstuffs not harmful to human health are placed on the market.

  1.4  The Commission considers that experience of implementing this Directive shows that these principles remain valid, and that the Directive — which currently does not apply to products of animal origin — should be recast to extend to all foodstuffs. It also believes that a number of its detailed provisions should be revised to take account of recent developments in food hygiene, with emphasis being placed on the objectives to be attained rather than on the detailed measures needed. This in turn implies a need for food operators to define their own procedures, thus providing greater flexibility alongside simpler legislation.

  1.5  First, the proposal would introduce a requirement for all food business operators (other than primary producers) to operate a fully-documented food safety management system. This would be based on HACCP[10] principles, which the Commission says involve the systematic assessment of all procedures involved in a food operation, and are widely regarded as the most effective approach to preventing food safety problems. This approach would identify those points critical to product safety, together with control measures, critical limits, monitoring procedures and corrective actions. It would also require documentation in order to provide an audit trail.

  1.6  Secondly, the proposal would seek to ensure good hygiene practice throughout the food chain, starting with primary production, in order to provide a "farm to fork" approach to food safety. Thus, although primary producers would not be subject to the full application of HACCP principles, they would be required to monitor hazards to food safety, and to eliminate them or reduce them to an acceptable level. The proposal provides that methods of doing so should be addressed in guides to good practice, in combination with those already required under relevant existing legislation.

  1.7  Thirdly, the proposal would aim to improve traceability by requiring the registration of food businesses, and the allocation to each of them of a registration number, which those concerned (except at retail level) would have to use to identify any foodstuffs they produce. Food businesses would also need to have in place adequate procedures to withdraw food where it presented a risk to consumer health, and they would be required both to notify the competent authority where this proves necessary, and to keep adequate records enabling them to identify the supplier of ingredients and foods used in the operation.

  1.8  The definition of "food business" would mean that these requirements would apply "as appropriate" to primary producers, and there would also be a measure of flexibility in applying controls to small and medium-sized enterprises (especially those situated in regions with special geographical constraints) and to the manufacture of traditional products, so long as the overall objectives of the Regulation were not compromised. The proposal would also require imports from Third Countries and food exported to non-member states to comply with prescribed standards.

(b) Specific hygiene rules for food of animal origin

  1.9  The Commission recalls that, nearly 40 years ago, it was recognised that the different approaches by Member States to products of animal origin created barriers to intra-Community trade, and served to protect national markets. At that time, the only solution seen was full harmonisation, laying down a prescriptive approach in areas such as the construction of premises, hygiene measures, and production processes. This was first put into practice in Directive 64/433/EEC on trade in fresh meat, and, since then, there have been a dozen or so further measures setting out detailed hygiene rules in various areas.[11] However, although the Commission recognises that these have helped to maintain a high level of health protection and ensure free circulation within the Community, it considers that the requirements are unnecessarily complicated; repeat similar or identical requirements, and thus overlap each other; and can at times be contradictory. It is therefore proposing that those requirements which are identical for a range of products should be spelt out in a single set of common rules, with any detailed provisions needed for a particular product being contained in specific annexes. Products would be classified as raw or processed. This would then provide the basis for defining the scope of any specific hygiene legislation, though the amount of detail required would in part depend upon the extent to which HACCP principles were introduced and also on the existence of codes of good hygiene practice.

(c) Detailed rules for the organisation of official controls on products of animal origin

  1.10  These would include all aspects which may affect the public or animal health safety of such products during all stages of production, including processing, storage and transport. They would cover such issues as the qualifications of inspectors, frequency of inspections, detailed procedures for both ante and post-mortem meat inspection, and record keeping. The existing controls would remain largely unchanged, though there would be provision for some relaxation of the current requirements for veterinary supervision in licensed meat premises.

(d) Animal health rules governing the production, placing on the market and importation of products of animal origin intended for human consumption

  1.11  As with the public health measures referred to in paragraph 1.9 above, rules to prevent the spread of animal diseases, such as swine fever and foot-and-mouth disease through products of animal origin, are set out in a number of Council Directives. Since the rules in question have no direct impact on consumer health, they are now being presented in a separate proposal dealing solely with animal health.

The Government's view

  1.12  The Government's view on the first three areas above are set out in an Explanatory Memorandum of 29 September 2000 from the Parliamentary Under-Secretary of State at the Department of Health (Ms Gisela Stuart). She says that the UK has been active in drawing to the attention of the Commission and Member States the shortcomings and inconsistencies of current Community food hygiene legislation, and that, in general, what is now proposed accords with key UK policy objectives in this area. She describes these as the protection of the public in relation to food, coherent legislation throughout the food chain, and the introduction of proportionate controls.

  1.13  On specific aspects of the proposals, the Minister says that the key feature is the introduction of the requirement to operate fully HACCP principles. She points out that these are internationally accepted as the system of choice for food safety management, have been endorsed by the Government's independent Advisory Committee on the Microbiological Safety of Food (ACMSF), and promoted by the Government for a number of years. She says that some existing hygiene legislation already embodies certain HACCP principles, which are known more usually as a "hazard analysis approach" in the retail and catering sectors, and as "own checks" where they appear in certain sector-specific Directives for products of animal origin. The Commission's proposal follows the approach of the Codex Alimentarius Commission, and, in extending the application of HACCP principles to all food businesses (other than those at the primary production level), it accords with existing government policy.

  1.14  The Minister also deals specifically with the use of HACCP in slaughterhouses, where she points out the Community hygiene law is exceptional in not requiring meat producers to have some form of hazard assessment and control system in place. She adds that, although many producers have followed this approach voluntarily or at the behest of their customers, the Pennington Group (which was set up following the E.coli outbreak in Lanarkshire) recommended in 1997 that all slaughterhouses producing fresh meat for human consumption should adopt HACCP. She also points out that the Government subsequently accepted the Meat Industry Red Tape Review's recommendation that there should be a radical overhaul of meat inspection, and a change to a risk-based system of checks, and she considers that a HACCP-type approach would target operators' controls in the most critical areas, thus providing better safeguards.

  1.15  On the more general aspects of the proposals, the Minister says that protection of public health is of paramount concern, and will underpin the Government's response to them. She adds that concentrating controls on those aspects of food production which are critical to safety, instead of on unnecessarily prescriptive elements, emphasising the responsibility of manufacturers to produce safe food, and providing a flexible and risk-based system, is consistent with existing government policy. She also favours a refocusing of enforcement inspections on key issues of food safety by auditing food safety management arrangements, particularly producers' critical controls, corrective action plans, and hazard review procedures.

  1.16  Another aspect of the proposals highlighted by the Minister is the importance of the application, for the first time, of hygiene controls from primary producers through to sale or supply to the final consumer, by the use of a single risk-based approach based on HACCP principles. She contrasts this with the "piecemeal and inconsistent" approach to food safety currently encouraged by the many current Directives, and comments that it should remove many of the difficulties faced by manufacturers producing a variety of products currently subject to differing requirements. It would also simplify the task of enforcement officers.

  1.17  Finally, the Minister observes that control measures should be proportionate to the risks posed to consumers, and that the Government considers that there is scope to seek further rationalisation and simplification without compromising food safety. In particular, she believes the Commission will need to clarify how the proposals on the registration of food businesses and identification of produce to improve traceability will work in practice, and also carry out a rigorous analysis to ensure that what is proposed would be effective, proportionate and appropriately dealt with in the proposed legislation. She also suggests that the flexibilities provided for producers in certain circumstances would need to be carefully balanced against the primary objective of safeguarding public health, and she identifies one particular concern as the possibility of derogations for small and medium operators from the need for a veterinary presence in slaughterhouses.

  1.18  The Minister's Explanatory Memorandum also touches on two other aspects of the proposals. First, as regards the proposed legal base, she says that the Government intends to seek clarification from the Commission on the reasons for the inclusion of Article 95 for proposal (a), and its omission in the case of proposals (b) and (c). It will also seek clarification on whether Article 37 needs to be included as a base for these last two proposals.

  1.19  Secondly, as regards the possible costs, the Minister has provided a draft initial Regulatory Impact Assessment, which she says will be updated following consultation with interested parties. In the meantime, the Assessment points out that Department of Health studies suggest that up to 4.5 million people a year may suffer from food-borne disease, with up to 750,000 of these having to consult their doctor. Deaths from food poisoning each year are put at around 50-60, and the annual cost to the National Health Service and business at up to £350 million a year.

  1.20  Against this background, the Assessment says that consumers would benefit from safer food as a result of enhanced hygiene controls, whilst food producers and retailers would gain from the removal of outdated and unnecessary controls, their replacement by a single, systematic approach to all aspects of food safety, and the focusing of technical resources onto critical parts of the production process. However, it also suggests that there would be some "significant" non-recurring costs associated with the introduction of HACCP systems, though compliance costs will vary greatly according to the extent to which those systems are already in place. In this respect, the smaller food businesses are likely to be hardest hit, though the effect could be mitigated by the provision enabling Member States to seek derogations for them. The Assessment also points out that, where the proposals on registration exceed existing UK requirements, there could be significant administrative costs.

  1.21  The Government's views on proposal (d), dealing with animal health rules, have been set out in an Explanatory Memorandum of 21 September 2000 from the Minister of State (Lords) at the Ministry of Agriculture, Fisheries and Food (Baroness Hayman). She says that the proposal is in line with UK policy objectives, and seeks to provide simplified legislation which is proportionate and based on the principles of risk assessment and the best available scientific advice, and to ensure the removal of unnecessary prescriptive elements which do not safeguard animal health. Imports of products of animal origin from third countries would be subject to the same requirements as at present. The Minister adds that the UK's aim will be to resist any changes which threaten the proportionality of the proposal. She too has provided a draft initial Regulatory Impact Assessment, which is subject to consultation with interested parties, but, since no practical change would be introduced by the proposal, she expects the consultation exercise to confirm that there should not be any financial impact on UK business.


  1.22  Even if food safety were not such a topical subject as it has now become, these would be significant proposals, not least because of their scope and their impact on an area of wide significance, both to producers (at all levels), retailers and also to consumers. We therefore have no hesitation in recommending them for debate in European Standing Committee C. This will give Members an opportunity to raise questions ranging from the numerous points of detail contained in the Annexes to the proposed Regulations to some of the wider points of principle identified by the Ministers, including the considerations referred to in paragraph 1.17 above.

  1.23  Obviously, the timing of the debate must be a matter for the Government, and we understand that the negotiating process for these various measures is expected to be a lengthy one. Consequently, it would appear sensible to delay any debate at least until after the results of the Government's consultation exercise are known and there has been an opportunity for it to update the two initial Regulatory Impact Assessments. On the other hand, we hope that the House will be given an opportunity to examine these documents in good time for it to be able to make a meaningful contribution to the line taken by Ministers in the Council.

9   (20875) 5761/00; see HC 23-x (1999-2000), paragraph 2 (1 March 2000). Back

10   Hazard Analysis and Critical Control Points. Back

11   These include poultrymeat, trichina examination, meat products, hygiene of milk production, egg products, live bivalve molluscs, fishery products, rabbit meat and farmed game meat, wild game meat, milk and milk products, the handling of fishing products on board vessels, gelatine, frogs legs and snails, and minced meat. Back

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