Opinion of the Economic and Social Committee on:

- the "Proposal for a Regulation of the European Parliament and of the Council on the hygiene of foodstuffs",

- the "Proposal for a Regulation of the European Parliament and of the Council laying down specific hygiene rules for food of animal origin",

- the "Proposal for a Regulation of the European Parliament and of the Council laying down detailed rules for the organisation of official controls on products of animal origin intended for human consumption",

- the "Proposal for a 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 consumption", and

- the "Proposal for a Directive of the European Parliament and of the Council 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"

(2001/C 155/09)

On 17 July 2000 the Council decided to consult the Economic and Social Committee, under Articles 37, 95 and 152(4)(b) of the Treaty establishing the European Community, on the above-mentioned proposals.

The Section for Agriculture, Rural Development and the Environment, which was responsible for preparing the Committee's work on the subject, adopted its opinion on 8 March 2001. The rapporteur was Mr Verhaeghe.

At its 380th plenary session of 28 and 29 March 2001 (meeting of 28 March) the Economic and Social Committee adopted the following opinion by 78 votes to one, with ten abstentions.

1. Introduction

1.1. Overall summary

1.1.1. The present proposals result from a recast of Community legislation on

- food hygiene as contained in Directive 93/43/EEC on the hygiene of foodstuffs and in a number of directives governing the production and placing on the market of products of animal origin,

- animal-health rules related to the placing on the market of products of animal origin, as contained in a number of directives,

- official controls on products of animal origin contained in the current directives.

1.1.2. These directives (seventeen in total) have been gradually developed since 1964 in response to the needs of the internal market, but also with due regard to the need for a high level of consumer protection. The large number of directives involved, the intermingling of different disciplines (hygiene, animal health, official controls) and the existence of different hygiene regimes for products of animal origin and other food have led to a complex situation. This situation can be improved by recasting the legislation and separating the food hygiene aspects from the animal-health and official control issues.

1.1.3. The Commission proposals respond to a number of actions announced in the annex to the White Paper on Food Safety(1). The recast of existing legislation makes for a comprehensive and integrated approach, covering all food from the farm to the point of sale to the consumer. This leads to better coherence and transparency of food legislation. In addition, the role of the various stakeholders in the food chain is better defined.

1.1.4. The leitmotif throughout the recast of the hygiene rules is that food operators bear full responsibility for the safety of the food they produce. The observance of basic hygiene rules (GHP)(2) and - for operators in fields other than primary production - the implementation of the principles of the HACCP system(3) must ensure this safety. This is in line with the approach advocated at international level by the Codex Alimentarius.

1.1.5. The recasting exercise has resulted in the drafting of four proposals for regulations on (i) overall food hygiene, (ii) specific hygiene rules for food of animal origin, (iii) official controls and (iv) animal-health rules governing the production, placing on the market and importation of products of animal origin intended for human consumption. A directive is also attached repealing existing legislation in the above-mentioned fields.

1.1.6. The Commission believes that Community law in the form of regulations presents a number of advantages, such as the guarantee of uniform application throughout the single market, better transparency and the possibility for rapid updating to take account of technical and scientific developments.

1.2. Integrated approach

1.2.1. The overall hygiene rules currently found in Directive 93/43/EEC are to be applied to all foodstuffs, including products of animal origin which at present fall outside its scope.

1.2.2. At the same time, these rules have been revised in order to take account of recent developments in food hygiene. From now on, the revised rules are to apply to the entire food chain "from farm to table". Under these rules, the seven principles of the HACCP system have to be applied as set out in the Codex Alimentarius. They also require the traceability of food and their ingredients, and they refer to the concept of food safety objectives (FSOs)(4).

1.3. Food of animal origin

1.3.1. The present hygiene rules for food of animal origin are being simplified by recasting fourteen directives. This has made it possible to identify a set of rules common to all food, thus avoiding the repetitions, overlaps and inconsistencies in the current directives. Some specific rules have been retained, however, for the various classes of foodstuffs.

1.3.2. The regulation is divided into sections as follows: scope (retail sale and product definition), approval of establishments, health marking, detailed requirements, microbiological criteria, temperatures for storage and transport, small production units, imports from non-member countries, quality and labelling and the exclusion of certain materials from the manufacture of products.

1.4. Animal-health requirements

1.4.1. The animal-health rules are designed to prevent the spread of animal diseases not considered transmissible to humans through products of animal origin. Since these diseases have no direct impact on consumer health, it made sense to address them separately from hygiene rules as such.

1.4.2. A high level of protection is also required in this field. The proposed regulation indicates - among other things - which animal diseases may be transmitted via products of animal origin, and how to eliminate transmission risk.

1.5. Official controls

1.5.1. In accordance with the Commission's intentions announced in the White Paper, a proposal covering official food and feed control is expected to be available shortly. The current proposal for a regulation covers only the control of products of animal origin intended for human consumption. It establishes in particular the responsibilities of the official services in the Member States, the action to be taken in the case of risk to the consumer, the training of control officials, the application of contingency plans, controls on imported products, inspections by the Commission and safeguard measures.

1.5.2. It must be remembered that, because of their specific nature, some products such as meat require particular rules. Intensive discussions are under way at the moment on the revision of current inspection procedures so as to address the hazards that are linked to modern methods of food production. So that the Commission can react promptly at the end of these discussions, the separate proposal that has been drawn up sets out the inspection procedures in detail. Pending the outcome of the scientific assessment, the present rules are to continue to apply.

1.6. The external dimension

With the globalisation of the food market, growing concerns are emerging about food safety. Countries are particularly sensitive to risks relating to microbiological or chemical contaminants which have to be eliminated during foodstuff production and transport. This is reflected in international obligations and agreements, and in the enhanced role of international organisations such as the Codex Alimentarius and the International Office of Epizootics. The Commission proposals seek to respond to this challenge by introducing requirements with regard to the hygienic quality of imported food taking account of international standards and guidelines.

1.7. Ongoing development

It is likely that in the coming years there will be a need to adapt legislation again depending on the outcome of the self-checking regimes run by operators, the establishment of codes of good hygiene practice, Member States' implementation of inspections and audits and all new technical developments.

2. General comments

2.1. The new Commission food hygiene proposals largely reflect earlier Committee opinions. On the whole, these proposals represent a major step forward, for which the Commission is to be commended.

2.2. The Committee endorses in particular:

- the principles underlying the new proposals (recitals 3 and 12 of draft Regulation (EC) No 2000/0178), including:

- the primary responsibility of food operators for food product safety. Each operator is to be responsible for the safety of products under his or her control from primary production to delivery to the consumer;

- the "farm to table" approach;

- the obligation to apply HACCP (in the sectors concerned) and traceability;

- compatibility with international trade agreements;

- the choice of regulations rather than directives, because by restricting Member States' scope for interpretation, these make for better consumer protection and fairer competition between companies (section IX of the explanatory memorandum).

3. Specific comments

3.1. Hygiene of foodstuffs

3.1.1. Scope

The Committee is pleased that the new regulations are to apply to all stages of food production and distribution. In particular - and in contrast to current legislation - they are to apply henceforth to the primary sector, i.e. to products of the soil, of stock farming, of hunting and fisheries. The Committee feels, however, that the scope should broadly cover the production of all food ingredients, including products of mineral origin and products that are the result of chemical synthesis. Article 2 of draft Regulation (EC) No 2000/0178 should be reworded accordingly.

3.1.2. Definitions (Article 2 of draft Regulation (EC) No 2000/0178)

3.1.2.1. Pending a definition of "food safety objective", the list of definitions should be expanded to include, among others, definitions of "food", "objective", "performance standard" and the English term "requirements" which has been translated in different ways - in French, for example, as dispositions ("provisions") or conditions ("conditions").

3.1.2.2. With a view to simplification and also to avoid confusion, the definitions should be brought into line with the Codex Alimentarius definitions that have been drawn up or revised recently, e.g. food hygiene and food safety.

3.1.3. Responsibility of food business operators

3.1.3.1. The wording of the first indent of recital 12 of draft Regulation (EC) No 2000/0178 should be amended to state that responsibility for food safety rests with all food business operators for the section of the food chain covered by their operations, in line with the wording of Article 3 - General obligation - of the proposal for a regulation on the overall hygiene of foodstuffs.

3.1.3.2. In particular, the text (Annex I of draft Regulation (EC) No 2000/0178) should stress the responsibility of the various partners in the primary production chain which, from now on, is to be covered by food hygiene law. These partners - whether the agrochemical industry, seed producers, feed manufacturers, the developers, vendors and carriers of such products or farmers themselves - must see to it - each in his or her respective field - that agricultural produce placed on the market does not contain unacceptable levels of biological or chemical residues. While maintaining a high level of health protection, the administrative burden borne by small firms and the craft sector should be kept to a minimum.

3.1.4. Regional aspects (Article 4(4) of draft Regulation (EC) No 2000/0178)

To avoid penalising typical European products, the Committee emphasises the need to adapt hygiene rules to their traditional production methods, and to the production of small quantities without in any way compromising food safety. Moreover, the Committee feels that the requisite adjustments must be laid down and supervised at Community level in order to ensure optimum protection of consumers' health and fair competitive conditions. The future European food authority could play a scientific assessment role here.

3.1.5. Retail trade (Article 9(2) of draft Regulation (EC) No 2000/0178 and Annex II, point 2 of draft Regulation (EC) No 2000/0179)

The Committee feels that the exclusion of the retail trade from the scope of the new regulations is wholly unwarranted in the case of major distribution establishments (supermarkets and hypermarkets) with rooms in which large quantities of animal products are prepared (e.g. meat cutting rooms). Such establishments must meet the appropriate specific hygiene rules.

3.1.6. HACCP/Hygiene guides and codes (Articles 5 and 7 of draft Regulation (EC) No 2000/0178)

3.1.6.1. The obligation placed on food operators to apply the seven principles of the HACCP system as defined by the Codex Alimentarius is a welcome move, but greater stress must be put on the prior need to comply with good hygiene practice.

3.1.6.2. In this respect, the Committee stresses the importance of training that is commensurate with the work of staff, since product safety requires the involvement of all players - each at his or her respective level (Annex II, Chapter XII of draft Regulation (EC) No 2000/0178).

3.1.6.3. The Committee feels that the Member States should be encouraged to assess their own working and employment conditions in the light of the HACCP system, paying particular attention to the consultation of sectoral representatives, workers and consumers.

3.1.6.4. The Committee feels that the adoption of food safety objectives (FSO) should make for the more uniform application of food hygiene law.

3.1.6.5. After a reasonable adjustment period, renewed consideration should be given to the retention of all the hygiene rules set out in draft Regulation (EC) No 2000/0178 for animal products alongside the requirement that HACCP principles must be applied.

3.1.6.6. In the interests of uniformity, the hygiene guides provided for under Article 7 of draft Regulation (EC) No 2000/0178 - whether compendiums of good hygiene practice or guides for using HACCP - should be based on the Codex Alimentarius models. Where these relate to industrial products marketed and/or manufactured across the European Union, they should be drawn up from the start at European level.

3.1.6.7. The purpose of these guides is to help food operators comply with the legal requirements concerning food hygiene and safety. For example, the codes of good practice provided for in Chapter II of Annex I of draft Regulation (EC) No 2000/0178 describe the measures to be taken for good stock-farming and animal-health management, and especially for the proper use of veterinary medicinal products(5). In this respect, the Committee thinks that the Regulation should specify the framework within which these codes must be developed in order to ensure that the requisite zootechnical and veterinary skills are catered for. This must be done in consultation with all interested parties.

3.1.7. Microbiological criteria/storage temperatures (Article 6, draft Regulation (EC) No 2000/0178) - product quality provisions (section II, point 2(j); explanatory memorandum)

3.1.7.1. The Committee is pleased that the microbiological criteria and storage temperatures laid down in the current vertical directives are to be reviewed and, where required, substantiated scientifically, as the Committee itself was calling for. This procedure will make it possible to bring European legislation into line with the WTO Agreement on the Application of Sanitary and Phytosanitary Measures [better known as the SPS Agreement(6)].

3.1.7.2. Moreover, the Committee takes due note of the Commission's undertaking to remove non-health-related quality provisions from hygiene documents as quickly as possible.

3.1.8. Traceability - Registration or approval of food businesses (Articles 9 and 10 of draft Regulation (EC) No 2000/0178)

3.1.8.1. The Committee feels that, where required, it must be possible to quickly determine the origin of foodstuffs placed on the market, or even to establish their full history. To do that, all food operators must be able to retrace the origin of the ingredients or products for which they are responsible. Traceability of foodstuffs is thus secured at every stage - or in successive stages - from primary production to final consumer.

3.1.8.2. The Committee therefore endorses the fact that the rules are to oblige all operators to ensure the traceability of their products. It feels that the rules must confine themselves to the principles involved and leave it to the operators, especially small firms, to choose how to ensure the traceability of their products. This approach is necessary to respond to conditions which sometimes vary widely depending on the sectors and products involved.

3.1.8.3. The Committee feels that registering all businesses in the food chain is an enormous administrative task which may be carried out at local, regional or even national level, depending on circumstances. Registering businesses is a key factor in traceability. For processed products, it is an additional tool alongside the indication of the manufacturing batch.

3.1.8.4. In theory, approval of an establishment is an assurance of compliance with good hygiene practice. The Committee supports the retention of the approval system as the rule for establishments which manufacture or handle microbiologically sensitive products, particularly products of animal origin. However, in order to secure both a uniform level of safety and fair competition, it is essential that the Commission draw up unambiguous criteria on which to base the decision to approve or simply register an establishment.

3.1.9. Health mark (Annex II, point 4 of draft Regulation (EC) No 2000/0179)

3.1.9.1. As its name implies, this mark affirms that the products to which it is affixed are deemed to be safe. For example, the health mark on meat or shellfish guarantees consumers that the products have been subject to an official inspection covering both their origin and state. The Committee feels that, nowadays, this official guarantee is indispensable.

3.1.9.2 There is a different rationale behind the health marking of processed products, such as prepared meats and milk products. In this case, the health mark guarantees that approval has been granted to the production plant concerned - i.e. that it meets the requisite hygiene rules. For the company, therefore, the health mark is a certificate of conformity (such as those issued by certifying bodies) but does not mean that the products themselves have been subject to inspection. Accordingly, the Committee feels that, in the case of processed products, the health mark need not be administered by the public authorities. The Committee would like to see further consideration given to this issue in order to establish cases where the health mark could be administered by recognised private bodies.

3.1.10. Composite products (Annex I, point 8.1 of draft Regulation (EC) No 2000/0179)

The Committee is pleased that composite products no longer fall under the hygiene rules specifically designed for animal products. However, there is still room for improving the current draft since, in some cases, specific rules should nonetheless apply to composite products (e.g. breaded fish fillets which warrant a priori the same hygiene precautions as non-breaded fillets).

3.1.11. Export to non-member countries (Article 12 of draft Regulation (EC) No 2000/0178)

The Committee recognises the need to raise the profile of European foodstuffs on external markets, not least in developing countries. However, this must not damage the competitiveness of European companies. Hence, the Committee feels that the requirement that exported products conform to European legislation must be adapted to take account of specific circumstances in the importing countries. For instance, specific local conditions in the importing country may warrant the use of preservatives banned in products marketed in Europe.

3.1.12. Committee procedures (Article 15 of draft Regulation (EC) No 2000/0178 and Article 6 of draft Regulation (EC) No 2000/0179) - entry into force of the new regulations (Article 17 of draft Regulation (EC) No 2000/0178 and Article 7 of draft Regulation (EC) No 2000/0179)

3.1.12.1. Although not stipulated in the current draft, the Committee welcomes the fusion in due course of the Standing Committee for Foodstuffs and the Standing Veterinary Committee. This fusion should make for simpler, more coherent administration.

3.1.12.2. Moreover, the Committee considers that it would be more reasonable to provide for a brief adjustment period starting on the date on which the new regulations enter into force, not least to give the primary sector time to draw up codes of good hygiene practice correctly.

3.2. Official controls on food products of animal origin (draft Regulation (EC) No 2000/0180)

3.2.1. The Committee feels that the respective responsibilities of the Member States and the Commission are not sufficiently clear from the text. The Committee opinion on the White Paper on Food Safety(7) has already stressed the importance of effective Commission supervision of enforcement of Community rules.

3.2.2. Moreover, there are still too many texts(8) relating to veterinary checks and general and specific rules for official controls. It would be clearer and more practical to consolidate all these texts.

3.2.3. The Committee notes that official controls on farms [Annex I, point 1(a)] cover not only compliance with hygiene rules, but also compliance with animal welfare rules and legislation on animal feed and residues. On the issue of controls on animal feed, the Committee feels that controls on manufactured products should be carried out at the production stage before such products reach the farm.

3.2.4. Meat inspection rules (Annex II) have been revised, not least to give more importance to ante-mortem inspection. In this connection, it should be made clear that ante-mortem inspection must take account of the stock-farming data which farmers are required to collect (Annex I, Chapter II, point 2 of draft Regulation (EC) No 2000/0178).

3.2.5. The Committee feels that the text should include a reference to harmonised legislation on animal products deemed during the veterinary inspection to be unfit for human consumption.

3.3. Animal-health rules relating to trade in food products of animal origin (draft Regulation (EC) No 2000/0181)

3.3.1. The purpose of this Regulation is to prevent the spread of animal diseases via food products of animal origin in intra-Community or international trade.

3.3.2. The proposal also includes provisions for official controls. The Committee notes furthermore that, in this area, the Commission's supervisory role is clearly stipulated (Article 6).

3.3.3. The animal-health rules for imports from non-member countries overlap with the hygiene rules set out in the proposed Regulation relating specifically to the hygiene of food products of animal origin; this generates confusion. In particular, the text stipulates that a list of approved third countries is to be compiled in the light of animal-health criteria [Article 8(1)], while the specific hygiene Regulation also provides for a list to be drawn up - this time on the basis of hygiene criteria (Annex III, point 1 of draft Regulation (EC) No 2000/0179).

3.3.3.1. All these provisions should be consolidated so that there is just one set of rules covering both the public health (hygiene) and animal health aspects.

3.3.4. The Committee notes that the annexes to this Regulation contain some very interesting information. This is particularly true of the table Treatments in order to eliminate animal health risks from meat and the point entitled Treatment to eliminate animal health risks from milk.

3.3.5. Endorsement of these health measures at international level would greatly assist international trade in food products of animal origin. The Committee thus strongly encourages the Commission to endorse and promote these measures.

4. Conclusions

In conclusion, the Committee would make the following food hygiene recommendations.

4.1. The same hygiene rules and the same control methods must apply at all stages in the food chain - from primary production to delivery to the final consumer.

4.2. All raw materials and ingredients used in food production, including minerals and substances that are the result of chemical synthesis, must be covered by these hygiene regulations.

4.3. The obligation placed on food operators to apply the seven principles of the HACCP system is essential, but, equally, the prior need to comply with good hygiene practice must also be underlined.

4.4. Each operator at each stage in the food chain remains fully responsible for the safety of his or her products.

4.5. Traceability must be secured at every stage or in successive stages throughout the food chain, though the type and size of the enterprises should be borne in mind.

4.6. Certain key definitions are missing from the drafts (e.g. the definition of food). These definitions should be established under general food law, which is also under discussion and to which hygiene documents will have to refer.

4.7. Basic safety standards will have to apply to "regional" and/or "traditional" foodstuffs since these will circulate freely within the single market.

4.8. Retail outlets in which large quantities of food of animal origin are prepared and/or cut must meet the specific hygiene rules applicable to these food products.

4.9. European foodstuffs intended for export outside the EU must meet the appropriate standards laid down in the legislation of the importing country and/or the Codex Alimentarius. In the absence of such standards, it is perfectly justified to require that these foodstuffs comply with European legislation.

Brussels, 28 March 2001.

The President

of the Economic and Social Committee

Göke Frerichs

(1) COM(1999) 719 final.

(2) GHP: Good hygiene practice, as set out in the annex to Directive 93/43/EEC and the Codex Alimentarius international code of practice.

(3) HACCP: Hazard Analysis Critical Control Points.

(4) FSO: Food Safety Objective in line with Article 6(2) of the new proposed Regulation on the hygiene of foodstuffs.

(5) See appendix, point 1.

(6) SPS Agreement: WTO Agreement on the Application of Sanitary and Phytosanitary Measures.

(7) OJ C 204, 18.7.2000.

(8) See appendix, point 2.

APPENDIX I

to the Opinion of the Economic and Social Committee

Point 1

Definition of "veterinary medicinal product" under Article 1 of Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products, and Article 1 of Directive 81/851/EEC of 28 September 1981 on the approximation of the laws of the Member States relating to veterinary medicinal products, which includes hormones: ("any substance or combination of substances which may be administered to ... animals with a view to ... modifying physiological functions").

Point 2

- Directive 89/397/EEC of 14 June 1989 (official control of foodstuffs) and Directive 93/99/EEC of 29 October 1993 (additional measures concerning the official control of foodstuffs),

- Directive 89/662/EEC of 11 December 1989 (veterinary checks in intra-Community trade with a view to the completion of the internal market) and,

- Directive 90/675/EEC of 10 December 1990 as last amended by Directive 97/78/EEC of 18 December 1997 (principles governing the organisation of veterinary checks on products entering the Community from third countries).

APPENDIX II

to the Opinion of the Economic and Social Committee

Defeated amendment

The following amendment, which received at least one quarter of the votes cast, was defeated during the discussion:

Point 3.1.2.3.

Add a new point (3.1.2.3.), to read:

"Without wishing to compromise on the objectives of the proposal to amend a number of hygiene directives, closer examination of certain definitions and how they are applied in practice is necessary in order to avoid unworkable situations."

Reason

If the proposal is finalised in its present form, primary producers and small-scale traditional farms in particular will face serious problems as a result of numerous general definitions and implementation decisions that are not consistent with practice.

Result of the vote

For: 24, against: 46, abstentions: 12.