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# 52001AE0404

**Opinion of the Economic and Social Committee on the "Proposal for a Regulation of the European Parliament and of the Council laying down the general principles and requirements of food law, establishing the European Food Authority, and laying down procedures in matters of food safety" **

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Official Journal C 155 , 29/05/2001 P. 0032 - 0038 *

Opinion of the Economic and Social Committee on the "Proposal for a Regulation of the European Parliament and of the Council laying down the general principles and requirements of food law, establishing the European Food Authority, and laying down procedures in matters of food safety"

(2001/C 155/08)

On 22 December 2000 the Council of the European Union decided to consult the Economic and Social Committee, under Articles 37, 95, 133 and 152 (4) (b) of the Treaty establishing the European Community on the above-mentioned proposal.

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 (meeting of 28 March 2001) the Economic and Social Committee adopted the following opinion by 92 votes to six with five abstentions.

1. Introduction and antecedents

1.1. On 8 November 2000, the Commission approved its proposal for a Regulation of the European Parliament and Council laying down the general principles and requirements of food law, establishing the European Food Authority, and laying down procedures in matters of food safety.

1.2. The proposal is a centre-piece of the 84 legislative measures on food and feed safety to be proposed over the next three years as a result of the Commission's White Paper on Food Safety, adopted in January 2000. The White Paper is a fundamental rethink of the EU's existing food and feed policy and a response to the growing consumer concern over the safety of our food.

1.3. The White Paper was discussed in the ESC and lead to an opinion(1), adopted by a very large majority, in May 2000.

1.4. A number of suggestions included in the ESC report on the White Paper have been incorporated in the proposal, namely those concerning increased attention to crisis management, the inclusion of some competence on nutrition as well as of drinking water in the foodstuffs definition and questions relating to aquaculture, fisheries and sea produce.

1.5. It is also worth noting that Article 29 of the proposal reflects the major concerns raised by the ESC over potential conflicts between national and EU scientific opinions, although, as indicated in the detailed comments, the ESC feels that the solution offered does not go far enough in giving the European Food Authority (EFA) scientific precedence. Article 35 demonstrates commitment to resolve problems of coordination between the respective EU and national authorities, again a point considered of primary importance in ESC discussions on the White Paper.

1.6. Suggestions not taken up include those concerning social aspects, which have been referred to other legal instruments. The Committee stresses that the opinions adopted by the EFA may have significant consequences on aspects such as safety at work, employment and industry competitiveness and will return to these issues in future Opinions on specific aspects of food safety.

1.7. In earlier discussions on the subject of an EU Food Authority, many members raised questions on the composition of the Board of the proposed European Food Authority (EFA), underlining, for example, the need to include primary food producers so as to underline the integrated approach to the food chain. Also, major doubts were voiced about the EFA's ability, given its limited funding, to communicate with the public.

1.8. This opinion will look in detail at the proposal, subdivided into Chapter 2 "General Food Law", Chapter 3 "European Food Authority (EFA)", Chapter 4 "Rapid Alert System, Crises Management and Emergencies" and Chapter 5 "Procedures and final provisions".

2. General comments

2.1. The Committee appreciates the efforts by the Commission to bring this proposal forward speedily. It will ensure equally efficient treatment of the proposal and hopes the other Institutions involved will do likewise, taking into account the public concern in this field and the need to dispose as soon as possible of an adequate European instrument for risk assessment in these matters.

2.2. The Committee regrets that revision of the legislative measures set out in the White Paper antecedes agreement on the new fundamental principles and requirements of EU Food Law and the establishment of the EFA. Thus, the EFA will play a key role in future food law development but will be established only after these measures are revised. In view of the timetable indicated at the Nice Summit in December 2000 (EFA to be operational in early 2002), the Committee invites the European institutions to consider if some elements of the proposal could be put in place before that date.

2.3. The Committee favours greater use of the Regulation as EU legislative means since this strengthens uniform application and implementation and contributes to improved functioning of the Single Market for the benefit of consumers and industry alike. In this case however, the ESC is surprised at the high number of concepts for which the definition is either vague or non-existent (e.g. in Article 19, the expressions "where possible", "at an appropriate stage", "representative organisations", "in appropriate fashion", Article 6 paragraph 3, "other factors as legitimate to the matter under consideration", paragraph 1 "the circumstances of the case or the nature of the measure"). Since law laid down by Regulation is directly applicable such vagueness could lead to problems of legal interpretation and as such is unacceptable.

2.4. The Committee feels more clarity is needed as to whom exactly the various Articles of the Regulation are addressed. There should be no place for ambiguity in respect of the responsibilities of Member States, stakeholders and others. One example of this potential for confusion is Article 8, where the first indent seems to be addressed to Member States, while the second seems to place an obligation on food producers. The current proposal has also to take account of the fact that the food-chain players are very diverse and have different needs with regard to the rules they have to comply with, in order to achieve the intended result, namely food safety. Hence the special situation of the SMEs in the food chain should receive appropriate attention.

2.5. The Committee is surprised at the degree of inconsistency between the recitals on the one hand and on the other the body of the draft Regulation as found in the Articles. This seems unjustified and could lead to further problems of interpretation. By way of example, the fifth recital indicates that the principles and definitions of food law listed in the Regulation should form a common basis for all measures governing food, while in Article 3 it is stated that the definitions given there apply "for the purposes of this Regulation".

2.6. The Committee welcomes this new approach to EU Food Law, with its emphasis on food safety, but recommends a continuous integration with firmly established key principles on which much food regulation has been based, such as free movement, mutual recognition, proportionality and subsidiarity. Among the objectives of food law, reference should be made not only to food safety but also to other aspects, developing the "European food model" based on the principles of quality, diversity and safety, as defined at the Biarritz Agriculture Council.

2.7. The Committee is also convinced that the emphasis which it shares given to consumer protection will sustain other prime objectives of the Union, such as the better functioning of the Single Market and the competitiveness of the EU food industry. Only by restoring consumer confidence and guaranteeing proper monitoring, traceability and controls will it be possible to avoid disruption of the Single Market and neo-protectionist attitudes.

2.8. As regards the EFA, the ESC reserves its right to comment in more detail once the EFA has been in operation for a reasonable period of time. Although structures, working methods and the like appear to have been thoroughly thought through, only the working of the new body in practice will allow proper evaluation of its strengths and weaknesses. Therefore, the Committee insists that it be included with the EU Institutions specifically listed to receive EFA working programmes and activity reports (see comments on Article 24, 7, 3).

2.9. The Committee feels that the proposed Regulation should contain more of a blueprint for effective action. In order to ensure that food safety remains a priority also within the ESC, the Committee will organise periodically an ad hoc evaluation of developments in this area, in order to enable an on-going involvement of organised civil society and to contribute to transparency, dialogue and communication towards the public.

2.10. The ESC agrees with the term "Authority" chosen for this new body since this underlines the clear intent for this new structure to be the cornerstone of the new EU policy on food safety. The ESC is, however, aware of the different implications that the term "Authority" might have in different jurisdictions of the EU and therefore would recommend a list of the key characteristics of this term, and of the specific topics on which scientific advice must be required prior to any legislative act. The new body should be empowered to act as a final arbitrator in the case of conflicting scientific opinion, or, at least, take precedence in cases of conflict concerning issues within its realm of responsibility.

3. Specific comments

Chapter I: Scope and definitions

3.1. Article 2 ("Definition of foodstuff"). The definition seems very broad and corresponds to the "integrated approach" towards the food chain. On certain aspects, however, the definition is much tighter. By defining foods in relation to pharmaceuticals the definition runs the risk of not taking into account recent developments in the food market. Foods making health claims, such as "disease risk reduction" claims, which some would today consider to be equal to prevention claims, could therefore fall under the definition of a medicine and not under the category of foods with claimed health effects where they actually belong.

3.1.1. The second paragraph of the definition does not include "food supplements" even though a vertical Directive on this is currently going through the co-decision process(2). The Committee would recommend the inclusion of this term in the definition, since in the past it has often given rise to classification difficulties, especially in relation to pharmaceutical products.

3.2. Article 3 ("Other definitions"). Under indent 1, it is interesting to note that while excluded from the definition of "foodstuff", animal feed is considered to be an integral part of "Food Law". It is the ESC's view that the use of terms and concepts in the various Articles should be double-checked in order to avoid any kind of misunderstanding. Also indent 3 (food business operator) needs further explanation, particularly when considering the translation given in other language versions of the Regulation and the important responsibility given to these "operators", for example, under Article 10. The Committee regrets the missed opportunity to define concepts such as "misleading", "adulteration", etc.

Chapter II: General Food Law

3.3. Article 5 ("General objectives"). With reference to the comment under point 2.7 above, the proper functioning of the Single Market should be included in paragraph 1. The Committee notes that questions relating to protection of animals and the environment are included in a regulation on food law. The Committee assumes that these two objectives will be considered only to the extent that they are directly relevant to food safety. The Committee also wonders how the Commission intends to ensure that these objectives are also complied with by imported food, as provided for in Article 16(1) ("requirements which are at least equivalent").

3.4. Article 5 ("General objectives"). Paragraph 3, while generally in line with the basic principles of the SPS agreement, is loosely phrased enabling the EU to opt out of international obligations seemingly without having to provide detailed justification.

3.5. Article 6 ("Protection of health"). As referred to above (point 2.3), the statement in paragraph 1 that Food Law be based on risk analysis "except where this is not appropriate to the circumstances or the nature of the measure", needs to be clarified. Diverging from a principle which could be considered as one of the most fundamental in the new approach, should only be possible in well-defined circumstances. The reference to "other factors as legitimate to the matter under consideration" in paragraph 3 needs the same clarification/definition and also pre-empts discussions currently being held at international level. In conformity with the ESC's opinion on the White Paper, it should be decided how these "other legitimate factors", such as the environment, sustainability and animal welfare, are to be properly represented and balanced in a food policy in which safety is the primary objective (see White Paper opinion point 3.18).

3.6. Article 7 ("Precautionary Principle"). It is not very logical that a principle which has received such high-level attention remains undefined in the Regulation. Moreover the concept of "scientific uncertainty", on which the Precautionary Principle seems to depend, needs to be made more specific. It is a generally accepted fact that "scientific certainty" is not a realistic goal in this context. Concerning the Precautionary Principle, the ESC refers to its own opinion on this issue, adopted on 12 July 2000 (see conclusions point 14.2)(3).

3.7. Article 8 ("Protection of consumers' interests"). The Committee shares the Commission's fundamental concerns as voiced in this Article. However some further detail on how it can be ensured that the labelling, advertising and presentation of foods will not mislead the consumer should be considered. Much research has, for example, been done on the labelling needs of consumers and the frequent requests (see conclusions of Intergroup Food of the EP) for a fundamental review of existing EU labelling policy are not taken up in this proposal.

3.8. Article 9 ("Traceability"). The Committee thinks in principle that the traceability of foodstuffs should be secured at every stage - or in successive stages - from primary production to final consumers. It assumes that a number of open questions remain regarding the practical application of this principle in the various food sectors and the financial impact of the corresponding systems, and that these will require clarification.

3.9. Article 12 ("Food safety requirements"). The exact relation between the text of this Article and the General Product Safety Directive needs clarification.

3.10. Between Article 16 ("Food imported into the Community") and Article 17 ("Food exported from the Community"), the Commission should consider introducing an Article dealing with so-called "transit goods". Under indent 1 of Article 16, the Committee feels the term "at least equivalent" should be made more precise in order to avoid many different interpretations. As far as the exportation of food and feed under Article 17 is concerned, the ESC feels that this should be done in accordance with the laws and regulations of the importing country, taking into account as a minimum the agreed Codex rules on the respective issues, except when there is evidence that public health is at risk.

3.11. Article 19 ("Public consultation"). The Committee considers that this Article should be rephrased as follows: "There shall be open and effective stakeholder consultation throughout all stages of the elaboration of food law."

3.12. Article 20 ("Public information"). Communication of this kind of potentially sensitive information should always be correct and objective. "Public authorities" in line 4 of this Article should be properly defined.

Chapter III: European Food Authority

3.13. Article 21 ("Mission of the Authority"). The Committee welcomes the broad scope of this mission but emphasizes the need to set priorities in the interest of efficiency. It is the view of the ESC that the tasks and responsibilities of the EFA should be clearly defined and demarcated. The extension of the EFA's responsibilities to areas which could jeopardise its core mission should be avoided.

3.13.1. True to its position on the White Paper, the ESC welcomes the inclusion of nutrition as an integral part of the EFA's mission and trusts that clear boundaries will be drawn around its remit, which should relate to scientific issues and focus on food safety. Health promotion programmes and the like should remain the responsibility of the Commission and its specialised services.

3.13.2. More clarity is needed on the accountability of the EFA. The draft Regulation seems to indicate that the EFA is ultimately only accountable to the Commission. This is not in line with the ESC's opinion on the White Paper, which stated that the EFA should also be made accountable to the European Parliament and the Member States (see White Paper Opinion point 3.17).

3.13.3. Under indent 3, in order to ensure that the opinions of the EFA and the role of science in decision-making is formally recognised, the ESC would suggest that during the decision-making process on food matters the EFA should be consulted to check the scientific logic and consistency of proposals at the time of their introduction into the process and before their final adoption.

3.14. Article 22 ("Tasks of the Authority"). In indent a) the ESC considers it be included under the "Community Institutions". Indent l) in combination with Article 39 ("Communication") indicates that the public will receive direct information from the EFA on the Risk Assessment aspects of a certain issue, while the Risk Managers will communicate on the legislative and other measures taken on the same issue. This gives rise to crucial questions about the means and effectiveness of the EFA's communications, which could affect its public credibility and indeed its prospects of success. The EFA has to command respect for the depth of its scientific resources, the soundness of its judgements, and the speed of its response to emergencies. It will need very quickly to win the confidence of the consumers via the existing media, and it is vital that the maximum benefit be gained from having a single authoritative voice.

3.15. Article 23 ("Bodies of the Authority"). The Committee feels that the change in the terminology for the scientific bodies in indent d) could confuse users, or be seen as a reduction in their authority and their capacity to provide adequate technical scientific support in the longer term.

3.16. Article 24 ("Management Board"). Clarification is needed on the likely composition and procedures/criteria to be used for the selection of candidates. As stated above, the ESC would stress the need for primary, secondary and tertiary operators of the food sector to be on the board so as to underline the integrated approach to the food chain (see 1.7). The ESC regrets that mention is made neither of this Committee nor of the Committee of the Regions, even though both have proven that as far as food safety is concerned, their membership provides valuable contributions. In the same spirit, the ESC draws attention to indent 7, paragraph 3, as already referred to in point 2.8.

3.17. Article 26 ("Advisory Forum"), paragraph 6 and Article 27 ("Scientific Committee and scientific panels"), paragraph 8. The participation of the Commission (Risk Manager) in the meetings of the Advisory Forum, (as well as in the Scientific Committee, the Scientific Panels and the Working Groups, as scheduled under Article 27) must demonstrate an overriding determination to keep a clear frontier between Risk Assessment and Risk Management.; paragraph 8 of the Article should therefore be reinforced. Indent 1 should provide for deputy representatives. It is difficult to see how one representative alone can ensure proper feed-back and involvement of the widest possible national network.

3.18. Article 27 ("Scientific Committee and Scientific Panels"). The ESC would like to see the possibility included of organising specific Task Forces on issues which do not fall specifically under the responsibility of one of the announced Panels. The possibility of organising hearings should also be included in this Article. The titles of the Panels should be more flexible so as to include subjects as consequences of pollution on the food chain, and food intolerance. The Committee stresses also the need to include a panel on the delicate question of traditional production and food safety.

3.19. Article 28 ("Scientific opinions"). The question arises of how and by whom decisions will be made as to which of the many opinions requested from the EFA will be given priority.

3.20. Article 29 ("Conflicting scientific opinions"). Paragraph 3 seems to indicate that in case of conflict between Risk Assessors the final decision on a risk assessment issue is taken by the Risk Manager. Surely, as already mentioned in 2.10, the final arbitrator in such cases must be the EFA. Paragraph 4 does not give a solution for this kind of potential conflict and needs further clarification.

3.21. Article 32 ("Collection of data"). The ESC should be included in the list of Institutions mentioned in indent 6, to which the EFA will communicate its results on data collection.

3.22. Article 33 ("Identification of emerging risks"). The ESC should be included in the list of Institutions receiving information on emerging risks.

3.23. Article 34 ("System of Rapid Alert"). The ESC is aware of the concern of several Member States relating to the management of the Rapid Alert System by the EFA. It should be made absolutely clear what is understood by the "day to day management" of this system and what the specific roles of Commission and EFA are.

3.24. Article 41 ("Consumer and other interested parties"). The ESC notes that the Commission has taken on board its recommendation regarding dialogue with consumers and stakeholders, and hopes that the final text might be enhanced with a statement to the effect that this dialogue should be secured with all those involved in the food chain.

3.25. Article 42 ("Adoption of the Authority's budget") in combination with Article 44 ("Fees received by the Authority"). The Committee feels that the terminology in certain language versions should be changed in order to make it clear that it is not a matter of taxes or duties but of the cost of services rendered. Fees to be received for services performed should never jeopardise the independence and objectivity of the Authority. The ESC requests an indication of which services performed by the EFA could potentially lead to the payment of fees.

3.26. Article 48 ("Participation of third countries"). The ESC feels that due to the imminent and crucial importance of this issue, the suggested rules should be made much more precise and specific.

Chapter IV: Rapid Alert System, Crises Management and Emergencies

3.27. Article 53 ("Crisis unit"). The ESC feels that the role of the Crisis Unit in this Article is focused too much on the management of crises once they have occurred and does not mention what this Committee considers of much greater importance, i.e. the prevention of crises. The Crisis Unit should therefore not be a body set up only once a crisis has occurred but a permanent one intended to help avoid crisis situations. In the case of an actual crisis, it could always be strengthened by adding extra staff and resources.

Chapter V: Procedures and final provisions

3.28. Article 59 ("Mediation procedure"). This Article seems to introduce a special complaints procedure for free trade in cases relevant to food safety. The ESC wonders if this is necessary and if it would not be more appropriate to amend the overall procedure.

3.29. Article 60 ("Evaluation"). Paragraph 2 of Article 60,1 indicates that the Management Board will study the conclusions of the evaluation and then, if necessary, make recommendations to the Commission on changes to the EFA and its working methods. Following a thorough evaluation of conclusions would the Management Board itself not be in a better position to decide on ways forward? Formulated like this, the impression is easily gained that the EFA is to all intents and purposes just another division of the Commission. The ESC feels that this evaluation report should also be presented to the other EU Institutions, including the ESC, and that comments of all these need to be taken into account in the ultimate conclusions.

3.30. Article 62 ("Competence of the European Medicines Evaluation Agency"). Although this Article states that the Regulation should apply "without prejudice to the competence" of the EMEA, the ESC would like to stress, as it did already in its opinion on the White Paper (see point 3.17 c), that the EFA's relationship with EMEA will be particularly important, especially when dealing with borderline products where there may be difficulties determining whether a product is a foodstuff or a medicine. Some further detail on how this relationship will develop in practice seems justified. The ESC also feels that, in the same spirit, a special Article should be devoted to the link between the EFA and the Dublin office for food controls (FVO).

4. Conclusions

4.1. As stated above, the Committee appreciates the major effort by the Commission to bring the current proposal together, which illustrates the key importance it attaches to food safety. The introduction of an all encompassing plan, with improved structures, involving the whole food chain and based on the principles of openness, excellence and transparency can only be applauded.

4.2. However, the vagueness of certain articles and principles, the inconsistency between various parts of the document as well as lack of clarity concerning the exact division of various responsibilities requires further work if the Regulation is to achieve its aims.

4.3. The Regulation should primarily contain a blueprint for effective action. The real challenge is to do things better than before and to increase overall confidence in the whole food chain. The ESC intends to follow future developments in order to ensure that developments on food safety issues will focus mainly on results and preventive measures; it will therefore organise periodical ad hoc evaluations of developments in this area, ensuring consistency and dialogue on these issues.

4.4. In order to be able to evaluate progress on food safety matters and to judge if the new system is living up to its expectations, the ESC stresses the need for evaluation criteria, such as increased/decreased consumer confidence, the occurrence and handling of food crises, closer co-operation between stakeholders, etc.

4.5. If there is a general consensus about the important role of the future EFA, the ESC feels that this should be taken to its logical conclusion, which would be to allow the EFA a role within the decision-making process on food, focusing on the protection of scientific consistency, maintaining at all times both a neutral stance and a realistic separation between Risk Assessment and Risk Management. The ESC volunteers to transform this concept into more concrete plans and suggests setting up a joint working group on this issue with all the other European institutions and relevant stakeholders.

Brussels, 28 March 2001.

The President

of the Economic and Social Committee

Göke Frerichs

(1) OJ C 204 of 18.7.2000, p. 21.

(2) OJ C 14, 16.1.2001.

(3) OJ C 268, 19.9.2000.

APPENDIX

to the Opinion of the Economic and Social Committee

Defeated amendments

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

Point 3.8

Add the following:

"It is therefore necessary to establish, depending on whether the product is for human or animal consumption, the thresholds for substances and ingredients contained in the product, in order to make the traceability system feasible and functional, in particular for SMEs".

Reason

The proposed wording allows a reasonable interpretation of the traceability principle, by establishing the substance thresholds for certain types of product, and thus enabling operators to fulfil their obligations.

Result of the vote

For: 24, against: 63, abstentions: 3.