COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT pursuant to the second subparagraph of Article 251 (2) of the EC Treaty concerning the common position of the Council on the adoption of 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

1. Background

- Adoption of the proposal by the Commission: 8 November 2000 [1]

[1] COM(2000) 716 final 2000/0286(COD) of 8.11.2000

- Opinion of the Economic and Social Committee: 28 March 2001 [2]

[2] OJ C/2001/155 of 29.05.2001 p.32

- Opinion of the Committee of the Regions: 14 June 2001 [3]

[3] CDR/2001/64

- Opinion of the European Parliament at first reading:12 June 2001 [4]

[4] A5-0198/2001 final of 12.06.2001

- Date of political agreement in Council: 28 June 2001 (unanimity without the Commission)

- Date of transmission of the amended proposal: 8 August 2001

- Date of adoption of the common position: 17 September 2001

2. Purpose of the Commission's proposal

On 8 November 2000, the Commission adopted a proposal for a regulation laying down the general principles of food law, establishing the European Food Authority, and laying down procedures for matters with a direct or indirect impact on food and feed safety. This proposal develops a comprehensive, integrated approach to regulating the food supply chain with an independent Food Authority as a key component to implement this new approach.

This Communication is intended to inform the European Parliament of the Commission's opinion on the Common Position of the Council. The Common Position was adopted on 17 September 2001. The Commission's amended proposal, following on from the European Parliament's first reading of 12 June 2001, was presented on 8 August 2001.

3. Comments by the Commission on the common position

3.1. General remarks

The Commission notes with satisfaction that the Common Position of the Council broadly reflects the substance and spirit of its proposal.

Almost all the changes adopted by the Council were in line with the central objectives of the proposal and have been endorsed by the Commission. However, certain changes are not in line with the views of the Commission. In particular, the Article in the Common Position referring to the Management Board of the Food Authority differs significantly from the orientation of the Commission.

3.2. Consideration of the amendments proposed by Parliament at first reading accepted by the Commission and integrated in the Common Position

Of the 189 amendments adopted by the Parliament during the first reading the Commission was able to accept approximately 100. The Council has integrated many of these into its Common Position. The Commission is pleased that the Common Position takes many of the amendments proposed by the European Parliament and accepted by the Commission into account.

Recitals

Several amendments concerning the Recitals are introduced in the Common Position since they are in line with overall concept of this proposal. These include greater clarification on the application of this Regulation to the different parts of the food chain. In addition, more precision is given on the consideration of factors that may legitimately be taken into consideration when making risk management decisions.

Certain amendments put forward for the Articles have been placed in the recitals as they elaborate and motivate the text. For example, inclusion of a reference to fish farming in relation to feed businesses, helps the understanding of the reference in the definition in Article 3 (5) to the term "producers producing".

For the same reasons of providing greater clarity and motivation, the amendments in relation to the EFA task on emerging risk, and the link between the exchange of information and co-operation with the potential for this to minimise diverging opinions, have been integrated in the recitals.

Chapters I and II

In relation to the definitions and General food law, the Commission is pleased that the Common Position takes into account many of the amendments proposed by the European Parliament and accepted by the Commission particularly as regards:

Amendments to the definitions have been included adding clarity to the definitions of food law, placing on the market, feed business, primary production. In particular, by taking into account a number of amendments in the definition of stages of production, processing and distribution, the scope of Chapter II is made more precise.

The amendment concerning the prohibition of unsafe food from the market, though this is not placed in the Article suggested by the Parliament but in the Article on the Food Safety Requirement.

Inclusion of the concept that dangerous foods and feeds should not be exported has been included in the Common Position.

Clarification in several articles on how the provisions apply to animal feed.

Clarification of the transparency and public consultation.

Possibility for the Competent Authorities to take control action even if a food or feed is in compliance with relevant food law but there are reasons to suspect that despite such conformity the food or feed is unsafe.

Chapter III

In relation to the European Food Authority, the Commission is pleased that the Common Position takes into account many of the amendments proposed by the European Parliament and accepted by the Commission particularly as regards:

Clarification that the primary mission of the Authority is food safety.

Commission retaining responsibility for the management of the rapid alert system.

Open and transparent appointment of the Executive Director.

Strengthening of contact and dialogue between the Executive Director and the European Parliament.

Role of the Advisory Forum as a mechanism for exchange of information and pooling of knowledge and clarification of its advisory role in relation to the drafting of the Authority's work programme.

Reinforcement of the openness of the Advisory Forum with the possibility to invite representatives of the European Parliament and other relevant bodies.

Reinforcement of the openness of the Scientific Committee and panels with the possibility to invite observers and to organise public hearings.

In relation to the reinforcement of transparency, the requirement for the Authority to publish the following: the Authority's internal rules, programmes of work, Advisory forum's internal procedures, list of competent organisations which may assist the Authority, agendas and minutes of the Scientific Committee and panels and information on which the scientific opinions are based. In addition, a significant number of these publication have to be made available without delay or immediately.

Requirements for independence are extended to the Executive Director (declarations of interests in particular).

Clarification that the Authority's financial regulations will be in line with the requirements related to the Anti-fraud Office.

More precise procedures in relation to the adoption of the Authority's budget, and discharge given to the Executive Director by the European Parliament acting now on a recommendation from the Council.

Clarification on the scope of participation of countries which have concluded agreements with the Community by the virtue of which they have adopted and apply Community legislation in the field covered by this Regulation in the Authority.

Chapters IV and V

In relation to the Rapid Alert system, Crisis Management, Emergency Procedures and final provisions, the Commission is pleased that the Common Position takes into account many of the amendments proposed by the European Parliament and accepted by the Commission particularly as regards :

Clearer link provided between the confidentiality rules for the Rapid Alert system and the information principle required in Chapter II.

Extension of the emergency procedure to feed.

Regular external evaluation every 6 years of the Authority's impact. This evaluation will take into account the views of the stakeholders and the results will be forwarded to the Council and the European Parliament.

3.3. Consideration of the amendments proposed by Parliament at first reading accepted by the Commission and not integrated in the Common Position

The following amendments which were acceptable to the Commission have not been integrated into the Common Position:

- Recital 19 which relates to Amendment 8 on the precautionary principle. The Commission believes that the essence of this amendment which relates to the non-discriminatory application of the precautionary principle should be included in this recital.

- Amendments 10, 70 and 75 require food and feed business operators to not prevent or discourage any person from co-operating with the competent authorities, where this may prevent, reduce or avoid a risk to health. The Commission believes that these amendments should be in a recital, and integrated into Articles 18 (3) and 19 (3) respectively. However, some elements of these amendments go beyond the scope of this Regulation. Therefore the Commission can accept only that, in order to reduce, prevent or avoid a risk to health, food and feed business operators should not prevent or discourage any person from co-operating with the Competent Authorities.

- Amendment 132 specifies that consumer and other stakeholders' organisations should clearly be able to co-operate with the Food Authority. The Commission considers that this Amendment is in line with the Article 33 (5) which provides for close co-operation between the Authority and all organisations working in the field of data collection. Therefore, this amendment should be integrated in the corresponding recital 50.

- Amendment 96 emphasises the requirement for communication from the Authority on nutrition to take account of dietary habits within the European Union. This amendment is in line with Article 40(4) and should therefore be integrated in the corresponding recital 56.

- Amendment 92 was accepted in principle provided that a rewording made it clear that the Authority, which is responsible for risk assessment, would not be involved in risk management activities. This issue is also very important for the Council. Therefore the Commission considers that the Amendment should be integrated into the text but the Authority can only assist the risk manager in the interpretation and consideration of the scientific opinions when the Commission has so requested.

- Amendment 106 was accepted in principle by the Commission. It provides the possibility for the Chairperson of the Scientific Committee to attend Management Board meetings. The Commission considers that this amendment should be included since it creates a useful communication link between the Scientific Committee and panels and the Management Board. However, it is also important not to create confusion between the management role of the Board and the scientific independent role of the Scientific Committee and panels. Therefore, the Chairperson of the Scientific Committee can attend when invited to do so by the Management Board.

- Although most of amendment 107 was accepted in the Council Common Position, a part of this Amendment relating to a hearing of the candidates in the European Parliament before the final appointment of the Executive Director by the Management Board was not accepted. The Commission considers that a hearing, not of all candidates, but of the candidate selected by the Management Board, before the final appointment of the Executive Director, should not significantly delay the process of appointment and would increase public confidence in the Authority.

- Amendment 113 which was accepted in principle/in part by the Commission is not retained in the Council Common Position. The principle of regular meetings of the Advisory Forum at the Chairperson's invitation or at the request of at least a third of its members should be integrated in the text, since it is in line with the reinforced role of the Advisory Forum agreed by Council, Commission and European Parliament.

- In line with Amendment 188, several practical considerations need to be taken into account to ensure that the Authority will function at the optimum of its capacities, in a cost effective manner and in close co-operation with the Commission and the Member States competent bodies.

It is important to stress that the Commission considers, that several amendments accepted by the Commission do not need to be expressly added in the text, as they are already included. These are:

Amendment 2 which relates to requirements applying equally to foods and feeds from third countries as they do to food and feed from the Community is already contained in Recital 8. The same recital already covers, in part Amendment 27 and 47, although feeds and imported food are specifically highlighted in the new definition of stages of production, processing and distribution in Article 3(16).

Amendment 5 which highlights the need to cover the whole chain and agricultural inputs was already covered by Recitals 11 and 12. The part of Amendment 5 relating to the catering industry was not acceptable to the Commission or the Council.

The principle of Amendment 84 is already covered in the text of Article 5.3 on international obligations.

Amendment 90 specifically requires the European Parliament to be added to the reference to the Community Institutions. However as the European Parliament is a Community institution it is not necessary to add this in Article 23 a. In addition, Article 29 (scientific opinions) clearly enables the European Parliament to request the Authority to address a scientific matter.

Amendment 126 was aimed at ensuring that the collection of data in relation to biological risk was focused on food safety. It was accepted in principle by the Commission, on the basis that all biological risks that may have a direct or indirect impact on the food production chain should be covered. It is considered that this amendment is covered by a new sentence in Article 22(2) that specifies the EFA mission in relation to data collection: "the Authority shall collect and analyse data to allow the characterisation and monitoring of risk which have a direct or indirect impact on food and feed safety".

Amendments 149 and 150, related to the publication of conclusions of scientific opinions and accepted in principle, are covered by Article 38 on transparency since the opinions of the Scientific Committee and panels and therefore the conclusions of these opinions, are immediately published after adoption. In addition, any conclusions of the scientific opinions relating to the foreseeable health effects shall not on any account be kept confidential in Article 39. Amendment 150 was accepted by the Commission only in relation with the publication of all scientific opinions and not in relation to the part of this amendment suggesting that recommendations to risk managers should be a part of scientific opinions.

3.4. Points of convergence between the Common Position and the Commission's proposal

The Common Position and the Commission's proposal are convergent.

The Commission takes due note of certain amendments made by the Council which are intended to provide clarification or information.

Chapters I and II General food law:

The main thrust of the original proposal on Chapters I and II remains unchanged although the text has been significantly re-ordered with some articles placed into a more logical order with principles separated from requirements. The definitions, particularly the definitions of food, food law, traceability and primary production have been clarified. The definition of stages of production, processing and distribution has been significantly redrafted so that the scope of Chapter II which covers these stages is clearer. An additional definition "final consumer" is included, and the definition of 'official control' deleted for inclusion in a more specific text on controls.

Article 4 includes now an obligation to adapt existing food law principles and procedures before a specific date, which previously was covered by Article 64 of the original proposal and consequently this is deleted. These new arrangements for the application of various articles were designed in common agreement between the Council and Commission Legal Services.

Article 5 is in principle the same although there is some change in emphasis in relation to fair trade practices. After Article 6 the text is significantly re-ordered. Articles 6 to 10 reflect the substance of the original proposal. There are some minor changes in emphasis in relation to the import and export of food in Articles 11 and 12 and importantly, food that may be injurious to health or unsafe feed shall not be exported from the Community. On the Precautionary Principle, the Common Position changes the original text. The changes are acceptable to the Commission.

The Articles on food and feed safety requirement (14 and 15) are now better aligned with the general product safety directive with the addition of a paragraph which enables products to be withdrawn or otherwise controlled even though they are in conformity with specific requirements of food law but are found to be unsafe.

Chapter III European Food Authority:

Article 22 (mission of the Authority) has been amended to ensure that while retaining a wide scope, the Authority's mission will remain focused on food and feed safety. Therefore the mission of the Authority in relation to animal health, animal welfare and plant health issues that are not linked to food and feed safety, is now limited to scientific opinions. The scope on nutrition is maintained with some slight changes concerning the communication on nutrition linked to Community health programmes.

The new wording of Article 22 (5) underlines that co-operation between the Authority, the Commission and the Member States is needed to ensure the coherence between risk assessment, risk management and risk communication functions.

The management of the rapid alert system will remain in the Commission (deletion of this task in Articles 22 and 23 and new wording in Articles 35 and 50). However, the Authority will be a member of this network.

The role of the Advisory Forum (Article 27) has been specified more completely, since this body of the Authority will ensure the functional link with the Member States' similar bodies.

The conditions of referral to the Authority of a request for scientific opinions have been completed and the situations in which a request may be amended or refused specified (Article 29).

Several new provisions in relation to transparency have been added in particular in Articles 32, 36 and 38.

Chapter IV (Rapid Alert System, crisis management and crisis situations)

This chapter has been amended in relation to rapid alerts (see above), to extend the emergency procedure to feed (Article 53 and 54) and to align this emergency procedure with the Common Position on official inspections in the field of animal nutrition [5].

[5] OJ no. C/93 of 23.03.2001

Chapter V Procedures and final provisions:

The Commission can agree to most of the changes, in particular those in relation to the transfer of the provision of Article 64 of the original proposal to Article 4, and the commencement of the Authority on 1 January 2002.

3.5. Commission reserves on the Council Common Position that are not in relation with the European Parliament amendments

In addition to the parliamentary amendments referred to in part 3.3 above, the Commission has a reserve on the following in the Common Position:

The Council concluded that it would prefer a Management Board composed of 16 Members selected on the basis of competence, relevant experience and geographical distribution plus one representative of the Commission rather than representation from all three Community institutions with 4 representatives of stakeholder organisations which was the basis of the Commission's original proposal. The Commission considers that further consideration needs to be given to the relationship between the different criteria for the Board's constitution including size, balance and nomination process.

In addition, the Article relating to the procedures to establish the Seat was deleted. The Commission considers that several practical and operational considerations need to be taken into account to ensure that the Authority will function at the optimum of its capacities, in a cost effective manner and in close co-operation with the Commission and the Member States' competent bodies, having regard to the Commission's White Paper on Food Safety.

The directly applicable requirements (Articles 11, 12, 14 to 20) in this proposal are fundamental to food safety. For this reason the Commission does not agree that their application should be postponed for three years. These requirements should be in place before this and taking into account the position of the Council, the Commission believes that a maximum of 2 years provides sufficient time for administrative and legal amendments in the Member States.

4. Conclusion

On the basis of the Common Position, the legislative procedure may now proceed with the second reading in the European Parliament. The Commission considers that there is a solid basis for a final decision to be taken before the end of 2001 in order to respect the deadlines set up by the Nice Summit for the establishment of the European Food Authority in early 2002 even if a limited number of issues need to be discussed further.

5. Statements by the Commission for the minutes

The Commission has asked that the following statements be inserted when the Common Position is adopted:

5.1. Concerning Articles 3 and 18:

"The Commission can confirm that the proposed definition (15) and Article 18 on traceability will apply at the level of primary production. The 'stages of production and distribution' (defined in definition (16)) are covered by traceability (defined in (15) and elaborated in Article 18). The stages of production and distribution include primary production (definition (17)). Article (2) states that when a plant is harvested it becomes a food. Therefore the farm from which this has been harvested has to comply with this requirement for traceability from that point."

5.2. Concerning Article 4:

"The Commission agrees that existing sectorial feed law will be reviewed in order to take into account the general principles contained in this regulation as appropriate."

5.3. Concerning Articles 11 and 12:

"The Commission can confirm that the general requirements in Articles 11 and 12 are without prejudice to more detailed provisions in specific texts which elaborate the powers of the competent authorities to accept, reject or otherwise deal with foods presented for importation. The Commission will present to the Council and European Parliament in the coming months a text on the control of food and feed which will contain the detailed powers of the competent authorities in this respect."

5.4. Concerning Article 14:

"The Commission will present in the following months a proposal to modify the labelling directive in order to address the issues related to the declaration of ingredients which make up less than 25% of the final product and to ensure that where ingredients are known allergens, but where only the name of the category needs to be indicated, an indication will be required as to the presence of such allergens, to enable susceptible consumers to avoid these products. The text on general food law in no way prejudices the work in this respect."

5.5. Concerning Article 14:

"The Commission agrees to consider the possibility of studying the problems related to regionalisation of food-related zoonotic diseases in the context of their work on zoonoses."

5.6. Concerning Article 22(5)(b):

"The core activity of the Authority will be food safety.

Work which is not directly or indirectly related to food safety carried out by the existing scientific committees which are competent in the fields of the new Committee and Panels of the Authority is currently approximately 5% of the overall total. The preparatory work undertaken by the Commission in order for make the financial Statement, and on which this is based, indicates that this level will be the same in the Authority.

Work which is not related to food safety and in particular that which is related to animal health, welfare and plant health shall remain within this limited proportion in the Authority."