Legal provisions of COM(2007)672 - Common authorisation procedure for food additives, food enzymes and food flavourings (presented by the Commission pursuant to Article 250 (2) of the EC Treaty)

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dossier COM(2007)672 - Common authorisation procedure for food additives, food enzymes and food flavourings (presented by the Commission pursuant ...
document COM(2007)672 EN
date October 24, 2007

Contents

CHAPTER I - GENERAL PRINCIPLES

Article 1 - Subject matter and scope

1. This Regulation lays down a common assessment and authorisation procedure (hereinafter referred to as the “common procedure”) for food additives, food enzymes, food flavourings and sources of food flavourings used or intended for use in or on foodstuffs (hereinafter referred to as the “substances”), which contributes to the free movement of these substances food within the Community and to a high level of protection of human health and protection of consumers' interests .

This Regulation shall not apply to smoke flavourings falling within the scope of Regulation (EC) No 2065/2003 of the European Parliament and of the Council of 10 November 2003 on smoke flavourings used or intended for use in or on foods.

2. The common procedure shall set the procedural arrangements for updating the lists of substances the marketing of which is authorised in the Community pursuant to Regulation (EC) No XXX/2006, Regulation (EC) No YYY/2006 and Regulation (EC) No ZZZ/2006 (hereinafter referred to as the “sectoral food laws”).

3. The criteria according to which substances can be included on the Community list provided for in Article 2, the content of the Regulation referred to in Article 7 and, where applicable, the transitional provisions concerning ongoing procedures are laid down in each sectoral food law.

Article 2 - Community list of substances

1. Under each sectoral food law, substances that have been authorised to be placed on the Community market shall be included on a list the content of which is determined by the said law (hereinafter referred to as the “Community list”). The Community list shall be updated by the Commission. It shall be published in the Official Journal of the European Union .

2. “Updating the Community list” means:

(a) adding a substance to the Community list;

(b) removing a substance from the Community list;

(c) adding or changing conditions, specifications or restrictions associated with the presence of a substance on the Community list.

CHAPTER II - COMMON PROCEDURE

Article 3 - Main stages of the common procedure

1. The common procedure for updating the Community list may be initiated either on the initiative of the Commission or following an application. Applications may be made by a Member State or by an interested party, who may represent several interested parties, according to the conditions provided for by the implementing measures referred to in Article 9(1)(a) (hereinafter referred to as “the applicant”).

2. The Commission shall seek the opinion of the European Food Safety Authority (hereinafter referred to as “the Authority”) in advance, in accordance with Article 5.

However, for the updates referred to in Article 2(2)(b) and (c), the Commission shall seek the opinion of the Authority only if these updates are liable to have an effect on public human health.

3. The common procedure shall end with the adoption by the Commission of a regulation implementing the update, in accordance with Article 7.

4. By way of derogation from paragraph 3, the Commission may end the common procedure and decide not to proceed with a planned update, at any stage of the procedure, if it judges that such an update is not justified. Where applicable, it shall take account of the opinion of the Authority, any relevant provisions of Community law and any other legitimate factors relevant to the matter under consideration.

In such cases, where applicable, the Commission shall make this information public subject to the provisions of Article 12, and shall inform the applicant directly, indicating in its letter the reasons for the update not being considered justified.

Article 4 - Initiating the procedure

1. On receipt of an application to update the Community list, the Commission:

(a) shall acknowledge receipt of the application in writing to the applicant within 14 working days of receiving it;

(b) where applicable, notify the Authority of the application and request its opinion.

The application shall be made available to the Member States by the Commission.

2. Where it initiates the procedure on its own initiative, the Commission shall inform the Member States and make public the fact and, where applicable, request the opinion of the Authority.

Article 5 - Opinion of the Authority

1. The Authority shall give its opinion within six nine months of receipt of a valid application.

2. The Authority shall forward its opinion to the Commission, the Member States and, where appropriate, the applicant.

Article 6 - Additional information concerning risk assessment

1. In duly justified cases Where the Authority requests additional information from applicants, the period referred to in Article 5(1) may be extended. After consulting the applicant, the Authority shall lay down a period within which this information can be provided and inform the Commission of the additional period needed. If the Commission does not object within eight working days of being informed by the Authority, the period referred to in Article 5(1) shall be automatically extended by the additional period.

2. If the additional information is not sent within the additional period referred to in paragraph 1, the Authority shall finalise its opinion on the basis of the information already provided.

3. Where applicants submit additional information on their own initiative, they shall send it to the Authority and to the Commission. In such cases, the Authority shall give its opinion within the original period , unless there are special reasons for extending the period as referred to in Article 10.

4. The additional information shall be made available to the Member States by the Authority.

Article 7 - Updating the Community list

1. Within nine months of the Authority giving its opinion, the Commission shall submit to the Committee referred to in Article 14(1) a draft regulation updating the Community list, taking account of the opinion of the Authority, any relevant provisions of Community law and any other legitimate factors relevant to the matter under consideration.

The regulation updating the Community list shall explain the considerations on which it is based. Where the draft regulation is not in accordance with the opinion of the Authority, the Commission shall explain the difference reasons for its decision .

2. The regulation shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 14(3) (2) .

3. On imperative grounds of urgency, the Commission may use the urgency procedure referred to in Article 14 (4) for the removal of a substance from the Community list and for adding, removing or changing conditions, specifications or restrictions associated with the presence of a substance on the Community list.

Article 8 - Additional information concerning risk management

1. Where the Commission requests additional information from applicants on matters concerning risk management, it shall determine, together with the applicant, a period within which this information can be provided. In such cases, the Commission may extend the period referred to in Article 7 may be extended accordingly and shall inform the Member States of the extension .

2. If the additional information is not sent within the additional period referred to in paragraph 1, the Commission shall act on the basis of the information already provided.

CHAPTER III - MISCELLANEOUS PROVISIONS

Article 9 - Implementing measures

1. In accordance with the procedure referred to in Article 14(2), within a period of no longer than 24 months from the adoption of each sectoral food law, the implementing measures for this Regulation shall be adopted, and shall concern in particular:

(a) the content, drafting and presentation of the application referred to in Article 4(1);

(b) the arrangements for checking the validity of applications;

(c) the type of information that must be included in the opinion of the Authority referred to in Article 5.

2. With a view to the adoption of the implementing measures referred to in paragraph 1(a), the Commission shall consult the Authority, which, within six months of the date of entry into force of this Regulation, shall present it with a proposal concerning the data required for risk assessment of the substances concerned.

Article 10 - Extension of time periods

The periods referred to in Article 5(1) and Article 7 may be extended by the Commission on its own initiative or, where applicable, at the Authority’s request, if the nature of the matter in question so justifies, without prejudice to Article 6(1) and Article 8(1). In such cases, where appropriate, the Commission shall inform the applicant and the Member States of the extension and the reasons for it.

Article 11 - Transparency

The Authority shall ensure the transparency of its activities in accordance with Article 38 of Regulation (EC) No 178/2002. In particular, it shall make its opinions public without delay. It shall also make public any request for its opinion as well as any time period extension pursuant to Article 6(1).

Article 12 - Confidentiality

1. Among the Information provided by applicants , may be given confidential treatment may be given to information only where the disclosure of which thereof might significantly harm their competitive position.

Information relating to the following shall not, in any case, be considered confidential:

(a) the name and address of the applicant and the name of the substance;

(b) a clear description of the substance and the conditions for its use in or on specific foodstuffs or food categories;

(c) information that is relevant to the assessment of the safety of the substances;

(d) where applicable, the analysis method(s).

2. So that paragraph 1 can be implemented, applicants shall indicate which of the information provided they wish to be treated as confidential. Verifiable justification must be given in such cases.

3. The Commission shall decide which information can remain confidential and notify the applicants and the Member States accordingly.

4. After being made aware of the Commission’s position, applicants shall have three weeks in which to withdraw their application so as to preserve the confidentiality of the information provided. Confidentiality is preserved until this period expires.

5. The Commission, the Authority and the Member States shall take the necessary measures to ensure appropriate confidentiality of the information received by them under this Regulation, except for information which must be made public if circumstances so require in order to protect human health, animal health or the environment.

6. If an applicant withdraws, or has withdrawn, its application, the Authority, the Commission and the Member States shall respect the confidentiality of commercial and industrial information, including research and development information, as well as information the confidentiality of which is the subject of disagreement between the Commission and the applicant.

7. The implementation of paragraphs 1 to 6 shall not affect the circulation of information between the Commission, the Member States and the Authority.

Article 13 - Emergencies

In the event of an emergency concerning a substance on the Community list, particularly in the light of an opinion of the Authority, measures shall be adopted in accordance with the procedures referred to in Articles 53 and 54 of Regulation (EC) No 178/2002.

Article 14 - Committee

1. The Commission shall be assisted by the Standing Committee on the Food Chain and Animal Health established by Article 58 of Regulation (EC) No 178/2002.

2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having due regard to the provisions of Article 8 thereof.

The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.

3. Where reference is made to this paragraph, Article 5a(1) to (4), and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.

4. Where reference is made to this paragraph, Article 5a(1), (2), (4) and (6), and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.

3. The Committee shall adopt its Rules of Procedure.

Article 15 - Competent authorities of the Member States

Not later than six months after the entry into force of this Regulation, the Member States shall forward to the Commission and to the Authority, in relation to each sectoral food law, the name and address of the national competent authority for the purposes of the common procedure, as well as a contact point therein.

CHAPTER IV - FINAL PROVISION

Article 16 - Entry into force

This Regulation shall enter into force on the twentieth day following its publication in the Official Journal of the European Union .

For each sectoral food law, it shall apply from the date of application of the measures referred to in Article 9(1).

Article 9 shall apply from the date of entry into force of this Regulation.

This Regulation shall be binding in its entirety and directly applicable in all Member States.