Regulation (EC) No 1331/2008 of the European Parliament and of the Council of 16 December 2008 establishing a common authorisation procedure for food additives, food enzymes and food flavourings (Text with EEA relevance)Text with EEA relevance
Published date | 31 December 2008 |
Official Gazette Publication | Diario Oficial de la Unión Europea, L 354, 31 de diciembre de 2008,Gazzetta ufficiale dell’Unione europea, L 354, 31 dicembre 2008,Journal officiel de l’Union européenne, L 354, 31 décembre 2008 |
02008R1331 — EN — 27.03.2021 — 001.001
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►B | REGULATION (EC) No 1331/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 December 2008 establishing a common authorisation procedure for food additives, food enzymes and food flavourings (Text with EEA relevance) (OJ L 354 31.12.2008, p. 1) |
Amended by:
Official Journal | ||||
No | page | date | ||
►M1 | REGULATION (EU) 2019/1381 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 20 June 2019 | L 231 | 1 | 6.9.2019 |
▼B
REGULATION (EC) No 1331/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 16 December 2008
establishing a common authorisation procedure for food additives, food enzymes and food flavourings
(Text with EEA relevance)
CHAPTER I
GENERAL PRINCIPLES
Article 1
Subject matter and scope
1. This Regulation lays down a common procedure for the assessment and authorisation (hereinafter referred to as the common procedure) of food additives, food enzymes, food flavourings and source materials of food flavourings and of food ingredients with flavouring properties used or intended for use in or on foodstuffs (hereinafter referred to as the substances), which contributes to the free movement of food within the Community and to a high level of protection of human health and to a high level of consumer protection, including the protection of consumer 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 ( 1 ).
2. The common procedure shall lay down the procedural arrangements for updating the lists of substances the marketing of which is authorised in the Community pursuant to Regulation (EC) No 1333/2008 [on food additives], Regulation (EC) No 1332/2008 [on food enzymes] and Regulation (EC) No 1334/2008 [on flavourings and certain food ingredients with flavouring properties for use in and on foods] (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:
adding a substance to the Community list;
removing a substance from the Community list;
adding, removing 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 started 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, in accordance with the conditions provided for by the implementing measures referred to in Article 9(1)(a) (hereinafter referred to as the applicant). Applications shall be sent to the Commission.
2. The Commission shall seek the opinion of the European Food Safety Authority (hereinafter referred to as the Authority), to be given in accordance with Article 5.
However, for the updates referred to in Article 2(2)(b) and (c), the Commission shall not be required to seek the opinion of the Authority if the updates in question are not liable to have an effect on 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, the views of Member States, 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 inform the applicant and the Member States directly, indicating in its letter the reasons for not considering the update justified.
Article 4
Initiating the procedure
1. On receipt of an application to update the Community list, the Commission:
shall acknowledge receipt of the application in writing to the applicant within 14 working days of receiving it;
where applicable, shall as soon as possible notify the Authority of the application and request its opinion in accordance with Article 3(2).
The application shall be made available to the Member States by the Commission.
2. Where it starts the procedure on its own initiative, the Commission shall inform the Member States and, where applicable, request the opinion of the Authority.
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