02008R1331 — EN — 27.03.2021 — 001.001
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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 (OJ L 354 31.12.2008, p. 1) |
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REGULATION (EU) 2019/1381 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 20 June 2019 |
L 231 |
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6.9.2019 |
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
Article 2
Community list of substances
‘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
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.
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
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.
Article 5
Opinion of the Authority
Article 6
Additional information concerning risk assessment
Article 7
Updating the Community list
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.
In those cases where an opinion of the Authority has not been requested, the nine-month period shall start from the date the Commission receives a valid application.
Article 8
Additional information concerning risk management
CHAPTER III
MISCELLANEOUS PROVISIONS
Article 9
Implementing measures
In accordance with the regulatory 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 by the Commission, and shall concern in particular:
the content, drafting and presentation of the application referred to in Article 4(1);
the arrangements for checking the validity of applications;
the type of information that must be included in the opinion of the Authority referred to in Article 5.
Article 10
Extension of time periods
In exceptional circumstances, 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 the Commission shall, where appropriate, inform the applicant and the Member States of the extension and the reasons for it.
Article 11
Transparency
Where the Commission requests the opinion of the Authority in accordance with Article 3(2) of this Regulation, the Authority shall make public without delay the application for authorisation, relevant supporting information and any supplementary information supplied by the applicant, as well as its scientific opinions, in accordance with Articles 38 to 39e of Regulation (EC) No 178/2002. The Authority shall also make public any request for its opinion as well as any extension of period pursuant to Article 6(1) of this Regulation.
Article 12
Confidentiality
In addition to the items of information referred to in Article 39(2) of Regulation (EC) No 178/2002 and pursuant to Article 39(3) thereof, the Authority may also grant confidential treatment with respect to the following items of information, where the disclosure of such information is demonstrated by the applicant to potentially harm its interests to a significant degree:
where applicable, information provided in detailed descriptions of starting substances and starting preparations and on how they are used to manufacture the substance subject to the authorisation, and detailed information on the nature and composition of the materials or products in which the applicant intends to use the substance subject to the authorisation, except for information which is relevant to the assessment of safety;
where applicable, detailed analytical information on the variability and stability of individual production batches of the substance subject to the authorisation, except for information which is relevant to the assessment of safety.
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
Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having 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.
Where reference is made to this paragraph, Article 5a(1) to (4) and (5)(b) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.
The time-limits laid down in Article 5a(3)(c) and (4)(b) and (e) of Decision 1999/468/EC shall be two months, two months and four months respectively.
Article 15
Competent authorities of the Member States
Not later than six months after the entry into force of each sectoral food law, 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 20th 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 20 January 2009.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
( 1 ) OJ L 309, 26.11.2003, p. 1.