
CHAPTER I
Article 1 

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 ... 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.
2. The common procedure shall lay down the procedural arrangements for determining the authorisation status of substances for the purposes of 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 authorised and, where applicable, the transitional provisions concerning ongoing procedures are laid down in each sectoral food law.
Article 2 

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(3. “Authority” means—
(a) as regards  England and Wales, the Food Standards Agency;
(b) as regards Scotland, Food Standards Scotland;
(4. “prescribe”, means prescribe by regulations;
(5. “appropriate authority” means—
(a) in relation to England, the Secretary of State;
(b) in relation to Wales, the Welsh Ministers;
(c) in relation to Scotland, the Scottish Ministers;
(6. “Regulation 234/2011” means Commission Implementing Regulation (EU) No. 234/2011 implementing Regulation (EC) No. 1331/2008 of the European Parliament and of the Council establishing a common authorisation procedure for food additives, food enzymes and food flavourings;
(7. ‘Substance’ includes a flavouring substance under evaluation, within the meaning given in Regulation (EC) No 1334/2008.
Article 2A 
The appropriate authority must determine the authorisation status of substances in accordance with the sectoral food law concerned and this Regulation.
Article 2B 

(1. For the purposes of this Regulation, determining the authorisation status of a substance is to consist of the appropriate authority determining whether or not to:
(a) authorise the placing on the market, or the use in or on food, of a substance;
(b) modify the authorisation of a substance, including modifying any conditions, restrictions or specifications associated with the authorisation concerned;
(c) revoke or suspend the authorisation of a substance.
(2. For the purposes of paragraph 1, a modification, suspension or revocation of an authorisation may specify a period of time, or different periods of time, within which—
(a) existing stocks of the substance concerned, and any products derived from it or containing it, may be placed on the market or used;
(b) the substance concerned, and any products derived from it or containing it, may continue to be produced, placed on the market or used;
(c) the labelling of the substance concerned, and any products derived from it or containing it, may continue to be applied.
(3. The appropriate authority may prescribe other transitional measures not falling within paragraph 2 in relation to the modification, suspension or revocation of an authorisation under the sectoral food law concerned and this Regulation.
(4. In this Article, “authorisation” includes the permission for a substance to be placed on the market or used in or on food under the sectoral food law concerned, and for this purpose includes food enzymes for which an application for initial authorisation has been entered in the Register under Regulation (EC) No 1332/2008 and flavouring substances under evaluation under Regulation (EC) No 1334/2008; and related terms are to be construed accordingly.
Article 2C 

(1. The Authority must establish and maintain a list (the “domestic list”) of substances, the placing on the market, or the use in or on food, of which is permitted in accordance with the sectoral food law concerned and this Regulation.
(2. The Authority must make the domestic list available to the public.
CHAPTER II
Article 3 

1. The common procedure for determining the authorisation status of a substance may be started either on the initiative of the Authority or following an application. Applications may be made ... by an interested party, who may represent several interested parties, in accordance with the conditions provided for by Regulation 234/2011. Applications shall be sent to the appropriate authority.
2. The appropriate authority shall seek the opinion of the Authority, to be given in accordance with Article 5.However, for a determination of the authorisation status of a substance described in Article 2B(1)(b) or (c), the appropriate authority shall not be required to seek the opinion of the Authority if any changes as a result of the determination in question are not liable to have an effect on human health.
3. The common procedure is to end with the appropriate authority determining the authorisation status of the substance concerned, in accordance with Article 7.
4. By way of derogation from paragraph 3, the appropriate authority may end the common procedure and decide not to proceed with determining the authorisation status of a substance, at any stage of the procedure, if it judges that such a determination is not justified. Where applicable, it shall take account of the opinion of the Authority, ..., any relevant provisions of  assimilated  law and any other legitimate factors relevant to the matter under consideration.In such cases, where applicable, the appropriate authority shall inform the applicant ... directly, indicating in its letter the reasons for not determining the authorisation status of the substance concerned.
Article 4 

1. On receipt of an application to determine the authorisation status of a substance, the appropriate authority:
(a) shall acknowledge receipt of the application in writing to the applicant within 14 working days of receiving it;
(b) where applicable, shall as soon as possible notify the Authority of the application and request its opinion in accordance with Article 3(2).
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Article 5 

1. The Authority shall give its opinion within nine months of receipt of a valid application.
2. The Authority shall forward its opinion to the appropriate authority and, where applicable, the applicant.
Article 6 

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 ....
2. If the additional information is not sent to the Authority 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 .... In such cases, the Authority shall give its opinion within the original period without prejudice to Article 10.
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Article 7 

1. Within nine months of receiving the opinion of the Authority, the appropriate authority must determine the authorisation status of the substance concerned, taking into account the opinion of the Authority, any relevant provisions of  assimilated  law and any other legitimate factors relevant to the matter under consideration.In those cases where the Authority has not given an opinion, the nine month period starts from the date the appropriate authority receives a valid application.
(1A. Where the appropriate authority makes a determination as to the authorisation status of a substance:
(a) the appropriate authority must:
(i) specify the date on which the authorisation, modification, suspension or revocation is to have effect; and
(ii) communicate the determination to the Authority;
(b) the Authority must update the domestic list referred to in Article 2C accordingly.
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3. Where the determination is not in accordance with the opinion of the Authority, the appropriate authority must explain the reasons for its determination.
4. The measures, designed to amend non-essential elements of each sectoral food law, relating to the revocation of the authorisation of substances generally, may be prescribed by the appropriate authority after seeking advice from the Authority.
5. On grounds of efficiency, the measures designed to amend non-essential elements of each sectoral food law, inter alia, by supplementing it, relating to the authorisation of substances generally and for modifying conditions, specifications or restrictions associated with the authorisation of substances generally, may be prescribed by the appropriate authority after seeking advice from the Authority.
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Article 8 

1. Where the Authority requests additional information from applicants on matters concerning risk management, it shall determine, together with the applicant, a period within which that information can be provided. In such cases, the period referred to in Article 7 may be extended accordingly. ...
2. If the additional information is not sent within the additional period referred to in paragraph 1, the Authority shall act on the basis of the information already provided.
CHAPTER III
Article 9 

1. ... The implementing measures for this Regulation may be prescribed by the appropriate authority after seeking advice from the Authority, 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.
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Article 10 
In exceptional circumstances, the periods referred to in Article 5(1) and Article 7 may be extended by the Authority on its own initiative ..., if the nature of the matter in question so justifies, without prejudice to Article 6(1) and Article 8(1). In such cases the Authority shall, where appropriate, inform the applicant ... of the extension and the reasons for it.
Article 11 
The Authority must make its opinions public without delay. It shall also make public any request for its opinion as well as any extension of period pursuant to Article 6(1).
Article 12 

1. Among the information provided by applicants, confidential treatment may be given to information the disclosure of which might significantly harm their competitive position.Information relating to the following shall not, in any circumstances, be regarded as confidential:
(a) the name and address of the applicant;
(b) the name and a clear description of the substance;
(c) the justification for the use of the substance in or on specific foodstuffs or food categories;
(d) information that is relevant to the assessment of the safety of the substance;
(e) where applicable, the analysis method(s).
2. For the purposes of implementing paragraph 1, 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 Authority shall decide after consulting with the applicants which information can remain confidential and shall notify applicants ... accordingly.
4. After being made aware of the Authority's position, applicants shall have three weeks in which to withdraw their application so as to preserve the confidentiality of the information provided. Confidentiality shall be preserved until this period expires.
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6. If an applicant withdraws, or has withdrawn, its application, the appropriate authority and the Authority shall not disclose confidential information, including information the confidentiality of which is the subject of disagreement between the Authority and the applicant.
7. The implementation of paragraphs 1 to 6 shall not affect the circulation of information between the appropriate authority and the Authority.
Article 13 
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Article 14 
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Article 14A 

(1. Any power to make regulations under this Regulation—
(a) so far as exercisable by a Minister of the Crown, is exercisable by statutory instrument;
(b) so far as exercisable by the Welsh Ministers, is exercisable by statutory instrument.
(2. Any power to make regulations under this Regulation includes power—
(a) to make different provision in relation to different cases or classes of case (including different provision for different areas or different classes of business);
(b) to provide for such exceptions, limitations and conditions, and to make such supplementary, incidental, consequential or transitional provisions, as the appropriate authority considers necessary or expedient.
(3. 
                      Any statutory instrument or Scottish statutory instrument  containing regulations under this Regulation is subject to annulment in pursuance of a resolution—
(a) in the case of England, of either House of Parliament;
(b) in the case of Wales, of  Senedd Cymru;
(c) in the case of Scotland, of the Scottish Parliament.
(4. In this Regulation, any power—
(a) of the Secretary of State to make regulations is limited to regulations which apply in relation to England only;
(b) of the Welsh Ministers to make regulations is limited to regulations which apply in relation to Wales only;
(c) of the Scottish Ministers to make regulations is limited to regulations which apply in relation to Scotland only.
Article 15 
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CHAPTER IV
Article 16 
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.
...Done at Strasbourg, 16 December 2008.
For the European Parliament
The President
H.-G. PÖTTERING
For the Council
The President
B. LE MAIRE