Commission Regulation (EU) No 257/2010 of 25 March 2010 setting up a programme for the re-evaluation of approved food additives in accordance with Regulation (EC) No 1333/2008 of the European Parliament and of the Council on food additives (Text with EEA relevance)

1 This Regulation sets up a programme for the re-evaluation by the European Food Safety Authority (hereinafter referred to as ‘EFSA’) of approved food additives, as provided for in Article 32 of Regulation (EC) No 1333/2008.

2 Approved food additives, for which the re-evaluation by EFSA is already completed at the time of the adoption of this Regulation, shall not be re-evaluated again. Those food additives are listed in Annex I.

For the purposes of this Regulation, the following definitions shall apply: (a) ‘approved food additive’ means a food additive authorised before 20 January 2009 and listed in Directive 94/35/EC of the European Parliament and of the Council of 30 June 1994 on sweeteners for use in foodstuffs , Directive 94/36/EC of the European Parliament and of the Council of 30 June 1994 on colours for use in foodstuffs or in Directive 95/2/EC of the European Parliament and of the Council of 20 February 1995 on food additives other than colours and sweeteners ; (b) ‘business operator’ means any natural or legal person responsible for ensuring that the requirements of Regulation (EC) No 1333/2008 are met within the food business under its control; (c) ‘interested business operator’ means a business operator interested in the continuity of the authorisation of one or more approved food additives; (d) ‘original dossier’ means a dossier on the basis of which the food additive was evaluated and permitted for use in food before 20 January 2009.

1 Approved food additives shall be re-evaluated in the following order and within the following deadlines: (a) the re-evaluation of all approved food colours listed in Directive 94/36/EC shall be completed by 31 December 2015; (b) the re-evaluation of all approved food additives other than colours and sweeteners listed in Directive 95/2/EC shall be completed by 31 December 2018; (c) the re-evaluation of all approved sweeteners listed in Directive 94/35/EC shall be completed by 31 December 2020.

2 For certain food additives within the functional classes referred to in paragraph 1 more specific deadlines are set out in Annex II to this Regulation. Those food additives shall be evaluated first among the other food additives of the same functional class.

3 By way of derogation from paragraphs 1 and 2, EFSA may at any moment start the re-evaluation of a food additive or a group of food additives with priority, on a request from the Commission or on its own initiative, if new scientific evidence emerges that (a) indicates a possible risk for human health or (b) may in any way affect the safety assessment of that food additive or group of food additives.

When re-evaluating an approved food additive, EFSA shall: (a) examine the original opinion and the working documents of the Scientific Committee on Food (‘SCF’) or EFSA; (b) examine, where available, the original dossier; (c) examine the data submitted by the interested business operator(s) and/or any other interested party; (d) examine any data made available by the Commission and Member States; (e) identify any relevant literature published since the last evaluation of each food additive.

1 In order to acquire the data from the interested business operators and/or other interested parties, EFSA shall make open call(s) for data for the food additives under re-evaluation. In specifying the timetable for data submission, EFSA shall allow a reasonable time period after the entry into force of this Regulation, to allow the interested business operator and/or any other interested party to meet this duty.

2 The data referred to in paragraph 1 may comprise among others: (a) study reports from the original dossier as evaluated by the SCF or EFSA or the Joint FAO/WHO Expert Committee on Food Additives (JECFA), (b) information on the data on the safety of the food additive concerned not previously reviewed by the SCF or the JECFA, (c) information on the specifications of the food additives presently in use, including information on particle size and relevant physicochemical characteristics and properties, (d) information on the manufacturing process, (e) information on analytical methods available for determination in food, (f) information on the human exposure to the food additives from food (e.g. consumption pattern and uses, actual use levels and maximum use levels, frequency of consumption and other factors influencing exposure), (g) reaction and fate in food.

1 The interested business operator(s) and any other interested party shall submit the data related to the re-evaluation of a food additive as referred to in Article 5(2), within the period set by EFSA in its call for data. In the submission the interested business operator and the other interested parties shall include the data requested by EFSA by following, to the extent possible, the applicable guidance on submissions for food additive evaluations .

2 Where there are several interested business operators they may, when possible, submit the data collectively.

3 If during the re-evaluation additional information considered to be relevant for the re-evaluation of a particular food additive is needed, EFSA shall request from the interested business operators, and shall invite other interested parties, to submit this information by an open call for data. It shall set a deadline within which that information shall be submitted having considered, where relevant, the interested business operator's and/or other interested parties' view of the time required. In such cases, EFSA shall make the request for the additional information well in advance so that the overall deadlines for the re-evaluation as set out in Article 3(1) and in Annex II are not affected.

4 Information which has not been submitted within the deadline set by EFSA shall not be taken into account in the re-evaluation. However, in exceptional cases, EFSA may decide with the agreement of the Commission to take into account information submitted after the deadline, if that information is significant for the re-evaluation of a food additive.

5 Where the requested information has not been submitted to EFSA within the set deadlines, the food additive may be removed from the Union list in accordance with the procedure laid down in Article 10.3 of Regulation (EC) No 1333/2008 .

In the framework of the re-evaluation of a food additive, the interested business operator(s) or any other interested party shall inform EFSA and the Commission of any information available in relation to any environment risks from the production, use or waste of that food additive.

1 Confidential treatment may be given to information the disclosure of which might significantly harm the competitive position of business operators or other interested parties.

2 Information relating to the following shall not, in any circumstances, be regarded as confidential: (a) the name and address of the interested business operator; (b) the chemical name and a clear description of the substance; (c) information 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) the method(s) of analysis in food.

3 For the purposes of paragraph 1, the interested business operator(s) and the other interested parties shall indicate which of the information provided they wish to be treated as confidential. Verifiable justification shall be given in such cases.

4 On a proposal from EFSA, the Commission shall decide after consulting the interested business operator and/or the other interested parties which information may remain confidential and shall notify the EFSA and the Member States accordingly.

5 The Commission, EFSA and the Member States shall, in accordance with Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents , take the necessary measures to ensure appropriate confidentiality of the information received 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 The implementation of paragraphs 1 to 5 shall not affect the circulation of information between the Commission, EFSA and the Member States.

Every year in December, EFSA shall inform the Commission and the Member States on the progress of the re-evaluation programme.

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