Amendments to Regulation (EU) No 257/2010
Article 1
Regulation (EU) No 257/2010 is amended as follows: (1) in Article 4, point (c) is replaced by the following: ‘(c) examine the data submitted by the interested business operator(s) and/or any other interested party in accordance with Articles 5, 6 and 7 of this Regulation;’; (2) the following Articles 7a to 7e are inserted: ‘Article 7a Follow-up of EFSA opinions 1. Where, on the basis of the information referred to in Article 4, EFSA cannot confirm the safety of a food additive, of its uses or levels of use or recommend changes to the specifications, the Commission may take or request EFSA to take further steps, including the organisation of calls for data, in order to complete the safety assessment. 2. Where the data and information requested in accordance with paragraph 1 has not been submitted or where it does not allow to confirm the safety of the food additive, of its uses or levels of use or specifications, the food additive may be removed from the Union list in accordance with the procedure referred to in Article 10(3) of Regulation (EC) No 1333/2008. Article 7b Pre-submission advice Where EFSA is required or requested to deliver an opinion in accordance with this Regulation, the staff of EFSA shall, at the request of interested business operator(s) or any other interested, party provide advice on the rules applicable to, and the content required for the submission of information pursuant to Articles 4 to 7a. Such advice shall be provided in accordance with Article 32a of Regulation (EC) No 178/2002 of the European Parliament and of the Council ( *1 ) , which shall apply mutatis mutandis . Article 7c Notification of studies Interested business operators and other interested parties shall, without delay, notify EFSA of the title and the scope of any study commissioned or carried out by them to support the re-evaluation of an approved food additive in accordance with Articles 4 to 7a of this Regulation, as well as the laboratory or testing facility carrying out that study, and its starting and planned completion dates. Laboratories and other testing facilities located in the Union shall also, without delay, notify the Authority of the title and the scope of any study commissioned by business operators and other interested parties, carried out by such laboratories or other testing facilities to support the re-evaluation of an approved food additive in accordance with Articles 4 to 7a of this Regulation, its starting and planned completion dates, as well as the name of the business operators or interested parties who commissioned such a study. Studies notified in accordance with this article shall be included by EFSA in the database referred to in Article 32b(1) of Regulation (EC) No 178/2002. Article 7d Format of submissions Prior to the adoption of standard data formats pursuant to Article 39f of Regulation (EC) No 178/2002, data submitted in accordance with this Regulation shall be submitted in an electronic format allowing for the downloading, printing and searching of documents. After the adoption of standard data formats pursuant to Article 39f of Regulation (EC) No 178/2002, data shall be submitted in accordance with those standard data formats. Article 7e Transparency Where EFSA is required or requested to deliver an opinion in accordance with this Regulation, it shall consult stakeholders and the public on the basis of the non-confidential version of the data submitted pursuant to this Regulation, in accordance with Article 32c(2), of Regulation (EC) No 178/2002, which shall apply mutatis mutandis . ( *1 ) Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety ( OJ L 31, 1.2.2002, p. 1 ).’;" (3) Article 8 is replaced by the following: ‘Article 8 Confidentiality Upon submission of data in accordance with this Regulation, the interested business operator or other interested party may submit a request to treat certain parts of the information or data as confidential. Such request shall be accompanied by verifiable justification. Such confidentiality requests shall be assessed in accordance with Article 12 of Regulation (EC) No 1331/2008, which shall apply mutatis mutandis .’