Commission Implementing Regulation (EU) 2021/148 of 8 February 2021 amending Regulation (EU) No 257/2010 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)
Commission Implementing Regulation (EU) 2021/148of 8 February 2021amending Regulation (EU) No 257/2010 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)THE EUROPEAN COMMISSION,Having regard to the Treaty on the Functioning of the European Union,Having regard to Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additivesOJ L 354, 31.12.2008, p. 16., and in particular Article 32 thereof,After consulting the European Food Safety Authority,Whereas:(1)Commission Regulation (EU) No 257/2010Commission 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 (OJ L 80, 26.3.2010, p. 19). sets up a programme for the re-evaluation by the European Food Safety Authority ("EFSA") of the safety of food additives that were already permitted in the Union before 20 January 2009.(2)Regulation (EU) 2019/1381 of the European Parliament and the CouncilRegulation (EU) 2019/1381 of the European Parliament and of the Council of 20 June 2019 on the transparency and the sustainability of the EU risk assessment in the food chain and amending Regulations (EC) No 178/2002, (EC) No 1829/2003, (EC) No 1831/2003, (EC) No 2065/2003, (EC) No 1935/2004, (EC) No 1331/2008, (EC) No 1107/2009, (EU) 2015/2283 and Directive 2001/18/EC (OJ L 231, 6.9.2019, p. 1). amended Regulation (EC) No 178/2002Regulation (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). and Regulation (EC) No 1331/2008Regulation (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).. Those amendments are aimed at strengthening the transparency and the sustainability of the EU risk assessment in all areas of the food chain where EFSA delivers a scientific risk assessment.(3)The amendments to Regulation (EC) No 178/2002 introduced new provisions concerning, amongst other issues: general pre-submission advice by the staff of EFSA at the request of a potential applicant and the obligation to notify studies commissioned or carried out by business operators to support an application or notification and the consequences in case of non-compliance with that obligation. It also introduced provisions on the public disclosure, by EFSA, of all scientific data, studies and other information supporting applications, with the exception of confidential information, early on in the risk assessment process, followed up by a consultation of third parties. The amendments also set out specific procedural requirements for the submission of confidentiality requests and the assessment thereof by EFSA in relation to the information submitted by an applicant, where the Commission requests the opinion of EFSA.(4)Regulation (EU) 2019/1381 also amended Regulation (EC) No 1331/2008 to include provisions ensuring consistency with the adaptations of Regulation (EC) No 178/2002 and taking into account sectoral specificities with respect to confidential information.(5)Regulation (EU) 2019/1381 does not contain provisions concerning the procedure for re-evaluation of food additives set out by Regulation (EU) No 257/2010. Indeed, while Regulation (EU) 2019/1381 sets out rules concerning applications and notifications, Regulation (EU) No 257/2010 gives an important role not only to business operators interested in the continuity of the approval of a food additives but also to other interested parties such as industry or consumer organisations. Therefore, the re-evaluation of a food additive does not require the submission of an application by a designated applicant and all interested business operators and other interested parties may submit data and information to that end.(6)It nevertheless appears appropriate to provide for levels of transparency and confidentiality in the context of this procedure that are comparable to those applicable in the context of the procedure for updating the Union list of approved food additives, while taking into account of the specificities of the re-evaluation procedure. In particular, it is appropriate to provide that certain rules applicable to the procedure for updating of the Union list of approved food additives also apply in the framework of the re-evaluation procedure but concern all interested business operators and other interested parties. This is the case of the possibility, provided for in Article 32a of Regulation (EC) No 178/2002, to request from the staff of EFSA a pre-submission advice whenever EFSA will be required or requested to provide an opinion, the obligation set out in Article 32b of the same Regulation to notify to EFSA relevant studies, the obligations as regards the form of the submissions set out in Article 39f of Regulation (EC) No 178/2002 and the confidentiality rules provided for in Article 39 of Regulation (EC) No 178/2002 and in Article 12 of Regulation (EC) No 1331/2008.(7)As regards the obligation to notify relevant studies, a further adaptation to the procedure is, however, required. The procedural consequences provided for by Article 32b of the Regulation (EC) No 178/2002 in case of non-compliance with its provisions result in delays in the assessment of the re-submitted applications. However, given that delays in the re-evaluation of already approved food additives mean that they may remain on the market longer than they would otherwise, those procedural consequences are not appropriate in the context of the re-evaluation procedure additives and should not be provided for.(8)Furthermore, while Article 38(1) of Regulation (EC) No 178/2002 already provides for the publication of the information and data submitted for the re-evaluation of food additives by EFSA, in order to increase the transparency and the effectiveness of the re-evaluation procedure, it is appropriate to provide for a consultation of third parties, like the one provided for Article 32c of Regulation (EC) No 178/2002, in order to identify whether other relevant scientific data or studies are available on the food additive being re-evaluated.(9)The re-evaluation of food additives should allow EFSA to conclude on the safety of the concerned food additives, their uses, levels of use and specifications. Experience has shown that the data obtained from the calls for data carried out by EFSA is not always sufficient to allow EFSA to confirm the safety of specific food additives, their uses, levels of use and specifications without however identifying major safety concerns. Given that the aim of the re-evaluation programme is to ensure that the safety of food additives can be fully re-evaluated before a decision to maintain or remove them from the Union list is taken, it is appropriate to clarify that further steps, such as further calls for data, may be taken as a follow up to an opinion of EFSA in order to complete the re-evaluation of the concerned food additive. Such further steps should however not extend the re-evaluation procedure beyond what is appropriate to allow drawing conclusions on the safety of the concerned food additives, their uses, levels of use and specifications. Therefore, it is also appropriate to clarify that, where information is not submitted in reply to those steps or where the information submitted is insufficient, the Commission may close the re-evaluation procedure and take a risk management decision based on the existing EFSA opinion. Since those requests made as a follow up to the first opinion of EFSA are part of the re-evaluation procedure, the same rules should apply as regards the procedure and its transparency and confidentiality.(10)The objectives of Regulation (EU) 2019/1381 could not be attained within the framework of the procedure of re-evaluation of food additives if the setting up by Regulation (EU) No 257/2010 of the re-evaluation programme was considered as the request for a scientific output, the date of which determines the applicable transparency and confidentiality rules. Therefore, in order to ensure the effectiveness of Regulation (EU) 2019/1381, this Regulation should apply from the date of application of that Regulation and to data and information submitted in relation to re-evaluation procedures effectively launched by EFSA after that date and to steps taken after that date as follow-up of EFSA opinions, such as calls for data launched after that date.(11)The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,HAS ADOPTED THIS REGULATION: