Foodlaw-Reading
Dr David Jukes, The University of Reading, UK
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Commission consultation, 5 October 2020
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Consultation document: COMMISSION IMPLEMENTING REGULATION (EU) …/... of XXX 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 A copy of the draft regulation is available on this site (click on image). For more details, see the Commission's Consultation Page. |
The consultation is open from 5th October to 7th November 2020. The following are the recitals from the draft Regulation:
Commission Regulation (EU) No 257/2010 [see Note 1 below] 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.
Regulation (EU) 2019/1381 of the European Parliament and the Council [see Note 3 below] amended Regulation (EC) No 178/2002 of the European Parliament and of the Council [see Note 4 below] and Regulation (EC) No 1331/2008 of the European Parliament and of the Council [see Note 5 below]. 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.
The amendments to Regulation (EC) 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.
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.
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.
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.
As regards the obligation to notify relevant studies, some adaptations to the re-evaluation of the procedure are, however, required. On the one hand, 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 resubmitted applications. However, delays in the re-evaluation of already approved food additives mean that they may remain on the market longer than they would otherwise. It is therefore appropriate that, when providing for the obligation to notify studies relevant for the re-evaluation, specific procedural consequences are set out in order to avoid unnecessary delays in the procedure. On the other hand, given that EFSA is responsible for managing the database of studies provided in Article 32b of Regulation (EC) No 178/2002, it is appropriate that it verifies whether the obligation to notify studies has been complied with and, depending on whether it is required or requested to deliver and opinion or not, it takes a decision in this regard itself or informs the Commission of its views.
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, along the consultation 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.
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 call 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 either. 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.
The objectives of Regulation (EU) 2019/1381 could not be attained within the framework of the procedure of revaluation of food additives if the setting up by Regulation (EU) No 257/2010 of the revaluation 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.
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed.
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