Implementing regulation 2021/148 - Amendment of Regulation (EU) No 257/2010 setting up a programme for the re-evaluation of approved food additives in accordance with Regulation 1333/2008 on food additives

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1.

Current status

This implementing regulation has been published on February  9, 2021 and entered into force on March  1, 2021.

2.

Key information

official title

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
 
Legal instrument Implementing regulation
Number legal act Implementing regulation 2021/148
Regdoc number C(2021)562
CELEX number i 32021R0148

3.

Key dates

Document 08-02-2021; Date of adoption
Publication in Official Journal 09-02-2021; OJ L 44 p. 3-6
Effect 01-03-2021; Entry into force Date pub. +20 See Art 2
27-03-2021; Application See Art 2
End of validity 31-12-9999

4.

Legislative text

9.2.2021   

EN

Official Journal of the European Union

L 44/3

 

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)

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 additives (1), and in particular Article 32 thereof,

After consulting the European Food Safety Authority,

Whereas:

 

(1)

Commission Regulation (EU) No 257/2010 (2) 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 Council (3) amended Regulation (EC) No 178/2002 (4) and Regulation (EC) No 1331/2008 (5). 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...


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This text has been adopted from EUR-Lex.

 

5.

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