(1)

Regulation (EC) No 1925/2006 harmonises the national rules in Member States on the addition of vitamins and minerals and of certain other substances to foods.

(2)

Commission Implementing Regulation (EU) No 307/2012 (2) lays down, in particular, implementing rules for the application of the procedure referred to in Article 8(4) and (5) of Regulation (EC) No 1925/2006 concerning the safety assessment by the European Food Safety Authority (‘the Authority’) of the substances under scrutiny listed in Part C of Annex III thereto.

(3)

Regulation (EU) 2019/1381 of the European Parliament and the Council (3) amended Regulation (EC) No 178/2002 of the European Parliament and of the Council (4). Those amendments are aimed at strengthening the transparency and the sustainability of the EU risk assessment in all areas of the food chain where the Authority delivers a scientific risk assessment.

(4)

The amendments to Regulation (EC) No 178/2002 introduced new provisions concerning, amongst others, general pre-submission advice by the staff of the Authority at the request of a potential applicant and the obligation to notify studies commissioned or carried out by business operators to support an application and the consequences in case of non-compliance with that obligation. The amendments also introduced provisions on the public disclosure, by the Authority, of all scientific data, studies and other information supporting applications, with the exception of duly justified confidential information, early on in the risk assessment process, followed up by a consultation of third parties.

(5)

Although Regulation (EU) 2019/1381 does not contain any provisions concerning the risk assessment of substances or ingredients, which had been listed to Annex III to Regulation (EC) No 1925/2006, its provisions are of direct relevance to that procedure, as outlined in Article 8(4) and (5) of Regulation (EC) No 1925/2006. These provisions concern the pre-submission phase, as regards pre-submission advice and the notification of commissioned studies, as well as the risk assessment phase, as regards transparency and confidentiality requirements and public consultations. They govern mainly application-based processes initiated by food business operators.

(6)

Regulation (EC) No 1925/2006 gives an important role in demonstrating the safety of a particular substance under scrutiny listed in Part C of Annex III thereto not only to food business operators, but also to other interested parties, such as industry or consumer organisations. Therefore, the evaluation of a substance under scrutiny does not require the submission of an application by a designated applicant, but all interested business operators and other interested parties may submit data and information to that end.

(7)

It is necessary to ensure that the procedure for the safety assessment of the substance under scrutiny listed in Part C of Annex III to Regulation (EC) No 1925/2006 is governed by provisions comparable to those in Regulation (EU) 2019/1381 both for the pre-submission and the risk assessment phases.

(8)

In view of the above, Implementing Regulation (EU) No 307/2012 should be aligned with the amendments to Regulation (EC) No 178/2002 introduced by Regulation (EU) 2019/1381, in particular as regards (i) the possibility, provided for in Article 32a, to request pre-submission advice from the staff of the Authority, whenever the Authority is required or requested to provide an opinion; (ii) the obligation, set out in Article 32b, to notify relevant studies to the Authority; (iii) the obligation of the Authority to consult third parties set out in Article 32c, (iv) the obligations as regards the form of the submissions set out in Article 39f, and (v) the confidentiality rules provided for in Article 39.

(9)

The provision by the Authority, upon request, of pre-submission advice on the rules applicable to, and the content required for the submission of the files demonstrating the safety of a substance under scrutiny, listed in Part C of Annex III to Regulation (EC) No 1925/2006, can improve the quality of the submissions, and thus provide support to the safety assessment. However, food business operators and any other interested parties may not be able to make full use of the pre-submission advice due to the deadline for the submission of their files. In the interest of the improved quality of the scientific assessment, food business operators and other interested parties should be able to request pre-submission advice for a potential submission from the day of the adoption of an opinion by the Authority under Article 8(2)(b) of Regulation (EC) No 1925/2006, which identifies the possibility of harmful effects on health associated with the intake of a substance, but acknowledges that scientific uncertainty persists.

(10)

The studies required to prove the safety of a substance under scrutiny, listed in Part C to Annex III to Regulation (EC) No 1925/2006, take in account a number of factors and therefore may vary significantly. Extending the period for food business operators or interested parties to submit files from 18 to 24 months from the date on which a substance has been listed in Part C of Annex III to Regulation (EC) No 1925/2006 can facilitate the preparation and submission of files, and therefore provide support to the safety assessment.

(11)

The obligation to notify relevant studies set out in Article 32b of Regulation (EC) No 178/2002 should apply also to food business operators or interested parties who intend to submit for evaluation the file as defined in Article 2 of Implementing Regulation (EU) No 307/2012. A further adaptation to the procedure of Article 32b of Regulation (EC) No 178/2002 is however, required. The procedural consequences provided for by Article 32b of Regulation (EC) No 178/2002 in case of non-compliance with its provisions result in delays in the assessment of the file. However, given the imperative time limit of 4 years prescribed by Article 8(5) of Regulation (EC) No 1925/2006 delays in the evaluation could mean that the prescribed time limit would not be respected. Therefore, those procedural consequences are not appropriate in the context of the evaluation procedure for substances placed in part C of Annex III to Regulation (EC) No 1925/2006 and should not be provided for. In order to allow the Commission to take a decision concerning a substance under scrutiny listed in Part C of Annex III to Regulation (EC) No 1925/2006 within the required deadline, only files submitted within 24 months from the date on which a substance has been listed in that Annex should be taken into consideration.

(12)

Regulation (EU) 2019/1381 shall apply from 27 March 2021. Therefore, in order to ensure legal certainty and clarity with regard to transparency requirements for procedure under Article 8(4) of Regulation (EC) No 1925/2006 and to allow for uniform implementation of the transparency and confidentiality requirements for the EU risk assessment for all concerned sectors, it is necessary that this Regulation enters into force on the third day following that of its publication. For the reasons of legal certainty this Regulation should apply to the files submitted to the Authority from that date onwards.

(13)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

(1)

Article 5 is replaced by the following:

(2)

the following Articles are inserted: