Delegated regulation 2021/571 - Amendment of the Annex to Regulation 609/2013 as regards the list of substances that may be added to infant and follow-on formula, baby food and processed cereal-based food - Main contents
Please note
This page contains a limited version of this dossier in the EU Monitor.
Contents
official title
Commission Delegated Regulation (EU) 2021/571 of 20 January 2021 amending the Annex to Regulation (EU) No 609/2013 of the European Parliament and of the Council as regards the list of substances that may be added to infant and follow-on formula, baby food and processed cereal-based food| Legal instrument | delegated regulation |
|---|---|
| Number legal act | Delegated regulation 2021/571 |
| Regdoc number | C(2021)192 |
| CELEX number i | 32021R0571 |
| Document | 20-01-2021; Date of adoption |
|---|---|
| Publication in Official Journal | 08-04-2021; OJ L 120 p. 1-3 |
| Effect | 28-04-2021; Entry into force Date pub. +20 See Art 2 |
| End of validity | 31-12-9999 |
8.4.2021 |
EN |
Official Journal of the European Union |
L 120/1 |
COMMISSION DELEGATED REGULATION (EU) 2021/571
of 20 January 2021
amending the Annex to Regulation (EU) No 609/2013 of the European Parliament and of the Council as regards the list of substances that may be added to infant and follow-on formula, baby food and processed cereal-based food
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) No 609/2013 of the European Parliament and of the Council of 12 June 2013 on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control and repealing Council Directive 92/52/EEC, Commission Directives 96/8/EC, 1999/21/EC, 2006/125/EC and 2006/141/EC, Directive 2009/39/EC of the European Parliament and of the Council and Commission Regulations (EC) No 41/2009 and (EC) No 953/2009 (1), and in particular Article 16 thereof,
Whereas:
(1) |
The Annex to Regulation (EU) No 609/2013 establishes a Union list of substances that may be added to one or more of the categories of food referred to in Article 1(1) of that Regulation. |
(2) |
The Annex to Regulation (EU) No 609/2013 currently authorises the addition of calcium L-methylfolate as a source of folate to food for special medical purposes and to total diet replacement for weight control. |
(3) |
Following an application requesting that the use of calcium L-methylfolate as a source of folate is authorised also in infant formula, follow-on formula, processed cereal-based food and baby food, at the levels necessary to meet the compositional requirements for folate set out by the Union legislation for those foodstuffs, the Commission requested the European Food Safety Authority (‘the Authority’) to provide an opinion on the safety and bioavailability of that substance when added to the concerned foodstuffs. In its opinion of 27 November 2019 (2), the Authority concluded that calcium L-methylfolate is a source from which folate is bioavailable and that it is safe under the proposed uses and use levels for the target population that is infants (< 12 months) and young children (12-< 36 months). |
(4) |
The Commission considers that the Authority’s opinion gives sufficient grounds to establish that calcium L-methylfolate is not of a safety concern as a source of folate when used in infant formula, follow-on formula, processed cereal-based food and baby food at the required levels. Therefore, calcium L-methylfolate should be included in the list set out in Annex to Regulation (EU) No 609/2013, as a source of folate in those categories of foods. |
(5) |
Regulation (EU) No 609/2013 should therefore be amended accordingly. |
HAS ADOPTED THIS REGULATION:
Article 1
The Annex to Regulation (EU) No 609/2013 is amended in accordance with the Annex to this Regulation.
Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 20 January 2021.
For the Commission
The President
Ursula VON DER LEYEN
-
EFSA NDA Panel, Scientific Opinion on Calcium l-methylfolate as a source of folate added for nutritional purposes to infant and follow-on formula, baby food and processed cereal-based food, EFSA Journal, doi: 10.2903/j.efsa.2020.5947.
ANNEX
The Annex to Regulation (EU) No 609/2013 is amended as follows:
(a) |
in substance ‘Folate’, the entry ‘calcium-L-methylfolate’ is replaced by the following:
|
More
This text has been adopted from EUR-Lex.
This dossier is compiled each night drawing from aforementioned sources through automated processes. We have invested a great deal in optimising the programming underlying these processes. However, we cannot guarantee the sources we draw our information from nor the resulting dossier are without fault.
This page is also available in a full version containing the legal context, de Europese rechtsgrond, other dossiers related to the dossier at hand and the related cases of the European Court of Justice.
The full version is available for registered users of the EU Monitor by ANP and PDC Informatie Architectuur.
The EU Monitor enables its users to keep track of the European process of lawmaking, focusing on the relevant dossiers. It automatically signals developments in your chosen topics of interest. Apologies to unregistered users, we can no longer add new users.This service will discontinue in the near future.