Address https://gelex.eu/eli/EU/regulation/2021/571@2021-01-20/en

Contents

1. Preamble
2. 1. Article 1
   2. Article 2
3. ANNEX
4. ANNEX

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, 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, 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

ANNEX

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: calcium-L- methylfolate X X X X

Versions

1. 2021-01-20

Cited by

• Commission Implementing Regulation (EU) 2022/202 of 14 February 2022 correcting Implementing Regulation (EU) 2017/2470 establishing the Union list of novel foods (Text with EEA relevance) Regulation · Grade B

  The specification limits for mercury (≤ 1,0 mg/kg) and platinum (≤ 2 mg/kg) for Calcium L-Methylfolate laid down in Implementing Regulation (EU) 2021/1318 refer to the limits in the specifications of this novel food authorised as a source of folate in infant formula, follow-on formula, processed cereal-based food and baby food by Commission Delegated Regulation (EU) 2021/571. However, the specification limits of ≤ 1,5 mg/kg for mercury and ≤ 10 mg/kg for platinum were also originally authorised by the Irish competent authority in 2008, based on a favourable opinion on the safety of the novel f

• Commission Implementing Regulation (EU) 2021/1318 of 9 August 2021 correcting Implementing Regulation (EU) 2017/2470 establishing the Union list of novel foods, Decision 2008/968/EC authorising the placing on the market of arachidonic acid-rich oil from Mortierella alpina as a novel food ingredient and Implementing Regulation (EU) 2020/484 authorising the placing on the market of lacto-N-tetraose as a novel food (Text with EEA relevance) Regulation · Grade B

  The novel food Calcium L-Methylfolate was authorised under certain conditions of use by the Irish competent authority in January 2008 under the provisions of Regulation (EC) No 258/97, on the basis of a favourable opinion on the safety of the novel food by the European Food Safety Authority. The novel food was erroneously not included in the initial Union list. It is therefore appropriate that Calcium L-Methylfolate is added to the Union list of authorised novel foods, taking also into account that Calcium L-Methylfolate was authorised as a source of folate in infant formula, follow-on formula