On February 14, 2022, the European Commission issued Regulation (EU) 2022/202, correcting Implementing Regulation (EU) 2017/2470 establishing the Union list of novel foods.

Commission Implementing Regulation (EU) 2021/1318 (4) corrected the Union list of authorised novel foods to include the novel food ‘Calcium L-Methylfolate’ which, although authorised in January 2008 by the Irish competent authority under certain conditions of use in accordance with Regulation (EC) No 258/97, was erroneously not included in the Union list when the initial list was established. The conditions of use of ‘Calcium L-Methylfolate’ in food supplements as defined in Directive 2002/46/EC of the European Parliament and of the Council (5), that were included in the Union list, erroneously excluded infants and young children from the targeted users’ group, whereas the original authorisation did authorise that use. Therefore, a correction of the entry ‘Calcium L-Methylfolate’ in Table 1 of the Annex to Implementing Regulation (EU) 2017/2470 is necessary.

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 (6). 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 food by the European Food Safety Authority (7). It is therefore necessary to correct Table 2 of the Annex to Implementing Regulation (EU) 2017/2470 accordingly.

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.