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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)

Implementing Regulation (EU) 2022/202 · Regulation · 3 articles

Data as of 2026-07-04 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗

Article 1

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The Annex to Implementing Regulation (EU) 2017/2470 is corrected in accordance with the Annex to this Regulation.

Article 2

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

Supplementary provisions

ANNEXSupplementary provisions

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ANNEX The Annex to Implementing Regulation (EU) 2017/2470 is corrected as follows: (1) the entry for ‘Calcium L-Methylfolate’ is replaced by the following: (a) in Table 1 (Authorised novel foods): Authorised novel food Conditions under which the novel food may be used Additional specific labelling requirements Other requirements ‘ Calcium L-Methylfolate Specified food category Maximum levels (expressed as folic acid) The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Calcium L-Methylfolate’.’ Foods for special medical purposes and total diet replacement for weight control as defined in Regulation (EU) No 609/2013 In accordance with Regulation (EU) No 609/2013 Infant formulae and follow-on formula as defined by Regulation (EU) No 609/2013 In accordance with Regulation (EU) No 609/2013 Processed cereal-based foods and baby foods for infants and young children as defined by Regulation (EU) No 609/2013 In accordance with Regulation (EU) No 609/2013 Food supplements as defined in Directive 2002/46/EC In accordance with Directive 2002/46/EC Food fortified in accordance with Regulation (EC) No 1925/2006 In accordance with Regulation (EC) No 1925/2006 and (b) in Table 2 (Specifications): Authorised Novel Food Specifications ‘ Calcium L-Methylfolate Description: The novel food is produced by chemical synthesis starting from folic acid. It is a white to light yellowish, almost odourless, crystalline powder, sparingly soluble in water and very slightly soluble or insoluble in most organic solvents. Definition: Chemical formula: C 20 H 23 CaN 7 O 6 Systematic name: N-{4-[[((6S)-2-amino-1,4,5,6,7,8-hexahydro-5-methyl-4-oxo-6-pteridinyl)methyl]amino]benzoyl}-L-glutamic acid, calcium salt. CAS Numbers: 129025-21-4 (Calcium salt with an unspecified ratio of L-5-MTHF/Ca 2+ ) and 151533-22-1 (Calcium salt with specified 1:1 ratio of L-5-MTHF/Ca 2+ ). Molecular weight: 497,5 Daltons Synonyms: L-methylfolate, calcium; L-5-methyltetrahydrofolic acid, calcium salt [(L-5-MTHF-Ca)]; (6S)-5-methyltetrahydrofolic acid, calcium salt [(6S)-5-MTHF-Ca]; (6S)-5-methyl-5,6,7,8-tetrahydropteroyl-L-glutamic acid, calcium salt, and L-5-methyl-tetrahydrofolic acid (L-5-MTHF) without the cation specified. Structural formula: Characteristics Purity: > 95 % (Dry basis) Water: ≤ 17,0 % Calcium (on anhydrous and solvent free basis): 7,0 – 8,5 % Calcium D-methylfolate (6R, αS isomer): ≤ 1,0 % Other folates and related substances: ≤ 2,5 % Ethanol: ≤ 0,5 % Contaminants Infants and young children General population excluding infants and young children Lead: ≤ 1 mg/kg Lead: ≤ 1 mg/kg Boron: ≤ 10 mg/kg Boron: ≤ 10 mg/kg Cadmium ≤ 0,5 mg/kg Cadmium ≤ 0,5 mg/kg Mercury ≤ 1,0 mg/kg Mercury ≤ 1,5 mg/kg Arsenic ≤ 1,5 mg/kg Arsenic ≤ 1,5 mg/kg Platinum ≤ 2 mg/kg Platinum ≤ 10 mg/kg Microbiological criteria: Total viable aerobic counts: ≤ 1 000 CFU/g Total yeast and mould count: ≤ 100 CFU/g CFU: Colony Forming Units’ (2) the entry for ‘ Cistus incanus L. Pandalis herb’ in Table 2 (Specifications) is replaced by the following: Authorised Novel Food Specifications ‘ Cistus incanus L. Pandalis herb’ Description: Cistus incanus L. Pandalis herb; species belonging to the Cistaceae family and native to the Mediterranean region, Chalkidiki Peninsula. The novel food consists of the dried and cut aerial parts (young shoots with woody parts) of Cistus incanus L. Pandalis’

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