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)

• CELEX: Implementing Regulation (EU) 2022/202
• Articles: 3

Article 1

The Annex to Implementing Regulation (EU) 2017/2470 is corrected 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 .

Schedules & Appendices

ANNEX

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’