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)
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)
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 ↗
The second paragraph of Article 1 of the Decision 2008/968/EC is corrected as follows:
‘The addition of fungal oil from Mortierella alpina to infant formulae and follow-on formulae shall be limited by its content of arachidonic acid according to the rules specified in Annex I, 5.7 and in Annex II, 4.7 to Directive 2006/141/EC. Its use in formulae for infants shall be in accordance with the provisions of Council Directive 89/398/EEC ( *1 ) on the approximation of the laws of the Member States relating to foodstuffs intended for particular nutritional uses.
ANNEX
(1)
The Annex to Implementing Regulation (EU) 2017/2470 is corrected as follows:
(a)
the entry for ‘Arachidonic acid-rich oil from the fungus Mortierella alpina ’ in Table 1 (Authorised novel foods) is replaced by the following:
Authorised novel food
Conditions under which the novel food may be used
Additional specific labelling requirements
Other requirements
“ Arachidonic acid-rich oil from the fungus Mortierella alpina
Specified food category
Maximum levels
The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Oil from Mortierella alpina’ or ‘Mortierella alpina oil’”
Infant formula and follow-on formula as defined in Regulation (EU) No 609/2013
In accordance with Regulation (EU) No 609/2013
Foods for special medical purposes for infants as defined in Regulation (EU) No 609/2013
In accordance with Regulation (EU) No 609/2013
(b)
the following entry is inserted between the entry for ‘ Calanus finmarchicus oil’ and the entry for ‘Chewing gum base (monomethoxypolyethylene glycol)’ in Table 1 (Authorised novel foods) and Table 2 (Specifications):
—
Table 1:
“ 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 excluding food supplements for infants and young children
In accordance with Directive 2002/46/EC
Food fortified in accordance with Regulation (EC) No 1925/2006
In accordance with Regulation (EU) No 1925/2006
—
Table 2:
“ 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 %
Lead: ≤ 1 mg/kg
Boron: ≤ 10 mg/kg
Cadmium ≤ 0.5 mg/kg
Mercury ≤ 1.0 mg/kg
Arsenic ≤ 1.5 mg/kg
Platinum ≤ 2 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)
Point (2) of the Annex to Implementing Regulation (EU) 2020/484 is corrected as follows:
The entry for ‘Lacto-N-tetraose (‘LNT’) (microbial source)’ in Table 2 (Specifications) is replaced by the following:
“ Lacto- N -tetraose (‘LNT’) (microbial source)
Definition:
Chemical formula: C 26 H 45 NO 21
Chemical name: β-D-Galactopyranosyl-(1→3)-2-acetamido-2-deoxy-β-D-glucopyranosyl-(1→3)-β-D-galactopyranosyl-(1→4)-D-glucopyranose
Molecular mass: 707.63 Da
CAS No 14116-68-8
Description:
Lacto- N -tetraose is a purified, white to off-white amorphous powder or agglomerates that is produced by a microbial process.
Source:
Genetically modified strain of Escherichia coli strain K-12 DH1
Characteristics/Composition:
Appearance: White to off white powder or agglomerates
Sum of lacto- N -tetraose, D-Lactose and lacto- N -triose II (% of dry matter): ≥ 90.0 % (w/w)
Lacto- N -tetraose (% of dry matter): ≥ 70.0 % (w/w)
D-Lactose: ≤ 12.0 % (w/w)
Lacto- N -triose II: ≤ 10.0 % (w/w)
Para -lacto- N -hexaose-2: ≤ 3.5 % (w/w)
Lacto- N -tetraose fructose isomer: ≤ 1.0 % (w/w)
Sum of other carbohydrates: ≤ 5.0 % (w/w)
Moisture: ≤ 6.0 % (w/w)
Ash, sulfated: ≤ 0.5 % (w/w)
pH (20 °C, 5 % solution): 4.0 -6.0
Residual protein: ≤ 0.01 % (w/w)
Microbiological criteria:
Aerobic mesophilic bacteria total plate count: ≤ 1 000 CFU/g
Enterobacteriaceae : ≤ 10 CFU/g
Salmonella spp.: Negative/25 g
Yeast: ≤ 100 CFU/g
Mould: ≤ 100 CFU/g
Residual endotoxins: ≤ 10 EU/mg
CFU
:
Colony Forming Units”
