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) 
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on 
novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing 
Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) 
No 1852/2001 (1), and in particular Article 12 thereof,
Whereas:
(1) Pursuant to Article 8 of Regulation (EU) 2015/2283, the Commission was to establish, by 1 January 2018, the 
Union list of novel foods authorised or notified under Regulation (EC) No 258/97 of the European Parliament and 
of the Council (2).
(2) The Union list of novel foods authorised or notified under Regulation (EC) No 258/97 was established by Commission Implementing Regulation (EU) 2017/2470 (
3).
(3) The Commission has identified errors in the Annex to Implementing Regulation (EU) 2017/2470. Corrections are needed in order to provide clarity and legal certainty to food business operators and to the Member States’ 
competent authorities, thus providing for the proper implementation and use of the Union list of novel foods.
(4) The novel food ‘Arachidonic acid-rich oil from the fungus Mortierella alpina’ was authorised under certain conditions 
of use by Commission Decision 2008/968/EC (
4), by the Dutch competent authority (5), and also pursuant to 
Article 5 of Regulation (EC) No 258/97. The related food category ‘Foods for special medical purposes for 
premature infants as defined in Regulation (EU) No 609/2013’ erroneously refers only to premature infants, 
although the authorisation in the food category concerned should refer to infants without being restricted to 
premature infants. Therefore, it is necessary to correct Article 1 of the Decision 2008/968/EC and the entry ‘Arachidonic acid-rich oil from the fungus Mortierella alpina’ in Table 1 of the Annex to Implementing Regulation 
(EU) 2017/2470.
(1)OJ L 327, 11.12.2015, p. 1.
(2)Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food 
ingredients (OJ L 43, 14.2.1997, p. 1).
(3)Commission Implementing Regulation (EU) 2017/2470 of 20 December 2017 establishing the Union list of novel foods in accordance 
with Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods (OJ L 351, 30.12.2017, p. 72).
(4)Commission Decision 2008/968/EC of 12 December 2008 authorising the placing on the market of arachidonic acid-rich oil from 
Mortierella alpina as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (OJ 
L 344, 20.12.2008, p. 123).
(5)Letter of 19 December 2011 (https://ec.europa.eu/food/system/files/2016-10/novel-food_authorisation_2011_auth-letter_arachidoni c_acid_rich_oil_en.pdf).EN Official Journal of the European Union 10.8.2021                                                                                                                                           L 286/5  (5) 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 (6). 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, processed cereal-based food and baby food by Commission Delegated 
Regulation (EU) 2021/571 (
7).
(6) The novel food ‘Lacto-N-tetraose (‘LNT’) (microbial source)’ was authorised under certain conditions of use by 
Commission Implementing Regulation (EU) 2020/484 (8). In the specifications, the chemical formula of Lacto-N- 
tetraose was erroneously referred to as C 26H45O21 instead of the correct C 26H45NO 21. In the description of Lacto-N- 
tetraose, the wording of ‘or agglomerates’ was erroneously omitted, and the minor ingredient ‘lacto-N-triose II’ is 
erroneously referred to as ‘lacto-N-tetraose II’. Therefore, the specifications of the ‘Lacto-N-tetraose (‘LNT’) 
(microbial source)’ relating to the chemical formula of Lacto-N-tetraose and to lacto-N-tetraose II in Table 2 of the 
Annex to Implementing Regulation (EU) 2020/484 and Implementing Regulation (EU) 2017/2470 should be 
corrected accordingly.
(7) Decision 2008/968/EC and Implementing Regulations (EU) 2017/2470 and (EU) No 2020/484 should be corrected 
accordingly.
(8) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on 
Plants, Animals, Food and Feed,
HAS ADOPTED THIS REGULATION:
Article 1
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 (*) on the approximation of the laws of the Member States relating to foodstuffs intended for particular 
nutritional uses.
_____________
(*) Council Directive 89/398/EEC of 3 May 1989 on the approximation of the laws of the Member States relating to 
foodstuffs intended for particular nutritional uses (OJ L 186, 30.6.1989, p. 27).’
Article 2
The Annex to Implementing Regulation (EU) 2020/484 is corrected in accordance with the Annex to this Regulation.
Article 3
The Annex to Implementing Regulation (EU) 2017/2470 is corrected in accordance with the Annex to this Regulation.
(6)https://doi.org/10.2903/j.efsa.2004.135.
(7)Commission Delegated Regulation (EU) 2021/571 of 20 January 2021 amending the Annex to Regulation (EU) No 609/2013 of the 
European Parliament and of the Council as regards the list of substances that may be added to infant and follow-on formula, baby food 
and processed cereal-based food (OJ L 120, 8.4.2021, p. 1).
(8)Commission Implementing Regulation (EU) 2020/484 of 2 April 2020 authorising the placing on the market of lacto-N-tetraose as a 
novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission 
Implementing Regulation (EU) 2017/2470 (OJ L 103, 3.4.2020, p. 3).EN Official Journal of the European Union L 286/6                                                                                                                                           10.8.2021  Article 4
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, 9 August 2021.
For the Commission
The President
Ursula VON DER LEYENEN Official Journal of the European Union 10.8.2021                                                                                                                                           L 286/7  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 usedAdditional specific labelling 
requirementsOther requirements
“Arachidonic acid-rich oil 
from the fungus Mortierella 
alpinaSpecified 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 609/2013In accordance with Regulation (EU)  
No 609/2013
Foods for special medical purposes for 
infants as defined in Regulation (EU)  
No 609/2013In 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 609/2013In accordance with Regulation (EU)  No 609/2013
Infant formulae and follow-on formula as defined by Regulation (EU)  
No 609/2013In 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 609/2013In accordance with Regulation (EU)  No 609/2013
Food supplements as defined in Directive 2002/46/EC excluding food 
supplements for infants and young 
childrenIn accordance with Directive  2002/46/EC
Food fortified in accordance with 
Regulation (EC) No 1925/2006In accordance with Regulation (EU)  No 1925/2006EN Official Journal of the European Union L 286/8                                                                                                                                           10.8.2021  — 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 20H23CaN 7O6
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/Ca2+).
Molecular weight: 497,5 DaltonsSynonyms: 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 %EN Official Journal of the European Union 10.8.2021                                                                                                                                           L 286/9  Other folates and related substances: ≤ 2.5 %
Ethanol: ≤ 0.5 %Lead: ≤ 1 mg/kgBoron: ≤ 10 mg/kg
Cadmium ≤ 0.5 mg/kg
Mercury ≤ 1.0 mg/kg
Arsenic ≤ 1.5 mg/kgPlatinum ≤ 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
26H45NO 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 agglomeratesSum 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)EN Official Journal of the European Union L 286/10                                                                                                                                         10.8.2021  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 -6.0Residual 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/gResidual endotoxins: ≤ 10 EU/mg
CFU: Colony Forming Units”EN Official Journal of the European Union 10.8.2021                                                                                                                                         L 286/11