This article collects EU’s amendments to Commission Implementing Regulation (EU) 2017/2470 Establishing the Union List of Novel Foods in 2024. Please note that only the applicant can place corresponding novel food on the market, with a protection period of 5 years, unless a subsequent applicant obtains an authorization for that novel food without reference to the protected scientific data or with the agreement of the initial applicant.
October 18: Involving magnesium L-threonate
Magnesium L-threonate is authorized as a novel food to be used in food supplements for adults, excluding pregnant and lactating women. Specification for this novel food is provided as well.
Read more at Commission Implementing Regulation (EU) 2024/2694.
October 17: Involving vitamin D2 mushroom powder
Specification of vitamin D2 mushroom powder is revised.
Read more at Commission Implementing Regulation (EU) 2024/2682.
July 31: Involving Schizochytrium limacinum (TKD-1) oil; Schizochytrium sp. (CABIO-A-2) oil; Ashitaba stem juice; Schizochytrium sp. oil rich in DHA and EPA; 2'-FL and 2'-FL (microbial source)
Here are the amendments issued on July 31:
July 30: Involving 2'-Fucosyllactose (2'-FL); Yarrowia lipolytica yeast biomass; Partially hydrolysed protein from spent barley (Hordeum vulgare) and rice (Oryza sativa); Protein extract from pig kidneys; LNFP-I and 2'-FL mixture; as well as a traditional food from a third country
Here are the amendments issued on July 30:
June 7: Authorization of isomaltulose powder in food
Commission Implementing Regulation (EU) 2024/1611: The novel food “isomaltulose powder” has received authorization for use in all foods, excluding foods and drinks intended specifically for infants and young children. This Regulation specifies the novel food's specifications, conditions for use and labeling requirements.
The followings are the labeling requirements:
1. The designation of the novel food on the labelling of the foodstuffs containing it shall be “isomaltulose powder”.
2. The designation of the novel food on the labelling shall be accompanied by indication that the “Isomaltulose is a source of glucose and fructose”.
April 10: Authorization of calcidiol monohydrate in food supplement
Commission Implementing Regulation (EU) 2024/1052: The novel food “calcidiol monohydrate” has received authorization for use in food supplement. This Regulation specifies the novel food's specifications, conditions for use, labeling requirements, and data protection. The following are the requirements of the use conditions.
Specified food categories where the novel food may be used | Maximum levels |
Food supplements as defined in Directive 2002/46/EC, excluding food supplements for infants and young children | - 10 μg/day for children from 11 years of age and adults - 5 μg/day for children from 3 to 10 years of age |
April 10: Authorization of protein concentrate from Lemna gibba and Lemna minor in cereal bar, food supplement, etc.
Commission Implementing Regulation (EU) 2024/1048: The novel food “protein concentrate from Lemna gibba and Lemna minor” has received authorization for use in food supplement, cereal bar, etc. This Regulation specifies the novel food's specifications, conditions for use, labeling requirements, and data protection. The following are the requirements of the use conditions.
Specified food categories where the novel food may be used | Maximum levels |
Cereal bars | 10 g/100 g |
Prepacked bread and rolls | 1.7 g/100 g |
Powdered drink mixes | 20 g/100 g |
Noodles | 6 g/100 g |
Food supplements as defined in Directive 2002/46/EC for the adult population | 1 g/day |
April 10: Authorization of 3′-Sialyllactose sodium salt produced using a derivative strain of Escherichia coli W (ATCC 9637) in certain milk products, baby food, food supplement, etc.
Commission Implementing Regulation (EU) 2024/1047: The novel food “3′-Sialyllactose sodium salt produced using a derivative strain of Escherichia coli W (ATCC 9637)” has received authorization for use in food supplement, milk products, etc. This Regulation specifies the novel food's specifications, conditions for use, labeling requirements, and data protection. The following are the requirements of the use conditions.
Specified food categories where the novel food may be used | Maximum levels |
Unflavoured pasteurised and unflavoured sterilised (including UHT) milk products | 0.25 g/L |
Unflavoured fermented milk-based products | - 0.25 g/L (beverages) - 0.5 g/kg (products other than beverages) |
Flavoured fermented milk-based products including heat-treated products | - 0.25 g/L (beverages) - 2.5 g/kg (products other than beverages) |
Beverages (flavoured drinks, excluding drinks with a pH less than 5) | 0.25 g/L |
Cereal bars | 2.5 g/kg |
Infant formula as defined under Regulation (EU) No 609/2013 | 0.2 g/L in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer |
Follow-on formula as defined under Regulation (EU) No 609/2013 | 0.15 g/L in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer |
Processed cereal-based food and baby food for infants and young children as defined under Regulation (EU) No 609/2013 | - 0.15 g/L (beverages) in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer - 1.25 g/kg for products other than beverages |
Milk based drinks and similar products | 0.15 g/L (beverages) in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer |
Total diet replacement foods for weight control as defined under Regulation (EU) No 609/2013 | - 0.5 g/L (beverages) - 5.0 g/kg (products other than beverages) |
Food for special medical purposes as defined under Regulation (EU) No 609/2013 | In accordance with the particular nutritional requirements of the persons for whom the products are intended |
Food supplements as defined in Directive 2002/46/EC, excluding food supplements for infants and young children | 1.0 g/day |
April 10: Authorization of beta-glucan from Euglena gracilis microalgae in food supplement, cereal bar, etc.
Commission Implementing Regulation (EU) 2024/1046: The novel food “beta-glucan from Euglena gracilis microalgae” has received authorization for use in food supplement, cereal bar and total diet replacement for weight control. This Regulation specifies the novel food's specifications, conditions for use, labeling requirements, and data protection. The following are the requirements of the use conditions.
Specified food categories where the novel food may be used | Maximum levels |
Cereal bars | 670 mg/100 g |
Total diet replacement for weight control as defined in Regulation (EU) No 609/2013 | 600 mg/day |
Food supplements as defined in Directive 2002/46/EC, excluding food supplements for infants and young children | - 100 mg/day for children from 3 to 9 years of age - 150 mg/day for children from 10 to 17 years of age - 200 mg/day for adults |
April 10: Authorization of monosodium salt of L-5-methyltetrahydrofolic acid in food supplement, baby food, etc.
Commission Implementing Regulation (EU) 2024/1037: The novel food “monosodium salt of L-5-methyltetrahydrofolic acid” has received authorization for use in food supplement, baby food, etc. This Regulation specifies the novel food's specifications, conditions for use, labeling requirements, and data protection. The following are the requirements of the use conditions.
Specified food categories where the novel food may be used | Maximum levels (expressed as folic acid) |
Food supplements as defined in Directive 2002/46/EC, excluding food supplements for infants and young children | In accordance with Directive 2002/46/EC |
Infant formula and follow-on formula as defined in 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 in Regulation (EU) No 609/2013 | In accordance with Regulation (EU) No 609/2013 |
Foods for special medical purposes as defined in Regulation (EU) No 609/2013 | In accordance with Regulation (EU) No 609/2013 |
Total diet replacement for weight control as defined in Regulation (EU) No 609/2013 | In accordance with Regulation (EU) No 609/2013 |
Food fortified in accordance with Regulation (EC) No 1925/2006 | In accordance with Regulation (EC) No 1925/2006 |
April 9: Revision on the specification of galacto-oligosaccharide
Commission Implementing Regulation (EU) 2024/1027: Galactose is removed from the specification of the novel food “galacto-oligosaccharide”. The revision comes into effect on April 29, 2024.
Items to be revised | Revision |
Galactose | Min.0.8% (DM) → (Deleted) |
April 9: Revision on the specification of astaxanthin-rich oleoresin from Haematococcus pluvialis algae
Commission Implementing Regulation (EU) 2024/1026: The specification of the novel food “astaxanthin-rich oleoresin from Haematococcus pluvialis algae” is revised as below. The revision comes into effect on April 29, 2024.
Items to be revised | Revision |
Composition |
|
- Protein | 0.3-4.4% → ≤4.4% |
Specification of Carotenoids % w/w |
|
- 9-cis-astaxanthin | 0.3-17.3% → 0.3-30.0% |
- Astaxanthin monoesters | 79.8-91.5% → 66.7-91.5% |
- Astaxanthin diesters | 0.16-19.0% → 0.16-32.5% |
April 9: Revision on the use condition of lactitol
Commission Implementing Regulation (EU) 2024/1023: EU expands the allowed forms of lactitol in food supplements, since the form of the food supplement is not of relevance for the safety of the novel food. The revision comes into effect on April 29, 2024.
Items to be revised | Revisions |
Allowed use scope | Food supplements as defined in Directive 2002/46/EC (capsules, tablets or powder) intended for the adult population → Food supplements as defined in Directive 2002/46/EC intended for the adult population |
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