Q2 2023 Novel Food Approval Summary: EU Newly Approves Four Novel Foods, Including One HMO

EU,Food,Novel,Registration,Approval,Analysis

As of June 30, 2023, a total of four novel food have been approved by European Union (EU) in the second quarter of 2023. These products are listed below.

Table 1. Newly Approved Novel Food

No.	Date	Name
1	2023.5.12	Cellobiose
2	2023.5.15	6’-Sialyllactose sodium salt produced by derivative strains of E. coli BL21(DE3)
3		Iron milk caseinate
4	2023.5.17	Aqueous ethanolic extract of Labisia pumila

1. Cellobiose

On May 12, 2023, the European Commission issued the COMMISSION IMPLEMENTING REGULATION (EU) 2023/943, authorizing the placing on the market of Cellobiose as a novel food and amending Implementing Regulation (EU) 2017/2470. This Regulation entered into force on June 1, 2023.

Applicant: SAVANNA Ingredients GmbH

By the end of June 1, 2028 (data protection period), the novel food cellobiose is authorized for placing on the market within the EU only by SAVANNA Ingredients GmbH, unless:

a subsequent applicant obtains authorization for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or;
with the agreement of “SAVANNA Ingredients GmbH”.

Authorized usage scopes and maximal usage levels:

Authorized novel food	Conditions under which the novel food may be used
Cellobiose	Specified food category	Maximum levels
	Food supplements as defined in Directive 2002/46/EC for the general population, excluding infants and young children	3 g/day
	Dried, canned-tinned, raw cured (or seasoned), cooked cured (or seasoned) meat	2 g/100 g
	Fresh raw, preserved, or partly preserved sausages	2 g/100 g
	Meat-based spreadable-textured specialties	2 g/100 g
	Liver-based spreadable-textured specialties	2 g/100 g
	Savory sauce dry preparation	40 g/100 g
	Table-top sweeteners in powder form	60 g/100 g
	Table-top sweeteners in tablets	60 g/100 g
	Additional specific labeling requirements
	The designation of the novel food on the labeling of the foodstuffs containing it shall be ‘cellobiose’. The labeling of food supplements containing cellobiose shall bear a statement that those food supplements should not be consumed by infants and young children.

2. 6’-Sialyllactose sodium salt produced by derivative strains of E. coli BL21(DE3)

On May 15, 2023, the European Commission issued the COMMISSION IMPLEMENTING REGULATION (EU) 2023/948, and authorizing the placing on the market of 6’-Sialyllactose sodium salt produced by derivative strains of Escherichia coli BL21(DE3) as a novel food and amending Implementing Regulation (EU) 2017/2470. This Regulation entered into force on June 4, 2023.

Applicant: Chr. Hansen A/S

By the end of June 4, 2028 (data protection period), the novel food 6’-Sialyllactose sodium salt is authorized for placing on the market within the EU only by Chr. Hansen A/S, unless:

a subsequent applicant obtains authorization for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or;
with the agreement of Chr. Hansen A/S.

Authorized usage scopes and maximal usage levels:

Authorized novel food	Conditions under which the novel food may be used
*6’-Sialyllactose sodium salt produced by derivative strains of E. coli* BL21(DE3)**	Specified food category	Maximum levels
	Infant formula as defined under Regulation (EU) No 609/2013	0.70 grams per liter (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	0.70 g/L in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer
	Processed cereal-based foods for infants and young children and baby foods for infants and young children as defined under Regulation (EU) No 609/2013	0.70 g/L or 0.70 grams per kilogram (g/kg) in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer
	Milk-based drinks and similar products intended for young children	0.70 g/L in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer
	Foods for special medical purposes for infants and young children as defined under Regulation (EU) No 609/2013	In accordance with the particular nutritional requirements of the infants and young children for whom the products are intended but in any case not higher than 0.70 g/L or 0.70 g/kg in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer.
	Foods for special medical purposes as defined under Regulation (EU) No 609/2013 excluding foods for infants and young children	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, for the general population, excluding infants and young children	1.8 g/day
	Additional specific labeling requirements
	The designation of the novel food on the labeling of the foodstuffs containing it shall be ‘6’-Sialyllactose sodium salt’. The labeling of food supplements containing 6’-Sialyllactose (6’-SL) sodium salt must bear a statement that: they should not be consumed by children under three years of age; they should not be consumed if other foods containing added 6’-sialyllactose sodium salt are consumed on the same day.

3. Iron milk caseinate

On May 15, 2023, the European Commission issued the COMMISSION IMPLEMENTING REGULATION (EU) 2023/949, and authorizing the placing on the market of iron milk caseinate as a novel food and amending Implementing Regulation (EU) 2017/2470. This Regulation entered into force on June 4, 2023.

Applicant: Société des Produits Nestlé S.A.

By the end of June 4, 2028 (data protection period), the novel food iron milk caseinate is authorized for placing on the market within the EU only by Société des Produits Nestlé S.A., unless:

a subsequent applicant obtains authorization for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or;
with the agreement of Société des Produits Nestlé S.A.

Authorized usage scopes and maximal usage levels:

Authorized novel food	Conditions under which the novel food may be used
Iron milk caseinate	Specified food category	Maximum levels
	Milk and dairy powder products	500 mg/100 g (≤ 10 mg Fe/100 g)
	Soft drinks marketed in relation to physical exercise	85 mg/100 g (≤ 1.7 mg Fe/100 g)
	Powder cocoa beverage preparations	400 mg/100 g (≤ 8 mg Fe/100 g)
	Powder or liquid malt-based coffee substitutes	1050 mg/100 g (≤ 21 mg Fe/100 g)
	Cereal bars	350 mg/100 g (≤ 7 mg Fe/100 g)
	Noodles other than glass noodles	75 mg/100 g (≤ 1.5 mg Fe/100 g)
	Stock cubes or granulates (bouillon base)	4750 mg/100 g (≤ 95 mg Fe/100 g)
	Single meal replacements for weight control	120 mg/100 g (≤ 2.4 mg Fe/100 g)
	Total diet replacement for weight control as defined under Regulation (EU) No 609/2013	Total diet replacement for weight control as defined under Regulation (EU) No 609/2013
	Foods for special medical purposes as defined under Regulation (EU) No 609/2013 excluding foods for infants and young children	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, for the adult population	700 mg/day (≤ 14 mg Fe/day)
	Food supplements as defined in Directive 2002/46/EC, for children and adolescents under 18 years of age, excluding infants and young children	350 mg/day (≤ 7 mg Fe/day)
	Additional specific labeling requirements
	The designation of the novel food on the labeling of the foodstuffs containing it shall be ‘iron milk caseinate’. The labeling of food supplements containing iron milk caseinate shall bear a statement that: they should not be consumed by children under three years of age; and they should not be consumed if other foods containing iron milk caseinate and/or if other foods with added iron are consumed the same day.

4. Aqueous ethanolic extract of Labisia pumila

On May 17, 2023, the European Commission issued the COMMISSION IMPLEMENTING REGULATION (EU) 2023/972, and authorizing the placing on the market of aqueous ethanolic extract of Labisia pumila as a novel food and amending Implementing Regulation (EU) 2017/2470. This Regulation entered into force on June 6, 2023.

Applicant: Medika Natura Sdn. Bhd.

By the end of June 6, 2028 (data protection period), the novel food aqueous ethanolic extract of Labisia pumila is authorized for placing on the market within the EU only by Medika Natura Sdn. Bhd., unless:

a subsequent applicant obtains authorization for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or;
with the agreement of Medika Natura Sdn. Bhd.

Authorized usage scopes and maximal usage levels:

Authorized novel food	Conditions under which the novel food may be used
Aqueous ethanolic extract of Labisia pumila	Specified food category	Maximum levels
	Food supplements as defined in Directive 2002/46/EC for the adult population, excluding pregnant and breastfeeding women	350 mg/day
	Additional specific labeling requirements
	The designation of the novel food on the labeling of the foodstuffs containing it shall be ‘aqueous ethanolic extract of Labisia pumila’. The labeling of food supplements containing the novel food shall bear a statement that they should only be consumed by persons 18 years of age and above excluding pregnant and breastfeeding women.

Note: The data in this article is for reference only. Please refer to the official information published by Official Journal of the European Union.

If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.

We have launched a LinkedIn newsletter to keep you up to date on the latest developments across the chemical industry including food and FCMs and personal and home care.