News: Novel Food
In November, the EU Commission approved two more Human Milk Oligosaccharides (HMOs) as novel foods. These include:
- 3-Fucosyllactose produced by a derived strain of Escherichia coli K-12 DH1
- 6′-Sialyllactose sodium salt produced by a derived strain of Escherichia coli W (ATCC 9637)
The EU Commission approves another Human Milk Oligosaccharide (HMO) as a novel food in June:
- 6′-Sialyllactose sodium salt, produced by a derived strains of Escherichia coli BL21(DE3)
The European Commission authorised the following novel foods as traditional food from a third country in February and March 2023:
- dried nuts of Canarium ovatum Engl., commonly known as Pili nuts, and
- dried nuts of Canarium indicum L., called “Kenari nuts”
The European Commission authorised the following three milk oligosaccharides as novel food in January 2023:
- Lacto-N-tetraose produced by derivative strains of Escherichia coli BL21(DE3),
- 3-Fucosyllactose produced by a derivative strain of Escherichia coli BL21(DE3) and
- 3’-Sialyllactose sodium salt produced by derivative strains of Escherichia coli BL21(DE3).
In all 3 cases the applicant only is authorised to place on the market within the Union the novel food, for a period of 5 years from the date of entry into force of this Regulation, unless a subsequent applicant obtains an authorisation for that novel food without reference to the scientific data protected pursuant to Article 3 or with the agreement of the applicant.
The European Commission authorised further insects as novel food in January 2023:
- Acheta domesticus (house cricket) partially defatted powder and
- frozen, paste, dried and powder forms of Alphitobius diaperinus larvae (lesser mealworm).
In both cases only the applicant is authorised to place on the market within the Union the novel food, for a period of 5 years from the date of entry into force of this Regulation, unless a subsequent applicant obtains an authorisation for that novel food without reference to the scientific data protected pursuant to Article 3 or with the agreement of the applicant.
With Implementing Regulation (EU) 2022/965 of 21 June 2022, the kernels from the edible variety of Jatropha curcas L. were authorised as a novel food and included in the Union list of authorised novel foods (Implementing Regulation (EU) 2017/2470). The Regulation is applicable from 12 July 2022. For a period of 5 years, only the original applicant, the company 'JatroSolutions GmbH', may place the novel food on the Union market.
With the implementing regulation (EU) 2022/47, the pulp of the coffee cherry, dried or as an infusion thereof, was approved as a novel food. The regulation is applicable from 03 February 2022. The placing on the market of the novel food is not limited to the two applicants.
On 5 December 2021, the migratory locust (Locusta migratoria) was authorised as a novel food (Implementing Regulation (EU) 2021/1975). For a period of 5 years, only the original applicant, the Dutch company Fair Insects BV, may place the novel food on the market.
The migratory locust is thus, after the yellow mealworm, the second insect species to be authorised as a novel Food in Europe. Frozen, dried or powdered migratory locusts may be marketed as such, as well as in the following food categories:
On 5 December 2021, the miracle berry (Synsepalum dulcificum) was authorised as a novel food (Implementing Regulation (EU) 2021/1974). For a period of 5 years, only the original applicant, the Spanish company Medicinal Gardens S.L., may place the novel food on the market.
In July 2021, the European Food Safety Authority (EFSA) published three opinions concerning novel food safety evaluations on calcium fructoborate, Locusta migratoria, and calcidiol.
In June 2021, the European Food Safety Authority (EFSA) published the following opinions concerning novel food safety evaluations.
- Safety of 3‐FL (3‐Fucosyllactose) as a novel food pursuant to Regulation (EU) 2015/2283.
EFSA concluded that 3-Fucosyllactose, a human-identical milk oligosaccharide, is safe under the proposed conditions of use. The intended uses are foods for infants and toddlers, including foods for special medicinal purposes and food supplements. - Safety of dried fruits of Synsepalum dulcificum as a novel food pursuant to Regulation (EU) 2015/2283.
EFSA concluded that the dried fruits of Synsepalum dulcificum, called ‘wonderberry’, is safe under the proposed conditions of use. When used as or in food supplements for adults (excluding pregnant and lactating women), a maximum daily intake of 0.7 g/day applies.
Following the begin of the application of Regulation (EU) 2019/1381 on the transparency and sustainability of the EU risk assessment in the food chain from 27 March 2021, the European Food Safety Authority (EFSA) updated several administrative and scientific guidance documents.
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