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Regulation

Commission Implementing Regulation (EU) 2021/882 of 1 June 2021 authorising the placing on the market of dried Tenebrio molitor larva 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 (Text with EEA relevance)

CELEX
Implementing Regulation (EU) 2021/882
Date of document
Articles
5
Source
EUR-Lex
Article 1

1.   Dried Tenebrio molitor larva, as specified in the Annex to this Regulation, shall be included in the Union list of authorised novel foods established in Implementing Regulation (EU) 2017/2470.

2.   For a period of five years from the date of entry into force of this Regulation, only the initial applicant:

Company: SAS EAP Group;

Address: 35 Boulevard du Libre Échange, 31650 Saint-Orens-de-Gameville, France,

is authorised to place on the market within the Union the novel food referred to in paragraph 1, unless a subsequent applicant obtains authorisation for the novel food without reference to the data protected pursuant to Article 2 of this Regulation or with the agreement of SAS EAP Group.

3.   The entry in the Union list referred to in paragraph 1 shall include the conditions of use and labelling requirements laid down in the Annex to this Regulation.

Article 2

The studies contained in the application file on the basis of which the novel food referred to in Article 1 have been assessed by the Authority, claimed by the applicant as proprietary and without which the novel food could not have been authorised, shall not be used for the benefit of a subsequent applicant for a period of five years from the date of entry into force of this Regulation without the agreement of SAS EAP Group.

Article 3

The Annex to Implementing Regulation (EU) 2017/2470 is amended in accordance with the Annex to this Regulation.

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 .

Schedules & Appendices

ANNEX

ANNEX

The Annex to Implementing Regulation (EU) 2017/2470 is amended as follows:

(1)

in Table 1 (Authorised novel foods), the following entry is inserted in alphabetical order:

Authorised novel food

Conditions under which the novel food may be used

Additional specific labelling requirements

Other requirements

Data protection

‘Dried Tenebrio molito r larva (yellow mealworm)

Specified food category

Maximum levels

1.

The designation of the novel food on the labelling of the foodstuffs containing it shall be “Dried Tenebrio molitor larva (yellow mealworm)”.

2.

The labelling of the foodstuffs containing dried Tenebrio molitor larva (yellow mealworm) shall bear a statement that this ingredient may cause allergic reactions to consumers with known allergies to crustaceans and products thereof, and to dust mites. This statement shall appear in close proximity to the list of ingredients.

Authorised on 22 June 2021. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.

Applicant: SAS EAP Group, 35 Boulevard du Libre Échange, 31650 Saint-Orens-de-Gameville, France.

During the period of data protection, the novel food is authorised for placing on the market within the Union only by SAS EAP Group, unless a subsequent applicant obtains authorisation for that 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 SAS EAP Group.

End date of the data protection: 22 June 2026.’

Dried Tenebrio molitor larva, whole or in powder

Protein products

10 g/100 g

Biscuits

10 g/100 g

Legumes-based dishes

10 g/100 g

Pasta-based products

10 g/100 g

(2)

in Table 2 (Specifications), the following entry is inserted in alphabetical order:

Authorised Novel Food

Specification

‘Dried Tenebrio molito r larva (yellow mealworm)

Description/Definition:

The novel food is the whole, thermally dried yellow mealworm, either whole (blanched, oven-dried larva) or in the form of a powder (blanched, oven-dried, ground larva). The term “mealworm” refers to the larval form of Tenebrio molitor , an insect species that belongs to the family of Tenebrionidae (darkling beetles).

The entire mealworms are meant for human consumption and no parts are removed.

A minimum 24 hours fasting period is required before the thermal drying step, to allow the larvae to discard their bowel content.

Characteristics/Composition:

Ash (% w/w): 3,5 – 4,5

Moisture (% w/w): 1-8

Crude protein (N x 6,25) (% w/w): 56–61

Digestible Carbohydrates  ( *1 ) (% w/w): 1–6

Fat (% w/w): 25–30

of which saturated (% w/w): 4–9

Peroxide value (Meq O 2 /kg fat): ≤ 5

Dietary fibre (% w/w): 4–7

Chitin (% w/w): 4–7

Heavy metals:

Lead: ≤ 0,075 mg/kg

Cadmium: ≤ 0,1 mg/kg

Mycotoxins:

Aflatoxins (Sum of B1, B2, G1, G2): ≤ 4 μg/kg

Aflatoxin B1: ≤ 2 μg/kg

Deoxynivalenol: ≤ 200 μg/kg

Ochratoxin A: ≤ 1 μg/kg

Microbiological criteria:

Total aerobic colony count: ≤ 10 5 CFU  ( *2 ) /g

Yeasts and moulds: ≤ 100 CFU/g

Escherichia coli : ≤ 50 CFU/g

Salmonella spp.: Not detected in 25 g

Listeria monocytogenes : Not detected in 25 g

Sulfite-reducing Anaerobes: ≤ 30 CFU/g

Bacillus cereus (presumptive): ≤ 100 CFU/g

Enterobacteriaceae (presumptive): < 10 CFU/g

Coagulase-positive staphylococci : ≤ 100 CFU/g

( *1 )   Digestible carbohydrates = 100 – (crude protein + fat + dietary fibre + ash + moisture).

( *2 )   CFU: colony forming units.’

5 articles

Cite this act

Commission Implementing Regulation (EU) 2021/882 of 1 June 2021 authorising the placing on the market of dried Tenebrio molitor larva 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 (Text with EEA relevance) (EUR-Lex). Retrieved via LawPlayer, https://lawplayer.com/eu/act/32021R0882

© European Union, https://eur-lex.europa.eu, 1998-2026. Reuse authorised under Commission Decision 2011/833/EU, provided the source is acknowledged.

EU-EurLex-Reuse-2011-833

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