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Commission Implementing Regulation (EU) 2022/169 of 8 February 2022 authorising the placing on the market of frozen, dried and powder forms of yellow mealworm (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)

Commission Implementing Regulation (EU) 2022/169 of 8 February 2022 authorising the placing on the market of frozen, dried and powder forms of yellow mealworm (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)

Implementing Regulation (EU) 2022/169 · Regulation · 5 articles

Data as of 2026-07-04 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗

Article 1

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1.   Frozen, dried and powder forms of yellow mealworm ( 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: Fair Insects BV; address: Industriestraat 3, 5107 NC Dongen, the Netherlands, 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 Fair Insects BV. 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

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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 Fair Insects BV.

Article 3

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

Article 4

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This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .

Supplementary provisions

ANNEXSupplementary provisions

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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: Authorised novel food Conditions under which the novel food may be used Additional specific labelling requirements Other requirements Data protection ‘Frozen, dried and powder forms of yellow mealworm ( Tenebrio molitor larva) Specified food category Maximum levels (g/100g) (marketed as such or reconstituted according to the instructions) 1. Depending on the form used, the designation of the novel food on the labelling of the foodstuffs containing it shall be ‘frozen yellow mealworm ( Tenebrio molitor larva)’, ‘dried yellow mealworm ( Tenebrio molitor larva)’, or ‘yellow mealworm ( Tenebrio molitor larva) powder’. 2. The labelling of the foodstuffs containing frozen, dried and powder forms of yellow mealworm ( Tenebrio molitor larva) 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 1 March 2022. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283. Applicant: Fair Insects BV, Industriestraat 3, 5107 NC Dongen, the Netherlands. During the period of data protection, the novel food is authorised for placing on the market within the Union only by Fair Insects BV, 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 Fair Insects BV. End date of the date protection: 1 March 2027.’ Frozen Dried or powder Frozen, dried and powder forms of yellow mealworm ( Tenebrio molitor larva)     Multigrain bread and rolls; crackers and breadsticks 30 10 Cereal bars 30 15 Dried pasta based products; pasta based dishes (excluding dried puffed pasta); pizza and pizza-like dishes 15 10 Dried stuffed pasta based products 30 15 Pre-mixes (dry) for baked products 30 15 Sauces 30 10 Potato, legumes based dishes 15 10 Whey powder 40 20 Meat analogues 80 50 Soups and salads 20 5 Chips/crisps 40 20 Beer-like beverages; mixed alcoholic drinks; alcoholic drink mixes 1 1 Chocolate confectionary 30 10 Nuts, oilseeds and chickpeas 40 30 Frozen fermented milk-based products 15 5 Meat preparations 40 16 (2) in Table 2 (Specifications), the following entry is inserted: Authorised Novel Food Specification ‘Frozen, dried and powder forms of yellow mealworm ( Tenebrio molitor larva) Description/Definition: The novel food are frozen, dried and powder forms of yellow mealworm ( Tenebrio molitor larva). The term ‘mealworm’ refers to the larval form of Tenebrio molitor , an insect species that belongs to the family of Tenebrionidae (darkling beetles). Another identified scientific synonym is Tenebrio molitor Linnaeus. The entire mealworms are meant for human consumption, no parts are removed. A minimum 24 hours fasting period is required before killing the insects by freezing, to allow the larvae to discard their bowel content. The novel food is intended to be placed on the market in three different forms, namely: whole, blanched and frozen T. molitor larva (frozen); whole, blanched and freeze-dried T. molitor larva (dried) which may be in powder form (powder). Parameters Frozen Dried or powder Characteristics/Composition Ash 0,9-1,10 3,6-4,1 Moisture (% w/w) 69-75 ≤ 5 Crude protein (N x 6,25) (% w/w) 14-19 54-60 Fat (% w/w) — of which saturated fatty acids (% fat) 7-12,5 20-29 27-30 20-29 Digestible carbohydrates (% w/w) 1-2 4-8 Dietary fibre (% w/w) 1,2-3,5 4-6 Chitin(*) (% w/w) ≤ 3 4-9 Peroxide value (Meq O 2 /kg fat) ≤ 5 ≤ 5 Contaminants Heavy metals     Lead (mg/kg) ≤ 0,01 ≤ 0,075 Cadmium (mg/kg) ≤ 0,05 ≤ 0,1 Mycotoxins     Aflatoxins (Sum of B1, B2, G1, G2) (μg/kg) ≤ 4 ≤ 4 Aflatoxin B1 (μg/kg) ≤ 2 ≤ 2 Deoxynivalenol (μg/kg) ≤ 200 ≤ 200 Ochratoxin A (μg/kg) ≤ 1 ≤ 1 Dioxins and PCBs     Sum of dioxins and dl-PCBs (UB, WHO-TEQ2005)(**) (pg/g fat) ≤ 0,75 ≤ 0,75 Microbiological criteria Total aerobic colony count (CFU/g) ≤ 10 5 ≤ 10 5 Enterobacteriaceae (presumptive) (CFU/g) ≤ 100 ≤ 100 Escherichia coli (CFU/g) ≤ 50 ≤ 50 Listeria monocytogenes Absence in 25g Absence in 25g Salmonella spp. Absence in 25g Absence in 25g Bacillus cereus (presumptive) (CFU/g) ≤ 100 ≤ 100 Coagulase positive Staphylococci (CFU/g ≤ 100 ≤ 100 Sulfite-reducing Anaerobes (CFU/g) ≤ 30 ≤ 30 Yeasts and moulds (CFU/g) ≤ 100 ≤ 100 (*) Chitin calculated as the difference between the Acid Detergent Fibre fraction and the Acid Detergent Lignin fraction (ADF-ADL), as described by Hahn et al. (2018). (**) Upper bound sum of polychlorinated dibenzo-para-dioxins (PCDDs)-polychlorinated dibenzofurans (PCDFs) and dioxin-like polychlorinated biphenyls (PCBs) expressed as World Health Organization toxic equivalent (using WHO-TEFs of 2005)). CFU: colony forming units.’

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Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.

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