Commission Implementing Regulation (EU) 2023/58 of 5 January 2023 authorising the placing on the market of the frozen, paste, dried and powder forms of Alphitobius diaperinus larvae (lesser mealworm) as a novel food and amending Implementing Regulation (EU) 2017/2470 (Text with EEA relevance)

Article 1

1.   The frozen, paste, dried and powder forms of Alphitobius diaperinus larvae (lesser mealworm) are authorised to be placed on the market within the Union.
The frozen, paste, dried and powder forms of Alphitobius diaperinus larvae shall be included in the Union list of novel foods set out in Implementing Regulation (EU) 2017/2470.
2.   The Annex to Implementing Regulation (EU) 2017/2470 is amended in accordance with the Annex to this Regulation.

Article 2

Only the company Ynsect NL B.V. ( 9 ) is authorised to place on the market within the Union the novel food referred to in Article 1, 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 Ynsect NL B.V.

Article 3

The scientific data contained in the application file and fulfilling the conditions laid down in Article 26(2) of Regulation (EU) 2015/2283 shall not be used for the benefit of a subsequent applicant for a period of 5 years from the date of entry into force of this Regulation without the agreement of Ynsect NL B.V.

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 .

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:
Authorised novel food
Conditions under which the novel food may be used
Additional specific labelling requirements
Other requirements
Data protection
‘ Frozen, paste, dried and powder forms of Alphitobius diaperinus larvae (lesser mealworm)
Specified food category
Maximum levels (g/100g)
1.
The designation of the novel food on the labelling of the foodstuffs containing it shall be “Frozen/paste Alphitobius diaperinus larvae (lesser mealworm)” or “Dried/powder Alphitobius diaperinus larvae (lesser mealworm)” depending on the form used.
2.
The labelling of food supplements containing the novel food shall bear a statement that those food supplements should not be consumed by persons under 18 years of age.
3.
The labelling of the foodstuffs containing frozen, paste, dried or powder forms of Alphitobius diaperinus larvae (lesser 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 26.1.2023. This inclusion is based on proprietary scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.
Applicant: Ynsect NL B.V, Harderwijkerweg 141B, 3852 AB Ermelo, the Netherlands.
During the period of data protection, the novel food is authorised for placing on the market within the Union only by Ynsect NL B.V., unless a subsequent applicant obtains authorisation for that novel food without reference to the proprietary scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283, or with the agreement of Ynsect NL B.V.
End date of the data protection: 26.1.2028.’
Cereal bars
25 (Dried form)
25 (Powder form)
Bread and rolls
20 (Powder form)
Processed and breakfast cereals
10 (Dried form)
10 (Powder form)
Porridge
15 (Powder form)
Pre-mixes (dry) for baked products
10 (Powder form)
Dried pasta-based products
10 (Powder form)
Stuffed pasta-based products
28 (Frozen or paste form)
10 (Powder form)
Whey powder
35 (Powder form)
Soups
15 (Powder form)
Cereal-, pasta-based dishes
5 (Powder form)
Pizza-based dishes
5 (Dried form)
5 (Powder form)
Noodles
10 (Powder form)
Snacks other than chips
10 (Dried form)
10 (Powder form)
Chips/crisps
10 (Powder form)
Crackers and bread sticks
10 (Powder form)
Peanut butter
15 (Powder form)
Ready-to-eat savoury based sandwich
20 (Powder form)
Meat preparations
14 (Frozen or paste form)
5 (Powder form)
Meat analogues
40 (Frozen or paste form)
15 (Powder form)
Milk and dairy analogues
10 (Powder form)
Chocolate confectionary
5 (Powder form)
Food supplements as defined in Directive 2002/46/EC for the adult population
4 g/day (Powder form)
(2)
in Table 2 (Specifications), the following entry is inserted:
Authorised novel food
Specification
‘ Frozen, paste, dried and powder forms of Alphitobius diaperinus larvae (lesser mealworm)
Description/Definition:
The novel food consists of the frozen, paste, dried, and powder forms of the whole lesser mealworm. The term “lesser mealworm” refers to the larval form of Alphitobius diaperinus , an insect species that belongs to the family of Tenebrionidae (darkling beetles).
The entire lesser mealworms are meant for human consumption, no parts are removed.
The novel food is intended to be marketed in 4 different forms, namely: (i) whole blanched and frozen A. diaperinus larvae (ADL frozen), (ii) paste from whole blanched, ground, and frozen A. diaperinus larvae (ADL paste), (iii) whole blanched, and freeze-dried A. diaperinus larvae (ADL dried), and (iv) powder from whole blanched, freeze-dried and ground A. diaperinus larvae (ADL powder).
A minimum 24 hours fasting period is required to allow the larvae to discard their bowel content before killing the insects by a thermal treatment.
Characteristics/Composition (ADL frozen or paste):
Ash (% w/w): ≤ 1,5
Moisture (% w/w): 65-80
Crude protein (N × 6,25) (% w/w): 12-25
Digestible Carbohydrates (% w/w): 0,4-2
Fat (% w/w): 5-12
Peroxide value (Meq O 2 /kg fat): ≤ 0,2
Dietary fibre (% w/w): 1-4
( *1 ) Chitin (% w/w): 1,0-2,6
Heavy metals:
Lead: ≤ 0,1 mg/kg
Cadmium: ≤ 0,05 mg/kg
Mycotoxins:
Aflatoxins (Sum of B1, B2, G1, G2): ≤ 4 μg/kg
Aflatoxin B1 (μg/kg): ≤ 2
Deoxynivalenol: ≤ 200 μg/kg
Ochratoxin A: ≤ 1 μg/kg
Microbiological criteria:
Total aerobic colony count: ≤ 10 5
( *2 ) CFU/g
Yeasts and moulds: ≤ 100 CFU/g
Escherichia coli : ≤ 50 CFU/g
Salmonella spp.: Absence in 25 g
Listeria monocytogenes : Absence in 25 g
Sulphite-reducing Anaerobes: ≤ 30 CFU/g
Bacillus cereus : ≤ 100 CFU/g
Enterobacteriaceae: ≤ 100 CFU/g
Coagulase-positive staphylococci : ≤ 100 CFU/g
Characteristics/Composition (ADL dried or powder):
Ash (% w/w): ≤ 5
Moisture (% w/w): 1-5
Crude protein (N × 6,25) (% w/w): 50-70
Digestible Carbohydrates (% w/w): 1,5-3,5
Fat (% w/w): 20-35
Peroxide value (Meq O 2 /kg fat): ≤ 5
Dietary fibre (% w/w): 3-6
( *1 ) Chitin (% w/w): 3,0-9,1
Heavy metals:
Lead: ≤ 0,1 mg/kg
Cadmium: ≤ 0,05 mg/kg
Mycotoxins:
Aflatoxins (Sum of B1, B2, G1, G2): ≤ 4 μg/kg
Aflatoxin B1 (μg/kg): ≤ 2
Deoxynivalenol: ≤ 200 μg/kg
Ochratoxin A: ≤ 1 μg/kg
Microbiological criteria:
Total aerobic colony count: ≤ 10 5 CFU/g
Yeasts and moulds: ≤ 100 CFU/g
Escherichia coli : ≤ 50 CFU/g
Salmonella spp.: Absence in 25 g
Listeria monocytogenes : Absence in 25 g
Sulfite-reducing Anaerobes: ≤ 30 CFU/g
Bacillus cereus : ≤ 100 CFU/g
Enterobacteriaceae: ≤ 100 CFU/g
Coagulase-positive staphylococci : ≤ 100 CFU/g
( *1 )   Chitin calculated as Acid Detergent Fibre.
( *2 )   CFU: Colony Forming Units.’

Commission Implementing Regulation (EU) 2023/58 of 5 January 2023 authorising the placing on the market of the frozen, paste, dried and powder forms of Alphitobius diaperinus larvae (lesser mealworm) as a novel food and amending Implementing Regulation (EU) 2017/2470 (Text with EEA relevance)

Schedules & Appendices

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