1. Frozen, dried and powder forms of Acheta domesticus , 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 5 years from the date of entry into force of this Regulation, only the initial applicant:
company: Fair Insects B.V.;
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 B.V.
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.
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 5 years from the date of entry into force of this Regulation without the agreement of Fair Insects B.V.
The Annex to Implementing Regulation (EU) 2017/2470 is amended in accordance with the Annex to this Regulation.
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .
ANNEXSupplementary provisions
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 Acheta domesticus (house cricket)
Specified food category
Maximum levels (g/100g)
(marketed as such or reconstituted according to the instructions)
1.
The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Frozen Acheta domesticus (house cricket)’, ‘Dried/powdered Acheta domesticus (house cricket)’depending on the form used.
2.
The labelling of the foodstuffs containing frozen, dried or powder forms of Acheta domesticus (house cricket) shall bear a statement that this ingredient may cause allergic reactions to consumers with known allergies to crustaceans, molluscs and products thereof, and to dust mites.
This statement shall appear in close proximity to the list of ingredients.
Authorised on 3 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 data protection: 3 March 2027.’
Frozen
Dried or powder
Frozen, dried, and powder forms of Acheta domesticus
Protein products other than meat analogues
40
20
Bread and rolls
30
10
Bakery wares, cereal bars, and stuffed pasta products
30
15
Biscuits
30
8
Pasta-based products (dry)
3
1
Soups and soup concentrates or powders
20
5
Processed potato products, legumes- and vegetable- based dishes, and pasta- or pizza-based products
15
5
Corn flour based snacks
40
20
Beer-like beverages, alcoholic drink mixes
1
1
Nuts, oilseeds and chickpeas
40
25
Sauces
30
10
Meat preparations
40
16
Meat analogues
80
50
Chocolate confectionary
30
10
Frozen fermented milk based products
15
5
(2)
in Table 2 (Specifications), the following entry is inserted:
Authorised Novel Food
Specification
‘ Frozen, dried and powder forms of Acheta domesticus (house cricket)
Description/Definition:
The novel food consists of the whole, frozen, dried and powder forms of the house cricket. The term ‘house cricket’ refers to the adult Acheta domesticus , an insect species that belongs to the Gryllidae family.
The novel food is intended to be marketed in three different forms, namely: (i) thermally processed and frozen whole A. domesticus (AD frozen); (ii) thermally processed and freeze-dried whole A. domesticus (AD dried), and (iii) thermally processed freeze-dried and ground whole A. domesticus (whole AD powder).
A minimum 24 hours fasting period is required before killing the insects by freezing, to allow the adults to discard their bowel content.
Characteristics/Composition (AD frozen):
Ash (% w/w): 0,6–1,2
Moisture (% w/w): 76–82
Crude protein (N x 6,25) (% w/w): 12–21
Digestible Carbohydrates (% w/w): 0,1–2
Fat (% w/w): 3–12
of which saturated (% w/w): 36–45
Peroxide value (Meq O 2 /kg fat): ≤ 5
Dietary fibre (% w/w): 0,8–3
( * ) Chitin (% w/w): 0,7–3,0
Heavy metals:
Lead: ≤ 0,05 mg/kg
Cadmium: ≤ 0,06 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
Dioxins and dioxin like PCBs
Sum of dioxins and dioxin-like PCBs UB, ( ( ** ) WHO 2005 PCDD/F-PCB-TEQ): ≤ 1,25 pg/g fat
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 (presumptive): ≤ 100 CFU/g
Enterobacteriaceae (presumptive): < 100 CFU/g
Coagulase-positive staphylococci : ≤ 100 CFU/g
Characteristics/Composition (AD dried or powder):
Ash (% w/w): 2,9–5,1
Moisture (% w/w): ≤ 5
Crude protein (N x 6,25) (% w/w): 55–65
Digestible Carbohydrates (% w/w): 1–4
Fat (% w/w): 29–35
of which saturated (% w/w): 36–45
Peroxide value (Meq O 2 /kg fat): ≤ 5
Dietary fibre (% w/w): 3–6
( * ) Chitin (% w/w): 5,3-10,0
Heavy metals:
Lead: ≤ 0,05 mg/kg
Cadmium: ≤ 0,06 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
Dioxins and dioxin like PCBs
Sum of dioxins and dioxin-like PCBs UB, ( ( ** ) WHO 2005 PCDD/F-PCB-TEQ): ≤ 1,25 pg/g fat
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 (presumptive): ≤ 100 CFU/g
Enterobacteriaceae (presumptive): < 100 CFU/g
Coagulase-positive staphylococci : ≤ 100 CFU/g
( * ) Dietary fibre may not include chitin due to different analytical methods.
( ** ) 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.’
