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.
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.
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 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.’
