1. Frozen, dried and powder forms of Locusta migratoria , 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 5 December 2021, 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 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 data 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 5 December 2021 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 Locusta migratoria (migratory locust)
Specified food category
Maximum levels (g/100 g)
(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 Locusta migratoria (migratory locust)’, ‘dried/powder Locusta migratoria (migratory locust)’, ‘Whole Locusta migratoria (migratory locust) powder’ depending on the form used.
2.
The labelling of the foodstuffs containing frozen dried or powder forms of Locusta migratoria (migratory locust) shall bear a statement that this ingredient may cause allergic reactions to consumers with known allergies to crustaceans, molluscs and products thereof, and to mites.
This statement shall appear in close proximity to the list of ingredients.
Authorised on 5.12.2021.
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: 5.12.2026.’
Frozen
Dried or
Powder
Frozen, dried and powder forms of Locusta migratoria
Processed potato products; legumes-based dishes and pasta-based products
15
5
Meat analogues
80
50
Soups and concentrated soups
15
5
Canned/jarred legumes and vegetables
20
15
Salads
15
5
Beer-like beverages, Alcoholic drink mixes
2
2
Chocolate confectionery
30
10
Nuts, oilseeds and chickpeas
20
Frozen fermented milk-based products
15
5
Sausages
30
10
(2)
in Table 2 (Specifications), the following entry is inserted:
Authorised Novel Food
Specifications
‘Frozen, dried and powder forms of Locusta migratoria (migratory locust)
Description/Definition:
The novel food consists of the frozen, dried and powder forms of migratory locust. The term ‘migratory locust’ refers to the adult of Locusta migratoria , an insect species that belongs to the Acrididae family (subfamily Locustinae).
The novel food is intended to be marketed in three different forms, namely: (i) thermally processed and frozen L. migratoria (LM frozen); (ii) thermally processed and freeze-dried L. migratoria (LM dried), and (iii) thermally processed freeze-dried and ground whole L. migratoria (whole LM powder). The LM dried may be marketed as such or in powder.
For LM frozen and LM dried, legs and wings must be removed to reduce the risk of intestinal constipation that could be possibly caused by ingestion of the large spines on the insect tibia. The whole LM powder is obtained via mechanical grinding of the insect with legs and wings, and sieving to reduce particle size below 1 mm.
A minimum 24 hours fasting period is required before killing the insects by freezing, to allow the adults to discard their bowel content.
Parameters
LM frozen
LM dried
Whole LM powder
Characteristics/Composition
Ash (% w/w)
0,6 -1,0
2,0 -3,1
1,8 -1,9
Moisture (% w/w)
67 -73
≤ 5
≤ 5
Crude protein (N × 6,25 ) (% w/w)
11 -21
43 -53
50 – 60
Fat (% w/w)
7 -13
31 -41
31 -41
Saturated fatty acids (% fat)
35 -43
35 -43
35 -43
Digestible carbohydrates (% w/w)
0,1 -2,0
0,1 -2,0
1,0 -3,5
( *1 ) Dietary fibre (% w/w)
1,5 -3,5
5,5 -9,0
5,5 -9,0
Chitin (% w/w)
1,7 -2,4
6,4 -10,4
10,5 -13,9
Peroxide value (Meq O 2 /kg fat)
≤ 5
≤ 5
≤ 5
Contaminants
Lead (mg/kg)
≤ 0,07
≤ 0,07
≤ 0,07
Cadmium (mg/kg)
≤ 0,05
≤ 0,05
≤ 0,05
Aflatoxins (Sum of B1, B2, G1, G2) (μg/kg)
≤ 4
≤ 4
≤ 4
Aflatoxin B1 (μg/kg)
≤ 2
≤ 2
≤ 2
Deoxynivalenol (μg/kg)
≤ 200
≤ 200
≤ 200
Ochratoxin A (μg/kg)
≤ 1
≤ 1
≤ 1
Sum of dioxins and dioxins-like PCBs UB ( ( *2 ) WHO 2005 PCDD/F-PCB-TEQ) (pg/g fat)
≤ 1,2
≤ 1,2
≤ 1,2
Microbiological criteria
Total aerobic colony count ( ( *3 ) CFU/g)
≤ 10 5
≤ 10 5
≤ 10 5
Enterobacteriaceae (presumptive) (CFU/g)
≤ 100
≤ 100
≤ 100
Escherichia coli (CFU/g)
≤ 50
≤ 50
≤ 50
Listeria monocytogenes
Not detected in 25 g
Not detected in 25 g
Not detected in 25 g
Salmonella spp.
Not detected in 25 g
Not detected in 25 g
Not detected in 25 g
Bacillus cereus (presumptive) (CFU/g)
≤ 100
≤ 100
≤ 100
Coagulase positive Staphylococci (CFU/g
≤ 100
≤ 100
≤ 100
Sulfite-reducing Anaerobes (CFU/g)
≤ 30
≤ 30
≤ 30
Yeasts and moulds (CFU/g)
≤ 100
≤ 100
≤ 100
( *1 ) Dietary fibre may not include chitin due to different analytical methods.
( *2 ) 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)).
( *3 ) CFU: colony forming units’.
