1. UV-treated powder obtained from whole Tenebrio molitor larvae is authorised to be placed on the market within the Union.
UV-treated powder obtained from whole Tenebrio molitor 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.
Only the company Nutri’Earth ( 7 ) 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 10 February 2025, 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 Nutri’Earth.
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 Nutri’Earth.
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
‘ UV-treated powder of whole Tenebrio molitor larvae (yellow mealworm)
Specified food category
Maximum levels (g/100 g)
(Maximum levels of vitamin D 3 (μg/100 g food))
1.
The designation of the novel food on the labelling of the foodstuffs containing it shall be “UV-treated Tenebrio molitor larvae (yellow mealworm) powder”.
2.
The labelling of the foodstuffs containing UV-treated powder of whole Tenebrio molitor larvae (yellow 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 or, in the absence of a list of ingredients, in close proximity to the name of the food.
3.
Where the novel food is added to final product that contain an amount of vitamin D that is considered significant in accordance with Point 2 of Part A of Annex XIII to Regulation (EU) No 1169/2011, the designation of the novel food shall be accompanied by “containing vitamin D produced by UV treatment”, and the nutrition declaration shall contain the amount of vitamin D.
Authorised on 10 February 2025. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.
Applicant: “Nutri’Earth”, 68 rue Louis Joseph Gay Lussac, 62220 Carvin, France.
During the period of data protection, the novel food UV-treated powder of whole Tenebrio molitor larvae (yellow mealworm) is authorised for placing on the market within the Union only by “Nutri’Earth”, 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 “Nutri’Earth”.
End date of the data protection: 10 February 2030.’
Bread and rolls
4,0 (≤ 3,2 μg vitamin D 3 /100 g food)
Cakes
4,0 (≤ 3,2 μg vitamin D 3 /100 g food)
Pasta-based products
3,5 (≤ 2,8 μg vitamin D 3 /100 g food)
Processed potato products
3,0 (≤ 2,4 μg vitamin D 3 /100 g food)
Cheese and cheese products
1,0 (≤ 0,8 μg vitamin D 3 /100 g food)
Fruit and vegetable compotes
3,5 (≤ 2,8 μg vitamin D 3 /100 g food)
(2)
in Table 2 (Specifications), the following entry is inserted:
Authorised novel food
Specification
‘ UV-treated powder of whole Tenebrio molitor larvae (yellow mealworm)
Description/Definition :
The novel food is the ultra-violet (UVB) light treated powder obtained from whole, thermally treated and ground Tenebrio molitor larvae (yellow mealworm).
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.
A minimum 24 hours fasting period is required before the thermal drying step, to allow the larvae to discard their bowel content.
Characteristics/Composition :
Crude protein (N x 6,25) (% w/w): 50,0 – 55,0
Fat (% w/w): 30,0 – 37,0
Total carbohydrates (% w/w): 6,0 – 7,5
Crude fibre (% w/w): 3,0 – 4,5
Chitin* (% w/w): 5,5-8,5
Ash (% w/w): 3,0 – 4,0
Moisture (% w/w): 1,4 – 3,5
Peroxide value (meq O 2 /kg fat): ≤ 5,0
Water activity (a w ): < 0,6
Vitamin D 3 (μg/100 g): 35,0 – 79,0
Manganese (mg/kg): ≤ 11,5
Copper (mg/kg): ≤ 16,0
Heavy metals :
Lead (mg/kg): ≤ 0,02
Cadmium (mg/kg): ≤ 0,1
Mercury (mg/kg): ≤ 0,005
Arsenic (mg/kg): ≤ 0,05
Mycotoxins :
Aflatoxin B1 (μg/kg): ≤ 2
Aflatoxins (Sum of B1 + B2 + G1 + G2, μg/kg): ≤ 4
Deoxynivalenol (μg/kg): ≤ 200
Ochratoxin A (μg/kg): ≤ 1
Dioxins and PCBs:
PCDDs/F + PCB TEQ (pg/g fat): ≤ 0,75
Microbiological criteria:
Bacillus cereus : ≤ 100 CFU**/g
Clostridium perfringens : ≤ 10 CFU/g
β-Glucuronidase-positive Escherichia coli : ≤ 10 CFU/g
Aerobic mesophilic bacteria: ≤ 10 5 CFU/g
Listeria monocytogenes : Not detected in 25 g
Yeasts and moulds: ≤ 100 CFU/g
Enterobacteriaceae: < 10 CFU/g
Coagulase-positive staphylococci: ≤ 100 CFU/g
Sulfite-reducing anaerobes: < 10 CFU/g
Salmonella spp.: Not detected in 25 g
*
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); PCDDs/F + PCB TEQ: 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 Factors (TEQ) (using WHO-TEFs of 2005).
**
CFU: Colony Forming Units.’