法律人 LawPlayer logo

資料由法律人 LawPlayer整理提供·EU law / curated by LawPlayer from EUR-Lex

Regulation

Commission Implementing Regulation (EU) 2022/169 of 8 February 2022 authorising the placing on the market of frozen, dried and powder forms of yellow mealworm (Tenebrio molitor larva) as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council, and amending Commission Implementing Regulation (EU) 2017/2470 (Text with EEA relevance)

CELEX
Implementing Regulation (EU) 2022/169
Date of document
Articles
5
Source
EUR-Lex
Article 1

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.

Article 2

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.

Article 3

The Annex to Implementing Regulation (EU) 2017/2470 is amended in accordance with the Annex to this Regulation.

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 .

Schedules & Appendices

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, 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.’

5 articles

Cite this act

Commission Implementing Regulation (EU) 2022/169 of 8 February 2022 authorising the placing on the market of frozen, dried and powder forms of yellow mealworm (Tenebrio molitor larva) as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council, and amending Commission Implementing Regulation (EU) 2017/2470 (Text with EEA relevance) (EUR-Lex). Retrieved via LawPlayer, https://lawplayer.com/eu/act/32022R0169

© European Union, https://eur-lex.europa.eu, 1998-2026. Reuse authorised under Commission Decision 2011/833/EU, provided the source is acknowledged.

EU-EurLex-Reuse-2011-833

本頁資料來源:EUR-Lex·整理提供:法律人 LawPlayer· lawplayer.com