ANNEX IISupplementary provisions
ANNEX II Annexes X, XIV and XV of Regulation (EU) No 142/2011 are amended as follows: (1) in Annex X, Chapter II, Section 1, Part A is replaced by the following: ‘A. Raw materials 1. Only animal by-products which are Category 3 material or products which are derived from such animal by-products, other than the Category 3 materials referred to in Article 10(n), (o) and (p) of Regulation (EC) No 1069/2009, may be used for the production of processed animal protein. 2. Processed animal protein derived from farmed insects, intended for the production of feed for farmed animals other than fur animals, may only be obtained from the following insect species: (i) Black Soldier Fly ( Hermetia illucens ) and Common Housefly ( Musca domestica ); (ii) Yellow Mealworm ( Tenebrio molitor ) and Lesser Mealworm ( Alphitobius diaperinus ); (iii) House cricket ( Acheta domesticus ), Banded cricket ( Gryllodes sigillatus ) and Field Cricket ( Gryllus assimilis ).’; (2) in Annex XIV, Chapter I is amended as follows: (a) in Section 1, Table 1, the first row is replaced by the following: ‘1 Processed animal protein, including mixtures and products other than petfood containing such protein, and compound feeds containing such proteins as defined in Article 3(2)(h) of Regulation (EC) No 767/2009 Category 3 materials referred to in Article 10(a), (b), (d), (e), (f), (h), (i), (j), (k), (l) and (m). (a) The processed animal protein must have been produced in accordance with Section 1 of Chapter II of Annex X; and (b) the processed animal protein shall comply with the additional requirements set out in Section 2 of this Chapter. (a) In the case of processed animal proteins excluding fishmeal: Third countries listed in Part 1 of Annex II to Regulation (EU) No 206/2010. (b) In the case of fishmeal: Third countries listed in Annex II to Decision 2006/766/EC. (a) In the case of processed animal protein other than those derived from farmed insects: Annex XV, Chapter 1. (b) In the case of processed animal protein derived from farmed insects: Annex XV, Chapter 1a.’ (b) in Section 2, the following point 5 is added: ‘5. Processed animal protein obtained from farmed insects may be imported into the Union provided that it has been produced in compliance with the following conditions: (a) the insects belong to one of the following species: — Black Soldier Fly ( Hermetia illucens ) and Common Housefly ( Musca domestica ), — Yellow Mealworm ( Tenebrio molitor ) and Lesser Mealworm ( Alphitobius diaperinus ), — House cricket ( Acheta domesticus ), Banded cricket ( Gryllodes sigillatus ) and Field Cricket ( Gryllus assimilis ); (b) the substrate for the feeding of insects may only contain products of non-animal origin or the following products of animal origin of Category 3 material: — fishmeal, — blood products from non-ruminants, — di and tricalcium phosphate of animal origin, — hydrolysed proteins from non-ruminants, — hydrolysed proteins from hides and skins of ruminants, — gelatine and collagen from non-ruminants, — eggs and egg products, — milk, milk based-products, milk-derived products and colostrum, — honey, — rendered fats; (c) the substrate for the feeding of insects and the insects or their larvae have not been in contact with any other materials of animal origin than those mentioned in point (b) and the substrate did not contain manure, catering waste or other waste.’; (3) Annex XV is amended as follows: (a) in Chapter 1, the title of the model Health Certificate is replaced by the following: ‘Health certificate For processed animal protein, other than those derived from farmed insects, not intended for human consumption, including mixtures and products other than petfood containing such protein, for dispatch to or for transit through ( 2 ) the European Union ’; (b) the following Chapter 1a is added: ‘CHAPTER 1a Health certificate For processed animal protein derived from farmed insects not intended for human consumption, including mixtures and products other than petfood containing such protein, for dispatch to or for transit through ( 2 ) the European Union Text of image COUNTRY: Veterinary certificate to EU Part I: Details of dispatched consignment I.1. Consignor Name Address Tel. I.2. Certificate reference No I.2.a. I.3. Central competent authority I.4. Local competent authority I.5. Consignee Name Address Postcode Tel. I.6. Person responsible for the load in EU Name Address Postcode Tel. I.7. Country of origin ISO code I.8. Region of origin Code I.9. Country of destination ISO code I.10. Region of destination Code I.11. Place of origin Name Approval number Address Name Approval number Address Name Approval number Address I.12. Place of destination Custom warehouse Name Approval number Address Postcode I.13. Place of loading I.14. Date of departure I.15. Means of transport Aeroplane Ship Railway wagon Road vehicle Other Identification Documentation references I.16. Entry BIP in EU I.17. Text of image I.18. Description of commodity I.19. Commodity code (HS code) I.20. Quantity I.21. Temperature of product Ambient Chilled Frozen I.22. Number of packages I.23. Seal/Container No I.24. Type of packaging I.25. Commodities certified for: Animal feedingstuff Technical use Production of petfood I.26. For transit through EU to third country Third country ISO code I.27. For import or admission into EU I.28. Identification of the commodities Approval number of establishments Species (Scientific name) Nature of commodity Manufacturing plant Net weight Batch number Text of image COUNTRY Processed animal protein derived from farmed insects not intended for human consumption including mixtures and products other than petfood containing such protein II. Health information II.a. Certificate reference No II.b. I, the undersigned official veterinarian, declare that I have read and understood Regulation (EC) No 1069/2009 of the European Parliament and of the Council (1a) and in particular Article 10 thereof, and Commission Regulation (EU) No 142/2011 (1b), and in particular Section 1 of Chapter II of Annex X, and Chapter I of Annex XIV thereto and certify that: II.1. the processed animal protein derived from farmed insects or product described above contains exclusively processed animal protein not intended for human consumption that: (a) has been prepared and stored in an establishment or plant approved, validated and supervised by the competent authority in accordance with Article 24 of Regulation (EC) No 1069/2009, and (b) has been prepared exclusively from farmed insects of the following species: (2) either [— Black Soldier Fly (Hermetia illucens);] (2) and/or [— Common Housefly (Musca domestica);] (2) and/or [— Yellow Mealworm (Tenebrio molitor);] (2) and/or [— Lesser Mealworm (Alphitobius diaperinus);] (2) and/or [— House cricket (Acheta domesticus);] (2) and/or [— Banded cricket (Gryllodes sigillatus);] (2) and/or [— Field Cricket (Gryllus assimilis).] and (c) has been processed by method [1]-[2]-[3]-[4]-[5]-[7] (2) as set out in Chapter III of Annex IV to Regulation (EU) No 142/2011; and (d) the substrate for the feeding of farmed insects may only contain products of non-animal origin or the following products of animal origin of Category 3 material: — fishmeal; — blood products from non-ruminants; — di and tricalcium phosphate of animal origin; — hydrolysed proteins from non-ruminants; — hydrolysed proteins from hides and skins of ruminants; — gelatine and collagen from non-ruminants; — eggs and egg products; — milk, milk based-products, milk-derived products, and colostrum; — honey; — rendered fats; and (e) the substrate for the feeding of insects and the insects or their larvae have not been in contact with any other materials of animal origin than those mentioned in point (d) and the substrate did not contain manure, catering waste or other waste. Part II: Certification Text of image COUNTRY Processed animal protein derived from farmed insects not intended for human consumption including mixtures and products other than petfood containing such protein II. Health information II.a. Certificate reference No II.b. II.2. the competent authority examined a random sample immediately prior to dispatch and found it to comply with the following standards (3): Salmonella: Absence in 25 g: n = 5, c = 0, m = 0, M = 0 Enterobacteriaceae: n = 5, c = 2, m = 10, M = 300 in 1 g; II.3. the product has undergone all precautions to avoid recontamination with pathogenic agents after treatment; II.4. the end product: (2) either [was packed in new or sterilised bags,] (2) or [was transported in bulk in containers or other means of transport that were thoroughly cleaned and disinfected before use,] which bear labels indicating ‘NOT FOR HUMAN CONSUMPTION/PROCESSED INSECT PROTEIN — SHALL NOT BE USED IN FEED FOR FARMED ANIMALS EXCEPT AQUACULTURE AND FUR ANIMALS’; II.5. the end product was stored in enclosed storage; II.6. the processed animal protein derived from farmed insects, or product described above, does not contain and is not derived from (2) either [(a) specified risk material as defined in point 1 of Annex V to Regulation (EC) No 999/2001 of the European Parliament and of the Council (4); (b) mechanically separated meat obtained from bones of bovine, ovine or caprine animals except if the animals from which the animal-by products or derived product have been obtained, were born, continuously reared and slaughtered in a country or region classified as posing a negligible BSE risk in accordance with Commission Decision 2007/453/EC (5), in which there has been no BSE indigenous cases, (c) animal by-product or derived product obtained from animals which have been killed, after stunning, by laceration of central nervous tissue by means of an elongated rod-shaped instrument introduced into the cranial cavity, or by means of gas injected into the cranial cavity, except for animals born, continuously reared and slaughtered in a country or region classified as posing a negligible BSE risk in accordance with Decision 2007/453/EC.] (2) or [bovine, ovine and caprine materials other than those derived from animals born, continuously reared and slaughtered in a country or region classified as posing a negligible BSE risk in accordance with Decision 2007/453/EC.] II.7. the processed animal protein or product described above: (2) either [does not contain milk or milk products of ovine or caprine animal origin.] (2) or [contains milk or milk products of ovine or caprine animal origin which: (a) derive from ovine and caprine animals which have been kept continuously since birth in a country where the following conditions are fulfilled: (i) classical scrapie is compulsorily notifiable; (ii) an awareness, surveillance and monitoring system is in place; (iii) official restrictions apply to holdings of ovine or caprine animals in the case of a suspicion of TSE or a confirmation of classical scrapie; (iv) ovine and caprine animals affected with classical scrapie are killed and completely destroyed; (v) the feeding to ovine and caprine animals of meat-and-bone meal or greaves of ruminant origin, as defined in the World Organisation for Animal Health (OIE) Terrestrial Animal Health Code, has been banned and effectively enforced in the whole country for a period of at least the preceding seven years; Text of image COUNTRY Processed animal protein derived from farmed insects not intended for human consumption including mixtures and products other than petfood containing such protein II. Health information II.a. Certificate reference No II.b. (b) originate from holdings where no official restriction is imposed due to a suspicion of TSE; (c) originate from holdings where no case of classical scrapie has been diagnosed during the preceding seven years or, following the confirmation of a case of classical scrapie: (2) either [all ovine and caprine animals on the holding have been killed and destroyed or slaughtered, except for breeding rams of the ARR/ARR genotype, breeding ewes carrying at least one ARR allele and no VRQ allele and other ovine animals carrying at least one ARR allele;] (2) or [all animals in which classical scrapie was confirmed have been killed and destroyed, and the holding has been subjected for two years at least since the confirmation of the last classical scrapie case to intensified TSE monitoring, including testing with negative results for the presence of TSE in accordance with the laboratory methods set out in point 3.2 of Chapter C of Annex X to Regulation (EC) No 999/2001, of all of the following animals which are over the age of 18 months, except ovine animals of the ARR/ARR genotype: — animals which have been slaughtered for human consumption; and — animals which have died or been killed on the holding but which were not killed in the framework of a disease eradication campaign.]] Notes Part I: — Box reference I.6: Person responsible for the consignment in the European Union: this box is to be filled in only if it is a certificate for a transit commodity; it may be filled in if the certificate is for an import commodity. — Box reference I.12: Place of destination: this box is to be filled in only if it is a certificate for a transit commodity. The products in transit can only be stored in free zones, free warehouses and custom warehouses. — Box reference I.15: Registration number (railway wagons or container and lorries), flight number (aircraft) or name (ship); information is to be provided in the event of unloading and reloading. — Box reference I.19: use the appropriate HS code: 05.05; 05.06; 05.07; 05.11 or 23.01. — Box reference I.25: technical use: any use other than for animal consumption. — Box reference I.26 and I.27: fill in according to whether it is a transit or an import certificate. — Box reference I.28: Species: insects, specify its scientific name. Part II: (1a) OJ L 300, 14.11.2009, p. 1. (1b) OJ L 54, 26.2.2011, p. 1. (2) Delete as appropriate. (3) Where: n = number of samples to be tested; m = threshold value for the number of bacteria; the result is considered satisfactory if the number of bacteria in all samples does not exceed m; Text of image COUNTRY Processed animal protein derived from farmed insects not intended for human consumption including mixtures and products other than petfood containing such protein II. Health information II.a. Certificate reference No II.b. M = maximum value for the number of bacteria; the result is considered unsatisfactory if the number of bacteria in one or more samples is M or more; and c = number of samples the bacterial count of which may be between m and M, the sample still being considered acceptable if the bacterial count of the other samples is m or less. (4) OJ L 147, 31.5.2001, p. 1. (5) Commission Decision 2007/453/EC of 29 June 2007 establishing the BSE status of Member States or third countries or regions thereof according to their BSE risk (OJ L 172, 30.6.2007, p. 84). — The signature and the stamp must be in a different colour to that of the printing. — Note for the person responsible for the consignment in the European Union: This certificate is only for veterinary purposes and has to accompany the consignment until it reaches the border inspection post. Official veterinarian/Official inspector Name (in capital letters): Qualification and title: Date: Signature: Stamp: ’