Commission Regulation (EU) 2025/1377 of 15 July 2025 amending and correcting Regulation (EU) No 142/2011 as regards certain requirements for the placing on the market and imports of animal by-products and derived products not intended for human consumption
Date: 2025-07-15
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: animal feedingstuffs, animal health, health control, health risk, import (EU), insect, market approval, material of animal origin, veterinary inspection, waste management




L_202501377EN.000101.fmx.xml












Official Journal of the European Union


EN
L series













2025/1377


16.7.2025







            COMMISSION REGULATION (EU) 2025/1377
of 15 July 2025
         
amending and correcting Regulation (EU) No 142/2011 as regards certain requirements for the placing on the market and imports of animal by-products and derived products not intended for human consumption
(Text with EEA relevance)


THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,


Having regard to Regulation (EC) No 1069/2009 of the European Parliament and of the Council of 21 October 2009 laying down health rules as regards animal by-products and derived products not intended for human consumption and repealing Regulation (EC) No 1774/2002 (Animal by-products Regulation) (1), and in particular Article 15(1), point (c), Article 18(3), point (a), Article 20(11), point (a), Article 21(6), points (c) and (d), Article 27, point (g), Article 41(3), first and third subparagraphs, and Article 42(2) thereof,

Whereas:







(1)


Commission Regulation (EU) No 142/2011 (2) lays down implementing measures for the public and animal health rules for animal by-products and derived products laid down in Regulation (EC) No 1069/2009, including rules for the placing on the market and imports from third countries of such products.












(2)


In light of recent outbreaks of highly pathogenic avian influenza (HPAI) and the observed occurrence of the HPAI virus infection in certain categories of mammals in the Union territory, it is necessary to lay down additional risk mitigation measures to prevent the introduction and spread of the HPAI virus from poultry materials to other species. Therefore, the special feeding rules for Category 2 material laid down in Article 13 of Regulation (EU) No 142/2011 should be amended.












(3)


Category 2 material obtained from birds that were not killed or did not die as a result of the presence or suspected presence of a disease communicable to humans or animals may be fed to fur animals in accordance with Article 13(1), point (b), of Regulation (EU) No 142/2011. The Avian Influenza overview, published by the European Food Safety Authority (3), (‘the Authority’) suggests that the mutations with potential public health implications of the HPAI virus likely emerge upon transmission to mammals. Therefore, to prevent the risk of the introduction and spread of the HPAI virus to animals of mammalian species and the possible emergence of mutations with potential increased animal and public health implications in the Union, it is necessary to lay down additional conditions where such Category 2 material is fed to animals without prior processing. In particular, before the authorisation for feeding of Category 2 material obtained from birds, in accordance with Article 13(1), point (b), of Regulation (EU) No 142/2011, there should be a risk assessment of the competent authority which concludes that the risk for the introduction and spread of the HPAI virus at regional, national and Union level is negligible. Article 13 of Regulation (EU) No 142/2011 should, therefore, be amended accordingly.












(4)


Regulation (EC) No 999/2001 of the European Parliament and of the Council (4), as amended by Commission Regulation (EU) 2022/2246 (5), prohibits the entry into the Union of urine hunting lures derived from cervids. This prohibition should be reflected in Article 25 of Regulation (EU) No 142/2011, as well as in Chapter 17 of Annex XV to that Regulation.












(5)


In addition, Article 25 of Regulation (EU) No 142/2011 lays down rules for the import, transit, and export of animal by-products and of derived products. Processed beeswaxes under CN code 1521 90 99  intended for use as final technical products, other than for use in feed production, fertilisers, apiaries, cosmetics, or pharmaceuticals, do not come in contact with farmed animals and do not pose a risk to animal health. Therefore, such processed beeswaxes should be included in the products listed in Article 25(2) of Regulation (EU) No 142/2011, the importation into and the transit through the Union of which are not subject to any animal health conditions. Article 25 of Commission Regulation (EU) No 142/2011 should, therefore, be amended accordingly.












(6)


Chapter IV, Section 2 of Annex IV to Regulation (EU) No 142/2011 provides for a list with a detailed description of alternative processing methods for the production of biodiesel and renewable fuels. Used cooking oil, referred to in Article 2(2), point (g)(iii), of Regulation (EC) No 1069/2009 may be used as a starting material in the production of biodiesel and renewable fuels. The wording of alternative processing methods referred to in Chapter IV, Section 2, points D, J and L, of Annex IV to Regulation (EU) No 142/2011 should therefore be amended, so as to clarify the use of starting material in the new alternative processing methods.












(7)


Following an application for the authorisation of an alternative method submitted by Ireland, as provided for in Article 20 of Regulation (EC) No 1069/2009, the Authority published a Scientific Opinion on the ‘Evaluation of an alternative method for production of biodiesel from processed fats derived from Category 1, 2 and 3 animal by-products’ (6).












(8)


Following an application for the authorisation of an alternative method submitted by Austria, as provided for in Article 20 of Regulation (EC) No 1069/2009, the Authority published a Scientific Opinion on the ‘Evaluation of the application for new alternative biodiesel production process from rendered fat including Category 1 animal by-products’ (7).












(9)


Both of those alternative methods have been considered by the Authority as safe alternative methods for the processing of processed and rendered fats into biodiesel. Therefore, those two new alternative processing methods should be included in Chapter IV, Section 2 of Annex IV to Regulation (EU) No 142/2011.












(10)


Annex IV to Regulation (EU) No 142/2011 lays down rules for the use and disposal of derived products obtained by alternative processing methods. Chapter IV, Section 3 of Annex IV to Regulation (EU) No 142/2011 should, therefore, be amended, so as to lay down rules for the use and disposal of products derived from those two new alternative processing methods.












(11)


Annex V to Regulation (EU) No 142/2011 lays down rules for composting and biogas transformation. Recently, ‘frass’ as defined in Annex I, point 61, to Regulation (EU) No 142/2011 has been included in Chapter 1, Section 2 of Annex XI to that Regulation in order to introduce safe parameters for heat treatment of frass. It is necessary to also lay down standard transformation parameters for composting or biogas transformation of frass. Annex V to Regulation (EU) No 142/2011 should, therefore, be amended accordingly.












(12)


Regulation (EU) No 142/2011, as amended by Commission Regulation (EU) 2021/1925 (8), includes silkworms (Bombyx mori) in the list of authorised insect species for the manufacturing of processed animal protein in the Union, as set out in Annex X, Chapter II, Section 1, to Regulation (EU) No 142/2011. It is, therefore, appropriate to allow imports into the Union of processed animal protein derived from silkworms (Bombyx mori). Indonesia applied to the Commission to be listed in Annex XIV to Regulation (EU) No 142/2011 as a third country authorised for imports into and transit through the Union of processed animal protein of insect origin. The Commission carried out an in-depth assessment of the applicant third country’s veterinary legislation and the capacity of its competent authorities to perform official controls in relation to petfood imported into the Union. It was concluded that the competent authorities of Indonesia can comply with the relevant health conditions for the import of processed petfood containing processed animal protein of insect origin. It is therefore justified to add Indonesia to the list of third countries set out in Annex XIV to Regulation (EU) No 142/2011 from where processed petfood, containing processed animal protein of insect origin, may be imported into and transit through the Union.












(13)


Commission Regulation (EU) 2022/384 (9) amended Table 1 in Chapter I, Section 1, and Table 2 in Chapter II, Section 2 of Annex XIV to Regulation (EU) No 142/2011. That amendment concerned, among others, the alignment of the list of third countries authorised for imports into the Union of animal by-products and derived products with the list of third countries, territories or zones thereof authorised for the entry into the Union of consignments of fresh meat of ungulates set out in Part 1 of Annex XIII to Commission Implementing Regulation (EU) 2021/404 (10). However, it appears that during the alignment, the list for imports of animal by-products for the manufacture of pharmaceuticals was established incorrectly, as a result of which some third countries were erroneously listed as eligible for imports of animal by-products for the manufacturing of pharmaceutical products. That error should be corrected by a new wording in Chapter II, Table 2, row 14, of Annex XIV to Regulation (EU) No 142/2011.












(14)


Following the introduction, in accordance with the amendments made to Regulation (EU) No 142/2011 by this Regulation, of two new alternative methods for the use or disposal of animal by-products or derived products in Annex IV to Regulation (EU) No 142/2011, Table 2, row 17, column ‘Raw material (reference to provisions of Regulation (EC) No 1069/2009)’ in Annex XIV to Regulation (EU) No 142/2011 should be amended to include a reference to those two new alternative methods, in order to allow imports into the Union of raw materials for the manufacturing of renewable fuels.












(15)


The competent authorities of Japan provided the Commission with an updated list of their exporters of photogelatine. Table 3 in Chapter II, Section 11, of Annex XIV to Regulation (EU) No 142/2011 should be amended to take account of that updated list of exporters. That Annex should, therefore, be amended accordingly.












(16)


Regulation (EC) No 999/2001, as amended by Commission Regulation (EU) 2021/1372 (11), authorises processed animal protein derived from insects to be used for feeding poultry and porcine animals, therefore the labelling requirements for imported consignment should be adapted. Following the introduction of silkworms (Bombyx mori) to the list of authorised insect species for the production of processed animal protein intended for the manufacturing of feed, the relevant health certificate should be adapted. The health certificate for processed animal protein derived from farmed insects for dispatch to or for transit through the Union set out in Chapter 1A of Annex XV to Regulation (EU) No 142/2011 should be amended as regards the required labelling and the list of authorised insect species.












(17)


Regulation (EU) No 142/2011, as amended by Regulation (EU) 2021/1925, lays down rules for the placing on the market of processed frass. It is appropriate to introduce relevant animal health requirements for imports of frass from third countries which are at least as stringent as those applicable to the placing on the Union market of frass. The prohibition of imports of urine hunting lurs from cervids should be inserted in the certificate for imports of manure. The health certificate for imports of processed manure set out in Chapter 17 of Annex XV, to Regulation (EU) No 142/2011 should be amended to allow also the imports of processed frass into the Union and prohibit the imports of urine hunting lures. Annex XV to Regulation (EU) No 142/2011 should, therefore, be amended accordingly.












(18)


Regulation (EU) No 142/2011 should, therefore, be amended accordingly.












(19)


The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,





HAS ADOPTED THIS REGULATION:



Article 1
Regulation (EU) No 142/2011 is amended and corrected as follows:






(1)


in Article 13(1), the following subparagraph is added:

                              ‘The competent authority may only authorise the feeding of unprocessed Category 2 material obtained from birds to the animals referred to in the first subparagraph on their territory, if a risk assessment of the competent authority concludes that the risk for the introduction and spread of the HPAI virus at regional, national and Union level is negligible.’;










(2)


Article 25 is amended as follows:






(a)


in paragraph 1, the following point (d) is added:






‘(d)


urine hunting lures derived from cervids.’;














(b)


in paragraph 2, the following point (f) is added:






‘(f)


derived beeswaxes ready to sell products, not intended for uses as feed, petfood, fertilisers, apiaries, cosmetics or pharmaceuticals.’;


















(3)


Annexes IV, V, XIV and XV are amended in accordance with Part 1 of the Annex to this Regulation;










(4)


Annex XIV is corrected in accordance with Part 2 of the Annex to this Regulation.






Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.




This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 15 July 2025.


For the Commission


The President

Ursula VON DER LEYEN
            





(1)  
            OJ L 300, 14.11.2009, p. 1, ELI: http://data.europa.eu/eli/reg/2009/1069/oj.

(2)  Commission Regulation (EU) No 142/2011 of 25 February 2011 implementing Regulation (EC) No 1069/2009 of the European Parliament and of the Council laying down health rules as regards animal by-products and derived products not intended for human consumption and Implementing Council Directive 97/78/EC as regards certain samples and items exempt from veterinary checks at the border under that Directive (OJ L 54, 26.2.2011, p. 1, ELI: http://data.europa.eu/eli/reg/2011/142/oj).

(3)  Avian influenza overview December 2022 – March 2023 (EFSA Journal 2023; 21(3):7917).

(4)  Regulation (EC) No 999/2001 of the European Parliament and of the Council of 22 May 2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies (OJ L 147, 31.5.2001, p. 1, ELI: http://data.europa.eu/eli/reg/2001/999/oj).

(5)  Commission Regulation (EU) 2022/2246 of 15 November 2022 amending Annexes VIII and IX to Regulation (EC) No 999/2001 of the European Parliament and of the Council as regards chronic wasting disease in live cervids (OJ L 295, 16.11.2022, p. 1, ELI: http://data.europa.eu/eli/reg/2022/2246/oj).

(6)  
            EFSA Journal 2020; 18(4):6089.

(7)  
            EFSA Journal 2021; 19(4):6511.

(8)  Commission Regulation (EU) 2021/1925 of 5 November 2021 amending certain Annexes to Regulation (EU) No 142/2011 as regards the requirements for placing on the market of certain insect products and the adaptation of a containment method (OJ L 393, 8.11.2021, p. 4, ELI: http://data.europa.eu/eli/reg/2021/1925/oj).

(9)  Commission Regulation (EU) 2022/384 of 4 March 2022 amending Annex XIV to Regulation (EU) No 142/2011 as regards adaptation of the lists of third countries, territories or zones thereof from which the entry into the Union of animal by-products and derived products is permitted (OJ L 78, 8.3.2022, p. 1, ELI: http://data.europa.eu/eli/reg/2022/384/oj).

(10)  Commission Implementing Regulation (EU) 2021/404 of 24 March 2021 laying down the lists of third countries, territories or zones thereof from which the entry into the Union of animals, germinal products and products of animal origin is permitted in accordance with Regulation (EU) 2016/429 of the European Parliament and the Council (OJ L 114, 31.3.2021, p. 1, ELI: http://data.europa.eu/eli/reg_impl/2021/404/oj).

(11)  Commission Regulation (EU) 2021/1372 of 17 August 2021 amending Annex IV to Regulation (EC) No 999/2001 of the European Parliament and of the Council as regards the prohibition to feed non-ruminant farmed animals, other than fur animals, with protein derived from animals (OJ L 295, 18.8.2021, p. 1, ELI: http://data.europa.eu/eli/reg/2021/1372/oj).




ANNEX
PART 1

Amendments to Annexes IV, V, XIV and XV to Regulation (EU) No 142/2011

Annexes IV, V, XIV and XV to Regulation (EU) No 142/2011 are amended as follows:






(1)


in Annex IV, Chapter IV is amended as follows:






(a)


Section 2 is amended as follows:






(i)


point D(2)(a)(ii) is replaced by the following:






‘(ii)


in the case of Category 3 materials, other than used cooking oil, any of the processing methods 1 to 5 or processing method 7 or, in the case of material derived from fish, processing methods 1 to 7 as set out in Chapter III;’;














(ii)


in point J(1)(a), the following subpoint is added:






‘(iv)


used cooking oil of Category 3 material.’;














(iii)


point L(1)(b) is replaced by the following:






‘(b)


used cooking oil of Category 3 material, rendered fats and fish oil complying with point J(1)(a) of this Section.’;














(iv)


the following points M and N are added:






‘M.


Production of biodiesel from processed fats derived from Category 1, 2 and 3 animal by-products






1.


Starting materials
For this process, rendered fats of Category 1, 2 or 3 material and used cooking oil of Category 3 material may be used.










2.


Processing methods
Except where fish oil are used which have been produced in accordance with Section VIII of Annex III to Regulation (EC) No 853/2004 (*1), or where rendered fat are used which have been produced in accordance with Section XII of Annex III to Regulation (EC) No 853/2004, the fat fraction derived from animal by-products shall be first processed using:






(a)


in the case of Category 1 or 2 materials, processing method 1 (pressure sterilisation) as set out in Chapter III of this Annex; and










(b)


in the case of Category 3 material, other than used cooking oil, any of the processing methods 1 to 5 or processing method 7 or, in the case of material derived from fish, processing methods 1 to 7 as set out in Chapter III of this Annex.














3.


After processing in accordance with one of the processing methods referred to in point 2, starting materials referred to in point 1 shall be subject to the following steps:






(a)


a pre-cleaning process for the removal of insoluble impurities in excess of 0,15 %. The resulting cleaned liquids obtained from the precleaning process shall be pumped to the biodiesel tank at the establishment where the cleaned liquids are stored, as biodiesel feedstocks, until processing;










(b)


an acidic esterification/transesterification (1,5 % methane sulfonic acid (MSA) w/w; 140 °C; 5,5 bar absolute pressure (bara); 4 hours) for conversion of the cleaned feedstock into biodiesel; and










(c)


fractional distillation: the biodiesel shall be fractionated (≥ 220 °C; 10 to 35 millibar (mbara)) into multiple refined products, each containing carbon chains of a particular length, resulting in batches of biodiesel with differing specifications.














4.


The competent authority shall assess the HACCP plan which checks and records the main processing parameters of the steps described in points 1, 2 and 3.














N.


Biodiesel production process using rendered fats of Category 1, 2 and 3 animal by-products






1.


Starting materials
For this process, a fat fraction derived from animal by-products of Category 1, 2 or 3 materials shall be used.










2.


Processing methods






(a)


Except where fish oil are used that have been produced in accordance with Section VIII of Annex III to Regulation (EC) No 853/2004, or where rendered fat are used which have been produced in accordance with Sections XII of Annex III to Regulation (EC) No 853/2004, the fat fraction derived from animal by-products shall be first processed using:






(i)


in the case of Category 1 or 2 materials, processing method 1 (pressure sterilisation) as set out in Chapter III of this Annex; and










(ii)


in the case of Category 3 material, other than used cooking oil, any of the processing methods 1 to 5 or processing method 7 or, in the case of material derived from fish, processing methods 1 to 7 as set out in Chapter III of this Annex; in the case of fat from ruminant origin, insoluble impurities in excess of 0,15 % by weight shall be removed.














(b)


The following biodiesel production process shall consist of a conversion phase of esterification and transesterification in a single step at a temperature of at least 200 °C, pressure of at least 70 bar with a retention time of at least 15 minutes, using MgO as a catalyst and in the presence of an alcohol (methanol) followed by vacuum distillation (at ≥ 150 °C, ≤ 10 mbar) of the end-product, biodiesel.














3.


The competent authority shall assess the HACCP plan which checks and records the main processing parameters of the steps described in points 1 and 2;









(*1)  Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific hygiene rules for food of animal origin (OJ L 139, 30.4.2004, p. 55, ELI: http://data.europa.eu/eli/reg/2004/853/oj).’;"
                        














(b)


in Section 3, in point 2(b), the introductory sentence is replaced by the following:

                                       ‘the biodiesel production process referred to in Section 2, points D, M and N, may be:’;














(2)


in Annex V, in Chapter I, in Section 1, in point 2, the following point (g) is added:






‘(g)


processed frass that has been processed in accordance with Annex XI, Chapter I, Section 2, point (b);’;














(3)


Annex XIV is amended as follows:






(a)


in Chapter I, in Section 2, point 5(a) is replaced by the following:






‘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 (Alphi tobius diaperinus),










—


house cricket (Acheta domesticus), banded cricket (Gryllodes sigillatus) and field cricket (Gryllus assimilis),










—


silkworm (Bombyx mori);’;






















(b)


in Chapter II, in Section 1, Table 2 is amended as follows:






(i)


in row 12, in the fifth column entitled ‘Third countries’ lists’, point (b) is replaced by the following:






‘(b)


In the case of dogchews and petfood other than raw petfood:
Third countries listed in Part 1 of Annex XIII, in Part 1 of Annex XIV, or in Part 1, Section A, of Annex XV to Implementing Regulation (EU) 2021/404, and the following third countries:






(AL)


Albania










(EC)


Ecuador










(DZ)


Algeria










(GE)


Georgia (only processed petfood other than canned petfood)










(LK)


Sri Lanka










(SA)


Saudi Arabia (only processed petfood of poultry origin)










(SV)


El Salvador










(TW)


Taiwan










(ID)


Indonesia (only processed petfood containing processed animal protein of insect origin)




In the case of fish material, third countries listed in Annex IX to Implementing Regulation (EU) 2021/405.’;














(ii)


in row 17, in the third column entitled ‘Raw materials (references to provisions of Regulation (EC) No 1069/2009)’, point (a) is replaced by the following:






‘(a)


In the case of materials destined for the production of biodiesel, biodiesel oleochemical products or renewable fuels referred to in points L, M and N of Section 2 of Chapter IV of Annex IV:
Categories 1, 2 and 3 materials referred to in Articles 8, 9 and 10.’;


















(c)


in Chapter II, in Section 11, Table 3 is replaced by the following:

‘Table 3


Imports of photogelatine










Third country of origin


Plants of origin


Member State of destination


Border inspection post of first entry into the Union


Approved photographic factories




Japan


Nitta Gelatin Inc., 2-22 Futamata Yao-City, Osaka 581-0024 Japan
Jellice Co., Ltd. 4-1, Sakae 4-Chome, Tagajo-City, Miyagi 985-0833 Japan


The Netherlands


Rotterdam
airport Schiphol – Amsterdam


Fujifilm Manufacturing Europe B.V., Oudenstaart 1, 5047 TK Tilburg, The Netherlands




Nitta Gelatin Inc., 2-22 Futamata Yao-City, Osaka 581-0024 Japan


Czechia


Hamburg


FOMA Bohemia, spol. SRO Jana Krušinky 1604 501 04 Hradec Králové, Czechia




United States


Eastman Gelatine Corporation, 227 Washington Street, Peabody, MA, 01960 USA
Gelita North America, 2445 Port Neal Industrial Road Sergeant Bluff, Iowa, 51054 USA


Czechia


Hamburg


FOMA Bohemia spol. SRO Jana Krušinky 1604 501 04 Hradec Králové, Czechia’


















(4)


Annex XV to Regulation (EU) No 142/2011 is amended as follows:






(a)


Chapter 1a is replaced by the following:

                                                ‘
                                                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 through2 the European Union






























                                          ’
                                       










(b)


Chapter 17 is replaced by the following:

                                                ‘CHAPTER 17

Health certificate







 



For processed manure, derived products from processed manure, processed frass and processed guano from bats intended for dispatch to or for transit through2 the European Union











 




















                                          ’
                                       








PART 2

Correction to Annex XIV to Regulation (EU) No 142/2011

In Annex XIV, in Chapter II, in Section 1, in Table 2, in row 14, in the fifth column entitled ‘Third countries lists’, point (b) is corrected and replaced by the following:






‘(b)


In the case of animal by-products for the manufacture of pharmaceuticals:
Third countries listed in Part 1 of Annex XIII or in Part 1 of Annex XIV to Implementing Regulation (EU) 2021/404; and in Annexes I, V, and VI to Implementing Regulation (EU) 2021/405.
In the case of material from fish, third countries listed in Annex IX to Implementing Regulation (EU) 2021/405.’.






(*1)  Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific hygiene rules for food of animal origin (OJ L 139, 30.4.2004, p. 55, ELI: http://data.europa.eu/eli/reg/2004/853/oj).’;’



ELI: http://data.europa.eu/eli/reg/2025/1377/oj
ISSN 1977-0677 (electronic edition)