(Utkast) Kommisjonsforordning (EU) .../... om endring og retting av forordning (EU) Nr. 142/2011 med hensyn til visse krav til omsetning og import av animalske biprodukter og avledede produkter
Biproduktforordningen: endringsbestemmelser om omsetning og import
Utkast til kommisjonsforordning sendt til Europaparlamentet og Rådet for klarering og publisert i EUs komitologiregister 27.2.2024
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BAKGRUNN (fra kommisjonsforordningen)
(1) Commission Regulation (EU) No 142/2011 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, (‘EFSA’) 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 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, as amended by Commission Regulation (EU) 2022/2246, 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 Annex XV, Chapter 17, to that Regulation.
(5) In addition, Article 25 of Regulation (EU) No 142/2011 lays down rules for 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 not be subject to official controls at border control posts. Article 25 of Commission Regulation (EU) No 142/2011 should, therefore, be amended accordingly.
(6) Annex IV, Chapter IV, Section 2, 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, paragraph 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 Annex IV, Chapter IV, Section 2, points D, J and L, to Regulation (EU) No 142/2011 should therefore be amended so as to lay down unambiguous application of harmonised rules for legal clarity.
(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, EFSA 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”.
(8) Following an application for the authorisation of an alternative method, as provided for in Article 20 of Regulation (EC) No 1069/2009, submitted by Austria, 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”.
(9) Both of those alternative methods have been considered by EFSA as safe alternative methods for the processing of processed and rendered fats into biodiesel.
(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. 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) “Frass” as defined in Annex I, point 61, to Regulation (EU) No 142/2011 should be allowed as a starting material for composting or biogas transformation. Annex V to Regulation (EU) No 142/2011 should, therefore, be amended accordingly.
(12) Annex VIII, Chapter V to Regulation (EU) No 142/2011 provides that certain Category 1 and 2 derived products must be marked by mixing with a chemical marker glyceroltriheptanoate (GTH) to identify the presence of Category 1 and 2 derived products in the feed for farmed animals. The final products of the two newly introduced renewable fuels alternative processing methods, provided for in the amendments to be made to Annex IV, Chapter IV, to Regulation (EU) No 142/2011 by this Regulation, should be excluded from the obligation of mixing with GTH laid down in Annex VIII, Chapter V, to Regulation (EU) No 142/2011, when used for internal combustion engines only since fuel may not be intended for feed uses. Annex VIII to Regulation (EU) No 142/2011 should, therefore, be amended accordingly.
(13) Regulation (EU) No 142/2011, as amended by Regulation (EU) 2021/1925, 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.
(14) Commission Regulation (EU) 2022/384 amended Tables 1 and 2 in Annex XIV to Regulation (EU) No 142/2011 to align 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 Annex XIII to Commission Implementing Regulation (EU) 2021/404, and the list of third countries or regions thereof authorised for the entry into the Union of consignments of certain fishery products set out in Annex IX to Commission Implementing Regulation (EU) 2021/405. However, it appears that during the alignment, the list for imports of animal by-products for the manufacture of pharmaceuticals was transposed wrongly 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 the new wording in Annex XIV, Chapter II, Table 2, row 14.
(15) Following the introduction of two new alternative methods in Annex IV to Regulation (EU) No 142/2011 by this Regulation, Table 2 in Annex XIV to Regulation (EU) No 142/2011 should be amended to include a reference to those two new alternative methods to allow imports into the Union of raw materials for the manufacturing of renewable fuels.
(16) The competent authorities of Japan provided the Commission with an updated list of their exporters of photogelatine. Table 3 in 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.
(17) Regulation (EC) No 999/2001, as amended by Regulation (EU) 2021/1372 authorises processed animal protein derived from insects to be used for feeding poultry and porcine animals. The health certificate for processed animal protein derived from farmed insects for dispatch to or for transit through the European Union set out in Chapter 1A of Annex XV to Regulation (EU) No 142/2011 should be amended as regards the required labelling to take account of that authorisation.
(18) 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 allow imports of processed frass under those rules. The health certificate set out in Chapter 17 of Annex XV to Regulation (EU) No 142/2011 should be amended with a reference to processed frass.
(19) Regulation (EU) No 142/2011, as amended by Regulation (EU) 2021/1925, includes silkworms (Bombyx mori) in the list of authorised insect species for the production of processed animal protein intended for the manufacturing of feed for farmed animals. The certificate for imports of processed animal protein set out in Chapter 1A of Annex XV to Regulation (EU) No 142/2011 should be amended in order to facilitate imports of processed animal protein derived from silkworms.
(20) Regulation (EC) No 999/2001, as amended by Regulation (EU) 2022/2246, prohibits imports into the Union of urine hunting lures from cervids from third countries. Urine hunting lures from cervids are included in the definition of ‘manure’ in Article 3, point (20), of Regulation (EC) No 1069/2009. 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 with a reference to the prohibition of imports of urine hunting lures from cervids.
(21) Annex XV to Regulation (EU) No 142/2011 should, therefore, be amended accordingly.
(22) Regulation (EU) No 142/2011 should, therefore, be amended accordingly.
(23) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,