HEALTH & CONSUMERS DIRECTORATE-GENERAL
Directorate G - Veterinary and International affairs
G2 - Animal health
Brussels,
SANCO/7132/2012 Rev2
Guidance on applying the Animal By-Products Legislation, Regulation (EC) No 1069/2009 and Regulation (EU) No 142/2011
Working document
This document does not necessarily represent
the views of the Commission services
Presented at the meeting of the Standing Committee on the Food Chain and Animal
Health, section Animal Health and Welfare
on[]
Guidance on applying the Animal By-Products Legislation, Regulation (EC) No 1069/2009 and Regulation (EU) No 142/2011
Prepared by the Trade and zootechnics sector of Animal health Unit of the European Commission’s Directorate-General for Health and Consumer Protection
This guidance is not an authoritative interpretation of EU law in this area. Please note that the understanding of the applicable provisions provided for in this guidance document is without prejudice to the exclusive competence of the Court of Justice of the European Union to interpret Union law
Until the publication of amendment 7188R6- EN voted by Member States at the 10 September 2012 SCoFCAH meeting the guidance document Guidance on the implementation of the certification procedures established in Commission Regulation (EU) No 142/2011(SANCO/07015/2012)presented at the meeting of the Standing Committee on the Food Chain and Animal Health, section Animal Health and Welfare on 7 February 2012 should be applicable.
Contents
1.General issues
1.1.Should household and small community composting facilities be in the scope of Regulation (EC) No 1069/2009?
1.2.If antibodies are grown from bacteria with no animal origin material involved, is this commodity still within the scope of the ABP legislation?
1.3.Should production of fat balls for feeding of birds be subject to the ABP legislation?
1.4.Can we produce rendered fats and fish oil within the same processing plant at the same time?
1.5.Does the spray drying of blood, which is derived from carcases considered fit for human consumption and involves the heat treatment of plasma, result in a blood product or a blood meal?
1.6.Is an animal that have been in an experiment for the diagnosis of particular enzootic diseases be considered after slaughter, as category 1 materials, as referred to under Article 8 (1)(a)(iv) to R1069/2009.
1.7.Is a cell culture derived from laboratory animals which have been produced more than 5 years ago still subject to the animal by-products legislation?
1.8.I am the owner of a small shop and I am selling also some foodstuffs. The foodstuffs are only candies and sweets, like chocolate bars, packed and ready to use. All candies and chocolates contain ingredients of animal origin like milk, eggs etc., but in very small amounts. Do I need to follow rules on disposal of animal by-products?
1.9.Is it possible to carry out the validation of alternative transformationparameters for composting on in pilot scale plant (laboratory trial) or is it necessary for the validation of alternative transformation parameters to be carried out in an industrial scale plant?
1.10.For the validation of alternative transformation parameters is it possible to derogate from the requirement to demonstrate that the process achieves the reduction of infectivity titre of thermoresistant viruses such as parvovirus by at least 3 log10, is these viruses are not identified as a relevant hazard?
1.11.Is it possible to use Category 1 materials [Article 8 (a) (v) of Regulation 1069/2009] other than those referred to in Article 8(b)(ii) for the feeding of endangered or protected species of necrophagous birds in their natural habitat? For example entire bodies of wild boar in regions endemic for tuberculosis, suspected of being infected with the diseases. In the wild, it is impossible to avoid the ingestion of these bodies by vultures.
1.12.Is there a limit to the size of samples of animal by-products and derived products imported from third countries, which are destined for research and diagnostic purposes?
2.Placing on the market within the EU
2.1.Who can place former foodstuffs meeting the requirements of Annex X Section 10 of regulation 142/2011 for feeding to farmed animals on the market as revised on the SCoFCAH meeting on 10 September?
2.2.Should feeding of laboratory animals be covered under rules on research and diagnostic material?
2.3.Are feeding trials of pet animals subject to the requirements on trade samples?
2.4.Can a Member State of destination ask for pre-notification in case of dispatch of processed manure?
2.5.is it necessary that a consignment of derived products which have been declared as the end point in the manufacturing chain would be accompanied by a commercial document?
3.imports from the Third countries into the EU
3.1.Are animal by-products and derived products produced in third countries from raw material or derived products of the EU origin eligible for export to the EU eventhough the EU is not listed as authorized third country for the export into the EU?
3.2.Is it true that no specified risk material (SRM)-related certification is required related to cervid materials (e.g. in pet food)?
3.3.Is it true that border inspection posts can allow materials being imported with certification for human consumption to be downgraded for other uses?
3.4.Is any certification (or listing in TRACES) required for meeting the requirements of Article 25, point 2(b) of Regulation (EU) No 142/2011?
3.5.Is it true that facilities exporting research and diagnostic samples to the EU do not need to be listed in TRACES?
3.6.Is it true that no certificate is required and exporting facilities in third countries do not need to be listed on TRACES to export several samples to the EU?
3.7.Regarding the Chapter 6(A) health certificate, section I.11 and I.28, if a game trophy is treated and packaged at one facility, but then exported through a different warehouse, how is the certificate completed? [For other certificates, the treatment facility number would go in I.28, and the warehouse facility number would go in I.11, but there is no place for the treatment facility number in I.28.]
3.8.Can processed animal protein (other than manure) be imported for fertilizer/soil improvers? If so, with which certificate?
3.9.Are there any by-products not listed in the TECHNICAL SPECIFICATIONS FOR THE COMPETENT AUTHORITIES OF THIRD COUNTRIES that third countries would be required to have listed in TRACES?
3.10.Shall the statement laid down in Section II.2.5 of the Certificate Chapter 8 referred to in Annex XV to Regulation (EU) 142/2011 "in containers sealed under the responsibility of the competent authority" be applicable also in case of Fed Ex type shipments (parcels)?
3.11.Should the consignment of treated feathers or down sent to private individuals for non-industrial purposes be subject to veterinary checks?
3.12.What specific terminology is acceptable in Section I.28 of the health certificates for the “species (scientific name)”?
3.13.Is it acceptable to prepare section I.5 of the Health Certificates as follows for consignments that are only transiting the EU?
3.14.Should the biodiesel produced in third countries be a subject to veterinary checks?
3.15.Boxes I.3 and I.4 of the import certificates require the indication of the “Central competent authority” and of the “Local competent authority”. In many cases, the “Central competent authority” does not sign the certificate. Is it sufficient if either the local or the central authority is indicated?
3.16.Finished pet food products can be imported from third countries using certificate 8 as trade samples (see also point 2.3). In box I.19 of certificate 8, is it possible to use the HS code 23.09 (pet food)?
3.17.For certificate 8 in box II.1 trade samples must be labelled “TRADE SAMPLE NOT FOR HUMAN CONSUMPTION”. In case of groups of trade samples (e.g. different packed pet food products imported in one assembled consignment) are imported, is it necessary to label each single trade sample?
3.18.For certificate 8, box I.12 requires the place of destination in the EU. In case of trade samples, can the shipment be divided and be sent for example to different destinations/institutions within the Member State of destination, e.g. for conducting feeding trials?
3.19.For importing trade samples under certificate, are there quantitative limitations, i.e. a maximum tonnage?
3.20.The model certificates 3 (A) to 3 (C), 3 (E) and 3 (F) prohibit the use of hides and skins from ruminants. Since this is not fully aligned with Art 10 (iii) of Regulation (EU) 1069/2009 can the reference to ruminants be deleted in the relevant certificates?
1.General issues
1.1.Should household and small community composting facilities be in the scope of Regulation (EC) No 1069/2009?
Households and small community composting facilities intended for the composting of catering waste for non–commercial purposes should be exempted from the scope of the Regulation. However, given that the catering waste has not undergone an approved composting treatment the output should be regarded as untreated catering waste and as such the operator is under an obligation to keep such material away from livestock which may feed on it (Article 2.2(g) of the regulation (ii) refers).
Therefore persons responsible for such composting plants should use the compost only for local use as fertilizer e.g. in backyards gardens or parks. As soon as the compost become subject to transport or trade, the composting plant must be a subject to an approval procedure.
1.2.If antibodies are grown from bacteria with no animal origin material involved, is this commodity still within the scope of the ABP legislation?
Purified antibodies are not considered as animal by-products if it concerns antibodies grown from bacteria.
However where bacteria-grown antibodies are contained within a stabilizer / carrier substrate that is an ABP (i.e. Bovine serum albumin (BSA) or Foetal Bovine Serum (FBS)), the additional documentation may be required from the Member State concerned.
1.3.Should production of fat balls for feeding of birds be subject to the ABP legislation?
Establishments for the production of fat balls for feeding of birds should be subjected onlyto requirement laid down by Regulation (EC) No 183/2005.
It is assumed that rendered fats shall be a Category 3 material referred to in Regulation (EC) No 1069/2009 which is obtained in approved slaughterhouse. With reference to Article 23(4) of Regulation (EC) No 1069/2009 "no notification with a view to registration shall be required for activities with respect to which establishments generating animal by-products have already been approved or registered in accordance with Regulation (EC) No 852/2004 or Regulation (EC) No 853/2004; and for activities with respect to which establishments or plants have already been approved in accordance with Article 24 of this Regulation".
However, only the competent authority has the possibility to verify the actual situation and in particular compliance with the provisions of Article 24 (1) (j) (iii) of Regulation (EC) No 1069/2009 on the spot. Only in case the exemptions of Article 23 (4) of Regulation 1069/2009 do not apply, a registration under Article 23 (1) - (3) of Regulation 1069/2009shall be required.
1.4.Can we produce rendered fats and fish oil within the same processing plant at the same time?
With reference to Point 8 and 9 of Annex I and Section 3 of Chapter II of Annex X rendered fats and fish oil should be understood as different commodities. However, there are no legal grounds to prohibit the processing of animal by-products and fishery products into rendered fats and fish oil within the same establishment.
1.5.Does the spray drying of blood, which is derived from carcases considered fit for human consumption and involves the heat treatment of plasma, result in a blood product or a blood meal?
It results in a blood product.
1.6.Is an animal that have been in an experiment for the diagnosis of particular enzootic diseases be considered after slaughter, as category 1 materials, as referred to under Article 8 (1)(a)(iv) to R1069/2009.
The situation describesanimals referred to in Article 2(b) of Directive 86/609/EEC which had been subject to experiments referred to in Article 2(d) of aforementioned Directive. With reference to Article 8(a)(iv) of Regulation 1069/2009 “animals used for experiments as defined by Article 2(d) of Directive 86/609/EEC without prejudice to Article 3(2) of Regulation (EC) No 1831/2003;” must be declared as Category 1 material. Disposal and use of Category 1 material is described in Article 12 of Regulation (EC) No 1069/2009.
1.7.Is a cell culture derived from laboratory animals which have been produced more than 5 years ago still subject to the animal by-products legislation?
No, it is not. Cell cultures obtained from laboratory animals and intended to be reference culture in inter-laboratory exchange are not subject to the requirements laid down in the animal by-products legislation.
1.8.I am the owner of a small shop and I am selling also some foodstuffs. The foodstuffs are only candies and sweets, like chocolate bars, packed and ready to use. All candies and chocolates contain ingredients of animal origin like milk, eggs etc., but in very small amounts. Do I need to follow rules on disposal of animal by-products?
The animal by-products legislation does not provide for derogation in such cases. However, the disposal of all animal by-products is not a realistic option, in particular when it would lead to unsustainable costs. The animal by-products legislation lays down public health and animal health rules for animal by-products and derived products, in order to prevent and minimise risks to public and animal health arising from those products, and in particular to protect the safety of the food and feed chain.
If the operator has no intention to dispatch former foodstuffs into production chain of feeding-stuff, he may participate in the system for disposal of foodstuffs based on waste legislation, the competent authority may delegate such disposal of former foodstuffs, which contain small quantity of animal by-products referred to in Section 10 of Annex X to Regulation (EU) No 142/2011, to relevant competent authority.
1.9.Is it possible to carry out the validation of alternative transformation parameters for composting on in pilot scale plant (laboratory trial) or is it necessary for the validation of alternative transformation parameters to be carried out in an industrial scale plant?
Only industrial scale plant may provide with the real situation which is necessary for the validation of any parameters which are based to legislation subject to assessment for the purpose of validation, registration or approval of alternative treatments.
1.10.For the validation of alternative transformation parameters is it possible to derogate from the requirement to demonstrate that the process achieves the reduction of infectivity titre of thermoresistant viruses such as parvovirus by at least 3 log10, is these viruses are not identified as a relevant hazard?
It is up to the competent authority to decide the scope of the assessment and the extension of their capacity in this sector. If the competent authority cannot provide assessment please consult EFSA.
1.11.Is it possible to use Category 1 materials [Article 8 (a) (v) of Regulation 1069/2009] other than those referred to in Article 8(b)(ii) for the feeding of endangered or protected species of necrophagous birds in their natural habitat? For example entire bodies of wild boar in regions endemic for tuberculosis, suspected of being infected with the diseases. In the wild, it is impossible to avoid the ingestion of these bodies by vultures.
It is impossible to avoid the feeding of necrophagous birds with wild animals which die in the wild for the reason of disease communicable to humans or animals.
However, feeding of necrophagous with Category 1 material reffered to in Article 8(a)(v) should not be an authorize method for disposal of named aniamal by-products.
1.12.Is there a limit to the size of samples of animal by-products and derived products imported from third countries, which are destined for research and diagnostic purposes?
No, there is no such limit.
2.Placing on the market within the EU
2.1.Who can place former foodstuffs meeting the requirements of Annex X Section 10 of regulation 142/2011 for feeding to farmed animals on the market as revised on the SCoFCAH meeting on 10 September?
Only registered feed business operators registered under Regulation (EC) No 183/2005 may collect, handle, store and place on the market former foodstuffs.
2.2.Should feeding of laboratory animals be covered under rules on research and diagnostic material?
The definition of research and diagnostic samples laid down in point 38 of Annex I and the requirements for dispatch of research and diagnostic samples laid down in Section 1 of Chapter I of Annex VI to Regulation (EU) No 142/2011have never directly mentioned feeding of laboratory animals.
However, laboratory animals are to be intended only for participation in research and diagnostic trials. Therefore, feed for laboratory animals when not complying with therequirements of petfood production may be produced, placed on the market or imported under the rules on research and diagnostic material.
2.3.Are feeding trials of pet animals subject to the requirements on trade samples?
Feeding trials of pet animals may be subject to requirement on trade samples. Petfood is a derived product referred to point 2 of Article 3(2) of Regulation (EC) No 1069/2009. Feeding trials of pet animals should be considered as feed for "particular studies or analyses with a view to carrying out a production process or developing feedingstuffs or other derived products," and shall be allowed for trade samples. This applies to EU produced pet food and imported pet food.
2.4.Can a Member State of destination ask for pre-notification in case of dispatch of processed manure?
The pre-notification procedure referred to in Article 48(1) of Regulation (EC) No 1069/2009 is not applicable in case of trade in processed manure. Processed manure which has been processed in accordance with requirements laid down in Section 2 of Chapter II of Annex XI to Regulation (EU) No 1420/2011 should be declared as a derived product. Aforementioned Article 48(1) may be applicable on to unprocessed manure.
Member States may apply only the notification in TRACES. With reference to point 2 of Chapter III of Annex VIII to Regulation (EU) No 1420/2011 " Member States may require that proof of the arrival of the consignments is provided by the TRACES system or by a fourth copy of the commercial document which is sent back by the receiver to the producer." If the Member State of destination insists on receipt of TRACES information which shall arrive to the local veterinary Unit of destination atthe same time as the operator at the place of dispatch would enter it into the TRACES system, the effect would be similar to application of Article 48(1) of Regulation (EC) No 1069/2009.
2.5.is it necessary that a consignment of derived products which have been declared as the end point in the manufacturing chain would be accompanied by a commercial document?
No.
3.imports from the Third countries into the EU
3.1.Are animal by-products and derived products produced in third countries from raw material or derived products of the EU origin eligible for export to the EU eventhough the EU is not listed as authorized third country for the export into the EU?
Yes, any animal by-products and derived products produced in third countries from raw material or derived products of the EU origin should be eligible for export to the EU if the third country of export is listed in list of authorized third countries for the import into the EU referred to in Table 1 or Table 2 of Chapter I of Annex XIV to Regulation (EU) No 1420/2011.