CELEX: 62019CJ0836
Reference for a preliminary ruling
Public health
Health rules concerning animal by-products not intended for human consumption
Regulation (EC) No 1069/2009
Article 9(d) and Article 10(a) and (f)
Classification of products
Decomposition, spoilage and the presence of foreign bodies in the material
Effect on original classification

This request for a preliminary ruling concerns the interpretation of Article 9(d) and Article 10(a) and (f) of 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) (
OJ 2009 L 300, p. 1
).
The request has been made in proceedings between Toropet Ltd, a company registered under the law of England and Wales that operates an offal processing establishment in Germany, and Landkreis Greiz (administrative district of Greiz, Germany) concerning a decision by that district ordering the disposal of certain animal by-products.
Legal framework
European Union law
Regulation (EC) No 178/2002
Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (
OJ 2002 L 31, p. 1
) provides in Article 14(5):
‘In determining whether any food is unfit for human consumption, regard shall be had to whether the food is unacceptable for human consumption according to its intended use, for reasons of contamination, whether by extraneous matter or otherwise, or through putrefaction, deterioration or decay.’
Regulation (EC) No 1013/2006
Article 2(2) of Regulation (EC) No 1013/2006 of the European Parliament and of the Council of 14 June 2006 on shipments of waste (
OJ 2006 L 190, p. 1
) defines ‘hazardous waste’ by reference to the definition provided in Article 1(4) of Council Directive 91/689/EEC of 12 December 1991 on hazardous waste (
OJ 1991 L 377, p. 20
).
Regulation (EC) No 853/2004
Annex I to 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 2004 L 139, p. 55
and corrigendum
OJ 2004 L 226, p. 22
) provides, in points 1.9 and 8.1:
‘1.9 “Carcase” means the body of an animal after slaughter and dressing.
…
8.1 “Products of animal origin” means:
–
food of animal origin, including honey and blood;
–
live bivalve molluscs, live echinoderms, live tunicates and live marine gastropods intended for human consumption;
and
– other animals destined to be prepared with a view to being supplied live to the final consumer.’
Regulation No 1069/2009
Recitals 2, 5, 6, 11, 29, 35, 36 and 38 of Regulation No 1069/2009 state:
‘(2)
Animal by-products arise mainly during the slaughter of animals for human consumption, during the production of products of animal origin such as dairy products, and in the course of the disposal of dead animals and during disease control measures. Regardless of their source, they pose a potential risk to public and animal health and the environment. This risk needs to be adequately controlled, either by directing such products towards safe means of disposal or by using them for different purposes, provided that strict conditions are applied which minimise the health risks involved.
…
(5)
Community health rules for collection, transport, handling, treatment, transformation, processing, storage, placing on the market, distribution, use or disposal of animal by-products should be laid down in a coherent and comprehensive framework.
(6)
Those general rules should be proportionate to the risk to public and animal health which animal by-products pose when they are dealt with by operators at different stages of the chain from collection to their use or disposal. The rules should also take into account the risks for the environment posed during those operations. The Community framework should include health rules on the placing on the market, including intra-Community trade and import, of animal by-products, where appropriate.
…
(11)
… The chief objectives of the rules on animal by-products, namely the control of risks to public and animal health and the protection of the safety of the food and feed chain, should be clearly laid down. The provisions of this Regulation should permit the achievement of those objectives.
…
(29)
Animal by-products and derived products should be classified into three categories which reflect the degree of risk that they pose to public and animal health, on the basis of risk assessments. While animal by-products and derived products posing a high risk should only be used for purposes outside the feed chain, their use posing a lower risk should be permitted under safe conditions.
…
(35)
… For any other animal by-products which are not listed under one of the three categories, the categorisation by default as Category 2 material should be maintained for precautionary reasons, in particular to reinforce the general exclusion of such material from the feed chain for farmed animals, other than fur animals.
(36)
Other legislation which has entered into force following the adoption of [Regulation No 178/2002], namely Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs [(
OJ 2004 L 139, p. 1
)], Regulation No 853/2004 and Regulation (EC) No 183/2005 of the European Parliament and of the Council of 12 January 2005 laying down requirements for feed hygiene [(
OJ 2005 L 35, p. 1
)], and to which Regulation (EC) No 1774/2002 [of the European Parliament and of the Council of 3 October 2002 laying down health rules concerning animal by-products not intended for human consumption (
OJ 2002 L 273, p. 1
)] is complementary, places the primary duty of complying with Community legislation, aimed at protecting public and animal health, on the food and feed business operators. In line with that legislation, operators carrying out activities under this Regulation should also be primarily responsible for ensuring compliance with this Regulation. That obligation should be further clarified and specified as regards the means by which traceability is ensured, such as separate collection and channelling of animal by-products. …
…
(38)
Animal by-products should only be used if the risks to public and animal health are minimised in the course of their processing and the placing on the market of derived products manufactured on the basis of animal by-products. If this option is not available, the animal by-products should be disposed of under safe conditions. The options available for the use of animal by-products of the different categories should be clarified in coherence with other Community legislation. In general, the options for a higher risk category should be available for the lower risk categories as well, unless special considerations apply in view of the risk attached to certain animal by-products.’
Article 2(1)(a) of Regulation No 1069/2009 reads as follows:
‘This Regulation shall apply to:
(a)
animal by-products and derived products which are excluded from human consumption under Community legislation; …’
Article 3 of that regulation, entitled ‘Definitions’, provides, in paragraphs 3, 4, 10 and 11:
‘For the purposes of this Regulation, the following definitions shall apply:
…
3.
“products of animal origin” means products of animal origin as defined in point 8.1 of Annex I to Regulation (EC) No 853/2004;
4.
“carcase” means carcase as defined in point 1.9 of Annex I to Regulation (EC) No 853/2004;
…
10.
“competent authority” means the central authority of a Member State competent to ensure compliance with the requirements of this Regulation or any authority to which that competence has been delegated; it also includes, where appropriate, the corresponding authority of a third country;
11.
“operator” means the natural or legal persons having an animal by-product or derived product under their actual control, including carriers, traders and users’.
Article 4 of Regulation No 1069/2009, entitled ‘Starting point in the manufacturing chain and obligations’, provides, in paragraphs 1 to 3:
‘1.   As soon as operators generate animal by-products or derived products falling within the scope of this Regulation, they shall identify them and ensure that they are dealt with in accordance with this Regulation (starting point).
2.   Operators shall ensure at all stages of collection, transport, handling, treatment, transformation, processing, storage, placing on the market, distribution, use and disposal within the businesses under their control that animal by-products and derived products satisfy the requirements of this Regulation which are relevant to their activities.
3.   Member States shall monitor and verify that the relevant requirements of this Regulation are fulfilled by operators along the entire chain of animal by-products and derived products as referred to in paragraph 2. For that purpose, they shall maintain a system of official controls in accordance with relevant Community legislation.’
Article 7 of that regulation, entitled ‘Categorisation of animal by-products and derived products’, provides, in paragraph 1:
‘Animal by-products shall be categorised into specific categories which reflect the level of risk to public and animal health arising from those animal by-products, in accordance with the lists laid down in Articles 8, 9 and 10.’
Article 8 of that regulation, entitled ‘Category 1 material’, provides, in point (g):
‘Category 1 material shall comprise the following animal by-products:
…
(g)
mixtures of Category 1 material with either Category 2 material or Category 3 material or both.’
Article 9 of the same regulation, entitled ‘Category 2 material’, provides, in points (d) and (h):
‘Category 2 material shall comprise the following animal by-products:
…
(d)
products of animal origin which have been declared unfit for human consumption due to the presence of foreign bodies in those products;
…
(h)
animal by-products other than Category 1 material or Category 3 material.’
Article 10 of Regulation No 1069/2009, entitled ‘Category 3 material’, provides, in points (a) and (f):
‘Category 3 material shall comprise the following animal by-products:
(a)
carcases and parts of animals slaughtered or, in the case of game, bodies or parts of animals killed, and which are fit for human consumption in accordance with Community legislation, but are not intended for human consumption for commercial reasons;
…
(f)
products of animal origin, or foodstuffs containing products of animal origin, which are no longer intended for human consumption for commercial reasons or due to problems of manufacturing or packaging defects or other defects from which no risk to public or animal health arise;
…’
Article 14 of that regulation, entitled ‘Disposal and use of Category 3 material’, reads as follows:
‘Category 3 material shall be:
(a)
disposed of as waste by incineration, with or without prior processing;
(b)
recovered or disposed of by co-incineration, with or without prior processing, if the Category 3 material is waste;
(c)
disposed of in an authorised landfill, following processing;
(d)
processed, except in the case of Category 3 material which has changed through decomposition or spoilage so as to present an unacceptable risk to public or animal health, through that product, …
…’
Article 24 of that regulation, entitled ‘Approval of establishments or plants’, provides:
‘1.   Operators shall ensure that establishments or plants under their control are approved by the competent authority, where such establishments or plants carry out one or more of the following activities:
(a)
processing of animal by-products by pressure sterilisation, by processing methods referred to in point (b) of the first subparagraph of Article 15(1) or by alternative methods authorised in accordance with Article 20;
…
(h)
handling of animal by-products after their collection, by way of operations such as sorting, cutting, chilling, freezing, salting, removal of hides and skins or of specified risk material;
…’
Article 25 of that regulation, entitled, ‘General hygiene requirements’, provides as follows in paragraph 1(e):
‘Operators shall ensure that establishments or plants under their control carrying out the activities referred to in Article 24(1)(a) and (h):
…
(e)
have appropriate arrangements for the cleaning and the disinfection of containers and vehicles in place to avoid risks of contamination.’
Under Article 28 of Regulation No 1069/2009, entitled ‘Own checks’,
‘Operators shall put in place, implement and maintain own checks in their establishments or plants in order to monitor compliance with this Regulation. They shall ensure that no animal by-products or derived products suspected or discovered not to comply with this Regulation leave the establishment or plant, unless destined for disposal.’
Regulation (EU) No 142/2011
Annex IV to Commission Regulation (EU) No 142/2011 of 25 February 2011 implementing Regulation (EC) No 1069/2009 and implementing Council Directive 97/78/EC as regards certain samples and items exempt from veterinary checks at the border under that Directive (
OJ 2011 L 54, p. 1
) provides as follows in point 3 of Chapter I, Section 4:
‘The following requirements shall apply in addition to the general conditions set out in Section 1:
…
3.
Processing plants processing Category 3 material shall have in place an installation to check the presence of foreign bodies, such as packaging material or metallic pieces, in the animal by-products or derived products, if they are processing materials which are destined for feeding. Such foreign bodies shall be removed before or during processing.’
German law
Law on animal by-products disposal
The Tierische Nebenprodukte-Beseitigungsgesetz (Law on animal by-products disposal) of 25 January 2004 (BGBl. 2004 I, p. 82), in the version applicable to the dispute in the main proceedings (BGBl. 2016 I, p. 1966), (‘the Law on animal by-products disposal’) provides as follows in Paragraph 1, entitled ‘Scope’:
‘This law is intended to implement [Regulation No 1069/2009] and any directly applicable legal acts of the Community or the European Union adopted under that regulation.’
Paragraph 3 of the Law on animal by-products disposal, entitled ‘Disposal obligation’, reads as follows:
‘(1)   Where, in accordance with the provisions referred to in Paragraph 1,
1.
Category 1 animal by-products within the meaning of Article 8 of Regulation (EC) No 1069/2009,
2.
Category 2 animal by-products within the meaning of Article 9 of Regulation (EC) No 1069/2009, with the exception of manure, guano, digestive tract content, milk, milk-based products, colostrum, eggs and egg-based products, or
3.
products derived from the animal by-products referred to in points 1 and 2
are to be recovered, collected, identified, transported, stored, treated, processed, used or disposed of, the competent authority shall lay down the conditions for recovery, collection, identification, transport, storage, treatment, processing, use and disposal. The competent authority must recover, collect, identify, transport, store, treat, process, use or dispose of
1.
Category 1 animal by-products,
2.
Category 2 animal by-products with the exception of manure, guano, digestive tract content, milk, milk-based products, colostrum and eggs and egg-based products, and
3.
products derived from the animal by-products referred to in points 1 and 2
generated in its territory in accordance with the directly applicable legal acts referred to in Paragraph 1, with this law and with any provisions adopted under it. Until such time as the animal by-products and derived products generated at their premises are recovered by the competent authority, the obligations on owners to identify, transport and store them, under the provisions of the directly applicable legal acts referred to in Paragraph 1, remain unchanged. The competent authority may have recourse to third parties in order to discharge its obligations under the second sentence. The second sentence also applies to dead wild animals where the competent authority has ordered use, processing or disposal for reasons relating to the control of animal diseases.
(2)   The second sentence of subparagraph 1 shall not apply where the animal by-products and derived products are intended for the manufacture of feed and of derived products referred to in Articles 33 and 36 of Regulation (EC) No 1069/2009 and where the animal by-products and derived products have been collected, identified, transported, stored, treated, processed or used by operators, establishments or plants registered in accordance with Article 23 of Regulation (EC) No 1069/2009 or approved in accordance with Article 24 of Regulation (EC) No 1069/2009.
(3)   In respect of the animal by-products and derived products referred to in the first sentence of subparagraph 1, the competent authority may transfer the obligation to recover, collect, identify, transport, store, treat, process, use or dispose of the animal by-products or derived products fully or in part to the operator of a processing establishment or incineration or co-incineration plant that is a natural person or legal person existing under private law, with the consent of that person, provided:
1.
there is no contrary overriding public interest,
2.
the processing establishment or incineration or co-incineration plant complies with the requirements applicable to the processing method concerned, set out in Articles 6, 8 and 9 of 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 (
OJ 2011 L 54, p. 1
), as amended, and
3.
compliance with the other provisions of Regulation (EC) No 1069/2009, the legal acts adopted to implement it, this law and any provisions adopted under it is guaranteed.
Where those obligations are transferred in part, the transfer may be subject to the condition that the processing establishment or incineration or co-incineration plant recovers, collects, identifies, transports, stores, treats, processes, uses or disposes of the animal by-products and derived products generated in a particular area, where required in the public interest.
(4)   The competent authority may require a processing establishment or incineration or co-incineration plant temporarily to authorise shared use of the establishment or plant, in return for reasonable remuneration based on the costs and outputs, to process or dispose of the animal by-products or derived products referred to in the first sentence of subparagraph 1 generated outside the catchment area of the processing establishment or incineration or co-incineration plant, where it is reasonable to do so and the animal by-products or derived products cannot be usefully processed or disposed of in any other way or without considerable additional cost. If no agreement can be reached on the remuneration, that remuneration shall be set by the competent authority.’
Paragraph 12 of the Law on animal by-products disposal, entitled ‘Monitoring’, provides:
‘(1)   The competent authority and, in matters within the competence of the Bundeswehr (federal army), the services designated by the Federal Defence Ministry shall monitor compliance with the provisions of the directly applicable legal acts referred to in Paragraph 1, the provisions of this law and any regulations adopted under it and enforceable orders issued in accordance with the directly applicable legal acts referred to in Paragraph 1, this law or any regulation adopted under it.
(2)   The competent authority may, on a case-by-case basis, issue the orders required for compliance with the provisions of the directly applicable legal acts referred to in Paragraph 1 of this law and any regulations adopted under this law. This provision shall also apply after the registration referred to in Article 23 of [Regulation No 1069/2009] and after the grant of approval under Article 24 of [Regulation No 1069/2009].’
Thuringian law implementing the Law on animal by-products disposal
The Thüringer Ausführungsgesetz zum Tierische Nebenprodukte-Beseitigungsgesetz (Thuringian law implementing the Law on animal by-products disposal) of 10 June 2005 (Thür GVBl. 2005, p. 224), provides as follows in Paragraph 2, entitled ‘Persons responsible for the processing and disposal of Category 1 and Category 2 animal by-products’:
‘(1)   The administrative and urban districts shall be competent public law entities (disposal bodies) within the meaning of Paragraph 3, subparagraph 1, of the Law on animal by-products disposal. They shall perform that task under self-administration arrangements.
(2)   To perform that task, the disposal bodies referred to in subparagraph 1 may form an association of local entities. Their operating arrangements shall be set by the constitution. That disposal body shall be solely responsible for performing that task through the association.’
Paragraph 3 of the Thuringian law implementing the Law on animal by-products disposal, entitled ‘Catchment areas’, reads as follows:
‘(1)   The Ministry for Veterinary Affairs shall, in consultation with the disposal bodies, lay down regulations determining the areas within which those bodies must recover, collect, transport, store, treat, process or dispose of the animal by-products referred to in the first sentence of subparagraph 1 of Paragraph 3 of the Law on animal by-products disposal. In that respect, it must have regard to the interests of protecting against animal diseases, production of the animal by-products referred to in the first sentence of subparagraph 1 of Paragraph 3 of the Law on animal by-products disposal, conditions relating to movement and the capacity of the processing plants.
(2)   The Ministry for Veterinary Affairs may, in extremely exceptional cases, authorise the treatment, processing or disposal of the animal by-products referred to in the first sentence of subparagraph 1 of Paragraph 3 of the Law on animal by-products disposal at processing establishments or incineration or co-incineration plants outside the catchment area laid down in accordance with subparagraph 1.’
Thuringian Regulation on catchment areas under the Law on animal by-products disposal
The Thüringer Verordnung über die Einzugsbereiche nach dem Tierische Nebenprodukte-Beseitigungsgesetz (Thuringian Regulation on catchment areas under the Law on animal by-products disposal) of 11 October 2005 (Thür GVBl. 2005, p. 355) provides, in Paragraph 1:
‘For the materials referred to in the first sentence of subparagraph 1 of Paragraph 3 of the [Law on animal by-products disposal] in the version applicable on the material date, the catchment area of the processing establishment at Elxleben in the Sömmerda administrative district shall be the entire territory of the
Land
.’
The dispute in the main proceedings and the questions referred for a preliminary ruling
Toropet operates an establishment in Germany approved under Regulation No 1069/2009 as an intermediate plant for Category 3 material within the meaning of Article 10 of that regulation, and is also registered as a transporter of animal by-products. However, the company is not authorised to handle Category 1 and Category 2 material within the meaning of Articles 8 and 9 of that regulation. In the course of its activities, Toropet processes animal offal which it sells, including to manufacturers of animal food, recyclers of animal fat and biogas plants.
On 23 January 2018, in the course of an administrative inspection carried out at that intermediate plant, the administrative district of Greiz observed the presence of mould, putrefaction and foreign bodies, such as plaster pieces, plastic residues and sawdust, in 38 box pallets containing Category 3 animal by-products. Because of those defects, the administrative district of Greiz recategorised the material concerned as Category 2 and ordered the immediate disposal of the 38 box pallets by means of enforcement by a third party which took place the same day. Toropet was required to pay the costs of those operations, amounting to EUR 2 346.17.
The enforcement was confirmed by a decision of the administrative district of Greiz of 25 January 2018, in which the district stated that, because of those defects, the material at issue could no longer be categorised in Category 3 and had to be categorised in Category 2. Neither Toropet nor its commercial partner, which was to undertake the processing of that material, is authorised to handle Category 2 material. In addition, because there was no separate chilling room, the material at issue could not be stored on site until an amicable solution was found.
On 9 October 2018, Toropet brought an action before the Verwaltungsgericht Gera (Administrative Court, Gera, Germany) for annulment of the decision of 25 January 2018.
In its action, Toropet alleges that the administrative district of Greiz erred by recategorising the material at issue in Category 2 without carrying out a scientific examination. It disputes the finding that the material was bad, rotten or mouldy. Toropet asserts that the criterion used by the veterinarians and the district of Greiz, that is to say, whether the products are fit for human consumption, goes beyond the provisions of Article 10 of Regulation No 1069/2009.
Toropet states that it is clear from Article 14(d) of that regulation that the decomposition and spoilage of animal by-products does not justify downgrading them to a lower category, because they can be recovered under Article 14(b) and disposal is not always necessary. According to Toropet, the animal by-products at issue could come within Article 10(f) of that regulation, since that article excludes only products that pose a significant risk due to animal diseases. It believes that meat changed by mould or putrefaction does not give rise to such a risk. The presence of foreign bodies such as plaster pieces, plastic residues and sawdust in the material concerned cannot give rise to reclassification, to the extent that merely mechanical separation is possible.
Toropet asserts in particular that because Category 3 material is not intended for human consumption, whether or not the material at issue is fit for human consumption is irrelevant.
The referring court notes that the animal by-products at issue were predominantly material originally categorised in Category 3 under either Article 10(a) of Regulation No 1069/2009, which covers carcases and parts of animals slaughtered which are fit for human consumption but are not intended for human consumption, or Article 10(f) of that regulation, which covers products of animal origin, or foodstuffs containing products of animal origin, which are no longer intended for human consumption for commercial reasons or other reasons from which no risk to public or animal health arises.
According to that court, decomposition and spoilage of Category 3 material render, in principle, that material unfit for human consumption and give rise to a risk to public and animal health. It therefore has doubts regarding whether such changes must lead to the material concerned being recategorised in a different category.
The referring court recalls that, as can be seen from recital 11 and Article 1 of Regulation No 1069/2009, the chief objective of the regulation is to control risks to public and animal health and protect the safety of the food and feed chain. Hazardousness is therefore not limited to public health. Article 14(d) of that regulation moreover emphasises that decomposition and spoilage pose risks to public and animal health.
The referring court nevertheless believes that Article 14(d) of Regulation No 1069/2009 may militate against amending the original classification of the material concerned as a result of decomposition or spoilage. According to that court, it can be inferred from that article that decomposition and spoilage affect in principle only the use of Category 3 material, rather than its classification. In its view, while under Article 14(d) of that regulation that material cannot be used to manufacture feed, it seems, in contrast, that it can be used for other purposes, including recovery by co-incineration, in accordance with Article 14(b) of the regulation.
The referring court is also uncertain as to the interpretation to be given to Article 9(d) of Regulation No 1069/2009. Under that article, material which has been declared unfit for human consumption due to the presence of foreign bodies must be categorised as Category 2. Nevertheless, point 3 of Chapter I, Section 4, of Annex IV to Regulation No 142/2011 makes it clear that the presence of foreign bodies is not sufficient to cause the material concerned to be categorised in Category 2, since the regulation requires plants that process Category 3 material to have in place an installation to check the presence of foreign bodies, which must be removed before or during processing. The referring court is also uncertain as to whether preventing the risk of the presence of foreign bodies is relevant where the Category 3 material is not intended for processing into animal feed but for incineration or the production of biodiesel.
In those circumstances, the Verwaltungsgericht Gera (Administrative Court, Gera) decided to stay the proceedings and to refer the following questions to the Court of Justice for a preliminary ruling:
‘(1)
Is Article 10(a) of Regulation No [1069/2009] to be interpreted as meaning that the original classification as Category 3 material is lost if fitness for human consumption no longer applies due to decomposition and spoilage?
(2)
Is Article 10(f) of Regulation No 1069/2009 to be interpreted as meaning that the original classification as Category 3 material for products of animal origin, or foodstuffs containing products of animal origin, is lost if a risk to public or animal health arises from the material as a result of later decomposition or spoilage processes?
(3)
Is the provision of Article 9(d) of Regulation No 1069/2009 to be interpreted restrictively as meaning that material mixed with foreign bodies such as sawdust is only to be categorised as Category 2 material when the material is to be processed and is destined for feeding purposes?’
The questions referred
By its three questions, which it is appropriate to examine together, the referring court asks, in essence, whether Article 10(a) and (f) of Regulation No 1069/2009 must be interpreted as meaning that animal by-products originally categorised as Category 3 material in accordance with that article, which have been changed by decomposition or spoilage, or mixed with foreign bodies, such as pieces of plaster or sawdust, with the effect that they are no longer fit for human consumption and/or are not free of any risk to public or animal health, do not comply with the level of risk associated with that classification and must, as a result, be reassigned to a lower category.
In order to answer those questions, it is necessary, first, to clarify the detailed provisions by which an animal by-product is assigned to a particular category before, second, analysing whether that classification is immutable or whether an animal by-product can be recategorised because, subsequently to its original classification, it has either undergone decomposition or spoilage or has become mixed with foreign bodies.
First of all, as regards the detailed provisions by which an animal by-product is assigned to a particular category, the classification of animal by-products and derived products is governed by Title I, Chapter I, Section 4 of Regulation No 1069/2009, which consists of Articles 7 to 10.
According to Article 7(1) of that regulation, animal by-products are categorised into specific categories on the basis of the level of risk they present to public and animal health. Specifically, the regulation establishes three categories, under Articles 8, 9 and 10, covering Category 1, Category 2 and Category 3 material respectively. Animal by-products fall by definition into one of those three categories. Accordingly, material which the EU legislature considered low risk is in Category 3 while the material in Category 1 and Category 2 poses a high risk to public and animal health, with Category 1 material posing the highest risk.
First, it is clear from the wording of Article 9(h) of Regulation No 1069/2009 that the list of Category 2 material includes animal by-products other than material in Category 1 or Category 3, meaning that Category 2 is a default classification. Furthermore, as the Advocate General noted in point 62 of his Opinion, in the light of recital 35 of that regulation, according to which any animal by-product not listed under one of the three categories must by default be considered to be Category 2 material, Article 9(h) of that regulation must be interpreted broadly as meaning that it covers any animal by-product not categorised in another category.
The lists of Category 1 and Category 3 material, set out in Articles 8 and 10 of Regulation No 1069/2009, are therefore exhaustive and must accordingly be interpreted strictly to the effect that, first, they include only the material listed expressly in those articles and, second, under Article 7(1) of that regulation, that material must comply with the level of risk associated with the relevant category.
It follows that only material expressly referred to in Category 3 and which complies with the level of risk associated with that category comes within Category 3.
Second, as the Advocate General stated in point 54 of his Opinion, the level of risk is also the relevant criterion for the final use of animal by-products. Regulation No 1069/2009, in Articles 12 to 14, read in the light of recital 38, laid down lists of options for use and disposal for each category of material and the rules applicable to each category in order to minimise that level of risk, although not thereby preventing the options for use and disposal available to a high-risk category from being available also to material in low-risk categories.
In the present case, it is clear from the order for reference that the material at issue in the main proceedings was originally categorised in Category 3, under Article 10(a) and (f) of Regulation No 1069/2009.
While Article 10(a) of that regulation provides that Category 3 covers carcases and parts of animals slaughtered which are fit for human consumption but are not intended for human consumption for commercial reasons, Article 10(f) covers material such as products of animal origin which are no longer intended for human consumption for commercial reasons or other reasons or due to problems of manufacturing or packaging defects or other defects from which no risk to public or animal health arises. The criterion for determining whether an animal by-product falls within one of those provisions is therefore the requirement that it be fit for human consumption and/or free of any risk to public or animal health.
In determining whether food is fit for human consumption, Article 14(5) of Regulation No 178/2002 provides that food is unfit for human consumption where it is unacceptable for human consumption for reasons of contamination, whether by extraneous matter or otherwise, or through putrefaction, deterioration or decay.
In the second place, it is necessary to examine whether defects associated with decomposition or spoilage and with the presence of foreign bodies, such as the defects detected during the administrative inspection of 23 January 2018 described in paragraph 26 of this judgment, are such as to modify the level of risk posed by the material originally classified as Category 3 material, within the meaning of Article 10(a) and (f), and therefore justify recategorising that material in Category 2.
It should be emphasised at the outset that neither Article 7 of Regulation No 1069/2009 nor any other provision of that regulation expressly provides for material originally categorised in Category 3 to be downgraded to a lower category. Merely stating as it does that the categorisation of an animal by-product reflects the level of risk it poses to public and animal health, the wording of Article 7 does not serve to determine whether material can be reclassified.
Accordingly, since Article 10(a) and (f) of Regulation No 1069/2009 contains no helpful clarifications, in order to interpret that provision it is necessary to have regard in particular to the context in which it is used and the objectives pursued by the rules of which it is part (see, to that effect, judgment of 19 October 2017, Vion Livestock,
C‑383/16
,
EU:C:2017:783
, paragraph
and the case-law cited).
As regards, first, the objectives pursued by Regulation No 1069/2009, it can be seen from Article 1 and recitals 2, 5, 6 and 11 of that regulation that the chief objectives pursued by the rules on animal by-products are adequately to control risks to public and animal health, to protect the safety of the food and feed chain and to establish a coherent and comprehensive framework of health rules that are proportionate to the health risk which animal by-products pose when they are dealt with by operators at different stages of the chain from their collection to their use or disposal.
It follows that the EU legislature intended to control the risks to public and animal health adequately and proportionately throughout the operations involving animal by-products, which implies that it must be possible to reassess the classification of an animal by-product at any time during those operations and, therefore, to recategorise that by-product where it no longer satisfies the conditions laid down for its original classification.
Second, the context of Articles 7 and 10 of Regulation No 1069/2009 supports that interpretation.
Under Article 4(2) of that regulation, all operators have a duty to ensure that animal by-products satisfy the rules under that regulation ‘at all stages of collection, transport, handling, treatment, transformation, processing, storage, placing on the market, distribution, use and disposal’ of those animal by-products.
It should also be highlighted that, according to recital 36, Regulation No 1069/2009 provides that the operators are primarily responsible for ensuring compliance with that regulation in order to protect public and animal health. In that respect, operators have a duty to comply with the requirements of that regulation which are relevant to their activities when treating animal by-products. Against that background, Article 28 of Regulation No 1069/2009 requires operators, by means of a system of own checks, to ensure that no animal by-products suspected or discovered not to comply with the regulation leave the establishment or plant, unless destined for disposal.
Similarly, under Article 4(3) of Regulation No 1069/2009, Member States are to maintain a system of official controls by which they monitor and verify that operators fulfil the requirements of that regulation along the entire chain of animal by-products. That article also confirms that operators must verify at each stage of the chain of operations whether the animal by-products are in fact still in the category in which they were originally categorised.
It is therefore apparent from the context of Article 10(a) and (f) of Regulation No 1069/2009 and from the objectives pursued by the rules of which those provisions are part that the original assignment of material to a specific category must be monitored and verified along the entire chain of operations so that if that material no longer corresponds to the level of risk originally associated with it, it must be recategorised in order to ensure the safety of the human and animal food chain. Accordingly, as the Advocate General noted in point 80 of his Opinion, classification in a category is not immutable but is, rather, contingent on the level of risk associated with that category being maintained.
It follows that where material such as that at issue in the main proceedings, which was originally categorised in Category 3 under Article 10(a) and (f) of Regulation No 1069/2009, is changed by decomposition or spoilage or by the presence of foreign bodies with the effect that it is no longer fit for human consumption and/or is not free of any risk to public or animal health, that change must necessarily give rise to it being reassigned to a lower category.
Indeed, as both the referring court and the European Commission have noted, the decomposition or spoilage of Category 3 material gives rise to toxins which render it, in principle, unfit for human consumption and also create a risk to human and animal health.
Accordingly, animal by-products originally categorised in Category 3, such as those at issue in the main proceedings, which pose a higher level of risk than that permitted for the purposes of being assigned to that category lose their Category 3 classification.
It follows that, as noted in paragraph 42 of this judgment, according to Article 9(h) of Regulation No 1069/2009, animal by-products other than Category 1 or Category 3 material fall within Category 2. Article 9(h) must therefore apply to animal by-products which, as the result of decomposition or spoilage, pose too high a level of risk to satisfy the requirements to be Category 3 material.
As regards the presence of foreign bodies such as pieces of plaster or sawdust in the material at issue in the main proceedings, first, it is apparent from the information in the request for a preliminary ruling and the file before the Court that, given the nature of those foreign bodies, they are not regarded as hazardous waste within the meaning of Regulation No 1013/2006. Accordingly, as the Advocate General noted in point 43 of his Opinion, that mixture is, in principle, subject to application of Regulation No 1069/2009 (see, to that effect, judgment of 3 September 2020, P.F. Kamstra Recycling and Others,
C‑21/19 to C‑23/19
,
EU:C:2020:636
, paragraph
).
Second, it should be recalled that point 3 of Chapter I, Section 4, of Annex IV to Regulation No 142/2011 requires plants processing Category 3 material to have in place an installation to check the presence of foreign bodies, such as packaging material or metallic pieces. Accordingly, in line with the observations of the Advocate General in point 45 of his Opinion and of the Commission and the district of Greiz, that provision only covers foreign bodies mixed with Category 3 material where they can be removed easily, safely and in compliance with the level of risk requirements laid down for that category by Regulation No 1069/2009.
However, foreign bodies such as pieces of plaster or sawdust, even assuming that they can be detected, may be so closely bound up with the animal by-product that it may be at least difficult if not impossible to extract them, and they therefore cannot be regarded as foreign bodies covered by point 3 of Chapter I, Section 4, of Annex IV to Regulation No 142/2011.
It should be pointed out, as the Advocate General does in point 74 of his Opinion, that the mixture of animal by-products with foreign bodies such as pieces of plaster or sawdust has the same characteristics and in particular the same level of risk as the Category 2 material referred to in Article 9(d) of Regulation No 1069/2009 which covers ‘products of animal origin which have been declared unfit for human consumption due to the presence of foreign bodies’. A mixture such as that at issue in the main proceedings must therefore be classified in Category 2 either under Article 9(d), in the case of products of animal origin within the meaning of that provision, or under Article 9(h) of that regulation in the case of other animal by-products.
Lastly, the argument according to which it can be inferred from Article 14(d) of Regulation No 1069/2009 that decomposition or spoilage affects the use of Category 3 material rather than its classification must fail, since that interpretation conflicts with both the objective and the scheme of Regulation No 1069/2009.
As indicated in paragraph 45 of this judgment, Articles 12 to 14 of Regulation No 1069/2009 laid down lists of options for use and disposal for the Category 1 to Category 3 material referred to in Articles 8 to 10 respectively of that regulation, always in accordance with the level of risk posed by each of the various categories. Accordingly, Article 14 of that regulation does not establish any requirements to be satisfied for the purposes of assigning materials to categories, which are defined exclusively in Articles 8 to 10 of the same regulation, and therefore cannot undermine the system inherent to the categorisation established by the EU legislature in Articles 8 to 10.
In the same context, Toropet’s line of argument that material originally categorised in Category 3 can remain in that category even where it is affected by decomposition or spoilage or despite being mixed with foreign bodies, since that material may be intended not to be processed into animal feed but for other purposes, such as incineration or processing into biogas, cannot be accepted. A change in the original use intended for the material at issue cannot justify its remaining in Category 3 given the high level of risk it poses to public and animal health.
It follows from all the foregoing considerations that the three questions should be answered as follows: Article 7(1), Article 9(h) and Article 10(a) and (f) of Regulation No 1069/2009, read in with the light of Article 4(2) of that regulation, must be interpreted as meaning that animal by-products originally categorised as Category 3 material, under Article 10(a) and (f) of that regulation, which have been changed by decomposition or spoilage, or mixed with foreign bodies, such as pieces of plaster or sawdust, with the effect that they are no longer fit for human consumption and/or are not free of any risk to public or animal health, do not comply with the level of risk associated with that classification and must, as a result, be reassigned to a lower category.
Costs
Since these proceedings are, for the parties to the main proceedings, a step in the action pending before the national court, the decision on costs is a matter for that court. Costs incurred in submitting observations to the Court, other than the costs of those parties, are not recoverable.

On those grounds, the Court (Fourth Chamber) hereby rules:

Article 7(1), Article 9(h) and Article 10(a) and (f) of 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), read in conjunction with Article 4(2) of that regulation, must be interpreted as meaning that animal by-products originally categorised as Category 3 material, under Article 10(a) and (f) of that regulation, which have been changed by decomposition or spoilage, or mixed with foreign bodies, such as pieces of plaster or sawdust, with the effect that they are no longer fit for human consumption and/or are not free of any risk to public or animal health, do not comply with the level of risk associated with that classification and must, as a result, be reassigned to a lower category.

Signatures
(
*1
)	Language of the case: German.