Contents
Judgment of the Court (Eighth Chamber)11 December 2025note(Reference for a preliminary ruling — Regulation (EU) No 528/2012 — Article 3(1)(a) — Concept of biocidal product — Condition as to the intended purpose of the product — Vinegar-based products intended for use as both foodstuffs and cleaning products/disinfectants for foodstuffs (multi-purpose products) — Scope of Regulation No 528/2012 — Article 2(1) and (2) — Annex V — List of the types of biocidal products covered by the regulation — Protection of human and animal health and the environment)In Case C‑473/24,REQUEST for a preliminary ruling under Article 267 TFEU from the Bundesgerichtshof (Federal Court of Justice, Germany), made by decision of 27 June 2024, received at the Court on 4 July 2024, in the proceedingsSpeyer & Grund GmbH & Co. KGvWerner & Mertz GmbH,THE COURT (Eighth Chamber),composed of S. Rodin, acting as President of the Chamber, N. Piçarra and N. Fenger (Rapporteur), Judges,Advocate General: R. Norkus,Registrar: E. Sartori, Administrator,having regard to the written procedure and further to the hearing on 22 May 2025,after considering the observations submitted on behalf of:– Speyer & Grund GmbH & Co. KG, by C. Eggers and C. Böhler, Rechtsanwälte,– Werner & Mertz GmbH, by T.C. Körber and V. Warnecke, Rechtsanwälte,– the German Government, by J. Möller and R. Kanitz, acting as Agents,– the European Commission, by T.S. Bohr, I. Galindo Martín and R. Lindenthal, acting as Agents,after hearing the Opinion of the Advocate General at the sitting on 4 September 2025,gives the following
Judgment
1This request for a preliminary ruling concerns the interpretation of Article 2(1) and of point (e) of the first subparagraph of Article 2(2), of the first indent of Article 3(1)(a) of, and Annex V to, Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (OJ 2012 L 167, p. 1), as amended by Regulation (EU) No 334/2014 of the European Parliament and of the Council of 11 March 2014 (OJ 2014 L 103, p. 22), and by Commission Delegated Regulation (EU) 2019/1819 of 8 August 2019 (OJ 2019 L 279, p. 1) (‘the Biocides Regulation’), of Article 1(5)(e) of Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ 2008 L 353, p. 1) (‘the CLP Regulation’), and of Article 2(6)(d) of Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ 2006 L 396, p. 1, and corrigendum OJ 2007 L 136, p. 3), as amended by the CLP Regulation (‘the REACH Regulation’).
2The request has been made in proceedings between Speyer & Grund GmbH & Co. KG, a company which sells and promotes certain products composed of water and citric acid and/or acetic acid, and Werner & Mertz GmbH, a company selling cleaning products, concerning an action for unfair competition brought by the latter.
Legal context
The Biocides Regulation
3Recitals 1, 3, 18 and 19 of the Biocides Regulation state:(1) Biocidal products are necessary for the control of organisms that are harmful to human or animal health and for the control of organisms that cause damage to natural or manufactured materials. However, biocidal products can pose risks to humans, animals and the environment due to their intrinsic properties and associated use patterns.…(3) The purpose of this Regulation is to improve the free movement of biocidal products within the Union while ensuring a high level of protection of both human and animal health and the environment. … This Regulation should be underpinned by the precautionary principle to ensure that the manufacturing and making available on the market of active substances and biocidal products do not result in harmful effects on human or animal health or unacceptable effects on the environment. ……(18) Certain biocidal products and treated articles as defined in the Regulation are also regulated by other Union legislation. It is therefore necessary to draw clear borderlines in order to ensure legal certainty. A list of product-types covered by this Regulation with an indicative set of descriptions within each type should be set out in an Annex to this Regulation.(19) Biocidal products intended to be used not only for the purposes of this Regulation, but also in connection with medical devices, such as disinfectants used to disinfect surfaces in hospitals and medical devices, may pose risks other than those with which this Regulation is concerned. Therefore, such biocidal products should comply, in addition to the requirements laid down in this Regulation, with the relevant essential requirements …’
4Article 1(1) of that regulation provides:‘The purpose of this Regulation is to improve the functioning of the internal market through the harmonisation of the rules on the making available on the market and the use of biocidal products, whilst ensuring a high level of protection of both human and animal health and the environment. The provisions of this Regulation are underpinned by the precautionary principle, the aim of which is to safeguard the health of humans, the health of animals and the environment. Particular attention shall be paid to the protection of vulnerable groups.’
5Article 2 of that regulation, entitled ‘Scope’, provides, in paragraphs 1 and 2 thereof:1. This Regulation shall apply to biocidal products and treated articles. A list of the types of biocidal products covered by this Regulation and their descriptions is set out in Annex V.2.Subject to any explicit provision to the contrary in this Regulation or other Union legislation, this Regulation shall not apply to biocidal products or treated articles that are within the scope of the following instruments:…(e) 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)] …;…Notwithstanding the first subparagraph, when a biocidal product falls within the scope of one of the abovementioned instruments and is intended to be used for purposes not covered by those instruments, this Regulation shall also apply to that biocidal product in so far as those purposes are not addressed by those instruments.’
6Article 3 of the same regulation, entitled ‘Definitions’, provides:1.For the purposes of this Regulation, the following definitions shall apply:(a) “biocidal product” means— any substance or mixture, in the form in which it is supplied to the user, consisting of, containing or generating one or more active substances, with the intention of destroying, deterring, rendering harmless, preventing the action of, or otherwise exerting a controlling effect on, any harmful organism by any means other than mere physical or mechanical action,…’
7Annex V to the Biocides Regulation, entitled ‘Biocidal product-types and their descriptions as referred to in Article 2(1)’, provides:‘Main group 1: Disinfectants…Product-type 4: Food and feed areaProducts used for the disinfection of equipment, containers, consumption utensils, surfaces or pipework associated with the production, transport, storage or consumption of food or feed (including drinking water) for humans and animals.Products used to be incorporated into materials which may enter into contact with food.Product-type 5: Drinking waterProducts used for the disinfection of drinking water for both humans and animals.…’
The REACH Regulation
8Article 2 of the REACH Regulation, entitled ‘Application’, provides, in paragraph 6 thereof:‘The provisions of Title IV shall not apply to the following mixtures in the finished state, intended for the final user:…(d) food … in accordance with 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)] including use:(i) as a food additive in foodstuffs …;…’
9Article 31 of that regulation, entitled ‘Requirements for safety data sheets’, which is under Title IV of the REACH Regulation, entitled ‘Information in the supply chain’, states, in paragraph 1(a) thereof, that the supplier of a substance or a mixture is to provide the recipient of the substance or mixture with a safety data sheet compiled in accordance with Annex II, where a substance or mixture meets the criteria for classification as hazardous in accordance with the CLP Regulation.
The CLP Regulation
10Article 1(5) of the CLP Regulation states:‘This Regulation shall not apply to substances and mixtures in the following forms, which are in the finished state, intended for the final user:…(e) food or feeding stuffs as defined in Regulation [No 178/2002] including when they are used:(i) as a food additive in foodstuffs …;…’
The dispute in the main proceedings and the questions referred for a preliminary ruling
11Speyer & Grund sells and promotes products under the brand SURIG and, in particular, a product consisting of water and acetic acid (7.5%) known as SURIG Essigspray UNIVERSAL, and a product consisting of water, acetic acid (10%) and citric acid (1.5%) known as SURIG Essigspray EXTRA.
12Those products are sold in transparent spray bottles which have, on their front labels, in addition to the brand and the name of the respective product, an image of unprocessed vegetables, a shiny kitchen sink and a seal with the words ‘tested food grade product’ and ‘100% plant origin’. On the back of those products, the labels state, inter alia, the following information: ‘The practical spray bottle makes it easy to use on salads, fruit and vegetables. … suitable not only for tasty salad dressings, but also a perfect addition to other dishes’.
13Werner & Mertz, which sells cleaning products, is of the view that Speyer & Grund’s promotion and sale of the SURIG Essigspray UNIVERSAL and SURIG Essigspray EXTRA as foodstuffs infringe the rules of fair competition, read in conjunction with the Biocides, CLP and REACH Regulations, in that the labelling and advertising requirements are not complied with, and may, furthermore, mislead consumers, since the products are in fact cleaning products.
14In those circumstances, Werner & Mertz requested the Landgericht Frankfurt am Main (Regional Court, Frankfurt am Main, Germany), in essence, to order Speyer & Grund to cease selling and/or promoting the products at issue in the main proceedings.
15That court upheld that request, taking the view that those products constitute biocidal products.
16Speyer & Grund brought an appeal against that decision before the Oberlandesgericht Frankfurt am Main (Higher Regional Court, Frankfurt am Main, Germany). That court, after having found, in essence, that those products constitute biocidal products, since the shape of the bottle, which the public associates exclusively with cleaning products, and the images shown on the labels of the products support that conclusion and that dual-purpose products are subject to the obligations arising from the Biocides, CLP and REACH Regulations, confirmed the first-instance decision.
17Hearing an appeal on a point of law (Revision) brought by Speyer & Grund, the Bundesgerichtshof (Federal Court of Justice, Germany), which is the referring court, has doubts as to whether dual-purpose products, such as those at issue in the main proceedings, fall within the scope of the Biocides, CLP and REACH Regulations.
18In those circumstances, the Bundesgerichtshof (Federal Court of Justice) decided to stay the proceedings and to refer the following questions to the Court of Justice for a preliminary ruling:(1) Is the first [indent] of point (a) of Article 3(1) of [the Biocides Regulation] to be interpreted as meaning that the intended purpose necessary for a product to be categorised as a biocidal product must be the sole or primary purpose, or is it sufficient that a product is also intended – albeit secondarily – to be used as a biocidal product?(2) Is the second sentence of Article 2(1), read in conjunction with Annex V to [the Biocides Regulation], to be interpreted as meaning that a biocidal product, which is (also) intended for cleaning food, falls within the scope of [that regulation] as a product of Product-type 4 (Food and feed area) in Main group 1 (Disinfectants)?(3) Is point (e) of the first subparagraph of Article 2(2) and the second subparagraph of Article 2(2) [of the Biocides Regulation] to be interpreted as meaning that a biocidal product, which is (also) intended for the cleaning/disinfection of foods, falls solely within the scope of [Regulation No 852/2004], and in particular is not included in the scope of [the Biocides Regulation] by virtue of the … exception [to the exclusion] provided for in the second subparagraph of Article 2(2) thereof?(4) Is the … [exclusion ratione materiae] for food provided for in point (e) of Article 1(5) of [the CLP Regulation] to be interpreted as meaning that that regulation applies to a product … which is intended as both a food as defined in Article 2 of [Regulation No 178/2002] and … a biocidal product as defined in Article 2(1) and the first sentence of point (a) of Article 3(1) of [the Biocides Regulation], notwithstanding that [exclusion ratione materiae], … [if necessary,] provided that the intended purpose as a biocide is the primary purpose?(5) Is the … [exclusion ratione materiae] for food provided for in point (d) of Article 2(6), read in conjunction with Title IV, of [the REACH Regulation,] to be interpreted as meaning that the application of Title IV to a product within the meaning of the fourth question … is not precluded, notwithstanding that [exclusion ratione materiae], if [necessary,] provided that the intended purpose as a biocide is the primary purpose?’
Consideration of the questions referred
The first question
19By its first question, the referring court asks, in essence, whether the first indent of Article 3(1)(a) of the Biocides Regulation must be interpreted as meaning that, for a product to fall within the concept of ‘biocidal product’, as defined in that provision, that product must be intended for use exclusively or primarily as a biocide, or whether such use may be merely incidental to other intended uses.
20According to settled case-law, it follows from the need for a uniform application of EU law and from the principle of equality, that the terms of a provision of EU law which makes no express reference to the law of the Member States for the purpose of determining its meaning and scope must normally be given an autonomous and uniform interpretation throughout the European Union; that interpretation must take into account the context of the provision and the purpose of the relevant regulations (judgment of 4 October 2024, AFAÏA, C‑228/23, EU:C:2024:829, paragraph 39 and the case-law cited).
21Under the first indent of Article 3(1)(a) of the Biocides Regulation, ‘biocidal product’ means ‘any substance or mixture, in the form in which it is supplied to the user, consisting of, containing or generating one or more active substances, with the intention of destroying, deterring, rendering harmless, preventing the action of, or otherwise exerting a controlling effect on, any harmful organism by any means other than mere physical or mechanical action’.
22The Court has held that it is thus apparent from the wording of that provision that a product must be classified as a ‘biocidal product’, within the meaning of that provision, if it satisfies three cumulative conditions. First, that product must consist of one or more ‘active substances’, whether because it contains those substances or because it generates them. Second, the product must pursue certain aims, namely destroying, deterring, rendering harmless, preventing the action of, or otherwise exerting a controlling effect on any harmful organism. Third, the mode of action of that product must be ‘other than mere physical or mechanical action’ (see, to that effect, judgment of 14 October 2021, Biofa, C‑29/20, EU:C:2021:843, paragraphs 26 and 28).
23As regards the second condition, which is the focus of the referring court’s questions, it is not apparent from the wording of the first indent of Article 3(1)(a) of the Biocides Regulation that the classification of a product as a ‘biocidal product’, within the meaning of that provision, requires that product to be intended for use exclusively or predominantly as a biocide.
24As to the context of that provision, it follows from the first subparagraph of Article 2(2) of the Biocides Regulation that, subject to any explicit provision to the contrary in that regulation or in other legislative acts of the European Union, that regulation does not apply to biocidal products falling within the scope of certain legal instruments listed in that article, such as Regulation No 852/2004.
25That being so, the second subparagraph of Article 2(2) of the Biocides Regulation contains a derogation from that rule, stipulating that, notwithstanding the first subparagraph, biocidal products covered by the instruments listed in the first subparagraph of Article 2(2) of that regulation, while being intended to be used for purposes not covered by those instruments, are to be subject to the Biocides Regulation in so far as those purposes are not addressed by those instruments.
26Furthermore, as is reflected in recital 1 of the Biocides Regulation, biocidal products can pose various risks to humans, animals and the environment due inter alia to their associated use patterns. As recital 19 of that regulation states, ‘biocidal products intended to be used not only for the purposes of this Regulation, but also in connection with medical devices … may pose risks other than those with which this Regulation is concerned [and] therefore such biocidal products should comply, in addition to the requirements laid down in this Regulation, with the relevant essential requirements set out in [the legal instruments concerning those devices]’.
27It follows that the context surrounding the first indent of Article 3(1)(a) of the Biocides Regulation confirms that the EU legislature took into account multi-purpose products, including their use as a biocide, without making the application of that regulation conditional on the product concerned having an exclusively biocidal purpose.
28As was noted, in essence, by the Advocate General in points 26 and 27 of his Opinion, the mere fact that a product has several intended uses does not prevent it from being classified, having regard to the condition relating to intended purpose, as a biocidal product, within the meaning of the first indent of Article 3(1)(a) of the Biocides Regulation.
29Moreover, the second subparagraph of Article 2(2) of the Biocides Regulation, read in the light of recitals 3 and 19 of that regulation, does not contain any details as to the nature or intensity of use as a biocide, which confirms that a product which is incidentally used as a biocide cannot be excluded from the scope of that regulation.
30A reading of that provision with a broad understanding of the classification of a product as biocidal product, to the effect that such a classification is not contingent upon an exclusive or predominant biocidal purpose, is in conformity with the objective of the Biocides Regulation, as is apparent from Article 1(1) of that regulation, read in the light of recital 3 thereof, which is, inter alia, to ensure a high level of protection of both human and animal health and the environment, it being stated that the provisions of that regulation are underpinned by the precautionary principle.
31Indeed, interpreting the first indent of Article 3(1)(a) of the Biocides Regulation as meaning that any biocidal purpose, even if merely secondary, of a given product suffices to consider that the second cumulative condition that a biocidal product must meet, referred to in paragraph 23 of the present judgment, is fulfilled, tends to protect, in the same way, all users of biocidal products, whether they use them in accordance with their secondary biocidal purpose or with their exclusive or primary biocidal purpose.
32Having regard to the foregoing, the answer to the first question is that the first indent of Article 3(1)(a) of the Biocides Regulation must be interpreted as meaning that, for a product to fall within the concept of ‘biocidal product’, as defined in that provision, that product does not necessarily have to be intended for use exclusively or primarily as a biocide, as such use may also be incidental to other intended uses.
The second and third questions
33By its second and third questions, the referring court asks, in essence, whether Article 2(1) and (2) of the Biocides Regulation, read in conjunction with Product-type 4 of Main group 1 in Annex V to that regulation, must be interpreted as meaning that a biocidal product which is intended for cleaning and disinfecting foodstuffs falls within the scope of that regulation.
34As a preliminary point, it should be stated that the examination of these questions is based on the premiss, which is that of the order for reference, according to which the products at issue in the main proceedings are intended for a dual purpose: as foodstuffs and as cleaning products/disinfectants of foodstuffs.
35Under Article 2(1) of the Biocides Regulation, that regulation is to apply to biocidal products and treated articles, with the list of the types of biocidal products covered by the regulation and their descriptions set out in Annex V thereto.
36As is stated in recital 18 of the Biocides Regulation, certain biocidal products are also regulated by other EU legislation, which makes it necessary to draw clear borderlines in order to ensure legal certainty and, therefore, to establish a ‘list of product-types covered by [that] regulation with an indicative set of descriptions within each type’ set out in an annex to that regulation.
37It thus follows from the wording of Article 2(1) of the Biocides Regulation, read in the light of recital 18 thereof, that the list of products covered by Annex V to that regulation must be considered exhaustive. Indeed, the term ‘indicative’ appearing in that recital relates only to the ‘descriptions’ for each type of product and not to the ‘list’ of types of biocidal product.
38It follows that, for a given product to fall within the scope of the Biocides Regulation, the mere fact that it corresponds to the definition of a biocidal product set out in Article 3(1) of that regulation is not sufficient. Such a product must, in addition, correspond to one of the product-types in Annex V to the Biocides Regulation.
39In that regard, Product-type 4, in Main group 1 of the product-types entitled ‘Disinfectants’, in Annex V to that regulation, mentions products used for the disinfection of equipment, containers, consumption utensils, surfaces or pipework associated with the production, transport, storage or consumption of food or feed (including drinking water) for humans and animals, as well as products used to be incorporated into materials which may enter into contact with food.
40It is apparent from the description of the biocidal products covered by Product-type 4, in Main Group 1 of the product-types in Annex V to the Biocides Regulation, that reference is made to the ‘surfaces’ not of the foodstuffs themselves, but to the surfaces on which those foodstuffs have been processed or which have been in contact with those foodstuffs. Moreover, the ‘products’ referred to in that provision must be understood as those used for the disinfection of materials and surfaces used for various actions involving food and feed.
41By contrast, that product-type 4 cannot be understood as meaning that the purposes referred to under that product-type relate to the disinfection of a foodstuff itself for consumption later.
42While, admittedly, Product-type 5, entitled ‘Drinking water’, included in the same Main group 1 in Annex V to that regulation, refers to products used for ‘the disinfection of drinking water for both humans and animals’, that product-type concerns only drinking water and not foodstuffs. If the intention of the EU legislature had been also to cover foodstuffs, they would have been expressly mentioned in that annex, given the importance of the safety of foodstuffs within the European Union.
43Furthermore, that reference to ‘drinking water’ cannot lead to the conclusion that the EU legislature intended to classify among the biocidal products falling within the scope of the Biocides Regulation, appearing in Annex V thereto, products such as the ones at issue in the main proceedings, in so far as, as has been noted in paragraph 37 of the present judgment, the list of products covered by that annex is exhaustive.
44Therefore, it must be found that products such as the ones at issue in the main proceedings, whose intended purpose is both as a foodstuff and as a cleaning product or disinfectant of foodstuffs, do not fall within the scope of the Biocides Regulation, as defined in Article 2(1) thereof, read in conjunction with Product-type 4 in Main group 1 in Annex V to that regulation.
45Moreover, the fact that the EU legislature reproduced, in the Biocides Regulation, Product-type 4 previously included in Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (OJ 1998 L 123, p. 1), whereas the former Product-type 20 referring to products used for the preservation of food or feedstocks by the control of harmful organisms, which had also been included in that directive, was not reproduced in the Biocides Regulation, supports the conclusion that products such as the ones at issue in the main proceedings, do not fall within the product-types listed in Annex V to that regulation.
46As regards the referring court’s questions relating to the applicability of the Biocides Regulation, on the basis of the second subparagraph of Article 2(2) thereof, to products whose intended purpose is both as a foodstuff and as a cleaning product or disinfectant of foodstuffs, it must be noted, first, that, while Article 2(1) of that regulation sets out the conditions for the application of that regulation, the first subparagraph of Article 2(2) thereof excludes from the scope of that regulation biocidal products which fall within the instruments listed in that first subparagraph. In particular, point (e) of the first subparagraph of Article 2(2) of the Biocides Regulation provides that, subject to any explicit provision to the contrary, that regulation is not to apply to biocidal products within the scope, inter alia, of Regulation No 852/2004.
47Second, the second subparagraph of Article 2(2) of the Biocides Regulation provides for an exception to that exclusion, indicating that, notwithstanding that first subparagraph, when a biocidal product falls within the scope of one of those instruments and is intended to be used for purposes not covered by those instruments, that regulation is to apply also to that biocidal product in so far as those purposes are not addressed by those same instruments.
48As has been pointed out, in essence, by the Advocate General in point 54 of his Opinion, however, given that the products at issue in the main proceedings, whose intended purpose is both as a foodstuff and as a cleaning product or disinfectant of foodstuffs, do not fall within the scope of that regulation since they do not meet the criteria laid down in Article 2(1) of the Biocides Regulation, it is not necessary to examine them subsequently in the light of paragraph 2 of that article.
49In the light of all the foregoing considerations, the answer to the second and third questions referred is that Article 2(1) and (2) of the Biocides Regulation, read in conjunction with Product-type 4 of Main group 1 in Annex V to that regulation, must be interpreted as meaning that a biocidal product which is intended for cleaning and disinfecting foodstuffs does not fall within the scope of that regulation.
The fourth and fifth questions
50Having regard to the answer given to the second and third questions, there is no need to answer the fourth and fifth questions.
Costs
51Since these proceedings are, for the parties to the main proceedings, a step in the action pending before the referring 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.
Operative part
On those grounds, the Court (Eighth Chamber) hereby rules:
1.The first indent of Article 3(1)(a) of Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products, as amended by Regulation (EU) No 334/2014 of the European Parliament and of the Council of 11 March 2014 and by Commission Delegated Regulation (EU) 2019/1819 of 8 August 2019,must be interpreted as meaning that, for a product to fall within the concept of ‘biocidal product’, as defined in that provision, that product does not necessarily have to be intended for use exclusively or primarily as a biocide, as such use may also be incidental to other intended uses.
2.Article 2(1) and (2) of Regulation No 528/2012, as amended by Regulation No 334/2014 and by Delegated Regulation 2019/1819, read in conjunction with Product-type 4 of Main group 1 in Annex V to that regulation,must be interpreted as meaning that a biocidal product which is intended for cleaning and disinfecting foodstuffs does not fall within the scope of that regulation.
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