C-473/24

Opinia rzecznika generalnegoTSUE2025-09-04CELEX: 62024CC0473ECLI:EU:C:2025:676

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Zagadnienie prawne
1. Czy przeznaczenie produktu jako biobójczego musi być wyłącznym lub głównym celem, czy wystarczy, że jest to cel wtórny, aby produkt został zaklasyfikowany jako produkt biobójczy w rozumieniu art. 3 ust. 1 lit. a) rozporządzenia BPR? 2. Czy produkt biobójczy przeznaczony do czyszczenia lub dezynfekcji żywności wchodzi w zakres rozporządzenia BPR jako produkt typu 4 (obszar żywności i pasz) w głównej grupie 1 (środki dezynfekujące) załącznika V? 3. Czy produkt biobójczy przeznaczony do czyszczenia/dezynfekcji żywności wchodzi wyłącznie w zakres rozporządzenia w sprawie higieny żywności, a nie w zakres rozporządzenia BPR na mocy wyjątku przewidzianego w art. 2 ust. 2 akapit drugi BPR? 4. Czy wyłączenie dla żywności przewidziane w art. 1 ust. 5 lit. e) rozporządzenia CLP należy interpretować w ten sposób, że rozporządzenie to ma zastosowanie do produktu, który jest zarówno żywnością, jak i produktem biobójczym, pod warunkiem, że cel biobójczy jest celem głównym? 5. Czy wyłączenie dla żywności przewidziane w art. 2 ust. 6 lit. d) rozporządzenia REACH należy interpretować w ten sposób, że zastosowanie tytułu IV do produktu o podwójnym zastosowaniu nie jest wykluczone, pod warunkiem, że cel biobójczy jest celem głównym?
Ratio decidendi
Rzecznik Generalny uznał, że przeznaczenie produktu jako biobójczego nie musi być jego jedynym celem, aby został on zaklasyfikowany jako produkt biobójczy, co wynika z kontekstu i celów rozporządzenia BPR, które dążą do wysokiego poziomu ochrony. Jednakże, produkty przeznaczone do czyszczenia lub dezynfekcji *samej żywności* nie wchodzą w zakres rozporządzenia BPR, ponieważ nie mieszczą się w żadnym z typów produktów wymienionych w wyczerpującym wykazie w załączniku V (w szczególności typ 4 dotyczy powierzchni mających kontakt z żywnością, a nie samej żywności). W konsekwencji, jeśli produkt nie spełnia kryteriów zakresu stosowania z art. 2 ust. 1 BPR, wyjątki z art. 2 ust. 2 BPR nie mają zastosowania. Odnośnie do rozporządzeń CLP i REACH, Rzecznik Generalny stwierdził, że wyłączenia dla żywności należy interpretować ściśle i nie mają one zastosowania do produktów o podwójnym zastosowaniu (żywność i produkt biobójczy), które wchodzą w zakres rozporządzenia BPR. Wynika to z szerokich celów ochronnych rozporządzeń CLP i REACH, które obejmują ochronę zdrowia ludzkiego i środowiska w szerszym zakresie niż przepisy dotyczące żywności, koncentrujące się głównie na bezpieczeństwie żywności.
Stan faktyczny
Sprawa dotyczy sporu między dwiema konkurencyjnymi firmami w Niemczech. Speyer & Grund GmbH & Co. KG sprzedaje produkty pod marką „SURIG” (np. „SURIG Essigspray UNIVERSAL” i „SURIG Essigspray EXTRA”), składające się z wody i kwasu octowego (7.5% lub 10%) oraz kwasu cytrynowego. Produkty te są pakowane w przezroczyste butelki ze spryskiwaczem, a ich etykiety sugerują zastosowanie jako żywność (np. do sałatek, warzyw) oraz zawierają oznaczenia takie jak „przetestowany produkt spożywczy” i „100% pochodzenia roślinnego”. Werner & Mertz GmbH, sprzedawca środków czyszczących, zarzucił Speyer & Grund naruszenie przepisów prawa konkurencji w związku z rozporządzeniami BPR, CLP i REACH, twierdząc, że produkty te są faktycznie środkami czyszczącymi i nie spełniają wymogów etykietowania i reklamy, wprowadzając konsumentów w błąd.
Rozstrzygnięcie
Rzecznik Generalny proponuje, aby Trybunał Sprawiedliwości udzielił następujących odpowiedzi na pytania prejudycjalne: 1. Art. 3 ust. 1 lit. a) akapit pierwszy rozporządzenia (UE) nr 528/2012 należy interpretować w ten sposób, że zamierzone zastosowanie produktu, wymagane do zaklasyfikowania go jako produktu biobójczego, nie musi być jego jedynym zamierzonym zastosowaniem. Jednakże produkt biobójczy przeznaczony do czyszczenia lub dezynfekcji żywności nie wchodzi w zakres stosowania tego rozporządzenia jako produkt typu 4 (obszar żywności i pasz) w głównej grupie 1 (środki dezynfekujące), w rozumieniu art. 2 ust. 1 akapit drugi w związku z załącznikiem V do tego rozporządzenia. 2. Ustalenie, czy produkt przeznaczony do czyszczenia lub dezynfekcji żywności wchodzi w zakres stosowania rozporządzenia nr 528/2012, zależy od jego klasyfikacji jako produktu biobójczego i od jego klasyfikacji jako jednego z typów produktów, o których mowa w załączniku V do tego rozporządzenia. Produkty, które nie wchodzą w zakres stosowania tego rozporządzenia na podstawie art. 2 ust. 1, nie mogą być badane pod kątem wyłączenia z tego zakresu przewidzianego w art. 2 ust. 2 tego rozporządzenia. 3. Wyłączenie żywności z zakresu stosowania rozporządzenia (WE) nr 1272/2008, przewidziane w art. 1 ust. 5 lit. e) tego rozporządzenia, należy interpretować w ten sposób, że nie ma ono zastosowania do produktów przeznaczonych do użytku zarówno jako żywność, jak i jako produkty biobójcze wchodzące w zakres stosowania rozporządzenia nr 528/2012. 4. Wyłączenie żywności z przepisów zawartych w tytule IV rozporządzenia (WE) nr 1907/2006, przewidziane w art. 2 ust. 6 lit. d) tego rozporządzenia, należy interpretować w ten sposób, że nie obejmuje ono produktów, które są przeznaczone do użytku zarówno jako żywność, jak i jako produkty biobójcze objęte rozporządzeniem nr 528/2012.

Pełny tekst orzeczenia

Provisional text OPINION OF ADVOCATE GENERAL NORKUS delivered on 4 September 2025 (1) Case C‑473/24 Speyer & Grund GmbH & Co. KG v Werner & Mertz GmbH (Request for a preliminary ruling from the Bundesgerichtshof (Federal Court of Justice, Germany)) ( Reference for a preliminary ruling – Chemical products – Product intended to be used both as food and as a biocidal product (dual-use products) – Applicability of Regulations (EU) No 528/2012, (EC) No 1272/2008 and (EC) No 1907/2006 to such a product – Labelling and information obligations ) 1.        The present case provides the Court of Justice with an opportunity to rule on the system of rules applicable to products intended for use both as food and as products for cleaning or disinfecting food (‘dual-use products’), and the consequences that flow from that system in terms, in particular, of the labelling of such products under Regulation (EU) No 528/2012 (2) (‘the Biocides Regulation’), Regulation (EC) No 1272/2008 (3) (‘the CLP Regulation’) and Regulation (EC) No 1907/2006 (4) (‘the REACH Regulation’). I.      Legal framework 2.        The following are relevant to the present case: Article 1(1), Article 2(1), Article 2(2)(e), as well as the second subparagraph of Article 2(3)(j) and (m), and Article 2(5)(a), Article 3(1)(a), (u) and (y), the first paragraph of Article 25, as well as Article 25(a), Article 69(1) and Article 72(1) of, and Annex I and Annex V, main group 1, product-type 4, to the Biocides Regulation; Article 1(1) and Article 2(1)(a) and Article 2(2) of Regulation No 852/2004 (5) (‘the Food Hygiene Regulation’); Article 2 of Regulation No 178/2002 (6) (‘the Food Regulation’); Article 1(5)(e)(i) of the CLP Regulation as well as Article 2(6)(d) and Article 31(1)(a) of the REACH Regulation. II.    The facts of the main proceedings, the questions referred for a preliminary ruling and the procedure before the Court of Justice 3.        Speyer & Grund GmbH & Co. KG (‘Speyer & Grund’) is a company that promotes and sells, under the trade mark ‘SURIG’, products consisting of water and acetic acid (7.5%), known as ‘SURIG Essigspray UNIVERSAL’, and products consisting of water, acetic acid (10%) and citric acid (1.5%), known as ‘SURIG Essigspray EXTRA’. Those products are packaged in transparent spray bottles. The label on the front of the products has on it, in addition to the word mark and the product name, an image of raw vegetables, a sparkling kitchen sink and a seal with the words ‘tested food grade product’ and ‘100% plant origin’. The label on the back of the products states, inter alia, the following: ‘…  The practical spray bottle makes it easy to mist salads, fruit and vegetables. … not only suitable for delicious vinaigrettes, but also elevates other foods …’. On one of the products it is also stated that the product is a food grade vinegar. 4.        Werner & Mertz GmbH (‘Werner & Mertz’), a company that sells cleaning products, submits that Speyer & Grund’s promotion and sale of the above products as food infringes the rules of competition law, read in conjunction with the Biocides, CLP and REACH Regulations, in that the requirements concerning labelling and advertising are not complied with. Such promotion and sale is also liable to mislead consumers, it argues, since the products in question are actually cleaning products. Werner & Mertz applied for an order requiring Speyer & Grund, in essence, to stop promoting those products and/or to stop promoting them as food, without the indications required, inter alia, by the Biocides and REACH Regulations. 5.        The Landgericht Frankfurt am Main (Regional Court, Frankfurt am Main, Germany), which takes the view that the Speyer & Grund products, taken as a whole, are biocidal products, on the basis of the shape of the bottle, which the public associates exclusively with cleaning products, and the images shown on the products, which point to that conclusion, and granted that application in its entirety. Hearing the case on appeal, the Oberlandesgericht Frankfurt am Main (Higher Regional Court, Frankfurt am Main, Germany), after finding, in essence, that dual-use products are not exempt from the obligations arising from the Biocides, CLP and REACH Regulations, upheld the judgment at first instance. 6.        The referring court, which has before it an appeal on a point of law brought by Speyer & Grund, wishes to know, in essence, whether dual-use products, such as those at issue in the main proceedings, fall within the scope of the Biocides, CLP and REACH Regulations. 7.        In those circumstances, the Bundesgerichtshof (Federal Court of Justice, Germany) decided to stay the proceedings and refer the following questions to the Court of Justice for a preliminary ruling: ‘(1)      Is the first sentence 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) of, 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 Regulation (EU) No 528/2012 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 [the Food Hygiene Regulation], and in particular is not included in the scope of [the Biocides Regulation] by virtue of the reverse exception provided for in the second subparagraph of Article 2(2) thereof? (4)      Is the area exception 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 [the Food Regulation] and as 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 area exception, if applicable[,] provided that the intended purpose as a biocide is the primary purpose? (5)      Is the area exception 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 referred for a preliminary ruling is not precluded, notwithstanding that area exception, if applicable provided that the intended purpose as a biocide is the primary purpose?’ 8.        The order for reference, dated 27 June 2024, was received at the Registry of the Court of Justice on 4 July 2024. Written observations were submitted by the applicant and defendant in the main proceedings, the German Government and the European Commission. The applicant and defendant in the main proceedings, as well as the Commission and the German Government, also took part in the hearing held on 22 May 2025. III. Analysis 9.        Before examining the questions referred by the referring court to the Court of Justice in the present case, it is appropriate to mention some specific matters relating, in particular, to the nature of the products at issue. It should be recalled that the present request for a preliminary ruling has been made in the context of a dispute between two competing companies concerning the sale, by the defendant in the main proceedings, of products consisting of water and acetic acid (7.5%), and of products consisting of water, acetic acid (10%) and citric acid (1.5%). 10.      It is worth noting that the main substance in the composition of the products at issue is acetic acid which is, first and foremost, a carboxylic acid. As an active substance, it appears under number 200-580-7 in Annex I to the Biocides Regulation, which is headed ‘List of active substances referred to in Article 25(a)’. (7) Its inclusion in that list is subject to the following restriction: ‘concentration to be limited so that each biocidal product does not require classification according to either Directive 1999/45/EC[ (8)] or [the CLP Regulation]’. 11.      Acetic acid is the main constituent of vinegar, which can be obtained, amongst other methods, by diluting acetic acid in water. In view of the composition of the products at issue, which is the result of exactly that dilution process, it is understandable that certain parties to the proceedings and interested parties, both in their observations and at the hearing, as well as the referring court, in its request for a preliminary ruling, have used the term ‘vinegar’ in reference to those products. For the same reason, in the analysis that follows I will also take considerations relating to vinegar into account. 12.      With that in mind, it seems to be common ground that vinegar can generally be used both as food (9) and as a household product. It is therefore a dual-use product, within the meaning indicated in point 1 of this Opinion. As I understand it, it is the concentration of the substance in question, namely acetic acid, that influences the acidity of the product and thus determines whether it is comestible. More specifically, only products with a low concentration of acetic acid are considered comestible, (10) while products intended for household use generally have a higher concentration, which differentiates them. 13.      However, the fact that a product with a low concentration of acetic acid is comestible and generally intended for culinary use does not mean that it cannot also be used for household purposes. On the other hand, the converse is not true: a higher concentration of acid will make the product more suitable for household use, because the solution is more effective, but unsuitable for consumption. (11) 14.      Following Delegated Regulation (EU) 2019/1819, (12) vinegar is listed as an active substance in Annex I to the Biocides Regulation. That listing is, however, subject to the following restrictions: ‘excluding vinegar that is not food and excluding vinegar that contains more than 10% acetic acid (whether or not it is food)’. Particular attention should be paid to those restrictions. They suggest that, in order to be eligible for the simplified authorisation procedure, the active substance ‘vinegar’ must either qualify as food, (13) or have a concentration of acetic acid that is less than 10%. Practically, it follows that a simplified application for authorisation cannot be made in respect of any product containing vinegar which does not qualify as food, or which has a concentration of acetic acid exceeding 10%, because it is regarded as harmful to an extent justifying a more rigorous approval procedure. In my view, that practical consequence confirms that the concentration of acetic acid is a decisive factor in determining whether or not a product is comestible. 15.      That being said, with regard in particular to the classification of a product as a ‘biocidal product’ within the meaning of the first indent of Article 3(1)(a) of the Biocides Regulation, a product must meet three conditions in order to fall within the scope of that provision. First, the product must consist of one or more ‘active substances’, whether because it contains those substances or because it generates them. Secondly, 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. Thirdly, the mode of action of that product must be ‘other than mere physical or mechanical action’. Those conditions are cumulative. (14) 16.      In that regard, where a product meets the legal definition of a ‘biocidal product’ and falls within the scope of the Biocides Regulation, (15) biocidal product authorisation holders (16) ‘shall ensure that biocidal products are classified, packaged and labelled in accordance with the approved summary of biocidal product characteristics’. (17) Furthermore, advertisements for biocidal products must, in principle, comply with the CLP Regulation and include the sentences: ‘Use biocides safely. Always read the label and product information before use’. (18) It is the failure of the defendant in the main proceedings to include that information that is challenged by the applicant. 17.      That being said, I will now examine the questions referred for a preliminary ruling by the referring court. A.      The first and second question referred for a preliminary ruling 18.      By its first question referred for a preliminary ruling, the referring court asks about the scope of the concept of ‘biocidal product’, as defined in the first indent of Article 3(1)(a) of the Biocides Regulation. That court wishes to know whether, in order for a product to fall within that concept, it must be intended solely or primarily for biocidal use, or whether a secondary use is sufficient. 19.      By its second question referred for a preliminary ruling, the referring court asks whether a biocidal product intended for cleaning or disinfection of food falls within the scope of the Biocides Regulation as a product of product-type 4 (Food and feed area) in main group 1 (Disinfectants), within the meaning of the second sentence of Article 2(1) of, read in conjunction with Annex V to, that regulation. 20.      In other words, by those questions, the referring court seeks to establish whether dual-use products, such as those at issue in the main proceedings, are governed by the Biocides Regulation. 1.      The intended use of dual-use products as a condition in the definition of ‘biocidal product’ 21.      As stated in point 15 of this Opinion, a product can only be classified as a ‘biocidal product’ if it meets the three cumulative conditions. However, in the context of the present case, it is only the second condition, relating to the intended use of the product, that requires interpretation. 22.      As a preliminary point, it should be noted that, although doubts have been expressed, in particular by the Commission, as to the exact intended use of the products at issue, that is to say whether they are intended for cleaning or disinfection of food, and/or also of surfaces in contact with food, it is clear from the request for a preliminary ruling that the Court of Justice is being asked about the first of those uses of the products at issue in the main proceedings concerning cleaning or disinfection of food. In that regard, it appears to be common ground that that use can be regarded as biocidal. (19) However, there is uncertainty as to whether, for the purposes of classification as a biocidal product, it is sufficient if that use is considered secondary, or whether it must be the only intended use of the product. 23.      Under the first indent of Article 3(1)(a) of the Biocides Regulation, a biocidal product is one intended to destroy, deter, render harmless, prevent the action of, or exert a controlling effect on any harmful organism. In other words, according to the wording of Article 3(1)(a) of that regulation, a product may be classified as ‘biocidal’ only if it is intended for one of the expressly listed uses. 24.      It is true that the wording of the first indent of Article 3(1)(a) of the Biocides Regulation focuses on the intended uses that give the product in question a biocidal effect. (20) However, there is nothing in that wording to indicate either that that intended use must be exclusive, or that a secondary intended use is sufficient. Given that the wording of the first indent of Article 3(1)(a) of the Biocides Regulation is silent on that point, it must, in my view, be interpreted in the light of the context of that article and the objectives pursued by the regulation. 25.      As regards the context of the first indent of Article 3(1)(a) of the Biocides Regulation, it should be noted that, under the second subparagraph of Article 2(2) of that regulation, that article being headed ‘Scope’, ‘when a biocidal product falls within the scope of one of the [instruments mentioned in Article 2(2)(a) to (k)] 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’. In addition, recital 18 of that regulation states that ‘certain biocidal products and treated articles as defined in the Regulation are also regulated by other Union legislation [and] it is therefore necessary to draw clear borderlines in order to ensure legal certainty’. Recital 19 of the same Regulation expressly states that ‘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] such biocidal products should [therefore] comply, in addition to the requirements laid down in this Regulation, with the relevant essential requirements set out in [the listed instruments]’. 26.      It follows that a biocidal product may, in accordance with the definition contained in the first indent of Article 3(1)(a) of the Biocides Regulation, have several uses, provided that one of them has the capacity to destroy, deter, render harmless, prevent the action of, or exert a controlling effect on any harmful organism. Generally speaking, uses are determined according to the purpose for which the product is intended to be used. 27.      Accordingly, the context surrounding the first indent of Article 3(1)(a) of the Biocides Regulation confirms, in my view, that the fact that a product has several intended uses does not prevent it from being classified, having regard to the condition relating to intended use, as a biocidal product. 28.      As regards the legal classification of the product, it should be noted that the Biocides Regulation does not contain any specific provision establishing a hierarchy between its own definition of ‘biocidal product’ and other definitions that may apply in the event of doubt and/or potential overlap of intended uses. (21) The absence of any such provision seems to me to militate in favour of the conclusion set out in point 27 of this Opinion. 29.      I would note, moreover, that the above conclusion is not undermined by the stipulation in the definition of ‘treated article’ (22) that such an article is classified as ‘biocidal product’ where its primary purpose is biocidal. That stipulation appears only in the definition of a treated article and not in the definition applicable to any substance or mixture classified as a ‘biocidal product’, within the meaning of the first indent of Article 3(1)(a) of the Biocides Regulation, which is the provision of concern to the referring court. Thus, in my view, it does not follow that a substance or mixture may only be classified as a ‘biocidal product’ if its sole function is biocidal. 30.      It follows that that context supports the conclusion that, so far as the condition relating to the intended use of a product is concerned, the mere fact that the product has several uses does not prevent it from being classified as a biocidal product. However, that cannot mean that there are no limits on classification as a biocidal product. It seems to me that administrative approval is required for the biocidal use. Thus, in order for a biocidal product to be placed on the market, essentially the following requirements must be met. First, both the product (23) and the active substance it contains must be approved for use in one of the product-types listed in Annex V to the Biocides Regulation. (24) Secondly, that product must be sufficiently effective in performing its biocidal function, a characteristic which necessarily relates to its intended use of destroying, deterring, rendering harmless, preventing the action of, or exerting a controlling effect on any harmful organism. That means, in particular, that its biocidal effect is recognised. (25) 31.      The conclusion that, so far as the condition relating to the intended use of a product is concerned, the mere fact that the product has several uses does not prevent it from being classified as a biocidal product, is supported by the objective pursued by the Biocides Regulation. 32.      As is apparent from Article 1(1) of that regulation, read in the light of recital 3 thereof, its purpose 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, while ensuring a high level of protection of both human and animal health and the environment, since its provisions are based on the precautionary principle. That level of protection might be seriously undermined if classification as a biocidal product was reserved for products whose sole purpose is biocidal, or in other words to destroy, deter, render harmless, prevent the action of, or exert a controlling effect on any harmful organism. (26) 33.      Moreover, as is apparent, in essence, from recital 5 of the Biocides Regulation, the rules of Directive 98/8/EC (27) were adopted in that regulation ‘in the light of experience’, while also seeking to ensure a higher level of protection of both human and animal health and the environment. 34.      It follows that the fact that the biocidal use of a product, even if that is not its only use, does not prevent that product from being classified as a ‘biocidal product’ within the meaning of the first indent of Article 3(1)(a) of the Biocides Regulation. 35.      That conclusion, however, calls for some further remarks concerning the determination of the intended use of a product. It is true that that determination must be made on the basis of objective factors, or in other words must result from a set of objective circumstances showing that a specific use has been assigned to that product. (28) However, if the determination of the intended use of the product were to stop there, sight might be lost of products which, from an objective point of view, may have several uses. In such a case, is the manufacturer’s intention to assign one use rather than another to the product it markets, expressed, in particular, by the choice of specific packaging and the information appearing on the packaging indicating that use, a factor to be taken into account in determining the intended use of the product? (29) The view that it is has been expressed, in particular, by the German Government and the Commission in the present case. 36.      The German Government takes the view that the decisive factor in determining the intended use of a product is the express or implied promotional claim made by the manufacturer. According to the Commission, the intended use of the products at issue must be determined on the basis of all relevant information available to consumers. (30) At the hearing, the Commission submitted that, in order to determine the intended use of the products at issue, it is necessary to have regard to a range of objective factors, as well as to subjective factors such as those arising from the product description given by the manufacturer in the course of marketing the product. 37.      In the present case, the observations of the German Government and the Commission seem to me to be particularly relevant having regard to the nature of products which, like those at issue in the main proceedings, can be seen from an objective point of view to have several intended uses. As is apparent from points 12 and 13 of this Opinion, vinegar can be used both as food and as a household product. In particular, the concentration of acetic acid is a decisive factor in determining which is the relevant use. However, while a low concentration makes vinegar fit for consumption, it does not prevent its use for household purposes. In such a case, it seems to me that the manufacturer has some latitude in choosing the intended use to be assigned to its product, and that choice crystallises when the product is marketed. (31) 38.      In that regard, factors such as the nature and composition of the product, its presentation, its packaging, (32) the information on its intended use given on the packaging, advertising and the distribution channels constitute, in my view, a range of factors capable of disclosing the manufacturer’s intention as regards the use it wishes to assign to the product it is marketing, which is ultimately for the referring court to determine. (33) 39.      The fact remains that, in order to fall within the scope of the Biocides Regulation, those products must also be capable of being classified as one of the product-types listed in Annex V to that regulation, which will be considered below. 2.      The scope of the Biocides Regulation 40.      Article 2(1) of the Biocides Regulation, which is headed ‘Scope’, provides that ‘this Regulation shall apply to biocidal products … [and] a list of the types of biocidal products covered by this Regulation and their descriptions is set out in Annex V’. (34) Thus, in order to fall within that regulation, a product must undergo a two-stage examination. It must, first, satisfy the conditions for classification as a ‘biocidal product’, within the meaning of the first indent of Article 3(1)(a) of that regulation, and, secondly, be capable of being classified as one of the biocidal product-types listed in Annex V to the Biocides Regulation. 41.      Annex V to the Biocides Regulation contains a list of biocidal product-types and their descriptions, as referred to in Article 2(1) of that regulation. It is apparent from the wording of main group 1, which is headed ‘Disinfectants’, that that group does not cover cleaning products which are not intended to have a biocidal effect. Product-type 4, which is headed ‘Food and feed area’, covers 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. 42.      It is clear from the express wording of Annex V that product-type 4, in main group 1, does not cover products intended to be used to clean or disinfect food. In that regard, I do not share the view of the referring court, mirrored in Werner & Mertz’s submissions, that the surfaces associated with the consumption of food include the surfaces of the food itself. 43.      In my view, a clear distinction must be drawn between, on the one hand, surfaces that are in contact with food, such as a kitchen counter or table, and, on the other, the surface of the food itself, for example the skin of a fruit or the rind of a cheese. First and foremost, the surface in contact with food is distinct from the food itself, whereas the surface of the food is its outer part. In particular, the surface of the food is regarded as its integral part and, as such, is intended to be consumed by the consumer. Conversely, a surface in contact with the food is not part of it; it forms part of the environment of the food and fulfils a distinct function, such as processing, preparation or storage of that food. 44.      It is apparent from the case-law that the list of product-types in Annex V is exhaustive. (35) Furthermore, as the Commission observes, Directive 98/8, which preceded the Biocides Regulation, included an additional product-type, namely product-type 20, headed ‘Preservatives for food or feedstocks’, which was not included in the Biocides Regulation in the light of the experience gained in applying that directive. (36) 45.      In any event, although recital 18 of the Biocides Regulation states that ‘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’, it should be noted that the adjective ‘indicative’ qualifies the word ‘set’ and not the word ‘list’. Accordingly, the fact that that adjective is used in connection with that list does not mean that that list can be interpreted as non-exhaustive. Nor can such an interpretation be justified by reference to the objective of protection pursued by that Regulation. That objective does not provide any basis for extending the scope of the Biocides Regulation to product-types not expressly provided for by the EU legislature. It is expressly stated in recital 18 of that Regulation that the insertion of the list of product-types covered by that Regulation is intended ‘to draw clear borderlines in order to ensure legal certainty’. 46.      Lastly, and as a supplementary point, I consider that products such as those at issue, intended for the cleaning or disinfection of food, do not fall within any other product-type referred to in main group 1 of Annex V to the Biocides Regulation. 47.      First, it will be recalled that main group 1 includes product-type 1, which is headed ‘Human hygiene’ and concerns biocidal products used for human hygiene purposes, applied on or in contact with human skin or scalps for the primary purpose of disinfecting the skin or scalp. It is self-evident that vinegar, which is acidic and may irritate the skin, cannot objectively be regarded as a human hygiene product. In any event, it is common ground between the parties that the products at issue in the main proceedings are not intended for such use. 48.      Secondly, product-type 2, which is in main group 1 and is headed ‘Disinfectants and algaecides not intended for direct application to humans or animals’ expressly states that it does not cover products used for direct contact with, inter alia, food. In the present case, it is alleged that the products in the main proceedings are used with food. 49.      Thirdly, product-type 3, which is headed ‘Veterinary hygiene’, covers products for disinfecting surfaces which come into contact with animals, with the result that the products at issue in the main proceedings are not in any way concerned. 50.      Fourthly, and lastly, product-type 5, which is headed ‘Drinking water’, expressly covers biocidal products ‘used for the disinfection of drinking water for both humans and animals’. In my view, it is absolutely clear that the products at issue, which are intended for the cleaning or disinfection of food, cannot fall within that product-type, given that it relates only to drinking water, strictly delimited by its description. Water differs from food in that its specific intended use is for human consumption as a beverage, unlike food which is intended for nourishment. 51.      For all those reasons, I propose that the answer to the first and second question referred for a preliminary ruling should be that the first sentence of Article 3(1)(a) of the Biocides Regulation must be interpreted as meaning that the intended use of a product that is required in order for that product to be classified as a biocide need not be its only intended use. However, a biocidal product intended for cleaning or disinfection of food does not fall within the scope of that regulation as a product of product-type 4 (Food and feed area) in main group 1 (Disinfectants), within the meaning of the second sentence of Article 2(1) of, read in conjunction with Annex V to, that regulation. B.      The third question referred for a preliminary ruling 52.      By its third question referred for a preliminary ruling, the referring court seeks to ascertain whether a biocidal product intended for cleaning or disinfection of food falls within the scope of the Food Hygiene Regulation or within the scope of the Biocides Regulation by virtue of the exception provided for in the second subparagraph of Article 2(2) thereof. 53.      In that regard, it should be stated, as a preliminary point, that Article 2(1) of the Biocides Regulation sets out the applicability conditions of that regulation, namely that it applies to products classified as biocides or treated articles, provided that they fall within the list of biocidal product-types described in Annex V of that regulation. The first subparagraph of Article 2(2) excludes biocidal products and treated articles from the scope of the regulation where they fall within the scope of certain other instruments which are listed in that subparagraph, in particular in point (e), which relates to the Food Hygiene Regulation. The second subparagraph of Article 2(2) contains an exception to that exclusion, under which the regulation does apply to biocidal products which, although covered by the instruments listed in the first subparagraph, are intended for uses which are not covered by those instruments. 54.      That having been said, as stated in points 40 to 51 of this Opinion, I do not consider that the products in question fall within the scope of the Biocides Regulation, because they cannot be classified as one of the product-types listed in Annex V to that regulation, and are thus eliminated at the second stage of the two-stage examination provided for as regards the applicability of that regulation. Given that the second subparagraph of Article 2(2) of that regulation is an exception to the first subparagraph, which contains an exception to Article 2(1), a product that does not meet the criteria laid down in Article 2(1) at the outset cannot go on to be examined in the light of Article 2(2). To take the contrary view would amount, in my opinion, to circumventing the rules delimiting the scope of the Biocides Regulation and artificially widening it, contrary to the intention of the EU legislature ‘to draw clear borderlines in order to ensure legal certainty’ (37) in determining the applicability of various legal instruments. 55.      As a supplementary point, in so far as the referring court’s third question is asked on the basis that the products at issue fall within the scope of the Food Hygiene Regulation, it must be stated that, as the German Government essentially submits, it is not pertinent to determine whether that regulation applies to the products at issue. The Biocides Regulation, which contains the exception under which it does not apply where the Food Hygiene Regulation applies, does not itself apply. 56.      I therefore propose that the answer to the third question referred for a preliminary ruling should be that whether a product intended for cleaning or disinfection of food falls within the scope of the Biocides Regulation depends, first, on its classification as a biocidal product and, secondly, on its classification as one of the product-types referred to in Annex V to that regulation. Products which do not fall within the scope of that regulation pursuant to Article 2(1) thereof cannot be examined having regard to the exclusion from that scope provided for in Article 2(2) of the Biocides Regulation. C.      The fourth question referred for a preliminary ruling 57.      By its fourth question referred for a preliminary ruling, the referring court seeks to ascertain whether the CLP Regulation applies to a dual-use product which is both food and a biocidal product, despite the fact that that regulation excludes food from its scope, provided that the biocidal function is predominant. Thus, by that question, the referring court asks the Court about the breadth of the exclusion from the scope of that regulation provided for in Article 1(5)(e). 58.      As a preliminary point, it should be noted that this question suggests that the referring court regards the products at issue as both food and biocidal products, and as falling within the scope of the Biocides Regulation. In that regard, I would repeat that, in my view, the products at issue in the main proceedings, in so far as they are intended for cleaning or disinfection of food, meet the conditions for classification under Article 3(1) of that regulation. The fact remains that, since those products cannot be classified as one of the product-types listed in Annex V to that regulation, and thus do not survive the second stage of the two-stage determination of its applicability, they are excluded from the scope of the Biocides Regulation. 59.      As a further preliminary point, I would observe that it is quite possible to doubt whether those two classifications can coexist, and whether the Biocides Regulation can apply to a product intended for use, inter alia, as food. Unlike food, a biocidal product is not intended to be ingested by humans. However, as explained in points 9 to 14 of this Opinion, the products in question have certain particularities in terms of their composition, in particular the presence of active substances whose concentration may make dual classification conceivable, to the extent that this depends on the intended use of those products. In so far as the products in question are made up of substances or mixtures, the issue may arise of whether they have properties capable, in appropriate cases, of justifying their classification as hazardous to human health and the environment. (38) If so, they cannot escape the systems of legal rules designed to ensure a high level of protection for human health and the environment. (39) 60.      That having been said, for the reasons set out in point 58 of this Opinion, it does not seem to me that an answer to the fourth question, concerning the relationship between the CLP Regulation, on the one hand, and the Biocides Regulation, on the other, would assist the referring court in resolving the dispute in the main proceedings. However, in case the Court does not accept my proposed answers to the first two questions, it is appropriate to continue the analysis as set out below. 61.      Article 1(5)(e) of the CLP Regulation provides that that regulation ‘shall not apply to substances and mixtures in the following forms, which are in the finished state, intended for the final user: … food or feeding stuffs as defined in [the Food Regulation] …’. It also provides that that exclusion includes foodstuffs used as a food additive, as a flavouring in foodstuffs, as an additive in feeding stuffs and in animal nutrition, within the meaning of the legal instruments to which that article refers. 62.      Interpreted literally, that provision would lead to the conclusion that any substance or mixture, in the finished state, intended for a final user as food must, on that ground, automatically be excluded from the scope of the CLP Regulation. Such a substance or mixture would thus escape the requirements, inter alia, of hazard classification and hazard communication in the form of labelling. Hence, any product composed of that substance or mixture and intended to be ingested by humans within the meaning of the definition of food would be excluded from the scope of that regulation. On the other hand, the wording of Article 1(5)(e) of that regulation does not provide any clarification as to the situation where a product has several uses, one of which is as food. 63.      In that regard, it should be noted that the CLP Regulation is intended to apply, in principle, to all substances and mixtures supplied in the European Union, except where other EU legislation lays down more specific rules on classification and labelling, as, for example, does the Food Regulation. (40) The CLP Regulation is based essentially on the concepts of ‘substance’ (41) and ‘mixture’, (42) which, as is apparent from that regulation, are based on the properties of the substances and mixtures. Furthermore, that regulation lays down rules with a view to ‘harmonising the criteria for classification of substances and mixtures, and the rules on labelling and packaging for hazardous substances and mixtures’. (43) Amongst other things, those rules require manufacturers to determine which properties of substances and mixtures should lead to a classification as hazardous, in order for the hazards of substances and mixtures to be properly identified and communicated. (44) 64.      The exclusion from the scope of the CLP Regulation provided for in Article 1(5)(e) is, however, based on the definition of ‘food’ in the Food Regulation, which is based on the intended use of the product, and not the properties of the substances or mixtures it contains. (45) The other exclusions provided for in Article 1(5) of that regulation relate to medicinal products, veterinary medicinal products, cosmetic products and medical devices, as defined in the specific legislative instruments referred to in that provision, by reference in each case to their intended use. 65.      It follows that that exclusion, which constitutes an exception (46) to the general rule defining the scope of the CLP Regulation, is conditional, in that its application depends on the substances and mixtures in a particular form, and in their finished state, being intended for use as food, or in other words on the specific intended use being that of food. It is thus linked to their specific use as food within the meaning of the Food Regulation. The stipulations concerning form and finished state contained in that exclusion relate, in my view, to the products being placed on the market as finished products, implying an intention on the part of the manufacturer to present them as being intended for use, according to any reasonable expectation, as food. 66.      As I see it, that exclusion applies where the sole intended use of a product is as food. (47) In that regard, it is true that recital 11 of the CLP Regulation states that that regulation should, as a general principle, apply to all substances and mixtures supplied in the European Union, except where other EU legislation lays down more specific rules on classification and labelling – as, for example, does the Food Regulation. It can be inferred from this that the intention of the EU legislature was to prevent duplication of the rules applicable to products capable of affecting human health, by ensuring that they are subject to distinct requirements, in particular as regards labelling. 67.      However, it seems logical to me that a product that meets both the definition of food and that of a biocidal product should not escape the rules laid down by the CLP Regulation simply because it is food and irrespective of whether its biocidal use is predominant. (48) That conclusion follows from the objective pursued by that regulation, which is to ensure a high level of protection of human health and the environment. Given that a biocidal product contains active substances which, by their nature, are capable of having adverse effects on human health and the environment, it cannot escape the legal rules intended to provide such protection. 68.      Furthermore, I am of the view that, in order to determine which set of legal rules applies to the products at issue, it is also necessary to bear in mind the type of protection intended to be provided, first, by the food legislation, and secondly, by the legislation relating to biocidal products or substances and mixtures. The objective of the Food Regulation is, in essence, to protect human life and health, taking account, where appropriate, of the protection of animal health and welfare, plant health and the environment, (49) in so far as the protection of health is connected with food safety. However, it is first and foremost the Biocides Regulation and the CLP Regulation that are intended to ensure a high level of protection of human and animal health and the environment. (50) It is apparent from those two regulations that the classification and labelling rules laid down cover a wider range of dangers, in particular environmental dangers, than is covered by the food legislation, the objective of which remains focused on the protection of human health and, in particular, food safety. 69.      Thus, it can be seen that the classification and labelling rules applicable to food differ from those applicable to substances and mixtures. Those objectives would not be met if a dual-classification product was not considered to be covered by the CLP Regulation on the basis of the exclusion for food. It is true that the legislative provisions relating to food are more specific to the protection of human health, but they do not cover, amongst other things, the protection of the environment. Consequently, they cannot take precedence over the legislative provisions relating to mixtures and substances, but must be applied in conjunction with them. (51) 70.      Furthermore, Article 2(3)(m) of the Biocides Regulation provides that ‘subject to any explicit provision to the contrary in this Regulation or other Union legislation, this Regulation shall be without prejudice to the following instruments: … the [CLP Regulation]’. Moreover, the Biocides Regulation states in Article 69(1) and Article 72(1), relating to advertising of biocidal products, in essence, that the rules laid down in the CLP Regulation also apply to biocidal products. That context seems to me to militate in favour of the conclusion that that regulation applies to dual-use products. 71.      Lastly, I would repeat, though only as a supplementary point and without prejudice to my proposed answer to the fourth question, that the products at issue consist of water and acetic acid (7.5%) (SURIG Essigspray Universal), and of water, acetic acid (10%) and citric acid (1.5%) (SURIG Essigspray EXTRA). In that regard, I would point out that it is apparent from the request for a preliminary ruling that the latter product was classified as a ‘hazardous mixture’ within the meaning of the first paragraph of Article 3 of, read in conjunction with Annex I to, the CLP Regulation. Against that background, it is conceivable that the question may arise of whether a substance or mixture, thus classified as hazardous and therefore triggering the application of the rules relating, inter alia, to labelling as required by that regulation, may also be classified, in particular, as food. Article 14(1) of the Food Regulation expressly provides that food shall not be placed on the market if it is unsafe. (52) 72.      I would add that, among the hazards addressed by the CLP Regulation are, in particular, acute toxicity, skin corrosion and irritation or serious eye damage. (53) With that in mind it may be difficult to see how such hazardous substances could, in any circumstances, be intended to be ingested by humans and thus meet the definition of food, though that is a matter for the referring court to determine. 73.      Furthermore, as I understand it, the requirements of the CLP Regulation, in particular as regards labelling, apply only if, following evaluation of a substance, it is identified as presenting a physical, health or environmental hazard, as referred to in Annex I to that Regulation. (54) The specific labelling rules laid down by that regulation, which relate, to use its own wording, to ‘a substance or mixture classified as hazardous’, cannot apply to food. That having been said, there may still be doubt as to the applicability of those rules to products which, though falling within the definition of a biocidal product, are not classified as hazardous substances or mixtures. Thus, in my opinion, the answer to the question whether that regulation applies to a product which is classified both as food and as a biocidal product depends more on the examination of the properties of the substances or mixtures it contains than on its dual classification. (55) It will be for the referring court to determine whether the products at issue contain hazardous substances or mixtures and are therefore subject to the specific rules laid down in respect of such substances or mixtures by the CLP Regulation. My proposed answer to the fourth question is given on the basis that, as the referring court suggests, that is indeed the case, at least in relation to the product SURIG Essigspray EXTRA. 74.      In the light of the foregoing, I propose that the answer to the fourth question should be that the exclusion of food from the scope of the CLP Regulation, provided for in Article 1(5)(e) of that regulation, must be interpreted as not applicable to products intended for use both as food and as biocidal products falling within the scope of the Biocides Regulation. D.      The fifth question referred for a preliminary ruling 75.      By its fifth question referred for a preliminary ruling, the referring court asks whether a product which can be classified both as food and as a biocidal product falls within the scope of Title IV of the REACH Regulation, even though food is excluded from that regulation. The referring court thus invites the Court to rule on the scope of the exclusion provided for in Article 2(6)(d) of that regulation. 76.      As a preliminary remark, it should be noted that, as in the case of the fourth question, the referring court appears to take the view that the products at issue can be classified both as food and as a biocidal product. (56) That being so, in so far as it may assist, I would analyse the fifth question as set out below. 77.      It will be recalled that Article 2 of the REACH Regulation, which is headed ‘Application’, provides, in paragraph 6(d), that ‘the provisions of Title IV shall not apply to the following mixtures in the finished state, intended for the final user: … food … in accordance with [the Food Regulation] including use: (i) as a food additive in foodstuffs …’. 78.      The wording of Article 2(6)(d) of the REACH Regulation does not expressly address the situation described by the referring court, in which a product is classified both as food and as a biocidal product, and falls within the scope of the Biocides Regulation. In other words, that wording does not provide any indication as to whether or not a classification as food takes precedence over a classification as a biocidal product, such that a product classified as both is excluded from that regulation. 79.      I would observe that the REACH Regulation, just like the CLP Regulation, which amended it, places the concepts of ‘substance’ (57) and ‘mixture’ at the heart of the system of rules it establishes. (58) The REACH Regulation applies, in principle, to all substances and mixtures, (59) subject to the express exclusions provided for in Article 2 of that regulation. In that regard, the exclusions provided for in that article can, in my view, be separated into two categories: general exclusions, such as those contained in paragraph 1 of that article, which exclude certain types of substances and mixtures from the scope of the regulation, even though they might meet the criteria attaching to that concept, and conditional exclusions, such as those contained in paragraph 6 of that article, which apply to such substances and mixtures by reason of their specific uses, in this case as food. 80.      As regards the exclusion of food, it can be inferred from that exclusion that the EU legislature considered that mixtures intended to be ingested by humans do not present risks of such seriousness that it would be appropriate for them to be subject to the monitoring system established by the REACH Regulation, including registration, evaluation and authorisation, (60) in order to control the risks to which such mixtures expose human health and the environment. 81.      That having been said, where a product has other uses, such as the biocidal use at issue in the present case, the exclusion provided for in Article 2(6)(d) of the REACH Regulation cannot, in my view, apply to that product. In that regard, first, I would note that it is apparent from the Biocides Regulation itself that it applies without prejudice to the REACH Regulation. (61) Secondly, the contrary view would undermine the objective of that regulation, which is to protect human health from exposure to chemical substances and to protect the environment. (62) As the Commission submits, that regulation aims to provide broader protection of human health than is guaranteed by the Food Regulation, which is essentially limited to food safety. Furthermore, protection of the environment would not be fully ensured if manufacturers could evade the rules relating, in particular, to registration and authorisation of substances and mixtures by selecting, from the uses of that product, an intended use that is excluded by the REACH Regulation, and assigning it to the product. Lastly, in view of the differences in the scope of those objectives and the fact that exceptions must be interpreted strictly, I consider that the referring court’s fifth question should be answered in the affirmative. (63) 82.      In the light of the foregoing, I propose that the answer to the fifth question referred for a preliminary ruling should be that the exclusion of food from the rules contained in Title IV of the REACH Regulation, provided for in Article 2(6)(d) of that regulation, must be interpreted as not covering products which are intended for use both as food and as biocidal products covered by the Biocides Regulation. IV.    Conclusion 83.      In the light of the foregoing considerations, I propose that the Court should answer the questions referred for a preliminary ruling by the Bundesgerichtshof (Federal Court of Justice, Germany) as follows: 1.      The first sentence 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 the intended use of a product that is required in order for that product to be classified as a biocide need not be its only intended use. However, a biocidal product intended for cleaning or disinfection of food does not fall within the scope of that regulation as a product of type 4 (Food and feed area) in main group 1 (Disinfectants), within the meaning of the second sentence of Article 2(1) of, read in conjunction with Annex V to, that regulation. 2.      The determination as to whether a product intended for cleaning or disinfection of food falls within the scope of Regulation No 528/2012, as amended by Regulation No 334/2014 and by Delegated Regulation 2019/1819, depends on its classification as a biocidal product and on its classification as one of the product-types referred to in Annex V to that regulation. Products which do not fall within the scope of that regulation pursuant to Article 2(1) thereof cannot be examined having regard to the exclusion from that scope provided for in Article 2(2) of that regulation. 3.      The exclusion of food from the scope 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, provided for in Article 1(5)(e) of that regulation, must be interpreted as not applicable to products intended for use both as food and as biocidal products falling within the scope of Regulation No 528/2012, as amended by Regulation No 334/2014 and by Delegated Regulation 2019/1819. 4.      The exclusion of food from the rules contained in Title IV of Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2016 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, as amended by Regulation No 1272/2008, provided for in Article 2(6)(d) of that regulation, must be interpreted as not covering products which are intended for use both as food and as biocidal products covered by Regulation No 528/2012, as amended by Regulation No 334/2014 and by Delegated Regulation 2019/1819. 1      Original language: French. 2      Regulation 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). 3      Regulation 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). 4      Regulation 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 Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 (OJ 2008 L 353, p. 1). 5      Regulation of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs (OJ 2004 L 139, p. 1, and corrigendum OJ 2013 L 160, p. 16), as amended by Regulation (EC) No 219/2009 of the European Parliament and of the Council of 11 March 2009 (OJ 2009 L 87, p. 109). 6      Regulation 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). 7      That list is part of a simplified authorisation procedure for certain biocidal products, provided for in Articles 25 to 28 of Chapter V of the Biocides Regulation. In essence, where ‘all the active substances contained in the biocidal product are listed in Annex I and satisfy any restriction specified in that Annex’, that regulation permits a simplified application to be made for authorisation to supply and use a biocidal product. With regard more specifically to that simplified authorisation procedure, it is designed to encourage the use of less harmful biocidal products. I do not think it is necessary to give a detailed description of the procedure in the context of the present case. 8      Directive of the European Parliament and of the Council of 31 May 1999 concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations (OJ 1999 L 200, p. 1). 9      For example, vinegar is listed as a food in Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives (OJ 2008 L 16, p. 16), as amended by Commission Regulation (EU) No 1129/2011 of 11 November 2011 amending Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of the Council by establishing a Union list of food additives (OJ 2011 L 295, p. 1) (see Part D, number 12.3). 10      As a general rule, the concentration in culinary vinegar is below 10%. In that regard, the defendant in the main proceedings draws attention to the fact that, under German law (see Paragraph 2 of the Essigverordnung (Verordnung über den Verkehr mit Essig und Essigessenz) (Regulation on trade in vinegar and vinegar essence), products containing less than 11% acetic acid may be sold as food. 11      As is apparent from the published scientific material, a higher concentration of acetic acid can cause irritation to the skin, eyes and respiratory tract, because its corrosive properties make it toxic. For example, oral administration of a solution with a concentration over 10% can cause caustic lesions to form in the digestive tract and depress the central nervous system (see Toxicology sheet No 24 – June 2021 edition of the Institut national de recherche et de la Sécurité (National institute for research and safety) (INRS), France). 12      Delegated Commission Regulation of 8 August 2019 amending Regulation (EU) No 528/2012 of the European Parliament and of the Council to include vinegar as an active substance in Annex I thereto (OJ 2019 L 279, p. 1). Thus, the inclusion of vinegar and, at an earlier stage, acetic acid, in Annex I to the Biocides Regulation means that those substances are not regarded as being of concern for human or animal health or the environment, provided that the restrictions attaching to them are complied with. 13      This means that where the authorisation to make a biocidal product available on the market has been obtained through the simplified procedure, that product contains a substance which, considered in isolation, would fall within the definition of food. Under the Food Regulation, food is defined as ‘any substance or product, whether processed, partially processed or unprocessed, intended to be, or reasonably expected to be ingested by humans’ (see the first paragraph of Article 2 of that regulation). 14      See judgment of 14 October 2021, Biofa (C‑29/20, EU:C:2021:843, paragraphs 26 and 28). 15      See Article 2(1) and Article 3(1)(a) of the Biocides Regulation. 16      Under Article 19(1)(a) of the Biocides Regulation, only biocidal products whose active substances have been approved for the product-type concerned may be authorised, and only if the conditions specified for those active substances are met. This means that a biocidal product will not be authorised on the internal market unless and until the active substance it contains has been assessed and approved. 17      See Article 69(1) of the Biocides Regulation. 18      See Article 72(1) of the Biocides Regulation. 19      It may be helpful to observe that it does not follow that the Biocides Regulation applies to the products at issue, because it remains necessary to determine whether those products, which have more than one intended use, (i) are properly classified as biocidal products, and (ii) fall within the scope of that regulation, which I will consider below. 20      In that regard, the Court of Justice has held that the gradation of the purposes of biocidal products set out in Article 3(1)(a) of Regulation No 528/2012 lists the purposes of biocidal products. These range from the destruction of the harmful organisms to their prevention (judgment of 19 December 2019, Darie, C‑592/18, EU:C:2019:1140, paragraph 41). Moreover, having regard to that wording, I do not find it inconceivable that a multiplicity of those purposes, each of which gives the product a biocidal effect, may fall within the wording. 21      For example, I note, in relation to medicinal products and food, the legislature has expressly provided for the definition of ‘medicinal product’ to take precedence over that of ‘food’ in cases of doubt (see Article 2(2) of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ 2001 L 311, p. 67)). In contrast, it appears that the system established by the Biocides Regulation is much more flexible as regards the combination of different classifications and their consequences as regards the rules applicable to the products concerned. 22      See the final sentence of Article 3(1)(a) of the Biocides Regulation. 23      Article 19(1) of the Biocides Regulation. 24      That approval is based on an opinion on the approval of the active substance produced by the European Chemicals Agency (ECHA), on the basis of the conclusions reached by the evaluating competent authority, in accordance with Article 8(4) of the Biocides Regulation. On receipt of that opinion, the Commission is to adopt an implementing regulation approving the active substance and stating the conditions attaching to that approval (see Article 9(1)(a) of that regulation). 25      See Article 19(1)(a) of the Biocides Regulation. Moreover, I think it is important to note that, as Advocate General Rantos stated in his Opinion in Biofa (C‑29/20, EU:C:2021:411, point 69), a product which contains an active substance approved by an implementing regulation will necessarily have to be classified as a ‘biocidal product’, within the meaning of Article 3(1)(a) of the Biocides Regulation, if its composition is identical to that of the approved active substance. 26      Furthermore, it is apparent from the case-law that the concept of ‘biocidal product’ is to be understood broadly (judgment of 19 December 2019, Darie, C‑592/18, EU:C:2019:1140, paragraph 42). In that regard, all the cumulative conditions making up that concept must, in my opinion, be interpreted broadly. 27      Directive 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). 28      Such circumstances would include, in particular, the technical characteristics of the product and its nature, which may be linked to the active substance it contains. 29      This is a separate issue from that of the assessment of whether the labelling on the products at issue in the main proceedings is misleading. As a general rule, it is not for the Court of Justice to rule on the question whether the labelling of certain products is likely to mislead the purchaser or consumer, that being a task for the national court (see, to that effect and by analogy, judgment of 10 September 2009, Severi, C‑446/07, EU:C:2009:530, paragraph 60). 30      For example, appearance, express statements, labelling and advertising. 31      That conclusion is inevitable, in my view, having regard to the principle of freedom to pursue a trade or profession, which is one of the general principles of EU law. The manufacturer has freedom as regards its business choices. Sale is one means by which that principle is put into practice. The principle is not absolute, however, in the sense that it must be viewed in relation to its social function. Consequently, restrictions may be imposed on the exercise of the freedom to pursue a trade or profession, provided that such restrictions in fact correspond to objectives of general interest pursued by the European Union and do not constitute, in relation to the aim pursued, a disproportionate and intolerable interference, impairing the very substance of the rights guaranteed (see, to that effect, judgment of 15 July 2004, Di Lenardo and Dilexport, C‑37/02 and C‑38/02, EU:C:2004:443, paragraph 82 and the case-law cited). In particular, it is important to avoid any circumvention of the requirements arising from the Biocides Regulation, for example the presentation of a product as food when, in view of its nature and the risks its use poses to human and animal health and the environment, that product must comply with the requirements of that regulation. 32      In that regard, at the hearing, Speyer & Grund explained that the decision to package the products at issue in spray bottles was part of a marketing strategy intended to draw attention to the products, to distinguish them from traditional products and to facilitate their use. 33      In that regard, I think it is important to emphasise that that determination must be approached with a degree of caution and confined to the specific case of dual-use products. 34      It may be helpful to note that the first subparagraph of Article 2(2) contains a list of instruments and provides that the Biocides Regulation does not apply to biocidal products which fall within the scope of those instruments. The second subparagraph of Article 2(2) provides that ‘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’. Lastly, Article 2(5)(a) provides that the Biocides Regulation does not apply to ‘food or feed used as repellents or attractants’. 35      See, to that effect, judgment of 1 March 2012, Söll (C‑420/10, EU:C:2012:111, paragraph 24). It is true that in that judgment, it was the list of biocidal products in Directive 98/8 that the Court of Justice ruled to be exhaustive. However, as the Biocides Regulation has repealed and replaced Directive 98/8, the interpretation of the provisions of that directive provided by the Court of Justice also applies to that regulation whenever the provisions of the two instruments of EU law may be regarded as equivalent (judgment of 19 December 2019, Darie, C‑592/18, EU:C:2019:1140, paragraph 29). As is apparent from a reading of Annex V, main group 1, product-type 4, to that directive, its wording is identical to that of Annex V, main group 1, product-type 4, to that regulation. 36      See recital 23 of the Biocides Regulation. 37      Recital 18 of the Biocides Regulation. 38      Recital 10 of the CLP Regulation. 39      In this case, the CLP Regulation (see Article 1(1) of that regulation). 40      Recital 11 of the CLP Regulation. 41      In Article 2(7) of the CLP Regulation, ‘substance’ is defined as ‘a chemical element and its compounds in the natural state or obtained by any manufacturing process, including any additive necessary to preserve its stability and any impurity deriving from the process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition’. 42      In Article 2(8) of the CLP Regulation, ‘mixture’ is defined as ‘a mixture or solution composed of two or more substances’. 43      Article 1(1)(a) of the CLP Regulation. 44      Recital 10 of the CLP Regulation. 45      It is worth keeping in mind that while, in principle, the purpose of a product is determined on the basis of objective factors, and to that extent a parallel can be drawn with the importance attached by the CLP Regulation to the properties of substances and mixtures, that will not be the correct approach in every case. As I have stated above, certain products may have several intended uses, in which case the intended use assigned to them is not necessarily based on their properties alone, but also on the intention of the manufacturer. 46      I would note that, according to settled case-law, exceptions to a principle must be interpreted strictly (see judgments of 10 November 2016, Baštová, C‑432/15, EU:C:2016:855, paragraph 59 and the case-law cited, and of 29 March 2012, Commission v Poland, C‑185/10, EU:C:2012:181, paragraph 31 and the case-law cited). 47      In that regard, it is expressly stated in Article 1(5)(e) of the CLP Regulation that that regulation ‘shall not apply to substances and mixtures in the following forms, which are in the finished state, intended for the final user: … food …’ (emphasis added). 48      As stated in points 21 to 39 of this Opinion, a product may be classified as biocidal even if its intended use is not exclusively biocidal. The same conclusion must be drawn with regard to whether that product is covered by the CLP Regulation. Given that that regulation does not make specific provision in that regard, I consider that determining whether an intended use was the principal or predominant use might prove difficult and would risk needlessly complicating the application of the legal rules intended to ensure a high level of protection. 49      See Article 5(1) of the Food Regulation. 50      See Article 1(1) of the Biocides Regulation and Article 1(1) of the CLP Regulation. 51      This conclusion would be different if the products in question were considered to be food only. In that case, I would be able to agree with the view expressed by the referring court, and reflected in Speyer & Grund’s submissions, that the provisions of the food legislation are undoubtedly more specific and must take precedence given that food is excluded from the scope of the CLP Regulation. 52      Pursuant to Article 14 of the Food Regulation, food is considered to be unsafe if it is injurious to health, because of its effects on the health of a person consuming it or the probable cumulative toxic effects, or if it is unfit for human consumption, because it is considered unacceptable for human consumption according to its intended use, in particular for reasons of contamination, whether by extraneous matter or otherwise, or through putrefaction, deterioration or decay. It seems to me that that prohibition also applies to food which may have other uses. 53      See Annex 1, table 1.1, to the CLP Regulation. 54      Article 5(1) of the CLP Regulation. 55      The fact that a product is classified as biocidal does not automatically mean that the substances it contains are classified as hazardous for the purposes of the CLP Regulation. In that regard, I would mention the active substances of natural origin listed in Annex I to the Biocides Regulation (for example, lavender oil or mint oil), or those in respect of which it is expressly provided that their concentration must be limited so that the biocidal product does not require classification under the CLP Regulation (for example, sodium acetate or acetic acid). It also bears repetition that products containing acetic acid may also escape classification under the CLP Regulation if they are authorised under the simplified procedure, since in such cases the acetic acid of which they are composed must be of limited concentration (see point 10 of this Opinion). 56      In that regard, see the considerations set out in points 58 to 60 of this Opinion, which also apply to the fifth question. 57      See Article 3(1) of the REACH Regulation. 58      See Article 3(2) of the REACH Regulation. 59      Recital 11 of the REACH Regulation. 60      Judgment of 10 September 2015, FCD and FMB (C‑106/14, EU:C:2015:576, paragraph 32). 61      Article 2(3)(j) of the Biocides Regulation. See also Article 70 of that regulation, which provides that, where appropriate, safety data sheets for active substances and biocidal products are to be prepared and made available in accordance with Article 31 of the REACH Regulation. 62      See Article 1(1) of the REACH Regulation. 63      That conclusion is without prejudice to the considerations I set out in the course of answering the fourth question (see points 71 to 73 of this Opinion), where I stated that it can be doubted whether a product that is classified as a biocide, falls within the scope of the Biocides Regulation, and is classified as a hazardous mixture – which, a priori, means that the REACH Regulation is engaged – can also fall within the definition of food.

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