Koppers Denmark and Others v Commission (Action for annulment - Public health - Biocidal products - Judgment) [2025] EUECJ T-9/23 (09 April 2025)

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URL: https://www.bailii.org/eu/cases/EUECJ/2025/T923.html
Cite as: EU:T:2025:382, ECLI:EU:T:2025:382, [2025] EUECJ T-9/23

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JUDGMENT OF THE GENERAL COURT (Eighth Chamber)

9 April 2025 (*)

( Action for annulment - Public health - Biocidal products - Regulation (EU) No 528/2012 - Renewal of the approval of creosote as an active substance for use in biocidal products of product-type 8 - Restrictions on the placing on the market of treated articles - Application for partial annulment of Implementing Regulation (EU) 2022/1950 - Contested provisions not severable from the rest of the act - Inadmissibility )

In Case T‑9/23,

Koppers Denmark ApS, established in Nyborg (Denmark), and the other applicants whose names are listed in the annex, (1) represented by R. Cana, E. Mullier and E. Lupo, lawyers,

applicants,

v

European Commission, represented by B. De Meester and R. Lindenthal, acting as Agents,

defendant,

supported by

French Republic, represented by B. Fodda, acting as Agent,

by

Kingdom of the Netherlands, represented by M. Bulterman, C. Schillemans and A. Hanje, acting as Agents,

and by

European Chemicals Agency (ECHA), represented by M. Heikkilä, C. Buchanan and N. Knight, acting as Agents,

interveners,

THE GENERAL COURT (Eighth Chamber),

composed of A. Kornezov, President, G. De Baere and K. Kecsmár (Rapporteur), Judges,

Registrar: P. Cullen, Administrator,

having regard to the written part of the procedure,

further to the hearing on 25 September 2024,

gives the following

Judgment

1        By their action under Article 263 TFEU, the applicants, Koppers Denmark ApS and the other legal persons whose names are listed in the annex, seek the annulment in part of Commission Implementing Regulation (EU) 2022/1950 of 14 October 2022 renewing the approval of creosote as an active substance for use in biocidal products of product-type 8 in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ 2022 L 269, p. 1; 'the contested regulation').

 Background to the dispute

2        The applicants are a group of several companies active on the European market at various stages of the supply chain for the marketing of the active substance creosote, which is a wood preservative that has been on the market for more than 150 years and that was first approved as an active biocidal substance by 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) in 2011 ('creosote'). It is used to protect wood used to make public utility poles, railway sleepers, equestrian fencing and poles or stakes used to grow fruit, hops and wine.

3        Creosote had been included in Annex I to Directive 98/8 for use in biocidal products of product-type 8, namely wood preservatives.

4        Commission Directive 2011/71/EU of 26 July 2011 amending Directive 98/8 to include creosote as an active substance in Annex I thereto (OJ 2011 L 195, p. 46) amended, with effect from 1 May 2013, Annex I to Directive 98/8 to include therein creosote as an approved active substance, intended for use in biocidal products of product-type 8, namely wood preservatives, for a period of 5 years, that is to say, until 30 April 2018.

5        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) repealed and replaced Directive 98/8 and became applicable on 1 September 2013. Under Article 86 of Regulation No 528/2012, creosote, among other active substances listed in Annex I to Directive 98/8, is deemed to have been approved under that regulation under the same conditions as those laid down in that directive (until 30 April 2018), as set out in paragraph 4 above.

6        In order for the approval of an active substance to be renewed, it is necessary to submit to the European Chemicals Agency (ECHA) an application for renewal at least 550 days before the expiry of the approval, in accordance with Article 13(1) of Regulation No 528/2012.

7        On 14 October 2022, the European Commission adopted the contested regulation in implementation of Regulation No 528/2012, on the basis, inter alia, of Article 14(4)(a) of the latter regulation.

8        It is apparent from recital 2 of the contested regulation that an application for the renewal of the approval of creosote for use in biocidal products of product-type 8 was submitted on 27 October 2016.

9        Pursuant to Article 12(1) of Regulation No 528/2012, the approval of active substances meeting the exclusion criteria may only be renewed if the active substance still meets at least one of the conditions set out in Article 5(2) of that regulation.

10      After the ECHA Biocidal Products Committee delivered its opinion on 4 December 2020 concluding, in essence, that creosote met the exclusion criteria laid down in Article 5(1)(a) and (e) of Regulation No 528/2012, the Commission conducted a public consultation in order to gather information as to whether the conditions for renewal of approval, set out in Article 5(2) of that regulation, were in fact met. From the information collected by the Commission and the views expressed by Member States, it appears that creosote and wood treated with creosote was still needed in many Member States for railway sleepers and for utility poles for electricity and telecommunications.

11      The Commission concluded, in the contested regulation, that the non-approval of creosote as an active substance for use in biocidal products would have a disproportionate negative impact on society in comparison to the risks arising from the use of that substance for the treatment of wood used to make railway sleepers and utility poles for electricity and telecommunications, that the condition set out in Article 5(2)(c) of Regulation No 528/2012 was therefore satisfied for those uses and that, therefore, the approval of the active substance at issue could be renewed under certain conditions.

12      Article 1 of the contested regulation provides that the approval of creosote as an active substance for use in biocidal products of product-type 8 is to be renewed, subject to the specifications and conditions set out in the Annex to that regulation.

13      The sole annex to the contested regulation lists, in the last column, entitled 'Specific conditions', of the table set out therein, first, the conditions attached to the authorisations of biocidal products ('the first part of the Annex') and, second, the conditions attached to the placing on the market of treated articles ('the second part of the Annex'). That column relating to specific conditions also states that 'creosote is considered a candidate for substitution in accordance with Article 10(1) …(a), (d) and (e), of Regulation … No 528/2012'.

14      According to the first part of the Annex, biocidal products may be authorised only 'to make railway sleepers, or utility poles for electricity or telecommunications' and products may only be authorised for use in Member States where the condition set out in Article 5(2)(c) of Regulation No 528/2012 is satisfied.

15      As regards the conditions for placing treated articles on the market, the second part of the Annex to the contested regulation provides that:

(1)      by 31 January 2023, ECHA is to make publicly available a list of Member States where railway sleepers treated with creosote may be placed on the market and a list of Member States where utility poles for electricity and telecommunications treated with creosote may be placed on the market;

(2)      as from 30 April 2023, only railway sleepers, or utility poles for electricity or telecommunications treated with creosote may be placed on the market in Member States included in the lists referred to above;

(3)      there is a labelling obligation on the person responsible for the placing on the market of a treated article, in accordance with the second subparagraph of Article 58(3) of Regulation (EU) No 528/2012;

(4)      there is an additional labelling obligation on the person responsible for the placing on the market of a treated article, which consists of including on the label of the treated article the following statement: 'during storage, treated wood shall not be accessible to the general public. Measures shall be taken to prevent unauthorised access. Treated wood must be stored on impermeable hard standing or on absorptive material to prevent runoff to the environment, and under shelter or covered with a tarpaulin. Any spill or contaminated material must be collected on such sites and disposed as hazardous waste';

(5)      as from 30 April 2023, there is an additional labelling obligation on the person responsible for the placing on the market of a treated article, which consists of including on the label of the treated article the following statement: 'only allowed for use as a railway sleeper' or 'only allowed for use as utility pole for electricity lines or for telecommunication lines', as appropriate;

(6)      as from 30 April 2023, there is an additional labelling obligation on the person responsible for the placing on the market of a treated article, which consists of including on the label of the treated article the following statement: 'the placing on the market is restricted to certain Member States of the European Union: verify on the website of the [ECHA] where the placing on the market is allowed.'

16      The contested regulation prohibits the placing on the market of treated articles, unless Member States proactively decide to authorise them on their territory (opt-in). That means that, from 30 April 2023, treated articles are indefinitely banned in the territories of any Member State which did not request to be included in the lists by 31 January 2023.

17      The placing on the market of railway sleepers treated with creosote is thus prohibited in Cyprus, Greece, Malta and the Netherlands, whereas the placing on the market of utility poles treated with creosote is prohibited in Belgium, Croatia, Denmark, France, Germany, Latvia, Lithuania, the Grand-Duchy of Luxembourg, Malta, the Netherlands, Romania, Slovakia and Slovenia.

18      In that regard, it should be noted that this is the first time that the Commission has decided, in the context of EU legislation on biocidal products, to regulate in that way 'the placing on the market of treated articles' by prohibiting the treated article, in the context of the approval of an active substance, unless certain Member States take steps to include themselves on a newly created ECHA list.

 Forms of order sought

19      The applicants claim, in essence, that the Court should:

–        partially annul the contested regulation, in so far as it introduces the conditions on the placing on the market of treated articles laid down in points 1, 2, 4 and 6 of the second part of the annex thereto;

–        order the Commission to pay the costs.

20      The Commission contends that the Court should:

–        dismiss the action as inadmissible or, in the alternative, as unfounded;

–        order the applicants to pay the costs.

21      The French Republic and the Kingdom of the Netherlands contend that the Court should dismiss the action.

22      ECHA contends that the Court should:

–        dismiss the action;

–        order the applicants to pay the costs.

 Law

23      The applicants claim that points 1, 2, 4 and 6 of the second part of the Annex to the contested regulation should be annulled, disputing the additional assessment made by the Member States in relation to the treated articles, notwithstanding the satisfaction, at EU level, of the condition laid down in Article 5(2)(c) of Regulation No 528/2012.

24      The applicants claim, in essence, that, by adopting points 1, 2, 4 and 6 of the second part of the Annex to the contested regulation ('the contested provisions'), the Commission infringed Article 14(4) and Article 58(2) and (3) of Regulation No 528/2012. In particular, they submit that that regulation does not empower the Commission to prohibit the placing on the market of treated articles in the manner provided for by the contested regulation, in particular in so far as, unlike the conditions of use of a biocidal product, the subsequent use of an article treated with such a product does not come within the scope of Regulation No 528/2012. The adoption of the contested provisions are thus contrary to the objective of the free movement of biocidal products within the European Union.

25      The applicants thus point to a circumvention of Regulation No 528/2012 and, in particular, of the effects arising from the approval at EU level of creosote by the contested regulation as an active substance for use in biocidal products of product-type 8, as a result of the restrictions on the use of that substance for the treatment of wood used to make railway sleepers and utility poles for electricity and telecommunications laid down by the contested provisions, which introduce an additional assessment not provided for by Regulation No 528/2012 which is also contrary to the objective of the free movement of biocidal products within the European Union.

26      As regards the admissibility of the action, the applicants submit, in essence, that the contested provisions are severable from the remainder of the contested regulation in view of the spirit and substance of that regulation, namely the renewal of the approval, at EU level, of creosote as an active substance for use in biocidal products of product-type 8. That renewal is enshrined in Article 1 of the contested regulation, which is not contested. In addition, the Annex to that regulation lays down two categories of specific conditions for approval relating, first, to the authorisation of biocidal products and, second, to the placing on the market of treated articles. Only some of the second category of conditions are covered by the applicants' action. Thus, the annulment of the contested provisions would affect neither the renewal of the approval of creosote nor the restrictions imposed on the authorisation of biocidal products. Indeed, the contested provisions, which relate solely to the placing on the market of treated articles, cannot, according to the applicants, be regarded as mandatory and essential conditions for the renewal of that approval, unlike the conditions relating to authorisations of creosote biocidal products.

27      The Commission submits that the action is inadmissible on the ground that the annulment of the contested provisions would alter the substance of the contested regulation. It states that the contested provisions are not severable from the remainder of that contested regulation in so far as they constitute essential and decisive conditions of that regulation. It submits that, in the event of its partial annulment, the risks posed by creosote would not be fully covered by that regulation since only the specific conditions for the authorisation of biocidal products would remain valid, without the specific conditions for placing treated articles on the market. The Commission submits that the conditions relating to the authorisation of biocidal products, set out in the first part of the Annex, are intrinsically linked to the specific conditions for the placing on the market of the treated articles, set out in the second part of that annex. Thus, those conditions should be regarded as a whole, forming a coherent set of measures to ensure adequate and comprehensive control of the risks stemming from the use of articles treated with creosote. The Commission adds that, were it not for the contested provisions, it would not have renewed the approval of creosote.

28      In that regard, as a preliminary point, it should be recalled that partial annulment of an EU act is possible only if the elements whose annulment is sought may be severed from the remainder of the act and a total annulment would go beyond the subject matter of the dispute (ultra petita) (judgments of 28 June 1972, Jamet v Commission, 37/71, EU:C:1972:57, paragraphs 10 to 12; of 10 December 2002, Commission v Council, C‑29/99, EU:C:2002:734, paragraph 45; and of 24 May 2005, France v Parliament and Council, C‑244/03, EU:C:2005:299, paragraphs 12 and 21).

29      That requirement of severability is not satisfied where the partial annulment of a measure would have the effect of altering its substance (see judgment of 18 March 2014, Commission v Parliament and Council, C‑427/12, EU:C:2014:170, paragraph 16 and the case-law cited).

30      Review of whether the contested provisions of an act are severable requires consideration of their scope, in order to be able to assess whether their annulment would alter the spirit and substance of that act (see judgments of 16 July 2015, Commission v Council, C‑425/13, EU:C:2015:483, paragraph 94 and the case-law cited, and of 9 November 2017, SolarWorld v Council, C‑205/16 P, EU:C:2017:840, paragraphs 38 and 39 and the case-law cited).

31      The Court has held, with regard to an implementing regulation adopted by the Commission, that the question whether partial annulment of an act would alter the substance of that act is an objective criterion, and not a subjective criterion linked to the political intention of the authority which adopted the measure at issue (judgments of 30 September 2003, Germany v Commission, C‑239/01, EU:C:2003:514, paragraph 37, and of 24 May 2005, France v Parliament and Council, C‑244/03, EU:C:2005:299, paragraph 14).

32      The Court has also accepted the principle of partial unlawfulness of a complex act, provided that the element annulled is severable from the act in question (judgment of 4 March 1998, De Abreu v Court of Justice, T‑146/96, EU:T:1998:50, paragraph 33).

33      It is on that basis that it is necessary to examine whether the contested provisions are severable from the remainder of the contested regulation.

34      The contested regulation was adopted on the basis of Article 14(4)(a) of Regulation No 528/2012, which empowers the Commission to establish, for the purposes of renewing the approval of an active substance for one or more product-types, the conditions for that approval in accordance with Article 4(3) of that regulation. Thus, the substance of the contested regulation is to renew the approval, subject to conditions, of creosote as an active substance for use in biocidal products of product-type 8 in accordance with Regulation No 528/2012. The substance of the contested regulation, which is an act of the Commission renewing the approval of an active substance at EU level, must therefore be determined by taking into account the provisions of Regulation No 528/2012 and Article 114 TFEU on the basis of which that regulation was adopted.

35      Indeed, the contested regulation constitutes an implementing regulation adopted on the basis of Article 14(4)(a) of Regulation No 528/2012. It follows that the contested provisions are based on Article 12 and Article 5(2)(c) of Regulation No 528/2012.

36      It must also be noted that Regulation No 528/2012 lays down rules governing, in particular, the establishment at EU level of a list of active substances that may be used in biocidal products.

37      As regards the conditions for the approval of such an active substance, it follows from recital 2 of Regulation No 528/2012 that that approval is defined by the provisions of that regulation. In accordance with recitals 1 and 3 thereof, that regulation establishes a specific balance between the free movement of biocidal products and a high level of protection of human and animal health and the environment (judgment of 19 January 2023, CIHEF and Others, C‑147/21, EU:C:2023:31, paragraph 64).

38      In that regard, Article 12(2) of Regulation No 528/2012 provides that, in the light of scientific and technical progress, the Commission is to review and, where appropriate, amend the conditions specified for the active substance referred to in Article 4(3) of that regulation. In particular, it is apparent from Article 4(3)(d) and (g) of that regulation that the approval of an active substance is to specify, as appropriate, the conditions relating to the 'manner and area of use [of the substance in question] including, where relevant, [its] use in treated articles', as well as 'other particular conditions based on the evaluation of the information related to that active substance'.

39      In that context, Article 58 of Regulation No 528/2012 regulates the placing on the market of treated articles. According to Article 58(2) of that regulation, that placing on the market is subject to two conditions. First, all the substances contained in the biocidal products with which the article has been treated, or which have been incorporated into it, must be approved. Second, all the conditions or restrictions specified in the act of approval must be met. Similarly, Article 58(3) of that regulation specifies that the labelling is to include, if the conditions associated with the approval of the active substances so require, in particular because of a risk of release into the environment of the active substances concerned, any relevant instructions for use. Those provisions expressly refer to the existence of any specific conditions affecting the placing on the market of treated articles that may have been adopted at the active substance approval stage (judgment of 17 January 2024, Troy Chemical Company and Troy v Commission, T‑297/21, not published, EU:T:2024:13, paragraph 275).

40      The abovementioned provisions thus establish a close link between, on the one hand, the risks to human health, animal health and the environment, associated with the active substance itself, and, on the other hand, the risks of the same nature posed by treated articles, on account of their treatment by a biocidal product composed of the active substance in question.

41      In the present case, it should be recalled that, as stated in recitals 5 and 6 of the contested regulation, creosote is an active substance which meets the exclusion criteria laid down in Article 5(1)(a) and (e) of Regulation No 528/2012, with the result that, pursuant to Article 12(1) of that regulation, the approval of that active substance may be renewed only if it meets at least one of the conditions set out in Article 5(2) of that regulation. In the present case, the Commission considered, in the contested regulation, that the condition laid down in Article 5(2)(c) of Regulation No 528/2012, according to which such an active substance may be approved if not approving it would have a disproportionate negative impact on society when compared with the risks that its use poses to human health, animal health and the environment, was satisfied.

42      It thus follows from Article 5(2)(c) of Regulation No 528/2012, read in conjunction with Article 12 of that regulation, that the renewal of the approval of an active substance under those provisions entails a balancing of the abovementioned risks posed by the active substance in question and the negative impact on society that its non-approval might entail.

43      The Commission carried out that balancing exercise in the contested regulation, examining, on the one hand, the risks posed by creosote to human health, animal health and the environment. In that regard, it found that that substance was carcinogenic and that creosoted wood posed risks both to human health – namely to workers responsible for the treatment of wood, pole and electricity pole installers and the general public – and to the environment, in particular in so far as there was a risk of direct losses to the soil, sewers or water in the absence of risk mitigation measures. The Commission analysed, on the other hand, the negative impact that non-approval of creosote would have on society. In that regard, it noted that creosote was still needed in many Member States for railway sleepers and for utility poles for electricity and telecommunications, examining possible alternatives for those uses. The Commission found that the non-renewal of the approval of creosote for those two uses could, first, have serious economic and technical repercussions on railway infrastructure operators, it being specified that railway sleepers were subject to rail infrastructure type approval or certification requirements for reasons related to the safety of people and that good operation of train infrastructures is essential for the proper functioning of society and economic activities. Second, the Commission noted that a non-renewal of approval of creosote could have an economic impact on electricity and telecommunication infrastructure operators, and create problems for the maintenance of that infrastructure in some Member States where substitution of creosote would still be difficult. On the basis of that analysis, the Commission concluded that the non-approval of creosote as an active substance for use in biocidal products would have a disproportionate negative impact on society when compared with the risks arising from the use of the substance for the treatment of wood used to make railway sleepers and utility poles for electricity and telecommunications.

44      In carrying out that balancing exercise, the Commission considered that the renewal of the approval of the active substance in question could take place only if that substance was subject to certain conditions concerning both the authorisations of biocidal products and the placing on the market of treated articles. According to the contested regulation, those conditions were intended to mitigate the risks to human health, animal health and the environment associated with biocidal products and treated articles, while limiting the negative impact that its possible non-approval would have on society.

45      Indeed, the risks which an active substance may pose to human and animal health and to the environment arise only through its use in a biocidal product or its incorporation into a treated article (judgment of 17 January 2024, Troy Chemical Company and Troy v Commission, T‑297/21, not published, EU:T:2024:13, paragraph 272).

46      That is particularly true in the present case, since, as the applicants confirmed at the hearing, creosote biocidal products are composed entirely of that active substance, with the result that, in practice, there is no material difference between the active substance itself and the biocidal product based on that active substance. Furthermore, the applicants also confirmed, at the hearing, that creosote biocidal products are not used autonomously, but are used exclusively to treat wood and therefore by application to the treated articles. Thus, it appears that, in the present case, the biocidal products cannot be used autonomously, but only in treated articles, with the result that there is an indissociable link between them.

47      In addition, in so far as the applicants dispute only some of the conditions for placing treated articles on the market, it must be noted that those conditions are intrinsically linked to other conditions laid down in the Annex to the contested regulation, which are not challenged by the applicants.

48      Accordingly, the condition relating to the placing on the market of treated articles introduced in point 4 of the second part of the Annex – which provides, in essence, that the label of treated articles must indicate certain storage conditions for those articles – reflects the sixth condition, which has similar content, set out in the first part of the Annex relating to biocidal products. That condition referred to in point 4 thus seeks to ensure that the conditions imposed for creosote biocidal products are not negated once those products have been applied to treated articles.

49      The same is true of the conditions relating to the placing on the market of treated articles introduced in points 1, 2 and 6 of the second part of the Annex – providing for the establishment of a list of the Member States in which treated articles may be placed on the market – which reflect the third condition in the first part of the Annex, relating to biocidal products, which is not challenged by the applicants, according to which the use of those products is authorised only in the Member States which satisfy the condition laid down in Article 5(2)(c) of Regulation No 528/2012.

50      The conditions laid down in the first and the second part of the Annex are therefore closely linked and together contribute to the balancing of, on the one hand, the risks to human health, animal health and the environment posed by the active substance in question, biocidal products based on it and treated articles, and, on the other hand, the negative impact that non-approval of that substance would have on society.

51      In the light of all those factors, the annulment of the contested provisions would have the effect of altering the spirit and substance of the contested regulation, within the meaning of the case-law cited in paragraph 30 above, in that it would necessarily affect the balancing exercise carried out by the Commission on which that regulation is based.

52      Accordingly, it must be held that the contested provisions are not severable from the contested regulation and that the partial annulment of that regulation, sought by the applicants, is impossible.

53      Since the applicants have not sought, even in the alternative, the annulment of the contested regulation in its entirety, the action must be dismissed as inadmissible.

54      That conclusion is without prejudice to the question, raised in the context of the first plea of the action, of the Commission's competence to impose, in an implementing regulation such as the contested regulation, conditions relating to the placing on the market of treated articles. In so far as that question concerns the substance, it is not the subject of the present judgment, which finds that the action is inadmissible.

 Costs

55      Under Article 134(1) of the Rules of Procedure of the General Court, the unsuccessful party is to be ordered to pay the costs if they have been applied for in the successful party's pleadings. Since the applicants have been unsuccessful, they must be ordered to bear their own costs and to pay those incurred by the Commission, in accordance with the form of order sought by the Commission.

56      In accordance with Article 138 of the Rules of Procedure, the French Republic, the Kingdom of the Netherlands and ECHA are to bear their own costs.

On those grounds,

THE GENERAL COURT (Eighth Chamber)

hereby:

1.      Dismisses the action;

2.      Orders Koppers Denmark ApS and the other applicants whose names are listed in the annex to bear their own costs and to pay those incurred by the European Commission;

3.      Declares that the Republic of France, the Kingdom of the Netherlands and the European Chemicals Agency (ECHA) are to bear their own costs.

Kornezov

De Baere

Kecsmár

Delivered in open court in Luxembourg on 9 April 2025.

V. Di Bucci

 

S. Papasavvas

Registrar

 

President


*      Language of the case: English.


1      The list of the other applicants is annexed only to the version sent to the parties and to the recipients referred to in Article 55 of the Statute of the Court of Justice of the European Union.

© European Union
The source of this judgment is the Europa web site. The information on this site is subject to a information found here: Important legal notice. This electronic version is not authentic and is subject to amendment.


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