Opinion of Advocate General Kokott delivered on 20 April 2023.

• Jurisdiction: European Union
• Celex Number: 62021CC0559
• ECLI: ECLI:EU:C:2023:321
• Date: 20 April 2023
• Court: Court of Justice (European Union)

OPINION OF ADVOCATE GENERAL

KOKOTT

delivered on 20 April 2023 (1)

Case C‑559/21 P

Global Silicones Council and Others

v

European Chemicals Agency (ECHA)

(Appeal – Establishment of a list of substances identified for eventual inclusion in Annex XIV to Regulation (EC) No 1907/2006 (REACH) (candidate list) – Entry of octamethylcyclotetrasiloxane (D4), decamethylcyclopentasiloxane (D5) and dodecamethylcyclohexasiloxane (D6) in the candidate list – Persistent, bioaccumulative and toxic substances (PBT) – Very persistent and very bioaccumulative substances (vPvB) – Bioaccumulation – Bioconcentration factor – Organometallic compounds – Legal characterisation of facts – Manifest error of assessment – Toxicity)

I. Introduction

1. Under the REACH Regulation, (2) the European Union is able to restrict the manufacturing, use or placing on the market of substances of very high concern. The Commission can thus make the use of such substances subject to authorisation. In preparation for this measure, the European Chemicals Agency (ECHA) must first place the substances in question on the ‘candidate list’, as a result of which certain requirements are imposed.

2. Substances which present a very high concern include those which are persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB). (3) These substances are degraded only very slowly or not at all and therefore have the potential to accumulate in parts of the environment. The effects of this accumulation are unpredictable in the long term. Such accumulation is also difficult to reverse in practice. Furthermore, PBT or vPvB substances may contaminate remote areas that should be protected from further contamination by hazardous substances resulting from human activity. (4)

3. The present appeal was lodged because ECHA regards the substances at issue, octamethylcyclotetrasiloxane (D4), decamethylcyclopentasiloxane (D5) and dodecamethylcyclohexasiloxane (D6), as PBT/vPvB substances. By the contested decision, (5) ECHA therefore included those three substances in the candidate list for the imposition of an authorisation requirement.

4. The appeal concerns, first and foremost, the rules governing the method for assessing bioaccumulation and certain scientific/factual objections to the application of those rules.

II. Legal framework

5. Article 13 of the REACH Regulation lays down general requirements for generation of information on intrinsic properties of substances. Test methods are addressed in paragraph 3:

‘Where tests on substances are required to generate information on intrinsic properties of substances, they shall be conducted in accordance with the test methods laid down in a Commission Regulation or in accordance with other international test methods recognised by the Commission or the Agency as being appropriate.’

6. The REACH Regulation empowers the Commission to make the use of certain substances subject to an authorisation requirement (Title VII).

7. PBT and vPvB substances in particular may be considered for an authorisation requirement under Article 57(d) and (e) of the REACH Regulation:

‘The following substances may be included in Annex XIV in accordance with the procedure laid down in Article 58:

…

(d) substances which are persistent, bioaccumulative and toxic in accordance with the criteria set out in Annex XIII of this Regulation;

(e) substances which are very persistent and very bioaccumulative in accordance with the criteria set out in Annex XIII of this Regulation;

(f) …’

8. Article 59 of the REACH Regulation sets out the procedure for the identification of substances referred to in Article 57 and provides that the ECHA must place the substances thus identified on a candidate list for eventual inclusion in Annex XIV.

9. Annex XIII to the REACH Regulation lays down the criteria for the identification of PBT and vPvB substances.

10. The second paragraph in the preamble to Annex XIII to the REACH Regulation describes the method for applying the criteria:

‘For the identification of PBT substances and vPvB substances a weight-of-evidence determination using expert judgement shall be applied, by comparing all relevant and available information listed in Section 3.2 with the criteria set out in Section 1. This shall be applied in particular where the criteria set out in Section 1 cannot be applied directly to the available information.’

11. The fourth paragraph in the preamble to Annex XIII to the REACH Regulation states that the ‘information used for the purposes of assessment of the PBT/vPvB properties shall be based on data obtained under relevant conditions’.

12. Under the fifth paragraph in the preamble to Annex XIII, ‘the identification shall also take account of the PBT/vPvB properties of relevant constituents of a substance and relevant transformation and/or degradation products’.

13. The sixth paragraph in the preamble to Annex XIII to the REACH Regulation provides that the Annex applies ‘to all organic substances, including organo-metals’.

14. Bioaccumulation is defined in Sections 1.1.2 and 1.2.2 of Annex XIII to the REACH Regulation by reference to the bioconcentration factor:

‘1.1.2. Bioaccumulation

A substance fulfils the bioaccumulation criterion (B) when the bioconcentration factor in aquatic species is higher than 2 000.

…

1.2.2. Bioaccumulation

A substance fulfils the “very bioaccumulative” criterion (vB) when the bioconcentration factor in aquatic species is higher than 5 000.’

15. In addition, Section 3.2 of Annex XIII to the REACH Regulation concerns the information to which regard is to be had:

‘3.2. Assessment Information

The following information shall be considered for the assessment of P, vP, B, vB and T properties, using a weight-of-evidence approach:

3.2.1. …

3.2.2. Assessment of B or vB properties:

(a) Results from a bioconcentration or bioaccumulation study in aquatic species;

(b) Other information on the bioaccumulation potential provided that its suitability and reliability can be reasonably demonstrated, such as

— Results from a bioaccumulation study in terrestrial species;

— Data from scientific analysis of human body fluids or tissues, such as blood, milk, or fat;

— Detection of elevated levels in biota, in particular in endangered species or in vulnerable populations, compared to levels in their surrounding environment;

— Results from a chronic toxicity study on animals;

— Assessment of the toxicokinetic behaviour of the substance;

(c) Information on the ability of the substance to biomagnify in the food chain, where possible expressed by biomagnification factors or trophic magnification factors.’

16. On the basis of Article 13(3) of the REACH Regulation, the Commission adopted Regulation (EC) No 440/2008, (6) which, in Section C.13 of its Annex, regulates bioaccumulation in fish: aqueous and dietary exposure.

17. The first paragraph of the introduction to Section C.13 explains the background to the test method:

‘This test method (TM) is equivalent to OECD test guideline (TG) 305 (2012). The major goal of this revision of test method is two-fold. Firstly, it is intended to incorporate a dietary bioaccumulation … test suitable for determining the bioaccumulation potential of substances with very low water solubility.’

18. The second paragraph of the introduction to Section C.13 gives the reasons for introducing a dietary test method:

‘… In addition, it has been recognised that testing very poorly water soluble substances may not be technically feasible. In addition, for substances with very low water solubility in the aquatic environment, exposure via water may be of limited importance in comparison to the dietary route. This has led to the development of a test method in which fish are exposed via their diet.’

19. The sixth paragraph of the introduction to Section C.13 explains the requirement for the aqueous exposure test:

‘… The aqueous exposure test is most appropriately applied to stable organic substances with log KOW values between 1,5 and 6,0 (13) but may still be applied to strongly hydrophobic substances (having log KOW > 6,0), if a stable and fully dissolved concentration of the test substance in water can be demonstrated. If a stable concentration of the test substance in water cannot be demonstrated, an aqueous study would not be appropriate thus the dietary approach for testing the substance in fish would be required (although interpretation and use of the results of the dietary test may depend on the regulatory framework).’

20. The eighth paragraph of the introduction to Section C.13 addresses the choice between different test methods:

‘The decision on whether to conduct an aqueous or dietary exposure test, and in what set-up, should be based on the factors in paragraph 3 considered together with the relevant regulatory framework. For example, for substances which have a high log KOW but still show appreciable water solubility with respect to the sensitivity of available analytical techniques, an aqueous exposure test should be considered in the first instance. However it is possible that information on water solubility is not definitive for these hydrophobic types of substances, so the possibility of preparing stable, measurable dissolved aqueous concentrations (stable emulsions are not allowed) applicable for an aqueous exposure study should be investigated before a decision is made on which test method to use … It is not possible to give exact prescriptive guidance on the method to be used based on water solubility and octanol-water partition coefficient “cut off” criteria, as other factors (analytical techniques, degradation, adsorption, etc.) can have a marked influence on method applicability for the reasons given above. However, a log KOW above 5 and a water solubility below ~ 0,01 – 0,1 mg/l mark the range of substances where testing via aqueous exposure may become increasingly difficult.’

21. The fifth paragraph of the...