Case T‑207/18

PlasticsEurope

v

European Chemicals Agency

Judgment of the General Court (Eighth Chamber), 16 December 2020

(REACH – Establishment of a list of substances identified with a view to their eventual inclusion in Annex XIV to Regulation (EC) No 1907/2006 – Supplement to the entry relating to the substance bisphenol A on that list – Articles 57 and 59 of Regulation No 1907/2006 – Manifest error of assessment – Weight of evidence approach – Exploratory studies – Intermediate uses – Proportionality)

1. Approximation of laws – Registration, evaluation and authorisation of chemicals – REACH Regulation – Substances of very high concern – Procedure for identification – Discretion of the EU authorities – Scope – No obligation for the European Chemicals Agency (ECHA) to take into account ongoing studies

   (European Parliament and Council Regulation No 1907/2006, Arts 57, 58(8) and 59)

   (see paragraphs 52-54)

2. Approximation of laws – Registration, evaluation and authorisation of chemicals – REACH Regulation – Substances of very high concern – Procedure for identification – Discretion of the EU authorities – Scope – Endocrine-disrupting substances capable of having serious effects on the environment – Weight of evidence approach – Power of the European Chemicals Agency (ECHA) to exclude irrelevant studies

   (European Parliament and Council Regulation No 1907/2006, Arts 57 and 59 and Annex XI)

   (see paragraphs 62-64)

3. Approximation of laws – Registration, evaluation and authorisation of chemicals – REACH Regulation – Substances of very high concern – Procedure for identification – Endocrine-disrupting substances capable of having serious effects on the environment – Weight of evidence approach – Taking into account of non-standard or exploratory studies – Whether permissible – Application of the precautionary principle

   (European Parliament and Council Regulation No 1907/2006, Art. 13(3), Art. 57(f) and Art. 59(3), and Annexes XI and XV)

   (see paragraphs 76-83, 88, 89)

4. Approximation of laws – Registration, evaluation and authorisation of chemicals – REACH Regulation – Substances of very high concern – Procedure for identification – Discretion of the EU authorities – Scope – Judicial review – Limits

   (European Parliament and Council Regulation No 1907/2006, Arts 57 and 59)

   (see paragraph 94)

5. Approximation of laws – Registration, evaluation and authorisation of chemicals – REACH Regulation – Substances of very high concern – Procedure for identification – Endocrine-disrupting substances capable of having serious effects on the environment – Weight of evidence approach – Weighting of data according to their scientific reliability – Compliance with the principle of scientific excellence

   (European Parliament and Council Regulation No 1907/2006, Art. 57(f) and Annex XI)

   (see paragraphs 102, 104, 107, 187, 188)

6. Approximation of laws – Registration, evaluation and authorisation of chemicals – REACH Regulation – Substances of very high concern – Procedure for identification – Endocrine-disrupting substances capable of having serious effects on the environment – Standard of proof

   (European Parliament and Council Regulation No 1907/2006, Art. 57(f))

   (see paragraphs 198-200, 205, 207, 208)

7. Approximation of laws – Registration, evaluation and authorisation of chemicals – REACH Regulation – Substances of very high concern – Procedure for identification – Endocrine-disrupting substances capable of having serious effects on the environment – Determination of the level of concern of a substance

   (European Parliament and Council Regulation No 1907/2006, Art. 57(f))

   (see paragraphs 217-229)

Résumé

By Decision ED 01/2018 of 3 January 2018, the European Chemicals Agency (ECHA) supplemented the existing entry relating to bisphenol A on the list of substances identified with a view to their eventual inclusion in Annex XIV to Regulation No 1907/2006, ( 1 ) in the sense that that substance had been identified as an endocrine disruptor that may have serious effects on the environment within the meaning of Article 57(f) of that regulation.

PlasticsEurope is an international professional association which represents and defends the interests of its members, consisting of undertakings manufacturing and importing plastic goods. Five of those undertakings are active in placing bisphenol A on the market in the European Union. That association brought an action against ECHA’s decision, in which it relied, inter alia, on the existence of several manifest errors of assessment in the identification of bisphenol A as a substance of very high concern under Article 57(f) of Regulation No 1907/2006.

The General Court dismissed the action, by ruling, inter alia, that ECHA correctly applied the weight of evidence approach. That judgment supplements the case-law resulting from the judgment in PlasticsEurope v ECHA (T‑636/17). ( 2 )

Findings of the Court

In the first place, the Court held that ECHA did not commit a manifest error in the assessment of the relevant evidence for the identification of bisphenol A as an endocrine disruptor that may have serious effects on the environment.

First, the Court found that the identification of the substance as being of very high concern was carried out using the weight of evidence approach. The Court stated that that approach, together with the discretion enjoyed by ECHA in the identification of substances of very high concern, mean that ECHA may exclude studies which it does not deem relevant. A manifest error of assessment can be found only if the ECHA had completely and wrongly disregarded a reliable study, the inclusion of which would have altered the overall assessment of the evidence in such a way that the final decision would have been implausible. However, that was not the case here.

Second, the Court noted that there is no prohibition in principle on ECHA taking into consideration ‘non-standard’ or ‘exploratory’ studies in order to substantiate, in the weight of evidence approach, findings based on standard studies. Furthermore, it stated that an approach which, as a general rule, excludes the use of non-standard or exploratory studies would make it impossible to identify substances which pose a risk to the environment; this would run counter to the precautionary principle, on which the provisions of that regulation are based.

In the second place, the Court found that ECHA also did not commit a manifest error of assessment in the identification of bisphenol A as an endocrine disruptor that may have serious effects on the environment giving rise to an equivalent level of concern to those of other substances listed in Article 57 (a) to (e) of Regulation No 1907/2006.

First of all, in so far as concerns the assessment of the evidence, the Court noted that ECHA followed a transparent and systematic methodology and complied with the principle of scientific excellence. It carried out a weighting of the data drawn from a multitude of scientific studies, whilst taking the reliability of each study into account. The Court found that it was the weight of evidence drawn from all of that data that permitted ECHA to reach its conclusions with regard to the intrinsic properties of bisphenol A as an endocrine disruptor.

The Court then rejected the argument that ECHA had failed to establish that there was scientific evidence of bisphenol A having serious effects on the environment on account of its endocrine disrupting properties, in accordance with Article 57(f) of Regulation No 1907/2006. In that connection, the Court recalled that the probability that a substance may have serious effects on the environment was sufficient to establish a causal link within the meaning of that article, ( 3 ) which does not require absolute proof of a causal relationship. ( 4 ) After examining the methodology followed, the Court upheld ECHA’s finding as to the existence of a plausible biological link between the endocrine mode of action of bisphenol A and serious effects. Thus, it found that ECHA did not fail to apply the requisite standard of proof.

Lastly, in so far as concerns the determination of the equivalent level of concern, provided for in Article 57(f) of Regulation No 1907/2006, the Court noted that that article does not lay down any criterion as regards the nature of the concerns that may be taken into consideration for the purposes of identifying a substance such as that at issue. The Court then pointed out that ECHA could not be criticised for having justified the level of concern raised by the effects of bisphenol A by relying on the uncertainties that it had identified for the determination of a safe level of exposure to that substance. Thus, the Court ruled that PlasticsEurope had failed to demonstrate how the ECHA had allegedly committed a manifest error of assessment.

( 1 ) Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396 2006, p. 1).

( 2 ) In the judgment of 20 September 2019, PlasticsEurope v ECHA (T‑636/17, EU:T:2019:639), the General Court dismissed the action brought by PlasticsEurope against ECHA’s decision supplementing the existing entry relating to bisphenol A on the list of substances identified for eventual inclusion in Annex XIV to Regulation No 1907/2006 as meaning that that substance had been identified as an endocrine disruptor that may have serious effects on human health.

( 3 ) Judgment of the General Court, 11 May 2017, Deza v ECHA (T‑115/15, EU:T:2017:329, paragraph 173.

( 4 ) Judgment of the General Court, 20 September 2019, PlasticsEurope v ECHA, T‑636/17, EU:T:2019:639, paragraph 94.