Case T‑636/17

PlasticsEurope

v

European Chemicals Agency

Judgment of the General Court (Fifth Chamber), 20 September 2019

(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 — Legal certainty — Legitimate expectations — 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 institutions — Scope — Judicial review — Limits

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

   (see paragraphs 58, 59)

2. Approximation of laws — Registration, evaluation and authorisation of chemicals — REACH Regulation — Substances of very high concern — Procedure for identification — Substances with endocrine disrupting properties that may have serious effects on human health — Standard of evidence — Assessment of the hazards of the substance — Demonstration of the possible adverse health effects of that substance

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

   (see paragraphs 89-102)

3. Approximation of laws — Registration, evaluation and authorisation of chemicals — REACH Regulation — Substances of very high concern — Procedure for identification — Taking into consideration of data other than those relating to the hazards linked to the intrinsic properties of the substances concerned

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

   (see paragraph 121)

4. Approximation of laws — Registration, evaluation and authorisation of chemicals — REACH Regulation — Substances of very high concern — Procedure for identification — Substances with endocrine disrupting properties that may have serious effects on human health — Criteria for assessment — Ability of the European Chemicals Agency (ECHA) to draw up its own criteria for the identification of a substance as a substance of very high concern — Absence of obligation for ECHA to draw up in advance and in writing scientific criteria permitting the identification of disruptors of very high concern

   (European Parliament and Council Regulation No 1907/2006, recital 15 and Art. 57(f))

   (see paragraphs 152, 153)

5. Approximation of laws — Registration, evaluation and authorisation of chemicals — REACH Regulation — Substances of very high concern — Establishment of a list of substances identified for eventual inclusion in Annex XIV to the REACH Regulation (Candidate List) — Amendment of an existing entry in the list of substances identified for eventual inclusion in Annex XIV to the REACH Regulation

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

   (see paragraph 177)

Résumé

On 20 September 2019, in its judgment in PlasticsEurope v ECHA (T‑636/17), the General Court dismissed an action for annulment of a decision whereby the European Chemicals Agency (ECHA) supplemented the existing entry relating to the substance bisphenol A on the list of identified substances with a view to their eventual inclusion in Annex XIV to Regulation No 1907/2006, ( 1 ) to the effect that bisphenol A had been identified as an endocrine disruptor that might have serious effects on human health. That case gave the General Court the opportunity to rule in detail on the standard of evidence provided for in Article 57(f) of Regulation No 1907/2006.

The applicant, PlasticsEurope, is an international professional association, established in Belgium and governed by Belgian law, which represents and defends the interests of over 100 member undertakings, made up of manufacturers and importers of plastic products. Four of those undertakings are active in placing bisphenol A (BPA) on the market in the European Union.

By decision ED/01/2017 of 4 January 2017, ECHA included bisphenol A in the ‘Candidate List’, that is, the list of substances identified with a view to their eventual inclusion in Annex XIV to Regulation No 1907/2006, on the ground that that substance had been identified as a substance toxic for reproduction within the meaning of Article 57(c) of that regulation. By judgment of 11 July 2019, ( 2 ) the General Court dismissed the applicant’s action against that decision.

By Decision ED/30/2017 of 6 July 2017, ECHA supplemented the existing entry relating to the substance bisphenol A on the list of Candidate Substances, stating that that substance was an endocrine disruptor that might have serious effects on human health within the meaning of Article 57(f) of Regulation No 1907/2006. ( 3 )

The applicant brought an action for annulment of the latter decision, claiming, in particular, that the information upon which ECHA based the conclusion set out in the contested decision did not meet the standard of evidence provided for in Article 57(f) of Regulation No 1907/2006.

By its judgment, the General Court, in essence, upheld the contested decision, holding that ECHA had met the standard of evidence provided for in Article 57(f) of Regulation No 1907/2006.

In that regard, the General Court observed that, under Article 57(f) of Regulation No 1907/2006, as is clear, inter alia, from the French version of that regulation, substances for which it is ‘scientifiquement prouvé’ (literally, ‘scientifically proven’) that they ‘peuvent’ (literally, ‘can’) have serious effects on human health or the environment which give rise to an equivalent level of concern to those of other substances listed in Article 57(a) to (e), may be included in Annex XIV to that regulation. By contrast, according to other language versions of that provision, such as the German, English and Italian versions, those serious effects must be ‘probable’ (German: wahrscheinlich; English: probable; Italian: probabilità). While, according to the majority of the language versions of Article 57(f) of Regulation No 1907/2006, there must be ‘scientific evidence’ that a given substance has possible or probable adverse effects, according to the German version, the answer to the question whether a substance has ‘probable effects’ must be based on ‘wissenschaftliche Erkenntnisse’ (scientific knowledge).

Next, the General Court distinguished the standard of evidence provided for in Article 57(f) of Regulation No 1907/2006 from the question whether it should be found that there exists an endocrine disruptor of very high concern when it is demonstrated that a substance has ‘possible’ negative effects or when it is demonstrated that a substance has ‘probable’ adverse effects. That second question refers to the nature of the effects observed and, consequently, to one of the factors that are the subject of the examination of the intrinsic properties of a substance.

In view of the fact that the assessment of the intrinsic properties of the substances referred to in Article 57(f) of Regulation No 1907/2009 is an assessment of the hazards of a substance, as opposed to an assessment of the risks arising from the practical use of a substance or exposure to it, and since the concept of ‘hazard’ describes a procedure ‘capable’ of having an adverse effect on human health, the General Court considered that a substance can be considered to be an endocrine disruptor of very high concern when it is demonstrated that it ‘may’ have adverse effects. ( 4 ) That approach is also in line with the precautionary principle referred to, inter alia, in Article 1(3) of Regulation No 1907/2006.

( 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 2006 L 396, p. 1).

( 2 ) Judgment of 11 July 2019, PlasticsEurope v ECHA (T‑185/17, not published, EU:T:2019:492).

( 3 ) It should be noted that, by decision ED/01/2018 of 3 January 2018, ECHA once again supplemented the existing entry relating to bisphenol A on the Candidate List, to the effect that that substance would also be an endocrine substance of extreme concern capable of having serious effects on the environment, still within the meaning of Article 57(f) of Regulation No 1907/2006. On 23 March 2018 the applicant brought an action against that third decision. Case T‑207/18 is still pending.

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