Judgment of the General Court (Eighth Chamber) of 10 November 2021 –
Sasol Germany and Others v Commission
(Case T‑661/19)
(REACH – Substances of very high concern – Establishment of a list of identified substances with a view to their eventual inclusion in Annex XIV to Regulation (EC) No 1907/2006 – Decision identifying the substance 4-tert-butylphenol as a substance meeting the criteria for inclusion in the list – Article 57 of Regulation (EC) No 1907/2006 – Weight of evidence approach – Manifest error of assessment – Proportionality)
1. Approximation of laws – Registration, evaluation and authorisation of chemicals – REACH Regulation – Substances of very high concern – Procedure for identification – Determination of the level of concern of a substance – Taking into account of data relating to human exposure reflecting the risk management measures in force – Whether permissible
(European Parliament and Council Regulation No 1907/2006, Art. 57(a) to (f), and Annexes I and XV)
(see paras 34, 53, 56, 58, 94, 95, 122, 123)
2. 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))
(see paras 35, 40, 43, 45)
3. 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 paras 52, 132)
4. Approximation of laws – Registration, evaluation and authorisation of chemicals – REACH Regulation – Substances of very high concern – Procedure for identification – Decision of the European Chemicals Agency (ECHA) identifying 4-tert-butylphenol as a substance of very high concern – Breach of principle of proportionality – None
(European Parliament and Council Regulation No 1907/2006, recital 16 and Arts 1(1), 14(6) and 59 and Annex XV)
(see paras 140, 141, 144, 145, 158-160)
5. Approximation of laws – Registration, evaluation and authorisation of chemicals – REACH Regulation – Substances of very high concern – Procedure for identification – Distinct from and independent of the evaluation procedure
(European Parliament and Council Regulation No 1907/2006, recitals 19 to 21 and 69 and Arts 14, 44 to 48 and 59)
(see para. 143)
Re:
Application under Article 263 TFEU seeking the annulment of Commission Implementing Decision (EU) 2019/1194 of 5 July 2019 on the identification of 4 tert-butylphenol (PTBP) as a substance of very high concern pursuant to Article 57(f) of Regulation (EC) No 1907/2006 of the European Parliament and of the Council (OJ 2019 L 187, p. 41).
Operative part
The Court:
2. | | Orders Sasol Germany GmbH, SI Group – Béthune and BASF SE to bear their own costs and to pay those incurred by the European Commission; |
3. | | Orders the Federal Republic of Germany and the European Chemicals Agency (ECHA) to bear their own costs. |