Case T‑837/16
Kingdom of Sweden
v
European Commission
Judgment of the General Court (Fifth Chamber), 7 March 2019
(REACH — Commission Decision authorising the use of lead sulfochromate yellow and of lead chromate molybdate sulfate red — Article 60(4) and (5) of Regulation (EC) No 1907/2006 — Examination of the lack of availability of alternatives — Error of law)
1. Approximation of laws — Registration, evaluation and authorisation of chemicals — REACH Regulation — Substances of very high concern — Authorisation decision — Conditions for granting authorisation — Assessment obligation on the part of the Commission — Scope — Obligation to take into account opinions of the European Chemicals Agency (ECHA) committees — Limits — Obligation to state reasons
(European Parliament and Council Regulation No 1907/2006, recitals 81 and 102 and Art. 60(4))
(see paragraphs 64-69)
2. Approximation of laws — Registration, evaluation and authorisation of chemicals — REACH Regulation — Substances of very high concern — Authorisation decision — Conditions for granting authorisation — Lack of availability of alternatives to the use of a substance of concern — Examination by the Commission — Burden of proof — Presence of evidence to support a conclusion that the Commission has not carried out a proper examination of the lack of availability of alternatives
(European Parliament and Council Regulation No 1907/2006, recitals 69 and 73 and Arts 60(4), (5), (8) and (9)(d) and 62(4)(e) and (f))
(see paragraphs 72-79, 81-85, 102)
3. Action for annulment — Judgment annulling a measure — Effects — Limitation by the Court — Maintenance of the effects of the contested measure until its replacement within a reasonable period — Justification on grounds of legal certainty
(Art. 264, second para., TFEU)
(see paragraphs 109-112)
Résumé
In the judgment in Sweden v Commission (T‑837/16), delivered on 7 March 2019, the General Court annulled a decision by which the Commission had authorised certain uses of lead sulfochromate yellow (C.I. Pigment Yellow 34) and lead chromate molybdate sulfate red (C.I. Pigment Red 104) under Regulation (EC) No 1907/2006. (1) That authorisation had been requested by DDC Maastricht BV with a view, in particular, to the use of those two pigments in paints for metal surfaces and road marking. The European Commission’s authorisation decision, which found, inter alia, that there was a lack of availability of alternatives to those two pigments, was challenged before the General Court by the Kingdom of Sweden, supported by the Kingdom of Denmark, the Republic of Finland and the European Parliament.
In the first place, the General Court found that, as regards the lead chromates at issue in the present case, it was common ground that it was not possible to determine a derived no-effect level for carcinogenic properties or for properties toxic for reproduction and that, consequently, the only legal basis capable of permitting the authorisation of those substances of very high concern was Article 60(4) of Regulation (EC) No 1907/2006. The contested decision is based on that provision.
In the second place, the General Court provided a number of clarifications concerning the allocation of tasks between the actors involved, in the context of the authorisation procedure referred to in Article 60(4) of Regulation No 1907/2006. Thus, it is for the Commission alone to verify whether the conditions provided for in that provision are fulfilled. In the context of the socio-economic analysis and the analysis of suitable alternatives, the Commission is required to take into account the opinions of the committees of the European Chemicals Agency (ECHA) referred to in Article 64(1) of Regulation No 1907/2006. Even though the Commission is not bound by an opinion, in the event that it decides substantially to disregard a technical or economic point of view expressed in such an opinion, the Commission must provide specific reasons for its findings.
In the third place, the General Court further clarified the concept of ‘alternatives’. It follows from Article 64(4), Article 60(5) and recital 69 of Regulation No 1907/2006 that an ‘alternative’ constitutes an ‘alternative substance’ or ‘technology’ which is relevant for the purposes of the authorisation procedure laid down in Regulation No 1907/2006 only to the extent that it is ‘suitable’. As regards that term, it aims to limit the number of relevant alternatives to the ‘safer’ alternatives, that is to say, substances or technologies whose use entails a lower risk as compared to the risk of using the relevant substance of very high concern. Moreover, that term means that there cannot merely exist an alternative in abstracto or one which is obtained in laboratory conditions or under conditions which are only of an exceptional nature. Furthermore, in the context of the socio-economic procedure, it is also necessary to determine whether the alternatives established during the authorisation procedure are technically and economically feasible ‘for the applicant’ for authorisation. Finally, if it is shown that socio-economic benefits outweigh the risk to human health or the environment arising from the use of the substance in question, authorisation may be granted if the applicant for authorisation submits a substitution plan within the meaning of Article 60(4)(c) of that regulation.
In the fourth place, with regard to the burden of proof, the General Court held that, although it indeed falls to the applicant for authorisation to show that no alternative is available, it is for the Commission to establish whether all the relevant facts and the technical and economic assessments relating to them support the conclusion that the conditions provided for in that provision are indeed fulfilled. Therefore, it is for the Commission, in accordance with its duty of care, to examine the condition concerning the lack of availability of alternatives in greater depth. If, following examination of the condition relating to the lack of availability of alternatives, there remain uncertainties relating to the scientific assessment, it must be concluded that in principle that condition is not fulfilled and that the Commission is therefore not entitled to grant an authorisation, even one which is conditional.
In the present case, the General Court found that the information provided by third parties during the procedure leading to the adoption of the contested decision demonstrated that, at the very least, as regards certain uses, there was no justification for the finding that alternatives were unavailable. According to the General Court, on the date of the adoption of the contested decision, the Commission’s examination of the condition relating to the lack of availability of alternatives, as provided for in Article 60(4) of Regulation No 1907/2006, had not been duly completed. Therefore, at that date, the authorisation at issue in the present case could not yet be granted.