Polynt SpA v European Chemicals Agency.
Date: 2017-03-15
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In determining whether, as Polynt claims, the General Court erred in law by holding, in paragraphs 61, 68, 71 and 81 of the judgment under appeal, that Article 57(f) of the REACH Regulation requires an analysis of the intrinsic properties of the substances concerned, to the exclusion of any consideration of data relating to human exposure reflecting the risk management measures in force, it must be recalled that, under Article 1(1) of the REACH Regulation, the purpose of that regulation is to ensure a high level of protection of human health and the environment, including the promotion of alternative methods for assessment of hazards of substances, as well as the free circulation of substances on the internal market while enhancing competitiveness and innovation. To that end, that regulation introduces an integrated system for monitoring chemical substances, including registration, evaluation and authorisation, together with possible restrictions on their use.
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As made clear, inter alia, in recitals 69 and 70 of the REACH Regulation, that regulation makes substances ‘of very high concern’ subject to careful attention. Those substances are thus subject to the authorisation regime laid down in Title VII of that regulation. Article 55 of that regulation states that the aim of the authorisation regime is ‘to ensure the good functioning of the internal market while assuring that the risks from substances of very high concern are properly controlled and that these substances are progressively replaced by suitable alternative substances or technologies where these are economically and technically viable’.
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The first stage under those authorisation arrangements is the procedure for identifying substances of very high concern on the basis of the criteria set out in Article 57 of the REACH Regulation. The second stage is the inclusion of those substances on the list of substances subject to authorisation set out in Annex XIV to that regulation, and the third and final stage concerns the procedure that leads, if appropriate, to the authorisation of a substance of very high concern.
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Article 57(a) to (c) of that regulation covers, first of all, substances meeting the criteria for classification in the hazard class carcinogenicity, mutagenicity or reproductive toxicity (‘CMR’) category 1A or 1B, in accordance with sections 3.5 to 3.7 of Annex I to Regulation No 1272/2008. Next, Article 57(d) and (e) covers substances which are persistent, bioaccumulative and toxic (‘PBT’) and those which are very persistent and very bioaccumulative (‘vPvB’), in accordance with the criteria set out in Annex XIII to the REACH Regulation. Those criteria are based on the assessment of the hazards presented by those substances. Lastly, Article 57(f) of that regulation covers all other substances which do not fulfil any of the foregoing criteria but ‘for which there is scientific evidence of probable serious effects to human health or the environment which give rise to an equivalent level of concern to those of other substances listed in points (a) to (e), and which are identified on a case-by-case basis in accordance with the procedure set out in Article 59’.
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It is thus clear from its wording that Article 57 of the REACH Regulation does not require, in respect of the substances concerned, a risk assessment to be carried out analogous to that required, in the context of the evaluation procedure, under section 6 of Annex I to that regulation, or, in the context of the authorisation procedure, under Article 64(4) thereof, or, as regards the restriction procedure, under Article 70 of that regulation. It is clear, furthermore, that Article 57 provides, at point (f), for an independent mechanism that makes it possible to identify, as being of very high concern, substances which have not already been designated as such under that provision.