Case C‑691/15 P
European Commission
v
Bilbaína de Alquitranes SA and Others
(Appeal — Environment — Regulation (EC) No 1272/2008 — Classification, labelling and packaging of certain substances and mixtures — Regulation (EU) No 944/2013 — Classification of pitch, coal tar, high-temperature — Categories of acute aquatic toxicity (H400) and chronic aquatic toxicity (H410) — Duty to act diligently — Manifest error of assessment)
Summary — Judgment of the Court (Sixth Chamber), 22 November 2017
Approximation of laws—Classification, packaging and labelling of substances and mixtures—Regulation No 1272/2008—Adaption to scientific and technical progress—Classification of pitch, coal tar, high-temperature amongst substances of aquatic toxicity—Discretion of the EU authorities—Scope—Judicial review—Limits
(European Parliament and Council Regulation No 1272/2008, as amended by Regulation No 944/2013)
Approximation of laws—Classification, packaging and labelling of substances and mixtures—Regulation No 1272/2008—Adaption to scientific and technical progress—Methodological approach for determining the classification of hazards to the aquatic environment—Taking into consideration of relevant factors not expressly referred to in the regulation—Lawfulness
(European Parliament and Council Regulation No 1272/2008, as amended by Regulation No 944/2013, Annex I, point 4.1.3.5.5)
Approximation of laws—Classification, packaging and labelling of substances and mixtures—Regulation No 1272/2008—Adaption to scientific and technical progress—Classification of pitch, coal tar, high-temperature amongst substances of aquatic toxicity—Classification on the basis of the properties of constituents—Lawfulness—Condition—Account taken of the level of the presence of the constituents concerned and their chemical effects—Limits—Taking into consideration of the hypothetical solubility rate of the constituents
(European Parliament and Council Regulation No 1272/2008, as amended by Regulation No 944/2013, Annex I, point 4.1.3.5.5)
See the text of the decision.
(see paras 34, 35)
The classification of a substance of unknown or variable composition, complex reaction products or biological materials (UVCB) in respect of the aquatic environmental hazards which it involves must be established in accordance with the provisions of Regulation No 1272/2008 on classification, labelling and packaging of substances and mixtures. Annex I to that regulation establishes that the approach for that classification is tiered and is dependent upon the type of information available for the mixture itself and for its components. Elements of the tiered approach include classification based on tested mixtures, classification based on bridging principles and the use of ‘summation of classified components’ and/or an ‘additivity formula’.
Point 4.1.3.5.5 of Annex I to Regulation No 1272/2008 does not provide for the use of criteria other than those expressly referred to in that provision. However, no provision expressly prohibits other factors liable to be relevant to the classification of a UVCB substance from being taken into consideration.
However, the indicated methodological approach is difficult due, inter alia, to the fact that the term substances covers a wide range of chemicals, many of which pose difficult challenges to a classification system based on rigid criteria. That document therefore highlights a complex interpretational problem, even for experts, presented by classification, in particular of so-called ‘complex or multi-component’ substances for which biodegradation, bioaccumulation, partitioning behaviour and water solubility all present problems of interpretation, where each component of the mixture may behave differently.
The EU legislature integrated the provisions of the Globally Harmonised System of Classification and Labelling of Chemicals (GHS) in Annex I to Regulation No 1272/2008, without demonstrating any intention to deviate from that approach. In those circumstances, it cannot be held that, by thus integrating the GHS in Regulation No 1272/2008, the EU legislature disregarded its methodological limitations.
The strict and automatic application of the summation method in all circumstances is liable to result in an undervaluing of the aquatic toxicity of a UVCB substance with few known constituents. Such a result cannot be regarded as consistent with the goal of protection of the environment and human health pursued by Regulation No 1272/2008.
Therefore, when it applies the summation method in order to determine whether a UVCB substance comes within the categories of acute or chronic aquatic toxicity, the Commission is not required to limit its assessment solely to the factors expressly referred to in point 4.1.3.5.5 of Annex I to Regulation No 1272/2008, to the exclusion of any other factor. In accordance with its duty to act diligently, the Commission is required to examine carefully and impartially other factors which, although not expressly referred to by those provisions, are nevertheless relevant.
(see paras 36, 39, 43, 45-47)
The classification method referred to in point 4.1.3.5.5 of Annex I to Regulation No 1272/2008 is based on the assumption that the constituents taken into consideration are 100% soluble. On the basis of that assumption, that summation method implies that there is a concentration level of constituents below which the threshold of 25% cannot be reached and, thus, consists of calculating the sum of the concentrations of the constituents coming within the categories of acute or chronic toxicity, each weighted by factor M corresponding to their toxicity profile.
It is, however, inherent in that method that it loses reliability in situations where the weighted sum of the constituents exceeds the level of concentration corresponding to the threshold of 25% in a proportion less than the ratio between the observed solubility rate at the level of the substance in question as a whole and the hypothetical solubility rate of 100%. In such situations, it thus becomes possible that the summation method may lead, in specific cases, to a result greater than or less than the level corresponding to the regulatory threshold of 25%, according to whether the hypothetical solubility rate of the constituents is taken into consideration or that of the substance as a whole.
(see paras 51, 52)