Judgments nº T-635/18 of Tribunal General de la Unión Europea, December 16, 2020

• Resolution Date: December 16, 2020
• Issuing Organization: Tribunal General de la Unión Europea
• Decision Number: T-635/18

(Non-contractual liability - Environment - Classification, labelling and packaging of certain substances and mixtures - Classification of pitch, coal tar, high-temp as an Aquatic Acute 1 (H400) toxic substance and as an Aquatic Chronic 1 (H410) toxic substance - Sufficiently serious breach of a rule of law intended to confer rights on individuals)

In Case T-635/18,

Industrial Química del Nalón, SA, established in Oviedo (Spain), represented by K. Van Maldegem, M. Grunchard, S. Saez Moreno and P. Sellar, lawyers,

applicant,

v

European Commission, represented by M. Wilderspin, R. Lindenthal and K. Talabér-Ritz, acting as Agents,

defendant,

supported by

Kingdom of Spain, represented by L. Aguilera Ruiz, acting as Agent,

and by

European Chemicals Agency (ECHA), represented by M. Heikkilä and W. Broere, acting as Agents,

interveners,

ACTION under Article 268 TFEU seeking compensation for the damage which the applicant claims to have suffered as a result of the adoption of Commission Regulation (EU) No 944/2013 of 2 October 2013 amending, for the purposes of its adaptation to technical and scientific progress, Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures (OJ 2013 L 261, p. 5), in so far as that regulation classified pitch, coal tar, high-temp (‘CTPHT’) as an Aquatic Acute 1 (H400) and Aquatic Chronic 1 (H410) substance,

THE GENERAL COURT (Eighth Chamber, Extended Composition),

composed of J. Svenningsen, President, R. Barents, C. Mac Eochaidh, T. Pynnä and J. Laitenberger (Rapporteur), Judges,

Registrar: E. Coulon,

gives the following

Judgment

Legal context

1 The purpose of Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ 2008 L 353, p. 1), as amended by Commission Regulation (EU) No 286/2011 of 10 March 2011 (OJ 2011 L 83, p. 1), is, according to Article 1 thereof, ‘to ensure a high level of protection of human health and the environment as well as the free movement of substances [and] mixtures … by: (a) harmonising the criteria for classification of substances and mixtures, and the rules on labelling and packaging for hazardous substances and mixtures’.

2 Recitals 5 to 8 of Regulation No 1272/2008 are worded as follows:

‘(5) With a view to facilitating worldwide trade while protecting human health and the environment, harmonised criteria for classification and labelling have been carefully developed over a period of 12 years within the United Nations (UN) structure, resulting in the Globally Harmonised System of Classification and Labelling of Chemicals (hereinafter referred to as “the GHS”).

(6) This Regulation follows various declarations whereby the Community confirmed its intention to contribute to the global harmonisation of criteria for classification and labelling, not only at UN level, but also through the incorporation of the internationally agreed GHS criteria into Community law.

(7) The benefits for enterprises will increase as more countries in the world adopt the GHS criteria in their legislation. The Community should be at the forefront of this process to encourage other countries to follow and with the aim of providing a competitive advantage to industry in the Community.

(8) Therefore it is essential to harmonise the provisions and criteria for the classification and labelling of substances, mixtures and certain specific articles within the Community, taking into account the classification criteria and labelling rules of the GHS, but also by building on the 40 years of experience obtained through implementation of existing Community chemicals legislation and maintaining the level of protection achieved through the system of harmonisation of classification and labelling, through Community hazard classes not yet part of the GHS as well as through current labelling and packaging rules.’

3 The first paragraph of Article 3 of Regulation No 1272/2008 provides:

‘A substance or a mixture fulfilling the criteria relating to physical hazards, health hazards or environmental hazards, laid down in Parts 2 to 5 of Annex I is hazardous and shall be classified in relation to the respective hazard classes provided for in that Annex.’

4 Annex I to Regulation No 1272/2008 sets out the criteria for classification of substances and mixtures in hazard classes.

5 Point 4.1.1.1 defines ‘aquatic toxicity’:

‘“Acute aquatic toxicity” means the intrinsic property of a substance to be injurious to an aquatic organism in a short-term aquatic exposure to that substance.

…

“Chronic aquatic toxicity” means the intrinsic property of a substance to cause adverse effects to aquatic organisms during aquatic exposures which are determined in relation to the life-cycle of the organism.

…’

6 Regarding, more specifically, the classification criteria for mixtures, point 4.1.3 provides:

‘4.1.3.1. The classification system for mixtures covers all classification categories which are used for substances, i.e. categories Acute 1 and Chronic 1 to 4. In order to make use of all available data for purposes of classifying the aquatic environmental hazards of the mixture, the following is applied where appropriate:

The “relevant components” of a mixture are those which are classified “Acute 1” or “Chronic 1” and present in a concentration of 0.1% (w/w) or greater, and those which are classified “Chronic 2”, “Chronic 3” or “Chronic 4” and present in a concentration of 1 % (w/w) or greater, unless there is a presumption (such as in the case of highly toxic components (see section 4.1.3.5.5.5)) that a component present in a lower concentration can still be relevant for classifying the mixture for aquatic environmental hazards. Generally, for substances classified as “Acute 1” or “Chronic 1” the concentration to be taken into account is (0.1/M)% (for [an] explanation [of the] M-factor see Section 4[.]1.3.5.5.5.).

4.1.3.2. The approach for classification of aquatic environmental hazards is tiered, and is dependent upon the type of information available for the mixture itself and for its components. Figure 4.1.2 outlines the process to be followed.

Elements of the tiered approach include:

- classification based on tested mixtures;

- classification based on bridging principles;

- the use of “summation of classified components” and/or an “additivity formula”.’

7 Point 4.1.3.5.5 of Annex I to Regulation No 1272/2008, entitled ‘Summation method’, provides:

‘4.1.3.5.5.1.1. In case of the substance classification categories Chronic 1 to Chronic 3, the underlying toxicity criteria differ by a factor of 10 in moving from one category to another. Substances with a classification in a high toxicity band therefore contribute to the classification of a mixture in a lower band. The calculation of these classification categories therefore needs to consider the contribution of any substance classified as Chronic 1, 2 or 3.

4.1.3.5.5.1.2. When a mixture contains components classified as Acute 1 or Chronic 1, attention must be paid to the fact that such components, when their acute toxicity is below 1 mg/l and/or chronic toxicity is below 0.1 mg/l (if non-rapidly degradable) and 0.01 mg/l (if rapidly degradable) contribute to the toxicity of the mixture even at a low concentration. Active ingredients in pesticides often possess such high aquatic toxicity but also some other substances like organometallic compounds. Under these circumstances the application of the normal generic concentration limits leads to an “under-classification” of the mixture. Therefore, multiplying factors shall be applied to account for highly toxic components, as described in Section 4.1.3.5.5.5.’

8 As regards the classification as Acute Category 1, point 4.1.3.5.5.3.1 of Annex I to Regulation No 1272/2008 provides:

‘First all components classified as Acute 1 are considered. If the sum of the concentrations (in %) of these components multiplied by their corresponding M-factors is greater than 25 % the whole mixture is classified as Acute 1.’

9 As regards the classification as Chronic Categories 1, 2, 3 and 4, point 4.1.3.5.5.4.1 of Annex I to Regulation No 1272/2008 provides:

‘First all components classified as Chronic 1 are considered. If the sum of the concentrations (in %) of these components multiplied by their corresponding M-factors is equal to or greater than 25 %, the mixture is classified as Chronic 1. If the result of the calculation is a classification of the mixture as Chronic 1, the classification procedure is completed.’

10 Regarding mixtures with highly toxic components, point 4.1.3.5.5.5 of that annex provides:

‘4.1.3.5.5.5.1. Acute 1 and Chronic 1 components with toxicities below 1 mg/l and/or chronic toxicities below 0.1 mg/l (if non-rapidly degradable) and 0.01 mg/l (if rapidly degradable) contribute to the toxicity of the mixture even at a low concentration and shall normally be given increased weight in applying the summation of classification approach. When a mixture contains components classified as Acute or Chronic 1, one of the following shall be applied:

- The tiered approach described in [points] 4.1.3.5.5.3 and 4.1.3.5.5.4 using a weighted sum by multiplying the concentrations of Acute 1 and Chronic 1 components by a factor, instead of merely adding up the percentages. This means that the concentration of “Acute 1” in the left column of Table 4.1.1 and the concentration of “Chronic 1” in the left column of Table 4.1.2 are multiplied by the appropriate multiplying factor. The multiplying factors to be applied to these components are defined using the toxicity value, as summarised in Table 4.1.3. Therefore, in order to classify a mixture containing Acute/Chronic 1 components, the classifier needs to be informed of the value of the...