Judgments nº T-108/17 of Tribunal General de la Unión Europea, April 04, 2019

• Resolution Date: April 04, 2019
• Issuing Organization: Tribunal General de la Unión Europea
• Decision Number: T-108/17

(REACH - Regulation (EC) No 1907/2006 - Bis(2-ethylhexyl) phthalate (DEHP) - Request for internal review of a decision on marketing authorisation rejected as unfounded - Error of law - Manifest error of assessment - Article 10 of Regulation (EC) No 1367/2006) In Case T-108/17,

ClientEarth, established in London (United Kingdom), represented by A. Jones, Barrister,

applicant,

v

European Commission, represented by G. Gattinara, R. Lindenthal and K. Mifsud-Bonnici, acting as Agents,

defendant,

supported by

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

intervener,

APPLICATION pursuant to Article 263 TFEU seeking the annulment of the letter of the Commission of 7 December 2016 by which that institution rejected a request for internal review of 2 August 2016 against Commission Implementing Decision C(2016) 3549 final of 16 June 2016, granting an authorisation for uses of bis(2-ethylhexyl) phthalate (DEHP) under Regulation (EC) No 1907/2006 of the European Parliament and of the Council,

THE GENERAL COURT (Fifth Chamber),

composed of D. Gratsias, President, A. Dittrich (Rapporteur) and I. Ulloa Rubio, Judges,

Registrar: F. Oller, Administrator,

having regard to the written part of the procedure and further to the hearing on 6 September 2018,

gives the following

Judgment

Background to the dispute

1 In adopting Commission Regulation (EU) No 143/2011 of 17 February 2011 amending Annex XIV to Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) (OJ 2011 L 44, p. 2), the European Commission included bis(2-ethylhexyl) phthalate, an organic compound essentially used to soften polyvinyl chloride (PVC) plastics, in Annex XIV to Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ 2006 L 396, p. 1, corrigendum OJ 2007 L 136, p. 3) because of the reproductive toxicity of that substance within the meaning of Article 57(c) of that regulation.

2 On 13 August 2013, three waste recycling companies (‘the authorisation applicants’) jointly submitted an application for authorisation under Article 62 of Regulation No 1907/2006, read in conjunction with Article 60(2) of that regulation, with a view to the placing on the market of DEHP for the following ‘uses’:

- ‘the formulation of recycled soft poly(vinyl chloride) (PVC) containing DEHP in compounds and dry-blends;

- the industrial use of recycled soft PVC containing DEHP in polymerprocessing by calendaring, extrusion, compression and injection moulding to produce PVC articles’.

3 In the analysis of the alternatives accompanying the application for authorisation, the authorisation applicants indicated the following:

‘DEHP is a plasticiser that has been used in the softening of PVC for the manufacture of plasticised or flexible PVC over several decades. ...

DEHP is therefore added to PVC before the plastic is converted into plastic articles and before those plastic articles become waste, i.e. a potentially valuable commodity for the [authorisation] applicants. Therefore, in the strictest sense, DEHP does not play any specific functional role for the [authorisation] applicants; it is merely present as a (largely unwanted) impurity in the waste that is collected, sorted, processed and then placed on the market in the form of recyclate. Nevertheless, the limited presence of DEHP (or other plasticisers) in the recyclate could theoretically be of some benefit to downstream users (the PVC converters):

- it may facilitate the processing of the recyclate material into new PVC articles; and

- it may allow the PVC converters to reduce the amount of neat (or “virgin”) DEHP (or other plasticiser) that they must add to their compounds before new flexible PVC articles are produced.’

4 In the application for authorisation, the authorisation applicants also stated that ‘DEHP d[id] not have a specific functional role for [them]’. That substance is merely present as a (largely unwanted) impurity in the waste that is collected, sorted, processed and then placed on the market in the form of recyclate. It is also apparent from that application for authorisation that the limited presence of DEHP in the recyclate may facilitate its processing into new PVC articles by reducing the amount of pure or virgin DEHP or other plasticisers that can be added to the compounds before new flexible PVC articles are produced.

5 On 10 October 2014, the Committee for Risk Assessment and the Committee for Socio-economic Analysis of the European Chemicals Agency (ECHA) produced their opinions on the application for authorisation. According to the Committee for Risk Assessment, the authorisation applicants had not demonstrated that the risks to the health of workers resulting from the two requested ‘uses’ were adequately controlled within the meaning of Article 60(2) of Regulation No 1907/2006. The Committee for Socio-economic Analysis, for its part, concluded that the authorisation could be granted in the present case, notwithstanding the existence of certain deficiencies in the analysis submitted by the authorisation applicants to demonstrate the socio-economic benefits resulting from the ‘uses’ for which the application for authorisation had been submitted, on the one hand, and on the basis of a ‘qualitative analysis’ including the relevant uncertainties, on the other.

6 On 22 October 2014, the Committee for Risk Assessment and the Committee for Socio-economic Analysis of the ECHA prepared a document containing a joint and consolidated version of their opinions. That document, which bears the reference ‘ECHA/RAC/SEAC Opinion No AFA-O-0000004151-87-17/D’, is entitled ‘Opinion on an Application for Authorisation for Bis(2-ethylhexyl) phthalate (DEHP) use: Formulation of recycled soft PVC containing DEHP in compounds and dry-blends’. On 24 October 2014, ECHA sent those opinions to the Commission.

7 On 12 December 2014, ECHA updated and supplemented the existing entry for DEHP in the ‘candidate list for eventual inclusion in Annex XIV’ referred to in Article 59(1) of Regulation No 1907/2006 (‘the candidate list’) by identifying it as a substance with endocrine-disrupting properties for which there was scientific evidence of probable serious effects on the environment which gave rise to an equivalent level of concern to that of other substances listed in Article 57(a) to (e) of Regulation No 1907/2006, all within the meaning of Article 57(f) of that regulation.

8 The application for authorisation was also discussed within the committee provided for in Article 133 of Regulation No 1907/2006.

9 On 16 June 2016, the Commission adopted Implementing Decision C(2016) 3549 final granting an authorisation for uses of bis(2-ethylhexyl) phthalate (DEHP) under Regulation No 1907/2006 (‘the authorisation decision’). By Article 1 of that decision, the Commission granted authorisation for the following ‘uses’:

- ‘the formulation of recycled soft poly(vinyl chloride) (PVC) containing DEHP in compounds and dry-blends;

- industrial use of recycled soft PVC containing DEHP in polymer processing by calendaring, extrusion, compression and injection moulding to produce PVC articles, except: toys and childcare articles; erasers; adult toys (sex toys and other articles for adults with intensive contact with mucous membranes); household articles smaller than 10 cm that children can suck or chew on; consumer textiles/clothing intended to be worn against the bare skin; cosmetics and food contact materials regulated under sector-specific Union legislation’.

10 According to Article 1 of the authorisation decision, in essence, authorisation was granted ‘in accordance with Article 60(4) of Regulation No 1907/2006, subject to full application of the risk management measures and operational conditions described in the chemical safety report submitted pursuant to Article 62(4)(d) of that Regulation, corresponding to each respective use and under the condition that the content of DEHP in recycled soft PVC in compounds and dry-blends authorised by this decision does not exceed 20% w/w’.

11 In Article 2 of the authorisation decision, the Commission fixed the review period for authorisation referred to in Article 60(9)(e) of Regulation No 1907/2006 at four years from the date of expiry laid down in Annex XIV to Regulation No 1907/2006, namely, 21 February 2019. In Article 3 of the authorisation decision, the Commission imposed monitoring arrangements within the meaning of Regulation No 1907/2006.

12 In Article 4 of the authorisation decision, the Commission stated that that decision was addressed to the authorisation applicants.

13 In recital 8 of the authorisation decision, the Commission declared that Regulation No 1907/2006 ‘d[id] not apply to waste as defined in Directive 2008/98/EC of the European Parliament and of the Council’, and that, accordingly, ‘the authorisation to place on the market and use recycled soft PVC compounds and dry-blends containing DEHP in accordance with Article 64 of [Regulation No 1907/2006] applie[d] to the extent that those compounds and dry-blends ha[d] ceased to be waste in accordance with Article 6 of that Directive’.

14 By letter of 2 August 2016 (‘the request for internal review’), the applicant, ClientEarth, which is a not-for-profit organisation whose purpose is inter alia the protection of the environment, requested that the Commission carry out an internal review of the authorisation decision under Article 10 of...