# 62019CJ0458

JUDGMENT OF THE COURT (First Chamber)

6 October 2021 (
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(Appeal – Action for annulment – Commission Implementing Decision C(2016) 3549 final – Authorisation for uses of bis(2-ethylhexyl) phthalate (DEHP) – Regulation (EC) No 1907/2006 – Articles 60 and 62 – Regulation (EC) No 1367/2006 – Request for internal review – Commission Decision C(2016) 8454 final – Rejection of the request)

In Case C‐458/19 P,

APPEAL under Article 56 of the Statute of the Court of Justice of the European Union, brought on 14 June 2019,

ClientEarth, established in London (United Kingdom), represented by A. Jones, Barrister, and J. Stratford BL,

ClientEarth

appellant,

the other parties to the proceedings being:

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

European Commission

defendant at first instance,

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

European Chemicals Agency (ECHA)

intervener at first instance,

THE COURT (First Chamber),

composed of J.‐C. Bonichot (Rapporteur), President of the Chamber, L. Bay Larsen, C. Toader, M. Safjan and N. Jääskinen, Judges,

Advocate General: J. Kokott,

Registrar: A. Calot Escobar,

having regard to the written procedure,

after hearing the Opinion of the Advocate General at the sitting on 25 February 2021,

gives the following

Judgment

Judgment

| 1 | By its appeal, ClientEarth asks the Court of Justice to set aside the judgment of the General Court of the European Union of 4 April 2019, ClientEarth v Commission (T‐108/17, EU:T:2019:215; ‘the judgment under appeal’), by which the General Court dismissed the action brought by ClientEarth seeking the annulment of Commission Decision C(2016) 8454 final of 7 December 2016 (‘the decision at issue’), which had rejected a request made by ClientEarth on 2 August 2016 for an internal review (‘the 2016 request for a review’) of 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 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), as amended by Commission Regulation (EU) 2016/217 of 16 February 2016 (OJ 2016 L 40, p. 5), (‘the REACH Regulation’). |
| --- | --- |

1

By its appeal, ClientEarth asks the Court of Justice to set aside the judgment of the General Court of the European Union of 4 April 2019, ClientEarth v Commission (T‐108/17, EU:T:2019:215; ‘the judgment under appeal’), by which the General Court dismissed the action brought by ClientEarth seeking the annulment of Commission Decision C(2016) 8454 final of 7 December 2016 (‘the decision at issue’), which had rejected a request made by ClientEarth on 2 August 2016 for an internal review (‘the 2016 request for a review’) of 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 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), as amended by Commission Regulation (EU) 2016/217 of 16 February 2016 (OJ 2016 L 40, p. 5), (‘the REACH Regulation’).

Legal context

Legal context

Aarhus Convention

Aarhus Convention

| 2 | Article 9(3) of the Convention on Access to Information, Public Participation in Decision-making and Access to Justice in Environmental Matters, signed at Aarhus (Denmark) on 25 June 1998 and approved on behalf of the European Community by Council Decision 2005/370/EC of 17 February 2005 (OJ 2005 L 124, p. 1), provides:
  ‘In addition and without prejudice to the review procedures referred to in paragraphs 1 and 2 above, each Party shall ensure that, where they meet the criteria, if any, laid down in its national law, members of the public have access to administrative or judicial procedures to challenge acts and omissions by private persons and public authorities which contravene provisions of its national law relating to the environment.’ |
| --- | --- |

2

Article 9(3) of the Convention on Access to Information, Public Participation in Decision-making and Access to Justice in Environmental Matters, signed at Aarhus (Denmark) on 25 June 1998 and approved on behalf of the European Community by Council Decision 2005/370/EC of 17 February 2005 (OJ 2005 L 124, p. 1), provides:

‘In addition and without prejudice to the review procedures referred to in paragraphs 1 and 2 above, each Party shall ensure that, where they meet the criteria, if any, laid down in its national law, members of the public have access to administrative or judicial procedures to challenge acts and omissions by private persons and public authorities which contravene provisions of its national law relating to the environment.’

The REACH Regulation

The REACH Regulation

| 3 | Article 55 of the REACH Regulation, entitled ‘Aim of authorisation and considerations for substitution’, states:
  ‘The aim of this Title 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. To this end all manufacturers, importers and downstream users applying for authorisations shall analyse the availability of alternatives and consider their risks, and the technical and economic feasibility of substitution.’ |
| --- | --- |

3

Article 55 of the REACH Regulation, entitled ‘Aim of authorisation and considerations for substitution’, states:

‘The aim of this Title 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. To this end all manufacturers, importers and downstream users applying for authorisations shall analyse the availability of alternatives and consider their risks, and the technical and economic feasibility of substitution.’

| 4 | Article 56 of the REACH Regulation, entitled ‘General provisions’, provides:
  ‘1.   A manufacturer, importer or downstream user shall not place a substance on the market for a use or use it himself if that substance is included in Annex XIV, unless:





  (a) | the use(s) of that substance on its own or in a mixture or the incorporation of the substance into an article for which the substance is placed on the market or for which he uses the substance himself has been authorised in accordance with Articles 60 to 64; ... |
| --- | --- | --- |

4

Article 56 of the REACH Regulation, entitled ‘General provisions’, provides:

‘1.   A manufacturer, importer or downstream user shall not place a substance on the market for a use or use it himself if that substance is included in Annex XIV, unless:

(a)

the use(s) of that substance on its own or in a mixture or the incorporation of the substance into an article for which the substance is placed on the market or for which he uses the substance himself has been authorised in accordance with Articles 60 to 64; ...

...’

| 5 | Article 57 of that regulation, entitled ‘Substances to be included in Annex XIV’, provides:
  ‘The following substances may be included in Annex XIV in accordance with the procedure laid down in Article 58:
  ...





  (c) | substances meeting the criteria for classification in the hazard class reproductive toxicity category 1A or 1B, adverse effects on sexual function and fertility or on development in accordance with Section 3.7 of Annex I to 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)]; |
| --- | --- | --- |

5

Article 57 of that regulation, entitled ‘Substances to be included in Annex XIV’, provides:

‘The following substances may be included in Annex XIV in accordance with the procedure laid down in Article 58:

...

(c)

substances meeting the criteria for classification in the hazard class reproductive toxicity category 1A or 1B, adverse effects on sexual function and fertility or on development in accordance with Section 3.7 of Annex I to 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)];

...

| (f) | substances – such as those having endocrine disrupting properties or those having persistent, bioaccumulative and toxic properties or very persistent and very bioaccumulative properties, which do not fulfil the criteria of points (d) or (e) – 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.’ |
| --- | --- |

(f)

substances – such as those having endocrine disrupting properties or those having persistent, bioaccumulative and toxic properties or very persistent and very bioaccumulative properties, which do not fulfil the criteria of points (d) or (e) – 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.’

| 6 | Article 58 of the REACH Regulation, entitled ‘Inclusion of substances in Annex XIV’, provides, in paragraph 1:
  ‘Whenever a decision is taken to include in Annex XIV substances referred to in Article 57, such a decision shall be taken in accordance with the procedure referred to in Article 133(4). ...
  ...’ |
| --- | --- |

6

Article 58 of the REACH Regulation, entitled ‘Inclusion of substances in Annex XIV’, provides, in paragraph 1:

‘Whenever a decision is taken to include in Annex XIV substances referred to in Article 57, such a decision shall be taken in accordance with the procedure referred to in Article 133(4). ...

...’

| 7 | Article 59 of the REACH Regulation, entitled ‘Identification of substances referred to in Article 57’, provides, in paragraph 1:
  ‘The procedure set out in paragraphs 2 to 10 of this Article shall apply for the purpose of identifying substances meeting the criteria referred to in Article 57 and establishing a candidate list for eventual inclusion in Annex XIV. The [European Chemicals] Agency shall indicate, within this list, the substances that are on its work programme according to Article 83(3)(e).’ |
| --- | --- |

7

Article 59 of the REACH Regulation, entitled ‘Identification of substances referred to in Article 57’, provides, in paragraph 1:

‘The procedure set out in paragraphs 2 to 10 of this Article shall apply for the purpose of identifying substances meeting the criteria referred to in Article 57 and establishing a candidate list for eventual inclusion in Annex XIV. The [European Chemicals] Agency shall indicate, within this list, the substances that are on its work programme according to Article 83(3)(e).’

| 8 | Article 60 of the REACH Regulation, entitled ‘Granting of authorisations’, states:
  ‘1.   The Commission shall be responsible for taking decisions on applications for authorisations in accordance with this Title.
  2.   Without prejudice to paragraph 3, an authorisation shall be granted if the risk to human health or the environment from the use of a substance arising from the intrinsic properties specified in Annex XIV is adequately controlled in accordance with Section 6.4 of Annex I and as documented in the applicant’s chemical safety report, taking into account the opinion of the Committee for Risk Assessment referred to in Article 64(4)(a). When granting the authorisation, and in any conditions imposed therein, the Commission shall take into account all discharges, emissions and losses, including risks arising from diffuse or dispersive uses, known at the time of the decision.
  ...
  3.   Paragraph 2 shall not apply to:





  (a) | substances meeting the criteria in Article 57(a), (b), (c) or (f) for which it is not possible to determine a threshold in accordance with Section 6.4 of Annex I; |
| --- | --- | --- |

8

Article 60 of the REACH Regulation, entitled ‘Granting of authorisations’, states:

‘1.   The Commission shall be responsible for taking decisions on applications for authorisations in accordance with this Title.

2.   Without prejudice to paragraph 3, an authorisation shall be granted if the risk to human health or the environment from the use of a substance arising from the intrinsic properties specified in Annex XIV is adequately controlled in accordance with Section 6.4 of Annex I and as documented in the applicant’s chemical safety report, taking into account the opinion of the Committee for Risk Assessment referred to in Article 64(4)(a). When granting the authorisation, and in any conditions imposed therein, the Commission shall take into account all discharges, emissions and losses, including risks arising from diffuse or dispersive uses, known at the time of the decision.

...

3.   Paragraph 2 shall not apply to:

(a)

substances meeting the criteria in Article 57(a), (b), (c) or (f) for which it is not possible to determine a threshold in accordance with Section 6.4 of Annex I;

| (b) | substances meeting the criteria in Article 57(d) or (e); |
| --- | --- |

(b)

substances meeting the criteria in Article 57(d) or (e);

| (c) | substances identified under Article 57(f) having persistent, bioaccumulative and toxic properties or very persistent and very bioaccumulative properties. |
| --- | --- |

(c)

substances identified under Article 57(f) having persistent, bioaccumulative and toxic properties or very persistent and very bioaccumulative properties.

4.   If an authorisation cannot be granted under paragraph 2 or for substances listed in paragraph 3, an authorisation may only be granted if it is shown that socio-economic benefits outweigh the risk to human health or the environment arising from the use of the substance and if there are no suitable alternative substances or technologies. This decision shall be taken after consideration of all of the following elements and taking into account the opinions of the Committee for Risk Assessment and the Committee for Socio-economic Analysis ...:

| (a) | the risk posed by the uses of the substance, including the appropriateness and effectiveness of the risk management measures proposed; |
| --- | --- |

(a)

the risk posed by the uses of the substance, including the appropriateness and effectiveness of the risk management measures proposed;

| (b) | the socio-economic benefits arising from its use and the socio-economic implications of a refusal to authorise as demonstrated by the applicant or other interested parties; |
| --- | --- |

(b)

the socio-economic benefits arising from its use and the socio-economic implications of a refusal to authorise as demonstrated by the applicant or other interested parties;

| (c) | the analysis of the alternatives submitted by the applicant under Article 62(4)(e) or any substitution plan submitted by the applicant under Article 62(4)(f), and any third party contributions submitted under Article 64(2); |
| --- | --- |

(c)

the analysis of the alternatives submitted by the applicant under Article 62(4)(e) or any substitution plan submitted by the applicant under Article 62(4)(f), and any third party contributions submitted under Article 64(2);

| (d) | available information on the risks to human health or the environment of any alternative substances or technologies. |
| --- | --- |

(d)

available information on the risks to human health or the environment of any alternative substances or technologies.

5.   When assessing whether suitable alternative substances or technologies are available, all relevant aspects shall be taken into account by the Commission, including:

| (a) | whether the transfer to alternatives would result in reduced overall risks to human health and the environment, taking into account the appropriateness and effectiveness of risk management measures; |
| --- | --- |

(a)

whether the transfer to alternatives would result in reduced overall risks to human health and the environment, taking into account the appropriateness and effectiveness of risk management measures;

| (b) | the technical and economic feasibility of alternatives for the applicant. |
| --- | --- |

(b)

the technical and economic feasibility of alternatives for the applicant.

...

7.   An authorisation shall be granted only if the application is made in conformity with the requirements of Article 62.

...

10.   Notwithstanding any conditions of an authorisation, the holder shall ensure that the exposure is reduced to as low a level as is technically and practically possible.’

| 9 | Article 62 of the REACH Regulation, entitled ‘Applications for authorisations’, is worded as follows:
  ‘...
  3.   Applications may be made for one or several substances that meet the definition of a group of substances in Section 1.5 of Annex XI, and for one or several uses. Applications may be made for the applicant’s own use(s) and/or for uses for which he intends to place the substance on the market.
  4.   An application for authorisation shall include the following information:
  ...





  (c) | a request for authorisation, specifying for which use(s) the authorisation is sought and covering the use of the substance in mixtures and/or the incorporation of the substance in articles, where this is relevant; |
| --- | --- | --- |

9

Article 62 of the REACH Regulation, entitled ‘Applications for authorisations’, is worded as follows:

‘...

3.   Applications may be made for one or several substances that meet the definition of a group of substances in Section 1.5 of Annex XI, and for one or several uses. Applications may be made for the applicant’s own use(s) and/or for uses for which he intends to place the substance on the market.

4.   An application for authorisation shall include the following information:

...

(c)

a request for authorisation, specifying for which use(s) the authorisation is sought and covering the use of the substance in mixtures and/or the incorporation of the substance in articles, where this is relevant;

| (d) | unless already submitted as part of the registration, a chemical safety report in accordance with Annex I covering the risks to human health and/or the environment from the use of the substance(s) arising from the intrinsic properties specified in Annex XIV; |
| --- | --- |

(d)

unless already submitted as part of the registration, a chemical safety report in accordance with Annex I covering the risks to human health and/or the environment from the use of the substance(s) arising from the intrinsic properties specified in Annex XIV;

| (e) | an analysis of the alternatives considering their risks and the technical and economic feasibility of substitution and including, if appropriate, information about any relevant research and development activities by the applicant; |
| --- | --- |

(e)

an analysis of the alternatives considering their risks and the technical and economic feasibility of substitution and including, if appropriate, information about any relevant research and development activities by the applicant;

| (f) | where the analysis referred to in point (e) shows that suitable alternatives are available, taking into account the elements in Article 60(5), a substitution plan including a timetable for proposed actions by the applicant. |
| --- | --- |

(f)

where the analysis referred to in point (e) shows that suitable alternatives are available, taking into account the elements in Article 60(5), a substitution plan including a timetable for proposed actions by the applicant.

5.   The application may include:

| (a) | a socio-economic analysis conducted in accordance with Annex XVI; |
| --- | --- |

(a)

a socio-economic analysis conducted in accordance with Annex XVI;

...’

Regulation (EC) No 1367/2006

Regulation (EC) No 1367/2006

| 10 | Article 10, entitled ‘Request for internal review of administrative acts’, of Regulation (EC) No 1367/2006 of the European Parliament and of the Council of 6 September 2006 on the application of the provisions of the Aarhus Convention on Access to Information, Public Participation in Decision-making and Access to Justice in Environmental Matters to Community institutions and bodies (OJ 2006 L 264, p. 13), provides, in paragraph 1, as follows:
  ‘Any non-governmental organisation which meets the criteria set out in Article 11 is entitled to make a request for internal review to the Community institution or body that has adopted an administrative act under environmental law or, in case of an alleged administrative omission, should have adopted such an act.
  ...’ |
| --- | --- |

10

Article 10, entitled ‘Request for internal review of administrative acts’, of Regulation (EC) No 1367/2006 of the European Parliament and of the Council of 6 September 2006 on the application of the provisions of the Aarhus Convention on Access to Information, Public Participation in Decision-making and Access to Justice in Environmental Matters to Community institutions and bodies (OJ 2006 L 264, p. 13), provides, in paragraph 1, as follows:

‘Any non-governmental organisation which meets the criteria set out in Article 11 is entitled to make a request for internal review to the Community institution or body that has adopted an administrative act under environmental law or, in case of an alleged administrative omission, should have adopted such an act.

...’

Background to the dispute

Background to the dispute

| 11 | Commission Regulation (EU) No 143/2011 of 17 February 2011 amending Annex XIV to Regulation No 1907/2006 (OJ 2011 L 44, p. 2) included in that annex DEHP, an organic compound essentially used to soften polyvinyl chloride (PVC) plastics, because of the reproductive toxicity of that substance within the meaning of Article 57(c) of the REACH Regulation. |
| --- | --- |

11

Commission Regulation (EU) No 143/2011 of 17 February 2011 amending Annex XIV to Regulation No 1907/2006 (OJ 2011 L 44, p. 2) included in that annex DEHP, an organic compound essentially used to soften polyvinyl chloride (PVC) plastics, because of the reproductive toxicity of that substance within the meaning of Article 57(c) of the REACH Regulation.

| 12 | On 13 August 2013, three waste recycling companies (‘the authorisation applicants’) jointly submitted an application for authorisation under Article 62 of the REACH Regulation, read in conjunction with Article 60(2) thereof (‘the application for authorisation’), with a view to the placing on the market of DEHP for the following ‘uses’:





  – | ‘the formulation of recycled soft polyvinyl chloride (PVC) containing DEHP in compounds and dry-blends; |
| --- | --- | --- |

12

On 13 August 2013, three waste recycling companies (‘the authorisation applicants’) jointly submitted an application for authorisation under Article 62 of the REACH Regulation, read in conjunction with Article 60(2) thereof (‘the application for authorisation’), with a view to the placing on the market of DEHP for the following ‘uses’:

–

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

| – | the industrial use of recycled soft PVC containing DEHP in polymer processing by calendering, extrusion, compression and injection moulding to produce PVC articles’. |
| --- | --- |

–

the industrial use of recycled soft PVC containing DEHP in polymer processing by calendering, extrusion, compression and injection moulding to produce PVC articles’.

| 13 | 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 |
| --- | --- | --- |

13

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.’ |
| --- | --- |

–

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.’

| 14 | On 10 October 2014, the Committee for Risk Assessment and the Committee for Socio-economic Analysis (‘SEAC’) of the European Chemicals Agency (ECHA) produced their opinions on the application for authorisation. |
| --- | --- |

14

On 10 October 2014, the Committee for Risk Assessment and the Committee for Socio-economic Analysis (‘SEAC’) of the European Chemicals Agency (ECHA) produced their opinions on the application for authorisation.

| 15 | 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, as required by Article 60(2) of the REACH Regulation. |
| --- | --- |

15

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, as required by Article 60(2) of the REACH Regulation.

| 16 | SEAC concluded that, notwithstanding the existence of certain deficiencies in the analysis submitted by the authorisation applicants to demonstrate the socio-economic benefits of the uses for which the application for authorisation had been submitted, authorisation could be granted on the basis of a ‘qualitative analysis’ including the relevant uncertainties. |
| --- | --- |

16

SEAC concluded that, notwithstanding the existence of certain deficiencies in the analysis submitted by the authorisation applicants to demonstrate the socio-economic benefits of the uses for which the application for authorisation had been submitted, authorisation could be granted on the basis of a ‘qualitative analysis’ including the relevant uncertainties.

| 17 | On 12 December 2014, ECHA updated and supplemented the existing entry for DEHP in the ‘candidate list for eventual inclusion in Annex XIV’ to the REACH Regulation, referred to in Article 59(1) of that regulation (‘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 the REACH Regulation, within the meaning of Article 57(f) of that regulation. |
| --- | --- |

17

On 12 December 2014, ECHA updated and supplemented the existing entry for DEHP in the ‘candidate list for eventual inclusion in Annex XIV’ to the REACH Regulation, referred to in Article 59(1) of that regulation (‘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 the REACH Regulation, within the meaning of Article 57(f) of that regulation.

| 18 | On 16 June 2016, the Commission adopted Implementing Decision C(2016) 3549 final granting an authorisation for uses of DEHP under the REACH Regulation (‘the authorisation decision’). |
| --- | --- |

18

On 16 June 2016, the Commission adopted Implementing Decision C(2016) 3549 final granting an authorisation for uses of DEHP under the REACH Regulation (‘the authorisation decision’).

| 19 | In 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; |
| --- | --- | --- |

19

In 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;

| – | the industrial use of recycled soft PVC containing DEHP in polymer processing by calendering, extrusion, compression and injection moulding to produce PVC articles ...’ |
| --- | --- |

–

the industrial use of recycled soft PVC containing DEHP in polymer processing by calendering, extrusion, compression and injection moulding to produce PVC articles ...’

| 20 | According to that provision, that authorisation was granted in accordance with Article 60(4) of the REACH Regulation. |
| --- | --- |

20

According to that provision, that authorisation was granted in accordance with Article 60(4) of the REACH Regulation.

| 21 | By its 2016 request for a review, ClientEarth, a non-profit organisation whose aim is the protection of the environment, requested the Commission to carry out an internal review of the authorisation decision on the basis of Article 10 of Regulation No 1367/2006. |
| --- | --- |

21

By its 2016 request for a review, ClientEarth, a non-profit organisation whose aim is the protection of the environment, requested the Commission to carry out an internal review of the authorisation decision on the basis of Article 10 of Regulation No 1367/2006.

| 22 | By the decision at issue, the Commission rejected that request as unfounded. |
| --- | --- |

22

By the decision at issue, the Commission rejected that request as unfounded.

The action before the General Court and the judgment under appeal

The action before the General Court and the judgment under appeal

| 23 | By application lodged at the Registry of the General Court on 17 February 2017, ClientEarth sought annulment of the decision at issue and of the authorisation decision. |
| --- | --- |

23

By application lodged at the Registry of the General Court on 17 February 2017, ClientEarth sought annulment of the decision at issue and of the authorisation decision.

| 24 | By decision of the President of the Fifth Chamber of the General Court of 29 June 2017, ECHA’s application for leave to intervene was granted. |
| --- | --- |

24

By decision of the President of the Fifth Chamber of the General Court of 29 June 2017, ECHA’s application for leave to intervene was granted.

| 25 | In paragraph 31 of the judgment under appeal, the General Court held that the action was manifestly inadmissible in so far as the appellant sought annulment of the authorisation decision. |
| --- | --- |

25

In paragraph 31 of the judgment under appeal, the General Court held that the action was manifestly inadmissible in so far as the appellant sought annulment of the authorisation decision.

| 26 | As regards the application for annulment of the decision at issue, the General Court, in paragraph 92 of the judgment under appeal, also rejected as inadmissible and, in any event, as unfounded, the first part of the first plea in law, which alleged errors of law and assessment in the interpretation of the concept of ‘use’ referred to in Article 56(1)(a) and in Article 62(4)(c) of the REACH Regulation. |
| --- | --- |

26

As regards the application for annulment of the decision at issue, the General Court, in paragraph 92 of the judgment under appeal, also rejected as inadmissible and, in any event, as unfounded, the first part of the first plea in law, which alleged errors of law and assessment in the interpretation of the concept of ‘use’ referred to in Article 56(1)(a) and in Article 62(4)(c) of the REACH Regulation.

| 27 | In paragraph 151 of the judgment under appeal, the General Court rejected as unfounded the second part of the first plea in law, which alleged the existence of errors of law and of assessment in connection with deficiencies in the chemical safety report. |
| --- | --- |

27

In paragraph 151 of the judgment under appeal, the General Court rejected as unfounded the second part of the first plea in law, which alleged the existence of errors of law and of assessment in connection with deficiencies in the chemical safety report.

| 28 | It held, in paragraph 167 of the judgment under appeal, that the arguments raised in support of the third part of the first plea in law, alleging the existence of errors of law and manifest errors of assessment as regards the assessment of appropriate alternatives, had to be examined in the context of the third plea in law. |
| --- | --- |

28

It held, in paragraph 167 of the judgment under appeal, that the arguments raised in support of the third part of the first plea in law, alleging the existence of errors of law and manifest errors of assessment as regards the assessment of appropriate alternatives, had to be examined in the context of the third plea in law.

| 29 | In paragraph 178 of the judgment under appeal, the General Court rejected as unfounded the fourth part of the first plea in law, which alleged infringement of Article 60(7) and Article 64(3) of the REACH Regulation, and rejected the first plea in law in its entirety. |
| --- | --- |

29

In paragraph 178 of the judgment under appeal, the General Court rejected as unfounded the fourth part of the first plea in law, which alleged infringement of Article 60(7) and Article 64(3) of the REACH Regulation, and rejected the first plea in law in its entirety.

| 30 | As regards the second plea in law alleging manifest errors of assessment vitiating the socio-economic assessment provided for in Article 60(4) of the REACH Regulation, the General Court, in paragraph 189 of the judgment under appeal, rejected as unfounded the first part of that plea, which alleged errors of law and manifest errors of assessment regarding the frame of reference for that analysis, and, in paragraph 204 of the judgment under appeal, rejected as inadmissible and, in any event, as unfounded, the second part of that plea, which alleged manifest errors of assessment regarding the assessment of the balance between risks and benefits. |
| --- | --- |

30

As regards the second plea in law alleging manifest errors of assessment vitiating the socio-economic assessment provided for in Article 60(4) of the REACH Regulation, the General Court, in paragraph 189 of the judgment under appeal, rejected as unfounded the first part of that plea, which alleged errors of law and manifest errors of assessment regarding the frame of reference for that analysis, and, in paragraph 204 of the judgment under appeal, rejected as inadmissible and, in any event, as unfounded, the second part of that plea, which alleged manifest errors of assessment regarding the assessment of the balance between risks and benefits.

| 31 | In paragraph 224 of the judgment under appeal, the General Court also rejected as unfounded the third part of that plea, which alleged a manifest error of assessment on the ground that certain information had not been taken into account in the context of that assessment. |
| --- | --- |

31

In paragraph 224 of the judgment under appeal, the General Court also rejected as unfounded the third part of that plea, which alleged a manifest error of assessment on the ground that certain information had not been taken into account in the context of that assessment.

| 32 | It then rejected the second plea in law in its entirety. |
| --- | --- |

32

It then rejected the second plea in law in its entirety.

| 33 | In paragraph 271 of the judgment under appeal, the General Court rejected as unfounded the third plea in law, which alleged errors of law and manifest errors of assessment in the analysis of alternatives. |
| --- | --- |

33

In paragraph 271 of the judgment under appeal, the General Court rejected as unfounded the third plea in law, which alleged errors of law and manifest errors of assessment in the analysis of alternatives.

| 34 | In paragraph 307 of the judgment under appeal, it rejected the fourth plea in law, which alleged a breach of the precautionary principle, as referred to in Article 191(2) TFEU. |
| --- | --- |

34

In paragraph 307 of the judgment under appeal, it rejected the fourth plea in law, which alleged a breach of the precautionary principle, as referred to in Article 191(2) TFEU.

| 35 | Accordingly, the General Court dismissed the action in its entirety. |
| --- | --- |

35

Accordingly, the General Court dismissed the action in its entirety.

Forms of order sought by the parties to the appeal

Forms of order sought by the parties to the appeal

| 36 | The appellant claims that the Court should:





  – | set aside the judgment under appeal; |
| --- | --- | --- |

36

The appellant claims that the Court should:

–

set aside the judgment under appeal;

| – | refer the case back to the General Court or; |
| --- | --- |

–

refer the case back to the General Court or;

| – | in the alternative, declare the action for annulment admissible and well founded and, consequently, annul the decision at issue; |
| --- | --- |

–

in the alternative, declare the action for annulment admissible and well founded and, consequently, annul the decision at issue;

| – | order the Commission to pay the costs, including the costs incurred by the interveners at first instance and in the appeal. |
| --- | --- |

–

order the Commission to pay the costs, including the costs incurred by the interveners at first instance and in the appeal.

| 37 | The Commission contends that the Court should:





  – | dismiss the appeal as unfounded; |
| --- | --- | --- |

37

The Commission contends that the Court should:

–

dismiss the appeal as unfounded;

| – | order the appellant to pay the costs. |
| --- | --- |

–

order the appellant to pay the costs.

| 38 | ECHA contends that the Court should:





  – | dismiss the appeal as unfounded; |
| --- | --- | --- |

38

ECHA contends that the Court should:

–

dismiss the appeal as unfounded;

| – | order the appellant to pay the costs. |
| --- | --- |

–

order the appellant to pay the costs.

The appeal

The appeal

| 39 | The appellant relies on seven grounds in support of its appeal. |
| --- | --- |

39

The appellant relies on seven grounds in support of its appeal.

The first ground of appeal

The first ground of appeal

Arguments of the parties

Arguments of the parties

| 40 | By its first ground of appeal, the appellant submits that the General Court was wrong to reject certain parts of its action for annulment as inadmissible. |
| --- | --- |

40

By its first ground of appeal, the appellant submits that the General Court was wrong to reject certain parts of its action for annulment as inadmissible.

| 41 | It submits, in the first place, that the General Court erred in law in finding, in paragraphs 53 and 54 of the judgment under appeal, that the action could relate only to the lawfulness of the decision at issue and not to whether the application for authorisation was sufficient. In the appellant’s view, that analysis does not comply with Article 9(3) of the Aarhus Convention or with the right to an effective remedy. |
| --- | --- |

41

It submits, in the first place, that the General Court erred in law in finding, in paragraphs 53 and 54 of the judgment under appeal, that the action could relate only to the lawfulness of the decision at issue and not to whether the application for authorisation was sufficient. In the appellant’s view, that analysis does not comply with Article 9(3) of the Aarhus Convention or with the right to an effective remedy.

| 42 | It adds that the General Court, in paragraph 54 of the judgment under appeal, wrongly made the admissibility of the appellant’s arguments regarding the authorisation decision subject to the alleged errors being expressly referred to in the Commission’s decision on the request for an internal review. |
| --- | --- |

42

It adds that the General Court, in paragraph 54 of the judgment under appeal, wrongly made the admissibility of the appellant’s arguments regarding the authorisation decision subject to the alleged errors being expressly referred to in the Commission’s decision on the request for an internal review.

| 43 | The appellant submits, in the second place, that the General Court erred in holding, in paragraphs 55 and 56 of the judgment under appeal, that not only the pleas in law, but also the arguments raised before it in the context of an action for annulment of a decision rejecting the 2016 request for a review, are admissible only in so far as they have already been presented in that request for review. |
| --- | --- |

43

The appellant submits, in the second place, that the General Court erred in holding, in paragraphs 55 and 56 of the judgment under appeal, that not only the pleas in law, but also the arguments raised before it in the context of an action for annulment of a decision rejecting the 2016 request for a review, are admissible only in so far as they have already been presented in that request for review.

| 44 | In its reply, the appellant submits that the Court of Justice stated, in the judgment of 12 September 2019, TestBioTech and Others v Commission (C‐82/17 P, EU:C:2019:719), that, while an action for annulment of a decision rejecting a request for internal review cannot be based on new grounds or on evidence which were not relied on in the request for internal review, the party requesting such a review is not required to reproduce exactly the same arguments in its action before the EU Courts. |
| --- | --- |

44

In its reply, the appellant submits that the Court of Justice stated, in the judgment of 12 September 2019, TestBioTech and Others v Commission (C‐82/17 P, EU:C:2019:719), that, while an action for annulment of a decision rejecting a request for internal review cannot be based on new grounds or on evidence which were not relied on in the request for internal review, the party requesting such a review is not required to reproduce exactly the same arguments in its action before the EU Courts.

| 45 | In the third place, the appellant adds that, in any event, some of the arguments which the General Court rejected as inadmissible, in paragraphs 61, 62, 74, 75, 85 to 87, 195 to 200 and 234 to 236 of the judgment under appeal, were referred to in its 2016 request for a review or were only expanding on that request. |
| --- | --- |

45

In the third place, the appellant adds that, in any event, some of the arguments which the General Court rejected as inadmissible, in paragraphs 61, 62, 74, 75, 85 to 87, 195 to 200 and 234 to 236 of the judgment under appeal, were referred to in its 2016 request for a review or were only expanding on that request.

| 46 | The Commission contends that the first ground of appeal cannot succeed. |
| --- | --- |

46

The Commission contends that the first ground of appeal cannot succeed.

| 47 | ECHA supports the Commission’s arguments. |
| --- | --- |

47

ECHA supports the Commission’s arguments.

Findings of the Court

Findings of the Court

| 48 | As regards the appellant’s argument relating to the error of law allegedly made by the General Court in that the latter found that the action brought against the authorisation decision was inadmissible, it should be noted that, as stated by the Commission, the appellant has not challenged paragraph 26 of the judgment under appeal, in which the General Court held that the appellant was not seeking annulment of the authorisation decision because the appellant considered that it did not satisfy the conditions laid down in Article 263 TFEU. |
| --- | --- |

48

As regards the appellant’s argument relating to the error of law allegedly made by the General Court in that the latter found that the action brought against the authorisation decision was inadmissible, it should be noted that, as stated by the Commission, the appellant has not challenged paragraph 26 of the judgment under appeal, in which the General Court held that the appellant was not seeking annulment of the authorisation decision because the appellant considered that it did not satisfy the conditions laid down in Article 263 TFEU.

| 49 | As regards the appellant’s argument relating to the error of law allegedly made by the General Court, in so far as the latter found that the arguments seeking to demonstrate possible errors made by the authorisation applicants were inadmissible, it should be noted, first, that the General Court did not err in law when it held, in paragraph 53 of the judgment under appeal, that, in the context of the present action, relating to the Commission’s decision on the request for an internal review, only pleas seeking to demonstrate that that decision was vitiated by errors of law or errors of assessment, and not pleas concerning the application for authorisation, were admissible. |
| --- | --- |

49

As regards the appellant’s argument relating to the error of law allegedly made by the General Court, in so far as the latter found that the arguments seeking to demonstrate possible errors made by the authorisation applicants were inadmissible, it should be noted, first, that the General Court did not err in law when it held, in paragraph 53 of the judgment under appeal, that, in the context of the present action, relating to the Commission’s decision on the request for an internal review, only pleas seeking to demonstrate that that decision was vitiated by errors of law or errors of assessment, and not pleas concerning the application for authorisation, were admissible.

| 50 | Second, contrary to what the appellant claims, it follows from paragraph 54 of the judgment under appeal not that only the elements ‘expressly’ set out in the Commission’s decision on the request for an internal review may be challenged before the General Court but that only the errors vitiating that decision may be the subject of such an action, as also follows from paragraphs 234 and 235 of the judgment under appeal. |
| --- | --- |

50

Second, contrary to what the appellant claims, it follows from paragraph 54 of the judgment under appeal not that only the elements ‘expressly’ set out in the Commission’s decision on the request for an internal review may be challenged before the General Court but that only the errors vitiating that decision may be the subject of such an action, as also follows from paragraphs 234 and 235 of the judgment under appeal.

| 51 | As regards the argument alleging that the General Court erred in law in holding, in paragraphs 55 and 56 of the judgment under appeal, that the pleas in law and also the arguments raised before it in the context of an action for annulment of a decision such as the decision at issue were admissible only if they had already been presented in the 2016 request for a review, it must be held that that argument is ineffective since the General Court, in any event, also found, as a supplementary point, that the appellant’s arguments in its first plea in law were unfounded, and that substantive assessment has not been challenged in the present appeal. |
| --- | --- |

51

As regards the argument alleging that the General Court erred in law in holding, in paragraphs 55 and 56 of the judgment under appeal, that the pleas in law and also the arguments raised before it in the context of an action for annulment of a decision such as the decision at issue were admissible only if they had already been presented in the 2016 request for a review, it must be held that that argument is ineffective since the General Court, in any event, also found, as a supplementary point, that the appellant’s arguments in its first plea in law were unfounded, and that substantive assessment has not been challenged in the present appeal.

| 52 | The appellant’s argument that only the active introduction or active deployment of a substance ‘into an industrial process’ constitutes ‘use’ within the meaning of Article 56(1)(a) of the REACH Regulation, which was rejected as inadmissible in paragraph 62 of the judgment under appeal, was rejected on the merits, in the alternative, in paragraphs 63 to 68 and 72 of the judgment under appeal. |
| --- | --- |

52

The appellant’s argument that only the active introduction or active deployment of a substance ‘into an industrial process’ constitutes ‘use’ within the meaning of Article 56(1)(a) of the REACH Regulation, which was rejected as inadmissible in paragraph 62 of the judgment under appeal, was rejected on the merits, in the alternative, in paragraphs 63 to 68 and 72 of the judgment under appeal.

| 53 | That is also the case for the appellant’s argument that the Commission in fact authorised a ‘process as a whole’, namely the ‘recycling of materials containing a substance of very high concern’, and granted authorisation for ‘processing of waste plastic’, in breach of EU waste legislation, and is the case for the argument relating to ‘end-of-waste’ status, which were rejected by the General Court as inadmissible, in paragraphs 75 and 87 of the judgment under appeal and, in any event, as unfounded in, respectively, paragraphs 76, 86, 88 and 89 of the judgment under appeal. |
| --- | --- |

53

That is also the case for the appellant’s argument that the Commission in fact authorised a ‘process as a whole’, namely the ‘recycling of materials containing a substance of very high concern’, and granted authorisation for ‘processing of waste plastic’, in breach of EU waste legislation, and is the case for the argument relating to ‘end-of-waste’ status, which were rejected by the General Court as inadmissible, in paragraphs 75 and 87 of the judgment under appeal and, in any event, as unfounded in, respectively, paragraphs 76, 86, 88 and 89 of the judgment under appeal.

| 54 | Similarly, the appellant’s argument concerning the assessment of the balancing of risks and benefits, which was rejected as inadmissible in paragraph 200 of the judgment under appeal, was held to be unfounded, in any event, in paragraph 204 of that judgment, and the argument that the analysis of alternatives proposed in the application for authorisation was deficient because the application did not identify a function of DEHP, which was rejected as inadmissible in paragraph 234 of the judgment under appeal, was, in any event, held to be unfounded in paragraph 236 of the judgment under appeal. |
| --- | --- |

54

Similarly, the appellant’s argument concerning the assessment of the balancing of risks and benefits, which was rejected as inadmissible in paragraph 200 of the judgment under appeal, was held to be unfounded, in any event, in paragraph 204 of that judgment, and the argument that the analysis of alternatives proposed in the application for authorisation was deficient because the application did not identify a function of DEHP, which was rejected as inadmissible in paragraph 234 of the judgment under appeal, was, in any event, held to be unfounded in paragraph 236 of the judgment under appeal.

| 55 | Since all the arguments put forward in support of the first ground of appeal are unfounded or ineffective, they must therefore be rejected. |
| --- | --- |

55

Since all the arguments put forward in support of the first ground of appeal are unfounded or ineffective, they must therefore be rejected.

The second ground of appeal

The second ground of appeal

Arguments of the parties

Arguments of the parties

| 56 | By its second ground of appeal, the appellant submits that the General Court placed an excessive burden of proof on non-governmental organisations. It refers, in that regard, to paragraphs 57, 112, 113, 148 to 150 and 248 to 251 of the judgment under appeal. |
| --- | --- |

56

By its second ground of appeal, the appellant submits that the General Court placed an excessive burden of proof on non-governmental organisations. It refers, in that regard, to paragraphs 57, 112, 113, 148 to 150 and 248 to 251 of the judgment under appeal.

| 57 | The appellant refers, in particular, to the judgment of 14 November 2013, ICdAand Others v Commission (T‐456/11, EU:T:2013:594, paragraph 61), in which it claims that the General Court imposed a lower standard of proof on other economic operators. |
| --- | --- |

57

The appellant refers, in particular, to the judgment of 14 November 2013, ICdAand Others v Commission (T‐456/11, EU:T:2013:594, paragraph 61), in which it claims that the General Court imposed a lower standard of proof on other economic operators.

| 58 | The Commission contends that the appellant in fact merely repeats the arguments put forward at first instance and that the second ground of appeal is, in any event, unfounded. |
| --- | --- |

58

The Commission contends that the appellant in fact merely repeats the arguments put forward at first instance and that the second ground of appeal is, in any event, unfounded.

| 59 | ECHA supports the Commission’s arguments. |
| --- | --- |

59

ECHA supports the Commission’s arguments.

Findings of the Court

Findings of the Court

| 60 | In this regard, it must be noted that it follows from the Court’s case-law that, in order to state in the manner required the grounds for conducting the review, a party requesting the internal review of an administrative act under environmental law is required to put forward facts or legal arguments of sufficient substance to give rise to serious doubts as to the assessment made in that act by the EU institution or body (see, to that effect, judgment of 12 September 2019, TestBioTech and Others v Commission, C‐82/17 P, EU:C:2019:719, paragraph 69). |
| --- | --- |

60

In this regard, it must be noted that it follows from the Court’s case-law that, in order to state in the manner required the grounds for conducting the review, a party requesting the internal review of an administrative act under environmental law is required to put forward facts or legal arguments of sufficient substance to give rise to serious doubts as to the assessment made in that act by the EU institution or body (see, to that effect, judgment of 12 September 2019, TestBioTech and Others v Commission, C‐82/17 P, EU:C:2019:719, paragraph 69).

| 61 | As regards the deficiencies alleged by the appellant in the risk assessment provided by the authorisation applicants, the General Court did not rule, in paragraphs 112 and 113 of the judgment under appeal, on the standard of proof required of the appellant, but found, in paragraph 114 of the judgment under appeal, that the arguments relied on by the appellant in that regard were ineffective. |
| --- | --- |

61

As regards the deficiencies alleged by the appellant in the risk assessment provided by the authorisation applicants, the General Court did not rule, in paragraphs 112 and 113 of the judgment under appeal, on the standard of proof required of the appellant, but found, in paragraph 114 of the judgment under appeal, that the arguments relied on by the appellant in that regard were ineffective.

| 62 | Furthermore, in paragraphs 148 and 149 of the judgment under appeal, the General Court merely found that the arguments relied on by the appellant were insufficient, taking the view that the appellant could not invoke the deficiencies in the safety report in isolation without specifically challenging SEAC’s assessment indicating that authorisation could be granted in the present case. |
| --- | --- |

62

Furthermore, in paragraphs 148 and 149 of the judgment under appeal, the General Court merely found that the arguments relied on by the appellant were insufficient, taking the view that the appellant could not invoke the deficiencies in the safety report in isolation without specifically challenging SEAC’s assessment indicating that authorisation could be granted in the present case.

| 63 | In making that assessment, the General Court therefore simply drew the appropriate conclusions from the principle referred to in paragraph 60 of the present judgment. |
| --- | --- |

63

In making that assessment, the General Court therefore simply drew the appropriate conclusions from the principle referred to in paragraph 60 of the present judgment.

| 64 | As regards the analysis of alternatives, it should be noted that, in paragraphs 248 to 250 of the judgment under appeal, referred to in the appeal, the General Court found that the appellant had not provided any evidence calling into question the factual assessments made by the Commission in the decision at issue as regards the lack of availability of alternatives. That conclusion was based on the finding that, first, the appellant had not explained on what basis the Commission had reached an outcome other than that contained in SEAC’s opinion on that subject and, second, that the appellant had not, in any event, specifically disputed, in its 2016 request for a review, the overall conclusion reached by the Commission as to the lack of availability of alternatives. |
| --- | --- |

64

As regards the analysis of alternatives, it should be noted that, in paragraphs 248 to 250 of the judgment under appeal, referred to in the appeal, the General Court found that the appellant had not provided any evidence calling into question the factual assessments made by the Commission in the decision at issue as regards the lack of availability of alternatives. That conclusion was based on the finding that, first, the appellant had not explained on what basis the Commission had reached an outcome other than that contained in SEAC’s opinion on that subject and, second, that the appellant had not, in any event, specifically disputed, in its 2016 request for a review, the overall conclusion reached by the Commission as to the lack of availability of alternatives.

| 65 | Contrary to what is claimed by the appellant, it is therefore not apparent from those paragraphs that the General Court had required it to provide a complete analysis of alternatives in place of the authorisation applicants, but merely that it found that the appellant had not indicated any substantive facts or legal arguments capable of raising reasonable doubts as to the Commission’s assessment. |
| --- | --- |

65

Contrary to what is claimed by the appellant, it is therefore not apparent from those paragraphs that the General Court had required it to provide a complete analysis of alternatives in place of the authorisation applicants, but merely that it found that the appellant had not indicated any substantive facts or legal arguments capable of raising reasonable doubts as to the Commission’s assessment.

| 66 | It follows from the foregoing that it does not in any way follow from the paragraphs of the judgment under appeal referred to in the second ground of appeal that the General Court imposed an excessively high burden of proof on the appellant, and the latter’s argument that a lower standard of proof had been imposed on other economic operators in a case other than the present case cannot, therefore, in any event, succeed. |
| --- | --- |

66

It follows from the foregoing that it does not in any way follow from the paragraphs of the judgment under appeal referred to in the second ground of appeal that the General Court imposed an excessively high burden of proof on the appellant, and the latter’s argument that a lower standard of proof had been imposed on other economic operators in a case other than the present case cannot, therefore, in any event, succeed.

| 67 | It follows that the second ground of appeal is unfounded and must be rejected. |
| --- | --- |

67

It follows that the second ground of appeal is unfounded and must be rejected.

The third ground of appeal

The third ground of appeal

Arguments of the parties

Arguments of the parties

| 68 | By its third ground of appeal, the appellant submits that the General Court breached the REACH Regulation, in particular Article 55 thereof, by finding, in paragraphs 71, 72, 79, 91, 162, 238 and 242 to 244 of the judgment under appeal, that the reduction in the production of virgin DEHP, which is made possible by the use of recycled DEHP, could constitute use in accordance with the REACH Regulation and form the basis of a relevant analysis of alternatives. |
| --- | --- |

68

By its third ground of appeal, the appellant submits that the General Court breached the REACH Regulation, in particular Article 55 thereof, by finding, in paragraphs 71, 72, 79, 91, 162, 238 and 242 to 244 of the judgment under appeal, that the reduction in the production of virgin DEHP, which is made possible by the use of recycled DEHP, could constitute use in accordance with the REACH Regulation and form the basis of a relevant analysis of alternatives.

| 69 | The appellant states, in the first place, that the General Court’s reasoning is based on an incorrect premiss, since the authorisation scheme laid down by the REACH Regulation concerns not the production of those substances in the European Union, but their use or placing on the market for use, as follows from Article 56 of that regulation. The articles into which DEHP is already incorporated could, moreover, be lawfully imported into the European Union. |
| --- | --- |

69

The appellant states, in the first place, that the General Court’s reasoning is based on an incorrect premiss, since the authorisation scheme laid down by the REACH Regulation concerns not the production of those substances in the European Union, but their use or placing on the market for use, as follows from Article 56 of that regulation. The articles into which DEHP is already incorporated could, moreover, be lawfully imported into the European Union.

| 70 | The appellant submits, in the second place, that, in so doing, the General Court erred in finding, in paragraph 91 of the judgment under appeal, that other mixtures, without DEHP, could be relevant alternatives, without taking into account the true function of DEHP, which is to allow the flexibility of the material. Similarly, the General Court was wrong to regard as sufficient, in paragraph 247 of the contested judgment, the mere reference to other sources of (virgin) PVC containing other plasticisers, without those plasticisers or the flexibility properties of the material even being mentioned. |
| --- | --- |

70

The appellant submits, in the second place, that, in so doing, the General Court erred in finding, in paragraph 91 of the judgment under appeal, that other mixtures, without DEHP, could be relevant alternatives, without taking into account the true function of DEHP, which is to allow the flexibility of the material. Similarly, the General Court was wrong to regard as sufficient, in paragraph 247 of the contested judgment, the mere reference to other sources of (virgin) PVC containing other plasticisers, without those plasticisers or the flexibility properties of the material even being mentioned.

| 71 | The appellant adds that, although Article 55 of the REACH Regulation provides for a ‘progressive’ replacement of substances, that replacement must nevertheless take place as soon as alternatives are available, contrary to what follows from paragraphs 243 and 244 of the judgment under appeal. By considering that other plasticisers or flexible materials are irrelevant to that assessment, the General Court precludes such a replacement. The appellant adds that it was common knowledge that other plasticisers, which were safer, were available to manufacture a flexible plastic product. |
| --- | --- |

71

The appellant adds that, although Article 55 of the REACH Regulation provides for a ‘progressive’ replacement of substances, that replacement must nevertheless take place as soon as alternatives are available, contrary to what follows from paragraphs 243 and 244 of the judgment under appeal. By considering that other plasticisers or flexible materials are irrelevant to that assessment, the General Court precludes such a replacement. The appellant adds that it was common knowledge that other plasticisers, which were safer, were available to manufacture a flexible plastic product.

| 72 | In its reply, the applicant claims that it did not confuse the concepts of ‘use’ and ‘function’ of the substance, but that, contrary to what is claimed by the Commission, it is the function of the substance that constitutes the relevant criterion for the analysis of alternatives. Therefore, if a substance performs a function in a mixture, the analysis of alternatives must necessarily be based on that function. |
| --- | --- |

72

In its reply, the applicant claims that it did not confuse the concepts of ‘use’ and ‘function’ of the substance, but that, contrary to what is claimed by the Commission, it is the function of the substance that constitutes the relevant criterion for the analysis of alternatives. Therefore, if a substance performs a function in a mixture, the analysis of alternatives must necessarily be based on that function.

| 73 | Moreover, according to the appellant, the Commission errs in stating that the analysis of alternatives must be carried out from the perspective of the authorisation applicants. |
| --- | --- |

73

Moreover, according to the appellant, the Commission errs in stating that the analysis of alternatives must be carried out from the perspective of the authorisation applicants.

| 74 | The Commission contends that this ground of appeal cannot succeed. |
| --- | --- |

74

The Commission contends that this ground of appeal cannot succeed.

| 75 | ECHA supports the Commission’s arguments. |
| --- | --- |

75

ECHA supports the Commission’s arguments.

Findings of the Court

Findings of the Court

| 76 | It should be noted that, of the various paragraphs of the judgment under appeal referred to by the appellant in its third ground of appeal, only paragraphs 238 and 242 to 244 of that judgment form part of the reasoning of that judgment relating to the breach of Article 55 of the REACH Regulation and of Article 60(4) and (5) of that regulation, as regards the analysis of alternatives. |
| --- | --- |

76

It should be noted that, of the various paragraphs of the judgment under appeal referred to by the appellant in its third ground of appeal, only paragraphs 238 and 242 to 244 of that judgment form part of the reasoning of that judgment relating to the breach of Article 55 of the REACH Regulation and of Article 60(4) and (5) of that regulation, as regards the analysis of alternatives.

| 77 | It should also be noted that, although the General Court’s analysis of the conformity of the alternatives taken into account by the Commission is part of the assessment of the facts, the third ground of appeal, however, also raises a question of law in so far as it relates to the conditions under which the Commission must assess alternatives. |
| --- | --- |

77

It should also be noted that, although the General Court’s analysis of the conformity of the alternatives taken into account by the Commission is part of the assessment of the facts, the third ground of appeal, however, also raises a question of law in so far as it relates to the conditions under which the Commission must assess alternatives.

| 78 | It must be noted, in this regard, that, as is apparent from the wording of Article 60(2) and (4) of the REACH Regulation, the authorisation schemes provided for by those provisions relate to the placing on the market with a view to the use, or relate to use of the substance which is the subject of the application for authorisation. |
| --- | --- |

78

It must be noted, in this regard, that, as is apparent from the wording of Article 60(2) and (4) of the REACH Regulation, the authorisation schemes provided for by those provisions relate to the placing on the market with a view to the use, or relate to use of the substance which is the subject of the application for authorisation.

| 79 | In addition, Article 3.24 of the REACH Regulation defines ‘use’ broadly as ‘any processing, formulation, consumption, storage, keeping, treatment, ..., mixing, production of an article or any other utilisation’ and Article 56(1)(a) of that regulation requires authorisation not only for the use of a substance on its own, but also where it is contained in a mixture. |
| --- | --- |

79

In addition, Article 3.24 of the REACH Regulation defines ‘use’ broadly as ‘any processing, formulation, consumption, storage, keeping, treatment, ..., mixing, production of an article or any other utilisation’ and Article 56(1)(a) of that regulation requires authorisation not only for the use of a substance on its own, but also where it is contained in a mixture.

| 80 | Therefore, the General Court did not err in law in finding, in paragraph 238 of the judgment under appeal, that the Commission had lawfully taken the view that the authorisation granted in the present case concerned the use of DEHP, as contained ‘in a mixture’. |
| --- | --- |

80

Therefore, the General Court did not err in law in finding, in paragraph 238 of the judgment under appeal, that the Commission had lawfully taken the view that the authorisation granted in the present case concerned the use of DEHP, as contained ‘in a mixture’.

| 81 | It also follows that the General Court was entitled to hold, in paragraph 239 of the judgment under appeal, that the assessment of alternatives could therefore be carried out in relation to that ‘mixture’ rather than by reference to the substance contained in it. |
| --- | --- |

81

It also follows that the General Court was entitled to hold, in paragraph 239 of the judgment under appeal, that the assessment of alternatives could therefore be carried out in relation to that ‘mixture’ rather than by reference to the substance contained in it.

| 82 | As regards the question of whether the General Court nevertheless erred in law in finding, inter alia, in paragraph 238 of the judgment under appeal, that the Commission had lawfully found that one of the ‘functions’ of DEHP, taken into account in order to examine alternatives, was ‘to reduce the amount of plasticiser that needs to be added in the production of articles made out of PVC’, it must be stated that it is not apparent from the paragraphs of the judgment under appeal referred to by the appellant in its third ground of appeal that the General Court should have invalidated the analysis of alternatives set out in Article 60(4) of the REACH Regulation on the ground that the Commission had not taken into account the flexibility of the material or even referred to it, since, on the contrary, it is apparent from both paragraphs 238 and 242 of the judgment under appeal that the Commission also took into account DEHP’s function as a plasticiser. |
| --- | --- |

82

As regards the question of whether the General Court nevertheless erred in law in finding, inter alia, in paragraph 238 of the judgment under appeal, that the Commission had lawfully found that one of the ‘functions’ of DEHP, taken into account in order to examine alternatives, was ‘to reduce the amount of plasticiser that needs to be added in the production of articles made out of PVC’, it must be stated that it is not apparent from the paragraphs of the judgment under appeal referred to by the appellant in its third ground of appeal that the General Court should have invalidated the analysis of alternatives set out in Article 60(4) of the REACH Regulation on the ground that the Commission had not taken into account the flexibility of the material or even referred to it, since, on the contrary, it is apparent from both paragraphs 238 and 242 of the judgment under appeal that the Commission also took into account DEHP’s function as a plasticiser.

| 83 | It must also be added that, in so far as the appellant argues that it was ‘common ground’ that safer alternative plasticisers were available to manufacture a flexible plastic product, the appellant calls into question the General Court’s assessment of the facts. Such an assessment cannot be examined in the context of the present appeal, save where there has been a distortion of the facts, something which is not alleged by the appellant. |
| --- | --- |

83

It must also be added that, in so far as the appellant argues that it was ‘common ground’ that safer alternative plasticisers were available to manufacture a flexible plastic product, the appellant calls into question the General Court’s assessment of the facts. Such an assessment cannot be examined in the context of the present appeal, save where there has been a distortion of the facts, something which is not alleged by the appellant.

| 84 | Furthermore, it is not apparent from paragraph 244 of the judgment under appeal that the General Court had taken the view that Article 55 of the REACH Regulation did not require alternatives to be used when available. In paragraph 244, the General Court merely noted that, as is apparent from the very wording of Article 55, the objective pursued is ‘progressively’ to replace substances of very high concern with suitable alternative substances or technologies ‘where these are economically and technically viable’. |
| --- | --- |

84

Furthermore, it is not apparent from paragraph 244 of the judgment under appeal that the General Court had taken the view that Article 55 of the REACH Regulation did not require alternatives to be used when available. In paragraph 244, the General Court merely noted that, as is apparent from the very wording of Article 55, the objective pursued is ‘progressively’ to replace substances of very high concern with suitable alternative substances or technologies ‘where these are economically and technically viable’.

| 85 | It follows that, since the various arguments put forward by the applicant in support of its third ground of appeal are unfounded, that ground must be rejected. |
| --- | --- |

85

It follows that, since the various arguments put forward by the applicant in support of its third ground of appeal are unfounded, that ground must be rejected.

The fourth ground of appeal

The fourth ground of appeal

Arguments of the parties

Arguments of the parties

| 86 | By its fourth ground of appeal, the appellant submits that the General Court erred in law in finding, in paragraphs 104 to 111 of the judgment under appeal, that the assessment of the conformity of the application for authorisation, laid down in Article 60(7) of the REACH Regulation, is purely formal and does not require the Commission to check whether the information provided by an applicant satisfies the substantive requirements of Article 62 of that regulation and Annex I to that regulation. |
| --- | --- |

86

By its fourth ground of appeal, the appellant submits that the General Court erred in law in finding, in paragraphs 104 to 111 of the judgment under appeal, that the assessment of the conformity of the application for authorisation, laid down in Article 60(7) of the REACH Regulation, is purely formal and does not require the Commission to check whether the information provided by an applicant satisfies the substantive requirements of Article 62 of that regulation and Annex I to that regulation.

| 87 | The appellant submits that it does not dispute the General Court’s interpretation of Article 60(7) of the REACH Regulation in paragraphs 104 and 106 of the judgment under appeal, in so far as the General Court considers that it is for the Commission to verify whether an application complies with the requirements of Article 62 of that regulation from a ‘formal’ point of view, without having to determine whether the chemical safety report ‘draws the right conclusions’ as regards, inter alia, the properties of a chemical substance. |
| --- | --- |

87

The appellant submits that it does not dispute the General Court’s interpretation of Article 60(7) of the REACH Regulation in paragraphs 104 and 106 of the judgment under appeal, in so far as the General Court considers that it is for the Commission to verify whether an application complies with the requirements of Article 62 of that regulation from a ‘formal’ point of view, without having to determine whether the chemical safety report ‘draws the right conclusions’ as regards, inter alia, the properties of a chemical substance.

| 88 | The appellant submits that the General Court erred, however, as regards what is to be understood by ‘formal’ verification, in that it stated, in paragraph 109 of the judgment under appeal, that, although Annex I to the REACH Regulation describes the elements that certain documents submitted by an applicant for authorisation must necessarily contain, such as a chemical safety report, that annex does not require the Commission, in the context of the examination incumbent on it under Article 60(7) of that regulation, read in conjunction with Article 62 thereof, to examine the substance of those elements. |
| --- | --- |

88

The appellant submits that the General Court erred, however, as regards what is to be understood by ‘formal’ verification, in that it stated, in paragraph 109 of the judgment under appeal, that, although Annex I to the REACH Regulation describes the elements that certain documents submitted by an applicant for authorisation must necessarily contain, such as a chemical safety report, that annex does not require the Commission, in the context of the examination incumbent on it under Article 60(7) of that regulation, read in conjunction with Article 62 thereof, to examine the substance of those elements.

| 89 | It submits that the judgment under appeal is contradictory in that the General Court stated, in paragraph 109 of that judgment, that the Commission is not required to carry out a substantive assessment at that stage of the procedure, while stating, in paragraph 112 of the judgment under appeal, that the Commission is required to assess whether the information provided is ‘verifiable’, which implies a certain examination of the substance of that information. |
| --- | --- |

89

It submits that the judgment under appeal is contradictory in that the General Court stated, in paragraph 109 of that judgment, that the Commission is not required to carry out a substantive assessment at that stage of the procedure, while stating, in paragraph 112 of the judgment under appeal, that the Commission is required to assess whether the information provided is ‘verifiable’, which implies a certain examination of the substance of that information.

| 90 | It submits, first, that a compliance check, even a ‘formal’ check, means that the Commission must verify whether the chemical safety report complies with the precise requirements set out in Annex I to the REACH Regulation, which provides for, inter alia, ‘adequately measured, representative’ exposure data. Secondly, in the appellant’s view, the General Court infringed Article 62 of and Annex I to that regulation by thus holding, in paragraph 112 of the judgment under appeal, that the authorisation applicants had complied with those requirements without such a verification having been carried out. |
| --- | --- |

90

It submits, first, that a compliance check, even a ‘formal’ check, means that the Commission must verify whether the chemical safety report complies with the precise requirements set out in Annex I to the REACH Regulation, which provides for, inter alia, ‘adequately measured, representative’ exposure data. Secondly, in the appellant’s view, the General Court infringed Article 62 of and Annex I to that regulation by thus holding, in paragraph 112 of the judgment under appeal, that the authorisation applicants had complied with those requirements without such a verification having been carried out.

| 91 | The Commission contends that the fourth ground of appeal cannot succeed. |
| --- | --- |

91

The Commission contends that the fourth ground of appeal cannot succeed.

| 92 | ECHA supports the Commission’s arguments. |
| --- | --- |

92

ECHA supports the Commission’s arguments.

Findings of the Court

Findings of the Court

| 93 | Under Article 60(7) of the REACH Regulation, an authorisation is to be granted ‘only if the application is made in conformity with the requirements of Article 62’. |
| --- | --- |

93

Under Article 60(7) of the REACH Regulation, an authorisation is to be granted ‘only if the application is made in conformity with the requirements of Article 62’.

| 94 | That provision therefore obliges the Commission to verify whether the application for authorisation contains all of the information required under Article 62 of that regulation and, in particular, under paragraph 4(d) of that provision, a chemical safety report ‘in accordance with Annex I covering the risks to human health and/or the environment from the use of the substance(s) arising from the intrinsic properties specified in Annex XIV’ to the REACH Regulation. |
| --- | --- |

94

That provision therefore obliges the Commission to verify whether the application for authorisation contains all of the information required under Article 62 of that regulation and, in particular, under paragraph 4(d) of that provision, a chemical safety report ‘in accordance with Annex I covering the risks to human health and/or the environment from the use of the substance(s) arising from the intrinsic properties specified in Annex XIV’ to the REACH Regulation.

| 95 | As the appellant acknowledges in its appeal, it follows that the General Court was entitled to hold, in paragraphs 104 and 106 of the judgment under appeal, that Article 60(7) of the REACH Regulation requires the Commission to verify whether an application for authorisation is in conformity with the requirements of Article 62 of that regulation from a formal point of view, without it being required, at that stage, to assess the merits of the elements submitted and, inter alia, whether the chemical safety report concerning a substance ‘draws the right conclusions’ as regards the properties of that substance. |
| --- | --- |

95

As the appellant acknowledges in its appeal, it follows that the General Court was entitled to hold, in paragraphs 104 and 106 of the judgment under appeal, that Article 60(7) of the REACH Regulation requires the Commission to verify whether an application for authorisation is in conformity with the requirements of Article 62 of that regulation from a formal point of view, without it being required, at that stage, to assess the merits of the elements submitted and, inter alia, whether the chemical safety report concerning a substance ‘draws the right conclusions’ as regards the properties of that substance.

| 96 | In addition, the examination of whether the elements thus required are verifiable constitutes a review that is separate from the verification of the merits of those elements, with the result that the appellant cannot validly claim that there is a contradiction between paragraph 109 of the judgment under appeal, in which the General Court stated that the Commission is not required to examine the substance, at that stage of the procedure, of the elements that must be provided by an applicant under Annex I to the REACH Regulation, and paragraph 112 of that judgment, which stated that the documents to be provided under Article 62(4) of that regulation must be verifiable. |
| --- | --- |

96

In addition, the examination of whether the elements thus required are verifiable constitutes a review that is separate from the verification of the merits of those elements, with the result that the appellant cannot validly claim that there is a contradiction between paragraph 109 of the judgment under appeal, in which the General Court stated that the Commission is not required to examine the substance, at that stage of the procedure, of the elements that must be provided by an applicant under Annex I to the REACH Regulation, and paragraph 112 of that judgment, which stated that the documents to be provided under Article 62(4) of that regulation must be verifiable.

| 97 | Furthermore, it must be stated that, even though the review which the Commission is required to carry out under Article 60(7) of the REACH Regulation, read in conjunction with Article 62 of that regulation, must not be superficial and requires that institution to verify at the very least that the information and documents required by that regulation are present, an examination such as that envisaged by the appellant as regards compliance with the requirements of Annex I to the REACH Regulation would lead the Commission also to take a decision on the quality of the data submitted, and to bring forward the substantive analysis which has to be carried out at a later stage by the institution in order to determine whether the conditions for authorisation have been satisfied. |
| --- | --- |

97

Furthermore, it must be stated that, even though the review which the Commission is required to carry out under Article 60(7) of the REACH Regulation, read in conjunction with Article 62 of that regulation, must not be superficial and requires that institution to verify at the very least that the information and documents required by that regulation are present, an examination such as that envisaged by the appellant as regards compliance with the requirements of Annex I to the REACH Regulation would lead the Commission also to take a decision on the quality of the data submitted, and to bring forward the substantive analysis which has to be carried out at a later stage by the institution in order to determine whether the conditions for authorisation have been satisfied.

| 98 | It follows that the fourth ground of appeal must be rejected as unfounded. |
| --- | --- |

98

It follows that the fourth ground of appeal must be rejected as unfounded.

The fifth ground of appeal

The fifth ground of appeal

Arguments of the parties

Arguments of the parties

| 99 | By its fifth ground of appeal, the appellant submits that the General Court erred in law in finding, in paragraphs 131 to 138 of the judgment under appeal, that Article 60(4) of the REACH Regulation allows the Commission to take a decision on the balance between risks and benefits without the information on risks satisfying the requirements of Annex I to that regulation. |
| --- | --- |

99

By its fifth ground of appeal, the appellant submits that the General Court erred in law in finding, in paragraphs 131 to 138 of the judgment under appeal, that Article 60(4) of the REACH Regulation allows the Commission to take a decision on the balance between risks and benefits without the information on risks satisfying the requirements of Annex I to that regulation.

| 100 | The appellant also submits that, contrary to what the General Court held in paragraphs 135 and 136 of the judgment under appeal, the REACH Regulation requires that the assessment of the exposure to risk should specifically relate to the use of the substance for which an authorisation is sought and that it be representative of that use. |
| --- | --- |

100

The appellant also submits that, contrary to what the General Court held in paragraphs 135 and 136 of the judgment under appeal, the REACH Regulation requires that the assessment of the exposure to risk should specifically relate to the use of the substance for which an authorisation is sought and that it be representative of that use.

| 101 | It adds that Article 62(4)(d) of the REACH Regulation requires a chemical safety report in accordance with Annex I to that regulation irrespective of the legal basis relied on to grant authorisation. |
| --- | --- |

101

It adds that Article 62(4)(d) of the REACH Regulation requires a chemical safety report in accordance with Annex I to that regulation irrespective of the legal basis relied on to grant authorisation.

| 102 | The appellant also refers to Article 60(10) of the REACH Regulation, which requires the authorisation holder to ensure that the exposure is reduced to as low a level as is technically and practically possible, whether authorisation is granted under Article 60(2) or 60(4) of that regulation. |
| --- | --- |

102

The appellant also refers to Article 60(10) of the REACH Regulation, which requires the authorisation holder to ensure that the exposure is reduced to as low a level as is technically and practically possible, whether authorisation is granted under Article 60(2) or 60(4) of that regulation.

| 103 | In its reply, the appellant adds that, in any event, paragraphs 130 and 131 of the judgment under appeal do not expressly confirm that the chemical safety report must be at least as complete and precise, for the purposes of applying Article 60(4) of the REACH Regulation, as for the application of Article 60(2) of that regulation, and it asks the Court to state that that must be the case. |
| --- | --- |

103

In its reply, the appellant adds that, in any event, paragraphs 130 and 131 of the judgment under appeal do not expressly confirm that the chemical safety report must be at least as complete and precise, for the purposes of applying Article 60(4) of the REACH Regulation, as for the application of Article 60(2) of that regulation, and it asks the Court to state that that must be the case.

| 104 | The appellant also submits that, contrary to what the Commission maintains, the appellant did not confuse the qualitative analysis carried out by SEAC with the risk assessment referred to in Annex I to the REACH Regulation, but considers, however, that there is a link between the socio-economic risk analysis, including qualitative data, and the underlying risk assessment carried out by the applicant under Annex I, which can include qualitative data only in a limited number of circumstances. It submits that there were serious gaps in the evidence submitted by the authorisation applicants, with the result that it was impossible to assess the risk in itself properly and to balance it properly against other factors in the socio‐economic analysis. |
| --- | --- |

104

The appellant also submits that, contrary to what the Commission maintains, the appellant did not confuse the qualitative analysis carried out by SEAC with the risk assessment referred to in Annex I to the REACH Regulation, but considers, however, that there is a link between the socio-economic risk analysis, including qualitative data, and the underlying risk assessment carried out by the applicant under Annex I, which can include qualitative data only in a limited number of circumstances. It submits that there were serious gaps in the evidence submitted by the authorisation applicants, with the result that it was impossible to assess the risk in itself properly and to balance it properly against other factors in the socio‐economic analysis.

| 105 | The Commission contends that the fifth ground of appeal cannot succeed. |
| --- | --- |

105

The Commission contends that the fifth ground of appeal cannot succeed.

| 106 | ECHA supports the Commission’s arguments. |
| --- | --- |

106

ECHA supports the Commission’s arguments.

Findings of the Court

Findings of the Court

| 107 | As a preliminary point, it must be noted that, under Article 60(7) of the REACH Regulation, an authorisation is granted only if the application is made in conformity with the requirements of Article 62 of that regulation, paragraph (4)(d) of which refers to a chemical safety report, drawn up in accordance with Annex I to that regulation, covering the risks to human health and the environment from the use of the substance or substances arising from the intrinsic properties specified in Annex XIV to the REACH Regulation. |
| --- | --- |

107

As a preliminary point, it must be noted that, under Article 60(7) of the REACH Regulation, an authorisation is granted only if the application is made in conformity with the requirements of Article 62 of that regulation, paragraph (4)(d) of which refers to a chemical safety report, drawn up in accordance with Annex I to that regulation, covering the risks to human health and the environment from the use of the substance or substances arising from the intrinsic properties specified in Annex XIV to the REACH Regulation.

| 108 | Moreover, Article 60(4) of the REACH Regulation applies as an alternative to Article 60(2) of that regulation, in cases where an authorisation cannot be granted under the latter provision. |
| --- | --- |

108

Moreover, Article 60(4) of the REACH Regulation applies as an alternative to Article 60(2) of that regulation, in cases where an authorisation cannot be granted under the latter provision.

| 109 | It follows from the wording and scheme of those various provisions that an authorisation may be granted under Article 60(4) of the REACH Regulation only if the applicant has produced a chemical safety report drawn up in accordance with Annex I to that regulation. |
| --- | --- |

109

It follows from the wording and scheme of those various provisions that an authorisation may be granted under Article 60(4) of the REACH Regulation only if the applicant has produced a chemical safety report drawn up in accordance with Annex I to that regulation.

| 110 | It does not follow from the paragraphs of the judgment under appeal referred to by the appellant in its fifth ground of appeal that the General Court held otherwise. |
| --- | --- |

110

It does not follow from the paragraphs of the judgment under appeal referred to by the appellant in its fifth ground of appeal that the General Court held otherwise.

| 111 | Furthermore, it also does not follow from the judgment under appeal that the General Court held that the chemical safety report provided by the authorisation applicants did not comply with the requirements of Annex I to the REACH Regulation. |
| --- | --- |

111

Furthermore, it also does not follow from the judgment under appeal that the General Court held that the chemical safety report provided by the authorisation applicants did not comply with the requirements of Annex I to the REACH Regulation.

| 112 | In that regard, in paragraph 112 of the judgment under appeal, the General Court also noted, first, that it was common ground between the parties that, as regards that report, the authorisation applicants had complied with the requirements of Annex I to the REACH Regulation and, secondly, that the appellant had also failed to provide evidence in its 2016 request for a review that would have justified a different analysis. |
| --- | --- |

112

In that regard, in paragraph 112 of the judgment under appeal, the General Court also noted, first, that it was common ground between the parties that, as regards that report, the authorisation applicants had complied with the requirements of Annex I to the REACH Regulation and, secondly, that the appellant had also failed to provide evidence in its 2016 request for a review that would have justified a different analysis.

| 113 | It should also be noted that, although the General Court stated, in paragraph 131 of the judgment under appeal, that the existence of uncertainties or deficiencies in that report could raise the question of whether, on the basis of the facts and evidence available to the Commission, the authorisation was capable of being granted under Article 60(4) of the REACH Regulation, that is a separate question from the one which is the subject of the present ground of appeal. |
| --- | --- |

113

It should also be noted that, although the General Court stated, in paragraph 131 of the judgment under appeal, that the existence of uncertainties or deficiencies in that report could raise the question of whether, on the basis of the facts and evidence available to the Commission, the authorisation was capable of being granted under Article 60(4) of the REACH Regulation, that is a separate question from the one which is the subject of the present ground of appeal.

| 114 | It follows that the fifth ground of appeal is unfounded and must be rejected. |
| --- | --- |

114

It follows that the fifth ground of appeal is unfounded and must be rejected.

The sixth ground of appeal

The sixth ground of appeal

Arguments of the parties

Arguments of the parties

| 115 | By its sixth ground of appeal, the appellant submits that the General Court erred in law in holding, in paragraphs 216 to 224 of the judgment under appeal, that only data relating to the intrinsic properties of a substance that were included in Annex XIV to the REACH Regulation are relevant for the risk assessment laid down in Article 60(4) of that regulation, and not information on the intrinsic properties included in the candidate list provided for in Article 59(1) of the REACH Regulation, but not referred to in that annex. |
| --- | --- |

115

By its sixth ground of appeal, the appellant submits that the General Court erred in law in holding, in paragraphs 216 to 224 of the judgment under appeal, that only data relating to the intrinsic properties of a substance that were included in Annex XIV to the REACH Regulation are relevant for the risk assessment laid down in Article 60(4) of that regulation, and not information on the intrinsic properties included in the candidate list provided for in Article 59(1) of the REACH Regulation, but not referred to in that annex.

| 116 | It thus takes the view that the Commission should have taken into account the information relating to the properties of DEHP as an endocrine disruptor which led ECHA to identify DEHP, in December 2014, as a substance of very high concern within the meaning of Article 57(f) of the REACH Regulation |
| --- | --- |

116

It thus takes the view that the Commission should have taken into account the information relating to the properties of DEHP as an endocrine disruptor which led ECHA to identify DEHP, in December 2014, as a substance of very high concern within the meaning of Article 57(f) of the REACH Regulation

| 117 | The appellant submits that the General Court wrongly relied solely on a literal interpretation of Article 60(2) and Article 62(4) of the REACH Regulation, without taking into account the context or the objective pursued by the EU legislature. |
| --- | --- |

117

The appellant submits that the General Court wrongly relied solely on a literal interpretation of Article 60(2) and Article 62(4) of the REACH Regulation, without taking into account the context or the objective pursued by the EU legislature.

| 118 | It also submits that the General Court stated, first, in paragraph 216 of the judgment under appeal, that the Commission is required to examine, of its own motion, all the relevant information available to it on the date of adoption of its decision, without the risk assessment being limited to examining the information provided in the application for authorisation, and, second, in paragraph 217 of that judgment, that it is not directly apparent from the wording of the first sentence of Article 60(4) of the REACH Regulation that the assessment must be based solely on information concerning the intrinsic properties of the substance under examination, as referred to in Annex XIV to that regulation. |
| --- | --- |

118

It also submits that the General Court stated, first, in paragraph 216 of the judgment under appeal, that the Commission is required to examine, of its own motion, all the relevant information available to it on the date of adoption of its decision, without the risk assessment being limited to examining the information provided in the application for authorisation, and, second, in paragraph 217 of that judgment, that it is not directly apparent from the wording of the first sentence of Article 60(4) of the REACH Regulation that the assessment must be based solely on information concerning the intrinsic properties of the substance under examination, as referred to in Annex XIV to that regulation.

| 119 | It also submits that Annex XVI to that regulation does not limit the scope of ‘the benefits for human health and the environment’ for the purpose of carrying out a socio-economic analysis. |
| --- | --- |

119

It also submits that Annex XVI to that regulation does not limit the scope of ‘the benefits for human health and the environment’ for the purpose of carrying out a socio-economic analysis.

| 120 | Moreover, in the appellant’s view, the General Court does not explain why Article 60(4) of the REACH Regulation does not refer solely to the properties referred to in Annex XIV to that regulation, unlike the wording of Article 60(2) and Article 62(4)(d) of that regulation. |
| --- | --- |

120

Moreover, in the appellant’s view, the General Court does not explain why Article 60(4) of the REACH Regulation does not refer solely to the properties referred to in Annex XIV to that regulation, unlike the wording of Article 60(2) and Article 62(4)(d) of that regulation.

| 121 | In its reply, the appellant submits that, in the judgment of 23 January 2019, Deza v ECHA (C‐419/17 P, EU:C:2019:52), cited by the Commission in its response, the Court did not rule on the Commission’s obligations when assessing an application for authorisation. |
| --- | --- |

121

In its reply, the appellant submits that, in the judgment of 23 January 2019, Deza v ECHA (C‐419/17 P, EU:C:2019:52), cited by the Commission in its response, the Court did not rule on the Commission’s obligations when assessing an application for authorisation.

| 122 | The Commission contends that the sixth ground of appeal cannot succeed. |
| --- | --- |

122

The Commission contends that the sixth ground of appeal cannot succeed.

| 123 | ECHA supports the Commission’s arguments. |
| --- | --- |

123

ECHA supports the Commission’s arguments.

Findings of the Court

Findings of the Court

| 124 | It should be noted that, although paragraphs 216 to 223 of the judgment under appeal referred to by the appellant in its sixth ground of appeal are presented by the General Court, in paragraph 216 of the judgment under appeal, as having been examined ‘in the alternative’, the sixth ground of appeal is not, however, ineffective, since those paragraphs in fact contain an analysis which is supplementary to, and not an alternative to, the analysis set out in paragraphs 211 to 215 of that judgment. |
| --- | --- |

124

It should be noted that, although paragraphs 216 to 223 of the judgment under appeal referred to by the appellant in its sixth ground of appeal are presented by the General Court, in paragraph 216 of the judgment under appeal, as having been examined ‘in the alternative’, the sixth ground of appeal is not, however, ineffective, since those paragraphs in fact contain an analysis which is supplementary to, and not an alternative to, the analysis set out in paragraphs 211 to 215 of that judgment.

| 125 | Furthermore, contrary to what the Commission submits, it does not appear that the Court of Justice ruled on the question raised in the context of the sixth ground of appeal in the judgment of 23 January 2019, Deza v ECHA (C‐419/17 P, EU:C:2019:52). |
| --- | --- |

125

Furthermore, contrary to what the Commission submits, it does not appear that the Court of Justice ruled on the question raised in the context of the sixth ground of appeal in the judgment of 23 January 2019, Deza v ECHA (C‐419/17 P, EU:C:2019:52).

| 126 | For that reason, the General Court did not err in law when it held, in paragraphs 217 to 220 of the judgment under appeal, that, even though it is not directly apparent from the wording of the first sentence of Article 60(4) of the REACH Regulation that the risk assessment to be carried out by the Commission must be based solely on information concerning the intrinsic properties of the substance under examination, as referred to in Annex XIV to that regulation, the wording of Article 60(2) and of Article 62(4)(d) of that regulation, which refer expressly to the intrinsic properties specified in Annex XIV to that regulation, support the conclusion that that must be the case. |
| --- | --- |

126

For that reason, the General Court did not err in law when it held, in paragraphs 217 to 220 of the judgment under appeal, that, even though it is not directly apparent from the wording of the first sentence of Article 60(4) of the REACH Regulation that the risk assessment to be carried out by the Commission must be based solely on information concerning the intrinsic properties of the substance under examination, as referred to in Annex XIV to that regulation, the wording of Article 60(2) and of Article 62(4)(d) of that regulation, which refer expressly to the intrinsic properties specified in Annex XIV to that regulation, support the conclusion that that must be the case.

| 127 | The General Court therefore correctly held, in paragraphs 221 to 223 of the judgment under appeal, that any details on the intrinsic properties of a substance which have been included in the candidate list provided for in Article 59(1) of the REACH Regulation, but not included in Annex XIV to that regulation, should not be taken into account during that assessment, given that, first, there are not only two different stages of the authorisation procedure provided for in that regulation and, secondly, the mere inclusion of certain intrinsic properties of a substance in the candidate list does not necessarily or automatically lead to the inclusion of those properties in Annex XIV to that regulation. |
| --- | --- |

127

The General Court therefore correctly held, in paragraphs 221 to 223 of the judgment under appeal, that any details on the intrinsic properties of a substance which have been included in the candidate list provided for in Article 59(1) of the REACH Regulation, but not included in Annex XIV to that regulation, should not be taken into account during that assessment, given that, first, there are not only two different stages of the authorisation procedure provided for in that regulation and, secondly, the mere inclusion of certain intrinsic properties of a substance in the candidate list does not necessarily or automatically lead to the inclusion of those properties in Annex XIV to that regulation.

| 128 | Furthermore, it does not follow either from the wording or from the scheme of Annex XVI to the REACH Regulation, relating to the elements which may be included in a socio-economic analysis, that a different interpretation should be adopted. |
| --- | --- |

128

Furthermore, it does not follow either from the wording or from the scheme of Annex XVI to the REACH Regulation, relating to the elements which may be included in a socio-economic analysis, that a different interpretation should be adopted.

| 129 | It follows that the sixth ground of appeal is unfounded and must be rejected. |
| --- | --- |

129

It follows that the sixth ground of appeal is unfounded and must be rejected.

The seventh ground of appeal

The seventh ground of appeal

Arguments of the parties

Arguments of the parties

| 130 | By its seventh ground of appeal, the appellant submits that the General Court breached the precautionary principle in paragraphs 284 to 295 of the judgment under appeal. |
| --- | --- |

130

By its seventh ground of appeal, the appellant submits that the General Court breached the precautionary principle in paragraphs 284 to 295 of the judgment under appeal.

| 131 | The appellant submits that the General Court misinterpreted its plea in law and that it was not arguing that that principle required the Commission to refuse authorisation if the conditions of Article 60(4) of the REACH Regulation were satisfied, but that that principle should guide the institution’s assessment when applying that provision. |
| --- | --- |

131

The appellant submits that the General Court misinterpreted its plea in law and that it was not arguing that that principle required the Commission to refuse authorisation if the conditions of Article 60(4) of the REACH Regulation were satisfied, but that that principle should guide the institution’s assessment when applying that provision.

| 132 | In the appellant’s view, where, as in the present case, uncertainties prevented a sufficient risk assessment, the Commission was required to take the view that the applicant for authorisation, under Article 60(4) of the REACH Regulation, had not discharged the burden of proving that the necessary conditions for obtaining that authorisation had been satisfied. |
| --- | --- |

132

In the appellant’s view, where, as in the present case, uncertainties prevented a sufficient risk assessment, the Commission was required to take the view that the applicant for authorisation, under Article 60(4) of the REACH Regulation, had not discharged the burden of proving that the necessary conditions for obtaining that authorisation had been satisfied.

| 133 | The appellant also submits that, contrary to what the General Court held, the precautionary principle is not limited to conferring on public authorities the power to adopt a specific measure, but must be applied when those authorities act, as is apparent from, inter alia, the judgments of 9 September 2011, Dow AgroSciences and Others v Commission (T‐475/07, EU:T:2011:445, paragraph 144), and of 25 July 2018, Confédération paysanne and Others (C‐528/16, EU:C:2018:583, paragraph 50). |
| --- | --- |

133

The appellant also submits that, contrary to what the General Court held, the precautionary principle is not limited to conferring on public authorities the power to adopt a specific measure, but must be applied when those authorities act, as is apparent from, inter alia, the judgments of 9 September 2011, Dow AgroSciences and Others v Commission (T‐475/07, EU:T:2011:445, paragraph 144), and of 25 July 2018, Confédération paysanne and Others (C‐528/16, EU:C:2018:583, paragraph 50).

| 134 | According to the appellant, the General Court therefore erred in law in finding that the socio-economic assessment provided for in Article 60(4) of the REACH Regulation had ‘freed’ the Commission from its duty to apply the precautionary principle when implementing that provision. |
| --- | --- |

134

According to the appellant, the General Court therefore erred in law in finding that the socio-economic assessment provided for in Article 60(4) of the REACH Regulation had ‘freed’ the Commission from its duty to apply the precautionary principle when implementing that provision.

| 135 | The Commission contends that the seventh ground of appeal is unfounded. |
| --- | --- |

135

The Commission contends that the seventh ground of appeal is unfounded.

| 136 | ECHA supports the Commission’s arguments. |
| --- | --- |

136

ECHA supports the Commission’s arguments.

Findings of the Court

Findings of the Court

| 137 | Contrary to what is argued by the appellant, it is not apparent from the paragraphs of the judgment under appeal referred to in its seventh ground of appeal that the Commission is not required to apply the precautionary principle when it has to examine an application for authorisation under Article 60(4) of the REACH Regulation. |
| --- | --- |

137

Contrary to what is argued by the appellant, it is not apparent from the paragraphs of the judgment under appeal referred to in its seventh ground of appeal that the Commission is not required to apply the precautionary principle when it has to examine an application for authorisation under Article 60(4) of the REACH Regulation.

| 138 | The General Court noted, in essence, in paragraph 292 of that judgment, that Article 60(4) of the REACH Regulation is the expression of the need to take into account that principle and the principle of proportionality where one of the conditions laid down in Article 60(2) of that regulation is not satisfied, in the present case, the condition concerning evidence of control of the risk posed to human health or the environment by the use of the substance at issue. |
| --- | --- |

138

The General Court noted, in essence, in paragraph 292 of that judgment, that Article 60(4) of the REACH Regulation is the expression of the need to take into account that principle and the principle of proportionality where one of the conditions laid down in Article 60(2) of that regulation is not satisfied, in the present case, the condition concerning evidence of control of the risk posed to human health or the environment by the use of the substance at issue.

| 139 | Furthermore, it cannot validly be argued that the precautionary principle precludes an authorisation being granted under Article 60(4) of the REACH Regulation on the sole ground that there is no proof of control of the risk, without calling into question the validity of that provision, which allows authorisation to be granted in such a situation. |
| --- | --- |

139

Furthermore, it cannot validly be argued that the precautionary principle precludes an authorisation being granted under Article 60(4) of the REACH Regulation on the sole ground that there is no proof of control of the risk, without calling into question the validity of that provision, which allows authorisation to be granted in such a situation.

| 140 | The appellant, however, does not dispute the validity of that provision, but rather the way in which it must be applied. |
| --- | --- |

140

The appellant, however, does not dispute the validity of that provision, but rather the way in which it must be applied.

| 141 | In view of the foregoing, the seventh ground of appeal cannot, therefore, succeed. |
| --- | --- |

141

In view of the foregoing, the seventh ground of appeal cannot, therefore, succeed.

| 142 | Consequently, since all of the grounds of appeal have been rejected, the appeal must be dismissed in its entirety. |
| --- | --- |

142

Consequently, since all of the grounds of appeal have been rejected, the appeal must be dismissed in its entirety.

Costs

Costs

| 143 | Under Article 184(2) of the Rules of Procedure of the Court of Justice, where an appeal is unfounded, the Court is to make a decision as to the costs. |
| --- | --- |

143

Under Article 184(2) of the Rules of Procedure of the Court of Justice, where an appeal is unfounded, the Court is to make a decision as to the costs.

| 144 | Article 138(1) of the Rules of Procedure, which is applicable to appeal proceedings by virtue of Article 184(1) thereof, provides that the unsuccessful party is to be ordered to pay the costs if they have been applied for in the successful party’s pleadings. |
| --- | --- |

144

Article 138(1) of the Rules of Procedure, which is applicable to appeal proceedings by virtue of Article 184(1) thereof, provides that the unsuccessful party is to be ordered to pay the costs if they have been applied for in the successful party’s pleadings.

| 145 | Since the appellant has been unsuccessful, it must be ordered to pay the costs, as applied for by the Commission. |
| --- | --- |

145

Since the appellant has been unsuccessful, it must be ordered to pay the costs, as applied for by the Commission.

| 146 | Under Article 184(4) of the Rules of Procedure, where the appeal has not been brought by an intervener at first instance, he or she may not be ordered to pay costs in the appeal proceedings unless he or she participated in the written or oral part of the proceedings before the Court. Where an intervener at first instance takes part in the proceedings, the Court may decide that he or she is to bear his or her own costs. |
| --- | --- |

146

Under Article 184(4) of the Rules of Procedure, where the appeal has not been brought by an intervener at first instance, he or she may not be ordered to pay costs in the appeal proceedings unless he or she participated in the written or oral part of the proceedings before the Court. Where an intervener at first instance takes part in the proceedings, the Court may decide that he or she is to bear his or her own costs.

| 147 | In accordance with those provisions, ECHA, an intervener at first instance, must be ordered to bear its own costs. |
| --- | --- |

147

In accordance with those provisions, ECHA, an intervener at first instance, must be ordered to bear its own costs.

| | On those grounds, the Court (First Chamber) hereby: |
| --- | --- |

On those grounds, the Court (First Chamber) hereby:

| | 1. | Dismisses the appeal; |
| --- | --- | --- |

1.

1.

Dismisses the appeal;

Dismisses the appeal;

| | 2. | Orders ClientEarth to bear its own costs and to pay the costs incurred by the European Commission; |
| --- | --- | --- |

2.

2.

Orders ClientEarth to bear its own costs and to pay the costs incurred by the European Commission;

Orders ClientEarth to bear its own costs and to pay the costs incurred by the European Commission;

| | 3. | Orders the European Chemicals Agency (ECHA) to bear its own costs. |
| --- | --- | --- |

3.

3.

Orders the European Chemicals Agency (ECHA) to bear its own costs.

Orders the European Chemicals Agency (ECHA) to bear its own costs.

| | Bonichot


  Bay Larsen


  Toader




  Safjan


  Jääskinen


  Delivered in open court in Luxembourg on 6 October 2021.


  A. Calot Escobar
  Registrar


  J.-C. Bonichot
  President of the First Chamber |
| --- | --- |

Bonichot

Bay Larsen

Toader

Safjan

Jääskinen

Delivered in open court in Luxembourg on 6 October 2021.

A. Calot Escobar

Registrar

J.-C. Bonichot

President of the First Chamber

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  *1
  )	Language of the case: English.

*1