ORDER OF THE COURT (Eighth Chamber)

27 March 2014 ([\*](#Footnote*))

(Appeal – Article 181 of the Rules of Procedure – Regulation (EC) No 1907/2006 (REACH regulation) – Restrictions on the placing on the market and use of acrylamide – Regulation (EU) No 366/2011 amending Annex XVII of Regulation (EC) No 1907/2006)

In Case C‐199/13 P,

APPEAL under Article 56 of the Statute of the Court of Justice of the European Union, brought on 9 April 2013,

**Polyelectrolyte Producers Group,** established in Brussels (Belgium),

**SNF SAS,** established in Andrézieux-Bouthéon (France),

**Travetanche Injection SPRL,** established in Brussels,

represented by K. Van Maldegem and R. Cana, avocats,

appellants,

the other parties to the proceedings being:

**European Commission,** represented by E. Manhaeve and P. Oliver, acting as Agents, assisted by J. Stuyck and A.-M. Vandromme, advocaten, with an
address for service in Luxembourg,

defendant at first instance,

**Kingdom of the Netherlands,** represented by M. Bulterman and B. Koopman, acting as Agents,

intervener at first instance,

THE COURT (Eighth Chamber),

composed of C.G. Fernlund (Rapporteur), President of the Chamber, A. Ó Caoimh and C. Toader, Judges,

Advocate General: N. Jääskinen,

Registrar: A. Calot Escobar,

having decided, after hearing the Advocate General, to give a decision by reasoned order, pursuant to Article 181 of the Rules
of Procedure of the Court,

makes the following

**Order**

1        By their appeal, Polyelectrolyte Producers Group, SNF SAS and Travetanche Injection SPRL seek to have set aside the judgment
of the General Court of the European Union in *Polyelectrolyte Producers Group and Others* v *Commission* (Case T‐368/11, EU:T:2013:53, ‘the judgment under appeal’), wherein the General Court dismissed as unfounded their action
for annulment of Commission Regulation (EU) No 366/2011 of 14 April 2011 amending Regulation (EC) No 1907/2006 of the European
Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards
Annex XVII (Acrylamide) (OJ 2011 L 101, p. 12; ‘the contested regulation’).

**Background to the dispute and the contested regulation**

2        Acrylamide is a substance used in the production of polyacrylamide, which is used in construction as a grouting agent.

3        Under Council Regulation (EEC) No 793/93 on the evaluation and control of the risks of existing substances (OJ 1993 L 84,
p. 1), acrylamide was included in the first priority list and the United Kingdom of Great Britain and Northern Ireland was
given responsibility for the evaluation of that substance by Commission Regulation (EC) No 1179/94 of 25 May 1994 concerning
the first list of priority substances as foreseen under Regulation No 793/93 (OJ 1994 L 131, p. 3).

4        The principles for the assessment of risks to man and the environment of existing substances in accordance with Regulation
No 793/93 were laid down by Commission Regulation (EC) No 1488/94 of 28 June 1994 (OJ 1994 L 161, p. 3).

5        The United Kingdom concluded that it was necessary to reduce the risk to the aquatic environment arising from the use of acrylamide-based
grouts, the risk to workers as a consequence of exposure arising from small­ and large­scale use of acrylamide-based grouts
and the risk to humans exposed via their environment to acrylamide as a consequence of the large-scale use of those products.

6        On the basis of the evaluation carried out by the United Kingdom, the Commission – by Recommendation 2004/394/EC of 29 April
2004 on the results of the risk evaluation and the risk reduction strategies for the substances: Acetonitrile; Acrylamide;
Acrylonitrile; Acrylic acid; Butadiene; Hydrogen fluoride; Hydrogen peroxide; Methacrylic acid; Methyl methacrylate; Toluene;
Trichlorobenzene (OJ 2004 L 144, p. 75) – recommended that the introduction at European Union level of restrictions on the
marketing and use of acrylamide in grouts for small­ and large­scale applications, in Council Directive 76/769/EEC of 27 July
1976 on the approximation of the laws, regulations and administrative provisions of the Member States relating to restrictions
on the marketing and use of certain dangerous substances and preparations (OJ 1976 L 262, p. 201), be considered. As regards
the security of workers, the European Union legislation in force at that time was regarded as providing adequate protection
to limit the risks of acrylamide.

7        On 4 February 2008, the Commission produced an impact assessment accompanying a draft decision amending Directive 76/769 as
regards acrylamide.

8        From 1 June 2008 and 1 June 2009 respectively, Regulation No 793/93 and Directive 76/769 were repealed by Article 139 of Regulation
(EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and
Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Regulation
No 793/93 and Regulation No 1488/94 as well as Directive 76/769 and Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC
(OJ 2006 L 396, p. 1; ‘the REACH regulation’).

9        Article 137(1)(a) of the REACH regulation contains transitional measures. It provides that, by 1 June 2010 at the latest,
the Commission is, if necessary, to prepare a draft amendment to Annex XVII to that regulation in accordance with any risk
evaluation and recommended strategy for limiting risks that has been adopted at Community level in accordance with Article 11
of Regulation No 793/93 as far as it includes proposals for restrictions in accordance with Title VIII of the REACH regulation
but for which a decision under Directive 76/769 has not yet been taken. Thus, the Commission prepared a draft amendment to
Annex XVII to the REACH regulation which contains the restrictions applicable to the manufacture, placing on the market and
use of certain dangerous substances, mixtures and articles.

10      On 14 April 2011, the Commission adopted the contested regulation. Article 1 of the contested regulation amended Annex XVII
to the REACH regulation and the following text concerning acrylamide was inserted into that annex:

‘Shall not be placed on the market or used as a substance or constituent of mixtures in a concentration, equal to or greater
than 0.1% by weight for grouting applications after 5 November 2012.’

**The action before the General Court and the judgment under appeal**

11      By application lodged at the Registry of the Court of First Instance on 8 July 2011, the appellants brought an action for
the annulment of the contested regulation. The Kingdom of the Netherlands intervened in support of the form of order sought
by the Commission.

12      By document lodged at the Registry of the General Court on 30 October 2012, Travetanche Injection SPRL sought the suspension
of operation of the contested regulation. By order of 5 November 2012 in Case T‐368/11 R *Travetanche Injection* v *Commission*, the President of the General Court granted that request, to the extent that the contested regulation concerns that company.

13      The action for annulment was based on three pleas in law.

14      By their first plea in law, the appellants claimed that the Commission had made a manifest error of assessment in the evaluation
of the risks on the basis of which the contested regulation was adopted. According to the appellants, the Commission had failed
to take all the relevant factors into account, had made a manifest error in the evaluation of the data relating to the exposure
to acrylamide and had taken into consideration a product containing a grouting agent distinct from acrylamide.

15      For the reasons set out in paragraphs 26 to 73 of the judgment under appeal, the General Court rejected the first plea in
law.

16      By their second plea in law, the appellants claimed that the contested regulation infringed the principle of proportionality,
since it was not appropriate to achieve its objective, namely protecting human health and the environment. According to the
appellants, it was based on information that did not relate to the placing on the market of acrylamide. In addition, they
submitted that the substances that may be used as substitutes for acrylamide might pose higher risks than acrylamide, and
that the Commission could have taken other more appropriate and less restrictive measures.

17      The General Court rejected that plea for the reasons set out in paragraphs 75 to 98 of the judgment under appeal.

18      By their third plea in law, alleging infringement of the obligation to state reasons, the appellants claimed that the Commission
had not explained why, in the contested regulation, the maximum level of concentration of acrylamide was fixed at 0.1%.

19      The General Court rejected that plea in law for the reasons set out in paragraphs 102 to 107 of the judgment under appeal.

**Forms of order sought**

20      The appellants claim that the Court should:

–        set aside the judgment under appeal and annul the contested regulation;

–        in the alternative, refer the case back to the General Court, and

–        order the Commission to pay the costs, including those incurred at first instance.

21      The Commission and the Kingdom of the Netherlands contend that the appeal should be dismissed and that the appellants should
be ordered to pay the costs.

**The appeal**

22      Under Article 181 of its Rules of Procedure, where an appeal is, in whole or in part, manifestly inadmissible or manifestly
unfounded, the Court may at any time, acting on a proposal from the Judge-Rapporteur and after hearing the Advocate General,
decide by reasoned order to dismiss that appeal in whole or in part. It is appropriate to apply that provision in the present
case.

23      The appellants rely on five grounds of appeal.

*The first ground of appeal, concerning the evaluation of risks*

24      This ground of appeal contests the General Court’s assessments in paragraphs 30, 32 to 40 and 44 to 62 of the judgment under
appeal. It is composed of three branches.

 The first branch of the first ground of appeal, concerning the scope of the judicial review exercised by the General Court

25      The appellants claim that the General Court erred in law, in paragraphs 29 and 30 of the judgment under appeal, in confining
itself to examining whether the European Union institutions had committed a manifest error or a misuse of power or even if
they had clearly exceeded the bounds of their discretion. The General Court limited the scope of its review by invoking the
highly complex nature of the scientific and technical assessments necessary to determine the restrictions on the use of acrylamide,
whereas the present case concerns only elementary uses of that substance. An issue of access to justice would arise if the
General Court could thus systematically restrict its review provided that review concerned the application of the REACH regulation.

26      In that respect, it must be pointed out, as the General Court did in paragraph 29 of the judgment under appeal, that, in an
area of evolving and complex technology such as that relating to the evaluation and monitoring of the risks posed by chemical
substances, the European Union institutions have a broad discretion, in particular as to the assessment of highly complex
scientific and technical facts, in order to determine the nature and scope of the measures which they adopt, and that review
by the European Union judicature has to be limited to verifying whether there has been a manifest error of assessment or a
misuse of powers, or whether the authorities have manifestly exceeded the limits of their discretion. In such a context, the
European Union judicature cannot substitute its assessment of scientific and technical facts for that of the European Union
authorities on whom alone the FEU Treaty has placed that task (Case C‐425/08 *Enviro Tech (Europe)*, EU:C:2009:635, paragraph 47, and Case C‐15/10 *Etimine*, EU:C:2011:504, paragraph 60).

27      Therefore, the General Court rightly held, in paragraph 30 of the judgment under appeal, that the case-law cited above is
applicable to the present case, on the ground that, ‘[e]ven if acrylamide grouts have been used in the same way for decades,
the determination of the nature and the extent of the restrictions in issue required an assessment of highly complex scientific
and technical facts’.

28      Nor did the General Court err in law in stating, in paragraph 31 of the judgment under appeal, that ‘the [European Union institutions’]
broad discretion, which implies limited judicial review of their exercise of that discretion, applies not only to the nature
and scope of the measures to be taken but also applies, to some extent, to the finding of the basic facts’.

29      In so ruling in accordance with the settled case-law of the Court of Justice, the General Court did not manifestly infringe
the appellants’ right to access to justice, since they were clearly able to challenge the contested regulation in order to
ensure the defence of their interests.

30      The first branch of the first ground of appeal is therefore manifestly unfounded.

 The second branch of the first ground of appeal, concerning the failure to take into account all of the relevant factors and
circumstances

31      The appellants claim that the General Court erred in law in holding, in paragraphs 32 to 40 of the judgment under appeal,
that the Commission had taken into consideration all the relevant factors necessary to evaluate the risks relating to the
use of acrylamide. According to the appellants, the Commission failed to take into account certain factors contained in a
letter sent to it by Polyelectrolyte Producers Group on 17 January 2006 concerning the use of acrylamide in small-scale grouting
applications in Belgium and the Netherlands.

32      However, it must be noted that, for the reasons stated in paragraphs 32 to 40 of the judgment under appeal, the General Court
rejected the complaint that the Commission had not taken into account two documents, namely a report of 14 March 2000 entitled
‘Risk Reduction Strategy and Analysis of Advantages and Drawbacks for Acrylamide’, prepared by a consultancy for the UK authorities,
and the aforementioned letter of 17 January 2006, in order to evaluate the risks relating to the use of acrylamide.

33      The General Court held, for the reasons set out in paragraphs 34 and 35 of the judgment under appeal, that the first of those
documents ‘was in fact taken into account by the Commission in the course of the administrative procedure leading up to adoption
of the contested regulation’. As regards the second document, the General Court essentially held, in paragraphs 38 and 39
of the judgment under appeal, that it was not relevant for the evaluation of the risks relating to exposure to acrylamide.
It is therefore apparent that the grounds of the judgment under appeal which are challenged by the appellants concern exclusively
factual assessments.

34      It is clear from Article 256 TFUE and the first paragraph of Article 58 of the Statute of the Court of Justice of the European
Union that the General Court has exclusive jurisdiction, first, to find the facts, except where the substantive inaccuracy
of its findings is apparent from the documents submitted to it, and, secondly, to assess those facts. When the General Court
has found or assessed the facts, the Court of Justice has jurisdiction under Article 256 TFEU to review the legal characterisation
of those facts by the General Court and the legal conclusions it has drawn from them (Case C‐584/11 P *Dow AgroSciences and Others* v *Commission*, EU:C:2013:281, paragraph 72 and the case-law cited).

35      The Court of Justice thus has no jurisdiction to establish the facts or, in principle, to examine the evidence which the General
Court accepted in support of those facts. Provided that the evidence has been properly obtained and the general principles
of law and the rules of procedure in relation to the burden of proof and the taking of evidence have been observed, it is
for the General Court alone to assess the value which should be attached to the evidence produced before it. Save where the
evidence adduced before the General Court has been distorted, the appraisal therefore does not constitute a point of law which
is subject to review by the Court of Justice (Case C‐105/04 P *Nederlandse Federatieve Vereniging voor de Groothandel op Elektrotechnisch Gebied* v *Commission*, EU:C:2006:592, paragraph 70, and Joined Cases C‐239/11 P, C‐489/11 P and C‐498/11 P *Siemens and Others* v *Commission*, EU:C:2013:866, paragraph 38 and the case-law cited).

36      Since the appellants have not invoked any distortion of the evidence adduced before the General Court, the second branch of
the first ground of appeal, contesting assessments of a factual nature, is therefore manifestly inadmissible.

 The third branch of the first ground of appeal, concerning infringement of Regulation No 1488/94

37      The appellants claim that the General Court erred in its interpretation of Regulation No 1488/94 in two respects. First, it
accepted the exclusive use of exposure data from a non-Member State relating to small-scale applications of grouting products.
Secondly, it relied on data used for the risk assessment relating to large-scale applications of grouting products which gave
rise to accidents in Sweden and Norway.

–       The exposure data relating to small scale applications of grouting products

38      The appellants complain that the General Court, in paragraphs 44 to 49 of the judgment under appeal, accepted the Commission’s
use of data from the United States concerning exposure to acrylamide through small-scale applications of that substance. In
their view, it was for the Commission to prove that the data in question concerned conditions relating to exposure which was
‘known or reasonably foreseeable in the light of available information on the substance’ pursuant to Article 3(3) of Regulation
No 1488/94. The data from the United States concerns different situations than those known in the European Union. Furthermore,
the General Court contradicted itself in accepting the use of that data, whereas, in paragraph 96 of that judgment, it stated
that ‘[r]isk management is not, however, subject to the same principles and rules in the United States as it is in the EU
since the legal and political frameworks are different’.

39      In that respect, it must be noted that, in paragraph 42 of the judgment under appeal, the General Court held as follows:

‘Under Article 3(1) of Regulation No 1488/94, “the risk assessment shall entail hazard identification and, as appropriate,
dose (concentration) - response (effect) assessment, exposure assessment and risk characterisation”. It must be based on “the
information on the substance submitted in accordance with Articles 3, 4, 7(1) and (2), 9(1) and (2) and 10(2) of Regulation
... No 793/93 and on other available information and shall normally be conducted in accordance with the procedures set out in
Articles 4 and 5 of [Regulation No 1488/94]”. Under Article 3(3) of Regulation No 1488/94, “in conducting an exposure assessment,
the rapporteur shall take into account those human populations or environmental spheres for which exposure to the substance
is known or reasonably foreseeable in the light of available information on the substance, with particular regard to manufacture,
transport, storage, formulation into a preparation or other processing, use and disposal or recovery.”’

40      In paragraph 46 of the judgment under appeal, the General Court inferred from the wording of those provisions and from that
of the relevant provisions of Regulation No 793/93 that ‘the risk assessment could, in principle, also be founded on data
other than those submitted pursuant to Regulation No 793/93 and that there was no requirement for those data to come from
the EU’. The General Court did not err in law, in paragraph 47 of the judgment under appeal, in considering that the provisions
in question ‘make no reference to exposure data from the EU and [that] there is thus no requirement that such data should
be available in order for a risk assessment to be undertaken’. The interpretation of Article 3(1) and (3) of Regulation No 1488/94
recommended by the appellants – besides the fact that it is not based on the wording of the provisions at issue – would lead
to available information being ignored merely because it is from a non-Member State. Such an interpretation would be clearly
contrary to the letter and the spirit of Article 3(1) and (3).

41      Contrary to what is claimed by the appellants, the General Court did not contradict itself in stating, in paragraph 96 of
the judgment under appeal, that the ‘[r]isk management is not, however, subject to the same principles and rules in the United
States as it is in the EU since the legal and political frameworks are different’. Although, in paragraphs 46 and 47 of the
judgment under appeal, the General Court ruled that the Commission’s use of certain exposure data for the purposes of the
risk assessment was lawful, in paragraph 96 it answered the appellants’ complaints concerning the lawfulness, in light of
the principle of proportionality, of the risk management measures adopted by the Commission, complaints which were based on
the fact that the United States authorities had not deemed it necessary to prohibit the use of acrylamide-based grouting products
in order to protect the health of workers which handled them.

42      As regards the issue of whether the data collected in the United States corresponded to conditions of acrylamide exposure
comparable to those in the European Union, the General Court concluded, in paragraph 49 of the judgment under appeal, that
‘the Commission took into account data relating to an exposure to acrylamide that was reasonably foreseeable, in accordance
with Article 3(3) of Regulation No 1488/94, and thus did not make a manifest error of assessment’. That conclusion is based
on factual grounds set out in paragraph 48 of the judgment under appeal. It follows that the appellants’ criticisms, directed
against those factual assessments, are manifestly inadmissible.

–       The exposure data relating to large-scale applications of grouting products

43      The appellants complain that, in paragraphs 50 to 62 of the judgment under appeal, the General Court rejected their arguments
seeking to demonstrate that the Commission made a manifest error of assessment in relying on data relating to exposure scenarios
in the context of the large-scale use of the grouting products. The Commission relied on data relating to accidents linked
to the use of such products during the construction of tunnels in Sweden and Norway. However, those products were used, as
the General Court pointed out in paragraph 57 of the judgment under appeal, in incorrect conditions. Therefore, according
to the appellants, that data could not be regarded as representative of normal usage since it related to exposure which was
not ‘known or reasonably foreseeable’ within the meaning of Article 3(3) of Regulation No 1488/94. The General Court therefore
infringed that provision in ignoring the existence of a manifest error of assessment by the Commission.

44      The appellants’ line of argument raises the question whether Article 3(3) of Regulation No 1488/94 precludes the Commission
from taking into account, for the purpose of evaluating the risks linked to the use of a substance, data relating to an exposure
to such a substance resulting from an incorrect usage of the product in which it is present.

45      Under Article 3(3) of Regulation No 1488/94, account must be taken of data relating to exposure which was ‘known or reasonably
foreseeable in the light of available information on the substance ... with particular regard to ... use’. That provision does
not make a distinction between whether or not the use which brought about an exposure to a substance was in accordance with
the applicable usage and security standards and it is sufficient that the exposure be ‘known or reasonably foreseeable’.

46      Therefore, the General Court neither contradicted itself nor erred in law in holding, in paragraph 61 of the judgment under
appeal, referring to paragraph 71 of *Etimine* (EU:C:2011:504), that ‘the Commission must take into account all handling and uses occurring in normal circumstances, which
encompasses, in particular, the need to take account of realistic and foreseeable accidents’.

47      Since the appellants’ line of argument is therefore manifestly unfounded, the third branch of the first ground of appeal must
be rejected.

48      In those circumstances, the first ground of appeal must be rejected as manifestly inadmissible in part and manifestly unfounded
in part.

*The second to fifth grounds of appeal*

49      By their second ground of appeal, contesting the reasons set out in paragraphs 65 to 69 of the judgment under appeal, the
appellants claim that the General Court erred in the assessment of the facts in refusing, in paragraph 66, to take into consideration
the fact that acrylamide is only present in N-methylolacrylamide (NMA) as an impurity.

50      According to the appellants, the restriction procedure laid down in Articles 68 and 69 of the REACH regulation is applicable
to substances ‘on their own, in preparations or in articles’, but not to impurities. Consequently, the risks arising from
the use of NMA-based grouting products cannot serve as a basis for the evaluation of the risks posed by acrylamide as a substance
‘on their own, in preparations or in articles’. In concluding that the Commission did not make an error of assessment in examining
the data relating to the use of NMA-based grouting products in order to justify the restrictions concerning acrylamide, the
General Court erred in its interpretation of Articles 68 and 69.

51      In addition, since acrylamide is an impurity and not a component of NMA-based grouting products, the appellants claim that:

–        the contested regulation does not achieve its objective of protecting human health or the environment and, contrary to what
the General Court held in paragraphs 74 to 80 of the judgment under appeal, it therefore infringes the principle of proportionality.
(third ground of appeal);

–        recital 4 in the preamble to the contested regulation does not state reasons in such a way as to enable the persons concerned
to understand the full significance of and the reasons for the measures laid down by that regulation, contrary to what the
General Court held in paragraph 102 of that judgment (fourth ground of appeal), and

–        the General Court misinterpreted the contested regulation in holding, in paragraphs 100 to 106 of that judgment, that it covers
NMA-based grouting products which contain acrylamide (fifth ground of appeal).

52      In that respect, it must be noted that, by their second ground of appeal, the appellants contest the assessment carried out
by the General Court in paragraphs 66 to 69 of the judgment under appeal as regards the issue whether acrylamide is only present
as an impurity in NMA-based grouting products. As noted in paragraph 34 of the present order, the Court has no jurisdiction
to review such a factual assessment in the context of an appeal. The second ground of appeal relied on by the appellants is
therefore manifestly inadmissible.

53      As regards the third to fifth grounds of appeal, they are based on the premise that the General Court erred in its assessment
of the facts. Since the Court does not have jurisdiction, in the context of an appeal, to review the accuracy of such a factual
premise, those grounds of appeal, even if they were well-founded, could not bring about the annulment of the judgment under
appeal. Those grounds of appeal must therefore be rejected as ineffective.

54      Since none of the five grounds of appeal relied on by the appellants can be upheld, the appeal must be dismissed in its entirety
as manifestly inadmissible in part and manifestly unfounded in part.

**Costs**

55      In accordance with the second paragraph of Article 184 of its Rules of Procedure, where the appeal is unfounded, the Court
shall make a decision as to costs. Under Article 138(1) of those Rules, which applies to the procedure on appeal by virtue
of Article 184 of those Rules, the unsuccessful party shall be ordered to pay the costs if they have been applied for in the
successful party’s pleadings. Since the Commission has applied for costs and the appellants have been unsuccessful, they must
be ordered to pay the costs.

56      Pursuant to Article 140(1) of the Rules of Procedure, which is also applicable to the procedure on appeal, according to which
the Member States which have intervened in the proceedings are to bear their own costs, the Kingdom of the Netherlands must
be ordered to bear its own costs.

On those grounds, the Court (Eighth Chamber) hereby orders:

1.      **The appeal is dismissed;**

2.      **Polyelectrolyte Producers Group, SNF SAS and Travetanche Injection SPRL shall pay the costs;**

3.      **The Kingdom of the Netherlands shall bear its own costs.**

[Signatures]

---

[\*](#Footref*) Language of the case: English.