CELEX: 62021CJ0702
Appeal
Biocidal products
Regulation (EU) No 528/2012
Delegated Regulation (EU) No 1062/2014
Active substance PHMB (1415; 4.7)
Refusal of approval as an existing active substance for use in biocidal products of product-types 1, 5 and 6
Approval as an existing active substance for use in biocidal products of product-types 2 and 4
Teratogenic effect
Human health risk assessment

By its appeal, Laboratoire Pareva seeks to have set aside the judgment of the General Court of the European Union of 15 September 2021,
Laboratoire Pareva and Biotech3D
v
Commission
(T‑337/18 and T‑347/18, EU:T:2021:594), by which the General Court dismissed its action for annulment, in Case T‑337/18, of Commission Implementing Decision (EU) 2018/619 of 20 April 2018 not approving PHMB (1415; 4.7) as an existing active substance for use in biocidal products of product-types 1, 5 and 6 (OJ 2018 L 102, p. 21; ‘the decision at issue’) and, in Case T‑347/18, of Commission Implementing Regulation (EU) 2018/613 of 20 April 2018 approving PHMB (1415; 4.7) as an existing active substance for use in biocidal products of product-types 2 and 4 (OJ 2018 L 102, p. 1; ‘the regulation at issue’).

Legal context

Regulation (EC)
No 1
272/2008
Chapter 1, entitled ‘Establishing harmonised classification and labelling of substances’, of Title V, entitled ‘Harmonisation of classification and labelling of substances and the classification and labelling inventory’, of Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ 2008 L 353, p. 1), includes Article 36 of that regulation, entitled ‘Harmonisation of classification and labelling of substances’, which states in paragraph 1:
‘A substance that fulfils the criteria set out in Annex I for the following shall normally be subject to harmonised classification and labelling in accordance with Article 37:
…
(c)      carcinogenicity, category 1A, 1B or 2 (Annex I, section 3.6);
…’
Article 37 of Regulation No 1272/2008, entitled ‘Procedure for harmonisation of classification and labelling of substances’, provides in paragraph 1:
‘A competent authority may submit to the [European Chemicals] Agency a proposal for harmonised classification and labelling of substances and, where appropriate, specific concentration limits or M-factors, or a proposal for a revision thereof.
The proposal shall follow the format set out in Part 2 of Annex VI and contain the relevant information provided for in Part 1 of Annex VI.’

Regulation (EU)
No 5
28/2012
Chapter II, entitled ‘Approval of active substances’, of Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (OJ 2012 L 167, p. 1), includes Article 8 of that regulation, entitled ‘Evaluation of applications’, which states:
‘1.      The evaluating competent authority shall, within 365 days of the validation of an application, evaluate it in accordance with Articles 4 and 5, including, where relevant, any proposal to adapt data requirements submitted in accordance with Article 6(3), and send an assessment report and the conclusions of its evaluation to the [European Chemicals] Agency.
Prior to submitting its conclusions to the [European Chemicals] Agency, the evaluating competent authority shall give the applicant the opportunity to provide written comments on the assessment report and on the conclusions of the evaluation within 30 days. The evaluating competent authority shall take due account of those comments when finalising its evaluation.
…
4.      Within 270 days of receipt of the conclusions of the evaluation, the [European Chemicals] Agency shall prepare and submit to the [European] Commission an opinion on the approval of the active substance having regard to the conclusions of the evaluating competent authority.’
Article 19 of Regulation No 528/2012, entitled ‘Conditions for granting an authorisation’, included in Chapter IV thereof, entitled ‘General principles governing the authorisation of biocidal products’, provides:
‘1.      A biocidal product other than those eligible for the simplified authorisation procedure in accordance with Article 25 shall be authorised provided the following conditions are met:
(a)      the active substances are approved for the relevant product-type and any conditions specified for those active substances are met;
(b)      it is established, according to the common principles for the evaluation of dossiers for biocidal products laid down in Annex VI, that the biocidal product, when used as authorised and having regard to the factors referred to in paragraph 2 of this Article, fulfils the following criteria:
(i)      the biocidal product is sufficiently effective;
(ii)      the biocidal product has no unacceptable effects on the target organisms, in particular unacceptable resistance or cross-resistance or unnecessary suffering and pain for vertebrates;
(iii)      the biocidal product has no immediate or delayed unacceptable effects itself, or as a result of its residues, on the health of humans, including that of vulnerable groups, or animals, directly or through drinking water, food, feed, air, or through other indirect effects;
(iv)      the biocidal product has no unacceptable effects itself, or as a result of its residues, on the environment …
…’

Delegated Regulation (EU)
No 1
062/2014
Chapter 2, entitled ‘Process for evaluation of dossiers’, of Commission Delegated Regulation (EU) No 1062/2014 of 4 August 2014 on the work programme for the systematic examination of all existing active substances contained in biocidal products referred to in Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ 2014 L 294, p. 1), contains Article 6 thereof, entitled ‘Evaluation of applications’, which provides in paragraph 7:
‘Upon finalisation of its hazard evaluation, the evaluating competent authority shall without undue delay and no later than at the time of submission of the assessment report pursuant to paragraph 3, as appropriate:
(a)      submit a proposal to the [European Chemicals] Agency pursuant to Article 37(1) of Regulation [No 1272/2008], where it considers that one of the criteria referred to in Article 36(1) thereof is fulfilled and not properly addressed in part 3 of Annex VI to that Regulation;
…’
Article 7 of Delegated Regulation No 1062/2014, entitled ‘Opinion of the [European Chemicals] Agency’, provides in paragraph 2:
‘Upon acceptance of the report, the [European Chemicals] Agency shall prepare and submit to the Commission an opinion on the approval of the substance/product-type combination or its inclusion in category 1, 2, 3, 4, 5 or 6 of Annex I to Regulation [No 528/2012], or both, having regard to the conclusions of the evaluating competent authority.
The [European Chemicals] Agency shall start the preparation of the opinion within either of the following deadlines, whichever is the later:
(a)      three months of the acceptance of the report;
(b)      the time limits provided for by Annex III.
The [European Chemicals] Agency shall submit the opinion to the Commission within 270 days of the start of the preparation.’

Background to the dispute
The background to the dispute was set out in paragraphs 13 to 31 of the judgment under appeal and may, for the purposes of the present proceedings, be summarised as follows.
Laboratoire Pareva is a manufacturer of the active substance polyhexamethylene biguanide hydrochloride (‘PHMB’). That substance is produced for biocidal purposes as a disinfectant and a preservative.
In the context of the programme for the evaluation of existing active substances established by Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (OJ 1998 L 123, p. 1), Laboratoire Pareva notified the Commission of PHMB (1415; 4.7) in combination with various product-types, under number CAS 91403-50-8 (‘Pareva’s PHMB’).
Under the same evaluation programme, Lonza, which is not connected to Laboratoire Pareva, notified the Commission of PHMB (1600; 1.8) in combination with various product-types under the two numbers CAS 27083-27-8 and 32289-58-0 (‘Lonza’s PHMB’).
Laboratoire Pareva and Lonza envisaged submitting a common dossier for PHMB. However, following various meetings and exchanges of correspondence, Lonza informed Laboratoire Pareva, by letter of 12 February 2007, that full cooperation between them for that purpose was not possible, given the difficulty of confirming that the two notifications related to exactly the same substance specification.
On 31 July 2007, Laboratoire Pareva submitted a dossier, within the meaning of Article 6 of Regulation No 528/2012, relating to the application for approval of Pareva’s PHMB for product-types 1 (human hygiene), 2 (disinfectants and algaecides not intended for direct application on humans or animals), 4 (Food and feed area disinfectants), 5 (drinking water) and 6 (preservatives for products during storage) to the French Ministry for Ecology and Sustainable Development, acting as the evaluating competent authority (‘the eCA’). Laboratoire Pareva enclosed a note explaining why it had not been possible to submit a common dossier with Lonza for PHMB.
By letter of 18 February 2008, the eCA informed Laboratoire Pareva that the dossier which it had submitted had not been considered adequate to enable the assessment of the hazards, risks and efficacy of Pareva’s PHMB.
Following several meetings and discussions between the eCA and Laboratoire Pareva, the latter submitted additional information, including new reports and studies for product-types 1, 2, 4, 5 and 6.
On 3 June 2016, the eCA sent Laboratoire Pareva a draft assessment report for the substance Pareva’s PHMB, within the meaning of Article 8(1) of Regulation No 528/2012, for those product-types.
In a position paper of 4 July 2016, entitled ‘Non-relevance of the PHMB classification as a “Persistent” substance’, Laboratoire Pareva submitted comments on the assessment of the persistent nature and toxicity of Pareva’s PHMB in the draft assessment report referred to in the preceding paragraph.
On 13 December 2016, the eCA sent the European Chemicals Agency (ECHA) its assessment report on Pareva’s PHMB and the conclusions of its evaluation, in accordance with Article 8(1) of Regulation No 528/2012.
On 3 March 2017, Laboratoire Pareva provided an additional document supplementing the position paper of 4 July 2016 referred to in paragraph 17 above.
Between May and September 2017, the ‘Efficacy’, ‘Environment’ and ‘Human health’ working groups of the ECHA Biocidal Products Committee (‘the BPC’) met to examine the assessment report referred to in paragraph 18 above. Laboratoire Pareva participated in those meetings.
On 3 and 4 October 2017, the BPC met in the presence of Laboratoire Pareva. Following that meeting, that committee adopted, by consensus, an opinion on Pareva’s PHMB, in accordance with Article 8(4) of Regulation No 528/2012 (‘the BPC’s opinion’). In essence, it considered that that PHMB could not be approved for product-types 1, 5 and 6 because of unacceptable risks to human health and the environment. By contrast, the committee took the view that the substance could be approved for product-types 2 and 4, subject to certain specifications and conditions.
In addition, the BPC concluded that Pareva’s PHMB was a substance of concern within the meaning of Article 28(2) of Regulation No 528/2012 since it was classified as a category 1B skin sensitiser, a category 2 carcinogen, a specific target organ toxicant by repeated exposure by inhalation, and a toxicant to aquatic life (category 1). It also considered that it was a candidate for substitution, within the meaning of Article 10 of that regulation, since it proved to be very persistent (vP) and toxic (T).
In November 2017, the eCA finalised its assessment report on Pareva’s PHMB as regards product-types 1, 2, 4, 5 and 6, taking into account the outcome of the discussions relating to that substance within the BPC.
On 20 April 2018, the Commission adopted the decision at issue. As is apparent from that decision, the Commission considered, in accordance with the BPC’s opinion, that Pareva’s PHMB should not be approved for product-types 1, 5 and 6 because of the unacceptable risks posed by that substance to human health and the environment.
On the same day, the Commission adopted the regulation at issue. As is apparent from recital 5 of that regulation, the Commission considered that biocidal products of product-types 2 and 4 could be expected to satisfy the requirements of Article 19(1)(b) of Regulation No 528/2012, provided that certain specifications and conditions set out in the annex to that regulation were met. In addition, it is apparent from recitals 7 and 8 of the regulation at issue that Pareva’s PHMB was very persistent (vP) and toxic (T), with the result that it fulfilled the criteria to be considered a candidate for substitution, within the meaning of Article 10 of Regulation No 528/2012, and that its approval could not exceed seven years.

The procedure before the General Court and the judgment under appeal
By applications lodged at the Court Registry on 1 June 2018, Laboratoire Pareva brought two actions, registered under case numbers T‑337/18 and T‑347/18, seeking annulment, respectively, of the decision at issue and of the regulation at issue (together, ‘the acts at issue’).
By decision of 4 February 2020, the President of the Seventh Chamber of the General Court, after hearing the parties, joined Cases T‑337/18 and T‑347/18 for the purposes of the oral part of the procedure.
In support of its actions, Laboratoire Pareva relied on four pleas in law: the first, alleging failure to follow the procedural steps required to adopt the acts at issue; the second, alleging a manifest error of assessment owing to the taking into account of irrelevant factors; the third, alleging a manifest error of assessment owing to the failure to take into account relevant factors; and, the fourth, alleging infringement of the right to be heard.
Pursuant to Article 68 of its Rules of Procedure, the General Court joined Cases T‑337/18 and T‑347/18 for the purposes of the decision closing the proceedings.
By the judgment under appeal, the General Court dismissed the actions in question in their entirety. In the first place, in paragraphs 65 to 88 of the judgment under appeal, the General Court held that the first part of the first plea, alleging infringement of Article 6(7)(a) of Delegated Regulation No 1062/2014, had to be rejected as ineffective and, in any event, as unfounded.
In that regard, the General Court held, in paragraphs 65 to 70 of that judgment, that Laboratoire Pareva’s argument that the eCA had infringed Article 6(7)(a) of Delegated Regulation No 1062/2014 was ineffective for the purposes of the annulment of the acts at issue, since Regulation No 528/2012 and Delegated Regulation No 1062/2014, on the one hand, and Regulation No 1272/2008, on the other, relate to different areas and govern two separate procedures, each organised in accordance with its own rules. Thus, even assuming that the eCA had infringed Article 6(7)(a) of Delegated Regulation No 1062/2014 by not submitting to the ECHA a proposal for harmonised classification of Pareva’s PHMB, that infringement would be incapable of vitiating the acts at issue.
In paragraphs 72 to 87 of the judgment under appeal, the General Court held that, ‘in any event’, even if the eCA had had to consider that the criteria relating to carcinogenicity were not adequately addressed in Part 3 of Annex VI to Regulation No 1272/2008 as regards Pareva’s PHMB, which should have led that eCA to submit a harmonised classification and labelling proposal in accordance with Article 6(7)(a) of Delegated Regulation No 1062/2014, Laboratoire Pareva had not demonstrated that the content of the acts at issue might have been different in the absence of non-compliance with that provision.
In particular, paragraph 81 of the judgment under appeal reads as follows:
‘As the Commission and the ECHA stated at the hearing, without being contradicted by [Laboratoire Pareva and Biotech3D Ltd & Co. KG], one of the human health concerns relating to Pareva’s PHMB was identified as being the teratogenic effect. A concentration level of 12 mg/kg/day of that substance was adopted in that regard, which constitutes the lowest concentration level among concentration levels to which the other effects of Pareva’s PHMB might manifest. Thus, that level was taken to be the reference dose with no-observed-adverse-effect (“NOAEL”) enabling the calculation of the acceptable exposure levels (“AEL”) for that substance for product-types 1, 5 and 6, which [Laboratoire Pareva and Biotech3D] also did not dispute either in their written pleadings or at the hearing.’
In the second place, in paragraphs 111 to 148 of the judgment under appeal, the General Court rejected the first part of the second plea, relating to the multiple instances of read-across to Lonza’s PHMB, on the ground that Laboratoire Pareva had not demonstrated that the authorities responsible for the assessment of Pareva’s PHMB had committed a manifest error of assessment by failing to examine carefully and impartially all the relevant aspects of the case or that they had manifestly exceeded their discretion by relying on a read-across approach.
More specifically, in paragraphs 125 to 132 of the judgment under appeal, the General Court held that Laboratoire Pareva’s arguments that the eCA and the ECHA had made a manifest error of assessment in applying a read-across to Lonza’s PHMB as regards the determination of the values relating to the acceptable exposure concentration (AEC) by inhalation were unfounded.
Paragraphs 133 and 134 of the judgment under appeal are worded as follows:
‘133      In any event, as is apparent from paragraph 81 [of the judgment under appeal], the teratogenic effect was identified as one of the concerns for human health of Pareva’s PHMB. A concentration level of 12 mg/kg/day of that substance was adopted in that regard, which constitutes the lowest concentration level among concentration levels to which the other effects of Pareva’s PHMB might manifest. Thus, that level was adopted as NOAEL of reference allowing the AEL for that substance, which [Laboratoire Pareva and Biotech3D] have not disputed either in their written pleadings or at the hearing. Therefore, the teratogenic effect, and not the subacute toxicity by inhalation, is the decisive factor for the assessment of the unacceptable risks for human health posed by Pareva’s PHMB.
134      Accordingly, even if the [arguments of Laboratoire Pareva and Biotech3D] seeking to challenge reliance on the read-across [to Lonza’s PHMB in the context of the assessment of Pareva’s PHMB as regards the determination of the values relating to the inhalation AEC] were well founded, they are not such as to call into question the outcome of the assessment of Pareva’s PHMB, with the result that they may also be rejected as ineffective.’

Forms of order sought by the parties before the Court of Justice
By its appeal, Laboratoire Pareva claims that the Court should:
–        order a measure of inquiry under Article 64(2)(b) of the Rules of Procedure of the Court of Justice for production of a written transcript of the hearing held before the General Court;
–        set aside the judgment under appeal, and
–        annul the acts at issue and award it the costs of the appeal and of the proceedings before the General Court or award it the costs of this appeal and refer the cases back to the General Court for reconsideration.
The Commission contends that the Court should:
–        reject the request for measures of inquiry;
–        dismiss the appeal, and
–        order Laboratoire Pareva to pay the costs.
The ECHA contends that the Court should:
–        dismiss the appeal as unfounded, and
–        order Laboratoire Pareva to pay the costs.

The request to order a measure of inquiry
The Court may, pursuant to Articles 63 and 64 of the Rules of Procedure, decide to prescribe a measure of inquiry. In the present case, the Court, after hearing the Advocate General, considers that it has at its disposal all the information necessary in order to rule on this appeal. Accordingly, the measure of inquiry requested by Laboratoire Pareva is not necessary.

The appeal
In support of its appeal, Laboratoire Pareva relies on two grounds. The first ground of appeal alleges that the General Court erred in law in that it failed to fulfil its duty to raise of its own motion a plea alleging that the statement of reasons for the acts at issue was inadequate. The second ground of appeal alleges a manifest distortion of the facts.

The first ground of appeal

Arguments of the parties
By its first ground of appeal, Laboratoire Pareva submits, in essence, that the General Court erred in law by not raising of its own motion a plea alleging that the statement of reasons provided in the acts at issue was inadequate.
More specifically, Laboratoire Pareva argues that, in paragraphs 81 and 133 of the judgment under appeal, the General Court held, in essence, that Pareva’s PHMB had a teratogenic effect and that that effect was the ‘decisive factor’ for the assessment of the unacceptable risks for human health posed by that substance. However, that assessment is not reflected in the acts at issue, in the BPC’s opinion, or in the eCA’s reports, and was introduced into the debate by the Commission only at the stage of the hearing before the General Court.
Although Laboratoire Pareva agrees that, during the proceedings before the General Court, it did not raise any plea alleging that the statement of reasons relating to the teratogenic effect of Pareva’s PHMB was inadequate, it submits that it was for the General Court to assess of its own motion whether the statement of reasons for the acts at issue as regards the teratogenic effect of that substance was adequate, which it failed to do.
In Laboratoire Pareva’s view, if the General Court had raised of its own motion the plea alleging that the statement of reasons for the acts at issue was inadequate, it would have concluded that the acts at issue were not supported by an adequate statement of reasons.
Laboratoire Pareva argues that, moreover, the statement of reasons for the acts at issue cannot be remedied by the reference to one of the recitals of those acts. In that regard, Laboratoire Pareva submits that, in paragraph 80 of the judgment under appeal, the General Court cites recital 5 of the contested decision and refers to Article 19(1)(b)(iv) of Regulation No 528/2012, which, according to the General Court, relates to unacceptable risks to human health whereas that provision actually  relates to unacceptable risks to the environment. Therefore, the reference to that recital cannot suffice for the view to be taken that the statement of reasons for the acts at issue is clear and unequivocal concerning the teratogenicity factor.
The ECHA and the Commission dispute both the admissibility and the merits of the first ground of appeal.

Findings of the Court
In the first place, it should be noted that, in the context of the first part of the first plea in its application at first instance, as is apparent from paragraphs 60 to 63 of the judgment under appeal, Laboratoire Pareva alleges that, in infringement of Article 6(7)(a) of Delegated Regulation No 1062/2014, the eCA failed to comply with its obligation to submit to the ECHA a proposal for harmonised classification of Pareva’s PHMB under Articles 36 and 37 of Regulation No 1272/2008, since that authority classified Pareva’s PHMB as a category 2 carcinogen.
In paragraphs 65 to 70 of the judgment under appeal, the General Court rejected that argument as ineffective on the ground that the infringement of Article 6(7)(a) of Delegated Regulation No 1062/2014 could not lead to the annulment of the acts at issue. As the General Court held in paragraphs 65 and 69 of the judgment under appeal, Regulation No 1272/2008, on the one hand, and Regulation No 528/2012 and Delegated Regulation No 1062/2014, on the other hand, relate to two different areas and govern two separate procedures, each organised in accordance with its own rules, since the EU legislature did not intend to make the approval procedure for an existing active substance subject to the procedure for harmonisation of classification and labelling of such a substance.
It is only on a subsidiary basis that the General Court held, in paragraphs 72 to 84 of the judgment under appeal, that Laboratoire Pareva’s argument was in any event unfounded.
It follows from the foregoing that the General Court’s assessment in paragraph 81 of the judgment under appeal is part of a statement of reasons of the General Court included for the sake of completeness.
According to settled case-law, complaints directed against the grounds included in a decision of the General Court purely for the sake of completeness cannot lead to that decision being annulled and are therefore ineffective (see, to that effect, judgment of 28 June 2005,
Dansk Rørindustri and Others
v
Commission
, C‑189/02 P, C‑202/02 P, C‑205/02 P to C‑208/02 P and C‑213/02 P, EU:C:2005:408, paragraph 148).
Accordingly, in so far as it refers to paragraph 81 of the judgment under appeal, Laboratoire Pareva’s argument must be rejected as ineffective.
In the second place, as regards Laboratoire Pareva’s contention relating to paragraph 133 of the judgment under appeal, it should be noted that that paragraph forms part of the General Court’s assessment relating to the first part of the second plea in the application at first instance, alleging a manifest error of assessment in that the eCA, the BPC and the Commission read-across to Lonza’s PHMB in multiple instances in their assessment of Pareva’s PHMB. Laboratoire Pareva argued, in essence, that, in the assessment of Pareva’s PHMB, the eCA, the BPC and the Commission had wrongly taken the inhalation AEC of Pareva’s PHMB from the studies carried out for Lonza’s PHMB, whereas those substances are different.
In paragraphs 125 to 132 of the judgment under appeal, the General Court held that the values relating to the inhalation AEC had been correctly determined and, accordingly, rejected Laboratoire Pareva’s arguments as unfounded.
More specifically, in paragraph 129 of the judgment under appeal, which, moreover, is not disputed in the appeal, the General Court held that, although Pareva’s PHMB and Lonza’s PHMB are not identical substances, that does not mean that those substances do not share certain relevant properties and have a similar toxicological profile. Since Laboratoire Pareva had failed to put forward a detailed explanation that made it possible to demonstrate that the two substances should have had manifestly different inhalation AEC values, the General Court concluded, in paragraph 132 of the judgment under appeal, that the eCA and the ECHA had not made a manifest error of assessment in relying on a read-across to Lonza’s PHMB.
It is only on a subsidiary basis that the General Court added, in paragraph 133 of the judgment under appeal, referring to paragraph 81 of that judgment, that, in any event, the reference values of Pareva’s PHMB were determined in the light of the teratogenic effect, and not of the subacute toxicity by inhalation. In paragraph 134 of the judgment under appeal, which, moreover, is not disputed in the appeal, the General Court inferred from this that, even if the argument seeking to challenge reliance on the read-across approach were well founded, that argument would not be such as to call into question the outcome of the risk assessment of Pareva’s PHMB.
It follows from the foregoing that the General Court’s assessment in paragraph 133 of the judgment under appeal is part of a statement of reasons of the General Court included for the sake of completeness.  In accordance with the case-law cited in paragraph 52 above, a complaint directed against a ground included purely for the sake of completeness must be rejected as ineffective.
It follows that the first ground of appeal must be rejected as ineffective.

The second ground of appeal

Arguments of the parties
By its second ground of appeal, Laboratoire Pareva maintains that the General Court manifestly distorted the evidence submitted to it.
Laboratoire Pareva argues that, first, in paragraphs 81 and 133 of the judgment under appeal, the General Court held that Pareva’s PHMB had a teratogenic effect even though no document in the file submitted for its examination supports such an assessment. The General Court’s assessment is therefore based only on the Commission’s assertion at the hearing. It is apparent from the eCA’s assessment report that, as regards Pareva’s PHMB, no teratogenic effect had been observed. Similarly, in the BPC’s opinion, the BPC concluded that Pareva’s PHMB was not genotoxic or reprotoxic, namely that it did not have a teratogenic effect. Thus, by stating paragraphs 81 and 133 of the judgment under appeal that the teratogenic effect of that substance was the decisive factor in the human health risk assessment, the General Court substituted its own reasoning for that contained in the acts at issue.
Laboratoire Pareva argues that, secondly, the General Court’s assessment in paragraph 81 of the judgment under appeal that Laboratoire Pareva did not contradict the Commission at the hearing when the latter stated that Pareva’s PHMB was teratogenic also constitutes a distortion. Laboratoire Pareva clearly and repeatedly disputed at the hearing that Pareva’s PHMB had a teratogenic effect.
Laboratoire Pareva maintains that the manifest distortion of the evidence in question led the General Court to make an incorrect assessment of the lawfulness of the acts at issue and should result in the judgment under appeal being set aside.
The Commission and the ECHA contend that the second ground of appeal should be rejected as entirely unfounded.

Findings of the Court
In accordance with settled case-law, where an appellant alleges distortion of the evidence by the General Court, he or she must, under Article 256 TFEU, the first paragraph of Article 58 of the Statute of the Court of Justice of the European Union and Article 168(1)(d) of the Rules of Procedure, indicate precisely the evidence alleged to have been distorted by the General Court and show the errors of appraisal which, in his or her view, led to such distortion. In addition, it is also settled case-law of the Court that distortion must be obvious from the documents in the Court’s file, without there being any need to carry out a new assessment of the facts and the evidence (judgment of 12 May 2022,
Klein
v
Commission
, C‑430/20 P, EU:C:2022:377, paragraph 23).
In the present case, it should be noted, first, that, contrary to what Laboratoire Pareva submits, the General Court did not hold, in paragraphs 81 and 133 of the judgment under appeal, that Pareva’s PHMB had a teratogenic effect justifying its classification as a substance toxic for reproduction on account of teratogenic effects. Rather, in those paragraphs of the judgment under appeal, the General Court merely observed that the teratogenic effects of Pareva’s PHMB had been relevant in the assessment of the risks posed by that substance to human health, with a view to setting the NOAEL and the AEL for that substance.
Thus, the General Court did not distort the evidence submitted for its examination when it stated that the concentration level of 12 mg/kg/day of Pareva’s PHMB was adopted because that level constituted the lowest concentration level among concentration levels to which the other effects of Pareva’s PHMB might manifest.
Secondly, Laboratoire Pareva’s claim that the General Court distorted the statements that it made at the hearing – from which it was clear that it disputed that Pareva’s PHMB had a teratogenic effect – must be rejected as being based on a misreading of the judgment under appeal.
In paragraph 81 of the judgment under appeal, the General Court noted that the Commission and the ECHA stated at the hearing, ‘without being contradicted by [Laboratoire Pareva], [that] one of the human health concerns relating to Pareva’s PHMB was identified as being the teratogenic effect’. In so doing, contrary to what Laboratoire Pareva claims, the General Court did not intend to state that Laboratoire Pareva had not disputed that Pareva’s PHMB had a  teratogenic effect. Rather, it is apparent from an overall reading of paragraph 81 of the judgment under appeal that Laboratoire Pareva had not disputed that the teratogenic effect had been decisive in setting the NOAEL and the AEL for that substance in the light of its being a concern for human health.
It follows that the second ground of appeal must be rejected as unfounded.
In the light of all the foregoing, the appeal should be dismissed in its entirety.

Costs
Under Article 184(2) of the Rules of Procedure, where the appeal is unfounded, the Court is to make a decision as to the costs. Article 138(1) of those rules, applicable to appeal proceedings pursuant to 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.
Article 140(1) of the Rules of Procedure provides that the Member States which have intervened in the proceedings are to bear their own costs.
Since the Commission and the ECHA have applied for costs, Laboratoire Pareva, which has been unsuccessful, must be ordered to pay the costs.
The French Republic shall bear its own costs.
On those grounds, the Court (Eighth Chamber) hereby:
1.
Dismisses the appeal;
2.
Orders Laboratoire Pareva to pay the costs;
3.
Orders the French Republic to bear its own costs.
Piçarra
Jääskinen
Gavalec
Delivered in open court in Luxembourg on 10 November 2022.
A. Calot Escobar

N. Piçarra
Registrar

Acting as President of the Chamber
*
Language of the case: English.