CELEX: 62018TJ0337
Biocidal products
Active substance PHMB (1415; 4.7)
Refusal of approval for product-types 1, 5 and 6
Conditional approval for product-types 2 and 4
Risks to human health and the environment
Regulation (EU) No 528/2012
Article 6(7)(a) and (b) of Delegated Regulation (EU) No 1062/2014
Harmonised classification of the active substance under Regulation (EC) No 1272/2008
Prior consultation of the ECHA
Manifest error of assessment
Read-across
Right to be heard

I.

Legal context
A.

Regulation (EU) No 528/2012 and Delegated Regulation (EU) No 1062/2014
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
) lays down rules governing, inter alia, the establishment, at EU level, of a list of active substances which may be used in biocidal products.
Article 4(1) of Regulation No 528/2012 provides that an active substance is to be approved for an initial period not exceeding 10 years if at least one biocidal product containing that active substance may be expected to meet the criteria in point (b) of Article 19(1) taking into account the factors set out in Article 19(2) and (5) thereof.
Article 6(1) of Regulation No 528/2012 defines the minimum data to be provided in the dossier submitted to the European Chemicals Agency (ECHA) in support of an application for approval. However, Article 6(3) of that regulation allows the applicant to propose to adapt certain data required which are part of the dossiers, in accordance with Annex IV to the regulation.
In addition, Article 7 of Regulation No 528/2012, concerning the submission and validation of applications, provides, inter alia, as follows:
‘1.   The applicant shall submit an application for approval of an active substance, or for making subsequent amendments to the conditions of approval of an active substance, to the [ECHA], informing it of the name of the competent authority of the Member State that it proposes should evaluate the application and providing written confirmation that that competent authority agrees to do so. That competent authority shall be the evaluating competent authority.
…
3.   Within 30 days of the [ECHA] accepting an application, the evaluating competent authority shall validate the application if the data required in accordance with points (a) and (b) and, where relevant, point (c) of Article 6(1) [of this Regulation,] and any justifications for the adaptation of data requirements, have been submitted.
…
4.   Where the evaluating competent authority considers that the application is incomplete, it shall inform the applicant as to what additional information is required for the validation of the application and shall set a reasonable time limit for the submission of that information. That time limit shall not normally exceed 90 days.
The evaluating competent authority shall, within 30 days of receipt of the additional information, validate the application if it determines that the additional information submitted is sufficient to comply with the requirement laid down in paragraph 3 [of this article].
The evaluating competent authority shall reject the application if the applicant fails to submit the requested information within the deadline …’
Article 8 of Regulation No 528/2012 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 [of this Regulation], including, where relevant, any proposal to adapt data requirements submitted in accordance with Article 6(3) [of this Regulation,] and send an assessment report and the conclusions of its evaluation to the [ECHA].
Prior to submitting its conclusions to the [ECHA], 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.
2.   Where it appears that additional information is necessary to carry out the evaluation, the evaluating competent authority shall ask the applicant to submit such information within a specified time limit, and shall inform the [ECHA] accordingly. As specified in the second subparagraph of Article 6(2) [of this Regulation,] the evaluating competent authority may, as appropriate, require the applicant to provide sufficient data to permit a determination of whether an active substance meets the criteria referred to in Article 5(1) or Article 10(1) [of this Regulation]. The 365-day period referred to in paragraph 1 of this Article shall be suspended from the date of issue of the request until the date the information is received. The suspension shall not exceed 180 days in total unless it is justified by the nature of the data requested or by exceptional circumstances.
…
4.   Within 270 days of receipt of the conclusions of the evaluation, the [ECHA] shall prepare and submit to the Commission an opinion on the approval of the active substance having regard to the conclusions of the evaluating competent authority.’
Article 10 of Regulation No 528/2012, on substances which are candidates for substitution, provides as follows:
‘1.   An active substance shall be considered a candidate for substitution if any of the following conditions are met:
…
(d)
it meets two of the criteria for being [a persistent, bioaccumulative and toxic substance] in accordance with Annex XIII to Regulation (EC) No 1907/2006;
…
4.   By way of derogation from Article 4(1) and Article 12(3) [of this Regulation,] the approval of an active substance that is considered as a candidate for substitution and each renewal shall be for a period not exceeding seven years.
…’
Article 19(1) of Regulation No 528/2012, relating to the conditions for granting an authorisation of a biocidal product, provides as follows:
‘A biocidal product … shall be authorised if the following conditions are met:
(a)
the active substances are included in Annex I [to this Regulation] or 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 [to the Regulation], 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 …’
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 No 528/2012 (
OJ 2014 L 294, p. 1
) lays down the rules for the carrying out of the aforementioned work programme.
In particular, Article 6(7) of Delegated Regulation No 1062/2014, in the version applicable to the facts of the case, provides as follows:
‘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 [ECHA] pursuant to Article 37(1) of Regulation (EC) 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;
(b)
consult the [ECHA] where it considers that one of the criteria in Article 5(1)(d) or (e) of Regulation (EU) No 528/2012, or the condition of Article 10(1)(d) of that Regulation, is fulfilled and not properly addressed in Annex XIV to Regulation (EC) No 1907/2006 or in the candidate list referred to in Article 59(1) of that Regulation.’
B.

Rules on the classification and labelling of chemical substances
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
), seeks to harmonise the criteria for classification of substances and mixtures, and the rules on labelling and packaging for hazardous substances and mixtures.
Article 36(1) and (2) of Regulation No 1272/2008 provides, inter alia, as follows:
‘1.   A substance that fulfils the criteria set out in Annex I [to the Regulation] for the following shall normally be subject to harmonised classification and labelling in accordance with Article 37 [of this Regulation]:
…
(c)
carcinogenicity, category 1A, 1B or 2 (Annex I, Section 3.6);
…
2.   A substance that is an active substance in the meaning of … Directive 98/8/EC shall normally be subject to harmonised classification and labelling. For such substances, the procedures set out in Article 37, paragraphs 1, 4, 5 and 6 [of the Regulation] shall apply.’
Article 37 of Regulation No 1272/2008, relating to the harmonisation procedure, provides as follows:
‘1.   A competent authority may submit to the [ECHA] a proposal for harmonised classification and labelling of substances …, or a proposal for a revision thereof.
…
2.   A manufacturer, importer or downstream user of a substance may submit to the [ECHA] a proposal for harmonised classification and labelling of that substance …
…
4.   The Committee for Risk Assessment of the [ECHA] set up pursuant to Article 76(1)(c) of Regulation (EC) No 1907/2006 shall adopt an opinion on any proposal submitted pursuant to paragraphs 1 or 2 within 18 months of receipt of the proposal, giving the parties concerned the opportunity to comment. The [ECHA] shall forward this opinion and any comments to the Commission.
5.   Where the Commission finds that the harmonisation of the classification and labelling of the substance concerned is appropriate, it shall, without undue delay, submit a draft decision concerning the inclusion of that substance together with the relevant classification and labelling elements in Table 3.1 of Part 3 of Annex VI [to the Regulation] …
A corresponding entry shall be included in Table 3.2 of Part 3 of Annex VI subject to the same conditions, until 31 May 2015.
…’
II.

Background to the dispute
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.
Biotech3D Ltd & Co. KG is a client of Laboratoire Pareva which uses PHMB (1415; 4.7) in the manufacture of biocidal products which it markets in the European Union.
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 European Commission of PHMB (1415; 4.7) in combination with various product-types, under number CAS 91403-50-8 (‘Pareva’s PHMB’ or ‘PHMB (1415; 4.7)’).
Under the same evaluation programme, Lonza (formerly Arch Chemicals), 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 PHMB (1415; 4.7) 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 evaluating competent authority’). Laboratoire Pareva enclosed a note explaining why it had not been possible to submit a common dossier for PHMB with Lonza.
By letter of 18 February 2008, the evaluating competent authority 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 PHMB (1415; 4.7).
Following several meetings and discussions between the evaluating competent authority and Laboratoire Pareva, the latter submitted additional information, including new reports and studies for product-types 1, 2, 4, 5 and 6.
In September 2015, Laboratoire Pareva obtained a new CAS number for PHMB (1415; 4.7), namely number 1802181-67-4.
On 3 June 2016, the evaluating competent authority sent Laboratoire Pareva a draft assessment report for the substance PHMB (1415; 4.7), within the meaning of Article 8(1) of Regulation No 528/2012, for product-types 1, 2, 4, 5 and 6 (‘the June 2016 draft assessment report’).
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 PHMB (1415; 4.7) in the June 2016 draft assessment report (‘the position paper of 4 July 2016’).
On 13 December 2016, the evaluating competent authority sent the 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 (‘the December 2016 assessment report’).
On 3 March 2017, Laboratoire Pareva provided an additional document supplementing the position paper of 4 July 2016 (‘the additional position paper of 3 March 2017’).
Between May and September 2017, the ‘Efficacy’, ‘Environment’ and ‘Human health’ working groups of the ECHA Biocidal Products Committee met to examine the December 2016 assessment report. Laboratoire Pareva participated in those meetings.
On 3 and 4 October 2017, the ECHA Biocidal Products Committee 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. 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 ECHA Biocidal Products Committee concluded that PHMB (1415; 4.7) 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 evaluating competent authority finalised its assessment report on PHMB (1415; 4.7) as regards product-types 1, 2, 4, 5 and 6, taking into account the outcome of the discussions relating to that substance within the ECHA Biocidal Products Committee (‘the November 2017 assessment report’).
On 20 April 2018, the Commission adopted Implementing Decision (EU) 2018/619 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 contested decision’). As is apparent from that decision, the Commission considered, in accordance with the opinion of the ECHA Biocidal Products Committee, that that substance should not be approved for those product-types because of the unacceptable risks that it posed to human health and the environment.
Also on 20 April 2018, the Commission adopted Implementing Regulation (EU) 2018/613 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 contested regulation’). 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 that regulation 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 that regulation, and that its approval could not exceed seven years.
III.

Procedure and forms of order sought
By applications lodged at the Court Registry on 1 June 2018, Laboratoire Pareva brought the action in Case T‑337/18 and, with Biotech3D, the action in Case T‑347/18.
By separate document lodged at the Court Registry on the same day, Laboratoire Pareva brought, in Case T‑337/18, an application for interim measures seeking suspension of the operation of the contested decision.
On 5 June 2018, by separate document lodged at the Court Registry, Laboratoire Pareva and Biotech3D brought, in Case T‑347/18, an application for interim measures seeking suspension of the operation of the contested regulation.
By order of 24 August 2018, Laboratoire Pareva and Biotech3D v Commission (
T‑337/18 R and T‑347/18 R
, not published,
EU:T:2018:587
), the President of the General Court dismissed the applications for interim measures referred to in paragraphs 33 and 34 above and reserved the costs.
By documents lodged at the Court Registry on 6 September and 26 September 2018, respectively, the ECHA and the French Republic applied for leave to intervene in support of the forms of order sought by the Commission in Cases T‑337/18 and T‑347/18.
On 28 September 2018, Laboratoire Pareva lodged at the Court Registry, by separate documents, two further applications for interim measures in the context of Case T‑337/18 and Case T‑347/18, respectively, based on the existence of new facts within the meaning of Article 160 of the Rules of Procedure of the General Court.
By orders of 25 October 2018, Laboratoire Pareva v Commission (
T‑337/18 R II
, not published,
EU:T:2018:729
), and of 25 October 2018, Laboratoire Pareva v Commission (
T‑347/18 R II
, not published,
EU:T:2018:730
), the President of the General Court dismissed the new applications for interim measures and reserved the costs.
By orders of the President of the Fourth Chamber of the General Court of 3 December 2018, the ECHA was granted leave to intervene in support of the forms of order sought by the Commission in Cases T‑337/18 and T‑347/18.
By decisions of the President of the Fourth Chamber of the General Court of 6 December 2018, the French Republic was granted leave to intervene in support of the forms of order sought by the Commission in Cases T‑337/18 and T‑347/18.
Following a change in the composition of the Chambers of the General Court, pursuant to Article 27(5) of the Rules of Procedure, the Judge-Rapporteur was assigned to the Seventh Chamber, to which the present cases were accordingly allocated.
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 accordance with Article 68(2) of the Rules of Procedure.
On 18 February 2020, the Court sent questions to the parties by way of measures of organisation of procedure provided for in Article 89 of the Rules of Procedure. The parties answered those questions within the period prescribed.
The hearing initially scheduled for 30 April 2020 having been postponed, the parties presented oral argument and replied to the oral questions put by the Court at the hearing on 24 September 2020.
In Case T‑337/18, Laboratoire Pareva claims that the Court should:
–
declare the action well founded and annul the contested decision;
–
order the Commission to pay the costs.
In Case T‑337/18, the Commission contends that the Court should:
–
dismiss the first plea in law as ineffective or unfounded;
–
dismiss the action as unfounded as to the remainder;
–
order Laboratoire Pareva to pay the costs.
In Case T‑337/18, the ECHA contends that the Court should:
–
dismiss the action as unfounded;
–
order Laboratoire Pareva to pay the costs.
In Case T‑347/18, Laboratoire Pareva and Biotech3D claim, in essence, that the Court should:
–
declare the action well founded and annul the contested regulation in so far as it classifies PHMB (1415; 4.7) as a candidate for substitution and makes its use subject to compliance with certain specifications and conditions;
–
order the Commission to pay the costs.
In Case T‑347/18, the Commission contends that the Court should:
–
dismiss the first plea in law as ineffective or unfounded;
–
dismiss the action as unfounded as to the remainder;
–
order Laboratoire Pareva and Biotech3D to pay the costs.
In Case T‑347/18, the ECHA contends that the Court should:
–
dismiss the action as unfounded;
–
order Laboratoire Pareva and Biotech3D to pay the costs.
In Cases T‑337/18 and T‑347/18, the French Republic contends that the Court should dismiss the actions.
IV.

Law
A.

Joinder of Cases T‑337/18 and T‑347/18 for the purposes of the decision closing the proceedings
Pursuant to Article 19(2) of the Rules of Procedure, the President of the Seventh Chamber of the General Court referred the decision on the joinder of Cases T‑337/18 and T‑347/18 for the purposes of the decision closing the proceedings, which fell within his remit, to the Seventh Chamber of the General Court.
The parties having been heard in the context of measures of organisation of procedure with regard to a possible joinder, it is appropriate for Cases T‑337/18 and T‑347/18 to be joined for the purposes of the decision closing the proceedings, on account of the connection between them.
B.

The admissibility of the action in Case T‑347/18
In Case T‑347/18, the Commission submits that the action is manifestly inadmissible since it was brought by Biotech3D, on the ground that the latter is neither directly nor individually concerned by the contested regulation.
In that regard, Laboratoire Pareva’s standing to bring proceedings, for the purposes of the fourth paragraph of Article 263 TFEU, is not disputed. Laboratoire Pareva is directly concerned by the contested regulation, in that that regulation, first, directly affects its legal situation and, second, leaves no discretion to the addressees entrusted with the task of implementing it, such implementation being purely automatic and resulting from EU rules, without the application of other intermediate rules. Moreover, as the party making an application for approval of an active substance, having submitted the dossier and participated in the evaluation procedure, Laboratoire Pareva is individually concerned by that regulation (see, to that effect, judgment of 19 December 2019, Probelte v Commission,
T‑67/18
,
EU:T:2019:873
, paragraph
).
Where one and the same action is involved, as soon as the standing to bring proceedings of one applicant is established, there is no need to examine the standing of the other applicants (see, to that effect, judgments of 24 March 1993, CIRFS and Others v Commission,
C‑313/90
,
EU:C:1993:111
, paragraph
, and of 9 June 2011, Comitato Venezia vuole vivere and Others v Commission,
C‑71/09 P, C‑73/09 P and C‑76/09 P
,
EU:C:2011:368
, paragraphs
and
).
Consequently, the action in Case T‑347/18 must be declared admissible, without it being necessary to examine Biotech3D’s standing to bring proceedings.
C.

Substance
In support of their actions, the applicants, Laboratoire Pareva and Biotech3D, rely on four pleas in law: the first, alleging failure to follow the procedural steps required to adopt the contested decision and the contested regulation; 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.
1.

The first plea in law, relating to failure to follow the procedural steps required to adopt the contested decision and the contested regulation
First, the applicants claim that the evaluating competent authority did not submit any proposal for harmonised classification of Pareva’s PHMB to the ECHA, in infringement of Article 6(7)(a) of Delegated Regulation No 1062/2014. Second, they submit that that authority failed to consult the ECHA beforehand on the persistence and toxicity of that substance, contrary to Article 6(7)(b) of that delegated regulation.
(a)

The first part of the first plea, alleging infringement of Article 6(7)(a) of Delegated Regulation No 1062/2014
The applicants submit that, in its December 2016 assessment report, the evaluating competent authority classified Pareva’s PHMB as a category 2 carcinogen. Consequently, pursuant to Article 6(7)(a) of Delegated Regulation No 1062/2014, that authority should have submitted to the ECHA a proposal for harmonised classification of that substance, for the purposes of Article 36 and Article 37(1) of Regulation No 1272/2008, before submitting to it its assessment report. That was, moreover, recognised by the Chair of the ECHA Biocidal Products Committee.
According to the applicants, the only exception to the obligation to submit the proposal referred to in paragraph 60 above is where there is already a harmonised classification of the substance in question for the purposes of Part 3 of Annex VI to Regulation No 1272/2008. Such a harmonised classification existed only for Lonza’s PHMB, which is a substance distinct from Pareva’s PHMB.
More specifically, Pareva’s PHMB and Lonza’s PHMB differ as regards four essential criteria, namely (i) mean average molecular weight, (ii) mean polydispersity, (iii) biguanide/guanidine ratio and (iv) apportionment and ratio of the end groups of the polymer chain. Those criteria show that Pareva’s PHMB is a longer polymer and a larger distribution of the polymer chains with a difference in chemical composition. That has an impact on the intrinsic properties of the PHMB source concerned, as demonstrated, for example, by the indicator relating to carcinogenicity. The December 2016 assessment report does not explain in any way why the classification of PHMB in Annex IV to Regulation No 1272/2008 could apply to Pareva’s PHMB.
The applicants take the view that the breach of the obligation under Article 6(7)(a) of Delegated Regulation No 1062/2014 had important consequences, since Laboratoire Pareva would have submitted studies the conclusions of which could have led the authorities to adopt a different harmonised classification for PHMB (1415; 4.7), as regards carcinogenicity, distinct from that of Lonza’s PHMB, which could have influenced the assessment of the risks posed by Pareva’s PHMB. In particular, if Pareva’s PHMB had not been classified as a category 2 carcinogen, which would have amounted to a significant difference from Lonza’s PHMB, any read-across to the latter substance would have been precluded. The applicants add that Laboratoire Pareva was deprived of its right to submit comments on the proposal for harmonised classification and to be heard before the ECHA Committee for Risk Assessment, contrary to what is provided for in Article 37(4) of Regulation No 1272/2008.
The Commission, supported by the ECHA and the French Republic, contests the applicants’ arguments.
It should be noted that Regulation No 528/2012 and Delegated Regulation No 1062/2014 lay down the rules applicable to the evaluation and approval of existing active substances within the meaning of those regulations, with a view to their use in biocidal products. Such approval is based on the assessment of the risks posed by those substances, taking into account the types of biocidal products in which they will be used and their proposed use. By contrast, Regulation No 1272/2008 seeks, inter alia, to harmonise the criteria for classification of substances and mixtures and rules on the labelling and packaging of hazardous substances and mixtures. That regulation is therefore applicable to any substance or mixture which meets the criteria relating to physical hazards, health hazards or environmental hazards, as set out in that regulation, including active substances used in biocidal products. Thus, those regulations relate to two different areas and govern two separate procedures, each organised in accordance with its own rules.
Article 6(7)(a) of Delegated Regulation No 1062/2014 provides that the evaluating competent authority is required, upon finalisation of its hazard evaluation and as the case may be, no later than the time of submission of its assessment report, to submit a harmonised classification and labelling proposal to the ECHA, in accordance with Article 37(1) of Regulation No 1272/2008, where, first, it considers that one of the criteria referred to in Article 36(1) of that regulation is fulfilled and, second, it considers that that criterion is not properly addressed in part 3 of Annex VI to that regulation.
It follows from Article 6(7)(a) of Delegated Regulation No 1062/2014 that the evaluating competent authority is required to submit a proposal for harmonised classification only after having carried out the examination of the existing active substance at issue and determined, on the basis of the complete dossier submitted by the applicant, first, what the effects of that substance were and, second, the risks that it represented, inter alia, for human health and the environment, taking into account the products-types in which its use was envisaged and the proposed uses.
Moreover, Regulation No 528/2012 and Delegated Regulation No 1062/2014 do not provide that the procedure for evaluating an active substance should be suspended where a proposal for harmonised classification and labelling is submitted under Article 6(7)(a) of Delegated Regulation No 1062/2014. More generally, it is by no means apparent from those regulations that the legislature intended to make the approval procedure for an existing active substance subject to the procedure for harmonisation of classification and labelling of such a substance, within the meaning of Regulation No 1272/2008.
On the contrary, it follows from those elements that the obligation imposed on the evaluating competent authority to submit a proposal for harmonised classification for an active substance for biocidal use constitutes a step preliminary to a classification procedure governed by Regulation No 1272/2008. As has been stated in paragraph 65 above, such a classification procedure is separate from the evaluation procedure laid down in Regulation No 528/2012, as implemented by Delegated Regulation No 1062/2014, for the purposes of approval of an active substance with a view to its use in biocidal products.
Thus, even if the applicants’ argument that the evaluating competent authority infringed Article 6(7)(a) of Delegated Regulation No 1062/2014 were well founded, such an irregularity could not lead to the annulment of the contested regulation and the contested decision. That argument of the applicants is therefore ineffective.
Furthermore, it should be noted that, at the hearing, the Commission, the French Republic and the ECHA stated that a new proposal for harmonised classification and labelling of PHMB substance (1415; 4.7) was expected. Thus, the Commission had not yet adopted any measure relating to that procedure, with the result that the applicants cannot properly rely on an infringement of the right to be heard in the context of the classification and labelling procedure in the present case, which concerns the contested decision and the contested regulation relating to the assessment and approval of PHMB (1415; 4.7).
In any event, even if the evaluating competent authority had had to consider that the criteria relating to carcinogenicity was not adequately addressed in Part 3 of Annex VI to Regulation No 1272/2008 as regards Pareva’s PHMB, with the result that it should have submitted a harmonised classification and labelling proposal in accordance with Article 6(7)(a) of Delegated Regulation No 1062/2014, it remains appropriate to verify whether, in the absence of non-compliance with that provision, the content of the contested decision and the contested regulation might have been different (see, to that effect, judgments of 9 September 2008, Bayer CropScience and Others v Commission,
T‑75/06
,
EU:T:2008:317
, paragraph
and the case-law cited, and of 9 September 2011, Dow AgroSciences and Others v Commission,
T‑475/07
,
EU:T:2011:445
, paragraph
), which it is for the applicants to demonstrate.
In that regard, the applicants claim, in essence, that Laboratoire Pareva could have put forward its point of view before the ECHA Committee for Risk Assessment and submit new studies for that purpose. That could have made it possible to exclude any classification of PHMB (1415; 4.7) as a category 2 carcinogen and, consequently, to consider Pareva’s PHMB to be a substance different to Lonza’s PHMB. Such a difference would thus have precluded any read-across to the latter substance.
First, it should be noted that the applicants refer to new studies the conclusions of which could have led the ECHA Committee for Risk Assessment not to classify PHMB (1415; 4.7) as a category 2 carcinogen, without, however, identifying the studies in question or the specific data contained therein capable of substantiating their position.
It is true that, during the hearing, the applicants claimed that Laboratoire Pareva could have submitted to the ECHA Committee for Risk Assessment the study carried out in accordance with Guideline 453 of the Organisation for Economic Cooperation and Development (OECD) for the Testing of Chemicals in order to demonstrate that PHMB (1415; 4.7) was not a carcinogenic substance. However, the applicants do not raise any detailed argument based on that study from which it may be concluded that, contrary to the evaluating competent authority and the ECHA Biocidal Products Committee, which had already examined it, the Committee for Risk Assessment could have reached a different conclusion on the carcinogenicity of Pareva’s PHMB. More generally, the applicants do not explain in detail how compliance with the obligation laid down in Article 6(7)(a) of Delegated Regulation No 1062/2014 could have led the Commission to approve that substance for product-types 1, 5 and 6, or to approve it on less stringent conditions than those laid down in the contested regulation in respect of product-types 2 and 4.
As regards the new studies on carcinogenicity, referred to by the applicants in their observations on the statements in intervention of the ECHA and the French Republic, it must be noted that they are not part of the file submitted to the Court and that the applicants’ assertions as to the findings that allegedly stem from them are neither quantified nor substantiated.
In that regard, a general reference to the draft report of the evaluating competent authority on the harmonised classification and labelling of Pareva’s PHMB and Lonza’s PHMB, annexed to the defence, cannot make up for that lack of detail and evidence. Furthermore, it is not for the Court to seek and identify in the annexes the pleas and arguments on which it may consider the action to be based, since the annexes have a purely evidential and instrumental function (see, to that effect, judgment of 17 September 2007, Microsoft v Commission,
T‑201/04
,
EU:T:2007:289
, paragraph
and the case-law cited).
Second, it is apparent from point 4.7 of the December 2016 assessment report, in its part common to product-types 1, 2, 4, 5 and 6, that the evaluating competent authority examined in detail the results of the study referred to in paragraph 75 above, as well as various
in vitro
studies. After examining those results, the evaluating competent authority concluded, in a manner that was not purely automatic, that the existing classification of PHMB as a category 2 carcinogenic substance could apply to Pareva’s PHMB. Thus, the applicants cannot validly claim that the evaluating competent authority did not explain how the classification of PHMB in Part 3 of Annex VI to Regulation No 1272/2008 could apply to Pareva’s PHMB.
In addition, the contested decision and the contested regulation are not based exclusively on the classification of Pareva’s PHMB as a category 2 carcinogenic substance, but on an assessment of the risks posed by that substance, taking into account all the effects which it may have and the product-types for which its use is envisaged.
First, it is apparent from recital 5 of the contested decision that biocidal products of product-type 1, 5 and 6 containing Pareva’s PHMB cannot be regarded as complying with the criterion laid down in Article 19(1)(b)(iv) of Regulation No 528/2012, since they present, inter alia, unacceptable risks to human health.
As the Commission and the ECHA stated at the hearing, without being contradicted by the applicants, 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 the applicants also did not dispute either in their written pleadings or at the hearing.
Therefore, even if, in the light of the studies submitted by Laboratoire Pareva, the ECHA Committee for Risk Assessment had been able to reject any classification of PHMB (1415; 4.7) as a category 2 carcinogen, that would not have made it possible to eliminate all unacceptable risks to human health or lead to the approval of Pareva’s PHMB. The same conclusion must be reached as regards the evaluation by that committee of the data which Laboratoire Pareva submitted in respect of skin sensitisation or the specific toxicity for certain target organs, since those hazards are not those used to determine the NOAEL of reference.
Second, as regards the risk assessment for product-type 2 and 4 biocidal products containing Pareva’s PHMB, the applicants have not explained the reasons why and to what extent a proposal for harmonised classification and labelling of Pareva’s PHMB could have altered, or even precluded, the specifications and conditions laid down in the annex to the contested regulation.
It is true that, under Article 19(4)(a) of Regulation No 528/2012, the classification of a substance as a category 2 carcinogen may prevent authorisation to make available on the market a biocidal product containing that substance for use by the general public. However, it is not apparent either from the applicants’ explanations or from the file submitted to the Court that the specifications and conditions imposed by the contested regulation were based on that provision, which, moreover, is not mentioned in that regulation. Furthermore, as has been stated in paragraph 81 above in relation to product-types 1, 5 and 6, the teratogenic effect constituted the critical limit used to determine the reference values for calculating the AEL to Pareva’s PHMB.
Moreover, the applicants do not demonstrate how the failure to classify Pareva’s PHMB as a category 2 carcinogenic substance could have prevented its classification as an active substance for substitution, within the meaning of Article 10(1) of Regulation No 528/2012, on account of its very persistent (vP) and toxic (T) substance characteristics.
Third, as regards the applicants’ argument that a different classification of Pareva’s PHMB as regards carcinogenicity would have made it possible to reject any read-across to Lonza’s PHMB, it should be noted that, in the context of the present plea, the applicants do not identify the various read-across at issue. Nor do they explain how any such read-across would have had a decisive impact on the assessment of the risks posed by Pareva’s PHMB for human health and the environment, with the result that the evaluation of that substance could have led to a different outcome from that set out, respectively, in the contested decision and in the contested regulation.
Consequently, the applicants have not demonstrated that, even if the evaluating competent authority had submitted a harmonised classification and labelling proposal to the ECHA pursuant to Article 6(7)(a) of Delegated Regulation No 1062/2014, before or at the time of sending it the December 2016 assessment report, the outcome of the evaluation procedure of Pareva’s PHMB could have been different from those set out in the contested decision and in the contested regulation, respectively.
Consequently, the first part of the first plea in law must be rejected as ineffective and, in any event, unfounded.
(b)

The second part of the first plea, alleging infringement of Article 6(7)(b) of Delegated Regulation No 1062/2014
The applicants claim that, under Article 6(7)(b) of Delegated Regulation No 1062/2014, the evaluating competent authority is required to consult the ECHA where it considers that the condition set out in Article 10(1)(d) of Regulation No 528/2012 is fulfilled and is not properly addressed in Annex XIV to Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (
OJ 2006 L 396, p. 1
) or in the candidate list referred to in Article 59(1) of that regulation. In the present case, since the two conditions laid down by that provision were met, the evaluating competent authority should have submitted Pareva’s PHMB to the assessment of the ECHA expert group on persistent, bioaccumulative and toxic substances (‘PBT substances’) before submitting its December 2016 assessment report to the ECHA. That consultation did not take place.
The applicants add that, had the issue been raised with the ECHA ‘PBT’ expert group, the outcome of the procedure could have been different because Laboratoire Pareva might have been able to defend its position with those experts to demonstrate that PHMB (1415; 4.7) did not meet the criteria required to be regarded as forming part of PBT substances. In particular, it could have submitted to them the results of several studies from which it could be concluded that the toxicity of that substance was significantly different depending on whether the test was performed in standard conditions or in natural conditions, as is apparent from its position papers submitted to the evaluating competent authority in July 2016 and March 2017. Moreover, according to the applicants, the importance of the opinion of the ECHA ‘PBT’ expert group is expressly clear from the Commission’s document bearing the reference CA-Sept13-Doc.8.3 – Final, entitled ‘Review programme of active substances: establishment of a work programme to meet the 2024 deadline’.
The Commission and the ECHA dispute the applicants’ arguments.
It should be recalled that a substance is considered to be a candidate for substitution when it meets one of the conditions listed in Article 10(1) of Regulation No 528/2012. In accordance with point (d) of that provision, such is the case for substances which meet two of the criteria required to be regarded as PBT substances, within the meaning of Annex XIII to Regulation No 1907/2006.
As regards Pareva’s PHMB, it is apparent from the December 2016 assessment report that the evaluating competent authority considered that substance to be, first, very persistent (vP) and, second, toxic (T). Pareva’s PHMB therefore satisfied, according to that authority, the criteria for a candidate for substitution, within the meaning of Article 10(1) of Regulation No 528/2012.
In addition, the Commission and the ECHA do not dispute that, when the December 2016 assessment report was sent to the ECHA, Pareva’s PHMB did not appear either in the list of substances subject to authorisation in Annex XIV to Regulation No 1907/2006, or on the candidate list referred to in Article 59(1) of that regulation, established by the ECHA.
Consequently, Article 6(7)(b) of Delegated Regulation No 1062/2014 applied in the present case.
However, contrary to what the applicants claim, that provision does not require the evaluating competent authority to consult the ECHA prior to the submission of its assessment report. Such a consultation must indeed take place no later than on the date on which the report is submitted.
In addition, it should be noted that Article 6(7)(b) of Delegated Regulation No 1062/2014 merely requires the evaluating competent authority to consult the ECHA but does not specify whether it is for the latter to contact its ‘PBT’ expert group in order to decide on the persistent, bioaccumulative and toxic character of an active substance within the meaning of Regulation No 1907/2006. In the absence of any specific indication in that regulation, such a clarification therefore falls within the remit of the internal organisation of that agency. It is necessary, in that regard, to refer to the Commission’s document bearing the reference CA-Sept13-Doc.8.3 – Final, referred to in paragraph 90 above. Point 4.3(b) of that document indicates that such consultation is highly preferable and strongly recommended. However, that document does not go so far as to impose a general obligation to that effect. In those circumstances, it must be acknowledged that, by those words, the ECHA has a certain discretion as to whether the ‘PBT’ expert group must be consulted where an evaluating competent authority seeks an opinion in accordance with Article 6(7)(b) of Delegated Regulation No 1062/2014.
As the Commission and the ECHA have stated, in order not to delay unnecessarily the work relating to the evaluation of an active substance, referral to the ECHA ‘PBT’ expert group, which is, moreover, an informal group, takes place only in cases in which there is no consensus on its PBT properties. That approach is, moreover, consistent with the objective set out in paragraph 3 of the Commission document bearing the reference CA-Sept13-Doc.8.3 – Final, that is to say to ensure the most efficient implementation of the biocidal products’ framework.
In the present case, it is apparent from the file that there was consensus within the ECHA Biocidal Products Committee on the very persistent (vP) and toxic (T) nature of PHMB (1415; 4.7), notwithstanding the fact that Laboratoire Pareva submitted the position paper of 4 July 2016 and the additional position paper of 3 March 2017 in order to challenge such properties.
In particular, it is apparent from the minutes of the meetings of the ‘Environment’ working group of the ECHA Biocidal Products Committee, in which Laboratoire Pareva participated, that discussions were held at those meetings concerning the need to take into account the position paper of 4 July 2016 and the additional position paper of 3 March 2017, despite their late submission. The ECHA thus agreed to take account of one of the new studies submitted by Laboratoire Pareva concerning toxicity. In addition, Laboratoire Pareva’s arguments relating to the degradability of PHMB (1415; 4.7) according to which that substance was very quickly linked with substrates, were examined.
Furthermore, it is apparent from the minutes of the meeting of the ECHA Biocidal Products Committee of 3 and 4 October 2017 that the arguments of Laboratoire Pareva – which participated in that meeting – on the need to consult the ‘PBT’ expert group were rejected on the grounds that (i) there was a clear consensus within the ‘Environment’ working group of that committee on the very persistent (vP) and toxic (T) properties of Pareva’s PHMB, (ii) it was unnecessary in practice to consult the ‘PBT’ expert group where it was pointless and, (iii) the ‘Environment’ working group had considerable experience of that issue.
As is apparent from paragraph 29 above, the evaluating competent authority amended the December 2016 assessment report in order to take account of the outcome of the discussions within the ECHA Biocidal Products Committee. The ECHA’s opinion on the very persistent (vP) and toxic (T) properties of PHMB (1415; 4.7) is therefore reflected in the November 2017 assessment report, as submitted to the Commission before the adoption of the contested decision and the contested regulation.
Furthermore, as regards Laboratoire Pareva’s claim that it was not heard on the classification of PHMB (1415; 4.7) as a very persistent (vP) and toxic (T) substance, it follows from the evidence brought to the attention of the Court in the present proceedings that Laboratoire Pareva was able to submit its observations on the June 2016 draft assessment report, including on the persistent, bioaccumulative and toxic properties of PHMB (1415; 4.7) before that report was sent to the ECHA.
Similarly, following the communication of the December 2016 assessment report to the ECHA, Laboratoire Pareva had the opportunity to comment on the persistence and toxicity of PHMB (1415; 4.7) in the context of meetings of the working groups of the ECHA Biocidal Products Committee. Under Article 75(1)(d) of Regulation No 528/2012, it is for that committee, and not the ‘PBT’ expert group, to prepare the ECHA’s opinions on the identification of active substances which are candidates for substitution.
In those circumstances, Article 6(7)(b) of Delegated Regulation No 1062/2014 has not been infringed.
Consequently, the second part of the first plea in law must be rejected, as must the first plea in its entirety.
2.

The second plea in law, alleging a manifest error of assessment relating to the taking into account of irrelevant factors and a failure to state reasons
The applicants claim that the contested decision and the contested regulation are vitiated by a manifest error of assessment in that the evaluating competent authority, the ECHA Biocidal Products Committee and the Commission read-across to Lonza’s PHMB in multiple instances in their assessment of Pareva’s PHMB, whereas the two substances are different. Moreover, sufficient reasons were not given for those instances of read-across to the Lonza’s PHMB.
(a)

The first part of the second plea, relating to the multiple instances of read-across to Lonza’s PHMB
The applicants claim that the evaluating competent authority, the ECHA Biocidal Products Committee and the Commission assessed Pareva’s PHMB by merely consistently reproducing the conclusions of the assessment of Lonza’s PHMB. They are two different substances, as shown, inter alia, by their distinct CAS numbers and their different mean average molecular mass (Mn) and Polydispersity index (PDI). The ECHA acknowledged, moreover, that at least one parameter was considered to be different for the two substances at issue. The contested decision and the contested regulation are thus based in significant and decisive part on data relating to another substance.
The applicants add that, even though instances of read-across were used only for one indicator, relating to inhalation toxicity, that approach had a negative impact on the assessment of PHMB (1415; 4.7). Available inhalation toxicity studies show very noticeable differences between Pareva’s PHMB and Lonza’s PHMB. Moreover, the dossier submitted by Laboratoire Pareva contains a study relating to the administration of a repeated oral dose, which could have been used in order not to use a default value.
The Commission, supported by the ECHA and the French Republic, contests the applicants’ arguments.
(1)

Preliminary observations
It should be borne in mind that, as is apparent from recital 3 thereof, the purpose of Regulation No 528/2012 is to improve the free movement of biocidal products within the Union while ensuring a high level of protection of both human and animal health and the environment. That regulation is underpinned by the precautionary principle to ensure that the manufacturing and making available on the market of active substances and biocidal products do not result in harmful effects on human or animal health or unacceptable effects on the environment.
To enable it to accomplish effectively the task entrusted to it and having regard to the complex scientific assessments which it must make when, in the course of examining requests for approval of active substances under Regulation No 528/2012, it assesses the risks posed by the use of those substances, the Commission must be allowed a wide discretion (see, to that effect and by analogy, judgment of 22 December 2010, Gowan Comércio Internacional e Serviços,
C‑77/09
,
EU:C:2010:803
, paragraph
).
The exercise of the Commission’s discretion is not, however, excluded from review by the Court. In the context of such a review, the courts of the European Union must verify whether the relevant procedural rules have been complied with, whether the facts admitted by the Commission have been accurately stated and whether there has been a manifest error of assessment or a misuse of powers (see, to that effect and by analogy, judgment of 22 December 2010, Gowan Comércio Internacional e Serviços,
C‑77/09
,
EU:C:2010:803
, paragraph
).
In particular, where a party claims that the institution competent in the matter has committed a manifest error of assessment, the Courts of the European Union must verify whether that institution has examined, carefully and impartially, all the relevant facts of the individual case, facts which support the conclusions reached (judgment of 22 December 2010, Gowan Comércio Internacional e Serviços,
C‑77/09
,
EU:C:2010:803
, paragraph
).
The Court must examine whether the assessment of Pareva’s PHMB is based on a systematic read-across to Lonza’s PHMB and whether the contested decision and the contested regulation are vitiated by a manifest error of assessment for that reason in the light of those principles.
(2)

Systematic reliance on read-across to Lonza’s PHMB
The applicants refer to a non-exhaustive number of examples of references to Lonza’s PHMB in the file submitted to the Court, which they describe as unlawful read-across to that substance. Those references are reflected, first, in the classification of Pareva’s PHMB as a category 2 carcinogenic substance in the December 2016 assessment report, second, in the values used to determine the acceptable exposure concentration (‘AEC’) by inhalation of Pareva’s PHMB, third, in the discussion table for the ad hoc follow-up meeting of the ‘Environment’ working group of the ECHA Biocidal Products Committee of 26 June 2017 concerning the determination of the predicted no-effect concentration (‘PNEC’) on sediments, fourth, in the discussions on the AEL which were the subject matter of the ad hoc follow-up meeting of the ‘Human health’ working group of the ECHA Biocidal Products Committee of 5 July 2017 and, fifth, in a list annexed to each of the applications.
It is appropriate to examine each of the examples mentioned by the applicants. Although, in their view, those examples are not exhaustive, it is nevertheless not for the Court to search in the file before it for any other possible references to Lonza’s PHMB which may be included in the documents stemming from the administrative procedure which led to the adoption of the contested acts. As is apparent from paragraph 77 above, it is not for the Court to seek and identify in the annexes the pleas and arguments on which it may consider the action to be based, since they have a purely evidential and instrumental function.
(i)

Classification of Pareva’s PHMB as a category 2 carcinogenic substance
First of all, it is true that, in the December 2016 assessment report, in its part common to product-types 1, 2, 4, 5 and 6, the evaluating competent authority found the existence of a harmonised classification of PHMB in Annex I to Regulation No 1272/2008. It is apparent from that classification that PHMB was considered to be a category 2 carcinogenic substance. However, after having made such a finding, the evaluating competent authority checked whether such a classification could also apply to PHMB (1415; 4.7), in the light of the data and studies submitted by Laboratoire Pareva in the dossier referred to in Article 6(1) of Regulation No 528/2012.
In particular, the evaluating competent authority examined the results of the study carried out in accordance with OECD Guideline 453 for the Testing of Chemicals, provided by Laboratoire Pareva. It noted that that study highlighted the carcinogenic potential of Pareva’s PHMB in view, in particular, of the hamartomas and adenomas of the hepatocellular species observed in the liver of rats. It concluded that the results of that study did not call into question PHMB’s existing classification as a category 2 carcinogenic substance, with the result that it also applied to Pareva’s PHMB.
In addition, the applicants acknowledged that the existing classification of PHMB in Annex I to Regulation No 1272/2008 was the result of a proposal for classification of PHMB submitted by the evaluating competent authority, which was based on studies relating not only to Lonza’s PHMB, but also, to some extent, to Pareva’s PHMB.
Therefore, it cannot be maintained that the evaluating competent authority relied exclusively on the results of studies carried out on Lonza’s PHMB, without any examination of the data specific to Pareva’s PHMB, in order to classify that substance as a category 2 carcinogen.
Next, more generally, the existing classification of PHMB, which appeared in Annex I to Regulation No 1272/2008, was in no way applied as such to Pareva’s PHMB, without any further assessment. On the contrary, it is apparent from the December 2016 and November 2017 assessment reports, in their part common to product-types 1, 2, 4, 5 and 6, that the evaluating competent authority carried out a detailed examination of the properties of Pareva’s PHMB, taking into account the available studies and the data provided by Laboratoire Pareva.
It follows from the foregoing that the applicants’ arguments that the classification of Pareva’s PHMB as a category 2 carcinogenic substance is based on a mere systematic reproduction of the data relating to Lonza’s PHMB are unfounded.
(ii)

Determination of the values relating to the inhalation AEC
The Commission and the ECHA acknowledged that a read-across to Lonza’s PHMB had actually been applied in the context of the assessment of Pareva’s PHMB as regards the determination of the values relating to the inhalation AEC, in the absence of any available study on that issue concerning that substance.
In the present case, first, it is apparent from the minutes of the meetings of the ‘Human health’ working group of the ECHA Biocidal Products Committee that, in its comments on the June 2016 draft assessment report, that is to say at a very advanced stage of the evaluation procedure, Laboratoire Pareva had submitted new use scenarios for product-types 2 and 4, inter alia, in the form of trigger sprays. In that context, in order to be able to assess risks in such use scenarios, the working group decided that it was necessary to establish a specific reference value with regard to inhalation toxicity. In the absence of any available study in the dossier, the working group then decided to examine, in the course of an ad hoc follow-up meeting, the reliance on read-across to Lonza’s PHMB.
In that regard, it is apparent from the dossier that Laboratoire Pareva had, admittedly, submitted a preliminary subacute inhalation toxicity study to the evaluating competent authority, but that that study had been considered unreliable because the analytical methodologies used had not been validated. Laboratoire Pareva had then indicated that another study was under way, but it did not ultimately submit any report on that study to the evaluating competent authority. The dossier therefore did not contain any specific study on the inhalation toxicity of Pareva’s PHMB, which the applicants do not dispute.
As regards the study relating to the administration of a repeated oral dose, which could allegedly have been used to derive the reference value for inhalation toxicity, it should be noted that that study does not concern the administration of a repeated dose by inhalation. As is apparent from point 4 of the minutes of the meetings of the ‘Human health’ working group of the ECHA Biocidal Products Committee, the oral, dermal and inhalation absorption values are not identical. In addition, the Commission stated, without being contradicted on that point by the applicants, that the values relating to the AEC are set in the context of assessments specific to the route concerned.
Second, it is true that the evaluating competent authority and the ECHA Biocidal Products Committee both considered that Lonza’s PHMB and Pareva’s PHMB were distinct substances.
However, the fact that Pareva’s PHMB and Lonza’s PHMB are not identical substances does not at all mean that they cannot share certain relevant properties and have a similar toxicological profile. That was, moreover initially the position of Laboratoire Pareva, since it had attempted to submit a common dossier with Lonza for the approval of PHMB.
As regards the four criteria allowing Pareva’s PHMB and Lonza’s PHMB to be differentiated, namely (i) the mean average molecular weight, (ii) the mean polydispersity, (iii) the biguanide/guanidine ratio, and (iv) the apportionment and ratio of the end groups of the polymer chain, the applicants do not put forward any detailed explanation that makes it possible to demonstrate why those two substances should have had manifestly different values as regards those criteria for inhalation AEC.
In addition, as is apparent from the minutes of the meetings of the ‘Human health’ working group of the ECHA Biocidal Products Committee, the evaluating competent authority stated that a potential local effect of Pareva’s PHMB, linked to inhalation exposure, could not be excluded on the ground that, first, the classification for ‘acute toxicity by inhalation’ appearing in Annex I to Regulation No 1272/2008 was based on the data of both PHMB sources and, second, Laboratoire Pareva’s preliminary subacute inhalation toxicity study had already shown irritation of the respiratory tract. On the basis of those factors, the majority of the members of the working group agreed to rely on a read-across to the value relating to the AEC of Lonza’s PHMB. The working group therefore did not accept the arguments of Laboratoire Pareva that its PHMB and Lonza’s PHMB had such different toxicological profiles that they precluded such a read-across.
Consequently, the applicants’ arguments that the evaluating competent authority and the ECHA made a manifest error of assessment in applying a read-across to Lonza’s PHMB are unfounded.
In any event, as is apparent from paragraph 81 above, 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 the applicants 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.
Accordingly, even if the applicants’ arguments seeking to challenge reliance on the read-across at issue 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.
(iii)

The discussion table for the ad hoc follow-up meeting of the ‘Environment’ working group of the ECHA Biocidal Products Committee of 26 June 2017
It is apparent from the discussion table for the ad hoc follow-up meeting of the ‘Environment’ working group of the ECHA Biocidal Products Committee of 26 June 2017 concerning the question of the calculation of the predicted concentration with no effect on sediment, that Laboratoire Pareva had provided a new study on the
Lumbriculus variegatus
species, accepted by the working group. In accordance with point 39 et seq. of Annex VI to Regulation No 528/2012, the working group proposed to apply an assessment factor to the results of that study, in view of its duration and the species concerned, in order to take into account the degree of uncertainty vitiating extrapolation to the real environment of the results of the test carried out on a limited number of species. That factor was, in the present case, 100.
In that regard, it has indeed been pointed out that the assessment factor used was consistent with the factor previously used in the assessment dossier of Lonza’s PHMB. That factor is not, however, indissociable from the data of the study provided by Laboratoire Pareva, specific to PHMB (1415; 4.7) to which it applies.
Furthermore, it is apparent from the discussion table at issue that Laboratoire Pareva had proposed, in a document submitted in conjunction with the study on the
Lumbriculus variegatus
species, to normalise the reference value of the concentration with no observed effect in order to take account of the organic carbon content. However, such normalisation was not accepted on the ground that it was not recommended under the ECHA Guidance on the Biocidal Products Regulation. In that regard, it was added, for information purposes, that such normalisation had not been carried out for Lonza’s PHMB either. It was thus proposed, for reasons of consistency, not to apply that factor to Pareva’s PHMB.
In the light of the foregoing, it is in no way apparent from the discussion table at issue that the results of the studies relating to Lonza’s PHMB were reproduced as such for the purpose of calculating the reference values of Pareva’s PHMB. The applicants’ arguments alleging a manifest error of assessment in that regard are therefore unfounded.
(iv)

The AEL which were the subject of the ad hoc follow-up meeting of the ‘Human health’ working group of the ECHA Biocidal Products Committee of 5 July 2017
The document prepared in the context of the ad-hoc follow-up meeting of the ‘Human health’ working group of the ECHA Biocidal Products Committee of 5 July 2017 summarises the issues which it is for that working group to resolve, together with the main arguments and numerical data in the dossier to be taken into account. More specifically, the document examines the data of the dossier submitted by Laboratoire Pareva concerning teratogenicity, in order to determine the NOAEL applicable to Pareva’s PHMB. That value was intended to then make it possible to calculate the AEL for that substance, necessary to assess its risks for human health.
Thus, while it is true that, on page 5 of that document, it is observed that ‘the [AEL of Pareva’s PHMB] will be of the same order as the Lonza dossier (0.0057 mg/kg bw/d)’, that finding is based on the data specific to the dossier submitted by Laboratoire Pareva.
It does not therefore follow from the finding at issue that the evaluating competent authority or the ECHA based the AEL of Pareva’s PHMB on the data of Lonza’s PHMB.
(v)

The other examples of references to Lonza’s PHMB, listed in Annex A 36 to the application in Case T‑337/18 and in Annex A 40 to the application in Case T‑347/18
It should be noted that the other examples of references to Lonza’s PHMB, referred to in Annex A 36 to the application in Case T‑337/18 and in Annex A 40 to the application in Case T‑347/18, do not show that the data relating to Lonza’s PHMB were used instead of those contained in Laboratoire Pareva’s dossier.
First, as regards the examples based on the documents entitled ‘RCOM of 31 March 2017’ and ‘RCOM completed by the evaluating competent authority’, it must be stated that those documents are not included in the file submitted to the Court, with the result that the examples relating thereto are not substantiated. In any event, those extracts are clearly comments, questions and proposals expressed by Member States for the purposes of the assessment of Pareva’s PHMB by the ECHA Biocidal Products Committee. They do not reflect any decision of that committee actually to make a read-across to Lonza’s PHMB.
Second, the extracts from the document entitled ‘Discussion table for the ECHA Working Group “Environment”’ concern comments or questions expressed by a Member State, which in no way prejudge the final position of the ECHA Biocidal Products Committee, and a response from the evaluating competent authority concerning absorption properties of PHMB. The answer is intended solely to ensure the consistency of the methods applied in the context of the assessment of Pareva’s PHMB and Lonza’s PHMB, without indicating that the data relating to Lonza’s PHMB were applied instead of the data stemming from the dossier for the approval of Pareva’s PHMB.
Third, the extracts from the document entitled ‘Discussion table for the ECHA’s “Human health” working group’, as well as those of the minutes of the meetings of the ECHA’s ‘Human health’ working group, the minutes of the meetings of the ECHA’s ‘Environment’ working group and the document entitled ‘Ad Hoc Follow-Up discussion on “ENV” issues’, are not a reflection of any decision of those working groups to apply to Pareva’s PHMB the data relating to Lonza’s PHMB. They merely demonstrate the intention of the participants in the working groups to ensure consistency in the methods applied in the context of the assessment of Pareva’s PHMB and Lonza’s PHMB. Moreover, the document entitled ‘Ad Hoc Follow-Up discussion on “ENV” issues’ does not appear in the file submitted to the Court, so that that example is not, in any event, substantiated.
Fourth, the two extracts from the document entitled ‘Ad Hoc Follow-Up discussion on TOX’ relate to reliance on a read-across to Lonza’s PHMB as regards the determination of the inhalation AEC. The applicants’ arguments alleging a manifest error of assessment concerning that read-across have already been examined and rejected in paragraphs 124 to 132 above.
Thus, none of the examples of references to Lonza’s PHMB, listed by the applicants in the list annexed to each of the applications permits the conclusion that the evaluating competent authority, the ECHA Biocidal Products Committee and the Commission systematically took the results of the examination of Lonza’s PHMB as a basis or referred, wrongly, to the data relating to Lonza’s PHMB. The applicants’ arguments alleging a manifest error of assessment in that regard are therefore unfounded.
It follows from all the foregoing that the applicants have not demonstrated that the authorities responsible for the assessment of PHMB (1415; 4.7) committed a manifest error of assessment by failing to examine carefully and impartially all the relevant aspects of the present case or that they manifestly exceeded their discretion by relying on a read-across approach. Therefore, the first part of the second plea must be rejected.
(b)

The second part of the second plea, alleging failure to state sufficient reasons concerning reliance on read-across
The applicants claim that a read-across to Lonza’s PHMB could be permitted only if it were accompanied by a sufficient and reliable description of the method applied, in accordance with point 1.5 of Annex IV to Regulation No 528/2012. That obligation constitutes a specific expression of the obligation to state reasons, laid down in Article 296 TFEU.
The document of the ECHA Biocidal Products Committee of 27 September 2017, entitled ‘Open Issues’, and the position paper of the evaluating competent authority on PHMB, drawn up for the purpose of discussions of the ‘Human health’ working group of that committee, together with Laboratoire Pareva’s comments (‘the toxicity position paper’), do not give a sufficient and reliable description of the method applied to make the read-across to Lonza’s PHMB. Moreover, that latter document was not sent to Laboratoire Pareva before the meetings of the working group concerned, and there was no opportunity to discuss the method to be applied in accordance with the procedural rules in force.
The Commission contests the applicants’ arguments.
It is apparent from the first introductory paragraph of Annex IV to Regulation No 528/2012, read in conjunction with Article 6(3) thereof, that that annex lays down the rules to be followed when an applicant proposes to adapt the data requirements laid down by that regulation. In that context, the fifth paragraph of point 1.5 of Annex IV to that regulation provides that, where the applicant proposes to rely on a read-across for substances which may be considered a group or ‘category’ of substances, it must provide adequate and reliable documentation of the method applied.
Thus, it follows from a combined reading of Article 6(3) of, and Annex IV to, Regulation No 528/2012 that the obligation to provide a sufficient and reliable description of the method applied in the event of read-across, laid down in that annex and relied on by the applicants, does not apply to the authorities responsible for evaluating an active substance.
However, it cannot be concluded therefrom that, where the authorities responsible for evaluating an active substance decide to remedy gaps in the dossier submitted by an applicant using a read-across approach, they are relieved of the obligation to provide an adequate and sufficient statement of reasons in that regard, in accordance with Article 296 TFEU. Such a statement of reasons must disclose clearly and unequivocally the reasoning followed by the authorities concerned, in such a way as to enable the applicant to ascertain the reasons for the read-across relied on and the competent court to exercise its power of review.
In the present case, it is apparent from the examination of the first part of the second plea above that the evaluating competent authority and the ECHA Biocidal Products Committee relied only on one read-across to the values of Lonza’s PHMB, which concerns the determination of the AEC inhalation value, due to the lack of availability of a study in the dossier for the approval of Pareva’s PHMB concerning that aspect.
In that regard, it is true that the document of the ECHA Biocidal Products Committee of 27 September 2017 entitled ‘Open Issues’ does not contain any detailed justification for the use of the read-across at issue.
However, the toxicity position paper specifically examines the question of a read-across between Pareva’s PHMB and Lonza’s PHMB as regards the determination of the AEC inhalation value. Thus, that document contains several comparative tables relating to the results of the studies available on the acute toxicity, the genotoxicity and the repeated toxicity of Pareva’s PHMB and Lonza’s PHMB. It is stated therein that those two substances are structurally similar from a physico-chemical point of view and they have only a slight different toxicity profile for oral acute toxicity and eye irritation,
The toxicity position paper states, moreover, that the classification of PHMB in Annex I to Regulation No 1272/2008, as regards inhalation toxicity, was carried out on the basis of data relating to Pareva’s PHMB and Lonza’s PHMB. It is also apparent that those two substances have a similar toxicity profile after repeated exposure and that respiratory tract irritation had been observed in the preliminary subacute inhalation toxicity study provided by Laboratoire Pareva, which the applicants do not dispute.
As is apparent from the minutes of the meetings of the ‘Human health’ working group of the ECHA Biocidal Products Committee, the content of the toxicity position paper was discussed within that working group, in the presence of Laboratoire Pareva. Reliance on the read-across at issue, based on the findings set out in paragraph 158 above, was the subject of an ad hoc follow-up meeting in which Laboratoire Pareva participated and was validated by the majority of the members of that group during that meeting.
Thus, Laboratoire Pareva was given the opportunity to understand the reasons which led the ECHA Biocidal Products Committee to make a read-across to Lonza’s PHMB. Those reasons clearly and unequivocally show the reasoning which led to reliance on the read-across approach and enabled Laboratoire Pareva to ascertain the justifications for the measure adopted and the Court to exercise its power of review.
In that regard, the fact that the toxicity position paper was not sent to Laboratoire Pareva prior to the first meeting of the ‘Human health’ working group of the ECHA Biocidal Products Committee, which took place from 29 May to 2 June 2017, has no bearing on the assessment of the reasons concerning reliance on the read-across to Lonza’s PHMB. It is not disputed that that document was sent to Laboratoire Pareva shortly after that first meeting, with the result that it had that document in its possession well before the adoption of the contested decision and the contested regulation.
Therefore, the complaint alleging a failure to state reasons in relation to reliance on a read-across to Lonza’s PHMB is unfounded.
The second plea in law must therefore be dismissed in its entirety.
3.

The third plea in law, alleging a manifest error of assessment relating to the failure to take into account relevant factors
The applicants claim that the contested decision and the contested regulation are vitiated by a manifest error of assessment on the ground that the evaluating competent authority and the ECHA Biocidal Products Committee did not take into account several relevant studies and documents submitted by Laboratoire Pareva.
According to the applicants, the evaluating competent authority and the ECHA Biocidal Products Committee relied on read-across to Lonza’s PHMB for the assessment of Pareva’s PHMB and regarded reliance on read-across as a default approach. The failure to take into account data specific to Pareva’s PHMB gave rise to the determination of penalising low reference values, as is shown by a position paper drawn up by an independent external consultant.
By deciding to disregard, in the exercise of its discretion, the data submitted in good faith by Laboratoire Pareva, the evaluating competent authority acted inconsistently, did not provide a full or an adequate explanation and did not agree to take account of new studies intended to replace the studies that had been provided in the dossier for the approval of Pareva’s PHMB and rejected.
The applicants add that, by relying on the method and conclusions of studies used for Lonza’s PHMB two years before the examination of Pareva’s PHMB, the ECHA Biocidal Products Committee based itself on the premiss that expert opinions and methods should not change, which is incorrect.
The Commission, supported by the ECHA, disputes the applicants’ arguments.
(a)

Preliminary observations
It should be borne in mind that the approval procedure for active substances laid down in Chapter II of Regulation No 528/2012 is based on the submission of an application for approval. In that regard, under Article 6 of that regulation, it is for the applicant to submit to the evaluating competent authority a complete dossier enabling it to verify whether the substance in question complies with the approval criteria for active substances, as defined in Article 4(1) of that regulation, in the light of the precautionary principle.
As is apparent from Article 7(3) and (4) of Regulation No 528/2012, after accepting a request for approval, the evaluating competent authority may, if it considers that the dossier is incomplete, grant the applicant an additional period within which to provide the missing information, which does not normally exceed 90 days. At the end of that period, an application which remains incomplete cannot be validated and is therefore rejected.
Conversely, if the data required under Article 6(1)(a) and (b) of Regulation No 528/2012 have been submitted and the dossier is therefore considered to be complete, the evaluating competent authority must validate the application.
Within 365 days of the validation of an application, the evaluating competent authority must assess that application on the basis of the applicant’s dossier. To that end, it may also ask the applicant to submit additional data necessary to clarify the dossier, in accordance with Article 8(2) of Regulation No 528/2012.
However, Regulation No 528/2012 and Delegated Regulation No 1062/2014 make no provision for the applicant to supplement his or her dossier on his or her own initiative after his or her application has been validated, whatever the grounds may be. Nor do those regulations provide for the possibility for the applicant to submit new information after the evaluating competent authority has sent him or her its draft assessment report for comment.
Nevertheless, it is apparent from the ECHA Biocidal Products Committee Guidelines on the introduction of new information during the peer review process of active substance approval of 20 January 2016 (‘the ECHA Guidelines on the introduction of new information’) that, in practice, it is sometimes necessary for that committee to gather additional information for the purposes of that examination. The submission of new information at that stage of the evaluation procedure is, however, subject to four conditions being satisfied. First, the period of 270 days within which the ECHA must deliver its opinion can be adhered to, second, it appears during the process that the outcome of the evaluation by the evaluating competent authority can be significantly changed, third, the new information is already available and can be submitted immediately after the meeting of the working group concerned and, fourth, that working group decided that new information was necessary and defined it.
Consequently, in the context of the evaluation of an active substance under Regulation No 528/2012 and Delegated Regulation No 1062/2014, neither the evaluating competent authority nor the ECHA are required to accept any further study or additional data which an applicant wishes to submit to them on his or her own initiative after that applicant’s dossier has been considered to be complete and has thus been validated by the evaluating competent authority.
Moreover, the mere claim that scientific and technical knowledge has evolved since the notification does not enable those who have notified an active substance and who are faced with the likelihood of a non-approval decision of that substance, or an approval regulation subject to conditions, to benefit from the opportunity to submit new studies and data for as long as doubts remain as to the safety of that active substance. Such an interpretation would run counter to the objective of a high level of protection of human and animal health and of the environment which underpins Regulation No 528/2012, in that it would be tantamount to granting to the notifier of the active substance – who has a better knowledge of the substance at issue – a right of veto over the possible adoption of a non-approval decision of that substance (see, to that effect and by analogy, judgment of 3 September 2009, Cheminova and Others v Commission,
T‑326/07
,
EU:T:2009:299
, paragraph
).
Admittedly, it cannot be ruled out that, in specific circumstances, it is necessary to take account of new documents or new data submitted by the applicant, which were not available at the time of validation of the dossier lodged by the applicant. As is apparent from paragraph 174 above, such a possibility is, moreover, provided for in the ECHA Guidelines on the introduction of new information.
However, it should be borne in mind that it is for the applicant to prove that the conditions of approval are met in order to obtain the approval of an active substance, and not for the Commission to prove that the conditions of approval are not met in order to be able to refuse it (see, to that effect and by analogy, judgment of 17 May 2018, BASF Agro and Others v Commission,
T‑584/13
,
EU:T:2018:279
, paragraphs
and
). In view of that allocation of the burden of proof, where an applicant considers that new data or studies, submitted after his or her dossier has been validated, should have been taken into account for the evaluation of the substance at issue, it is for that applicant to demonstrate that such data or studies could not be submitted before his or her dossier was validated, that they are necessary and that they manifestly call into question the outcome of the evaluation procedure.
(b)

The documents allegedly not taken into account in the assessment of Pareva’s PHMB
In respect of the documents and studies allegedly not taken into account in the assessment of Pareva’s PHMB, the applicants refer to the position paper of 4 July 2016, the additional position paper of 3 March 2017, several studies submitted to the ‘Environment’ working group of the ECHA Biocidal Products Committee, the comments on the toxicity position paper, a preliminary subacute inhalation toxicity study, and a report drawn up by an external consultant on the derivation of the values relating to AEL, the acute reference dose and the acceptable daily intake dated July 2017 (‘the external consultant’s report’). They also refer to seven new studies submitted to the ‘Efficacy’ working group of the ECHA Biocidal Products Committee.
(1)

The position paper of 4 July 2016, the additional position paper of 3 March 2017 and the list of new studies submitted to the ‘Environment’ working group of the ECHA Biocidal Products Committee
As a preliminary point, it should be recalled that, pursuant to Annex V to Commission Regulation (EC) No 2032/2003 of 4 November 2003 on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8 and amending Regulation (EC) No 1896/2000 (
OJ 2003 L 307, p. 1
), Laboratoire Pareva was required to submit a complete dossier for PHMB (1415; 4.7) by 31 July 2007 at the latest. However, the evaluating competent authority only considered that dossier to be complete in January 2016. Up until that date, Laboratoire Pareva had the opportunity to submit all the studies and all the documents which were supposed to enable the evaluating competent authority to assess Pareva’s PHMB.
It is apparent from the file submitted to the Court that Laboratoire Pareva sent the position paper of 4 July 2016 to the evaluating competent authority in the context of its comments on the June 2016 draft assessment report. That position paper was accompanied by a list of studies in preparation, which were to be carried out in accordance with OECD Guidelines 303A, 201, 212, 222, 208 and 225 for the Testing of Chemicals, respectively. On 3 March 2017, Laboratoire Pareva submitted a document supplementing that position paper, which included the results of the new studies mentioned.
As regards the list of studies annexed to each of the applications, it should be noted that it refers, first, to the studies referred to in paragraph 181 above and, second, to a study entitled ‘Étude comportement PHMBG (HPLC)’ (‘Study on PHMBG behaviour (HPLC)’) carried out by the École supérieure de physique et de chimie industrielles de la ville de Paris (ESPCI) in May 2016, a study entitled ‘Observation microscopique surface (Biophy-R)’ (‘Microscope observation of the surface (Biophy-R)’), also dated May 2016, and a study on the toxicity of PHMB on sediment-dwelling organisms, entitled ‘Tox to Sediment-Dwelling Phase Midge’, carried out in 2015 in accordance with OECD Guideline 218 for the Testing of Chemicals.
First, it is not disputed that the evaluating competent authority sent its December 2016 assessment report to the ECHA without waiting for the results of the studies mentioned in the document accompanying the position paper of 4 July 2016, referred to in paragraph 181 above. Nor did the evaluating competent authority follow the opinion expressed by Laboratoire Pareva in that document, which calls into question the approach followed with regard to the assessment of the persistence of PHMB (1415; 4.7).
However, the position paper of 4 July 2016 does not merely set out comments on the June 2016 draft assessment report, within the meaning of the second subparagraph of Article 8(1) of Regulation No 528/2012. On the contrary, as stated in its introduction, that position paper seeks to clarify how the persistence of Pareva’s PHMB should be evaluated. It refers, in particular, in that regard, to the results of the study entitled ‘Study on PHMBG behaviour (HPLC)’ carried out by ESPCI and the study entitled ‘Microscope observation of the surface (Biophy-R)’, of 2016, that is to say, after the validation of the dossier for the approval of Pareva’s PHMB. However, it is not apparent either from the file submitted to the Court or from the parties’ arguments that those studies were requested by the evaluating competent authority, within the meaning of Article 7(3) of Regulation No 528/2012.
As stated in paragraph 175 above, the evaluating competent authority was in no way required to accept additional data and studies submitted after the validation of the dossier for the approval of Pareva’s PHMB, nor, a fortiori, to wait for their results before sending its assessment report to the ECHA within the time limit laid down in Article 8(1) of Regulation No 528/2012.
Second, it is apparent from the file submitted to the Court that the position paper of 4 July 2016 and the new studies mentioned, examined in the additional position paper of 3 March 2017, were discussed at the meetings of the ‘Environment’ working group of the ECHA Biocidal Products Committee. That working group verified whether the new environmental studies submitted by Laboratoire Pareva after the validation of the dossier for the approval of PHMB (1415; 4.7) could be taken into account, in the light of the conditions laid down in the ECHA Guidelines on the introduction of new information.
The ‘Environment’ working group of the ECHA Biocidal Products Committee nevertheless reached the conclusion, after hearing Laboratoire Pareva’s arguments, that it was only necessary to take account of a new study on sediments. The impact of the results of that additional study was analysed at an ad hoc follow-up meeting of that working group.
Furthermore, during the ad hoc follow-up meeting referred to in paragraph 187 above, the results of the PHMB toxicity study on sediment-dwelling organisms, entitled ‘Tox to sediment-Dwelling Phase Midge’, carried out in accordance with OECD Guideline 218 for the Testing of Chemicals, and Laboratoire Pareva’s arguments regarding the interpretation of those results, were discussed.
In addition, the persistent properties of Pareva’s PHMB were examined by the ‘Environment’ working group of the ECHA Biocidal Products Committee, taking into account Laboratoire Pareva’s arguments on the degradability of PHMB (1415; 4.7).
Admittedly, the ‘Environment’ working group of the ECHA Biocidal Products Committee found that some of the new studies proposed by Laboratoire Pareva could not be accepted, in accordance with discussions that took place in the context of the assessment of Lonza’s PHMB. However, even if such an approach were unlawful, the fact remains that those studies were submitted out of time, which the applicants do not dispute, with the result that they did not, in any event, have to be accepted.
In addition, it is necessary to reject the applicants’ argument that, by insisting on the consistency of the method used to examine the two PHMB substances in order to reject certain new studies, the ECHA based itself on the incorrect premiss that expert opinions and methods should not evolve. The applicants do not indicate in any way how the methods on which the studies at issue are based had evolved after the validation of the dossier for the approval of Pareva’s PHMB.
Third, the applicants have not provided any explanation as to why the studies referred to in paragraph 181 above, which were submitted after the validation of the dossier for the approval of Pareva’s PHMB, could not have been submitted earlier. Nor do they explain, in detail, how those studies and those documents were necessary and should manifestly have made it possible to arrive at a different assessment of Pareva’s PHMB, with the result that that substance should have been authorised, or at least authorised subject to certain less restrictive conditions.
In particular, even though they state that the new studies and documents at issue were provided in order to replace the studies rejected by the evaluating competent authority, and that the failure to take account of those new studies and those documents resulted in a gap in the dossier for the approval of Pareva’s PHMB in terms of the environmental risk assessment, the applicants do not identify those gaps and do not provide any detailed arguments to establish that the conclusions of the evaluating competent authority and of the ECHA were manifestly incorrect in the light of the results of those studies.
In that regard, the applicants cannot merely make a general reference to an external consultant’s document on the risk characterisation ratio to support their assertion. As is apparent from paragraph 77 above, it is not for the Court to seek and identify in the annexes the arguments on which it may consider the action to be based, since they have a purely evidential and instrumental function.
Consequently, the applicants’ arguments alleging a manifest error of assessment on account of the failure to take into account the position paper of 4 July 2016, the additional position paper of 3 March 2017 and the new studies submitted to the ‘Environment’ working group of the ECHA Biocidal Products Committee must be rejected.
(2)

Laboratoire Pareva’s comments on the toxicity position paper and the preliminary subacute inhalation toxicity study
The toxicity position paper summarises the position of the evaluating competent authority concerning, inter alia, the possibility of relying on a read-across between Lonza’s PHMB and Pareva’s PHMB and the need to rely on such a read-across as regards the determination of the values relating to the inhalation AEC indicator for Pareva’s PHMB. That document also mentions Laboratoire Pareva’s objections regarding reliance on such a read-across, including its arguments concerning the possibility of using the preliminary subacute inhalation toxicity study that it had submitted to the evaluating competent authority.
As is apparent from paragraph 126 above, the ‘Human health’ working group of the ECHA Biocidal Products Committee examined the preliminary subacute inhalation toxicity study submitted by Laboratoire Pareva and took the view that it was unreliable because of the lack of validation of the analytical methods used, which the applicants do not dispute. Thus, even if the results of that study had showed that the level of toxicity of Pareva’s PHMB was much lower than that of Lonza’s PHMB, the ECHA cannot be criticised for not having taken such results into account.
Furthermore, as indicated in paragraph 131 above, Laboratoire Pareva’s arguments seeking to challenge reliance on instances of read-across to Lonza’s PHMB in order to determine the values relating to the inhalation AEC indicator were not accepted by the ‘Human health’ working group of the ECHA Biocidal Products Committee, which agreed to rely on a read-across to Lonza’s PHMB.
Moreover, as is apparent from paragraph 132 above, the applicants have not demonstrated that the evaluating competent authority and the ECHA made a manifest error of assessment in applying a read-across to Lonza’s PHMB as far as concerns the determination of the inhalation AEC values.
Consequently, the applicants’ arguments alleging a manifest error of assessment as a result of the failure to take into account, in the assessment of PHMB (1415; 4.7), Laboratoire Pareva’s comments on the toxicity position paper must be rejected.
(3)

The external consultant’s report
The external consultant’s report seeks to challenge the calculation of the values relating to the NOAEL and AEL, proposed by the evaluating competent authority on the basis of a prenatal developmental toxicity study in rabbits, provided by Laboratoire Pareva. That report examines, in particular, the results of that study, as updated by Laboratoire Pareva.
First, it must be noted that the external consultant’s report was submitted by Laboratoire Pareva to the ECHA in July 2017, after several meetings of the ECHA’s working groups concerning the application for approval of PHMB (1415; 4.7) and, therefore, at a very late stage of the evaluation procedure of that substance. As is apparent from paragraph 175 above, the ECHA was under no obligation to accept such a report which, according to the information produced before the Court, it had not requested.
Furthermore, the applicants have not explained why the external consultant’s report could not have been produced earlier.
Second, it is apparent from the file submitted to the Court that the ‘Human health’ working group of the ECHA Biocidal Products Committee did indeed examine, during a meeting held in September 2017, the amendments made by Laboratoire Pareva to the results of the prenatal developmental toxicity study in rabbits, which are precisely the subject of the external consultant’s report. The working group nevertheless concluded that those amendments had no impact on the values relating to the NOAEL. Moreover, it was agreed at that meeting that the evaluating competent authority would set out those amendments in its final assessment report.
Accordingly, the applicants’ arguments alleging a manifest error of assessment on account of the failure to take into account the external consultant’s report in the assessment of PHMB (1415; 4.7) must be rejected.
(4)

The seven new studies submitted to the ‘Efficacy’ working group of the ECHA Biocidal Products Committee
First of all, it is not disputed that Laboratoire Pareva submitted the seven new efficiency studies to the ‘Efficacy’ working group of the ECHA Biocidal Products Committee after the validation of the dossier for the approval of PHMB (1415; 4.7). It is not apparent either from the file submitted to the Court or from the parties’ arguments that those studies were requested by the evaluating competent authority, within the meaning of Article 7(3) of Regulation No 528/2012, or by the ECHA Biocidal Products Committee.
As is apparent from paragraph 175 above, the ECHA was therefore in no way required to accept the new studies at issue.
Next, in their replies to the written questions put by the Court, the applicants and the ECHA stated that the ‘Efficacy’ working group of the ECHA Biocidal Products Committee had nevertheless examined whether the seven new studies at issue could be taken into account. In that regard, it is apparent from the file submitted to the Court that that working group verified whether the conditions set out in the ECHA Guidelines on the introduction of new information, referred to in paragraph 174 above, were satisfied and concluded that that information was not necessary for the assessment of the efficacy of the substance at issue.
Lastly, at the hearing, the applicants explained that they had submitted the seven new studies at issue after the validation of the dossier for the approval of Pareva’s PHMB, on the ground that the efficacy studies originally included in that dossier had not been accepted. However, as is apparent from paragraphs 169 and 178 above, it is for the applicant to submit a complete dossier which shows that his or her active substance fulfils the criteria of Regulation No 528/2012 in order for it to be approved. Where an applicant submits studies which are not reliable or are incomplete to the evaluating competent authority, he or she cannot be recognised as having the right, after his or her dossier has been validated, to provide new studies without any restriction regarding timing, otherwise he or she would, de facto, be entitled to extend that evaluation procedure indefinitely, without it being possible to adopt a decision on the risks of the substance evaluated, even though that substance is on the EU market pending the adoption of that decision.
Nor do the applicants explain why those studies, which were intended to improve the risk characterisation ratio, could not have been provided earlier.
Consequently, the applicants’ arguments alleging a manifest error of assessment as a result of the failure to take into account the seven new studies on efficacy in the assessment of PHMB (1415; 4.7) must be rejected.
In the light of all the foregoing considerations, when they decided not to take into account all the new data and studies provided by Laboratoire Pareva after the validation of the dossier for the approval of PHMB (1415; 4.7), the evaluating competent authority and the ECHA did not disregard those new data and studies in a discretionary manner, but verified whether the conditions set out in the ECHA Guidelines on the introduction of new information were met.
It follows that the applicants have not demonstrated that the evaluating competent authority and the ECHA failed to examine carefully and impartially all the relevant aspects of the present case, with the result that the plea alleging a manifest error of assessment is unfounded.
That conclusion is not called into question by the applicants’ arguments alleging that the evaluating competent authority and the ECHA merely consistently reproduced the data relating to Lonza’s PHMB for the purpose of the assessment of Pareva’s PHMB, since it is apparent from paragraph 148 above that those arguments are unfounded. The applicants are therefore not justified in claiming that the evaluating competent authority and the ECHA rejected the new data and studies submitted by Laboratoire Pareva in favour of the data relating to Lonza’s PHMB.
Consequently, the third plea in law must be rejected.
4.

The fourth plea in law, alleging infringement of the right to be heard
The applicants claim that Laboratoire Pareva was not given the opportunity to present its view properly and effectively during the procedure leading to the adoption of the contested decision and the contested regulation.
First, in their opinion, the toxicity position paper was not sent to Laboratoire Pareva until 7 June 2017, after the meetings of the working group of the ECHA Biocidal Products Committee responsible for its examination. Second, none of the seven new efficacy studies aimed at refining the assessment for product-types 5 and 6 were taken into account, and several environmental studies were rejected without a clear or acceptable justification. Similarly, the position paper of 4 July 2016 and the additional position paper of 3 March 2017 were not taken into account.
According to the applicants, the studies and the documents referred to in paragraph 217 above could have had an impact on the outcome of the assessment of PHMB (1415; 4.7) and of the discussions of the working groups of the ECHA Biocidal Products Committee, since they could have led to different reference values being adopted (as regards, inter alia, the predicted no-effect concentration) and to thus alter the risk assessment results for the proposed product-types.
The Commission, supported by the ECHA, disputes the applicants’ arguments.
According to settled case-law, respect for the rights of the defence is, in all proceedings initiated against a person which are liable to culminate in a measure adversely affecting that person, a fundamental principle of EU law which must be guaranteed even in the absence of any rules governing the proceedings in question. That principle requires that the addressees of decisions which significantly affect their interests should be placed in a position in which they may effectively make known their views. The right to be heard in an administrative procedure taken against a specific person is a corollary of the rights of the defence (see judgment of 12 December 2014, Xeda International v Commission,
T‑269/11
, not published,
EU:T:2014:1069
, paragraphs
and
and the case-law cited).
By contrast, in the case of acts of general application, neither the process of drafting them nor those acts themselves require, in accordance with the general principles of EU law, such as the right to be heard, consulted or informed, the participation of the persons affected. That is not the case if an express provision of the legal context governing the adoption of that act confers a procedural right on an affected person (see judgment of 19 December 2019, Probelte v Commission,
T‑67/18
,
EU:T:2019:873
, paragraph
and the case-law cited).
In the present case, the contested decision includes a measure of general application refusing the approval of PHMB (1415; 4.7) as an existing active substance for use in product-types 1, 5 and 6. The contested regulation, for its part, establishes measures of general application concerning, first, the conditions for approval of that substance for product-types 2 and 4 and, second, the inclusion of that substance in the list of substances which are candidates for substitution.
Thus, the procedural rights of Laboratoire Pareva in the context of the procedure relating to the approval of PHMB (1415; 4.7) were those expressly provided for in Regulation No 528/2012 and Delegated Regulation No 1062/2014.
It is apparent from the second subparagraph of Article 8(1) of Regulation No 528/2012 and Article 6(4) of Delegated Regulation No 1062/2014 that, prior to submitting its conclusions to the ECHA, the evaluating competent authority is to 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 is to take due account of those comments when finalising its report.
In that regard, it is apparent from the file submitted to the Court that, following the communication of the June 2016 draft assessment report, Laboratoire Pareva had a period of 30 days within which to submit its comments on that draft. In that context, Laboratoire Pareva submitted the position paper of 4 July 2016.
Thus, Laboratoire Pareva exercised its right to submit comments on the draft assessment report of the evaluating competent authority, in accordance with the second subparagraph of Article 8(1) of Regulation No 528/2012 and Article 6(4) of Delegated Regulation No 1062/2014.
In addition, it is not disputed that Laboratoire Pareva attended the meetings of the working groups of the ECHA Biocidal Products Committee, during which the risks posed by PHMB (1415; 4.7) were examined, and the meeting of the ECHA Biocidal Products Committee of 3 and 4 October 2017, at which the opinion of that committee was adopted. It is also apparent from a list of contacts between the ECHA and Laboratoire Pareva, provided by the Commission as an annex to each of the defences, which has not been contested by the applicants, that Laboratoire Pareva had several opportunities to make known its views during the evaluation process of PHMB (1415; 4.7) by the ECHA Biocidal Products Committee.
As regards the studies and the documents which were not taken into account by the evaluating competent authority and the ECHA, it must be noted, as has been stated in paragraph 173 above, that neither Regulation No 528/2012 nor Delegated Regulation No 1062/2014 provides for the possibility, for the applicant, to submit new data and studies to the evaluating competent authority, or even to the ECHA, after that applicant’s dossier has been validated by the evaluating competent authority.
It is not disputed that the new data contained in the position paper of 4 July 2016 and the additional position paper of 3 March 2017, the new studies submitted to the ‘Environment’ working group of the ECHA Biocidal Products Committee and the seven new efficiency studies were submitted by Laboratoire Pareva after the validation of the PHMB (1415; 4.7) approval dossier, without having been requested by the evaluating competent authority or the ECHA. Laboratoire Pareva’s right to be heard cannot therefore have been infringed on account of the alleged failure to take account of those data and studies.
As regards the toxicity position paper, the Commission acknowledges that that document was not sent to Laboratoire Pareva until after the first meeting of the ‘Human health’ working group of the ECHA Biocidal Products Committee of 31 May 2017. However, that first meeting was not the only occasion for Laboratoire Pareva to put forward its arguments on the position of the evaluating competent authority set out in that position paper.
It is apparent from the minutes of the meetings of the ‘Human health’ working group of the ECHA Biocidal Products Committee that questions relating to the read-across to Lonza’s PHMB on the determination of the values relating to the inhalation AEC were the subject of an ad hoc follow-up meeting. In addition, Laboratoire Pareva again had the opportunity to present its views on the inhalation toxicity of PHMB (1415; 4.7) at the meeting of the ECHA Biocidal Products Committee on 3 and 4 October 2017.
More generally, the applicants have not identified any document, study or data on which the evaluating competent authority or the ECHA allegedly based the assessment of Pareva’s PHMB without giving Laboratoire Pareva the opportunity to express effectively its point of view in that regard. As the Commission stated at the hearing, almost 10 years elapsed between Laboratoire Pareva’s submission of its dossier for the approval of PHMB (1415; 4.7) and communication of the December 2016 assessment report to the ECHA. During that period, particularly long in view of the deadlines laid down in Regulation No 528/2012 for the validation of a dossier and the evaluation of an active substance on the basis of that regulation, the evaluating competent authority gave Laboratoire Pareva the opportunity to complete its approval dossier several times. In addition, as is apparent in particular from paragraph 100 above, the ECHA agreed to take into account a new study submitted by it, despite its lateness.
Consequently, the fourth plea in law is unfounded.
It follows from all the above that the applications must be dismissed.
V.

Costs
Under Article 134(1) of the Rules of Procedure, the unsuccessful party is to be ordered to pay the costs if they have been applied for in the successful party’s pleadings.
Since Laboratoire Pareva has been unsuccessful in Case T‑337/18, it must be ordered to pay the costs, in accordance with the forms of order sought by the Commission, including those relating to the proceedings for interim measures in the cases registered under numbers T‑337/18 R and T‑337/18 R II.
Since Laboratoire Pareva and Biotech3D have been unsuccessful in Case T‑347/18, they must be ordered to pay the costs, in accordance with the forms of order sought by the Commission, including those relating to the proceedings for interim measures registered under number T‑347/18 R. Laboratoire Pareva must also be ordered to pay the costs of the proceedings for interim measures registered under number T‑347/18 R II, in accordance with the forms of order sought by the Commission.
Under Article 138(1) of the Rules of Procedure, the Member States and institutions which have intervened in the proceedings are to bear their own costs. Under Article 1(2)(f) of the Rules of Procedure, the term ‘institutions’ means the institutions of the European Union referred to in Article 13(1) TEU and the bodies, offices or agencies established by the Treaties, or by an act adopted in implementation thereof, which may be parties before the General Court. According to Article 100 of Regulation No 1907/2006, the ECHA is a European Union body. The French Republic and the ECHA must therefore each bear their own costs.

On those grounds,
THE GENERAL COURT (Seventh Chamber)
hereby:

1.
Joins Cases T‑337/18 and T‑347/18 for the purposes of the present judgment;

2.
Dismisses the actions;

3.
In Case T‑337/18, orders Laboratoire Pareva to bear its own costs and to pay those incurred by the European Commission, including those incurred in the proceedings for interim measures registered under number T‑337/18 R and T‑337/18 R II;

4.
In Case T‑347/18, orders Laboratoire Pareva and Biotech3D Ltd & Co. KG to bear their own costs and to pay those incurred by the Commission, including those incurred in the proceedings for interim measures registered under number T‑347/18 R, and orders Laboratoire Pareva also to pay the costs incurred in the proceedings for interim measures registered under number T‑347/18 R II;

5.
Orders the French Republic and the European Chemicals Agency (ECHA) to each bear their own costs.

da Silva Passos
Reine
Sampol Pucurull
Delivered in open court in Luxembourg on 15 September 2021.
E. Coulon
Registrar
S. Papasavvas
President
(
*1
)	Language of the case: English.