Joined Cases T‑337/18 and T‑347/18
Laboratoire Pareva
and
Biotech3D Ltd & Co. KG
v
European Commission
Judgment of the General Court (Seventh Chamber), 15 September 2021
(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 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)
1. Approximation of laws – Biocidal products – Regulation No 528/2012 – Approval procedure for an active substance with a view to its use in biocidal products – Obligation of the evaluating competent authority to submit to the ECHA a proposal for a harmonised classification – Procedure for the classification, labelling and packaging of substances and mixtures – Separate procedures
(European Parliament and Council Regulations No 1272/2008 and No 528/2012; Commission Regulation No 1062/2014, Art. 6(7)(a))
(see paragraphs 65, 68, 69)
2. Approximation of laws – Biocidal products – Regulation No 528/2012 – Approval procedure for an active substance with a view to its use in biocidal products – Obligation of the evaluating competent authority to consult the ECHA prior to the submission of its assessment report – None – Obligation of the ECHA to consult the expert group on persistent, bioaccumulative and toxic substances – None
(European Parliament and Council Regulation No 528/2012; Commission Regulation No 1062/2014, Art. 6(7)(b))
(see paragraphs 96-98)
3. Approximation of laws – Biocidal products – Regulation No 528/2012 – Approval procedure for an active substance with a view to its use in biocidal products – Possibility for the applicant to supplement his or her dossier after his or her application has been validated or to submit new information after the draft assessment report has been sent – None – Exception – Conditions
(European Parliament and Council Regulation No 528/2012; Commission Regulation No 1062/2014)
(see paragraphs 173-178)
Résumé
Laboratoire Pareva is a manufacturer of the active substance polyhexamethylene biguanide hydrochloride (‘PHMB’), which is produced for biocidal purposes as a disinfectant and a preservative. In the context of the programme for the evaluation of existing active substances established by Directive 98/8, (1) Laboratoire Pareva notified the European Commission of PHMB (1415; 4.7) in combination with various products in order to obtain their approval.
The assessment report submitted by the evaluating competent authority was examined by the Biocidal Products Committee of the European Chemicals Agency (ECHA). In accordance with the opinion of the Committee, the Commission refused to approve PHMB as an existing active substance intended for use in product-types 1, 5 and 6 (2) on account of unacceptable risks to human health and the environment. By contrast, it approved it for product-types 2 and 4, subject to compliance with certain specifications and conditions. (3) Pareva brought two actions for annulment before the General Court against those Commission acts.
The Court dismisses the action and applies for the first time Regulation No 528/2012 in the context of an application for approval of an active substance. (4) It provides important information, inter alia, on the possibility of submitting new studies during the evaluation procedure of such a substance.
Findings of the Court
In the first place, the Court recalls that, pursuant to Article 6(7)(a) of Delegated Regulation No 1062/2014, (5) 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, what the effects of that substance were, on the one hand, and, on the other hand, the risks that it represented, inter alia, for human health and the environment, taking into account the product-types in which its use was envisaged and the proposed use scenarios. In that regard, the Court notes that the evaluation procedure for the purposes of approval of an active substance with a view to its use in biocidal products concerns a different area and is governed by a procedure different to that which relates to the harmonisation of the classification criteria and rules on labelling and packaging of such a substance. (6) Furthermore, the approval procedure for an existing active substance is not subject to the procedure for harmonisation of classification and labelling of such a substance. On the contrary, the obligation on the evaluating competent authority to submit a proposal for harmonised classification for an active substance for biocidal use constitutes a preliminary step in the classification and labelling procedure.
In the second place, as regards Article 6(7)(b) of Delegated Regulation No 1062/2014, the Court states that the evaluating competent authority is not required 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 to the ECHA. Furthermore, the Court acknowledges that the ECHA has a certain discretion as to whether it is necessary to refer the matter to its expert group on the persistent, bioaccumulative and toxic (‘PBT’) character of an active substance, which is an informal body, in the context of such a consultation. (7) While such referral to the expert group is highly preferable and strongly recommended, (8) it falls within the remit of the internal organisation of the ECHA. Moreover, in order not to delay unnecessarily the work relating to the evaluation of an active substance, referral to that group of experts occurs only where there is no consensus on its PBT properties.
In the third and final place, the Court points out that, in the context of the evaluation of an active substance, 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 the dossier submitted by that applicant 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 does not enable applicants who have notified an active substance 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 a possibility would run counter to the objective of a high level of protection of human and animal health and of the environment in that it would be tantamount to granting to those applicants a right of veto over the possible adoption of a non-approval decision of that substance. Admittedly, in specific circumstances, it may be 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. However, if that applicant considers that new data or studies, submitted after the validation of his or her dossier, should have been taken into account for the evaluation of the substance at issue, he or she must, by virtue of the burden of proof relating to the conditions of approval of an active substance, demonstrate that they could not be submitted before his or her dossier was validated, that they were necessary and that they manifestly called into question the outcome of the assessment procedure.