Order of the President of the General Court of 24 August 2018 –

Laboratoire Pareva and Biotech3D v Commission

(Cases T‑337/18 R and T‑347/18 R)

(Interim relief — Regulation (EU) No 528/2012 — Biocidal products — Active substance PHMB (1415; 4.7) — Approval refused — Application for interim measures — Prima facie case — Weighing up of competing interests)

1. Application for interim measures — Suspension of operation of a measure — Interim measures — Conditions for granting — Prima facie case — Urgency — Serious and irreparable damage — Cumulative nature — Balancing of all the interests involved — Order of examination and method of verification — Discretion of the court hearing the application for interim relief (Arts 256(1) TFEU, 278 TFEU and 279 TFEU; Rules of Procedure of the General Court, Art. 156(4)) (see paras 21, 23, 24, 28)

2. Application for interim measures — Formal requirements — Submission of applications — Brief summary of the pleas in law on which the application is based — Insufficient explanation of the grounds constituting a prima facie case — General reference to other documents (Arts 278 TFEU and 279 TFEU; Rules of Procedure of the General Court, Art. 156(4) and (5)) (see paras 30, 31, 57, 58)

3. Application for interim measures — Suspension of operation of a measure — Conditions for granting — Balancing of all the interests involved — Preponderance of the protection of public health over economic considerations — Precautionary principle to be taken into account (Art. 278 TFEU; Commission Regulation No 582/2012) (see paras 62, 78-81, 84, 85)

4. Application for interim measures — Suspension of operation of a measure — Interim measures — Conditions for granting — Urgency — Serious and irreparable damage — Burden of proof — Financial loss — Obligation to provide concrete and precise indications, supported by detailed documentary evidence — Situation liable to endanger the existence of the applicant company — Assessment having regard to the situation of the group to which the applicant company belongs (Arts 278 TFEU and 279 TFEU; Rules of Procedure of the General Court, Art. 156) (see para. 96)

5. Application for interim measures — Suspension of operation of a measure — Conditions for granting — Balancing of all the interests involved — Suspension of operation of a Commission decision refusing to approve a substance as an active substance for use in biocidal products — Risk usually having to be supported by an undertaking operating on a highly-regulated market — Preponderance of the protection of public health over economic considerations (Art. 278 TFEU; European Parliament and Council Regulation No 528/2012, Art. 19(1)(b)) (see paras 102-106)

Re:

Application pursuant to Articles 278 and 279 TFEU seeking suspension of operation of Commission Implementing Decision (EU) 2018/619 of 20 April 2018 not approving PHMB (1415; 4.7) as an existing active substance for use in biocidal products of product-types 1, 5 and 6 (OJ 2018 L 102, p. 21) and Commission Implementing Regulation (EU) 2018/613 of 20 April 2018 approving PHMB (1415; 4.7) as an existing active substance for use in biocidal products of product-types 2 and 4 (OJ 2018 L 102, p. 1), and the adoption of any other appropriate interim measures.

Operative part

1. Cases T‑337/18 R and T‑347/18 R are joined for the purpose of the present order.

2. The applications for interim measures are dismissed.