Action brought on 1 August 2014 – VSM Geneesmiddelen v Commission
(Case T-578/14)
Language of the case: English
Parties
Applicant: VSM Geneesmiddelen BV (Alkmaar, Netherlands) (represented by: U. Grundmann, lawyer)
Defendant: European Commission
Form of order sought
The applicant claims that the Court should:
Declare that the Commission has unlawfully failed to initiate the assessment of Health Claims on Botanical Substances by European Food Safety Authority for the Procedure foreseen by Article 13 Section 3 of the Regulation (EC) 1924/20061 since 01/08/2014; and
in the alternative, annul the decision, allegedly contained in the Commission’s letter of 29/06/2014, not to initiate the assessment of Health Claims on botanical substances by EFSA through the procedure foreseen by Article 13 before 01/08/2014.
Pleas in law and main arguments
In support of the action, the applicant submits that according to Article 13(3) of Regulation (EC) 1924/2006 – Health Claims Regulation (“HCR”), the European Commission was under an obligation to adopt a list of permitting claims of substances used in food at the latest by 31/01/2010. In preparation of the adoption of such list the European Food Safety Authority (EFSA) was commissioned to evaluate claims that had been submitted by the Member States. However, in September 2010 the Commission announced to suspend and review the assessment procedure as regards claims on botanical substances, where upon EFSA ceased to process these claims. The Commission suspended only the assessment procedure on botanical substances, but not the procedure on other, like chemical substances.
The applicant has called upon the European Commission with letter dated 23/04/2014 to instruct EFSA to resume without delay the assessment of health claims on botanical substances used in food, since it is strongly affected by the present legal backlog and uncertainty in the field of Health Claims on botanical substances used in food.
The Commission informed the applicant in its letter dated 19/06/2014 that it had received different concerns from Member States and stakeholders and that it will not initiate the assessment of Health Claims on botanicals at this stage. The applicant sent out a further letter to the Commission, dated 08/07/2014 with setting a deadline for initiation of the assessment of Health Claims on botanicals by EFSA, ending 31/07/2014. The Commission has not answered this letter.
It can thus be concluded that the European Commission failed to establish a complete list of permitted Health Claims on substances used in food as required by Article 13(3) HCR. Article 13 HCR does not only foresee clear timelines but also clearly defined procedures for the adoption of the list on Health Claims on substances used in food. The Regulation does not foresee any discretion for the European Commission to alter the procedural steps nor to extend the timelines.
Additionally, according to Recital 9, the Health Claims Regulation aims at establishing “general principles applicable to all claims”. This shows clearly that the legislator did not wish to establish different levels of assessments for specific kinds of substances. Therefore, all considerations taken by the European Commission with regard to a separate regime for the evaluation of claims on botanicals would not only lack any legal basis but would also contradict the overall aims of the Regulation.
________________________1 Regulation (EC) No 1924/2006 of the European Parliament and of the Council of 20 December 2006 on nutrition and health claims made on foods (OJ L 404, p.9)