The background to the complaint

1. This complaint concerns the European Commission's application of Regulation 1924/2006[1] on nutrition and health claims made for foods. This Regulation provides for the authorisation by the Commission of the inclusion of health claims in the labelling, presentation or advertising of foods. Specifically, the complaint relates to the Commission's allegedly wrongful refusal to reinsert the complainant's health claim in a list of health claims submitted to the European Food Safety Agency (hereinafter "EFSA") for scientific evaluation. The health claim in question is an appetite moderator and weight loss claim.  

2. Article 13[2] of Regulation 1924/2006 establishes different procedures for authorising health claims made on foods at EU level, among which are the following two:

(i) Article 13(2) of the Regulation applies when the claim has already been authorised by a Member State. Member States must communicate a list of all such claims to the Commission which then submits the claims to EFSA for scientific evaluation. Pursuant to Article 13(3), following EFSA's evaluation, the Commission adopts a Regulation containing a list of claims authorised at EU level. Pending the Commission decision, these claims "on hold" can continue to be made pursuant to Articles 28(5) and (6) of the Regulation.

(ii) Article 13(5) and 18 of the Regulation provides for the authorisation of health claims which have not previously been recognised at Member State level. These claims are subject to an individual authorisation procedure whereby the application is made by the food business operator itself to the national competent authority (and subsequently sent to EFSA for scientific assessment and to the Commission and the Member States for information), with a view to being added to the list of permitted health claims. In this case, the claim cannot be used until it has been formally authorised by the Commission. This procedure also applies to health claims which include a request for the protection of proprietary data (brand name).

3. The present complaint relates to the first of the above two procedures. With respect to deadlines, Article 13(2) of Regulation 1924/2006 provided that Member States had to send to the Commission the lists of claims by 31 January 2008 at the latest. Article 13(3) of the Regulation stated that the Commission had then to adopt the list of permitted claims by 31 January 2010 at the latest. However, because of the high number of health claims submitted by the deadline of 31 January 2008 (44 000 health claims) and the need for clarification, rectification and consultation with the Member States before submitting a consolidated list to EFSA, the Commission gave the Member States additional time to finalise their lists of health claims. It then submitted the consolidated list to EFSA on 12 March 2010.

4. The facts of the present case are as follows: In January 2008, the relevant national authorities included the complainant's health claim in the list of claims sent to the Commission in accordance with Article 13(2) of Regulation 1924/2006. The complainant's file, which had been submitted to the national authorities in October 2007, contained a request for the protection of proprietary data concerning its health claim.

5. On 25 March 2008, the relevant national authorities informed the complainant that its health claim could not be taken into consideration in its actual form since it contained a request for the protection of proprietary data and thus fell under the procedure of Article 13(5) of the Regulation (see paragraph 2 (ii)). As a result, on 27 March 2008, the complainant withdrew its request for the protection of proprietary data. However, when submitting a new file (in English) to the national authorities on 2 February 2009, the complainant reinserted its brand name again. On 5 May 2009, the national authorities informed the complainant again that it was not possible, under the Article 13(2) procedure, to submit a health claim file containing a request for the protection of proprietary data. On 29 June 2009, the complainant again withdrew its request for the protection of proprietary date in order to be able to benefit from the procedure of Article 13(2).

6. On 31 August and 3 September 2009, the complainant and the national authorities exchanged e-mails with regard to the question of whether, on the basis of the request for the protection of proprietary data, the complainant should, instead of the procedure under Article 13(2), follow the individual authorisation procedure under Article 13(5). The complainant made clear that it did not wish to withdraw its health claim from the list submitted under the procedure of Article 13(2) of the Regulation. However, in an e-mail of 22 December 2009 to the Commission, the relevant national authorities said that, among other health claims, the complainant's health claim should be withdrawn from the list submitted under the Article 13(2) procedure.

7. On 12 March 2010, the Commission officially submitted to EFSA the consolidated list of health claims. It had now finalised the consultation process with the Member States which it had undertaken in order to rectify the lists initially submitted in January 2008. Annex 2 to the Commission's letter containing the list of health claims withdrawn by the Member States, included the complainant's health claim.

8. By e-mail of 1 July 2010, and having been approached several times by the complainant with regard to the wrongful withdrawal of its health claim, the national authorities asked the Commission to reinsert the complainant's health claim in the list submitted to EFSA. They explained that their earlier request to have the health claim withdrawn was based on a misunderstanding (relating to a request by the complainant for the protection of proprietary data which had subsequently been withdrawn).  

9. The Commission replied to the national authorities on 20 September 2010, explaining that the consultation procedure with the Member States for compiling the list of claims to be submitted to EFSA had been finalised in March 2010, with the submission of the consolidated list. The list sent to EFSA thus constituted the agreement of the Member States as regards the totality of health claims sent to EFSA. The Commission concluded that reopening the list would constitute an inopportune precedent, but reminded the national authorities that an individual approval file could still be submitted in accordance with Articles 13(5) and 18 of Regulation 1924/2006.

10. The national authorities then informed the complainant, orally, of the Commission's response. Later, on 5 July 2011, the national authorities sent a copy of the Commission's reply to the complainant.

11. On 16 May 2012, the Commission adopted Regulation 432/2012 establishing a list of permitted health claims made on foods, other than those referring to the reduction of disease risk and to children's development and health[3]. However, for certain health claims included in the consolidated list, the authorisation procedure was still on-going as EFSA's evaluation or the Commission's decision making process was not finalised. Those claims could continue to be used. 

12. On 31 May 2012, the complainant wrote to the Commission again requesting that its health claim be reinserted in the list sent to EFSA. It explained that the earlier withdrawal was due to a simple administrative error by the national authorities. It pointed out that it faced serious negative consequences from the withdrawal of its health claim from the list. It argued that it could not use its weight loss health claim during the extended transitional period whereas other companies whose weight loss health claims were on the list could continue to use them during the transitional period. This, in the complainant's view, constituted unjustified discrimination.

13. The Commission replied to the complainant on 28 June 2012. It pointed out that Article 13(2) of Regulation 1924/2006 made Member States responsible for providing the Commission with the lists of health claims. The Commission stated that the health claim was presented by the relevant national authorities and included in the list for submission to EFSA for evaluation, but that, on 22 December 2009, the national authorities had requested that this claim be withdrawn. In response to their subsequent request for the claim to be reinserted, the Commission explained that the procedure in question had to be considered as finalised in March 2010 by the submission of the consolidated list of health claims to EFSA. The Commission pointed out that, following its letter of 20 September 2010 to the national authorities refusing to reinsert the claim, there had been no further exchange with the national authorities nor with any other Member State in relation to this claim.

14. The Commission suggested to the complainant that it raise the consequences of the matter with the national authorities, mindful of the fact that other health claims relating to the same substance as the complainant's one were included in the list that was pending before EFSA. The Commission concluded that it could not interfere in this question which should be resolved between the complainant and the national authorities.

15. On 9 August 2012, the complainant turned to the European Ombudsman.

The inquiry

16. The Ombudsman opened an inquiry into the complaint and asked the Commission for an opinion on the following allegation and claim:

The Commission was wrong to refuse the request of the national authorities to reinsert the complainant's claim among the claims to be evaluated by EFSA.

The Commission should, as soon as possible, reinsert the complainant's claim among the claims that are currently being evaluated by EFSA.

17. In his letter asking the Commission for an opinion, the Ombudsman noted that the Commission had not argued that it would be illegal to reinsert the health claim in question, but rather, that it would constitute an inappropriate precedent. This seems to imply two things: (i) that there is a risk that other similar requests would be put forward; and (ii) that reinserting this and potentially other health claims could have negative consequences for the on-going procedure. In relation to (i), the Ombudsman asked if the Commission was basing itself on any factual information suggesting that it can expect a large number of similar requests. In relation to (ii), the Ombudsman asked the Commission to describe in detail the negative consequences that reinserting the health claim would have for the procedure in question. This was important so that the Ombudsman could take a view as to whether the Commission's position to refuse to reinsert the health claim was proportionate. In other words, the Ombudsman asked if the Commission could either (i) prove that including the claim now would be illegal; or (ii) provide specific and detailed reasons as to why it could not reinsert the health claim in the list sent to EFSA. .

18. In the course of the inquiry, the Ombudsman received the opinion of the Commission on the complaint and, subsequently, the comments of the complainant in response to the Commission's opinion. In conducting the inquiry, the Ombudsman has taken into account the arguments and opinions put forward by the parties.

Allegation that the Commission wrongly refused to reinsert a health claim and the related claim

Arguments presented to the Ombudsman

19. In support of its allegation, the complainant argued that the national authorities requested the reinsertion of its health claim on the Commission's list to be submitted to EFSA because they had committed an error. It is thus not a question of adding to the list a new claim or a claim that was rejected in the past, but of reinserting, among claims on the list that still have to be evaluated, a claim that was initially communicated by the national authorities to the Commission.

20. In its opinion, the Commission argued that, whereas according to Article 13(2) of the Regulation, Member States had to provide the Commission with their lists by 31 January 2008, they were given considerable additional time to rectify any errors in compiling the list or to add claims to be submitted to EFSA, until 12 March 2010 when the Commission submitted the final consolidated list to EFSA. The Commission described in detail the various steps in the procedure, starting with the submission of a first draft list to EFSA on 31 July 2008 and concluding with the adoption of the final list on 12 March 2010. The granting of additional time (for a period of over two years) to the Member States allowing them to rectify errors or to add claims shows that the Commission acted in a pragmatic manner and took into account the difficulties of the consolidation process resulting from the extremely high number of health claims. The Commission thus concluded that its refusal to reopen the list of health claims submitted to EFSA was justified and does not amount to an instance of maladministration.

21. The Commission argued that reintroducing the health claim would open the door for other claims to be reintroduced as well. It stressed that the compilation of the list of Article 13(2) health claims to be submitted to EFSA for evaluation involved the withdrawal of 123 main entries on 9 November 2009. Accordingly, allowing the health claim to be reinserted would have created (legitimate) expectations for interested parties that, upon mere request of a national authority, claims withdrawn could still be submitted for authorisation after the consolidated list was submitted to EFSA on 12 March 2010. The Commission wanted to safeguard as much as possible the legal certainty of the procedure laid down in Article 13(2) and (3) of the Regulation which requires that the list of claims to be examined by EFSA is final at a certain point in time. The Commission also pointed out that there was a lot of lobbying from food business operators and associations in the field. It explained that if new claims were to be added to the consolidated list, these "claims on hold" would temporarily be allowed to be used without being subject to any scientific assessment. Operators might thus be tempted to make requests for insertion in the consolidated list with the only purpose of temporarily avoiding the scientific assessment of their claims under the procedures of Article 13(4) and (5) while continuing to sell their products to consumers in the meantime.

22. The Commission then pointed out that the fact that the health claim could not be reinserted in the list submitted to EFSA under the Article 13(2) procedure did not mean that the claim could not be submitted under some other procedure available. In particular, the procedures set out in Article 13(4) (a procedure to make changes to the list referred to in Article 13(3)) and 13(5) of the Regulation (a procedure to add claims to the list of permitted claims). The complainant thus had alternative means available for having its health claim authorised and the Commission would act accordingly.

23. In reply to the Ombudsman's specific questions the Commission stated that there were already other requests (including from the Austrian authorities and from a Dutch food business operator) to add claims to the consolidated list. The risk of similar requests being made is particularly high, considering the challenges the Commission received from food operators and other stakeholders to dilute the effects of the application of the Regulation and its implementing rules. The Commission mentioned in this respect that there were then four actions before the General Court for annulment of the Regulation. With regard to possible negative consequences of reinserting the health claim in the consolidated list, the Commission stated that agreeing to reinsert the claim would create a precedent that similar requests would be put forward and create expectations that the list communicated to EFSA could still be amended.

24. The Commission argued that reopening the list in this case would run against legal certainty because, in particular, of the transitional measures applicable to the claims in accordance with Article 28(5) and (6) of the Regulation[4]. The Commission pointed out that 123 claims had been withdrawn and could thus be challenged again by the operators if the consolidated list were to be reopened.

25. In its observations, the complainant pointed out that its health claim was initially contained in the list submitted by the national authorities to the Commission in January 2008, but was then withdrawn by error by the national authorities which confirmed this in their e-mail to the Commission of 1 July 2010.

26. The complainant argued that the Commission had failed in its opinion to reply to the Ombudsman's questions. The Commission did not demonstrate the real probability of a risk of a high number of similar requests for reinsertion of health claims. The Commission referred to only two requests for insertion of health claims (of which only one was made by a Member State), but not to requests for reinsertion of a previously included health claims. The complainant assumes thus that the Commission has not received any other request for the reinsertion of a health claim, and that the complainant's case is an isolated one. The complainant also argued that the actions for annulment of the Regulation and the external pressures by food operators mentioned by the Commission were not relevant for its case, since they did not concern the situation of a request for reinsertion of a health claim which was withdrawn due to an acknowledged error by a national administration.  The Commission can therefore not argue that the risk of similar requests is particularly high. The complainant stated that the Commission had referred only to purely hypothetical situations of similar requests being made.

27. The complainant stated that the Commission has not described the possible negative consequences that reinserting the health claim would have on the procedure. It argued that, in reality, the reinsertion of its health claim would have no consequences on the procedure.

28. The complainant stated that the Commission had also not demonstrated that reinserting its health claim would be illegal. It argued that the Commission wrongly invoked the principle of legal certainty. The complainant pointed out that the Commission itself had not respected - in a spirit of pragmatism - the deadline of 31 January 2008 (mentioned in Article 13(2) of the Regulation) by which Member States had to submit to it the lists of health claims. It argued that its claim was contained in the list initially submitted before the date of 31 January 2008. Moreover, the deadline of 31 January 2010 for the adoption by the Commission of the list of authorised claims was also not respected, since the list was adopted with a delay of 15 months. It is thus the legal certainty of the complainant which was violated in a flagrant way. The complainant argued that its health claim would still be contained in the list of "claims on hold" sent to EFSA had the Commission not extended in an arbitrary way the deadline of 31 January 2008 for submissions by Member States, thereby infringing the Regulation.

29. The complainant finally pointed out that the alternative solution proposed by the Commission was not an acceptable one. It argued that it had already suffered irreparable damages (not only profit loss, but also loss of the market to the advantage of its competitors whose health claims are pending) and that the damage would be even worse because of the length of the alternative procedure of Article 13(5). This procedure can thus not be seen as a remedy to correct an error committed by the national administration and the lack of cooperation by the Commission. On the basis of the above, the complainant maintained its demand that its health claim should be reinserted in the list of pending health claims.

The Ombudsman's assessment

30. The dispute in this case is about the reasoning put forward by the Commission's for why, once the national authorities recognised their error and asked the Commission to correct it by reinstating the complainant's health claim on the list sent to EFSA, it had to refuse that request.

31. The Ombudsman notes that Article 13(2) of the Regulation provides that Member States shall provide the Commission with lists of claims as referred to in paragraph 1 by 31 January 2008 at the latest accompanied by the conditions applying to them and by references to the relevant scientific justification. The Regulation does not provide any possibility for the Member States, after expiry of the deadline (which in the present case was extended), to change the list or to include new claims in the list sent to the Commission. The Ombudsman notes also that the Commission submitted various arguments as to why it could not reinsert a health claim or create an additional list after the submission procedure of Article 13(2) was closed. The arguments put forward by the Commission are reasonable.

32. It is reasonably foreseeable and not purely hypothetical to consider that other interested parties could claim the same as the complainant, namely the reopening of the procedure. Therefore, if the Commission had made an exception in the case of the complainant, others could expect that they would receive the same treatment. In this regard, the Ombudsman in particular notes that 123 other health claims were withdrawn from the list, according to the Commission.

33. Moreover, if the Commission were to agree to reinsert the complainant's health claim by creating, for instance, an additional list to be sent to EFSA, it would need to reopen the entire submission procedure foreseen in Article 13(2) of the Regulation and to set a new deadline for all submissions. It does not matter whether these new submissions would be reinsertions for whatever reason or insertions for the first time. The procedural effect would be the same. As rightly argued by the Commission, this would create legal uncertainty and unjustified delay. In addition, the Member States which all received additional time to correct their mistakes would be encouraged to be less diligent because mistakes in the lists of health claims could be corrected at any time by the Commission, upon Member States' requests.

34. It is also correct to say, as the Commission does, that there is another authorisation procedure with the same effect available, namely under Articles 13(5) and 18 of the Regulation.

35. Finally, the Commission's suggestion that the complainant should address itself to the national authorities in order to seek redress appears entirely reasonable. The complainant has indeed the possibility to claim damages from the national authorities for the damage it allegedly suffered as a result of their mistake.

36. On the basis of the above, the Ombudsman concludes that there has been no maladministration by the Commission in this case.

37. This conclusion is not affected by the complainant's observation that the Commission itself did not respect the deadline of 31 January 2008 by which the Member States had to send to it the lists of health claims. The complainant in other words argues that, had the deadline of 31 January 2008 been respected and not been extended, the issue of the withdrawal of its health claim would not have arisen since the national authorities would not have been able to make the mistake. This argument does not in fact support the complainant's case. First, the Ombudsman points out that the complainant's health claim which was included in the list sent to the Commission by the deadline of 31 January 2008 contained a request for the protection of proprietary data and could thus not have benefited from the procedure of Article 13(2) of the Regulation. It would thus have been against the complainant's own interests if the Commission had abided by the deadline of 31 January 2008. Second, by having allowed Member States to rectify, until 12 March 2010, lists previously submitted, the complainant was in fact given a chance to submit a new file to the national authorities not containing a request for the protection of proprietary data. It was therefore also in the complainant's interest - leaving aside the subsequent error made by the national authorities - that the deadline of 31 January 2008 was extended.

Conclusion

On the basis of the inquiry into this complaint, the Ombudsman closes it with the following conclusion:

There was no maladministration by the Commission.

The complainant and the Commission will be informed of this decision.

 

Emily O'Reilly