Case T‑296/12

The Health Food Manufacturers’ Association and Others

v

European Commission

‛Consumer protection — Regulation (EU) No 432/2012 — Health claims made on foods — Actions for annulment — Regulatory act not entailing implementing measures — Whether directly concerned — Admissibility — Infringement of Articles 13 and 28 of Regulation (EC) No 1924/2006 — Principle of sound administration — Non-discrimination — Incorrect assessment criteria — Regulation No 1924/2006 — Plea of illegality — Right to be heard — Legal certainty — Unreasonable transition period — List of claims on hold’

Summary — Judgment of the General Court (Eighth Chamber), 12 June 2015

Actions for annulment — Actionable measures — Concept — Measures producing binding legal effects — Preparatory measures — Not included — List published by the Commission of health claims under assessment and falling within the transitional regime laid down by Regulation No 1924/2006 — Act serving only to prepare for the final decision — Not included

Plea of illegality — Scope — Measures the illegality of which may be pleaded — General measure providing the basis of the contested decision — Need for a legal connection between the contested measure and the contested general act

Judicial proceedings — Application initiating proceedings — Formal requirements — Identification of the subject-matter of the dispute — Brief summary of the pleas in law on which the application is based — General reference to documents annexed to the application — Inadmissibility

Approximation of laws — Nutritional and health claims concerning foodstuffs — Regulations No 178/2002 and No 1924/2006 — Scientific assessment of risks — Health claims other than those referring to the reduction of disease risk and to children’s development and health — Application of Regulation No 1924/2006 as a lex specialis — Consequences

Approximation of laws — Nutritional and health claims concerning foodstuffs — Regulations No 178/2002 and No 1924/2006 — Health claims other than those referring to the reduction of disease risk and to children’s development and health — Adoption of the harmonised list of permitted claims — No obligation to adopt guidelines concerning assessment by the European Food Safety Authority (EFSA) of applications for approval of claims — No breach of the principle of legal certainty

Approximation of laws — Nutritional and health claims concerning foodstuffs — Regulation No 1924/2006 — Scientific assessment of risks — Requirement for a high level of health protection — Less stringent assessment carried out for health claims other than those referring to the reduction of disease risk and to children’s development and health — Exclusion

Approximation of laws — Nutritional and health claims concerning foods — Regulation No 1924/2006 — Health claims other than those referring to the reduction of disease risk and to children’s development and health — Adoption of the harmonised list of permitted claims — No obligation first to consult producers in the sector and other interested parties

Approximation of laws — Nutritional and health claims concerning foods — Regulation No 1924/2006 — Health claims other than those referring to the reduction of disease risk and to children’s development and health — Adoption of the harmonised list of permitted claims — Establishment of provisional measures applying to health claims on hold or under assessment — Identification of on-hold claims by reference to a number of websites — No breach of the principle of legal certainty

Approximation of laws — Nutritional and health claims concerning foods — Regulation No 1924/2006 — Health claims other than those referring to the reduction of disease risk and to children’s development and health — Adoption of the harmonised list of permitted claims — Application by the Commission of transitional measures to claims on hold or under assessment — Lawfulness

Approximation of laws — Nutritional and health claims concerning foodstuffs — Regulation No 1924/2006 — Health claims other than those referring to the reduction of disease risk and to children’s development and health — Adoption of the harmonised list of permitted claims — Commission exceeding a procedural time-limit — Relevance to the legality of the measure concerned — Conditions

Approximation of laws — Nutritional and health claims concerning foodstuffs — Regulation No 1924/2006 — Health claims other than those referring to the reduction of disease risk and to children’s development and health — Adoption of the harmonised list of permitted claims — Discretion of the Commission — Judicial review — Limits

Actions for annulment — Admissibility criteria — Interest in bringing proceedings — Bringing of a single action by two applicants — Admissibility of the action of one of the applicants — No need to examine the admissibility of the action in relation to the second applicant

The concept of ‘regulatory act’ for the purposes of the fourth paragraph of Article 263 TFEU must be understood as covering all acts of general application apart from legislative acts. Regulation No 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, constitutes a regulatory act. The said regulation was adopted by the Commission exercising its implementing powers, under the regulatory procedure with scrutiny, and, consequently, does not constitute a legislative act. Moreover, Regulation No 432/2012 is of general application in that it covers situations which are determined objectively and entails binding legal effects for a class of persons envisaged in a general and abstract manner. (see paras 34-37)

The condition of direct concern for the purposes of the fourth paragraph of Article 263 TFEU requires, first, that the contested measure directly affect the legal situation of the applicant and, secondly, that it leave no discretion to its addressees, which are entrusted with the task of implementing it, such implementation being purely automatic and resulting from the contested legislation itself without the application of other intermediate rules. In the case of an action brought against Regulation No 432/2012, it is for the applicant to identify, in order to demonstrate that it is directly affected for the purposes of the fourth paragraph of Article 263 TFEU, the claims concerned by the regulation which have an adverse effect on its legal situation. More specifically, it is required to demonstrate that, at the time of bringing its action before the Court, it used, in commercial communications relating to their products, claims which have been prohibited following the adoption of Regulation No 432/2012. In so far as it demonstrates that, in the marketing of its products, it was using health claims rejected by Regulation No 432/2012, it must be held that that regulation is capable of affecting its legal situation. Moreover, Regulation No 432/2012 does not leave any discretion to its addressees, since its implementation is clearly purely automatic and results from the contested regulation itself without the application of other intermediate rules. In that regard, pursuant to Article 2 of Regulation No 432/2012, the regulation is binding in its entirety and directly applicable in all Member States. (see paras 38, 40, 41, 44)

The activity of the Court of Justice and of the General Court is governed by the principle of the unfettered evaluation of evidence, and that it is only the reliability of the evidence furnished which is decisive when it comes to the assessment of its value. In order to assess the probative value of a document, regard should be had to the credibility of the account it contains, taking account in particular of the person from whom the document originates, the circumstances in which it came into being, the person to whom it was addressed and whether, on its face, the document appears to be sound and reliable. In that regard, the value of documents produced by an applicant must be held to be sufficiently established in the case of statements produced at the specific request of the Court, signed by the directors of the applicant undertaking, who are deemed to be in a position to be able to provide precise details in response to the information requested, and submitted via the lawyer representing the applicants in their action, who, as a collaborator in the administration of justice and as a result of the ethical requirements to which he is subject, is required to ensure the authenticity and veracity of those documents. (see para. 42)

See the text of the decision. (see para. 43)

The concept of regulatory acts which do not entail implementing measures, for the purposes of the fourth paragraph of Article 263 TFEU, is to be interpreted in the light of that provision’s objective, which, as is clear from its origin, consists in preventing an individual from being obliged to infringe the law in order to have access to a court. The question whether a regulatory act entails implementing measures should be assessed by reference to the position of the person pleading the right to bring proceedings under the third limb of the fourth paragraph of Article 263 TFEU. It is therefore irrelevant whether the act in question entails implementing measures with regard to other persons. In order to determine whether the measure being challenged entails implementing measures, reference should be made exclusively to the subject-matter of the action and, where an applicant seeks only the partial annulment of an act, it is solely any implementing measures which that part of the act may entail that must, as the case may be, be taken into consideration. Regulation No 432/2012 applies, by definition, automatically to associations of producers of food supplements, and its application does not require any measures on the part of national or European public authorities. It follows that Regulation No 432/2012 does not entail implementing measures within the meaning of the fourth paragraph of Article 263 TFEU. (see paras 46-50)

The EU legislature conferred on the Commission, by means of Article 13 of Regulation No 1924/2006, on nutrition and health claims made on foods, the task of establishing, at EU level, a harmonised list of authorised health claims, other than those referring to the reduction of disease risk and to children’s development and health. However, the wording of Article 13 of Regulation No 1924/2006 does not specify whether the lists of authorised health claims had to be adopted all at once, as claimed by the applicants, or whether, by contrast, that list could be adopted in several stages, thereby permitting the Commission to postpone the authorisation of the health claims whose evaluation, either by the European Food Safety Authority (EFSA) or itself, was still ongoing. In that regard, in the light of the objectives of Regulation No 1924/2006, as they appear both from recitals 1 and 2 in its preamble and from Article 1 thereof, Article 13(1) to (3) of the said regulation must be interpreted as containing an obligation for the Commission only to attain a result, namely that of adopting, after consulting EFSA, the list of permitted claims on the basis of the national lists provided by the Member States. There is nothing in the wording of that article of Regulation No 1924/2006, or in the recitals in the preamble to that regulation, which suggests that the EU legislature sought to deprive the Commission of its discretionary power to establish that list on a gradual basis and, in particular, to add to that list as and when technical evaluations have been completed by EFSA and verify itself the conditions established in the regulation. On the contrary, Article 13(1) to (3) of Regulation No 1924/2006 leave it to the discretion of that institution to define, in accordance with the principles laid down in Regulation No 1924/2006 and in EU law, the speed at which the list of permitted claims is to be adopted. In that regard, if the Commission is to be able to pursue effectively the objective assigned to it, account being taken of the complex technical assessments which it must undertake, it must be recognised as enjoying a broad discretion. Consequently, review by the EU judicature of the Commission’s assessments in a complex area is limited to such matters as examining whether exercise by the EU institutions of their powers is vitiated by a manifest error of assessment or a misuse of powers or whether the institutions have manifestly exceeded the limits of their discretion. (see paras 59, 60, 64, 65, 73)

See the text of the decision. (see paras 61-63)

Although it is true that, under Article 13(3) of Regulation No 1924/2006, the Commission was required to adopt the complete list of permitted claims by 31 January 2010 at the latest and that that list was adopted only in part by Regulation No 432/2012 on 16 May 2012, in the absence of a provision setting out either expressly or implicitly the consequences of failure to comply with procedural time limits, such a failure can entail the annulment, in whole or in part, of the measure to be adopted within the period in question only if it is shown that, had it not been for such an irregularity, the content of the measure might have been substantively different. (see para. 71)

It is apparent from the wording of Article 28(5) and (6) of Regulation No 1924/2006 that the application of transitional measures is provided for in respect of health claims which are in the evaluation process and in respect of which a decision is yet to be adopted by the Commission. Accordingly, irrespective of their classification within the three categories provided for in Article 13(1) of that regulation, there is nothing preventing claims which are on hold, waiting to be evaluated by EFSA or to be examined by the Commission, from benefiting from the transitional scheme provided for in that regulation. (see para. 83)

The fact that, for the purpose of identifying on-hold health claims that may still be used in accordance with Article 28(5) and (6) of Regulation No 1924/2006, following the adoption of Regulation No 432/2012, recitals 4 and 11 in the preamble to Regulation No 432/2012 refer to the websites of EFSA and the Commission, which make available to the public (i) the consolidated list of all ID codes of the health claims which have be submitted by the Member States pursuant to Article 13(2) of Regulation No 1924/2006 and (ii) the list setting out the ID codes of those claims which have been placed on hold, as well as the ID codes of the health claims which have been rejected does not constitute an infringement of the principle of legal certainty, which requires that legal rules be clear and precise, and that their consequences be foreseeable. In that regard, although it would have been desirable for the Commission to adopt, for both the on-hold claims and the rejected claims, a list bearing a similar format to the list of permitted claims, annexed to Regulation No 432/2012, in order to make the task of identification easier for interested parties, the fact that, in this instance, the Commission adopted a different approach cannot suffice to support a complaint of a lack of clarity or precision in that regard. Moreover, the fact that the authorities of a Member State consider it somewhat difficult to research which health claims are on hold is not, in itself, sufficient to accuse the Commission of a lack of precision or clarity, in so far as the claims placed on hold can be found by consulting the documents made publicly available by the Commission and EFSA. Similarly, the decision of the said authorities to provide a tool to food producers cannot be regarded as revealing the defective nature of Regulation No 432/2012, so as to bring about its annulment, but rather as a support mechanism put in place by those authorities, of their own volition, in exercising their powers. (see paras 86, 87, 89)

Pursuant to Article 41(2)(a) of the Charter of Fundamental Rights, the right to sound administration includes, inter alia, the right of every person to be heard, before any individual measure which would affect him or her adversely is taken. However, the right to sound administration, as it results from that provision, does not cover the process of enacting measures of general application. The right to be heard in an administrative procedure affecting a specific person cannot be transposed to the context of a legislative process leading to the adoption of general laws. Thus, in so far as Regulation No 432/2012 constitutes an act of general application, Article 41 of the Charter of Fundamental Rights is not applicable. (see paras 97-99)

Article 13(1) to (3) of Regulation No 1924/2006, as a legal basis for the adoption of Regulation No 432/2012, does not provide that the Commission is required to consult food business operators and other interested parties in the adoption procedure for the list of permitted claims. It is apparent from Article 13(2) of that regulation that only the Member States were empowered to provide the Commission with national lists of health claims intended to form the basis of the list of permitted claims. Accordingly, an applicant cannot invoke an infringement by the Commission of any right, on its part, to be consulted, based on Article 13(1) to (3) of Regulation No 1924/2006, in relation to the decision to adopt the list of permitted claims in several stages. (see para. 100)

See the text of the decision. (see paras 105, 110)

See the text of the decision. (see para.113)

It is apparent from a combined reading of recital 17 and Articles 5 and 6 of Regulation No 1924/2006 that the said regulation requires, first, that only health claims which have been scientifically proven may be used in the European Union and, second, that those claims are to be permitted only after a harmonised scientific evaluation by EFSA meeting the highest possible standards. That consideration is also applicable to the authorisation procedure referred to in Article 13(1) to (3) of Regulation No 1924/2006, in the context of which the Commission cannot request from EFSA a less stringent scientific evaluation in relation to claims coming under Article 13(5) of that regulation or Article 14 thereof. In that regard, it must be held that none of the provisions referred to above introduces different conditions, as regards the scientific evaluation to be carried out, between health claims depending on the provision which is applicable to them. Moreover, a scientific risk assessment carried out as thoroughly as possible on the basis of scientific advice founded on the principles of excellence, transparency and independence is an important procedural guarantee whose purpose is to ensure the scientific objectivity of the measures adopted and preclude any arbitrary measures. (see paras 129, 130)

Neither Regulation No 1924/2006 nor Regulation No 178/2002 contains any obligation for the Commission or EFSA to provide, before commencing the review procedure under Article 13(3) of Regulation No 1924/2006, specific scientific guidelines concerning how EFSA plans to review applications for approval of claims. The fact that EFSA subsequently adopted such guidelines in the light of the experience which it gained during the first reviews it carried out, is not such as to demonstrate an infringement of the principle of legal certainty. On the contrary, the adoption of those guidelines adds to legal certainty as regards interested parties, inter alia. (see para. 149)

It follows from the system established by Regulation No 178/2002, laying down the general principles and requirements of food law, establishing EFSA and laying down procedures in matters of food safety, in particular by Article 30 thereof, that, so far as concerns the requirements governing the procedure for adopting scientific opinions, that regulation constitutes an additional set of rules in relation to Regulation No 1924/2006, the application of which is precluded to the extent to which an EU rule, such as that regulation, contains specific provisions for the authorisation of health claims. In that regard, in so far as Article 13(3) of Regulation No 1924/2006 provides expressly that EFSA is entrusted with the task of performing the harmonised scientific evaluation of the lists of claims submitted by the Member States in accordance with Article 13(2) of that regulation, it must be held that Article 30(4) of Regulation No 178/2002 is not applicable in the context of the assessment of health claims other than those referring to the reduction of disease risk and to children’s development and health, with the result that EFSA is not required either to enter into negotiations with national authorities or to make public the documents accompanying those discussions in the context of the evaluations carried out. (see paras 160, 161)

See the text of the decision. (see para. 162)

The possibility provided by Article 277 TFEU of invoking the illegality of a measure of general application does not constitute an independent right of action and may only be sought incidentally, since where the main action is inadmissible the plea of illegality must also be declared inadmissible. Moreover, a plea of illegality raised indirectly under Article 277 TFEU, when challenging in the main proceedings the legality of another measure, is admissible only if there is a link between the contested measure and the provision forming the subject-matter of the plea. Since the purpose of Article 277 TFEU is not to enable a party to contest the applicability of any measure of general application in support of any action whatsoever, the scope of a plea of illegality must be limited to what is necessary for the outcome of the proceedings. It follows that the general measure claimed to be illegal must be applicable, directly or indirectly, to the issue with which the action is concerned. In that regard, the existence of such a link may be inferred, inter alia, from the finding that the measure against which the main action has been brought is essentially based on a provision of a measure whose legality is contested. (see paras 169, 170, 172)

Any measure the legal effects of which are binding on and capable of affecting the interests of the applicant by bringing about a distinct change in his legal position is an act or a decision which may be the subject of an action under Article 263 TFEU for a declaration that it is void. To determine whether an act or decision produces such effects, it is necessary to look to its substance. Moreover, in the case of acts or decisions adopted by a procedure involving several stages, in principle an act is open to review only if it is a measure definitively laying down the position of the institution on the conclusion of that procedure, and not a provisional measure intended to pave the way for the final decision. A list published by the Commission of health claims which are on hold pending assessment by EFSA or examination by the Commission, and which may be used in accordance with the transitional regime laid down by Article 28(5) and (6) of Regulation No 1924/2006 does not constitute a challengeable act. The adoption of a list the sole purpose of which is to compile a register of the health claims which are still being evaluated and in respect of which the Commission has not made a final decision constitutes merely an interim measure the purpose of which is to determine which health claims are, and which are not, to be included on the list of permitted claims. It is that latter list which constitutes the final decision. (see paras 201-203)

See the text of the decision. (see paras 206, 207)