News

Following the referral by the dBGH on I ZR 109/22 a preliminary ruling procedure is pending before the ECJ on C-386/23, in which the Opinion of the Advocate General was published. The text is kept as simple as possible and I will avoid excessive quotations. Lawyers may forgive me for this, but reproducing lines of case law will not help anyone. In my perception, there were already (deliberately coined?) statements in these proceedings when the question referred was published to the effect that health claims for botanicals were inadmissible. In my opinion, the opposite is the case, although of course the ECJ's decision remains to be seen. The statements are therefore subject to the condition that the ECJ follows the Advocate General.

The member states were to submit lists of health claims to the Commission by 31.01.2008, which they did. This closed the circle of possible health claims according to this list procedure.The Commission subsequently examined these claims and they were published in a separate list (Regulation as a delegated act) ( VO 432/2012). As is well known, however, not all of the lists submitted.

Since 31.01.2008, new health claims (claims based on new scientific evidence) can only be authorized according to the procedure of Art 18 (I am talking about claims other than risk-reduction claims or children's claims). This very brief historical outline is relevant to the transitional provisions cited by the Advocate General.

Current practice in Austria

To date, the predominant advisory practice - at least in Austria - and in my opinion also the assessment practice of the authorities has been as follows:

• Is a claim for a plant substance to be considered health-related?
• If so, is it “on-hold”?
• If yes, does the substance used for the on-hold claim correspond to the advertised substance?
• If so, is there generally accepted scientific data to justify it?
• If yes, which is to be assessed under the responsibility of the entrepreneur, the claim may be used under the other provisions of the HCVO (e.g. Art 5 and 10)?

This is based on the transitional provisions mentioned in the HCVO, which are now also cited by the Advocate General. However, a distinction must be made between these.

Transitional provisions

The Advocate General begins by saying in a sentence of 153 words (in German) that the HCVO precludes the use of claims for botanicals as long as the Commission's examination of inclusion in the relevant lists has not been (positively) completed, i.e. the claim is not on the list under Regulation 432/2012. But if you stop reading here, you are missing the point: This does not apply if the information may be used on a transitional basis in accordance with Art 28 (5) or (6).

So what do these two (not easy to grasp) transitional provisions mean?

Art 28 para 5 regulates for claims according to Art 13 para 1 lit a (importance for growth, development and bodily functions) that these

• until the adoption of the lists pursuant to Art 13 (3)
• under the responsibility of the entrepreneur

may be used if they

• comply with the HCVO and national legislation.

In concrete terms, this means that the lists in accordance with Art. 13 para. 3 are not adopted in full. The claim may be used under the responsibility of the entrepreneur. However: it must still be on-hold! This criterion is not clearly stated by the Advocate General, nor in some of the literature. However, it undoubtedly follows from the requirement that the claim must comply with the HCVO. However, this is only fulfilled in two variants:

• Either the information is included on the lists of the member states that were sent to the Commission by January 31, 2008 (then on-hold for botanicals).
• Or a new application is made in accordance with Art 13 (5) (then not on-hold but assessed in accordance with the procedure under Art 18).

A health claim that does not fulfill either of these conditions does not comply with the HCVO because there is no scenario of admissibility under the HCVO for it.

Health claims on botanicals about growth, development and bodily functions may therefore be used according to the previous assessment practice. If a botanicals claim has never been placed on the on-hold list, it may not be used (also if it has already been assessed negatively).

Since 2012, this follows from recitals 10 and 11 of Regulation 432/2012 ((10) From the claims submitted for evaluation, the Commission has identified a number of claims relating to the effects of botanicals, commonly referred to as “botanicals”, which have yet to be scientifically evaluated by the Authority. Certain other health claims also need to be re-evaluated before the Commission can decide on their inclusion in the list of permitted claims, or other claims already evaluated cannot be finalized by the Commission at this stage for other justified reasons. (11) Claims awaiting evaluation by the Authority or verification by the Commission shall be published on the Commission website and may continue to be used in accordance with Article 28(5) and (6) of Regulation (EC) No 1924/2006.

Art 28 para 6 regulates transitional provisions for (abbreviated) claims on mental function, weight, hunger and the health and development of children and recognizes two case groups:

• Claims that were authorized in a member state.

Sie werden von der Kommission bewertet und zugelassen oder nicht. Werden sie nicht zugelassen (daher abgelehnt) dürfen sie noch 6 Monate nach dem Beschluss verwendet werden. Mangels Beurteilung (on-hold) dürfen sie daher weiter verwendet werden. Sonstige Voraussetzungen gibt es keine. Die Zulässigkeit richtet sich nur nach nationalem Recht (Rn 49 im Schlussantrag des GA).

• If these claims were not approved nationallyan “application” under the HCVO had to have been submitted for them before January 19, 2008.

Application is generally a difficult term because there was no application procedure for the claims under Art 13 para 1 lit b and c (abbreviated: psyche and weight), but rather the lists. The fact that an additional application pursuant to Art 13 (5) is required for admissibility in the case of on-hold status does not appear to be appropriate. Therefore, in my opinion, the assessment as on-hold must also suffice here, although one can also be of the opposite opinion. These claims were a) never authorized nationally and b) no other requirements apply (e.g. corporate responsibility, Art 5 and 10 HCVO).

In a nutshell

In summary, it can therefore be said that hardly anything is likely to change in practice if the ECJ follows the Advocate General. Health claims that are on-hold may be used under certain conditions. What remains unclear is the legal situation of claims on psyche and weight that have never been approved nationally and are on-hold according to the list procedure of Art 13 para 2.

Jakob Hütthaler-Brandauer

PS: Artichoke contributes to the normal function of the digestive tract.