This judgement was published on 26 January. It resolves an appeal lodged against a decision of the Spanish Medicines Agency (AEMPS) that declared, in June 2019, that a product being marketed as a food supplement in Spain should be classified as a medicinal product.

The appellant relied on the principle of mutual recognition. The product was lawfully marketed in Portugal as a food supplement, which would allow it to be marketed in Spain.

On the application of the principle of mutual recognition

This judgment upholds the decision of the AEMPS regarding the prohibition to market the product. Although this decision is based on various merits, the rationale regarding the application of the principle of mutual recognition is nonetheless striking.

According to this principle, a Member State may not prohibit the sale of products that are legally marketed in another Member State, even if they have been produced according to different technical standards. States must clearly justify the grounds for restricting or refusing market access on the basis of “overriding reasons relating to the public interest”. A restriction to market access may only be justified on reasons of public interest if there are legitimate differences between the technical rules across States.

This judgment denies the application of the principle of mutual recognition by arguing that, pursuant to article 2(2) of Regulation 764/2008 (which is incorrectly quoted, as it was repealed by Regulation 2019/515), a State may prohibit marketing a product that is legally marketed in another Member State on the basis of a technical rule “that prohibits marketing a product in Spanish territory”. The judgment considers article 9(1) of RDL 1/2015 as a technical rule, whereby a marketing authorisation must be held for all medicinal products.

This interpretation, according to which RDL 1/2015 is a “technical rule” for the purposes of the application of Regulation 2019/515, is extraordinarily broad and allows the principle of mutual recognition to be artificially circumvented. In fact, Regulation 2019/515 states that prior authorisation procedures do not constitute technical rules and recalls that technical provisions are those covering aspects that have not been harmonised at Union level. This is clearly not the case of marketing authorisation requirements for medicinal products, which are set out in Directive 2001/83/EC.

La entrada Construction of the principle of mutual recognition in the marketing of food supplements aparece primero en Faus Moliner.

Since the mid-seventies, food products intended for dietary purposes and/or for particular nutritional uses have been regulated in Spain by Royal Decree 2685/1976. By means of such Royal Decree, the technical-healthcare regulations applicable to these products were approved. Thereafter, several modifications and further regulations on this matter have taken place. The considerable period of time elapsed, the scientific developments, and the gradual regulation of these products by EU regulations, have made Spanish legislation on this matter partially obsolete. For that reason, Spanish lawmakers have consider it necessary to simplify such Spanish legislation and adapt it to the control mechanisms provided by European regulations, in particular, to Regulation (EU) No 609/2013 of the European Parliament and of the Council of 12 June 2013 on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control, and delegated acts adopted pursuant to this Regulation.

Communication of placing on the market

The new Royal Decree 1412/2018 repeals the old one from 1976, and reorders these products, which are now called “food products destined for certain population groups” and which are grouped into the following categories: (a) infant formula, (b) follow-on formula based on protein hydrolysates, (c) follow-on formula based on substances other than those incorporated in the previous formulas, (d) foods for special medical purposes, and (e) total diet replacement for weight control.

Prior or simultaneous to the placing of any of these products on the Spanish market, the entity whose name and address appears on the label must send a notification using electronic means to the competent authorities. Such competent authorities are either ones of the Autonomous Region where the company has its registered offices or, in case such company is not registered in Spain, the Spanish Agency for Food Safety and Nutrition. The notification must include a copy of the product’s label and, if applicable, the EU Member State(s) where such product is already being legally marketed. Moreover, the authorities may request further information when they consider it necessary for effective control purposes. The inaccuracy, falsification or omission of essential data will imply that the product cannot continue being marketed. Labeling modifications as well as termination of placing on the market must also be notified.

Public provision of dietary products

The new Royal Decree includes provisions regarding how the National Health System will work when it comes to dietary products. The inclusion of foods for special medical purposes in the National Health System, therefore, their financing with public funds, will require a favorable decision of the competent authority responsible for receiving the notification of placing on the market of the relevant product. In case the authorities are regional, they must communicate their favorable decision to the Spanish Agency for Food Safety and Nutrition.

La entrada News on food products intended for specific groups of the population aparece primero en Faus Moliner.

On 28 March 2018, the Royal Decree 130/2018, of 16 March, amending Royal Decree 1487/2009, of 26 September, regarding food supplements, came into force. The purpose of the new Royal Decree is to update and clarify the regulatory framework applicable to food supplements in Spain. The main aspects regulated by this new regulation are the ones indicated below.

Nutrients and other substances

According to the applicable regulation, both in the EU and Spain, substances used in the manufacturing of food supplements are classified as “nutrients” and “other substances”.

The concept of “nutrients” is fully harmonized at European level, as there is a list applicable to the entire EU in which it is specifically stated which are the nutrients (understood as vitamins and minerals) that can be used to manufacture food supplements.

On the other hand, the concept of “other substances” is not harmonized in the European Union and, so far, has not been defined by Spanish legislation either. The new Royal Decree puts an end to this situation and incorporates a list of which are the “other substances” that may be used to manufacture food supplements in Spain. Moreover, such list contains moreover certain safety warnings with respect to such “other substances” that must be included in the labeling of such supplements.

Mutual recognition

The new Royal Decree expressly foresees the mutual recognition principle already contained in the European law which aims to guarantee the free circulation of food supplements in the EU market.

Such principle provides that if there are food supplements legally manufactured or marketed in an EU Member State it should be allowed for them to be marketed in Spain, regardless of the fact that they contain substances (other than nutrients) not specifically included in the new Royal Decree.

From our point of view, it would be desirable that the Spanish authorities provide a flexible interpretation of the new Royal Decree so that:

(i) it is allowed that food supplements which are legally marketed in other Member States enter into the Spanish market, and

(ii) national producers have the possibility to market in Spain food supplements containing substances not expressly included in the new Royal Decree, as long as such producers can prove that there is another food supplement with the same composition as the one that is intended to be marketed in Spain, which is being legally marketed in another Member State.

La entrada More possibilities in relation to the substances that can be used in the manufacturing of food supplements aparece primero en Faus Moliner.

A French distributor of food supplements was subject to criminal proceedings for selling, without authorisation, products whose contents exceeded the maximum amounts of nutrients that may be used pursuant to French regulations (Order 2006).

In the context of this procedure, the company claimed that the Order 2006 did not comply with EU law. As a result, the Tribunal de grande instance de Perpignan decided to refer three questions to the CJEU for a preliminary ruling.

Position of the CJEU

The first question referred to the CJEU was about the compatibility of the Order 2006 with Community principles of free movement of goods and of mutual recognition, given that said order did not establish a procedure for authorising the sale of food supplements for which the maximum amounts of nutrients exceeded those established by the order, in the event that said supplements were lawfully marketed in another Member State.

The CJEU established that the Order 2006 should set out a procedure that was readily accessible and could be completed within a reasonable time making it possible to obtain authorisation for the sale of food supplements lawfully manufactured or marketed in another Member State, even if their nutrient content exceeds the content allowed by Law.

Furthermore, it asserted that authorisation may only be refused if food supplements pose a genuine risk to public health and that said refusal must be open to challenge before the courts.

In terms of the second question posed, concerning the procedure for setting maximum amounts, the CJEU established that setting these amounts must be undertaken, on a case-by-case basis, taking into account the upper safe levels of the nutrients concerned, following a scientific assessment of the risks to human health. Furthermore, the court ruled that said assessment must be based on the relevant scientific data and not on purely hypothetical considerations.

In response to the third and final question, also regarding the setting of maximum amounts, the CJEU asserted that the scientific assessment of the risk mentioned in the preceding paragraph must not be based solely on national scientific opinions.

The judgment also states that recent and reliable international scientific opinions must be considered, based on which it concluded in favour of the possibility of setting higher limits of nutrients.

La entrada New possibilities in terms of the maximum amount of nutrients in food supplements aparece primero en Faus Moliner.

In 2012 the European Commission (EC) adopted Regulation 432/2012 authorising a list of health claims made on foods. Such list was issued in compliance with Regulation 1924/2006 which laid down the principle that such health claims need to be based on proper scientific evidence, entrusted the EC with the approval of a list of permitted claims based on the evaluation of the European Food Safety Authority (EFSA), and prohibited health claims made on foods that did pass this evaluation satisfactorily. On the same day the EC published on its webpage a second list of claims -regarding botanical substances– that were still being evaluated, and therefore they remained on hold and could continue to be used provisionally until a decision was reached.

Several food companies established in the United Kingdom and in the Netherlands brought an action for annulment against Regulation (EU) No 432/2012 as they understood that the evaluation criteria applied by EFSA to the scientific evidence were excessively stringent and erroneous. The applicants, moreover, argued that the health claims that were being used beforehand should benefit from a presumption of veracity, considered that their right to be heard before the approval of the list had been infringed, and they blamed the EC for having approved a list of health claims on hold that was not laid down in the regulation of 2006.

The position of the Court

The Court rejected the first argument based on the fact that Regulation 1924/2006 provides that these claims should only be authorised for use in the European Union after passing a scientific assessment of the highest possible standard by the EFSA. Also, the Court highlights that the applicants did not prove that the evaluation criteria applied by the EFSA were erroneous.

The Court also rejects the argument of fundamental rights being violated. The Court reminded that it is a fundamental principle of EU law, recognized by Article 41 of the Charter of Fundamental Rights, to warrant the defence right in every proceeding in which the person concerned might be adversely affected. But such right does not apply to this case insofar as the regulation does not aim to prohibit the marketing of the applicants’ goods but only to prevent the use of promotional claims which are not consistent with the requirements of the Union’s law.

Finally, it points out that the second list of claims on hold does not constitute a challengeable act, since an act is open to review only if it is a measure definitely laying down the position of the EC, and since the regulation of 2006 does not preclude the adoption of the list of permitted claims in several successive stages.

La entrada Approval of the list of the European Commission on health claims made on foods aparece primero en Faus Moliner.