Free Movement of Goods

One of the means to ensure the free movement of goods within the internal market, is the principle of mutual recognition. The principle derives from the case-law of the Court of Justice of the European Union and stems from Articles 34-36 of the Treaty on the functioning of the European Union and is further defined in Regulation (EU) 2019/515 on the mutual recognition of goods lawfully marketed in another country.

Ex.: With applying the mutual recognition principle, products lawfully marketed in one Member State can be sold in other Member States regardless of complying or not with the national technical rules of these Member States.

According to article 1 of Regulation (EU) 2019/515, the aim is to strengthen the functioning of the internal market by improving the application of the principle of mutual recognition and by removing unjustified barriers to trade. The mutual recognition principle ensures market access for goods that are not or are only partly subject to EU harmonization legislation.

Ex.: A botanical extract may be permitted without conditions in one Member State, be prohibited in another, while a third one allows it only under certain conditions. By applying the mutual recognition principle, unjustified barriers to trade are removed and an equal treatment for this botanical extract will be foreseen.

According to article 2 of Regulation (EU) 2019/515, it  applies to goods of any type and to administrative decisions that have been taken or are to be taken by a competent authority of a Member State of destination in relation to any such goods that are lawfully marketed in another Member State. Furthermore, the mutual recognition applies only to products which are not subject to EU harmonization legislation, or to aspects of products falling outside the scope of such legislation.

Ex.: The mutual recognition also only applies to unharmonized areas of law and it does not affect the classification of products based on definitions set in harmonized legislation. As explained, due to differences in the interpretation of the definition of “food supplement” in the directive, EU countries may refuse to accept products exceeding a certain size or energy value as food supplements, even though they are lawfully marketed under that category in another national.  Similarly, EU countries may apply medicinal classification to products marketed as food supplements in other EU countries. Such situations cannot be remedied by the mutual recognition principle. 

The mutual recognition principle ensures market access for goods that are not or are only partly subject to EU harmonization legislation. It creates the benefit that any good lawfully marketed and sold in one EU country can be marketed and sold in another. In principle, no national legislation must be complied with in the other EU country.

Ex.: A botanical extract may be permitted without conditions in one Member State, be prohibited in another, while a third one allows it only under certain conditions. By applying the mutual recognition principle, the botanical extract of this example could be lawfully placed on the market in the first country and would subsequently have to be accepted by the two other EU countries.

This regulation enables producers, manufacturers and importers to market and sell a product with more security of being lawfully when their product has already been lawfully placed on the market of one Member State. The products they legally market in one of the EU countries should not be subject to additional secondary requirements in the country to which they are exported. As the principle has its limitations the mutual recognition principle does not give an access to all Member States, but it does facilitate producers, manufacturers, and importers to develop a proper marketing technique.

Ex.: A good tip is to start marketing in Belgium. Here you have a relatively short notification procedure of about 1 month, you get proof of the notification with a registration letter and number, they also have clear rules and practices and they have a high level of expertise recognized by other Member States.

As mentioned above, the base of this principle lays in Articles 34-36 of the Treaty on the Functioning of the European Union. Regulation (EU) 2019/515 now further defines the rights and obligations for competent authorities and businesses when importing, marketing, and selling goods in another EU country. The regulation foresees a case-by-case procedure for the application of the mutual recognition principle. The competent authorities must assess the goods following a well-defined assessment procedure and when a restriction or denial occurs, obligatory elements must be included in the administrative decision.

Ex.: To reinforce the free movement of goods within the internal market, strict responsibilities are being laid on the Member States. Regulation (EU) 2019/515 requires stronger administrative cooperation to improve the application of the mutual recognition principle and more information to the businesses.

As an exception, a Member State can deny market access for a product lawfully marketed in another Member States, if he demonstrates that the protection of the public interest pursued is not equivalent and that its own national technical rules are necessary and proportionate in order to achieve protection of that public interest.

Ex.: Prohibitions or restrictions on the import are only allowed when justified by public order, public morality or security; protection of the health and life of humans, animals or plants; protection of national treasures of art, history or archaeology; or reasons of protection of industrial and commercial property.

No. As the principle has its limitations the mutual recognition principle does not give an access to all Member States.

Ex.: The mutual recognition principle does not apply if the authorities of an EU country can successfully invoke the protection of health and life after an in-depth risk assessment, with of course its own conditions and limitations. On top of this, it only applies to unharmonized areas of law and it does not affect the classification of products based on definitions set in harmonized legislation.

Harmonized law is available for where common standards across the internal market apply. Harmonized sectors are subject to common rules across the EU. They provide a clear and predictable legal framework for businesses. The principle of mutual recognition does not apply in the areas of harmonized legislation.

Ex.: Many products on the EU market are subject to harmonized rules that protect consumers, public health, and environment.

As the definition of food supplements leaves room open for some interpretation, for example, as to the definition of “small unit quantities”, Member States may not necessarily agree on the classification of a product as a food supplement. Since mutual recognition does not apply to the classification of products, it is sometimes unavoidable that a product is marketed under different classifications in different Member States.

Ex.: As Community law stands, and even with harmonized definitions of “food supplements” and “medicinal products”, the fact that a product is classified as a food supplement in a Member State could not prevent it from being classified as a medicinal product in the Member State of importation, if it displays the characteristics of such a product (cf. HLH Warenvertrieb and Orthica, paragraph 56).

In practice, mutual recognition does not apply to maximum limits of Vitamins and Minerals, as Member States can still adopt such limits in the absence of EU-wide rules. It would apply, however, if the said Vitamins and Minerals were naturally contained in the product, as active substances of botanical ingredients, for example. The application of the mutual recognition principle is not automatic when it comes to maximum levels of vitamins and minerals.

Ex.: A Member State may restrict on its territory the trade of food supplements legally marketed in another Member State by the application of non-harmonized national rules, such as the maximum limits of vitamins and minerals in accordance with the principle of mutual recognition, if these rules can be justified in the light of Article 36 of the Treaty on the Functioning of the European Union, e.g. by proving the existence of a real risk to public health.

In practice, mutual recognition does not apply to prohibited ingredients, as Member States can still adopt such prohibitions in the absence of EU-wide rules.

Ex.: Boric acid and sodium borate are for example sources of boron as per Directive 2002/46. However, in Belgium the use of boron is prohibited. Belgium in this case can make a derogation. This practice has been recently accepted by the Court of Justice of the European Union when specific circumstances concur.

Article 4(b) of Regulation 764/2008 foresees that Member States may request “relevant and readily available information on the lawful marketing of the product in another Member State”. In case the national authorities do not provide with a letter certifying the legality of the product, the “lawful marketing of the product” can be established by a valid proof of commercialization. Thus, legally speaking, the national authorities should follow the procedures envisaged under Regulation 764/2008 if such valid proof of commercialization is provided.

Ex.: In practice, this is not the case, and Member States require official documents from the health authorities of a Member State for applying the mutual recognition principle. Irrespective of the soundness of this approach from a legal point of view, we recommend notifying the product in Belgium or any other country which provides with a written proof which can serve as a valid document for the purposes of mutual recognition.