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Law no. 56/2021 regulating food supplements

By Tudor Nacev

The Law regulating food supplements (i.e. Law no. 56/2021) has been recently published in the Official Gazette. The newly published law replaces the Order no. 1069/2017 and aims at providing for general principles in relation to the commercialization process of food supplements in Romania, especially concerning the protection of consumers’ health. The law focuses on establishing proper and complete informing obligations, as well as on establishing rules for ensuring prevention of unfair trading practices. Thus, the new legislation brings the following major changes:

  • What are the conditions for placing food supplements on the market?

food supplements including only vitamins and minerals and/or mixtures of vitamins and minerals shall be notified to Ministry of Health, while food supplements including other ingredients shall be notified to institutions subordinated to the Ministry of Health;

for food supplements notified within other EU Member States, a simplified notification procedure is applicable;

for food supplements placed on the market from third countries, a procedure regulated by subsequent technical norms will be applicable.

  • How does the new law affect packaging and labelling of food supplements? Some labelling obligations have been waived, while new labelling obligations have been introduced, which may affect the current market practice and entail the proper adapting of market players;

  • How does the new law affect marketing campaigns? Marketing communications for food supplements must include only information comprised within the label and the prospect approved by the competent authority;

  • What are the risks for market players in case of non-observance of the new rules? Misdemeanors have been established for non-compliance with labelling and marketing communication obligations, while new terms are defined, for the sake of clarity (e.g., counterfeit food supplement). Fines are established in this regard, applicable by the National Authority for Consumer Protection, in line with the overall purpose of the new law – i.e., to ensure protection at consumer level. Manufacturing and preparation of counterfeit food supplements now constitutes criminal offence;

Given the fact that the law establishes only the main principles and guidelines in what concerns food supplements, it falls under the responsibility of the Ministry of Health to draft technical norms providing for further (more on-point) rules related to the commercialization of food supplements, within 90 days from the publishing of Law 56/2021.

Market players are also required to follow-up on the new law. Of course, for new food supplements, market players must meet the requirements of laid down by the new rules. Furthermore, for food supplements already placed on the market, if such products do not meet the newly established requirements, they may be marketed until the expiry of the minimum durability date, but not later than 12 months, provided that they do not contain ingredients other than those on the list of permitted plants and substances or do not pose a risk to consumers and are labelled in pursuant to regulations in force at the time of their introduction on the market.

Further regulations to follow – market players must be up to date with all developments.

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