The New Romanian Food Supplements Law – what it means for consumers and for the healthcare business – Lexology

A complex piece of legislation governing the regime of the food supplements was published with the Official Gazette of Romania on 1 April 2021. This was set up after long and highly debated parliamentary procedures since 2012 and confirmed by the Romanian Constitutional Court ruling in 2021.

The Law 56/2021 on food supplements (FS Law) will be applicable starting with 3 April 2021; more detailed implementation rules on manufacturing, sale and use of food supplements are expected to be issued by the Ministry of Health within 90 days (beginning of July 2021).

Main rules and provisions

Scope

The FS Law aims to provide, for the first time on the Romanian market, an unitary legal framework in the field of food supplements with respect to single regulation and regulatory body, market placement, advertising and enhanced consumer protection against misleading and counterfeit. The law transposes into Romanian legislation the relevant EU framework for food supplements .1

The changes are significant in the field as it offers more control to the competent authority to sign-off on the market placement and advertising of food supplements, in view of preventing unfair market practices.

Relevant products

The products covered by the FS Law are food supplements, marketed as foodstuffs and presented as such. Medicines and food supplements based exclusively on medicinal or aromatic plants, as well as hive products, are out of scope.

Competent authority

The FS Law appoints the Romanian Ministry of Health to be the competent authority in the field of food supplements2 as notified body and competent authority to sign off the advertising materials.

National Consumer Protection Authority (ANPC) is granted specific powers in relation to food supplements advertising and labelling.

Marketing food supplements

Market placement of food supplements is allowed based on the notification certificate, issued by the Romanian Ministry of Health. The notification procedure differs depending on the composition of the products and country of origin of the products.

Marketing of food supplements already notified in EU/EEA or imported from third countries

Food supplements already notified in another Member State of the EU/EEA are subject to more simplified procedure of notification to Ministry of Health. For food supplements imported from third countries, separate notification proceedings will be detailed in the implementing norms.

Labelling, presentation and advertising

The FS Law establishes certain conditions for the labelling and advertising of food supplements, in order to guarantee a higher protection, consumers access to information and prevention of excessive consumer intake of food supplements.

Dos

Donts

Sanctions

In case of breach of the FS Law provisions, the following sanctioning regime is applied:

Special attention is paid to criminal activities in relation to preparing or manufacturing counterfeit food supplements, as well as willingly placing, marketing, selling or distributing counterfeit food supplements on the market, sanctioned under the Romanian Criminal Code.

Compliance and transitory measures

Food supplements which are in line with FS Law provisions can continue to be marketed without following additional notification process. However, the advertising materials need to be submitted for approval to Ministry of Health within 6 months of the start of the implementing norms.

The relevant products which do not comply with FS Law provisions can be marketed only until the expiry of the minimum durability date (but not later than 12 months), provided that:

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The New Romanian Food Supplements Law - what it means for consumers and for the healthcare business - Lexology