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
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.
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.
The FS Law appoints the Romanian Ministry of Health to be the competent authority in the field of food supplements (2) 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.
- The labelling, presentation and advertising must respect some strict rules and marketing materials are subject to Ministry of Health sign off.
- Products shall be marketed under the name of ‘food supplements’ and no other designation.
- Food supplements can be delivered to consumers only in a pre-packaged form.
- The label needs to include the full list of ingredients, recommended daily dose, special advertisements and health claims etc.
- Labelling, presentation and commercial communications addressed to consumers and healthcare professionals shall not attribute to food supplements the property of preventing, treating or curing a human disease, or refer to such properties.
- No advertising materials can be placed on the market without the approval by the Ministry of Health.
- No claims are allowed if not in line with the label and the package leaflet, as approved by the Ministry of Health.
- Claims that an adequate and varied diet could not provide adequate and necessary nutrients for normal development and maintenance of a healthy life are not allowed.
- Do not promote the food supplements as other category of products, such as medical devices or foods and thus trying to circumvent FS law requirements.
In case of breach of the FS Law provisions, the following sanctioning regime is applied:
- administrative fines ranging between RON3,000 and RON15,000 (approx. EUR600 to EUR3,000), without excluding
- complementary measures e.g. temporary or permanent cessation of marketing the products, in addition to any other sanctions which are applicable under consumer protection legislation.
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:
- do not contain ingredients other than those provided by the FS Law or
- do not pose a risk to consumers and
- are labelled in accordance with the legal provisions in force at the time of placing on the market.
(1) Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements and creates the legal framework for implementing EU legislation such as Regulation (EC) No 1925/2006 of the European Parliament and of the Council of 20 December 2006 on the addition of vitamins and minerals and of certain other substances to foods or Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the provision of food information to consumers, amending Regulations (EC) No 1924/2006 and (EC) No 1925/2006 of the European Parliament and of the Council, and repealing Commission Directive 87/250/EEC, Council Directive 90/496/EEC, Commission Directive 1999/10/EC, Directive 2000/13/EC of the European Parliament and of the Council, Commission Directives 2002/67/EC and 2008/5/EC and Commission Regulation (EC) No 608/2004
(2) Manufactured based on vitamins, minerals, mixtures of vitamins and / or minerals; substances with a nutritional or physiological effect, other than vitamins and minerals; mixtures of vitamins and / or minerals with substances with a nutritional or physiological effect, other than vitamins and minerals; mixtures of vitamins and / or minerals with plant and / or animal extracts; mixtures of vitamins and / or minerals with plant and / or animal extracts, with substances with a nutritional or physiological effect, with plants and / or hive products