A new legal framework for food supplements
On 1 April 2021, Law no. 56/2021 regarding food supplements ("Law no. 56/2021") was published in the Romanian Official Gazette, Part I No. 332.
Law no. 56/2021 repeals Order no. 1.169/2007 regarding the approval of the food supplements rules ("Order no. 1.169/2007") and represents the new regulatory act dedicated exclusively to the marketing of food supplements. Its provisions establish the legal framework within which the marketing of food supplements as food products is presented and carried out.
Law no. 56/2021 transposes provisions from a number of relevant regulatory acts adopted at EU level, such as Directive 2002/46/CE on the approximation of the laws of the Member States relating to food supplements, thereby creating the necessary legal framework for the direct implementation of EC Regulation no. 1.925/2006 on the addition of vitamins, minerals and certain other substances to foods and also of EU Regulation no. 1.169/2011 on the provision of food information to consumers.
The result is that certain provisions of Order no. 1.069/2007 are reintroduced and, at the same time, new provisions are also established.
1. What constitutes a food supplement
According to Law no. 56/2021, food supplements means foods intended to supplement the diet and which are concentrated sources of nutrients or other substances having nutritional or physiological effect, alone or in combination, and marketed as a dose or in forms such as capsules, tablets, pills or similar, powdered sachets, vials of liquid, drip vials or similar forms of liquids and powders intended to be taken in small, measured quantities.
2. The general conditions for food supplements
A manufacturer, importer or person responsible for placing food supplements on the Romanian market will require a notification certificate.
Law no. 56/2021 defines a notification certificate as an administrative act, issued by the Ministry of Health, following the notification of the product (i.e. notification to the competent authority regarding the placing of a food supplement on the market).
The name under which the products covered by Law no. 56/2021 are to be marketed will be "food supplement". Food supplements shall only be marketed to the final consumer in prepackaged form.
Where the intention is only to market food supplements containing vitamins and minerals, and/or mixtures of vitamins and minerals, a notification of the competent authority shall be required by submitting to it a printed request notification accompanied by the model label for the product concerned, in both electronic and paper form.
Law no. 56/2021 provides that only vitamins and minerals covered by Community legislation may be used in the process of food supplement production. The maximum amount of vitamins and minerals present in the manufacturer recommended daily intake of food supplements shall be determined by considering the safe upper levels of vitamins and minerals established by scientific risk assessment and based on generally accepted scientific data.
In any labelling, presentation and commercial communications relating to food supplements, whether addressed to consumers or health professionals, it is prohibited to claim the ability of the product to prevent, treat or cure a human disease or to refer to the same.
Additionally, it is also prohibited to use direct affirmations or suggestions relating to the fact that varied and balanced diets cannot provide adequate amounts of nutrients.
Without prejudice to the current regulations regarding food labelling, the labelling applied on food supplements must contain the following additional particulars:
a) the designation of categories of nutrients and/or other substances having nutritional or physiological effect characterising the product;
b) the daily dose recommended by the manufacturer;
c) a warning not to exceed the daily dose recommended by the manufacturer;
d) a warning that food supplements should not replace a varied and balanced diet; and
e) a warning that products should be kept out of the reach of children.
Commercial communications for the promotion of food supplements must comply with the provisions of Law no. 56/2021 and special regulatory acts on advertising. In commercial communications to promote the properties of food supplements, only the information on the label, any food supplement leaflet and information approved by the competent authority, in accordance with the provisions of national/European legislation currently in force, shall be used.
3. Provisions regarding the competent authority in the field of food supplements
According to the provisions of Law no. 56/2021, the Ministry of Health is the competent authority related to the field of food supplements.
It is the Ministry of Health that issues the notification certificate following a notification relating to the placing of a food supplement on the market.
The Ministry of Health will post the following on its official online platform:
a) the list of necessary documents regarding the notification of food supplements;
b) the list of plants accepted in food supplements, obtained from the Ministry of Agriculture and Rural Development;
c) the list of substances having a nutritional or physiological effect and which are permitted in food supplements; and
d) the list of food supplements notified to the Ministry of Health, through the specialised operating structures.
Within 90 days of Law No. 56/2021 coming into force, the Ministry of Health will establish a set of technical rules regarding the manufacturing process and the marketing and use of food supplements. These rules will require approval by Government decision.
4. Illicit conduct and sanctions
Law no. 56/2021 provides that, depending on the nature of the infringement of its provisions, liability may be either a misdemeanor or a criminal act.
Failure to comply with the provisions of Law no. 56/2021 will result in misdemeanor liability for the following acts:
a) non-compliant labelling with the legislation currently in force;
b) the classification of food supplements in another food product category or medical devices, with the aim of circumventing the provisions of Law no. 56/2021;
c) the marketing of food supplements that have exceeded the date of minimum durability;
d) the marketing of food supplements without a notification certificate;
e) non-compliance with the legal provisions regarding ingredients from the lists displayed by the Ministry of Health on its official online platform, namely:
- the list of plants accepted in food supplements, obtained from the Ministry of Agriculture and Rural Development.
- the list of substances with nutritional or physiological effect allowed in food supplements; and
f) non-compliance with the legal provisions in force regarding the advertising of food supplements.
The commission of the above acts will primarily be punishable by an infringing fine, the amount of which will vary depending the seriousness of the offence. The minimum fine being RON 3,000 and the maximum RON 15,000. Complementary measures such as temporary or permanent cessation of the marketing activity can also be applied.
In addition to misdemeanor acts, Law no. 56/2021 also covers criminal acts committed against the public health. It will be a criminal offence for a person to prepare or manufacture counterfeit food supplements. It will also be a criminal offence to knowingly place counterfeit food supplements on the market or to knowingly offer, sell or distribute such counterfeit food supplements. The punishment for such acts, in accordance with the provisions of the Romanian Penal Code, is imprisonment from 3 months to 3 years or a criminal fine, complementarily accompanied by the prohibition of exercising certain rights (the equivalent of this specific criminal act can be found within the framework of Article 357 (1) of Romanian Penal Code).
5. Other important matters
The provisions of Law no. 56/2021 do not apply to drugs and medications as defined in Title XVIII "The Medication" of Law no. 95/2006 on health reform (as republished with subsequent amendments and additions) nor to food supplements based on herbal or aromatic plants or to beehive-based products, as regulated by Law no. 491/2003 (as republished with subsequent amendments and additions).
Food supplements that are placed on the market prior to Law no. 56/2021 coming into force and which comply with its provisions and also with the rules underlying the issue of a notification certificate, may continue to be marketed without the need for a new notification.
If a food supplement endangers the social values regarding human health, even though it complies with the provisions of Law no. 56/2021, the competent authority may temporarily issue an order to suspend or restrict the marketing, on Romanian territory, of that specific food supplement. In such cases, the European Commission will be swiftly notified.
6. The applicability of Law no. 56/2021
The provisions of Law no. 56/2021 have come into force and are applicable with effect from 4 April 2021.