Legal & Tax Alerts

New rules for food supplements

Law no. 56/2021 regarding the food supplements („Law no. 56/2021”) was published in the Official Gazette of Romania[1]. Law no. 56/2021 regulates the market of food supplements and aims to increase the level of protection and legal certainty for consumers when purchasing food supplements.

Food supplements are foods whose purpose is to supplement the diet and which are concentrated sources of nutrients or other substances with a nutritional or physiological effect, alone or in combination, that are marketed in dose forms, respectively in presentation forms such as capsules, tablets, pills or similar forms, powdered cachets, liquid ampoules, dropper bottles and other similar forms of liquids and powders intended to be taken in small, unit, measured quantities.

Law no. 56/2021 establishes the general conditions regarding food supplements, namely the certificate of notification issued by the Ministry of Health, the marketing and labelling of food supplements.

Also, Law no. 56/2021 establishes that non-compliance with the general conditions regarding food supplements constitutes an administrative offence and is sanctioned by the National Authority for Consumer Protection (“ANPC”) with fines between RON 3,000 and RON 15,000.

Last but not least, Law no. 56/2021 lays down transitional provisions regarding food supplements placed on the market prior to its entry into force. Thus, food supplements that comply with its provisions may continue to be marketed, without requiring a new notification, in compliance with the conditions underlying the issuance of the certificate of notification. Food supplements that do not comply with its provisions may be marketed until the expiry of the date of minimum durability, but not later than 12 months, provided that they do not contain ingredients other than those set out in the list of plants allowed in food supplements, taken from the Ministry of Agriculture and Rural Development and from the list of substances with nutritional or physiological effect allowed in food supplements or do not pose a risk to consumers and to be labelled in accordance with the legal provisions in force at the time of placing on the market.

Law no. 56/2021 entered into force on 03.04.2021.

 

[1] Published in the Official Gazette Part I, no. 332 from 01.04.2021

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