The draft introduces the provisions of 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.

Ordinance on food supplements

A new Law on foodstuffs was promulgated In Official Gazette No. 52 of 2020. The law came into force on the day of its promulgation.

Pursuant to § 8, paragraph 1 of the Transitional and Final Provisions of the Law on foodstuffs, regulations on its implementation shall be adopted, respectively issued, within 6 months from the entry into force of the Act.
In this regard, a draft Decree of the Council of Ministers for adoption of the Ordinance on Food supplements has been prepared.
The draft introduces the provisions of 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.
The draft Ordinance is issued on the basis of Article 81, paragraph 1 of the Law on foodstuffs.
The draft lays down:
- nutrients (vitamins and minerals) that can be used in the production of food supplements;
- substances having a nutritional or physiological effect that can be used in the production of food supplements;
- purity criteria for nutrients intended for use in food supplements;
- the information to be noted in the labelling, presentation and advertising of food supplements;
- plants and parts of plants which cannot be used in food supplements;
- substances which cannot be used in food supplements;
A number of amendments and additions have been made to the draft Ordinance in order to achieve both the full and correct transposition into national law of the requirements of 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 (OJ L 183, 12.07.2002) and to ensure compliance with the new requirements introduced by the Law on foodstuffs for the registration of food supplements when they are placed on the market in the
country and the maintenance of a public register.
Many important elements of the draft new regulation are the updating and further development of the current national requirements for food supplements, in particular:
- updating and refinement of maximum levels of vitamins and minerals in nutritional supplements;
- linking the provisions of the Ordinance on the daily intake of substances in food supplements for certain population groups to the requirements of Ordinance No. 1 of 2018 on physiological norms for the nutrition of population (promulgated in Official Gazette No. 11 of 2018);
- further developing and linking the provisions of the Ordinance on herbal substances, herbal preparations or combinations thereof in food supplements with the requirements of Ordinance No 5 of 2004 on the requirements to be met by herbal preparation centres and herbal stores (promulgated in Official Gazette No. 85 of 2004) (Ordinance No. 5 of 2004) and Ordinance on the Procedure for the Classification of Plants and Substances as Narcotic Drugs, adopted by Decree No. 293 of the Council of Ministers of 2011 (promulgated in Official Gazette No. 87 of 2011), and in particular - to prohibit the addition to food supplements of certain herbal
substances from plants listed in Regulation No 5 of 2004 and 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 (OJ L 404 of 30.12.2006), and/or classified as narcotic;
- create a new section in the Ordinance on substances that cannot be added to food supplements.
New provisions have been introduced for the mutual recognition, as required by Regulation (EU) 2019/515 of the European Parliament and of the Council of 19 March 2019 on the mutual recognition of goods lawfully marketed in another Member State and repealing Regulation (EC) No 764/2008 (OJ L 91, 29.03.2019), of food supplements lawfully marketed in another Member State.