Important change in dietary supplements. These substances will be banned

The draft regulation sets out a list of substances, other than vitamins and minerals, prohibited in the production of foodstuffs.

The regulation covered by the draft regulation will apply to entities producing and introducing foodstuffs, mainly dietary supplements, to the Polish market.

The adoption of the proposed solution is justified by the health safety of consumers. After the draft regulations enter into force, it will not be possible to market foodstuffs containing substances other than vitamins and minerals listed in the annex, and foodstuffs, mainly dietary supplements, containing them placed on the market on the territory of the Republic of Poland, will not be allowed to remain on the market longer. than 30 days after the entry into force of the Regulation.

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The purpose of the proposed regulation is to define a list of substances other than vitamins and minerals that are banned in the production of foodstuffs, due to the need to ensure the health safety of consumers. This applies in particular to dietary supplements.

The current regulation of the Minister of Health of October 9, 2007 on the composition and labeling of dietary supplements (Journal of Laws of 2018, item 1951) implements Directive 2002/46 / EC of the European Parliament and of the Council of June 10 2002 on the approximation of the laws of the Member States relating to food supplements (Journal of Laws EC L 183 of July 12, 2002, p. 51; EU Official Journal Polish special edition, chapter 13, vol. 29, p. 490). Pursuant to the provisions of this directive, the Regulation of the Minister of Health of October 9, 2007 on the composition and labeling of dietary supplements contains only a list of vitamins and minerals and their chemical forms that may be used in the production of dietary supplements and additional requirements for their content in supplements. diets.

On the other hand, the issues related to the presence of substances other than vitamins and minerals in dietary supplements are not regulated by EU regulations. Therefore, various substances are added to dietary supplements that may have a detrimental effect on the health and life of consumers. Matters related to the presence of these substances in dietary supplements are dealt with by the Team for Dietary Supplements at the Sanitary and Epidemiological Council, hereinafter referred to as the "Team".

On August 30, 2021, the Team adopted Resolution No. 6/2021 on certain plant substances and raw materials not allowed for use in dietary supplements. The list of plant substances and raw materials that cannot be used in dietary supplements, constituting Appendix 1 to the resolution in question, contains 7 substances or groups of plant substances and raw materials that should not be used in dietary supplements due to the need to ensure the health safety of consumers. This applies to the following substances or groups of substances: yohimbine hydrochloride and yohimbine group, methystine pepper (Piper methysticum) also known as kava kava, pancreatin, ibutamoren (ibutamoren mesylate), DMAA (specifically referred to as: 1,3-DMAA; 1,3-dimethylamylamine; 1,3-dimethylpentylamine; 2-amino-4-methylhexane; 2-hexanamine, 4-methyl- (9Cl); 4-methyl-2-hexanamine; 4-methyl-2-hexylamine; dimethylamylamine; geranamine; methylhexanamine; methylhexanenamine), ligandrol (LGD-4033) and ostarine (enobosarm).

In addition, on October 28, 2021, the Team adopted Resolution No. 9/2021 amending Resolution No. 6/2021 of August 30, 2021 on certain plant substances and raw materials not allowed for use in dietary supplements. In connection with this resolution, another 3 substances were added to Annex No. 1 to Resolution No. 6/2021 that should not be used in dietary supplements due to the need to ensure the health safety of consumers. These are the following substances: andarine, RAD-140, mites mites.

The basis of the above-mentioned Resolutions of the Team contain scientific data indicating a risk to consumer safety in the case of using substances and plant raw materials covered by the resolutions in the production of dietary supplements. The resolutions were adopted by a team of experts on the basis of the current knowledge derived from the literature, activities of other European Union (EU) countries, or the positions of EU bodies, and constitute an objective source of knowledge in the field of risks arising from the use of substances and raw materials listed in the production of dietary supplements vegetable.

In connection with the above, in the proposed regulation, due to the safety of consumers, all substances listed in the above-mentioned Team resolutions as prohibited substances in the production of foodstuffs. Thus, these substances will be banned in the production of foodstuffs, including dietary supplements, and, consequently, cannot be their ingredients.

Project: HERE

Source: RCL