The Polish Council for Supplements and Nutritional Foods (KRSiO) on 23 October submitted to the Sejm’s Friendly State special committee a legislative proposal that amends several provisions of the Food and Nutrition Safety Act regarding the classification of products as medicines vs. food supplements. The move is a last-ditch attempt by the industry to avoid potentially damaging effects of what it says is a flawed transposition of an EU directive specifying which food supplements may be sold in Europe, due to take effect on 1 January 2010. The industry fears that the new rules will paralyse the market for food supplements, and is prepared to take legal action as far as the European Court of Justice (ECJ) if its new proposal is rejected, KRSiO vice president Jaroslaw Lichodziejewski warned in an interview with Puls Biznesu.
KRSiO argues that the list of plant substances which is to serve as a guide for the determination of the status of products as medicines vs. food supplements is not precise enough, with no clear criteria regarding dosage or conditions of consumption. As a result, there is uncertainty over the status of several hundred "borderline" products currently sold as food supplements, which may have to be either withdrawn from the market as of next year or reclassified as medicines, a costly and time-consuming procedure. The Council’s legislative proposal, by contrast, does introduce clear criteria and methodology for product classification, based on laws adopted in other EU countries and on ECJ rulings.
Meanwhile, the Health Ministry is downplaying the problem, pointing out that makers of food supplements can receive free advice from the Chief Sanitary Inspectorate (GIS) on the status of individual products.
KRSiO had earlier lobbied for a new deadline of 2014 to comply with the new regulations, but the proposal received a negative recommendation from the Office of the Committee for European Integration (UKIE).
A detailed legal analysis of the problem appeared in the September issue of Pharma Poland News - Monthly Review and Analysis, in an article titled "Mutual recognition and dietary supplements: the new procedure and the interpretation of the Regulation by Polish authorities".