Representing a year of constant changes and adaptations to (new) food law requirements, national authorities also adopted new guidelines for the definition of products that may simultaneously fall within the definition of medicinal products and products that are subject to other regulations for human use ("Guidelines") in October 2014. These Guidelines shall be observed as (non-binding) guidance in cases of so-called borderline products.
The first installment of our two-part survey of Changes to Slovenia’s Food Legislation is available here.
Changes introduced by the Guidelines
Medical plants that are either allowed or prohibited to be added to foodstuffs have previously been regulated under the Rules on the classification of medical plants (Pravilnik o razvrstitvi zdravilnih rastlin). The Rules have been repealed with the introduction of the new Slovenian Medicinal Products Act (Zakon o zdravilih; "MPA") effective as of 22 March 2014, which also repealed the Rules classifying vitamin and mineral products for oral use that are in a pharmaceutical form as medicinal products (Pravilnik o razvrstitvi vitaminskih in mineralnih izdelkov za peroralno uporabo, ki so v farmacevtskih oblikah, med zdravila); these Rules had regulated the maximum levels of vitamins and minerals allowed to be added to food supplements.
The Public Agency of the Republic of Slovenia for Medicinal Products and Medical Devices (Javna agencija za zdravila in medicinske pripomočke; "JAZMP") issued the Guidelines in October 2014, disclosing the (i) new classification of medical plants, amongst which certain medical plants are allowed, while others are prohibited from being added to foodstuffs, and (ii) the recommended upper intake levels of minerals and vitamins in foodstuffs, whereby all maximum levels of minerals have remained the same, but most vitamin levels have been increased. With respect to the list of medical plants, some medical plants have, inter alia, been added to the list of those medical plants that are allowed to be added to foodstuffs (including for instance Goji berries, which previously had not been included in that list).
The Guidelines shall be amended from time to time in accordance with new scientific knowledge and evidence.
Particularly in the field of food supplements, such products may in some cases (also) fall within the definition of medicinal products ("borderline products").
Products that either contain (i) medical plants that are not listed as plants which can be used in foodstuffs yet are not explicitly prohibited from such usage, or (ii) daily doses of vitamins and minerals exceeding their recommended upper intake levels, are, as a general rule, identified and treated as medicinal products. Nonetheless, JAZMP, in its capacity as the competent authority for the classification of products for which doubt exists whether they should be classified (and marketed) as medicinal products or other product groups, may decide, upon request of the applicant, on such borderline products. The classification is always subject to a case-by-case (expert) assessment by JAZMP.
In addition to the Guidelines, which represent the core orientation document, JAZMP also takes into consideration the assessments of the European Food Safety Authority (EFSA), as well as other characteristics of the product, such as the overall presentation of the product and the impression the product is likely to make on the end consumer, possible side effects and risks associated for the individual and the public health.
While food supplements are subject to the free movement of legally produced and marketed goods rule within the EU, this freedom does not also apply to medicinal products. This being said, an individual EU member state may classify a respective product differently from that product’s existing classification in another member state; however, a justification must be provided for that differing classification (e.g. the necessity of achieving goals such as the protection of human life and health).