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 The Rules have been repealed with the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which also repealed the Rules classifying vitamin and mineral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.
Borderline products
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).
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.