Page 127 - Petelin, Ana. 2021. Ed. Zdravje starostnikov / Health of the Elderly. Proceedings. Koper: University of Primorska Press.
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the following sections, we will define what are DS, when is it beneficial to elderly and dietary supplements: benefits and risks 125
take them and what risks might occur with their (unsupervised) use.
Methods
PubMed database and the world wide web were searched with mesh terms
»prehranska dopolnila« – »dietary/food supplements«, »starostniki« – »elder-
ly«, »zakonodaja« – »legislation«, »interakcije« – »interactions« and their com-
binations. English language articles published after 2000 were included in nar-
rative review, as well as electronic sources regarding legislation in Slovenia and
Europe.
Results and discussion
Definition, regulation of DS and problematic related to it
A DS is defined according to the National Institutes of Health (n.d.) as a prod-
uct that is intended to supplement the diet, which contains one or more of the
following dietary ingredients: vitamins, minerals, herbs or other botanicals,
amino acids, and other substances or their components. It is intended to be
taken by mouth as a pill, capsule, tablet, or liquid form. DS are not meant to be
and therefore cannot be represented as a conventional food item or a sole item
of a meal or diet. They are also not intended to “treat, diagnose, prevent, or cure
disease” and must be identified as a DS on the label (Harris et al., 2017). In the
European Union (EU), DS are regulated as foods under the The Food Supple-
ments Directive (FSD) Directive 2002/46/EC, which establishes a definition for
DS, a list of allowable vitamins and minerals, and sets labelling requirements.
Substances other than vitamins and minerals are not directly covered by the
directive, and rules regulating these substances are still governed by individu-
al EU member states. The Directive calls for the establishment of harmonized
minimum and maximum dosage amounts; however, this has yet to be done
and remains a competence of EU member states (Sovereign Silver, n.d.). FSD
allows the Member States to implement only a notification procedure by which
DS are reported to the authorities at the time they are put on the market. How-
ever, some Member States have not considered it necessary to introduce a no-
tification obligation (Coppens, 2018). In Slovenia, the legal requirements on DS
are determined in Rules on food supplements - Pravilnik o prehanskih dopol-
nilih (Official Gazette of the Republic of Slovenia (RS) – Uradni list RS, No.
66/33) issued by the national Ministry of Health. From the 5th of August 2013,
the Ministry of Health no longer accepts new applications for DS and no longer
keeps a list of DS currently marketed in RS. DS are classified as foods and must
comply with an umbrella law on food, which states that all DS put on the mar-
ket, must be safe to use and not contain substances in a form or amount that
could pose a risk for human health. DS can be put on a market only by the food
business operators, that have the appropriately registered food plant in the RS.
The compliance with the food law on all the levels from manufacturing, dis-
take them and what risks might occur with their (unsupervised) use.
Methods
PubMed database and the world wide web were searched with mesh terms
»prehranska dopolnila« – »dietary/food supplements«, »starostniki« – »elder-
ly«, »zakonodaja« – »legislation«, »interakcije« – »interactions« and their com-
binations. English language articles published after 2000 were included in nar-
rative review, as well as electronic sources regarding legislation in Slovenia and
Europe.
Results and discussion
Definition, regulation of DS and problematic related to it
A DS is defined according to the National Institutes of Health (n.d.) as a prod-
uct that is intended to supplement the diet, which contains one or more of the
following dietary ingredients: vitamins, minerals, herbs or other botanicals,
amino acids, and other substances or their components. It is intended to be
taken by mouth as a pill, capsule, tablet, or liquid form. DS are not meant to be
and therefore cannot be represented as a conventional food item or a sole item
of a meal or diet. They are also not intended to “treat, diagnose, prevent, or cure
disease” and must be identified as a DS on the label (Harris et al., 2017). In the
European Union (EU), DS are regulated as foods under the The Food Supple-
ments Directive (FSD) Directive 2002/46/EC, which establishes a definition for
DS, a list of allowable vitamins and minerals, and sets labelling requirements.
Substances other than vitamins and minerals are not directly covered by the
directive, and rules regulating these substances are still governed by individu-
al EU member states. The Directive calls for the establishment of harmonized
minimum and maximum dosage amounts; however, this has yet to be done
and remains a competence of EU member states (Sovereign Silver, n.d.). FSD
allows the Member States to implement only a notification procedure by which
DS are reported to the authorities at the time they are put on the market. How-
ever, some Member States have not considered it necessary to introduce a no-
tification obligation (Coppens, 2018). In Slovenia, the legal requirements on DS
are determined in Rules on food supplements - Pravilnik o prehanskih dopol-
nilih (Official Gazette of the Republic of Slovenia (RS) – Uradni list RS, No.
66/33) issued by the national Ministry of Health. From the 5th of August 2013,
the Ministry of Health no longer accepts new applications for DS and no longer
keeps a list of DS currently marketed in RS. DS are classified as foods and must
comply with an umbrella law on food, which states that all DS put on the mar-
ket, must be safe to use and not contain substances in a form or amount that
could pose a risk for human health. DS can be put on a market only by the food
business operators, that have the appropriately registered food plant in the RS.
The compliance with the food law on all the levels from manufacturing, dis-
