In the European Union (EU), vitamins, minerals, amino acids,
essential fatty acids and other bioactive
substances, including botanicals, can be marketed as
food supplements (FS). Food supplements
meant to benefit human health contain claims on their
label stating their benefits. Since 2007, health
claims made on FS, are prohibited unless they are
authorised and included in the EU Register of
Nutrition and Health Claims on Food (the EU Register),
in accordance with the requirements of
Regulation (EC) nº 1924/2006.
Aims:
Here we review the evidence required to support health claims made on FS
considering the
legal framework of these foodstuffs and, as a case
study, analyse the health claims on articular joint
health included in the EU Register.The EFSA (European
Food Safety Authority) scientific opinions
related to those health claims are also considered. In
EU, some botanicals and other bioactive
substances can be marketed as medicinal or as FS. The
current regulatory issues on botanicals and
the debate on how to create a regulatory framework for
botanicals are mentioned.
Results:
By July 2020, 78 functional claims on joints health, non-authorised, were
included in the EU
Register. The great majority were Article 13.1 claims
(90%). All claims related to articular joints
function were made on various ingredients, mainly
bioactive substances that could be used in the
manufacturing of FS. Human trials conducted in diseased
population were a main statement for EFSA
unfavourable assessment of these claims as their data
cannot be extrapolated to the general
population because the mechanisms involved in the onset
and/or progression of osteoarthritis or
rheumatoid arthritis are largely unknown.
Conclusion:
Scientific substantiation is still the greatest challenge to take into
account in health
claims related to joint function. More research
regarding the human trials design and the choice of
adequate outcome variables and methods of measurement
could benefit future applications for health
claims in this area.
Author
(s) Details
Madalena
Bettencourt-Câmara
Center for Interdisciplinary Research Egas Moniz, CiiEM, Egas Moniz
Cooperativa de Ensino Superior CRL, Monte de Caparica, Portugal and Faculdade
de Farmácia da Universidade de Lisboa, Avenida Professor Gama Pinto, 1649-003
Lisboa, Portugal.
Bruno Sepodes
Faculdade de Farmácia da Universidade de Lisboa, Avenida Professor Gama
Pinto, 1649-003 Lisboa, Portugal.
Rosário Bronze
Faculdade de Farmácia da Universidade de Lisboa, Avenida Professor Gama
Pinto, 1649-003 Lisboa, Portugal and Instituto de Tecnologia Química e
Biológica, Av. da República, 2780-157 Oeiras, Portugal.
Maria-Eduardo Figueira
Faculdade de Farmácia da Universidade de Lisboa, Avenida Professor Gama
Pinto, 1649-003 Lisboa, Portugal.
View Book :- http://bp.bookpi.org/index.php/bpi/catalog/book/258
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