Supplements Legislation Flashcards
(14 cards)
What does the EU Food Supplements Directive 2002/46/EC specify?
Permitted vitamin/mineral substances, units of measurement, labelling, presentation, and advertising rules for food supplements.
What do Schedules 1 and 2 of the EU Directive list?
The allowed vitamins and minerals, and the forms in which they may be used.
Are other substances like amino acids and botanicals required to be listed under the EU Directive?
No, only vitamins and minerals are required.
Who approves new vitamin/mineral sources in the EU?
The European Food Safety Authority (EFSA).
Who oversees food supplement legislation in Ireland?
The Food Safety Authority of Ireland (FSAI).
Where can you find Irish regulations on food supplements?
http://www.irishstatutebook.ie/2003/en/si/0539.html
How are supplements regulated in the USA?
By the FDA. Supplements are considered safe until proven otherwise.
What does the EU require regarding nutrient levels in supplements?
Legal setting of maximum and minimum levels for vitamins and minerals.
Who classifies supplements as medicines in the UK?
The Medicines and Healthcare Products Regulatory Agency (MHRA).
What are the three classifications of supplements?
Licensed medicines, unlicensed preparations, and herbal products.
Who regulates herbal products in the UK?
MHRA under the Traditional Herbal Medicines (THM) Directive.
What types of claims are prohibited on supplement labels?
Claims about disease prevention/treatment, weight loss, doctor endorsements, and scare-based health claims.
What requirements apply to facilities making animal-based supplements in the EU?
They must be approved, tested for contaminants, and show the approval number on the label.
What are the rules for genetically modified (GM) ingredients in supplements?
Only allowed if authorised under EC Regulation 1829/2003, and GM presence must be declared on labels.
