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Labelling for cosmetic products and medical devices: rules, regulations and requirements
Abstract
In the author's last article, she wrote about the new 2013 EU regulations for cosmetic products which changed to the new Cosmetic Products Regulation 1223/2009 in July 2013 (Bowes, 2013). This paper will expand further on cosmetic product regulations by reviewing the legal labelling requirements for the cosmetics and ‘cosmeceuticals’ stocked by medical aesthetic practitioners, as well as their responsibilities as stockists selling directly to consumers. As it is equally important to understand the labelling requirements for medical devices such as dermal fillers, which are used frequently in aesthetic practice, the author will also explore these in the second half of the article. It is important to note that the labelling of prescription-only medicines, such as botulinum toxin, is outwith the scope of this article.
... For many years, there has been a problem of insufficient regulation of the safety of filers in the UK and the European Union (EU). Non-medical fillers were not subject to the same strict requirements as medical products and had less stringent safety standards than even toys or cosmetics (Bowes, 2014). This posed risks to consumers due to potentially unsafe products, unskilled filler insertion, lack of proper training and certification of providers, and unclear requirements for facilities and management of complications (Rowland-Warmann, 2020). ...
This year, the European Union cosmetic products regulations changed to Cosmetic Products Regulation 1223/2009. The new regulations apply to all cosmetic products, thereby affecting all aesthetic practitioners who stock products in their clinics. Lorna Bowes outlines the key points raised at this year's Cosmetic Compliance Summit and defines the role of Cosmetics Europe and the National Trading Standards Board