Consumer protection provided by the European medical device and cosmetic legislation for condoms and lubricants

• Published in: Regulatory toxicology and pharmacology Vol. 103; pp. 106 - 112
• Main Authors: Desmedt, B., Vanhamme, M., Vanhee, C., Rogiers, V., Deconinck, E.
• Format: Journal Article
• Language: English
• Published: Netherlands Elsevier Inc 01-04-2019
• Subjects: Allergies; Condoms; Condoms - adverse effects; Consumer Product Safety - legislation & jurisprudence; Cosmetics; Cosmetics - adverse effects; European Union; Humans; Irritation; Lubricants - adverse effects; Medical devices; Personal lubricants; Risk Assessment; Safety evaluation; Systemic toxicity; Personal lubricants; Medical devices; Risk assessment; Safety evaluation; Cosmetics; Condoms; Systemic toxicity; Allergies; Irritation
• ISSN: 0273-2300; 1096-0295
• DOI: 10.1016/j.yrtph.2019.01.022

Personal lubricants and lubricants used in condoms contain a number of ingredients which are also present in cosmetic products. These have to comply to the medical device regulation (745/2017) which should provide the same level of consumer protection, if not more, as foreseen in the legal framework of cosmetics (1223/2009). In the current study we developed an analytical method capable of identifying and quantifying 15 ingredients, commonly found in lubricants and cosmetics. Based upon their most important toxicological endpoint, the substances involved were grouped in three toxicological classes provoking either irritation, contact allergic dermatitis or systemic toxicity. The method was applied on 30 condoms and 54 personal lubricants present on the EU market. Their safety was assessed using the same reasoning as commonly applied for cosmetic ingredients. Higher mucosae susceptibility, the main exposed area for lubricants, was taken into account in this assessment.
The results show that the majority of the products studied are safe. Nevertheless, for some products the safety could not be confirmed. The results also highlight the fact that there is no consensus for a number of ingredients, used as well in cosmetics as in medical devices. Alignment between both legislations would improve the safety of these products and further raise the general level of consumer protection.
•Analytical methodology developed to quantify spermicides and preservatives.•Market study based upon 30 condoms and 54 personal lubricants.•Safety evaluated according to the methodology of the cosmetic legislation.•Some products with a doubtful safety profile can be found on the EU market.