Beauty is skin deep, but safety goes deeper - European Commission
Hyaluronic acid-based dermal fillers are injected into the skin to hydrate, replenish volume and reduce the appearance of wrinkles and fine lines. The procedures are not without risks – even when products that conform to EU standards are used.
"Regular market surveillance campaigns are crucial to protect consumers, but also to protect European businesses from unfair competition. The results of these tests confirm that market surveillance campaigns are necessary to enforce EU standards," said Vanessa Capurso, Policy Officer at the European Commission’s Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs (DG GROW).
Market surveillance authorities (MSAs) in 9 countries collected 17 samples of hyaluronic acid-based injectables and dermal fillers for testing. Permanent dermal fillers were excluded from the product scope.
An accredited laboratory conducted tests for: sterility, endotoxins, cytotoxicity and harmful chemicals.
All samples passed the sterility tests.
Three samples failed the initial tests for endotoxins. Retesting of these samples using another method found that only one exceeded the limits defined in the testing plan.
Another sample failed cytotoxicity testing – possibly due to the presence of Lidocaine, which is used as a local anaesthetic or to relieve skin irritation.
Tests for harmful chemicals don’t indicate a simple ‘pass’ or ‘fail’, but show which samples contain substances above an analytical evaluation threshold. Substances above this threshold are usually evaluated for health risks. Four samples had compounds that could present a toxicological hazard. These four, plus the one that exceeded defined endotoxin levels and the one that failed cytotoxicity testing, are being investigated further to determine if they pose a risk.
Because of the potential risks to consumers, the presence of the markings and instructions for those who administer these products is crucial.
Six (35%) of the 17 samples did not meet the requirements for markings and instructions. Problems encountered included lack of information, missing translations and reference numbers.
Manufacturers of these products were ordered to correct these shortcomings.
The testing was part of the Joint Actions on Compliance of Products (JACOP). Market surveillance authorities across the EU jointly selected and checked the compliance of products sold on the single market with EU health, safety and environmental standards.
Hyaluronic acid-based dermal fillers were one of the 16 product categories inspected.
