It has long been recognized that heavy metals, such as antimony (Sb), arsenic (As), cadmium (Cd), lead (Pb) and mercury (Hg), present a danger to humans and the environment. They are recognized as toxic, carcinogenic, toxic to reproduction and can generate allergic reactions if ingested or allowed to come into contact with our skin. Their use in cosmetics, as pigments, stabilizers and biocides, has been strictly regulated in several markets for a number of years.
Under European Union (EU) law, heavy metals are banned according to Regulation (EC) No. 1223/2009. EU regulations proscribe both the metallic form of the substance, if they are classified as hazardous substances, and any compound made from them. Regulation (EC) No. 1223/2009 does allow for traces of the substance to be included in cosmetic products, if that trace amount is small enough to be technically unavoidable in good manufacturing practice (GMP). Regulation (EC) No. 1223/2009 allows traces but does not give any specific limits. A trace amount must not present a danger to human health.
Without a specific limit defined in EU regulations for what constitutes an unavoidable trace of heavy metal, manufacturers need to look to orientation values to allow them to access their manufacturing techniques and make sure they stay within the scope of the law.
For many years, the German authorities have monitored cosmetics on the market. In 1985 and 1990, the German Federal Health Office (BGA) used these data to publish orientation values for heavy metals in cosmetic products. Monitoring done between 2010 and 2012 has now shown that the orientation values currently in circulation are out of date and should be recalculated. The Federal Office of Consumer Protection and Food Safety (BVL) has therefore reduced the limits for what should be technically avoidable in relation to heavy metals in cosmetics and has published new orientation values1.
|Element||Cosmetic products in general
a For the products make-up powder, rouge, eye shadow, eye liner, kajal, as well as theater, fan or carnival make-up: 5 mg/kg
b For theater, fan or carnival make-up: 2.5 mg/kg
It should be noted that the orientation value for soluble nickel has remained unchanged. According to Mitteilungen des Bundesgesundheitsamts: Technisch vermeidbare Gehalte an Nickel in kosmetischem Mitteln, Bundesgesundheitsblatt 35(7), published in 1992 by the BGA, the nickel content must not exceed 10 mg/kg, as determined by DIN EN 71, extraction solution: artificial sweat solution according to DIN 53160-1974.
The new reduced orientation values are reflective of two factors in cosmetic manufacturing. Firstly, there is now a greater awareness of these contaminants and, secondly, modern GMP manufacturing processes have been improved to a point where the old values are now redundant.
SGS Solutions: Cosmetic Safety Services
While EU Regulation (EC) No. 1223/2009 does not define trace in relation to heavy metals in cosmetic products, it is safe to assume that the updated levels published by the BVL are now being used in Germany’s market surveillance. Manufacturers are advised to check that their products do not contain levels above these new orientation values, in order to remain clearly within the context of the law. If the heavy metal content in a cosmetic does exceed one of the orientation values, it should be addressed and assessed in the safety report.
To help manufacturers remain compliant with the new levels, SGS offers a range of services dedicated to cosmetic product safety. Our specialists provide testing, inspection, auditing and consulting services to cosmetic manufacturers all around the world. Our global network of state-of-the-art laboratories can help you assess the heavy metal levels of your products and can offer custom-made solutions for all aspects of cosmetic product manufacturing. Partnering with SGS is the perfect solution for keeping your cosmetic products legal and on the market. Learn more about SGS’s Cosmetic Safety Services.
For further information, please contact:
Cosmetics, Personal Care & Household
SGS INSTITUT FRESENIUS GmbH
t: +49 6128 744 539