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Heavy metals, such as antimony (Sb), arsenic (As), cadmium (Cd), lead (Pb) and mercury (Hg), have long be recognized as being dangerous to humans and the environment. They are acknowledged as toxic, carcinogenic, toxic to reproduction and can create 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.

European Union (EU) law, Regulation (EC) No. 1223/2009, bans both the metallic form of the substance, if they are classified as hazardous substances, and any compound made from them. The law issues proscriptions on these heavy metals but does not give specific limits. The law does, however, make allowances for trace amounts of the substance, if the amount is small enough to be technically unavoidable in good manufacturing practice (GMP). It does make clear that the trace amount must not be a danger to human health.

The question manufacturers have to ask themselves is, what is a ‘technically avoidable’ level for heavy metals? To answer this question, manufacturers need to look at orientation values to allow them to assess their processing techniques and make sure they remain within the scope of the law.

The German authorities have monitored cosmetic products for a number of years. In 1985 and 1990, the German Federal Health Office (BGA) published orientation values for heavy metals in cosmetic products, based on this research. Monitoring done between 2010 and 2012 has now shown that the orientation values currently in circulation are out of date and should be recalculated.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 some heavy metals in cosmetic products and has published new orientation values.

The new orientation values for cosmetic products in general are (in mg/kg):

  • Lead (Pb): 2.0, except for make-up powder, rouge, eye shadow, eye liner, kajal, as well as theater, fan or carnival make-up where the amount is 5.0
  • Cadmium (Cd): 0.1
  • Mercury (Hg): 0.1
  • Arsenic (As): 0.5, except for theater, fan and carnival make-up where the amount is 2.5
  • Antimony (Sb): 0.5

The levels for toothpaste are lower (in mg/kg):

  • Lead (Pb): 0.5
  • Cadmium (Cd): 0.1
  • Mercury (Hg): 0.1
  • Arsenic (As): 0.5
  • Antimony (Sb): 0.5

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 acc. to DIN 53160-1974.

The reduction in technically avoidable levels relates to two factors in cosmetic manufacturing. Firstly, there is now a greater awareness of these contaminants and, secondly, GMP manufacturing processes have improved to a point where the old values are now redundant.

It is safe to assume that, while EU regulations do not define ‘trace’, in relation to heavy metals in cosmetic products, these new levels are being used in Germany’s market surveillance. Manufacturers should now check their products do not contain levels above these new orientation values, in order to remain clearly within the parameters of the law. If the heavy metal level is found to be in excess of these new orientation values, it should be addressed and assessed in the safety report.

SGS offers a range of services to help manufacturers remain compliant with these new levels. Cosmetic services include testing, inspections, audits and consulting services for manufacturers around the world. Their global network of state-of-the-art laboratories help companies assess the heavy metal levels of their products, and can offer custom-made solutions for all aspects of cosmetic product manufacturing. Partnering with SGS is the perfect solution for keeping cosmetic products legal and on the market. Learn more about SGS’s Cosmetic Safety Services.

For more information

i. V. Dr. Alexander Zeller

Cosmetics, Personal Care & Household

SGS INSTITUT FRESENIUS GmbH

Tel: +49 6128 744 539

Email: crs.media@sgs.com

Website: www.sgs.com/cpch

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