The use of heavy metals in cosmetic products has always been a complicated issue around the world and remains so to this day. From a technical standpoint, the use of any kind of heavy metal in a cosmetic product is strictly banned inside the European Union under EU Regulation 1223/2009. The regulation, designed to harmonize standards throughout the EU and to ensure greater levels of consumer safety, set out a number of guidelines for manufacturers to adhere to, including forbidding the use of heavy metals (like arsenic, lead, tin, chlorine, cobalt, mercury, and zinc) and introducing mandatory safety reporting to ensure products are in compliance. For manufacturers of cosmetic products, this can sound like bad news, however there are things that can be done to bring products into compliance and for many products there is a little leeway given.
Like many of the other New Approach Directives, the objective of Regulation 1223/2009 was to ensure greater safety on the European Market for both manufacturers and consumers. For this reason, the use of heavy metals (or any compound made from a heavy metal) in cosmetic products has been strictly forbidden on account of the risk such ingredients may pose to consumer health and safety. Before entering the European Market, under 1223/2009, each manufacturer of cosmetic products must provide a Cosmetic Product Safety Report (CPSR) supplied by an assessor who is fit to declare the product safe for market introduction, effectively creating a barrier for products with heavy metal ingredients from entering Europe. Steps like this have led to a widescale decrease in the use of dangerous heavy metals Europe-wide.
While this may seem like a strict, cover-all rule, there are some instances in which products containing trace amounts of a heavy metal can enter the EU marketplace. Though no limit for the maximum amount of a heavy metal allowed inside a cosmetic product exists in Europe (unlike in Canada or the USA for example), unintended trace amounts may be included in a cosmetic product under the condition that the amount included presents no danger to human health and that the trace amount is so small that it could not be avoided under any reasonable Good Manufacturing Practices (GMP) as laid out by accepted EU guidelines. This creates allowances for products which may be exposed to banned metals throughout their manufacturing processes, while in storage or being transported, or as a result of an impurity from any of its other accepted and legal ingredients.
Awareness on part of the manufacturer of any traces or inclusions of heavy metals in their cosmetic products is highly encouraged as there can be many negative outcomes for a product found not in keeping with EU regulations. European Competent Authorities perform regular market surveillance checks often resulting in non-compliant products being removed or banned from the market.
For more information on heavy metals in cosmetics, to talk about the Compliance path for your cosmetic product, or to contact our team of European regulatory experts, get in touch today!