The European Commission restricts the use of zinc oxide in cosmetic products
Between 2003 and 2014, the scientific committees of the European Commission, released several opinions on zinc oxide:
- zinc oxide may be considered as a non-toxic substance, including when used in cosmetic products (Ref. SCCNFP/0649/03);
- the use of the non-nano zinc oxide in cosmetic is safe up to a maximum concentration of 25% (ref: SCCP/0932/05);
- the use of zinc oxide nanoparticles at a concentration up to 25 % as a UV filter in sunscreens, can be considered not to pose a risk of adverse effects in humans after dermal application (Ref. SCCS/1489/2012 and SCCS/1518/13);
- the use of zinc oxide nanoparticles in spray products cannot be considered safe. Concern related to the use of zinc-oxide is limited to spray products that could lead to exposure of the consumer's lungs by inhalation. The SCCS also indicated that non-nano zinc oxide has similar toxic effects to nano zinc oxide, as far as lung toxicity after inhalation is concerned (Ref. SCCS/1539/14).
In light of these scientific opinions, the Commission considers that zinc oxide in non-nano form should be authorised for use as a UV filter in cosmetic products; zinc oxide in nano form should be authorised for use as a UV filter in cosmetic products. Both forms of the substance should be authorised at a maximum concentration of 25 %, except in applications that may lead to exposure of the end-user's lungs by inhalation. Additionally, it specifies that zinc oxide in nano form is only allowed if it complies with specific characteristics related to its purity, particle diameter, water solubility and coating.
The details of the restriction are listed in the Commission Regulation 2016/621/EC of 21 April 2016 amending Annex VI to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products.
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