Background

The European Commission issued a proposal for classification of titanium dioxide as a suspected carcinogen of category 2 by inhalation on 4 October 2019.  This decision followed a scientific opinion of 14 September 2017, published by ECHA’s Committee for Risk Assessment (RAC).

The recently accepted proposal has faced opposition from the industry, arguing that the classification of titanium dioxide as a carcinogen is not related to substance’s chemistry but rather the physical characteristics of the particles, such as shape and size of the particles and poor solubility – characteristics not specific to titanium dioxide but rather shared with many other substances.

New requirements

The Regulation sets out a requirement of cancer warning labels for mixtures in powder form containing 1% or more of titanium dioxide particles with an aerodynamic diameter of ≤ 10 µm. Although, other forms and mixtures do not fall under this classification, there are specific warnings that need to be applied to those that contain more than 1% of titanium dioxide.

However, under Cosmetic Regulation (EC) No 1223/2009, a substance classified as CMR substance of category 2, under Regulation (EC) No 1272/2008, is prohibited for use in cosmetic products, unless an exemption applies. That means sunscreen products and other cosmetic products which contain titanium dioxide and pose a risk of inhalation by the consumer may not be allowed on the EU market.

In light of the recent classification of the substance as a carcinogen, the Scientific Committee on Consumer Safety (SCCS) will reconsider the safety of titanium dioxide. On 5 February, the SCCS issued a request for a scientific opinion on titanium dioxide used in cosmetic products and now has six months to prepare its opinion. According to the Cosmetic regulation, a category 2 substance is permitted in cosmetic products, if the SCCS has evaluated the substance and found it safe for use.

The Regulation will enter into force 20 days after its publication in the Official Journal of the European Union and will apply from 9 September 2021.

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Just as the cosmetic products and the technology behind them is always developing and evolving, so does the legislation which the manufacturers have to follow in order to be eligible to sell their products.

Deciphering the demands of the legislation can often be challenging. In 2009, the EU has published a new Cosmetics Regulation 1223/2009/EC, which came into full effect on 11th July 2013 (replacing the EU Cosmetics Directive 76/768/EEC). The new Regulation brought several novelties and additional requirements for the Responsible person, manufacturers and distributors of the cosmetic products.

This Regulation establishes rules to be complied with by any cosmetic product made available on the market in order to ensure the functioning of the internal market and a high level of protection of human health. (EU Regulation 1223/2009, Article 1) Despite the changes in the legislation, consumer safety and free circulation of cosmetic products remain the main goals. Cosmetic products must be safe for human health when used under normal or reasonably foreseeable conditions of use.

As mentioned above, the EU Cosmetics Regulation 1223/2009 has replaced the EU Cosmetics Directive 76/768/EEC. A directive provides guidance to the EU member states, which then have to transpose the directive into their national legislation. Therefore, some differences in transpositions occur. A regulation, however, is directly applicable in all member states, leaving no room for different transpositions. All member states now have the same rules, which provides a simplification.

Cosmetic products can also be controlled by other legislations (general legislation, Aerosol Directive, REACH etc.). Some of these can be found here:

http://ec.europa.eu/consumers/sectors/cosmetics/regulatory-framework/index_en.htm#h2-legislation

Not knowing the law is, as always, no excuse and no defence. Penalties for non-compliance with the EU cosmetics legislation can be severe, so contact CE.way today in order to learn more about the EU cosmetics legislation framework and to get a trusted partner that will follow the ever-changing EU legislation for you, keeping you and your products compliant!

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