December 12, 2022 – On November 23, 2022, the General Court annulled Commission Delegated Regulation (EU) 2020/217 as regards the classification of titanium dioxide in powder form containing 1% or more particles with a diameter equal to or below 10 μm as a CMR substance.
The General Court is a constituent court of the Court of Justice of the European Union, and it is responsible for annulment applications. It is a first-instance Court: cases discussed there may be appealed to the Court of Justice on points of law.
The European Commission classified titanium dioxide in powder form containing 1% or more of particles with aerodynamic diameter ≤ 10 μm as a CMR of category 2 (carcinogenic by inhalation). The classification relies on a 2017 opinion issued by RAC (the Committee for Risk Assessment of ECHA). Consequently, the substance was included in the REACH list via Commission Delegated Regulation (EU) 2020/217 of October 4, 2019.
In three-joined cases, the General Court ruled on this classification and concluded that the European Commission must annul it for the following reasons.
Firstly, according to the Court judgment, the scientific study on which the RAC opinion was based was unreliable and, therefore, unacceptable.
Secondly, the European Commission did not meet the classification criterion of the REACH Regulation. Actually, only substances with an intrinsic property to cause cancer can be classified as carcinogenic. This is not the case of titanium dioxide, which may only be toxic when it has specific physical state, size, and quantity characteristics.
The implications for cosmetic products
Titanium dioxide has several functions in cosmetic formulations, including that of a colourant and a UV filter. Following the classification as CMR, in May 2021, the European Commission restricted its use in cosmetic products. Thus, Omnibus Act III sets some limitations in using titanium dioxide in powder form containing 1% or more of particles with aerodynamic diameter ≤ 10 μm.
Considering the General Court judgment, the European Commission will have to annul the classification and all the related acts. Hence, there will be implications for cosmetic products as well. COSlaw will follow the topic and immediately inform you about any updates!
Check COSlaw Case-Law section in the Library of documents where we collect all the judicial cases about the EU cosmetics regulatory framework.