EU Amends Cosmetics Regulation in Response to CMR Substances

In response to the carcinogenic, mutagenic, or toxic (CMR) classification of certain substances in Regulation (EU) 2020/217, Commission Regulation (EU) 2021/850 is published on May 28, 2021, to uniformly implement the prohibition and restriction of CMR substances within the internal market. Annex II, Annex III, Annex IV and Annex VI to Cosmetic Regulation (EC) 1223/2009 will be therefore updated.

Commission Regulation (EU) 2021/850 of May 26, 2021 amending and correcting Annex II and amending Annex III, IV, and VI to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products.

(A) The following substances are classified as CMR in Delegated Regulation (EU) 2020/217. Without any request for use in cosmetic products by way of exception in Article 15(1) of (EC) 1223/2009, these substances are therefore added into the prohibition list in cosmetic regulation.

The prohibition will be applied from October 1, 2021. 

(B)Titanium Dioxide (in powder form containing 1% or more of particles with an aerodynamic diameter of ≤10µm) is classified as Carcinogen Category 2 (inhalation) in Delegated Regulation (EU) 2020/217.

A request for its use in cosmetic product as an exception was submitted. 

With the conclusion of SCCS/1617/20 opinion on Titanium dioxide (TiO2) published on October 6, 2020, the use of Titanium Dioxide (in powder form containing 1% or more of particles with aerodynamic diameter of ≤10µm) shall be allowed only in face products in loose powder form and in hair aerosol spray products. Its restriction is therefore added into Annex III to (EC) 1223/2009. The new restriction will be applied from October 1, 2021. 

The use of Titanium Dioxide in Annex VI as a UV filter should therefore be allowed without prejudice to its restricted use under Annex III.

This update will be applied from October 1, 2021.

Titanium dioxide in powder form  containing 1 % or more of particles  with aerodynamic diameter ≤ 10 μm,  to be used in compliance with  Annex III, No [321]. 

For the product types under letter  (c) of column (f) in Annex III, No [321],  the maximum concentration in ready for use  preparation provided in column (g) of this entry applies.

The use of Titanium Dioxide in Annex IV as a colorant should therefore be allowed without prejudice to its restricted use under Annex III.

This update will be applied from October 1, 2021.

Titanium dioxide in powder form containing 1% or more of particles with aerodynamic  diameter ≤ 10 μm, to be used in compliance with Annex III, No [321]

(C)To align with the SCCS/1601/18 opinion published on June 20-21, 2019, entry of Salicylic acid in Annex III is therefore updated to include the following product types: body lotion, eye shadow, mascara, eyeliner, lipstick and roll-on deodorant with a maximum authorized concentration of use at 0.5%. 

This update will be applied on the 20th day following its publication.

(a), (b), (c)  Not to be used in preparations for  children under three years of age

Not to be used in applications that may lead  to exposure of the end-user’s  lungs by inhalation

Not to be used in oral products

For purposes other than inhibiting the developmentof micro-organisms  in the product. 

This purpose has to be apparent from the  presentation of the product

These levels are inclusive of any use  of salicylic acid.

(D)The prohibition entry of Nickel bis(tetrafluoroborate) was introduced twice by error. Entry 1427 will therefore be removed. 

This update will be applied on the 20th day following its publication. 

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With this regulation amendment, the cosmetic industry should particularly pay attention to the new requirement of Titanium dioxide in powder form containing 1 % or more of particles with aerodynamic diameter ≤ 10 μm. Cosmetic manufacturers are suggested to check the purity of Titanium Dioxide when raw material is purchased for production.

For inquiries, please contact:

Queenie Ho-yan TSE Technical Service Managert: +852 2765 3672

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