New Restrictions to D4, D5 and D6 – REACH amendment
Topic: NEW RESTRICTIONS TO D4, D5 AND D6

Date of publication: 16/05/2024

On May 16, 2024, the European Commission published the Commission Regulation (EU) 2024/1328 which amended Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), adding restrictions to octamethylcyclotetrasiloxane (D4), decamethylcyclopentasiloxane (D5) and dodecamethylcyclohexasiloxane (D6).

Background

Cyclic volatile methyl siloxanes (cVMS) are vastly used on formulations of consumer products, including cosmetics. These substances have become a subject of environmental contamination and risk assessment due to their widespread use and occurrence in different environmental matrices. 

On 2018, the Commission adopted Commission Regulation (EU) 2018/35 restricting the placing on the market of D4 and D5 in rinse-off cosmetic products. In the same year, the European Chemicals Agency (ECHA) considered D4, D5 and D6 as substances of very high concern (SVHC). D4 was identified as having persistent, bioaccumulative and toxic (PBT) properties. D5 and D6 were also identified as having PBT properties when they contain 0,1 % or more by weight of D4. 

On May 22, 2019, the Commission published an amendment to the Cosmetics Regulation (Commission Regulation (EU) 2019/831), which placed D4 in the Annex II (list of substances prohibited in cosmetics). 

Following D4 prohibition, D5 was updated for rinse-off cosmetic products, that must not contain a concentration of D5 higher than 0.1%. In leave-on cosmetic products, D5 was not restricted. 

These restrictions for D4 and D5 also apply to the UK. The upcoming limits will not directly apply in the UK. In March 2023, the Health and Safety Executive (HSE) opened a call for data to gather information on cyclosiloxanes to evaluate whether to restrict them under UK REACH further.

What’s new?

Commission Regulation (EU) 2024/1328 complements and extends the current restrictions. 

Since D4 is already banned under Annex II of the EU Cosmetics Regulation, its prohibition remains. D5 and D6 will now be restricted to concentrations below 0.1% in both rinse-off and leave-on cosmetic products.

What now?

Cosmetic products containing these substances shall not be placed on the market in concentrations equal to or greater than 0.1% after June 6, 2026. For leave-on products, these restrictions apply from June 6, 2027.

References

Kumari, K., Singh, A. & Marathe, D. Cyclic volatile methyl siloxanes (D4, D5, and D6) as the emerging pollutants in environment: environmental distribution, fate, and toxicological assessments. Environ Sci Pollut Res (2023)

Commission Regulation (EU) No 2024/1328 amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards octamethylcyclotetrasiloxane (D4), decamethylcyclopentasiloxane (D5) and dodecamethylcyclohexasiloxane (D6)

other REGULATORY UPDATES

Regulation (EU) 2022/692 – OMNIBUS ACT VI – New and Updated Classification of Cosmetic Ingredients

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Date of publication: 03/05/2022

Date of application: 01/12/2023

The Commission Delegated Regulation (EU) 2022/692 includes new or updated classification for 12 chemicals that may be used as cosmetic ingredients. Seven out of these 12 are now classified as carcinogenic, mutagenic or toxic to reproduction (CMR) and are banned from cosmetic products marketed in the EU.

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Date of application: 31/12/2025

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Any REGULATORY QUESTION?

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Ingredients: METHYL SALICYLATE, SODIUM HYDROXYMETHYLGLYCINATE, DBMC, MIBK

Date of publication: 15/09/2022

Date of application: 17/12/2022

The European Commission has published the Commission Regulation (EU) 2022/1531, which amends the Regulation (EC) No 1223/2009 as regards the use in cosmetic products of certain substances classified as CMR, by adding new entries to Annex II and Annex III and revising an entry in Annex V.

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SCCS Preliminary Opinion on Sodium Bromothymol Blue (C186) as hair dyeing

Ingredients: SODIUM BROMOTHYMOL BLUE (C186)

Date of publication: 28/10/2022

Following the request from the EU Commission for a scientific opinion on the hair dye Sodium Bromothymol Blue (C186), on October 2022 the Scientific Committee on Consumer Safety (SCCS) issued a preliminary opinion. In light of the data provided, when used in non-oxidative hair colouring products up to a maximum on-head concentration of 0.5%, the SCCS is of the opinion that the complete safety of Sodium Bromothymol Blue could not be assessed.

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