Regulations Update

Safeguarding the Environment: EU tightens Regulations on D4, D5, D6 in Cosmetic Products

2024.08.13

The European Commission has finalized and adopted Commission Regulation (EU) 2024/1328 on May 17, 2024 to further tighten the use of Octamethylcyclotetrasiloxane (D4), Decamethylcyclopentasiloxane (D5) and Dodecamethylcyclohexasiloxane (D6) under Annex XVII of REACH Regulation (EC) No 1907/2006.

 

Environmental Impact From D4, D5 AND D6

D4, D5 and D6 bring mainly environmental concerns. These substances are discharged into aquatic environments and the atmosphere, exhibiting persistence, bioaccumulation, and toxicity to aquatic life. They have a limited ability to degrade, as a result, they tend to accumulate in organisms, and pose substantial risks to aquatic ecosystems. The Agency’s Risk Assessment Committee (RAC) pointed out that cosmetic products containing D4, D5 and D6 are the main source of the release of D4, D5 and D6 into the environment.

 

Further Limitation on D4, D5 AND D6 in Cosmetic Products 

Except that Commission Regulation (EU) 2018/35 has already restricted the use of D4 and D5 in wash-off cosmetic products in a concentration not more than 0.1% by weight of either substance from January 31, 2020, the use of D4 and D5 in other cosmetic products, as well as the use of D6 in all cosmetic products, will be restricted to the same level of usage (<0.1% by weight of respective substance) from June 6, 2027.

 

It is important to note that, D4 is already prohibited in cosmetic product according to Annex II of Cosmetic Regulation (EC) No 1223/2009.

 

The table shows an overall restriction of D4, D5 and D6 in cosmetic products.

Substance(s)

CAS No.

Cosmetic Products

Cosmetic Regulation

(EC) No 1223/2009

REACH Regulation (EC) No 1907/2006

New amendment (EU) 2024/1328 to REACH Regulation

Octamethyl-cyclotetrasiloxane (D4)

556-67-2

 

Leave-on

Prohibited

Not regulated

<0.1%

(since June 6, 2027)

Wash-off

Prohibited

<0.1%

(since January 31, 2020)

-

Decamethyl-cyclopentasiloxane (D5)

541-02-6

 

Leave-on

Not regulated

Not regulated

<0.1%

(since June 6, 2027)

Wash-off

Not regulated

<0.1%

(since January 31, 2020)

-

Dodecamethyl-cyclohexasiloxane (D6)

540-97-6

 

Leave-on

Not regulated

Not regulated

<0.1%

(since June 6, 2027)

Wash-off

Not regulated

Not regulated

<0.1%

(since June 6, 2027)

 

Source:

  1. Cosmetic Regulation (EC) No 1223/2009 (consolidated version 04/04/2024)
  2. REACH Regulation (EC) No 1907/2006 (consolidated version 01/12/2023)
  3. New amendment (EU) 2024/1328 to REACH Regulation
 

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