The EU has revised the requirements for D4, D5 and D6 restrictions in Annex XVII of REACH

On May 17, 2024, the Official Journal of the European Union (EU) 2024/1328 amended item 70 of the list of restricted substances in Annex XVII of the REACH Regulation to restrict octamethylcyclotetrasiloxane (D4), decamethylcyclopentasiloxane (D5) and dodecamethylcyclohexasiloxane (D6) in substances or mixtures. The listing conditions for rinse cosmetics containing D6 and resident cosmetics containing D4, D5 and D6 have been added.

The new regulation, which will come into force on 6 June 2024, is binding as a whole and applies directly to all EU member states, mainly in the cosmetics, pharmaceutical, dry cleaning and other related industries.

Information on the new standard substance

1

八甲基环四硅氧烷 (D4)

CAS Number: 556-67-2

EC 编号：209-136-7

2

十甲基环五硅氧烷 (D5)

CAS Number: 541-02-6

EC 编号：208-764-9

3

十二甲基环六硅氧烷 (D6)

CAS Number: 540-97-6

EC 编号：208-762-8

Restricted Content

1

Not to be placed on the market

From 6 June 2026, substances with concentrations equal to or greater than 0.1% (by mass) shall not be placed on the market:

(a) as a substance in itself;

(b) as a constituent of other substances; or

(c) in mixtures;

2

Do not use

From 6 June 2026, it will not be used as a dry cleaning solvent for textiles, leather and fur.

3

as an exemption

(a) For D4 and D5 in wash-off cosmetics, point (c) of paragraph 1 shall apply after 31 January 2020.

For the purposes of this point, "wash-off cosmetics" means cosmetics as defined in point (a) of Article 2(1) of Article 2(1) of (EC) 1223/2009 that, under normal conditions of use, can be rinsed off with water after use;

(b) for all other cosmetics not mentioned in paragraph 3(a), paragraph 1 shall apply from 6 June 2027;

(c) for medical devices as defined in Article 1(4) of (EU) 2017/745 and in vitro diagnostic medical devices as defined in Article 1(2) of (EU) 2017/746, paragraph 1 shall apply from 6 June 2031;

(d) Paragraph 1 shall apply as of 6 June 2031 in the case of medicinal products as defined in Article 1, point 2, 2001/EC and veterinary medicines, as defined in Article 4(1) of (EU) 2019/6;

(e) For D5 as a solvent for dry cleaning of textiles, leather and fur, paragraphs 1 and 2 apply from 6 June 2034.

04

as an exemption

As an exemption, paragraph 1 does not apply to:

(a) D4, D5 and D6 placed on the market for the following industrial uses:

●As a monomer for the production of silicone polymers,

●As an intermediate in the production of other silicon substances,

●As a monomer in polymerization reactions,

● For the formulation or (re)packaging of mixtures,

●Used in the production of articles,

●Used for non-metallic surface treatment;

(b) D5 and D6 devices placed on the market for use in the treatment and care of scars and wounds, infection prevention of wounds and stoma care, as defined in Regulation (EU) 2017/745;

(c) D5 placed on the market for the cleaning or restoration of works of art and antiques;

(d) Placing D4, D5 and D6 on the market for laboratory reagents in R&D activities carried out under controlled conditions.

05

as an exemption

As an exemption, point (b) of paragraph 1 does not apply in the following cases:

●D4, D5 and D6 placed on the market as components of silicon polymers,

● Mixtures placed on the market as components of silicon polymers, with the exceptions specified in paragraph 6.

06

as an exemption

As an exemption, point (c) of paragraph 1 does not apply to mixtures placed on the market if:

(a) For bonding, sealing, gluing and casting, where the concentration of D4, D5 or D6 in the mixture is equal to or less than 1% (by mass);

(b) for protective coatings (including marine coatings) at a concentration of 0.5% or less than 0.5% by mass for D4 or 0.3% or less than D5 or D6;

(c) for equipment (other than those referred to in paragraph 6(d)) as defined in Article 1(4) of (EU) 2017/745 and Article 1(2) of (EU) 2017/746 where the concentration of D4, D5 or D6 in the mixture is equal to or less than 0.2% (by mass);

(d) devices used for dental impressions as defined in Article 1(4) of (EU) 2017/745 where the concentration of D5 in a mixture is equal to or less than 0.3% by mass, or D6 in a mixture is equal to or less than 1% by mass;

(e) For equine silicone insoles or horseshoes, the concentration of D4 in the mixture is equal to or less than 0.2% by mass, or the concentration of D5 and D6 is equal to or less than 1% by mass;

(f) For adhesion promoters, D4, D5 or D6 in a mixture at a concentration equal to or less than 0.5 per cent (by mass);

(g) For 3D printing, the concentration of D4, D5 or D6 in the mixture is equal to or less than 1% (by mass);

(h) For rapid prototyping and tool-making, or for high-performance applications stabilized by quartz fillers, the concentration of D5 in a mixture is equal to or less than 1% by mass, or the concentration of D6 in a mixture is equal to or less than 3% by mass;

(i) for pad printing or the manufacture of printing pads where the concentration of D5 or D6 in the mixture is equal to or less than 1% (by mass);

(j) For professional cleaning or restoration of works of art and antiques at a concentration of 1% or less (by mass) of D6 in the mixture.

07

as an exemption

As an exemption, paragraphs 1 and 2 do not apply to placing on the market or using D5 as a solvent in tightly controlled closed dry cleaning systems for textiles, leather and fur, where the cleaning solvent is recycled or incinerated.

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