On May 17, 2024, the Official Journal of the European Union (EU) published (EU) 2024/1328, revising item 70 of the restricted substances list in Annex XVII of the REACH regulation to restrict octamethylcyclotetrasiloxane (D4), decamethylcyclopentasiloxane (D5), and dodecylhexasiloxane (D6) in substances or mixtures. The new marketing conditions for rinse off cosmetics containing D6 and resident cosmetics containing D4, D5, and D6 will take effect on June 6, 2024.
According to the REACH regulation passed in 2006, the new regulations strictly restrict the use of the following three chemical substances in non gonococcal cosmetics and other consumer and professional products.
·Octamethylcyclotetrasiloxane (D4)
CAS No 556-67-2
EC No 209-136-7
·Decamethylcyclopentasiloxane (D5)
CAS No 541-02-6
EC No 208-764-9
·Dodecyl Cyclohexasiloxane (D6)
CAS No 540-97-6
EC No 208-762-8
https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202401328
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The specific new restrictions are as follows:
1. After June 6, 2026, it shall not be placed on the market: (a) as a substance itself; (b) As a constituent of other substances; Or (c) in the mixture, the concentration is equal to or greater than 0.1% of the weight of the corresponding substance;
2. After June 6, 2026, it shall not be used as a dry cleaning solvent for textiles, leather, and fur.
3. As an exemption:
(a) For D4 and D5 in washed cosmetics, point 1 (c) should apply after January 31, 2020. In this regard, "water washable cosmetics" refer to cosmetics as defined in Article 2 (1) (a) of Regulation (EC) No 1223/2009 of the European Parliament and of the Council, which, under normal conditions of use, are rinsed with water after use;
(b) All cosmetics other than those mentioned in paragraph 3 (a), paragraph 1 shall apply after June 6, 2027;
(c) For (medical) devices as defined in Article 1 (4) of Regulation (EU) 2017/745 and Article 1 (2) of Regulation (EU) 2017/746 of the European Parliament and the Council, the first paragraph shall apply after June 6, 2031;
(d) For drugs defined in Article 1, point 2 of Directive 2001/83/EC and veterinary drugs defined in Article 4 (1) of Regulation (EU) 2019/6, paragraph 1 shall apply after June 6, 2031;
(e) For D5 as a solvent for dry cleaning textiles, leather, and fur, paragraphs 1 and 2 shall apply after June 6, 2034.
4. As an exemption, paragraph 1 does not apply to:
(a) Put D4, D5, and D6 products on the market for the following industrial uses: - as monomers for the production of organosilicon polymers, - as intermediates for the production of other silicon substances, - as monomers in polymerization, - for formulation or (re) packaging of mixtures- Used for producing goods- Not used for metal surface treatment;
(b) Place D5 and D6 on the market for use as (medical) devices as defined in Article 1 (4) of Regulation (EU) 2017/745, for the treatment and care of scars and wounds, prevention of wounds, and care of stomas;
(c) Put D5 on the market for professionals to clean or restore art and antiques;
(d) Launch D4, D5, and D6 on the market as laboratory reagents for research and development activities under regulated conditions.
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5. As an exemption, point (b) of paragraph 1 does not apply to D4, D5, and D6 placed on the market: - as components of organosilicon polymers - as components of organosilicon polymers in mixtures specified in paragraph 6.
6. As an exemption, point (c) of paragraph 1 does not apply to mixtures containing D4, D5, or D6 as residues of organosilicon polymers placed on the market under the following conditions:
(a) The concentration of D4, D5 or D6 is equal to or less than 1% of the weight of the corresponding substance in the mixture, used for bonding, sealing, gluing and casting;
(b) A mixture of protective coatings (including ship coatings) with a concentration of D4 equal to or less than 0.5% by weight, or a concentration of D5 or D6 equal to or less than 0.3% by weight;
(c) The concentration of D4, D5 or D6 is equal to or less than 0.2% of the weight of the corresponding substance in the mixture, and is used as (medical) equipment as defined in Article 1 (4) of Regulation (EU) 2017/745 and Article 1 (2) of Regulation (EU) 2017/746, except for the equipment mentioned in paragraph 6 (d);
(d) D5 concentration equal to or less than 0.3% by weight of the mixture or D6 concentration equal to or less than 1% by weight of the mixture, used as an instrument defined in Article 1 (4) of Regulation (EU) 2017/745 for dental impressions;
(e) The concentration of D4 in the mixture is equal to or less than 0.2% by weight, or the concentration of D5 or D6 in any substance in the mixture is equal to or less than 1% by weight, used as silicon insoles or horseshoes for horses;
(f) The concentration of D4, D5 or D6 is equal to or less than 0.5% of the weight of the corresponding substance in the mixture, used as an adhesion promoter;
(g) The concentration of D4, D5 or D6 is equal to or less than 1% of the weight of the corresponding substance in the mixture, used for 3D printing;
(h) The concentration of D5 in the mixture is equal to or less than 1% by weight, or the concentration of D6 in the mixture is equal to or less than 3% by weight, used for rapid prototyping and mold manufacturing, or for high-performance applications stabilized by quartz fillers;
(i) D5 or D6 concentration is equal to or less than 1% of the weight of any substance in the mixture, used for pad printing or manufacturing; (j) D6 concentration is equal to or less than 1% of the weight of the mixture, used for professional cleaning or restoration of art and antiques.
7. As an exemption, paragraphs 1 and 2 do not apply to the placement on the market or use of D5 as a solvent in tightly controlled closed dry cleaning systems for textiles, leather, and fur, where the cleaning solvent is recycled or incinerated.
This regulation shall come into effect on the 20th day from the date of its publication in the Official Journal of the European Union, and shall have overall binding force and be directly applicable to all EU member states.
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Summary:
Due to D4, D5, and D6 being substances of high concern (SVHC), they exhibit high persistence and bioaccumulation (vPvB). D4 is also recognized as persistent, bioaccumulative, and toxic (PBT), and when D5 and D6 contain 0.1% or more of D4, they are also recognized as possessing PBT characteristics. Considering that the risks of PBT and vPvB products have not been fully controlled, restrictions are the most suitable management measure.
After the restriction and control of rinse products containing D4.D5 and D6, the control of non rinse products containing D4.D5 and D6 will be strengthened. At the same time, considering the current wide application scenarios, restrictions on the use of D5 in textiles, leather, and fur dry cleaning, as well as restrictions on the use of D4.D5 and D6 in pharmaceuticals and veterinary drugs, will be postponed.
Given the large-scale application of D4.D5 and D6 in the production of polydimethylsiloxane, there are no relevant restrictions on these uses. At the same time, in order to clarify the polysiloxane mixture containing residues of D4, D5, and D6, corresponding concentration limits have also been provided in different mixtures. Relevant companies should carefully read the relevant clauses to avoid the product being subject to restrictive clauses.
Overall, the restrictions on D4.D5 and D6 have relatively little impact on the domestic silicone industry. Companies can meet most of the restrictions by considering the residual issues of D4.D5 and D6.
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Post time: Jul-31-2024
