D4 and D5 Silicones UK’s Proposal Of Restrictions

The UK Competent Authorities has expressed the intention to ask the European Chemicals Agency (ECHA) to limit the use of the two cyclosiloxanes D4 (Cyclotetrasiloxane) and D5 (Cyclopentasiloxane). Expected for January 2015, the first deadline for the UK Competent Authorities to submit the restriction proposal to ECHA has been extended until 17 April 2015.

What would be the recommended limit?

The UK Competent Authorities recommendation will be to restrict these substances for use in concentrations up to 0.1% by weight of each in rinse-off personal care products in normal use conditions.

Why the recommendation?

Although D4 (Cyclotetrasiloxane) and D5 (Cyclopentasiloxane) are not listed in the Annex XV of REACH as being Substances of Very High Concern, there are concerns that they meet the criteria for very persistent (vP) and very bioaccumulative (vB) substances as per the Annex XIII of the REACh Regulation. The finding from the UK report shows that:

  • D4 meets the definition of a PBT and a vPvB substance
  • D5 meets the definition of a PvB substance

D5 is largely used in cosmetics, especially in hair care cosmetic products and it replaced in most of the cases the use of D4 in the last years.

Currently, the two substances are not regulated in Europe but several proposals about their use were made by Canada (to be added to the List of Toxic Substances and to develop regulation to limit their use in personal care products) and California (considering these substances as having “potential public health impacts”).

Next steps

On the basis of the persistence and bioaccumulation properties hazard assessment submitted by the UK Competent Authorities, the Member States Committees shall establish whether the two substances (D4 & D5) meet the criteria to be listed in Annex III of the REACh Regulation.

In this respect, a public consultation has been organised by ECHA on the basis of the PBT report proposed by the UK and stakeholders are encouraged to provide evidences that would assist the Member State Committee assess whether the criteria for PBT/vPvB are met for these substances.

Based on the final decision, the Responsible Persons and cosmetics manufacturers must take the necessary steps for compliancy with the provisions.

Further amendments based on information provided in response to this call for evidence or subsequent public consultation might be expected.

If you would like to know more on cosmetics products regulatory compliance, please contact us.

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