24 July 2015
Public Consultation Launched to Restrict Two Substances Commonly Found in Cosmetic Products
On 18 June 2015, the European Chemicals Agency (ECHA) launched a public consultation on a restriction proposal submitted by the United Kingdom. The UK has asked for an EU-wide restriction of Octamethylcyclotetrasiloxane (D4) and Decamethylcyclopentasiloxane (D5) in personal care products sold to EU consumers.
The scope of the restriction of D4 and D5 is confined to those personal care products that wash off with water within a few minutes of application, and which are placed on the EU market. The proposal will first be considered by ECHA’s committees for Risk Assessment (RAC) and Socio-economic Analysis (SEAC). The RAC and the SEAC are both scheduled to make their final opinions available by 10 June 2016. These opinions will then be sent to the European Commission which will have to decide whether or not the proposed restriction should be included in Annex XVII of the REACH Regulation. Annex XVII sets out the prohibition of a wide variety of products that contain hazardous substances (for example, certain phthalates in toys and childcare articles).
Hong Kong and mainland Chinese cosmetic product exporters may want to note the possible outcome of this proposal. If D4 and D5 are to be banned in personal care products, then manufacturers and exporters targeting the EU market will have to comply with the applicable restriction and make changes to the products affected by it.
The proposed restriction on personal care products that are washed off in normal use pertains to those that contain equal to or more than 0.1% by weight of D4 and D5. Normal use is defined according to individual product packaging instructions for how the product should be used, but is aimed at products that are intended to be washed off shortly after application. Personal care products, for the purposes of this restriction, are defined based on EU Regulation 1223/2009, also known as the Cosmetic Products Regulation, as “any substance or mixture intended to be placed in contact with external body parts (epidermis, hair, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance and or correction body odours and/or protecting them or keeping them in good condition”.
Examples of products falling within the scope of the proposed restriction include:
- Skin care products (e.g. bath oils),
- Make-up removing products (e.g. facial cleanser, scrubs and mud masks),
- Hair care products (e.g. shampoo and wash-off hair conditioner),
- Shower gels,
- Shaving foam, glide gel and lubricant.
The main motivator behind the proposed restriction is the nature of D4 and D5. D4 has persistent, bioaccumulative and toxic (PBT) properties while both D4 and D5 have very persistent and very bioaccumulative (vPvB) properties. This means that both D4 and D5 will persist in the environment for long periods of time and will accumulate in organisms, with unpredictable long-term effects.
Substances that are very persistent and very bioaccumulative may reach high levels in humans and/or the environment over long periods of time and may thus have unknown effects. PBT and vPvB substances may be gradually transported to areas far away from their emission sources, thus making it very difficult to protect even remote and pristine areas from these substances. Current scientific methods cannot determine or establish a “safe” concentration for PBT/vPvB substances in the environment.
The proposal indicates that many of these personal care products that are on the market do not contain D4 or D5. This is an indicator that finding and using substitutions for D4 and D5 in these types of products is both technically and economically feasible. Hong Kong producers of personal care products that are washed off in normal use may eventually have to conduct research into which products have been successfully produced and marketed without D4 or D5 as ingredients.
There is a six month public consultation period on the proposed restriction between 18 June 2015 and 18 December 2015. During this time, stakeholders, both within and outside the EU, are allowed to submit comments or additional information and data to be considered by the RAC and SEAC. The opinions delivered by the RAC and SEAC will reflect the comments and information received during the public consultation period. Hong Kong companies may be interested in contributing to the public consultation dialogue to voice their opinions and concerns or to provide data regarding these products and their use. Specific information is being requested from stakeholders including the following:
- Information on the type/category and number of different personal care product (PCP) formulations containing D4 or D5, that are currently sold by your company;
- Information on the typical concentration (% by weight) and overall tonnage of D4 or D5 sold by your company in the PCP formulations being marketed;
- Information on the transfer of D4 or D5 in different types of PCPs from the various external parts of the human body into clothes or on the subsequent emissions of D4 or D5 to wastewater from washing clothes;
- The identity and specific applications of alternatives to D4 and D5;
- Any human health or environmental issues concerning the use of alternatives to D4 and D5 in PCPs that are washed off in normal use;
- Information about potential testing and related costs that would have to be undertaken to ensure compliance with the proposed restriction.
Although the public consultation is open until 18 December 2015, the RAC and SEAC would appreciate receiving comments or information by 1 September 2015.
Please click the following to read:
- The Proposal for a Restriction of D4 and D5.
- Short Version of the Proposal for a Restriction of D4 and D5.
- Comments for Annex XV restriction report.
Hong Kong companies can use the third hyperlink above to submit comments within the framework of the public consultation.