2 June 2017
EU Plans to Limit D4 and D5 Substances in Cosmetics and Cleaning Items
Hong Kong traders of an array of goods, from cosmetics to cleaning (e.g., dry cleaning) products, should be warned that the European Chemicals Agency (ECHA) has submitted an intention to prepare a restriction for octamethylcyclotetrasiloxane (D4) and decamethylcyclopentasiloxane (D5) in April 2017.
The chemical substances D4 and D5 are used in personal care products (cosmetics) and other consumer or professional products. The expected restriction will be a tolerated concentration of only 0.1% or less of these substances. Hong Kong sellers should take note that this development will affect a number of personal care and industrial products which they may sell in the future to EU consumers.
On 13 April 2017, ECHA was notified of the European Commission’s intention to limit the concentration of D4 and D5 on products placed on the EU market to a maximum of 0.1% in the range of leave-on Personal Care Products (PCPs) and other consumer or professional products. The concentration limit of 0.1% will effectively ensure that any intentional use of the two targeted drop-in substances will cease, as such a low concentration would not allow for a fulfilment of their usual role as carrier substances.
Both D4 and D5 are silicone materials widely used in commercial production. The PCPs targeted by the intended limitation are mainly skin care products like moisturisers, products intended for application to the lips, foundation, make-up products and make-up removing products for the face and eyes; deodorants and antiperspirants; sun protection products and products for tanning without the sun; hair care products (e.g. leave-in conditioners, mousses and gels) as well as nail products and manicure preparations.
The product groups of cleaning products (e.g. for dry cleaning, waxes and polishes for cars and other vehicles, washing products) as well as those products that are disposed of in solid waste (e.g. cleaning wipes and baby wipes) are equally covered by this initiative.
Previously, on 20 February 2017, the European Commission had already submitted a draft amendment to the World Trade Organisation (WTO), proposing the same EU limitation but only on wash-off cosmetic products under Annex XVII of the REACH Regulation. The targeted product group had, at that time, comprised only wash-off skin care products (e.g. oils for use in the bath or shower); make-up removing products (e.g. facial cleansers, scrubs and mud masks); hair care products (e.g. shampoos and wash-off hair conditioners); shower gels and other PCPs including shaving foam.
However, the scope will now be enlarged to include leave-on PCPs as well as cleaning products.
The restriction of both D4 and D5 is considered to be necessary by the Commission as a response to the risks to the environment posed by the release of these substances to waste water. This is based on the March 2016 opinion of the EU Risk Assessment Committee (RAC) whose role it is to prepare opinions on questions relating to risks of chemicals to human health or the environment and to prepare the opinion of ECHA on proposals for restrictions. The RAC concluded that D4 meets the criteria set forth in Annex XIII of REACH so as to be identified as a persistent, bioaccumulative and toxic (PBT) substance as well as a very persistent, very bioaccumulative (vPvB) substance. D5 has been identified as vPvB.
Thus, although the proposed draft restriction had originally been limited to wash-off PCPs, the new approach of the Commission seems to be in line with the findings of the RAC. In the aforementioned report, the RAC considers that the relative contribution to total emissions from leave-on PCPs remains highly uncertain, and could be significant.
ECHA is, in consequence, currently developing an Annex XV dossier concerning the use of D4 and D5 in leave-on cosmetic products and for other consumer or professional products not covered in the earlier restriction proposal. ECHA is investigating the need for a restriction according to Article 69(1) of the REACH Regulation and has issued a call for evidence to which all interested parties (manufacturers, suppliers, distributors, importers as well as civil societies, scientific bodies and all other stakeholders) can submit information by August 2017.
After the public consultations, the expected date of submission of a draft restriction in accordance with Article 69(3) of the REACH Regulation is 13 April 2018. The date of the entry into force will depend upon the duration of the procedure.
Hong Kong traders may like to know that the annex to the earlier draft amendment concerning D4 and D5 (which only covered wash-off cosmetic products) had provided for a twenty-four month transition period. It is therefore possible that this same transition period will also apply to the future regulation covering all personal cosmetic products as well as cleaning products. The grace period of two years should allow for adjustments on the market.