European Chemicals Agency (ECHA) Restricts Microplastics and Siloxanes

by | Jul 9, 2019 | Cosmetics, European Regulatory, Medical Devices, Research/Science/Technology

Intentionally Added Microplastics:

Microplastics are manufactured and used in many products on the European market. These ‘intentional’ uses of microplastics are the focus of the proposed restrictions. The potential posed environmental and human health risks of microplastics are that they are small (easily ingested), resistant to environmental biodegradation, and practically impossible to remove from environment. They are primarily released to the environment down the drain, through municipal solid waste, or through direct release.

The proposed restriction on microplastics is comprised of 3 measures (from ECHA Annex XV Restriction Report)

  1. “a restriction on the placing on the market of microplastics on their own or in mixtures where their use will inevitably result in releases to the environment, irrespective of the conditions of use. For some of these uses, a transitional period is proposed to allow sufficient time for stakeholders to comply with the restriction.”
  2. “a labelling requirement to minimise releases to the environment for uses of microplastics where they are not inevitably released to the environment but where residual releases could occur if they are not used or disposed of appropriately”
  3. “a reporting requirement to improve the quality of information available to assess the potential for risks in the future.” (must report identity of the polymer(s) used, purpose and quantity used of the microplastic, and the quantity released to environment)

The proposed restriction is estimated to result in a reduction of approximately 400 thousand tonnes of microplastics emission over 20 years. With the third measure listed above, the ECHA has proposed a way to collect additional information on the uses for potential improvements in the future.

D4, D5, D6:

Octamethylcyclotetrasiloxane (D4), decamethylcyclopentasiloxane (D5), and dodecamethylcyclohexasiloxane (D6) are cyclic volatile methyl siloxane (cVMS) substances with four, five, and six siloxane groups, respectively. They are manufactured and used in a variety of European sectors, especially for leave-in and wash-out cosmetic products. D4, D5, and D6 were found by the ECHA to have persistent, bioaccumulative and/or toxic properties, which give rise to concerns due to their potential to accumulate in the environment and cause unpredictable, irreversible long-term effects.

The proposed restriction to D4, D5, and D6 (from ECHA Annex XV Restriction Report) is that they shall not be placed on the market as substances, or as constituents of other substances at a concentration equal to or greater than 0.1%. This restriction shall come into force at least 5 years following the publication in the Official Journal for leave-on cosmetic products, and after at least 10 years for use of D5 in dry cleaning. For all other uses, the restriction will come into force 2 years after publication in the Official Journal. There are some exceptions to the restrictions on D4, D5, and D6 use for medical device purposes and for non-cosmetic use.

For more information, please contact Focal Point Research Inc.  We are leading North American Regulatory and New Product Consultants for Medical Devices, Natural Health Products, OTC Drugs, Cosmetics, and other consumer products regulated by Health Canada and the U.S. FDA.