EU REACH: Three New Entries Land on Restricted Substances List

EU REACH: Three New Entries Land on Restricted Substances List

The European Commission recently announced three additions to the Restricted Substances List (Annex XVII) of the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Regulation.

Companies will need to survey their supply chains to determine if these substances are in use. If so, they must then determine whether they are compliant with applicable threshold requirements.

Entry 69: Methanol

In November 2017, European Union (EU) member states voted in favour of Poland’s proposal to restrict the use of methanol in windscreen washing and defrosting fluids over 0.6 percent. The requirement aims to reduce methanol poisoning from consumption of windscreen washing fluids or denatured alcohol, which are sometimes ingested by alcoholics. The new threshold requirements will also help prevent poisoning as a result of accidental ingestion by children. The proposal was developed in collaboration with various agencies in Finland, where nearly 40 people die each year from methanol-related incidents.

Requirements associated with this entry on the Restricted Substances List will be implemented on May 9, 2019.

Entry 70: Octamethylcyclotetrasiloxane and Decamethylcyclopentasiloxane

Octamethylcyclotetrasiloxane and decamethylcyclopentasiloxane are substances used in the manufacture of wash-off cosmetic products. The restriction of these cosmetic ingredients has been in motion since 2014, when the European Chemical Agency (ECHA) issued calls for evidence of their persistent, bioaccumulative and toxic (PBT) and very persistent, very bioaccumulative (vPvB) properties.

Since then, studies have found that inhalation of these substances can cause uterine adenomas in rats, among other findings. Despite a few delays, on January 11, 2018, the European Commission published its regulation to restrict the use of either substance at a concentration of over 0.1 percent. It comes into force on February 1, 2020.

Assent helps companies manage their data collection requirements while reducing compliance costs. Download the Product Compliance Suite Guide to learn more.

Entry 71: 1-methyl-2-pyrrolidone (NMP)

In November 2017, the EU approved a Dutch proposal to restrict the manufacture, marketing and usage of NMP, an organic solvent used in the petrochemical industry and in the manufacturing of various compounds, including pigments, cosmetics, insecticides, herbicides and fungicides. The proposal addressed risks to workers caused by inhalation and dermal exposure to the substance.

Beginning on May 9, 2020, usage of the substance at a concentration over 0.3 percent will be restricted unless companies can provide chemical safety reports, safety data sheets and Derived No-Effect Levels (DNELs) of 14.4 mg/m3 for exposure by inhalation and 4.8 mg/kg/day for dermal contact. Companies using the substance must also take the appropriate risk management measures to limit exposure at the same DNELs levels.

Meanwhile, use of the substance as a solvent or reactant in the wire coating process will be enforced beginning on May 9, 2024.

Stay Ahead of These Enforcement Dates

If these substances are used in your products, you will need to validate that the threshold levels are below those listed by the ECHA in time for the coming enforcement dates. Launching a quick engagement with suppliers will show if any of these substances are contained in your products above related article thresholds.

The Assent Compliance Platform can help you quickly respond to any product compliance requirement. With support from our Regulatory team, our up-to-date REACH Module allows you to quickly launch data collection campaigns to check your products for new substances of very high concern.

Learn more about the Assent Compliance Platform by visiting our website, or explore our REACH Module. You can also download our free REACH eBook here, or contact us at