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Control of Hazardous Materials in Products: Latest Regulations in Europe and the US

Written by Nemko | January 1, 2024
                                                                                                                                                                                       

- Europe with restrictions in the use of microplastics
The European Regulation (EU) 2023/2055, which is the latest amendment to the REACH Regulation, was made effective from October this year. This regulation restricts the use of synthetic polymer microparticles on their own or intentionally added to mixtures with the aim of reducing the emission of microplastics in everyday products.

The regulation defines microplastics as solid synthetic polymer particles smaller than 5 mm that are organic, insoluble and resistant to degradation. These types of particles are present in many types of products, even medical devices within the scope of the Regulation (EU) 2017/745.
Due
to not being biodegradable, such microplastics accumulate in animals, including fish and shellfish, and are consequently also consumed as food by humans. Microplastics have been shown to cause negative impact to both humans and the environment.
The restrictions will come in different stages according to the Regulation (EU) 2023/2055.

The official announcement may be seen
here.

- US with requirements for PFAS substances
In the US, the Environmental Protection Agency (EPA) manages the Toxic Substances Control Act (TSCA). The associated Chemical Substances Inventory contains all existing chemical substances that do not qualify for exemption.
EPA has announced a new TSCA Section 8(a)(7) requiring all industries to report PFAS chemical substances that were manufactured or imported dating back to 1 January 2011, which will create a large concern and a huge amount of work for the industry.  The deadline for reporting will be 8 May 2025.

PFAS chemicals are known as “forever chemicals,” a family of potentially thousands of synthetic chemicals that are extremely persistent in the environment and in our bodies. PFAS is short for Perfluoroalky & Polyfluoroalkyl Substances. These have elemental bonds of fluorine and carbon, which are extremely strong and difficult to disintegrate, so they may accumulate in humans, in drinking water and food as well as in the
environment.
PFAS chemicals have been highly utilized in various industries because of their ability to repel oil and water, and replacement is considered a major challenge to the industry.
In Europe, some of the PFAS under the REACH Regulation are already proposed to be banned.

For further information, please contact Kenny.Ho@nemko.com

 

(The article is based on the information provided by Kenny Ho and edited by T. Sollie)