OVERVIEW OF METHYLENE CHLORIDE


EUROPEAN UNION

In January 2016 dichloromethane (DCM) was included in the so-called Restriction List (Annex XVII) of the REACH Regulation under Entry no. 59. DCM was therefore not allowed anymore in the EU for use in paint strippers. The use of DCM in industrial parts cleaning is not affected by this restriction and therefore still allowed.    

In July 2021 Italy published its Substance Evaluation Report for DCM and concluded that a revised harmonized classification for DCM is needed. Currently, DCM is classified as cancerogen category 2, meaning suspected of causing cancer. With its current classification DCM does not meet the criteria for Substance of Very High Concern (SVHC).

Italy proposed a re-classification to cancerogen cat 1B, meaning may cause cancer, and mutagen category 2, meaning suspected of causing mutagenic effects. If the classification with cancerogen 1B is accepted, DCM will meet the criteria as SVHC.

A public consultation for comments on the proposed classification was open until November 2023. Currently, the European Chemical Agency (ECHA) is reviewing the received comments.

If the new classification will be accepted, DCM would eventually become an SVHC and will sooner or later be identified as substance which needs an authorisation (Substance on Annex XIV of REACH). In that case, the use of DCM will only be possible, if the user of the substance has a granted authorisation.

SAFECHEM will closely monitor the process and will inform as soon as new information is available.
 


UNITED STATES

Several solvents which are used in industrial parts cleaning operations, including prior and after heat treatment processes, are currently filed under Risk Evaluation by the Environmental Protection Agency (EPA).

The Risk Evaluation Process is the second step, following Prioritization and before Risk Management, under the Toxic Substances Control Act (TSCA).. The purpose is to determine whether a chemical substance presents an unreasonable risk to health or the environment, under the conditions of use, including an unreasonable risk to a relevant potentially exposed or susceptible subpopulation. As part of this process, the EPA must evaluate both hazard and exposure, exclude consideration of costs or other non-risk factors, use scientific information and approaches in a manner that is consistent with the requirements in TSCA for the best available science, and ensure decisions are based on the weight-of-scientific-evidence.

Currently all kind of brominated and chlorinated solvents are under review. This includes the use of  dichloromethane (DCM), perchloroethylene (PERC), trichloroethylene (TRIC) and 1-bromopropane (nPB) but also trans-dichloroethylene (t-DCE).

The EPA released a final revised evaluation on DCM in June 2021 and found unreasonable risks to workers, occupational non-users, consumers, and bystanders in 52 out of 53 conditions of use.

The EPA will develop ways to address the unreasonable risks identified and consider public comments on any risk management actions. Proposals by the EPA for DCM were already published in the Federal Register in May 2023 whereby they propose a prohibition of DCM in industrial parts cleaning application. Until mid of 2023 a public consultation was opened for comments on the proposed rule. Currently, the EPA is reviewing all received comments and will take them into consideration for their final rule for DCM under TSCA, which is expected in 2024. If the proposal enters into force, DCM will not be allowed anymore in vapor degreasing as of 450 days after the publication of the final rule.

SAFECHEM will closely monitor the process and will inform as soon as new information is available.

 


CHINA

China has filed a notice in relation to the so-called Blue Sky Plan in 2019, which aims to improve air quality in several big cities in China. This notice was the starting point for several legislative actions regulating and restricting air quality-affecting topics.

Under this plan a new Chinese standard was published in 2020 which regulates volatile organic compounds (VOC) in cleaning agents (GB 38508-2020). The regulation was released as a national standard in March 2020, followed by implementation on December 1st 2020.

The standard provides limit requirements for VOC, test methods and package marks of cleaning agents. This standard is applicable to cleaning agents containing VOC produced and used in industrial production and service activities. This standard is NOT applicable to cleaning agents used in aerospace, nuclear industry, military industry and semiconductor (including integrated circuit) manufacturing. These areas of industrial production are exempted.

Dichloromethane (DCM) is listed in this standard and therefore falls under this restriction. According to the standard, cleaning agents with a content of ≥ 20% of DCM may for example not be used in industrial production and service activities. Cleaning agents with a VOC content of ≥ 900 g/L may not be used in industrial production and service activities. The standard also defines the limit of VOC content in a cleaning product and therefore alternative formulations are needed in order to meet the requirement.

DCM supplied by SAFECHEM in China can only be used in the industries exempted from the standard, which include aerospace, nuclear industry, military industry and semiconductor (including integrated circuit) manufacturing.