EHS Regulations to Watch: December 2013 Update
EHS Regulations to Watch: December 2013 Update
Brief overview of three regulations to watch:
- Europe’s EU REACH consideration of restricting or banning refractory ceramic fibers (RCFs) which are commonly used as high-temperature insulation in manufacturing equipment. Note: SEMI provided formal feedback to the European Chemicals Agency (ECHA) arguing against restriction and further recommending that industry be allowed to use RCFs.
- Taiwan is drafting new legislation, similar to the European REACH regulation, to control all substances manufactured in or imported into the country. Note: The Taiwan EPA has tentatively agreed to allow SEMI member representatives to sit on an industry panel advising the government on the regulation.
- Europe’s draft legislation called “Market Surveillance Regulation” (unofficially abbreviated MSR). Changes system from every Member State being individually responsible for “surveilling” markets for products that don’t meet certain European-wide regulatory requirements. Note: SEMI has provided numerous comments to members of the European Parliaments as well as members of the European Council of Ministers. Some of the arguments and suggested revisions put forward by SEMI have been accepted.
All three regulations would have major implications for the semiconductor industry. Additional (background, implications, objectives, etc.) are below.
Under the REACH regulation, the European Chemicals Agency (ECHA) is currently considering restricting or banning certain potentially hazardous substances commonly used to manufacture semiconductor devices or within manufacturing equipment. One restriction target is RCFs (refractory ceramic fibers), which are commonly used as high-temperature insulation in manufacturing equipment.
Without a legal allowance for use, a restriction or ban on RCFs would force a re-design of manufacturing process steps or of the manufacturing tools, ultimately leading to increased costs and delays.
To ensure that RCFs are not restricted or otherwise, to ensure that industry can apply for authorized use if a specific substance is restricted.
In concert with ESIA, SEMI provided formal feedback to the European Chemicals Agency (ECHA) arguing against restriction and further recommending that industry be allowed to use RCFs.
ECHA has not yet responded to our feedback, but we are confident that RCFs will continue to be allowed to be used in semiconductor equipment.
Taiwan is currently drafting new legislation, similar to the European REACH regulation, to control all substances manufactured in or imported into the country. If enacted without revision, industry would have to register all existing substances and provide adequate hazard and exposure information to government authorities by 2015. Furthermore, companies would likely have to publically disclose the substances they are using.
Without an extension, materials suppliers would not likely be able to register all substances by the 2015 deadline and manufacturing would be deeply affected. Also important is that confidential business information would no longer be considered confidential.
To ensure that the Taiwan National Assembly and the Taiwan Environmental Protection Agency (EPA) make allowances for an extended registration deadline and protection of confidential business information.
In concert with TSIA, SEMI provided formal feedback to the Taiwan EPA and National Assembly arguing for the protection of CBI and an extension of the substance registration deadlines.
The Taiwan EPA has tentatively agreed to allow SEMI member representatives to sit on an industry panel advising the government on the regulation.
EU Market Surveillance
In early 2013, the European Commission proposed draft legislation called “Market Surveillance Regulation” (unofficially abbreviated MSR). Under the existing system, every European Member State is individually responsible for “surveilling” markets for products that don’t meet certain European-wide regulatory requirements. The current system creates confusion and duplication for companies operating in many European countries, and in some countries, an uneven economic playing field. The MSR proposal seeks to address these perceived shortcomings by enabling greater coherence of the rules governing market surveillance within and among Member States.
This proposal, if implemented without revision, will create significant uncertainties and risks for SEMI members as they market their products in Europe. For example, the presumption of regulatory conformity that currently exists could be called into question because small non-compliances in formalities are to be considered by surveillance authorities as evidence of more substantial risk, thereby requiring additional burdensome compliance activities (and potentially large business impacts). The regulatory basis for risk assessment is very subjective and this will make it very difficult for manufacturers to verify how their product risks will be evaluated prior to placing it on the market. Finally, companies may lose control of the conformity of their own products, as there is no distinction between different economic operators (e.g. manufacturers, importers, etc). Therefore, companies could be penalized for no fault of their own due to non-conformance of distributors or importing party (e.g. customer for professional products) of their products.
To ensure that SEMI members are not burdened by faulty regulatory provisions of the proposed regulation by advocating for revised language.
SEMI has provided numerous feedback comments to members of the European Parliaments as well as members of the European Council of Ministers. As the proposal is still undergoing debate and revision, more government engagement is predicted.
These government stakeholders have agreed with some of the arguments and suggested revisions put forward by SEMI.
December 3, 2013
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