Three Pending EHS Regulations to Watch

Three New EHS Regulations to Watch

SEMI members should be aware of three new EHS regulations.

Taiwan has proposed new rules to govern how chemicals substances will be managed in the country. The legislative proposal, if implemented without revision, might minimally create extreme problems for companies that operate in Taiwan or import products (including materials) to Taiwan. In a worst-case scenario, the current draft provisions could lead to an industry-wide issue. (More details on “Taiwan Proposes Vast New Rules to Manage Chemicals”)

South Korea recently enacted new legislation to manage chemicals substances in the country. As written, the new law may create extreme problems for companies that operate in Korea or import products (including materials and equipment) to Korea. In a worst-case scenario, the current legislation could lead to industry-wide issues. (More on “Korea Enacts New Legislation to Manage Chemicals”)

On February 13, 2013, the European Commission issued a draft proposal for a new regulation called “Market Surveillance Regulation”, unofficially abbreviated MSR. This proposal, if implemented without revision, will create significant uncertainties and risks for SEMI members as they market their products in Europe. (More on “EU Proposal to Change Market Surveillance of Products”)

Taiwan Proposes Vast New Rules to Manage Chemicals

Taiwan has proposed new rules to govern how chemicals substances will be managed in the country. The legislative proposal, if implemented without revision, might minimally create extreme problems for companies that operate in Taiwan or import products (including materials) to Taiwan. In a worst-case scenario, the current draft provisions could lead to an industry-wide issue.

Taiwan’s existing rules to manage chemicals are contained in the Toxic Chemical Substances Control Act (TCSCA), which was first enacted in 1986 and last revised in 2007.

In November 2012, the Taiwan Legislature proposed vast changes to TCSCA. If enacted, these changes would make Taiwan’s chemical management regulations similar to the REACH regulations in the European Union. Because of these similarities, the proposed changes are collectively referred to as “Taiwan REACH.” The draft legislative text actually references harmonization with EU REACH.

One significant revision is to mandate substance registration for all existing substances used in Taiwan in a set quantity such as greater than 1 ton per annum. The enforcement date was proposed to be one year from date of enactment. In other words, industry would have to register all existing substances (and provide adequate hazard and exposure information to government authorities) by 2014 (should the regulation be enacted this year).

Even though Taiwan EPA has requested all local manufactures and importer to register excluding full provision of hazard and exposure information since 2011, and most of them have done what they can do, in comparison, the EU REACH regulation staggered the registration deadlines (based on quantities used) and provided a minimum of four years of preparation for registration.

Some representatives from materials suppliers have expressed deep concern about the feasibility of these registration deadlines. If the REACH registration requirements are not met, materials suppliers cannot market substances in Taiwan and manufacturers will be deeply affected. There is reason to believe that the current Taiwan REACH proposal will significantly affect various high tech industries (semiconductor, photovoltaic, display, lighting, etc) in extremely negative ways.

Also troubling is that under the proposed rules, companies would likely have to publically disclose the substances they are using. There are no provisions to allow manufacturers to with-hold information considered intellectual property, as is the case in other countries. Also important is that nano-materials are treated differently than traditional substances under the proposed rules, with no scientific basis for a distinction.

Many materials suppliers operating in Taiwan have attempted to engage members of the Taiwan legislature in hopes of advocating for more reasonable provisions of Taiwan REACH. Unfortunately, these attempts have not been successful, partly because the legislative process has not been very transparent. Industry was only given little opportunity to comment on the proposed changes especially in the last legislative stage.

According to some experts, the legislative committee responsible for Taiwan REACH is moving quickly to vote on the proposal in the coming weeks. Therefore, time is of the essence.

Based on the significant business impact and lack of transparency of the legislative process, SEMI is seeking engagement from members and partners.

In concert with the SEMI Taiwan office, the SEMI EHS Division plans to address the current weaknesses of the Taiwan REACH proposal by advocating for its revision. For this, SEMI has created a working group to advocate on behalf of SEMI members.

If you are concerned about the likely negative effects of the Taiwan REACH legislative proposal, on your products, we urge you to get involved in the working group and assist SEMI in providing feedback comments to be delivered to various stakeholders in Taiwan. You can join the SEMI Taiwan REACH working group, by completing the online request form located here:

http://www.keysurvey.com/f/534339/5de3/

For additional information about Taiwan REACH and the SEM Taiwan REACH Working Group, please contact Sanjay Baliga (SEMI senior manager in San Jose) at sbaliga@semi.org.

 

Korea Enacts New Legislation to Manage Chemicals

South Korea recently enacted new legislation to manage chemicals substances in the country. As written, the new law may create extreme problems for companies that operate in Korea or import products (including materials and equipment) to Korea. In a worst-case scenario, the current legislation could lead to industry-wide issues.

Previously, Korea’s rules to manage chemicals were contained in the Toxic Chemicals Control Act (TCCA), which was first implemented in 1991 and last revised in 2008.

In April of 2013, the Korea National Assembly proposed and enacted vast changes to TCCA, with most provisions coming into effect in January 2015. The new legislation makes Korea’s chemical management regulations similar to the REACH regulations in the European Union. Because of these similarities, the proposed changes are collectively referred to as “Korea REACH” or “K-REACH”. In some official documentation, the new law is referred to as the Chemical Control Act (CCA).

The legislation calls on the Korean Minister of Environment (MoE) to propose specific regulations and enforcement provisions by the end of the year. To date, the MoE has provided only some scant information as to the direction of their regulatory proposals. But there is some significant cause for concern.

One significant concern is the likely mandate that all companies must register and provide adequate hazard and exposure information to government authorities of all new substances, regardless of the substance volumes. No low volume regulatory exclusions would apply to new substances, as is the case in the EU. Registering and providing sufficient documentation of safe use of new low volume substances would be especially costly. This provision may hinder the creation of new substances and stifle industry-wide innovation.

As currently written, the legislation would require companies to publically disclose the substances they are using. There are no provisions to allow manufacturers to with-hold information considered intellectual property, as is the case in other countries. The MoE has not indicated whether any draft regulation would protect confidential business information (CBI) from these disclosure requirements.

As currently written, the legislation does not provide any clear registration exclusions for substances used solely in research and development (R&D). The MoE has indicated that draft regulation would likely provide such an exemption, but this is not yet a certainty.

The MoE is open to industry feedback as it constructs its draft regulatory language. Based on the MoE openness for industry dialogue and the significant business impacts of the current legislation, SEMI is seeking engagement from members and partners.

In concert with the SEMI Korea office, the SEMI EHS Division plans to address the current weaknesses of the Korea REACH proposal by advocating for its revision. For this, SEMI has created a working group to advocate on behalf of SEMI members.

If you are concerned about the likely negative effects of the Korea REACH legislation on your products, we urge you to get involved in the working group and assist SEMI in providing feedback comments to be delivered to Korea government stakeholders. You can join the SEMI Korea REACH working group, by completing the online request form located here:

http://www.keysurvey.com/f/534339/5de3/

For additional information about Korea REACH and the SEM Korea REACH Working Group, please contact Sanjay Baliga (SEMI Senior Manager in San Jose) at sbaliga@semi.org.

 

EU Proposal to Change Market Surveillance of Products

On February 13, 2013, the European Commission issued a draft proposal for a new regulation called “Market Surveillance Regulation,” unofficially abbreviated MSR. This proposal, if implemented without revision, will create significant uncertainties and risks for SEMI members as they market their products in Europe.

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.

While the current MSR proposal is put forward with good intentions, its current language could affect SEMI members in extremely negative ways. The proposal also applies to all products covered by EU harmonisation legislation. It amends other EU Directives that include market surveillance activities as part of enforcement mechanism, so the regulatory impacts are profound and wide-reaching. Among these Directives as those that affect products of SEMI Member companies, including the Low Voltage Directive, the EMC Directive, the Pressure Equipment Directive, the RoHS Directive, and the Machinery Directive.

Our concerns about the MSR proposal, as currently written, are as follows:

  1. Each European Member State would have extremely broad surveillance authority, negating the intention of the proposal to remove duplication of the more than two dozen existing rule sets. There is no assurance of adequate governance addressing variation of compliance / enforcement across these Member States.
  2. The presumption of 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).
  3. The regulatory basis for risk assessment is very subjective. There are no standards or recommended best methods referenced for the required risk assessment method. It will be very difficult for manufacturers to verify how their product risks will be evaluated prior to placing it on the market.

  4. 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). 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.

In concert with the SEMI Europe office, the SEMI EHS Division plans to address our concerns with the MSR proposal by advocating for its revision. The European Commission has requested industry feedback to the MSR proposal by early September. In preparation for this, SEMI has created a working group to provide feedback comments on behalf of SEMI members.

If you are concerned about the likely negative effects of the MSR proposal on your products, we urge you to get involved in the working group and assist SEMI in providing feedback comments to be delivered to the European Commission. You can join the MSR working group, by completing the online request form located here:

http://www.keysurvey.com/f/534339/5de3/

For additional information about the MSR proposal and the SEMI MSR Working Group, please contact Sanjay Baliga (SEMI Senior Manager in San Jose) at sbaliga@semi.org.

August 6, 2013