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LEGISLATION & RULES

COM(03) 644 (01), October 23, 2003 Issued by the European Commission, this regulation establishes the REACH program and sets more stringent identification requirements of chemical substances. It also calls for the progressive substitution of the most dangerous chemicals when suitable alternatives have been identified, known by the acronym IST, or “Inherently Safer Technology” in the United States. Specifically, chemical manufacturers and importers are required to gather information on the properties of their substances and register this information in a central database. The European Chemicals Agency (ECA), based in Helsinki, Finland, will oversee the REACH program and will provide information on hazards to consumers and professionals.

Chemicals produced in volumes below 10 m.t./year are exempt from REACH standards if the substance is not considered to be of high concern to human health or the environment.

UPDATES, COMMENTS & OTHER REPORTS

June 2010 The ECHA has added additional chemical substances to the candidate list of Substances of Very High Concern (SVCH), increasing the number of on the list to 38 chemicals. Chemicals that feature on the list will be subject to the authorization phase of REACH. The European Commission announced earlier this year that it wants to increase the number of SVHCs on the candidate list to 135 by 2012. Suppliers of products that contain one of the SVCHs in a concentration above 0.1 percent by weight must provide their customers with the name of the SVHC contained in the product as well as any available information relating to the safe use of the product. Updates are expected as additional chemicals are classified. For more information, visit the ECHA’s website.

August 2009 On August 4, the American Chemistry Council (ACC) recommended specific guidelines for revising the Toxic Substances Control Act (TSCA). ACC’s 10 Principles for Modernizing TSCA represent a significant departure from existing requirements. Currently, TSCA requires EPA to provide scientific evidence that a chemical is unsafe before it can restrict use. ACC has proposed to shift the burden of proof to the industry. The safety of each chemical would have to be shown. Thus, ACC is calling for a much stronger chemical management policy similar to the REACH law in Europe.

REACH Implementation Schedule The REACH regulation was signed by the European Parliament on December 13, 2006 and by the Council of Europe on December 18, 2006. Once in force, REACH will require the registration of over 30,000 chemical substances over a period of eleven years. Going forward, the European Commission has outlined the following 11-year timeline for the program:

2007	2008		2010	2013	2018
June 1	June 1	June 1 thru November 30	November	June	June
REACH program begins.	European Chemical Agency becomes fully operational.	Pre-registration for phase-in substances begins.*	Registration deadline for carcinogens, mutagens and substances toxic to reproduction (CMR category 1 & 2) above 1 ton/year and substances classified as very toxic to aquatic organisms (R50/53) above 100 tons.	Registration deadline for substances in quantities of 100 tons and more and substances toxic for the aquatic environment.	Registration deadline for substances in quantities of 1 ton and more.

* New substances will need to be registered before they are placed on the market, thus there will be no pre-registration period for new chemicals. Instead, they should submit the registration dossier as required starting June 1, 2008. Also, voluntary registration prior to deadlines is possible. The ECA will begin collecting these dossiers on June 1^st as well.

Additional information on REACH can be found on the European Commission’s Web site at http://ec.europa.eu/environment/chemicals/reach/reach_intro.htm or contact Jude Brinkley, the Customer Liaison Manager with REACHReady, at jude.brinkley@reachready.co.uk. Information can also be found at REACHReady’s Web site at www.reachready.co.uk.

December 2008 If your company starts manufacturing or importing one ton or more of a chemical substance per year after December 1, 2008 you may benefit from late pre-registration provisions. REACH-IT, the web portal for companies to use to submit data to ECHA, will be enabled for submission of late pre-registrations beginning January 5, 2009. Please note, late pre-registration does not apply to companies that failed to meet the pre-registration deadline. These companies cannot continue producing or importing the substance until they have submitted a full registration dossier.

October 2008 The ECHA has published the initial Candidate List of 15 Substances of Very High Concern. As of October 28, suppliers to the European Union of substances identified on the Candidate List must provide a safety data sheet to their customers. Additionally, suppliers of products that contain one of these substances in a concentration above 0.1 percent by weight must provide their customers with the name of the SVHC contained in the product as well as any available information relating to the safe use of the product. Updates are expected as additional chemicals are classified. For more information, visit the ECHA’s website.

Independently, the International Chemical Secretariat, a non-profit environmental organization based in Sweden, has published its own list, the Substitute It Now (SIN) List. The SIN list identifies 220 chemicals and includes key raw materials and intermediates such as butadiene, carbon monoxide, benzene and hexane. The purpose of the list is to influence the REACH authorization procedure to fast-track the most urgent SVHCs for substitution. To view the list, click here.

August 2008 President Václay Klaus of the Czech Republic vetoed a law that would subject his country’s chemical industry to the European Union’s REACH legislation. In a statement issued to the media, Klaus commented, “There is no reason to further toughen legislation in this field. People are not endangered by chemicals.” He also noted that REACH deprives Europe’s chemical industry of competitiveness, stating that the law is “an unprecedented step” that would place the Czech chemical industry “under the direct control of European bureaucrats.”

July 2008 The European Chemical Agency (ECHA) has announced the first sixteen chemicals to be considered for the “candidate list” of substances that eventurally may be subject to stringent authorization requirements under REACH. ECHA is seeking comments relating to hazardous properties of these substances that qualify them as substances of very high concern (SVHC). Stakeholders are also asked to submit information on use and exposure as well as on safer alternative substances and techniques. Comments on the proposed substances are due on August 14, 2008. For more information, click here or visit ECHA’s website at www.echa.europa.eu.

January 3, 2006 Robert Westervelt, Editor-in-Chief of Chemical Week Magazine, has predicted there will be “mayhem in Helsinki” at the gates of the ECA as they begin to process the 30,000 chemical dossiers required by REACH. The key concern is that with just 100 staff manning the agency in 2007 rising to 400 in 2010, the rate at which the 30,000 dossiers can be handled is unclear.

The European Commission claims that REACH will simplify existing EU legislation on chemicals by replacing 40 existing pieces of legislation and creating a single system for all chemicals. However, the onus will be on industry to generate the data required and to identify the measures needed to manage the risks associated with hazardous substances. For many firms, registration will be the most costly and time-consuming part of compliance with REACH. Registration involves producing a dossier of information in collaboration with other manufactures or importers. Generally anyone that makes or imports a chemical into the EU above one ton per year will need to register the substance with the ECA.

RELATED ILTA ARTICLES

ILTA provides a monthly newsletter to its membership. Members may log in to the Member Resources page to access archived newsletters. The following is a list of articles ILTA has published in its newsletter relating to the mechanical dye injection requirement.

Momentum Continues to Build for TSCA Reform in the U.S., January 2010 Issue (p.5)
ACC Recommends a Precautionary Approach to Chemical Management in the US, September 2009 Issue (p.5)
EU May Soon Require Prior Authorization for Use of Certain Chemicals, June 2009 Issue (p.3)
European Chemicals Agency Publishes List of Substances of Very High Concern, November 2008 Issue (p.4)
European Union Begins Chemical Review Process Under REACH, August 2008 Issue (p.5)
GAO Report Favors REACH-Like Approach to the Toxic Substances Control Act October 2007 Issue (p.4)
Pact Between U.S. and E.U. May Lead to More Environmental Regulations, March 2007 Issue (p.3)
EU Signs Chemical REACH Law, January 2007 Issue (p.2)
European Chemical Regulation Proposal Reaches California, April 2006 Issue (p.2)
Comprehensive New European Chemical Legislation Within “Reach”, March 2006 Issue (p.2)