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Related International Activities

European Union (EU)

In 2005, Belgium completed, on behalf of the European Union, a risk assessment report on methylenediphenyl diisocyanate (MDI) isomers and mixtures (PDF) (234 pp., 1.20 MB, about PDF) Exit EPA Disclaimer (see p. 197 in particular). The risk assessment identifies risks to human health for both workers and consumers and the need for risk reduction measures that will ensure protection of workers and consumers from eye, skin, and respiratory tract irritation, respiratory and skin sensitization and lung effects induced by short-term repeated exposure. In the case of workers, the risk assessment assumes that in many scenarios engineering controls and use of personal protective equipment (PPE) will be used and will contribute to risk reduction. According to the risk assessment, similar assumptions cannot be made for consumer uses of MDI. The Risk Assessment also concluded that there was inadequate evidence of carcinogenicity in humans and limited evidence in experimental animals.

The EU Commission adopted amendments to Marketing and Use Directive (76/769/EEC) Exit EPA Disclaimer on December 16, 2008, to address concerns about the use of MDI-containing consumer products that were raised in the EU Risk Assessment Report. The MDI marketing and use directive lead to Commission Regulation which amended Annex XVII of REACH (PDF) (25 pp., 835 KB, about PDF)  Exit EPA Disclaimer to add a specific restriction of certain consumer uses of MDI (see #56 in Column 1). Effective December 27, 2010, all consumer products [manufactured and imported] into the EU containing concentrations of 0.1 percent or more MDI must include protective gloves which comply with certain EU safety requirements and specific warnings and use instructions.

The EU Registration, Evaluation, Authorization and Restriction of Chemical substances (REACH), Exit EPA Disclaimer went into effect in June 2007 and calls for the registration of all chemicals manufactured and imported into the EU market in quantities of one metric ton or more per year. Registration of chemicals already in commerce will be phased in over a period of 11 years and will involve an estimated 30,000 existing chemical substances. Under REACH, chemical risk assessments are conducted by manufacturers and importers, and chemical registrations are reported to the EU. This EU chemical regulation affects all global supply chains that produce and use chemicals, including U.S. exporters. Registration dossiers for chemicals produced in quantities of over 1,000 metric tons per year were required no later than November 30, 2010.

In a separate activity, as a result of a recommendation from the Technical Committee for Classification and Labelling, the EU Commission adopted amendments to its classification and labeling regulations for MDI. The European Commission, in Commission Directive 2008/58/EC, added a "limited evidence of carcinogencity" designation to its existing classification and labeling requirements for MDI, on August 21, 2008. This designation is based on limited evidence of carcinogenicity in animal studies only. Note that in conjunction with REACH, the EU also revised its classification and labeling requirements to align them with the United Nations Globally Harmonized System (GHS) .  As part of Commission Regulation (EC) 790/2009 (PDF) (439 pp., 8.42MB, about PDF) , the EU provided both the new (p. 32) and the old (p. 260) classification and labeling requirements for MDI. The new requirements are effective December 1, 2010.

OECD

Under the auspices of the Organization for Economic Cooperation and Development (OECD), the United States and other member countries have agreed to cooperatively investigate high production volume (HPV) chemicals by sponsoring the completion of screening information data sets (SIDS) for use in initial hazard assessments of the chemicals. A SIDS Initial Assessment Profile (SIAP) Exit EPA Disclaimer was prepared in November 2003 for a category of 4 MDI isomers. The SIAP recommended the MDI category for further work because of the human health concerns for local effects after repeated inhalation, irritation and sensitization.

Canada

Canada’s Occupational Health and Safety Act exit EPA has regulations governing the exposure of workers to designated substances, including isocyanates, setting workplace air exposure limits.

Read more information about spray foam quality control Canadian installation requirements.

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