Methylenediphenyl diisocyanates (MDIs) and Methylenediphenyl diamines (MDAs) Substance Grouping Update
Government of Canada's Final Screening Assessment, Proposed Risk Management Approach and Proposed application of the SNAc provisions
11 July 2017
Did you Know...
On June 10, 2017, a notice with respect to the final screening assessment for methylenediphenyl diisocyanates (MDIs) and methylenediphenyl diamines (MDAs) and a risk management approach for MDIs, and a notice of intent to apply the significant new activity (SNAc) provisions of the Canadian Environmental Protection Act, 1999 (CEPA) to MDAs, were published in the Canada Gazette, Part I, under the Government of Canada's Chemicals Management Plan.
Summary of Final screening assessment:
The substances part of the Methylenediphenyl Diisocyanate and Diamine (MDI/MDA) Substance Grouping are as follows:
- Benzene, 1,1'-methylenebis [4-isocyanato- (also referred as 4,4'-MDI), CASRN: 101-68-8
- Benzene, 1,1'-methylenebis [2-isocyanato- (also referred as 2,2'-MDI), CASRN: 2536-05-2
- Benzene, 1-isocyanato-2-[(4-isocyanatophenyl)methyl]- (also referred as 2,4'-MDI), CASRN: 5873-54-1
- Benzene, 1,1'-methylenebis[isocyanato- (also referred to as mixed MDI), CASRN:: 26447-40-5
- Isocyanic acid, polymethylenepolyphenylene ester (also referred as pMDI), CASRN: 9016-87-9
- Benzenamine, 4,4'-methylenebis- (also referred as 4,4'-MDA), CASRN: 101-77-9
- Formaldehyde, polymer with benzenamine (also referred as pMDA), CASRN: 25214-70-4
Environment and Climate Change Canada and Health Canada have assessed these substances to determine if they pose a risk to the environment or to human health. The final screening assessment, concludes that MDIs may be harmful to human health and meet the criteria set out in paragraph 64(c) of CEPA, and it is proposed that MDIs be recommended for addition to Schedule 1 of CEPA -the List of Toxic Substances. A risk management approach has been published that outlines the proposed risk management actions.
The final screening assessment concludes that MDAs are not entering the environment in a quantity or concentration or under conditions that constitute a danger to human health or the environment. However, as 4,4′-MDA and pMDA are recognized as having human health and ecological effects of concern, there is a concern that new activities that have not been identified or assessed could lead to these substances meeting the criteria set out in section 64 of CEPA. The Canadian government is proposing to amend the Domestic Substances List, to indicate that the Significant New Activity (SNAc) provisions apply to these substances.
Final Screening Assessment: http://www.ec.gc.ca/ese-ees/default.asp?lang=En&n=3139721E-1
Proposed Risk Management Approach:
The proposed risk management objective for MDIs is to reduce the general population's exposure resulting from the use of do-it-yourself (DIY) low-pressure two-component spray polyurethane foam (SPF) consumer products containing MDIs. The government is proposing to develop a Code of Practice under section 55 of CEPA with industry stakeholders. The code would be used to create standardized information and recommendations regarding the products to inform DIY users about proper personal protective equipment (PPE) and other conditions needed for the safe use of low-pressure two-component SPF consumer products.
The following are some proposed actions that may be included in the code of practice, which will be developed through discussions with stakeholders:
- Indication of specific respiratory PPE requirements shown in an image and described on the product outer packaging;
- Improved labelling to provide safety information on the product outer packaging, including cautionary warnings;
- Clear and detailed instructions for safe use of the product;
- Development of a generic respiratory protection plan to be included with the product;
- Product manufacturers to have a plan for training retailers on the potential risks of the products such that proper information would be provided to DIY consumers at the point of sale;
- Product manufacturers and retailers to provide consumers with materials on the potential risks of the products at the point of sale; and
- Proper PPE be made available for sale near the products or at the point of sale.
Proposed Risk Management Approach: http://www.ec.gc.ca/ese-ees/default.asp?lang=En&n=E05194C1-1
How to get involved…
Within 60 days of publication of the risk management approach for MDIs and the notice of intent to apply the SNAc provisions of CEPA to MDAs, namely August 9, 2017, any person may submit comments to the Minister of Environment and Climate Change with respect to the publications. Stakeholders are also encouraged to provide any information pertaining to the substance that may help inform decisions with respect to the risk management of MDIs and the potential application of the SNAc provisions to MDAs.
How we can help!
Intertek Scientific & Regulatory Consultancy understands the challenges that companies face in understanding the implications and impacts a regulatory update such as this brings. Do you need or wish to submit comments with respect to these publications or want to better understand the screening assessment and/or the risk management approach and identify what impacts this may have on your business? Intertek can help! Contact us and one of our experts will get back to you.
Today's expert blogger is Joyce Borkhoff. Joyce is the Director of the Intertek Chemicals Group and is well known for her ability to effectively characterize and communicate the impacts of the regulatory environment on the chemical industry. She is frequently invited to contribute to trade magazines and to present her advice and experience to a wide range of SME and large multi-national audiences. Her technical and regulatory experience and her deep knowledge of the Chemical Industry, makes Ms. Borkhoff uniquely qualified to provide practical, best-in-class service to help meet and understand Global Chemicals Management requirements.