Regulatory
REGULATORY NEWS FOR WEEK OF OCTOBER 21, 2020
Canadian Federal News
The Canadian Centre for Occupational Health and Safety (CCOHS) has launched a new customizable tool kit resource to help workplaces across Canada operate safely and prevent the spread of infection during the COVID-19 pandemic.
The updated draft screening assessments for substances in the Certain Organic Flame Retardants Substance Grouping have been published. It is proposed to conclude that three substances, melamine, TCPP, and TDCPP, may be harmful to human health and meet the criteria under section 64(c) of the Canadian Environmental Protection Act, 1999 (CEPA). Risk management scopes have been published concurrently to initiate discussions with stakeholders on the risk management options being considered.
Updated Risk Management Scope for 2-Propanol, 1-chloro-, phosphate (3:1) (TCPP) and 2-Propanol, 1,3-dichloro-, phosphate (3:1) (TDCPP). Chemical Abstracts Service Registry Numbers:
- 13674-87-8
- 13674-84-5
The draft screening assessment for benzenesulfonic acid, 4-methyl-, also referred to as p-toluenesulfonic acid, has been published. It is proposed to conclude that the substance does not meet any of the criteria set out in section 64 of CEPA.
The final screening assessment for the Triarylmethanes Group has been published. It is concluded that four of the six substances, Basic Violet 3, Malachite Green, Basic Violet 4, and Basic Blue 7, may be harmful to the environment and/or to human health and meet the criteria under section 64(a) and/or 64(c) of CEPA. A risk management approach has been published concurrently to outline the proposed risk management actions. It is also concluded that the remaining two substances do not meet any of the criteria set out in section 64 of CEPA.
The Government of Canada would like to inform you of the publication of the Notice with respect to perfluorohexane sulfonic acid, its salts and its precursors (PFHxS) on October 10, 2020, in the Canada Gazette, Part I, pursuant to the information gathering provisions of paragraph 71(1)(b) of the Canadian Environmental Protection Act, 1999:
- The notice applies to 33 substances.
- The deadline to report is November 20, 2020.
- To determine whether this notice applies to you, refer to sections 2, 3 and 4 of the notice.
- Responses to the section 71 notice can be made by downloading and completing an Excel Reporting Form and submitting it through Environment and Climate Change Canada’s Single Window.
- Any person not subject to this notice, who has an interest in a substance, may identify themselves by completing a voluntary Declaration of Stakeholder Interest.
- Persons who do not meet the requirements of the notice and have no interest in the 33 substances may submit a Declaration of Non-Engagement.
- Refer to the Information gathering initiatives web page and Guidance manual for additional information on responding to the notice, including how to submit the Reporting Form and Declarations of Stakeholder Interest and Non-Engagement.
Before to the review of the definition of a “supplement”, polymers required a comprehensive safety assessment but did not require registration when sold or imported into Canada as stand-alone products prior to sale or import. This notice serves to clarify the current regulatory requirements for products that are or contain polymers.
Health Canada’s Food Directorate completed a premarket safety assessment of a food additive submission seeking approval for the use of acid prolyl endopeptidase (a type of protease) from Aspergillus niger GEP in brewers’ mash; ale, beer, light beer, malt liquor, porter, stout; distiller’s mash, and protein hydrolysates (hydrolyzed animal, milk and vegetable protein). In addition, the use of this enzyme from this source was also requested in cereal- and plant-derived ingredients which will be further used as ingredients in the manufacture of non-alcoholic plant-based beverages.
- Establishment Licence Fees Remission Order (Indication of an Activity in respect of a COVID-19 Drug)
Drug submissions approved under the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 (the Interim Order) will not be subject to cost recovery fees. However, applications for new drug establishment licences, amendments, and the annual review of drug establishment licences issued in relation to COVID-19 drugs under the Interim Order are still subject to fees fixed in the Fees in Respect of Drugs and Medical Devices Order (the Fees Order). The application of cost recovery fees for these activities may hinder or delay access to drugs for the treatment, mitigation, or prevention of COVID-19.
The Food and Drug Regulations (FDR) contain emergency provisions, which can be used in certain circumstances to authorize access to human and veterinary drugs for Canadians in medical emergencies when a drug is not authorized for sale in Canada. These provisions are administered through the Special Access Program (SAP) for human drugs, and through the Emergency Drug Release (EDR) Program for veterinary drugs.
The Government of Canada is committed to providing the Canadian public and other stakeholders with the opportunity to participate in the development of regulatory initiatives. Health Canada invites stakeholders to submit comments on the proposed additions to the Hotlist, changes to the conditions for existing entries, changes to include new substance identifiers or make minor corrections to the Cosmetics Ingredient Hotlist, or any other suggestions. As applicable, please supply evidence to support your comments. Comments will be received until December 12, 2020.
Restrictions:
- Ethylhexyl Ethylhexanoate: Ethylhexyl Ethylhexanoate is being considered for addition to the list of restricted substances due to health concerns
- Azelaic acid and its salts: Azelaic acid and its salts are being considered for addition to the list of restricted substances due to therapeutic properties at certain concentrations and risk of skin irritation at high concentrations.
Prohibitions:
- Retinoic acid
- Alpha-hydroxy acids
- Eucalyptus oil
- Peroxide and peroxide generating compounds
- p-Hydroxyanisole
In addition to the above changes, several existing entries will be revised to include new synonyms and Chemical Abstract Service Registry (CAS) numbers or make minor corrections.
Canadian Provincial News
The Ontario government is launching a recruitment campaign to increase its team of frontline health and safety inspectors by 98 and help ensure workplaces across the province are doing their part to prevent the spread of COVID-19. With these new hires, there will be more labour inspectors on the ground than ever before in the province’s history.
O. Reg 545/20: Inventory of agents or combinations of agents for the purposes of Section 34 of the Act has revoked Regulation 852/90.
US News
To amend the National Environmental Policy Act of 1969 to impose time limits on the completion of certain required actions under the Act, and for other purposes.
The CSB issues safety recommendations to prevent the recurrence or reduce the likelihood or consequences of similar incidents or hazards in the future. Recommendations are issued to a variety of parties, including government entities, safety organizations, trade unions, trade associations, corporations, emergency response organizations, educational institutions, and public interest groups. Recommendations are published in CSB reports and are closed only by vote of the Board. The CSB tracks all recommendations and communicates regularly with recommendations recipients to ensure that the recommended corrective actions are implemented.
PMN Number: P-16-538 CAS number: 22256-71-9
PMN Number: P-18-308 CAS number: not available
International News
Due to the coronavirus disease (COVID-19) pandemic, IARC Monographs Meeting 128: Acrolein, Crotonaldehyde, and Arecoline, which was scheduled to take place on 3–10 November 2020, will now be held remotely on 29 October to 13 November 2020.
The European Commission has published its Chemicals Strategy for Sustainability as part of the European Green Deal. ECHA welcomes the strategy and looks forward to supporting its implementation. The chemicals strategy highlights that chemicals are fundamental for society and that a robust framework is needed to make the legislation stronger and more coherent.
It presents several actions for a toxic-free environment to protect people and the environment from hazardous chemicals. ECHA can play a key role in many of these areas with its scientific and technical competencies.
The European Commission has clarified when companies need to update their REACH registration dossiers. The requirement to update ‘without undue delay’ is in most cases specified as three months and, in more complex cases, up to 12 months.
(CHeMyCAl) The Chinese Ministry of Ecology and Environment (MEE), formerly the Ministry of Environmental Protection (MEP), issued the “Measures on the Environmental Management of New Chemical Substances” (MEE Order No. 12) on April 29, 2020, which will replace the current MEP Order No. 7 on January 1, 2021. To implement MEE Order No. 12, the MEE released the “Guidance for Environmental Management Registration of New Chemical Substances (Draft for Consultation)” (Draft Guidance) on August 17, 2020, to replace the current “Guidance for New Chemical Substances Notification and Registration” in effect under MEP Order No. 7 since October 15, 2010.
The Theme for the next meetings of the Conferences of the Parties to the Basel, Rotterdam and Stockholm conventions, and the associated High-Level Segment, from 19 to 31 July 2021, is “Global Agreements for a Healthy Planet; Sound Management of Chemicals & Waste”.
The WTO launched a new publication to answer commonly raised questions about trade and the environment at a virtual event on 16 October. “Short Answers to Big Questions on the WTO and the Environment” explores trade’s impact on the planet, the policies that governments enact to protect it and the role of the WTO regarding environmental issues.
Industrial chemicals with CAS numbers 3470-98-2, 1352216-91-1, 2209852-19-5, 13897-55-7, 13897-56-8, 2248118-60-5 and 2248118-61-6 have been added to the Australian Inventory of Industrial Chemicals in accordance with section 83 of the Industrial Chemicals Act 2019.
Other Relevant Information
Safety Share
(McGill Office for Science and Society) – The best way to prevent the spread of COVID-19 is to keep your distance from others, limit your social interactions, wear a mask and wash your hands frequently. Up until now, no one as suggested that we should start wearing protective eye goggles, though a new study in JAMA Ophthalmology argues that maybe we should be.
The COVID-19 pandemic has changed our world and the way we live, work, study and play. Some organizations have had to quickly close or have employees work remotely. October 29, 2020
10:30 am – 12:00 pm
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