Regulatory
REGULATORY NEWS FOR THE WEEK OF JULY 17, 2023
All substances new to Canada must follow the Canadian Environmental Protection Act’s (CEPA) New Substances Notification Regulations (NSN), which also cover drug, cosmetic and food ingredients (unless the substance appears on the Domestic Substances List (DSL) or the temporary Revised In-Commerce List (R-ICL)). Substances not appearing on either of these lists are notifiable before exceeding manufacturing or importing of 100 kg/year, or 1,000 kg/year if the substance is a polymer. A Ministerial Condition is a risk-management option available in the CEPA Regulatory Toolbox. Ministerial Conditions are only imposed on new substances notifications. CEPA Paragraph 84(1)(a) provides the Ministers with a very powerful tool that can allow, restrict or prohibit the use of a substance that the government assessors suspect or is capable of becoming toxic. A Ministerial Condition may be imposed on the Notifier. What happens when you want to import a substance that is subject to a Ministerial Condition? The short answer is that you must respect the notification trigger quantities of the NSN (100 kg/year unless a polymer which is 1,000 kg/yr. For a chemical a simple Schedule 4 is required 5 business days before exceeding 100 kg. A Schedule 9 polymer notification is required 30 days before exceeding 1,000 kg. Upon receipt of the Notification the New Substances Notification program may inform you that your notification will be subject to a Ministerial Condition. This process may take several weeks to months. It is very important to determine what the notification obligations are if you intend to import larger quantities once your notification has been assessed. This should be outlined in the assessment summary which will be communicated to you in the Acknowledgement email that will be issued once your notification is assessed. In the event that your situation exceeds the initial trigger quantity you may be required to submit the New Substances Notification Schedule related to the quantity involved and be prepared to explain why a notification wasn’t submitted in advance of the date of exceedance. In these situations we recommend you obtain guidance from an experienced consultant or contact the please contact the Substances Management Information Line at 1‐800‐567‐1999 (within Canada), 819‐938‐3232 (outside Canada), or [email protected]. The Canadian Food Inspection Agency (CFIA) issued a Notice to Industry about the Ministerial Order regulating box tree moth in Ontario. Directive D-22-04: Box tree moth (Cydalima perspectalis) – domestic and import phytosanitary requirements was implemented in May 2023. Under this directive, movement controls to prevent the spread of box tree moth from Ontario are in place. Health Canada is reviewing the summary assessments by the WHO’s International Agency for Research on Cancer (IARC) and the Joint Expert Committee on Food Additives (JECFA) published on July 13, 2023, and will review the full reports for each assessment once they are released. The department will determine whether action on aspartame is needed to protect Canadians, taking into consideration the scientific details from the full reports and information specific to the Canadian context for aspartame. Action Health Canada could take, if necessary, includes reducing one or more maximum levels of use for aspartame, further restricting which foods it may be used in, or no longer permitting it to be used as a food additive. The world of work is experiencing rapid, constant change, bringing with it new and emerging health and safety challenges. Are you up to date on the latest developments? The Changing World of Work forum will be held in Halifax, Nova Scotia September 26-27, 2023. Health Canada is seeking comments on a proposal to amend the List of Maximum Residue Limits (MRLs) for Veterinary Drugs in Foods (the List). Opened on July 11, 2023 and will close to new input on September 24, 2023. The Canadian Food Inspection Agency (CFIA) has launched a consultation with consumers and other interested stakeholders to obtain feedback on how to label the origin of imported food from contested territories. For the purpose of this consultation, a contested territory means an area outside of Canada that is subject to competing claims of control by third parties. The online public consultation will be open for 90 days, from July 10, 2023 to October 10, 2023. Health Canada is notifying interested parties of a consultation on a proposal to introduce new requirements for consumer chemical products under the Canada Consumer Product Safety Act (CCPSA). The proposal includes introducing classification criteria based on the Globally Harmonized System for Human Health Hazards of Concern (HHHOC) including carcinogens, mutagens, reproductive toxicity, specific target organ toxicity, and respiratory/skin sensitization. The consultation ends October 9, 2023. Under the Canada Consumer Product Safety Act (CCPSA), the Government of Canada, regulated parties – those who manufacture, import, advertise, sell or distribute consumer products in Canada – and consumers, all play important roles in addressing dangers to human health or safety posed by consumer products. The intent of this page is to inform regulated parties of Health Canada’s approach to the General Prohibitions (GPs) under the CCPSA. Health Canada may revisit certain aspects of this approach when warranted. Health Canada is proposing to update the Cosmetic Ingredient Hotlist. The proposal includes additions, changes to the conditions for existing entries and changes to include new substance identifiers or make minor corrections. The related notice was published in the Canada Gazette, Part I, announcing a 60-day public comment period ending July 19, 2023. However, understanding the importance of stakeholder engagement, we will accept late submissions, but for late submissions the program may focus its efforts on addressing comments that have an impact on the conclusion of the State of PFAS Report. Should the proposed conclusion of the State of PFAS Report be confirmed in the final report, there will be additional opportunities to engage and provide comments on potential risk management. Consultations continue throughout risk management tool development, implementation, and publication. The Consumer Product Safety Program would like to inform you that the following test methodologies have been updated: Chemistry Methods Mechanical Methods Flammability Methods To request a copy, please contact a Health Canada Consumer Product Safety Office via email [email protected] Enforcement officers will be able to impose fines to drivers or companies who violate the Commercial Vehicle Drivers Hours of Service Regulations. The Hours of Service Regulations are critical for promoting road safety as they mandate how long commercial drivers can operate their vehicles before they need rest. They also outline logging and reporting requirements for commercial vehicles and fleet operators. The Health Canada Pest Management Regulatory Agency (PMRA) is responsible for pesticide regulation in Canada. The public registry is where you can learn more about all pest control products registered for use in Canada. Three consultations were launched this past week, these cover:
The Single-Use and Plastic Waste Prevention Regulation will cover shopping bags, disposable food service accessories, oxo-degradable plastics and food service packaging made of polystyrene foam, PVC, PVDC, compostable or biodegradable plastics. WorkSafeBC is requesting feedback on proposed amendments to Part 14, Cranes and Hoists, sections 14.73.1 to 14.75, of the Occupational Health and Safety Regulation. The consultation phase gives stakeholders an opportunity to provide feedback before the proposed amendments are taken to public hearing. The Infrastructure Health and Safety Association (IHSA) is currently seeking applications to fill one upcoming vacancy on its Board of Directors. Start date October 2023. As part of its on-going compliance activities, FDA identifies foods that contain a substance for which there is no authorization as a food additive and then reviews the regulatory status of this substance. When FDA scientists determine that a substance is an unapproved food additive because it is not Generally Recognized as Safe (GRAS) for its intended use (and does not meet a listed exception), they may document their findings in a memo. Check out the recently posted memos. The U.S. Food and Drug Administration (FDA), the U.S. Department of Agriculture and the Department of Homeland Security made available the 120 Day Food and Agriculture Interim Risk Review, which provides a review of critical and emergent risks to the U.S. Food and Agriculture sector, as well as ways to mitigate those risks. This review will help inform the Federal Risk Mitigation Strategy, as outlined in the National Security Memorandum-16 (NSM-16). This document discusses what cumulative risk assessment is and how it could be used in the scientific and regulatory context of TSCA. A cumulative risk assessment will not always be the best approach, or possible to complete in the statutory timeframes provided for TSCA risk evaluations. But when chemicals are sufficiently similar toxicologically and are found to present co-exposures (i.e., meaning people are at exposed to multiple chemicals at the same time), a cumulative risk assessment may be appropriate. The Environmental Protection Agency (EPA) is adding a diisononyl phthalate (DINP) category to the list of toxic chemicals subject to the reporting requirements under the Emergency Planning and Community Right-to-Know Act (EPCRA) and the Pollution Prevention Act (PPA). In this action, EPA is adding the DINP category to the toxic chemical list as a category defined to include branched alkyl di-esters of 1,2 benzenedicarboxylic acid in which alkyl ester moieties contain a total of nine carbons. The DINP category meets the EPCRA chronic human health effects toxicity criterion because the members of the category can reasonably be anticipated to cause serious or irreversible reproductive dysfunctions as well as other serious or irreversible chronic health effects in humans, specifically, developmental, kidney, and liver toxicity. The final rule is effective on September 12, 2023. The U.S. Department of Transportation’s Federal Motor Carrier Safety Administration (FMCSA) issued regulatory guidance clarifying the definitions of “broker” and “bona fide agents.” The guidance offers clarification for brokers, dispatch services, trade associations and other stakeholders across the trucking industry. The California Air Resource Board has launched a new Clean Truck Logo as part of its ongoing efforts to promote and enhance the program. On 4 July, the OECD released 21 Test Guidelines to promote harmonised methods for chemical safety testing, keeping pace with current knowledge and emerging science technologies. Accepted internationally as standard methods for safety testing, the Guidelines are used by professionals in industry, academia and government involved in the testing and assessment of chemicals. Assessments of the health impacts of the non-sugar sweetener aspartame are released July 14, 2023 by the International Agency for Research on Cancer (IARC) and the World Health Organization (WHO) and the Food and Agriculture Organization (FAO) Joint Expert Committee on Food Additives (JECFA). Citing “limited evidence” for carcinogenicity in humans, IARC classified aspartame as possibly carcinogenic to humans (IARC Group 2B) and JECFA reaffirmed the acceptable daily intake of 40 mg/kg body weight. Safety Share These tiny beads, also known as jelly beads, hydro orbs, crystal soil, sensory beads or orb beads, are water-absorbing gel beads that can grow up to 1,500 times their size when placed in water. If ingested, water beads can continue to grow inside the body leading to potentially life-threatening injuries, such as intestinal or bowel obstruction. This year’s focus on cooking safety works to educate the public about simple but important steps they can take to help reduce the risk of fire when cooking at home, keeping themselves and those around them safe. Have an event you would like to share? Please send details to [email protected]. ChemEdge 2023 is bringing supply chain professionals all along the chemical distribution industry together to share best practices and business solutions. Asian Chemicals Forum (ACF) will cover a wide range of topics related to safe chemical management. “Diving into the future“ is the future-oriented motto of this year’s Annual Congress of Fecc (= the European Association of Chemical Distributors), which will return to beautiful Sitges/Barcelone from Monday, 11 September 2023 afternoon to Wednesday, 13 September afternoon. There is no other health and safety event like this in Canada. Make a plan to join us for this two-day national event that will bring together leaders, change makers, and subject experts representing government, labour, and workplaces, to share their knowledge and experience around current and emerging health and safety issues. The World Food Forum officially unveiled its theme for 2023: “Agrifood systems transformation accelerates climate action” and launched its activities for the year culminating in a series of global events, competitions and actions taking place from 16-20 October at the Rome headquarters of the Food and Agriculture Organization of the United Nations (FAO). The International Baking Association (IBA) trade fair, a leading trade fair for the baking and confectionery industry set for Oct. 22-26 in Munich, will feature an area focused on innovative start-up businesses. The next European Chemicals Agency (ECHA) Conference will take place on 28 February 2024 in Helsinki. As we are preparing the programme, we want to hear what would be the most important topics for you. So, fill in our short survey and help us shape a relevant and inspiring stakeholder event.Advocacy
Canadian Federal News
Canadian Provincial News
US News
International News
Other Relevant Information
EVENTS
Comments are closed