Regulatory
REGULATORY NEWS FOR THE WEEK OF FEBRUARY 14, 2022
We will be holding a free webinar on Wednesday, February 23rd from 12:00 to 1:00 pm ET on the regulatory obligations for importing chemicals and ingredients into Canada. This webinar will provide an overview of the various regulations that must be considered before importing or manufacturing a chemical, chemical product or ingredient to Canada. Click here to register. Some “personal care products” meet the definitions of both cosmetics and drugs. This may happen when a product has two intended uses. For example, shampoo is a cosmetic because its intended use is to cleanse the hair. An antidandruff treatment is a drug because its intended use is to treat dandruff. Consequently, an antidandruff shampoo is both a cosmetic and a drug, because it is intended to cleanse the hair and treat dandruff. Among other cosmetic/drug combinations are toothpastes that contain fluoride, deodorants that are also antiperspirants, and moisturizers and makeup marketed with sun-protection claims. Such products must comply with the requirements for both cosmetics and drugs. The increased demand and the constraints on the global supply chain have combined to place enormous strain on the nation’s warehouse and logistics industries, and has prompted the U.S. Department of Labor to take heightened action to ensure that warehouse and logistics workers’ wages and workplace rights are protected. With a potential result of food innovations that will create billions in economic value for Canada and environmental benefit for the world, Canadian Food Innovation Network (CFIN) and Ontario Genomics announced AcCELLerate-ON, Canada’s first regional cellular agriculture competition. Designed to spark food innovation, this $700,000 program will support the research and development of viable food production methods such as cell culture, precision fermentation, tissue engineering, scaffolding and hybridizing production capabilities. Federal Annual Declaration must be submitted by February 28 each year for substances appearing on Schedule 2 and 3. Environment and Climate Change Canada will be hosting a webinar series in order to provide a better understanding of the requirements under the Environmental Emergency Regulations, 2019 (E2 Regulations, 2019). The E2 program has prepared five different webinars on specific E2 Topics to be presented over the next months. 1. An Introduction to the E2 regulations: February 22, 2022 1:00 pm – 2:00 pm ET 2. Container systems: March 23, 2022 – 1:00 pm – 2:00 pm ET 3. Development of scenarios in an E2 plan: April 20, 2022 – 1:00 pm – 2:00 pm ET 4. Simulation Exercises: May 25, 2022 – 1:00 pm – 2:00 pm ET 5. Public Notification: June 22, 2022 – 1:00 pm – 2:00 pm ET The Fees in Respect of Drugs and Medical Devices Order was published in May 2019 and came into force on April 1, 2020. At that time, Health Canada made a commitment to engage with stakeholders annually to discuss key elements of cost recovery including performance, costs and program efficiencies. If you would like to participate, please register for your preferred session(s) up to 24 hrs before each event by clicking on the title and a formal invitation will be sent to you. The dates for each session are indicated below: 1. Humans Drugs – Innovators and Biologics session Tuesday, February 15 1:00pm – 3:30pm EST 2. Veterinary Drugs session Thursday, February 17 1:00pm – 2:30pm EST 3. Medical Devices session Tuesday, February 22 1:00pm – 3:30pm EST 4. Humans Drugs – Generics, OTCs and Biosimilars session Thursday, February 24 1:00pm – 3:30pm EST The Government of Canada is taking ambitious action to reduce plastic pollution through a comprehensive approach that addresses the entire life cycle of plastics. Alongside provinces and territories, it is moving forward on a Canada-wide strategy to achieve zero plastic waste by 2030. That is why the Government of Canada is committed to increasing the recycled content in certain plastic products and packaging to at least 50 percent by 2030. Canadians and stakeholders are invited to comment before March 14, 2022. This notice applies to the calendar years 2022, 2023 and 2024. Information pertaining to the 2022 calendar year shall be provided no later than June 1, 2023. Information pertaining to the 2023 calendar year shall be provided no later than June 3, 2024. Information pertaining to the 2024 calendar year shall be provided no later than June 2, 2025. Bill S-5 has passed first reading in the Senate on February 9th, 2022. The summary of the changes includes adding to the Domestic Substances List (DSL) food and drug substances that were in commerce between January 1, 1987 and September 13, 2002 (Revised In Commerce List) and allow for the deletion of a substance from the DSL when it is no longer in commerce in Canada. Expand certain regulation-making, information-gathering, and pollution prevention powers under that Act, including by adding a reference to products that may release substances into the environment. Expand the powers of the Minister of the Environment to vary either the contents of a significant new activity notice with respect to a substance not on the Domestic Substances List or the contents of the List itself. Extend the requirement, to notify persons of the obligation to comply with the significant new activity provisions of that Act when a substance that is subject to those provisions is transferred to them. The results of the premarket assessment support the safety of lactase from K. lactis DS 80496 for its requested uses. Consequently, Health Canada has enabled the use of lactase from K. lactis DS 80496 as described in the information document below by modifying the List of Permitted Food Enzymes, effective February 2, 2022.
Alberta will begin a careful and prudent plan to phase out public health measures, starting Feb. 8. The three-step approach will begin with lower-risk activities while maintaining protections for the health-care system, including continuing care facilities. With key public health and health system indicators continuing to improve, the Ontario government, in consultation with the Chief Medical Officer of Health, is cautiously and gradually easing public health measures sooner, with the next phase of measures being eased on February 17, 2022 at 12:01 a.m. The provincial government has announced that New Brunswick will move to Level 1 of the winter plan to manage COVID-19 on Friday, Feb. 18, at 11:59 p.m. This 2022-24 strategic plan outlines how our linkages will see that vision realized. Our plan has three focus areas: People, Prevention and Integrity. These are interconnected in all we do. The provincial requirement to provide proof of vaccination or negative tests in Saskatchewan businesses, workplaces and other public venues will end this Monday, February 14 at 12:01am. A bill to require the Federal Government to produce a national climate adaptation and resilience strategy. The U.S. Environmental Protection Agency (EPA) is extending the public comment period for the draft scope document for the Toxic Substances Control Act (TSCA) Risk Evaluation for Asbestos Part 2: Supplemental Evaluation Including Legacy Uses and Associated Disposals of Asbestos, to give stakeholders more time to review and comment. Comments can be submitted to docket EPA-HQ-OPPT-2021-0254 by March 1, 2022. On Feb. 9, the FDA released a guidance document titled Questions and Answers Regarding Channels of Trade Policy for Human Food Commodities with Chlorpyrifos Residues: Guidance for Industry. The guidance is intended to help food producers and processors who handle foods that may contain residues of the pesticide chemical chlorpyrifos. The Environmental Protection Agency (EPA) published a final rule on Aug. 30, 2021, revoking all tolerances for chlorpyrifos; these tolerances are set to expire on Feb. 28, 2022. The U.S. Food and Drug Administration issued a guidance for industry and investigators titled “COVID-19 Public Health Emergency: Policy on COVID-19-Related Sanitation Tunnels” to announce a policy discouraging sponsors from developing or seeking approval or authorization for the use of sanitation tunnels, which are tunnels, walkways, chambers, and similar systems, that spray humans with a mist of disinfectant or aerosolized antiseptic with the aim of preventing or treating COVID-19. The U.S. Food and Drug Administration issued a draft guidance for industry titled “Formal Meetings Between FDA and Sponsors or Requestors of Over-the-Counter Monograph Drugs.” The Federal Food, Drug, and Cosmetic Act (FD&C Act) requires FDA to issue guidance on formal meetings between the agency and sponsors or requestors of over-the-counter (OTC) monograph drugs (referred to as “meeting requesters”). This guidance specifies the procedures and principles for formal meetings between FDA and meeting requesters. As also required by the FD&C Act, it establishes procedures for meeting requesters to meet with FDA to obtain FDA’s advice on the studies and other information necessary to support submissions under section 505G of the FD&C Act, other matters relevant to the regulation of nonprescription drugs, and the development of new OTC monograph drugs. Finally, as required by the FD&C Act, the guidance also establishes procedures to facilitate efficient participation in joint meetings by multiple meeting requesters and/or organizations nominated by them to represent their interests. More information about the uses that authorisation is applied for, including the description of the function of the substance, exposure scenarios, possible alternatives identified by the applicants, together with socio-economic information, is available on our website. The deadline is 6 April 2021. France has submitted a proposal to restrict the placing on the market and reuse of treated articles containing creosote (EC 232-287-5, CAS 8001-58-9) and creosote-related substances. Safety Share The human body conducts electricity. Even low currents may cause severe health effects. Spasms, burns, muscle paralysis, or death can result depending on the amount of the current flowing through the body, the route it takes, and the duration of exposure. Cosmetic products (such as soaps, lotions, face and eye makeup, fragrances, etc.) can provoke allergic reactions in some people. Many people suffer from allergies and anyone at any age can develop allergies. Allergic reactions are the immune system’s overreaction to substances that may otherwise be harmless. An allergen can trigger the immune system to release chemical substances such as antibodies that result in allergy symptoms. Many people are familiar with seasonal allergies brought on by pollen from blooming plants, or with food allergies. Allergic reactions to cosmetics most often appear as itchy, red rashes on the skin – or contact dermatitis. Making Leaders Risk Aware and Push to Reduce Risk” and it will take place on February 16, 2022 from 12:30 to 1:15 p.m. ET. The roadside hazardous materials inspector enforces Carriage by Public Highway, Title 49 Part 177 in the federal Hazardous Materials Regulations. There are a few specific codes inspectors use on a regular basis. Step-by-Step Guide for Implementing a Fatigue Management Program The webinar provides an overview of new changes in REACH and CLP in terms of safety data sheets. The Society of Chemical Manufacturers & Affiliates (SOCMA) confirmed today that the Specialty & Custom Chemicals Show is on for February 28-March 2, at the Omni in Fort Worth, TX. The European Commission is hosting its second stakeholder workshop on Safe and Sustainable by Design chemicals and materials. The workshop is organised remotely and will present the draft methodology to define safe and sustainable by design criteria for chemicals and materials. The agenda for the 2022 American Food Sure Summit in Chicago is now live! Partners in Preventions hosts a variety of events and conferences throughout the year that raise awareness and provide educational and professional networking opportunities. Chemspec Europe is back in 2022 in Frankfurt, Germany. Due to COVID-19 health concerns, the 2022 event will be held on May 31-June 1 at Messe Frankfurt in Frankfurt, Germany.Advocacy
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