Regulatory
REGULATORY NEWS FOR THE WEEK OF SEPTEMBER 19, 2022
To update our clients who are engaged with the Non-prescription and Natural Health Product Directorate at Health Canada (NNHPD), for natural health products, we are experiencing increased delays beyond the service standards that are laid out for both site licence applications as well as product registrations. Some of these delays are significant and are impacting project timelines and delaying launches. Health Canada is working very diligently to work through this backlog, but for the short term, we’ve been informed to expect continued delays beyond the normal service standards for any type of request, including new or amended site licences, or new natural health product registrations. Health Canada is facing serious challenges because hand sanitizers are natural health products and thus must be registered prior to sale in Canada. During the peak of Covid, NNHPD licensed 4,263 hand sanitizers and issued 2,053 temporary COVID site licences – a bulge in submissions that could not have been anticipated. These applications were given priority, which meant that Health Canada could not meet its performance standards for non-COVID related NHP applications. Many of those temporary licences are in the process of conversion to full licence status, and many new site licence holders were unaware of the need to submit their licence renewal about three months in advance of expiry. Failure to submit early results in cancellation, and new licences must then be applied for. The net result of this extraordinary situation is continued significant delays licence application processing. While we at Food Preventive Control Services Canada and Chemical Compliance CA Inc. understand how Covid has impacted NNHPD’s processes, we continue to raise concerns about these delays and we will continue to engage with Health Canada to offer solutions to support system improvement to help get this backlog of requests through their systems. In Canada’s Natural Health Products Regulations, service standards are laid out according to product type: Site licence applications are split into three paths (each path has a 5-day administrative review for completeness): While this means that delays in obtaining licences and registrations will continue for the near future, Health Canada is committed to working through the current backlog. Please let us know of any specific situation that you experiencing. Anyone involved with poultry production from the small backyard to the large commercial producer should review their biosecurity activities to assure the health of their birds. An online event hosted by the Codex Secretariat at 12:00 CEST on Tuesday 20 September 2022 will see the launch of a new Codex survey to measure the use and impact of Codex standards
Healthy workers in healthy workplaces focuses on issues related to occupational diseases. n the industrial sector, the focus of the initiative will be on awareness and prevention of silica exposure in industrial workplaces. The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry entitled “Prior Notice of Imported Food Questions and Answers; Draft Guidance for Industry (Edition 4)”. The U.S. Department of Transportation’s Federal Highway Administration (FHWA) announced a final rule that will improve safety for all road users by ensuring that pavement markings are made more visible in dark or low light conditions. The Environmental Protection Agency (EPA) is proposing to amend the significant new use rules (SNURs) for certain chemical substances identified herein, which were the subject of one or more premanufacture notices (PMNs) and in some cases significant new use notices (SNUNs). Comments must be received on or before October 17, 2022. Under the new Executive Order, the U.S. Environmental Protection Agency (EPA), the U.S. Department of Agriculture (USDA) and the U.S. Food and Drug Administration (FDA) are renewing efforts to improve the clarity and efficiency of regulatory processes for biotechnology products. International Council for Harmonisation; Draft Guidance for Industry. The National Fire Protection Association® (NFPA®) Standards Council recently voted to issue the 2023 National Electrical Code® (NEC®). Used in all 50 states, the NEC is the benchmark for safe electrical design, installation, and inspection to protect people and property from electrical hazards. This advance notice of proposed rulemaking (ANPR) seeks input from stakeholders about how to update the United States Department of Agriculture (USDA) organic regulations on inert ingredients in pesticides used in organic production. The manufacturing industry is a major source of global carbon dioxide emissions. Industrial production will continue to shift to emerging and developing economies. OECD’s new “Framework for industry’s net-zero transition” is a step-by-step approach to assist emerging and developing economies in designing solutions for financing and to improve the enabling conditions that can accelerate industry’s transition. If you are an only representative of a non-EU manufacturer you will be asked to identify the non-EU manufacturer you represent, including their contact information in REACH-IT, from 26 April. You must have a separate REACH-IT account for each non-EU manufacturer you represent and have the necessary registrations for each of them. The innovative survey looks at how European workers are exposed to a selection of cancer risk factors to better identify those responsible for most of the exposures. Such reliable data are essential for both the safety and health of workers and a productive and sustainable economy. France has submitted an intention to restrict the placing on the market and reuse of treated articles with creosote or creosote-related substances. The restriction proposal is expected by 7 October 2022. The European Commission has published a call for evidence on a proposal for a basic regulation for ECHA. The initiative aims to strengthen the European Chemicals Agency (ECHA) governance, streamline the working methods of ECHA’s bodies and make their financing more sustainable. Safety Share Small and medium-sized workplaces rely on safety data sheets for understanding the hazards associated with the chemicals they are using. But what if you have more questions about the chemicals? At some point in our lives, we are all likely to be affected by a mental health problem, whether it’s through a family member, a friend, a colleague, or through personal experience. Promoting mental well-being at work makes good sense for both employees and organizations. The 2022 NSC Safety Congress & Expo will offer more than 125 educational opportunities including Professional Development Seminars, Keynotes and Technical Sessions. All designed to help you advance your career, earn CEUs and provide new skills to help you perform your day-to-day job better. The European Commission’s Directorate-General for Environment will organise the second part of the Fourth Annual Forum on Endocrine Disruptors on 21-22 September 2022, in collaboration with the French Agency for Food, Environmental and Occupational Health & Safety (ANSES). Theme: Collaborating for good The Summit is a full day event that will feature three panels, including an enforcers roundtable. Registrations are free and open to all virtually. Rodbell Auditorium, NIEHS, 111 TW Alexander Drive, Research Triangle Park, NC 27709 Canadian Institute of Food Science and Technology (CIFST) ALT launched in 2021 as a virtual event that focused on alternative food products, alternative technologies and innovative alternatives to how the food industry produces and distributes products to end users. The Canadian Agricultural Safety Association (CASA) co-ordinates, develops and leads national initiatives to help farmers, their families and workers recognize and manage safety risks. Safety starts with identifying hazards. Some are obvious, staring us in the face. This symposium will address drug development of products that contain nanomaterials in their formulation and how the newly finalized guidance to industry for products that contain nanomaterials can be implemented in filings to the FDA. This educational, two-day in person event will address topical workplace challenges employers face and provide insight on how to create a healthy and safe work environment. The discussions will also focus on hot topics in Food Safety Management Systems. The Global Forum on Environment on Mercury will bring together leading actors in the field of chemicals and waste management of mercury to promote effective engagement, collaboration and action on eliminating or reducing mercury from the supply chain. SQF Unites offers a unique combination of educational formats and engagement activities that you can tailor to meet your company and personal goals. Reserve for this complimentary session where we will discuss some of the updates expected in the soon to be released new CSA Z432 Safeguarding of Machinery standard.
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