Regulatory
REGULATORY NEWS FOR WEEK OF NOVEMBER 12, 2021
Canadian Federal News
Health Canada’s Food Directorate completed a safety assessment of modified vinegar for use as a preservative in various standardized meat and poultry products as well as in unstandardized preparations of meat and poultry products. The results of the assessment support the safety of modified vinegar when used as described in the information document below. Consequently, Health Canada has enabled this use of modified vinegar by modifying Part 2 of the List of Permitted Preservatives, effective November 8, 2021.
International Council for Harmonisation’s guideline entitled, “Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management” (ICH Q12) provides a framework to facilitate the management of post-approval Chemistry, Manufacturing and Controls (CMC) changes in a more predictable and efficient manner across the product lifecycle. Implementation of ICH’s Q12 Guideline will promote innovation and continual improvement in the biopharmaceutical and pharmaceutical sectors and strengthen quality assurance and reliable supply of product, including proactive planning of supply chain management. It will allow regulators (assessors and inspectors) to better understand the firm’s Pharmaceutical Quality Systems (PQSs) for the management of post-approval CMC changes.
This approach addresses 9 organic and inorganic substances that were identified as priorities for assessment as they met the categorization criteria under subsection 73(1) of the Canadian Environmental Protection Act, 1999 (CEPA) or were considered a priority based on other human health concerns as part of the Chemicals Management Plan (CMP). It is proposed that these substances no undergo further assessment at this time.
The draft screening assessment for the Flame Retardants group has been published. It is proposed to conclude that IPPP may be harmful to the environment and to human health and meets the criteria under paragraphs 64(a) and (c) of CEPA. It is also proposed to conclude that TPHP, BPDP, BDMEPPP and IDDP may be harmful to the environment and meet the criteria under paragraph 64(a) of CEPA, while TEP may be harmful to human health and meets the criteria under paragraph 64(c) of CEPA. A risk management scope has been published concurrently to initiate discussions with stakeholders on the risk management options being considered. It is also proposed to conclude that the remaining six substances do not meet any of the criteria set out in section 64 of CEPA.
The draft screening assessment for methylstyrenated phenol has been published. It is proposed to conclude that the substance may be harmful to the environment and meets the criteria under paragraph 64(a) of the Canadian Environmental Protection Act, 1999 (CEPA). A risk management scope has been published concurrently to initiate discussions with stakeholders on the risk management options being considered.
Effective January 15, 2022 exporters of food and animal commodities destined for the European Union (EU) will be required to use updated export certificates. Export certificates can be accessed through the Trade Control and Expert System New Technology (TRACES NT), which serves as the EU’s e-certification system.
In order to prepare industry for the transition to using TRACES NT and new export certification requirements, an early adoption approach is being developed with associated details for the stakeholders. As of November 15, 2021, all dairy exports to the EU will use the new certificates in TRACES NT as a part of early adoption.
Operators of dairy exporting establishments are urged to review the revised EU export certification requirements. Relevant sections of Commission Implementing Regulation (EU) 2020/2235, refer to Chapter 4 of Annex I on the notes for completion of the certificates and Annex III for the EU model certificate applicable to the products exported.
Health Canada is pleased to announce the development of the draft Guidance on clinical evidence requirements for medical devices and its companion piece which provides manufacturers a list of examples to consider. This guidance document is the result of a commitment under the Medical Devices Action Plan to improve the safety and effectiveness of medical devices and how they get to the Canadian market.
Canadian Provincial News
An updated Occupational Health and Safety Act (OHS Act) and revised regulations take effect December 1, 2021. The new act eliminates duplication and simplifies language to make OHS laws easier to understand and follow, resulting in healthier and safer workplaces and supporting investment attraction and job creation. Workers continue to have the same rights and protections under the revised OHS laws.
New and revised regulatory requirements affecting multiple industries will come into effect on December 1, 2021. These amendments impact combustible and flammable liquids and housekeeping.
As part of the 2021 Fall Economic Statement, the Ontario government will introduce legislation that, if passed, would raise the general minimum wage from $14.35 to $15.00 per hour effective January 1, 2022. Under the proposed changes, the special minimum wage rate for liquor servers would be eliminated and they would be entitled to the general minimum wage. Students under 18, homeworkers and hunting, fishing and wilderness guides would also see an increase in their special minimum wage rates.
Prince Edward Island’s minimum wage will increase by 70 cents to $13.70 per hour on April 1, 2022.
The circuit breaker will continue for another seven days in a large section of Zone 1 (Moncton region) and a large part of Zone 2 (Saint John region) as the overall case activity remains high and positivity rates are above the provincial average.
[/vc_column_text] The FDA is republishing fee rates under this OTC Monograph Drug User Fee Program (OMUFA)— an important step in implementing the OTC monograph reform provisions under the CARES Act. Hand sanitizer manufacturers not subject to the OMUFA facility fees are still subject to other applicable FDA requirements. The FDA will continue using its regulatory compliance and enforcement tools to protect consumers, including potentially dangerous or sub-potent hand sanitizers. The purpose of this guidance is to clarify, for the food industry, aspects of the application process for temporary marketing permits (TMPs). This guidance also describes a change that simplifies the label review process. It will streamline and improve the efficiency of the TMP application process. This guidance is intended to help the industry better understand and utilize the TMP application process. OSHA issued an Emergency Temporary Standard (ETS) on Vaccination and Testing to protect workers from the coronavirus. Employers with at least 100 employees will be required to adopt a vaccination policy unless they adopt a policy requiring unvaccinated workers to undergo weekly testing and wear a face covering at work. The U.S. Environmental Protection Agency (EPA) announced revisions to the 2018 mercury inventory reporting rule which requires reporting from persons who manufacture (including import) mercury or mercury-added products, or otherwise intentionally use mercury in a manufacturing process. The revisions released today mean that companies that import pre-assembled products that contain a mercury-added component are now required to report those imports to EPA under the mercury inventory reporting rule.US News
International News
GFSI recognized the great opportunity to not only answer the global food safety strategy for 2022-2030 specifically but also to further share industry insights and also provide overt support to the World Health Organization (WHO) on the implementation of the strategy. GFSI has welcomed the opportunity to collaborate with the WHO on bringing much-needed industry perspectives on their food safety strategy via engagement with industry leaders and members of the CGF. In the interests of transparency, GFSI is publishing both documents sent to WHO on 4th October: the WHO food safety strategy with GFSI comments in the document and an overall position paper on the strategic framework.
On 6 October 2021, the European Court of Justice published its judgment in Case C-458/19 P (Client Earth v. Commission) that concerns the authorisation process under the EU’s chemical legislation (REACH).
Germany has launched a second call for evidence to support the preparation of a REACH restriction of bisphenol A and further bisphenols that are of similar concern for the environment. The call for evidence aims to clarify remaining questions on potential alternatives and the socio-economic impacts of the restriction proposal. The deadline for comments is 22 December 2021.
Other Relevant Information
Safety Share
Fully vaccinated travellers coming to Canada must complete the mandatory pre-arrival molecular COVID-19 test and submit their mandatory information including their digital proof of vaccination in English or French using the free ArriveCAN (App or website) within 72 hours before arriving in Canada. Antigen tests, often called “rapid tests”, are not accepted. Fully vaccinated travellers who are eligible to enter Canada continue to be subject to mandatory random testing on arrival.
The U.S. Food and Drug Administration (FDA) is warning that getting alcohol-based hand sanitizer in the eyes from splashing or touching the eyes after use of hand sanitizer can result in serious injury, including severe irritation and damage to the surface of the eye. Eye exposure to hand sanitizer has been reported in all age groups; however, it has occurred most often in children. Such eye injuries have become much more frequent, likely due to the marked increase in the use of alcohol-based hand sanitizer during the COVID-19 pandemic.
The Canadian Centre for Occupational Health and Safety (CCOHS) has developed a free online course to help organizations in Canada create awareness and recognize the importance of psychological health and safety in the workplace. Psychological Health and Safety Awareness provides an introduction to workplace mental health including an overview of the six categories of psychosocial factors and how they impact the mental health of individuals and groups.
November is Fall Prevention Month. In Canada, falls are the leading cause of injury among elders.
While many of us enjoy the extra hour of sleep or play that comes with the end of Daylight Savings Time, we found ourselves wondering what effect, if any, the time change has on workplace injury rates – especially given the link that exists between the spring time change and increased workplace injuries. Does “falling back” have the same impact?
Comments are closed