Canada Regulatory News

On 26th of august 2022, the Canadian government published the final screening assessment of silver and its components under Canada Gazette. Based on the substance addressed in the third phase of the c...

On 26th of august 2022, the Canadian government published the final screening assessment of silver and its components under Canada Gazette. Based on the substance addressed in the third phase of the chemicals Management plan, silver and its compounds were considered for new action. These actions would be based on the Chemical management plans (CMP). Based on this legislation ,seven substances of silver and its components which could be found in the environment are listed. However, the silver components are not only limited to these seven category identification. It should also be considered that based on the proposed ecological conditions only the mentioned substances (listed below) would undergo any action.

1. Silver.
2. Nitric acid silver(1+) salt.
3. Silver chloride (AgCl).
4. Silver bromide (AgBr).
5. Sulfuric acid, silver(1+) salt.
6. Silver oxide (Ag2O).
7. Silver sulfide (Ag2S).

Furthermore, follow up activities on these seven substance groups are under consideration and would be published in future. Although this assessment tries to cover all the risks and health hazards regarding human life and environment, further initiatives and additional information might be considered in the future.

Canada has presented a long-awaited proposal to impose strict restrictions on a range of long-chain PFASs and flame retardants, as well as bans on dechloranplus (DP) and decabromodiphenyl ethane (DBDP...

Canada has presented a long-awaited proposal to impose strict restrictions on a range of long-chain PFASs and flame retardants, as well as bans on dechloranplus (DP) and decabromodiphenyl ethane (DBDPE). According to a Canada Gazette notice, adopting the proposal – which the Canadian government floated in a 2018 consultation document – would position the country to ratify and implement amendments to the Stockholm Convention on persistent organic pollutants (POPs) and help it achieve other environmental goals. 

The 'Prohibition of Certain Toxic Compounds Restrictions, 2022' would repeal and replace existing regulations prohibiting certain long-chain per- and polyfluoroalkyl substances, as well as persistent flame retardants. Within three years, the amended restrictions are expected to make the manufacture, use, sale, and import of DP and DBDPE, as well as items containing them, illegal. They also want to go to the "next step" of risk management for the following chemicals by eliminating current exemptions:
 

• perfluorooctanoic acid (PFOA);
• perfluorocarboxylic acids (LC-PFCA); 
• hexabromocyclododecane (HBCD); 
• and polybrominated diphenyl ethers (PBDEs), including decaBDE.

However, there are certain exceptions due to sunset. They include manufactured items containing PFOA and LC-PFCAs, an exemption for PFOS in certain photolithography processes and photographic films, and several carve-outs that had allowed the continued sale of products containing the regulated substances manufactured before 2017. According to the Stockholm Convention, an exemption will be granted until the end of 2025 for the use of aqueous film-forming foam (AFFF) containing PFOA or LC-PFCAs in emergency situations, as well as for testing reasons, provided emissions are properly contained and disposed of.

If no viable alternative exists, companies can seek permission to continue using DP, DBDPE, or HBCD for up to three years. Interested parties have 75 days to submit comments and 60 days to submit a notice of complaint requesting the government to create a board of review.

Health Canada has released a proposal for public comment to create a unified regulatory framework for disinfectants and sanitizers. In Canada, biocidal products are currently governed by distinct reg...

Health Canada has released a proposal for public comment to create a unified regulatory framework for disinfectants and sanitizers. In Canada, biocidal products are currently governed by distinct regulatory systems. Surface sanitizers are governed by the Pest Control Products Act, while disinfectants are governed by the Food and Drug Regulations (FDR) (PCPA). At present, The Food and Drugs Act is the only law that regulates products that claim to be disinfection and sanitizer (FDA).

According to the agency, the proposed revisions would "enable more international harmonisation, lower the administrative cost, provide stronger post-market control, and provide Canadians with more prompt access to biocides" by combining requirements from several rules. The proposed regulations also include the use of foreign decisions (UFD) pathway, which would allow applicants to use a trusted foreign regulatory authority's judgement when applying for market authorisation of an identical product in Canada. Also, the suggested flexibilities would allow these products to be regulated by the US EPA and other nations.

According to the proposed proposal, you only need to submit one application for marketing authorisation. This may include multiple products with slight deviations. However, the associated data package must be applied to all products listed in the application. The market authorisation holder, importer, or manufacturer would be required to submit recalls under the new guidelines. The public consultation will be open until July 16^th and the biocides laws would go into force a year after they are published in the Canada Gazette. The new biocides regulations would require registrants and holders of authorizations to complete an abridged application and acquire authorization within four years of its implementation.

Health Canada has recommended several changes to the pest control products regulation which would reduce the burden on administrative and regulatory laws. Recommended Changes include the following...

Health Canada has recommended several changes to the pest control products regulation which would reduce the burden on administrative and regulatory laws.

Recommended Changes include the following:

• Extension of the validity period for certain emergency registrations from one year to three years; 
• Exemption of the antimicrobials that are used in treating articles and regulated under the Food and Drugs Act, Feeds Act or Fertilisers Act; and  
• Provision of the ability to deny applications for products prohibited under the Stockholm Convention on Persistent Organic Pollutants (POPs).  

The draft proposal also includes the removal of the limit for n-nitrosodi-n-propylamine (NDPA), an impurity in pest control products that is a by-product of the chemical synthesis of certain compounds. Health Canada informs that this limit – applied in section 19 of the Regulation, is unnecessary because it already evaluates NDPA levels in the health and environmental risk assessment.  

The agency is also seeking clarity on the existing requirements and is trying to establish a definition for treated articles, along with setting out authorisation criteria which will imply that a treated article would not have to be registered under the pest control products regulation if the antimicrobial preservative is registered under the pest control products Act, if use is limited to preventing degradation or damage to the product from micro-organisms; and if the article is treated in accordance with approved application rates, method of application and uses of the registered antimicrobial preservative. 

The recommended changes aim to streamline information requirements for those sites that manufacture pest control products not classified as microbial agents.  

Public consultation on the amendment is open until 11 June 2022. The latest consultation of 2022 follows two regulatory pre-consultations conducted by the Pest Management Regulatory Agency in 2018 and 2020.

The proposed amendments would come into force after six months of its publication in the Canada Gazette. 

The Health Canada’s revised in-commerce list (R-ICL) of chemicals used in food, drugs, and cosmetics no longer includes 602 substances that are not commercially active. These substances are theref...

The Health Canada’s revised in-commerce list (R-ICL) of chemicals used in food, drugs, and cosmetics no longer includes 602 substances that are not commercially active. These substances are therefore not subject to notification under the Food and drug Act (F&DA).

The R-ICL is a list of substances used in products introduced into commerce between 1 January 1987 and 13 September 2001. Substances listed under the New Substance Notification Regulation (NSNR) are not subject to notification requirements for F&DA-related uses.

As proposed in October, the government aimed to remove 544 substances produced or imported in quantities less than 100 kilograms yearly. It also aimed to delist 125 pharmaceutical ingredients that were discontinued or never marketed.

In an announcement on 18 February, the government said that it was removing all 125 pharmaceutical ingredients and all 477 substances below the 100kg annual threshold.

67 chemicals were not removed at this time, according to Health Canada, "because they were identified as potentially having commercial activity in Canada." However, removed substances can re-enter the Canadian market through the NSNR, which come under the Canadian Environmental Protection Act, 1999 (CEPA).

The Canadian government has posted draft screening assessments for a batch of 34 chemical compounds, inclusive of lithium- and barium-containing substances. The government recommends that ...

The Canadian government has posted draft screening assessments for a batch of 34 chemical compounds, inclusive of lithium- and barium-containing substances. The government recommends that they pose a "low chance of damage to the environment".

The draft assessments under the Canadian Environment Safety Act (CEPA) endorse that the 34 substances do now not meet health or environmental hazard criteria essential for further regulatory movement. Consistent with the outcomes of a CEPA survey, most of the substances do not have direct consumer uses. However, some can be used to make food packaging materials while others are present in products available to customers along with cosmetics, sealants, and disinfectants.

In the draft screening assessment, ecological risks were characterised using the Ecological Risk Classification for Inorganic Substances (ERC-I). Based on the ERC-I analysis, the 34 substances in the assessment are considered "unlikely to cause ecological harm". As part of the screening, human biomonitoring data or "rapid screening" was analyzed to evaluate the potential for direct exposure from products as well as indirect exposure through the environment.

The government proposes that the substances do not meet any of the criteria in CEPA's section 64, which defines a substance as toxic if it enters the environment in a way that may cause harm based on the evidence presented in the draft screening assessment.

The 34 substances include lanthanum oxide, bismuth-containing substances, lithium, lithium chloride and lithium fluoride, as well as various other lithium salts.

The Pest Management Regulatory Agency (PMRA), on 7 March 2022, proposes a maximum residue limit for Pyraziflumid (PMRL2022-02).  The proposed limit includes: MRL (ppm)1 Ra...

The Pest Management Regulatory Agency (PMRA), on 7 March 2022, proposes a maximum residue limit for Pyraziflumid (PMRL2022-02).  

The proposed limit includes:

You can comment on this consultation before May 15, 2022. And the rule is meant to come into force between four to five months of posting the proposed MRL.