Canada Regulatory News

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 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. 

In January 2022, Cosmetic Alliance (CA) and a representative from their allied stakeholder coalition met with Health Canada (HC) officials to discuss the ban of cosmetics testing on animals in Canada....

In January 2022, Cosmetic Alliance (CA) and a representative from their allied stakeholder coalition met with Health Canada (HC) officials to discuss the ban of cosmetics testing on animals in Canada. HC is currently working on publishing a policy to end cosmetics testing on animals.

According to CA, the proposed policy is based on three points which are:

·       It should align with the ban of cosmetics animal testing in the European Union (EU).

·       It should fit and be workable within the Canadian regulatory framework.

·       It should be drafted by Health Canada.

There remains a lot of work for the government to do regarding the publication and implementation of this policy. However, it is expected that the government will want to have the initiative completed by August 2023 when the International Congress on Alternatives to Animal testing will be hosted in Canada at Niagara Falls, Ontario.

There is no universal ban on animal testing for cosmetics, however, many countries are moving in this direction. In September 2021, Mexico banned animal testing of cosmetics products, in addition to about 42 other nations. In the United States, seven states have implemented this ban while other states consider doing the same.

Transport Canada (TC) recently opened a discussion to revise Part 6 of the Transportation of Dangerous Products (TDG) and set new training requirements.  Published in the Canada Gazette Part 1 on...

Transport Canada (TC) recently opened a discussion to revise Part 6 of the Transportation of Dangerous Products (TDG) and set new training requirements. 

Published in the Canada Gazette Part 1 on 11 December 2021, the recommendations aim at providing a more grounded system for the training oversight by removing the words ‘adequately prepared’ from the TDG Regulations and inputting references to the new standard CAN/CGSB-192.3-202- Transportation of dangerous goods training, assessment, and competency.

This new move is fostered by the increasing mindfulness of the existing training provisions that do not provide a vigorous body of rules. Although most stakeholders meet or surpass the training requirements, TC inspectors have noticed that some employees need to know more about the knowledge and skills needed to do this dangerous goods transportation, despite having a valid training certificate. TDG monitoring program discovered that 55 of the 409 dangerous good incidents (that resulted in injury or death between 2014 and 2019) were ascribed to the lack of proper and adequate training.

Transport Canada has been working for quite some years on the issue. It started a targeted consultation in 2016, including more than 100 agents from government, specialists, companies, industry affiliations and training suppliers, after which there was a more firmly focused consultation with 35 of the stakeholders; and after that, there was an open online meeting. After all these came the improvement of measures and propositions for regulatory revision.

Last Update: 2022-01-26