Europe, as usual, is on the forefront of chemical regulatory developments. There are a lot of upcoming changes to be aware of if you sell products into the European Union (EU). Even if you do not currently deal with European compliance issues, it is good to be aware of what is happening there. Regulatory initiatives that begin in Europe often eventually make their way to North America. For example, we are starting to see implementation of new labeling requirements in the U.S. and Canada in alignment with the European Commission’s Regulation on Cosmetic Products (EC) No 1223/2009.
This article, exclusive to SPRAY, provides an overview of some key regulatory developments for hazardous chemicals that are currently happening in Europe.
REACH regulation 
The transition period for the implementation of Regulation (EU) 2020/878 has passed. All Safety Data Sheets (SDS) in the EU must now conform to the revised Annex II criteria as of Jan. 1, 2023. As discussed in my June 2021 SPRAY article, Annex II of EU’s Regulation on Registration, Evaluation, Authorization & Restriction of Chemicals (REACH) (EC) No 1907/2006 sets out the requirements for the compilation of SDS in the EU. The revision was carried out to incorporate updated EU requirements for nanoform substances, endocrine disruptors and unique formula identifiers (UFI) into appropriate sections of the SDS. Changes to SDS disclosure and chemical information requirements also need to be considered. EU national authorities have launched REACH-EN-FORCE (REF)-11, which is an enforcement project that will involve inspecting SDS and labels to ensure that chemicals sold in the EU market are compliant. Inspections are being carried out throughout 2023 and the results will be reported in 2024.
The core provisions of the REACH regulation have not been updated for the better part of 20 years. The European Commission planned to update REACH in late 2022 in accordance with Europe’s Chemicals Strategy for Sustainability Towards a Toxic-Free Environment. The strategy proposes the development of a horizontal essential use concept to apply across chemical legislation. The overall aim of the concept is to allow systematic decision-making to facilitate the phasing out of the most harmful substances by only allowing them when their use is proven essential for society.
Key topics expected to be addressed in the REACH revision include the essential use concept, registration of polymers and the use of the mixtures assessment factor. However, the update has now been extended to later this year. European Commission officials are facing criticism for delaying the publication of the REACH revision proposal. Members of the European Parliament’s Environment Committee have urged for the draft to be completed by Summer 2023 to avoid further delays. We are keeping an eye out for the release of the proposed amendment, which had not yet been published at the time of writing this article.
EU CLP Revisions
On March 31, the European Commission published Amending Regulation (EC) No 1272/2008 as regards hazard classes and criteria for the classification, labeling and packaging of substances and mixtures (CLP Amendment) in the European Journal. The CLP Amendment will incorporate three new sets of hazard classifications into the regulatory scheme for evaluation and labeling of hazardous chemicals distributed on the EU market.
The new classifications include:
• Endocrine Disruptors (ED) for human health or the environment
• Persistent, Bioaccumulative & Toxic (PBT); very Persistent & very Bioaccumulative (vPvB)
• Persistent, Mobile & Toxic (PMT); very Persistent & very Mobile (vPvM).
The deadline for classifying chemicals according to the new hazard criteria, as well as updating SDS and label information, will depend on when the product is first placed on the market and whether it is a substance or mixture:
• New Substances: May 1, 2025
• New Mixtures: May 1, 2026
• Existing Substances placed on the market before May 2025: Nov. 1, 2026
• Existing Mixtures placed on the market before May 2026: May 1, 2028
The motivation for the new hazard categories came about due to evidence suggesting that substances and mixtures with harmful properties were not fully addressed by the existing CLP building blocks and criteria. The CLP Amendment aims to ensure that products are being labeled with appropriate safety instructions based on their inherent hazards. The hope is that this will help encourage manufacturers, importers and downstream users to replace chemicals that have harmful properties with less hazardous substitutes to the greatest extent possible. As one of the deliverables of the Chemicals Strategy for Sustainability, the CLP Amendment establishes legally binding hazard identification of endocrine disruptors and provides criteria and hazard classifications to fully address environmental toxicity, persistency, mobility and bioaccumulation. The new hazard classifications pave the way for identification of the most harmful substances and will enable further legislative initiatives to restrict their use, especially in consumer products, and reduce their impact on human health and the environment.
Other upcoming changes to EU CLP
The Kigali Amendment incorporated Annex F into the Montreal Protocol, adding various hydrofluorocarbons (HFCs) to the list of controlled substances that countries have promised to phase down in production and consumption. According to the current Globally Harmonized System of Classification & Labeling of Chemicals (GHS) classification criteria, chemicals listed in the Montreal Protocol are categorized as hazardous to the ozone layer. HFCs were incorporated into the Montreal Protocol, not because they are ozone depleting substances (they are, in fact, harmless to the ozone layer), but due to their high global warming potential. Therefore, considering them as hazardous to the ozone layer under GHS criteria does not seem to be accurate or appropriate.
The adoption of the Kigali Amendment into GHS has already been discussed at the United Nations (UN) level and is expected to be implemented by 2024. The European Commission is then expected to begin transposing the GHS criteria into EU legislation. The EU is currently exploring different options for incorporating the Kigali Amendment into CLP and could end up including additional measures to be consistent with other EU regulations that are more ambitious than GHS criteria. For example, the CLP criteria for substances that are hazardous to the ozone layer covers all ozone-depleting substances and not those specifically identified in the Montreal Protocol. We could therefore also see some additional greenhouse gases included in addition to those found in Annex F of the Montreal Protocol and there could be other differences in how HFCs are handled under CLP in contrast to the UN GHS.
Additionally, changes to the harmonized classification for titanium dioxide may be on the horizon. Currently, according to Annex VI to CLP regulation (ATP 18), titanium dioxide is classified as carcinogenic in powder forms containing 1% or more of particles with aerodynamic diameter ≤ 10µm, but this classification was annulled in November 2022 by the Court of Justice of the European Union (CJEU). The General Court held that the requirement to base the classification of a carcinogenic substance on reliable and acceptable studies was not satisfied.
France has appealed the court’s decision to remove the carcinogen classification from titanium dioxide in certain powder forms. According to French regulators, the CJEU exceeded the limits of its judicial review by conducting its own evaluation and interpretation of the scientific data. The appeal process suspends the courts decision, meaning that the harmonized classification and labeling of titanium dioxide will continue to apply until a decision has been made. At the time of writing this article, there were no further updates about the status of the appeal.
Nexreg is committed to keeping SPRAY readers informed of the latest regulatory updates taking place in Europe and globally. We will be sure to provide updates as new changes to EU hazard communication requirements come into effect. SPRAY

Government of Canada publishes WHMIS 2022, amending Hazardous Products Regulations (GHS, Seventh Revised Edition)

Back in 2021, I wrote an article for SPRAY concerning Canada’s proposed amendments to the the Hazardous Products Regulations (HPR) and Schedule 2 of the Hazardous Products Act (HPA), which sets out the requirements for the Workplace Hazardous Materials Information System (WHMIS) in Canada. Two years later, I can finally return to discuss the implementation of this long-anticipated amendment.

On Jan. 4, 2023, Health Canada published the Regulations Amending the Hazardous Products Regulations (GHS, Seventh Revised Edition)1 and the Order Amending Schedule 2 to the Hazardous Products Act2 in the Canada Gazette, Part II.

The purpose of the amending regulations is to align Canada’s WHMIS with the Seventh Revised Edition, and certain provisions of the Eighth Revised Edition, of the Globally Harmonized System of Classification & Labeling of Chemicals (GHS). The changes are being implemented to enhance protection of workers by requiring more comprehensive and detailed health and safety information on product labels and Safety Data Sheets (SDS).

The regulations came into force on the date that they were registered, Dec. 15, 2022, which also marks the start of the three-year transition period for implementation. Starting Dec.15, 2025, all Canadian SDS will need to comply with WHMIS 2022.

Changes to aerosol classifications
To align with the more recent GHS revisions, Canada will be doing away with the “Flammable Aerosol” designation in favor of the “Aerosol” hazard categories. In addition to Aerosol 1 and Aerosol 2 classifications for aerosols that are considered flammable, the Aerosol 3 category will now be adopted for non-flammable aerosols. Previously, under WHMIS 2015, aerosol products were categorized as “Gases Under Pressure.” However, alignment with GHS Revision Seven will mean that the “Gases Under Pressure” classification need not apply to products classified as Aerosols. The criteria for determining the Aerosol Hazard category are not changing.

Changes to other classifications
The “Chemicals Under Pressure” Categories 1, 2 and 3 have been adopted from the GHS Eighth Revised Edition. It is worth noting that aerosol products cannot be Chemicals Under Pressure. Additionally, Chemicals Under Pressure are excluded from the Flammable Gases, Gases Under Pressure, Flammable Liquids and Flammable Solids categories.

Chemicals Under Pressure are liquids or solids that are pressurized with a gas at a pressure of 200 kPa or more at 20°C / 68°F, and that are packaged in a container other than an aerosol dispenser. The sub-categorization of the pressurized chemical depends on the mass percentage of flammable ingredients and the materials heat of combustion.

The flammable gas categories have been further sub-divided in accordance with GHS Seventh Revised Edition. New definitions have been added for Chemically Unstable Gas, Flammable Gas and Pyrophoric Gas. Flammable Gas Category 1 is becoming more granular, with new sub-categories that must be considered. Category 1 will be divided into Subcategory 1A and 1B, where Subcategory 1A can also be further subdivided into Chemically Unstable Gas A, Chemically Unstable Gas B and Pyrophoric Gas, depending on the physical properties. Test data takes priority over calculated data for classification. If the calculation method is used and it is determined that the product is a flammable gas, but further subcategorization is not possible, then it is required to take Category 1A as the “worst case” classification.

Test methods
The test criteria for Skin Corrosion have been changed to refer to “at least one animal” instead of “at least one of three animals” to reduce the amount of animal testing required for classification. References to test methods have also been updated, now referring to the most recent edition of the standard. For example, ISO 10156:2010 references have been updated to ISO 10156:2017. Several references from the “Recommendations on the Transport of Dangerous Goods: Manual of Tests & Criteria” have also been revised according to the newest version.

Other key changes
The amendment expands the allowable concentration ranges for hazardous chemicals disclosed on the SDS. In addition to being able to use the “true” concentration or one of the specified concentration ranges, it has been clarified that it is acceptable to use a concentration range that falls “entirely within” one of the concentration ranges set out in the HPR.

Various provisions have been clarified to reflect the intended meaning of the HPR. For example, various health hazard definitions now indicate that symptoms must occur following “exposure to a mixture or substance.” Previously, exposure was not addressed in the hazard definitions. The criteria for determining the subcategory of Skin Corrosion and Eye Irritation classifications have also been defined in more detail.

Changes to product labels will be needed in situations where the product classification has changed because of new classification criteria, test methods or the adoption of new hazard classes. Similarly, Section 2 of the SDS will need to be updated with the revised label elements, where applicable. Other updates to the SDS format will include changes to the Section 9 physical properties: The Appearance field is removed; Physical State and Color are added and there is also a new field for Particle Characteristics. The provision relating to transport in bulk has been repealed, and therefore this Section 14 information element becomes optional. The SDS header will also need to be updated to reference the newest version of the regulation.

How to ensure compliance
The good news is that companies will have an additional year to comply with the new requirements compared to the previously anticipated two-year transition period. The Government of Canada has implemented a three-year transitional period ending Dec. 14, 2025. Currently, SDSs and labels created according to both WHMIS 2015 and the new WHMIS 2022 requirements are compliant.

It is recommended to review your SDS for updates to chemical data and classification information at minimum every three years. The implementation of WHMIS 2022 is a good opportunity to check your documentation and ensure that the safety information for your products is up to date and compliant. Many SDS-authoring software providers are diligently working on solutions for the new requirements, which we can expect to see released over the next year. In the meantime, keep in mind that SDSs and labels must be updated within 90 and 180 days, respectively, of “significant new data” becoming available, such as product reformulations that can affect the product safety information.

It is recommended to review your SDS for updates to chemical data and classification information at minimum every three years.

The WHMIS 2015 Technical Guidance on the Requirements of the HPA and HPR3 has been an invaluable resource to assist suppliers with WHMIS GHS compliance, even detailing the parts of the regulations that are variances in contrast with the U.S.’s OSHA HazCom 2012 requirements for hazardous workplace chemicals. Although we have not heard anything yet from Health Canada about a WHMIS 2022 guidance document, this is something we will certainly be watching out for over the next couple of years as suppliers begin transitioning to the new regulatory scheme. Feel free to contact us at Nexreg for all your WHMIS 2022 compliance questions. SPRAY

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ECCC finally adopts VOC concentration limits of Certain Products Regulations

In early 2022, Environment & Climate Change Canada (ECCC) published the Volatile Organic Compound Concentration Limits for Certain Products Regulations in the Canada Gazette1. The goal of the Certain Products Regulations is to limit volatile organic compound (VOC) emissions from specific products manufactured or imported into Canada. The regulations were introduced to fulfill obligations according to Canada’s 2017 ratification of the Gothenburg Protocol and its amendments, which aim to improve air quality by addressing pollutants, including VOCs, that cause acidification and ground-level ozone. The VOC concentration limits have been in the works since as early as 2005, when stakeholders were first consulted on the Government of Canada’s intention to regulate VOC emissions from certain products. The first draft proposal was released in 2008, followed by updated revisions in 2013 and 2019. Nearly 20 years since the initial consultations, the proposal is finally becoming law.

“Certain Products” used in households and by institutional, industrial and commercial consumers will be regulated, including:

• Personal care products
• Automotive and household maintenance products
• Adhesives, adhesive removers, sealants and caulks
• Other miscellaneous products

Schedules 1 & 2 of the regulations establish VOC concentration limits and maximum emissions potential for approximately 130 product categories and sub-categories. The regulations, which apply to Canadian manufacturers and importers, also set out requirements for recordkeeping, product labeling and for any testing analysis, if pursued, to be performed by an accredited laboratory.

Most of the product categories align with California Air Resources Board’s (CARB) 2010 version of the Regulation for Reducing VOC Emissions from Antiperspirants & Deodorants and Regulation for Reducing Emissions from Consumer Products. Additionally, certain categories have been aligned with CARB’s 2013 Regulation for Reducing Emissions from Consumer Products amendments, including rubber and vinyl protectant; lubricants; footwear or leather care products; laundry pre-wash; oven or grill cleaner; and spot remover.

Two additional product categories not covered under CARB Regulations have also been added: structural waterproof adhesives, which are regulated by the U.S. Environmental Protection Agency and the Ozone Transport Commission, and acoustical sealants, which are specifically needed in the cold Canadian climate. Canada has also adopted higher concentration limits for categories including sealant and caulking products, paint thinner and multipurpose solvent in order to better accommodate Canadian climate or marketplace conditions.

ECCC has incorporated three alternative compliance options into the Regulations for companies that are unable to meet the VOC concentration and emission potential requirements:

1. Permit: Technical or economic non-feasibility
This permit, which is valid for two years and can only be renewed once, grants temporary relief from the regulatory requirements once the limits come into effect. Manufacturers and importers must prove that they cannot technically or economically meet the specifications for their product and provide a plan detailing how the commodity will be brought into compliance once the permit expires.

2. Permit: Products whose use results in lower VOC emissions
A product may exceed the specified VOC concentration limit if, due to the product design, formulation, delivery or other factors, it emits fewer total VOCs than a comparable compliant product when used according to the manufacturer’s instructions. To obtain this permit, which is valid for four years with no limit on renewal, the company must provide ECCC with evidence showing that the product’s use results in fewer VOCs released than a compliant product in the same category along with an estimate of the quantity imported or manufactured in a year.

3. VOC compliance unit trading system
Companies that exceed the concentration limit for one product may balance their emissions by averaging them with other products with VOC amounts below the required maximums. Compliance units may also be purchased via trading with other companies that have reformulated their products to VOC levels below the limits.

The VOC concentration limits and maximum emissions potentials for certain products come into effect on Jan. 1, 2024. Disinfectants have been granted one additional year for compliance, with VOC limits coming into force on Jan. 1, 2025. Starting next month, on Jan. 1, 2023, companies may begin applying for the alternative compliance options that have been made available in the regulations.

The regulations do not apply to products designed solely for manufacturing or processing purposes or those intended for scientific research. Since the regulations limit manufacture rather than sale of goods, there is no limit on the sell-through of products manufactured or imported prior to the dates coming into force.

ECCC developed a guidance document that will be used by enforcement personnel to assess compliance according to the regulatory provisions—Analytical Methods for Determining VOC Concentrations & VOC Emission Potential for the Volatile Organic Compound Concentration Limits for Certain Products Regulations2. Although there are currently no testing or general reporting obligations, it is the responsibility of the Canadian importer or manufacturer to ensure that products made available on the Canadian market meet the regulatory requirements. Records detailing the quantity and date of products manufactured or imported must be kept in Canada for at least five years; this could pose a challenge for manufacturers that do not have a Canadian place of business. Non-compliant companies are subject to various enforcement actions by the Government of Canada in accordance with the Canadian Environmental Protection Act: Compliance & Enforcement Policy.

Industry stakeholders have raised concerns that the regulations do not provide definitions for any of the product categories. Since the wording of the definitions was not adopted from CARB, this could lead to compliance challenges and confusion around product classification due to the lack of explicit criteria for various product types. ECCC has considered this feedback and noted that verbatim adoption of CARB definitions would not be consistent with Canadian regulatory drafting styles. This is because Canadian regulations are drafted in English and French, so they must have equivalent interpretations in both languages, and because Canada does not define terms that can be found in the dictionary. Although the wording of the product categories in the regulations may not exactly match the definitions used by California, ECCC has taken great care to ensure that the descriptions align in scope and application. The Department reviewed the definitions for all product categories and added precision to most of them to better align with CARB. ECCC has also stated that guidance materials will be provided that clarify the intent to align with CARB definitions.

The regulations indicate that if a product falls into more than one category set out in Schedule 1, then the lowest maximum VOC limit applying to a category in which the product belongs must be applied. Therefore, if there is any doubt as to which category a product falls into, it is advisable to consider the most conservative product group.

Visit the VOCs in Certain Products Webpage3 for more information about the regulations and to find forms for alternative compliance options. As always, feel free to reach out to Nexreg any time for regulatory compliance support; we will certainly be watching out for additional guidance materials that are published on this topic. SPRAY

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CEPA one step closer to becoming Canadian law
On June 9, the Senate Standing Committee on Energy, the Environment & Natural Resources completed its review of Bill S-5 and voted to strengthen it before returning it to the full Senate. Bill S-5 modernizes the Canadian Environmental Protection Act (CEPA), which aims to prevent pollution and to protect the environment, human life and health from the risks associated with toxic substances.

For the first time in federal law, Bill S-5 would require the government to consider the cumulative impacts of toxins on vulnerable populations and the environment and recognize that every individual in Canada has a right to a healthy environment. To protect that right, the Minister of Environment & Climate Change and the Minister of Health will be required to develop, consult on and publish a Plan of Chemicals Management Priorities within two years.

The multi-year plan will include the evaluation of substances and other chemicals management initiatives such as research, risk assessment and monitoring. The Minister of Environment & Climate Change will also be ordered to publish and maintain a “Watch list” of substances of potential concern. Schedule 1 of CEPA 1999 will be split into two parts. Part 1 includes the highest risk substances that are either persistent and bioaccumulative, or inherently toxic, and for which prohibition will be given priority. Other toxic substances will be added to Part 2 and will continue to be subject to standard risk management actions, such as pollution prevention.

Considering that CEPA has not been updated since the late 1990s, environmental groups have recently been pushing for improvements to better protect public health and the environment. Concerned parties are calling for further improvements to the bill in the House of Commons to address transparency, mandatory labeling of toxic ingredients and shorter regulatory timelines to eliminate dangerous toxic chemicals.

Bill S-5 will return to the Senate for additional debate and a final vote, which if passed, would refer it to the House of Commons. The Senate and the House must approve a bill before it can become law.

Canada bans single-use plastics
Plastic pollution has become a ubiquitous problem in recent years and due to the slow degradation rate of product packaging and other disposable items; we can be regrettably certain that plastic debris already present in our environment is not going anywhere soon. In response to this growing environmental concern, the Government of Canada published final regulations prohibiting manufacture and import of single-use plastics on June 20.
Products covered under the new ban include:
• Checkout bags;
• Cutlery;
• Foodservice-ware made from or containing problematic plastics that are hard to recycle;
• Ring carriers (i.e. those designed to surround beverage containers in order to carry them together);
• Stir sticks; and
• Straws (with some exceptions)

The ban on the import and manufacture of these items, with a few targeted exceptions, will come into effect in December 2022. To provide businesses time to transition to alternatives and exhaust current supply, the sale of specified single-use plastics will not be prohibited until December 2023. Additionally, Canada will be prohibiting the export of plastics in these six listed categories by the end of 2025.

TC proposes dangerous goods registration database
On June 25, Transport Canada (TC) released proposed amendments to the Transportation of Dangerous Goods Regulations (TDGR). The regulatory proposal would require any person who imports, offers for transport, handles or transports hazardous materials to register in a new database and to provide administrative information about their activities related to the handling of dangerous goods.

These changes have come about because previous audits of Canada’s Transportation of Dangerous Goods (TDG) Program found deficiencies that were deemed a public safety risk. Among the issues, the Commissioner of the Environment & Sustainable Development (CESD) highlighted that TC did not know who is involved in the handling and transport of dangerous goods in Canada and did not have sufficient information to understand the risks of some products and operations, or the means to collect such information. They also found the TC did not have the tools needed to assess risk and properly evaluate priorities for the risk-based oversight program.

Although TC has developed a risk-based system to prioritize its inspections of TDG Sites operated by persons involved in DG activities, the CESD found in 2020 that the information included in the system is outdated or incomplete. The dangerous goods registration database seeks to solve this problem by ensuring that TC is provided accurate and current data about those involved in dangerous goods activities in Canada.

Registrations would need to be renewed and updated annually and any changes to administrative information would need to be reported within 30 calendar days. There will be a one-year transition period to comply for those who are already involved in transport of dangerous goods in Canada. Those beginning new operations after the amendment comes into force would have 90 days to comply.

The comment period for the proposal ends on Sept. 3, 2022.

Interactive website pilot released
To modernize Canada’s regulatory system and enhance regulatory cooperation, the Treasury Board of Canada Secretariat (TBS) is requesting feedback from organizations and individuals impacted by Canadian regulations. A new interactive online platform called Let’s Talk Federal Regulations has been released to test new tools available to enhance engagement practices and aid in gathering information that will assist the development of new regulatory policies and initiatives in Canada.

The TBS is planning to post several projects on the Let’s Talk Federal Regulations platform to seek feedback on topics including:
• How to improve initiatives to modernize Canada’s regulatory system and regulatory processes;
• How Canada’s regulatory system can support economic recovery from the COVID-19 pandemic;
• Challenging regulatory processes and barriers that excessively impact trade, economic growth and innovation; and
• Suggestions on potential areas of regulatory cooperation with other jurisdictions to reduce regulatory misalign- ment and barriers to trade.

Each project will have a distinct topic, with tools made available for a specified period of time so that interested parties may submit their views, respond to or comment on proposals and review proposals received.

Check out the platform periodically to see if any projects are of interest to you and share your feedback or suggestions. New projects are expected to be added over the coming months.

Health Canada consults on supply chain transparency
In February of 2022, the Government of Canada announced its intent to enhance chemical ingredient transparency throughout the supply chain and to strengthen mandatory labeling for consumer products such as cosmetics, cleaning products and flame retardants in upholstered furniture.

Environment & Climate Change Canada and Health Canada carried out a series of workshops and interactive events in a policy lab format to collaboratively bring participants together to develop and test innovative solutions. The workshops, which were open to all Canadians, took place during the Spring and focused on how attendees believed the Canadian Government can take action to improve information about chemicals in product supply chains. The next phase of the policy lab will take place this Fall with a focus on refining potential solutions.

The Government of Canada intends to publish a broader strategy in 2023, outlining policy actions that could include new legislation, as well as voluntary or collaborative initiatives. We can expect to hear more about the possibility to require mandatory labeling of certain products by Spring 2023. SPRAY

A global regulatory review

Per- and polyfluoroalkyl substances (PFAS) are a group of synthetic organofluorine chemicals that have been getting a lot of attention lately. My colleague Mae Hrycak barely scratched the surface of this topic in the April 2022 Regulatory Landscape edition of SPRAY. This column will expand on the topic and provide a more in-depth overview of current global PFAS regulatory trends.

Used in a wide range of consumer and industrial applications since the 1940s, PFAS are commonly known as “forever chemicals” due to the strong carbon-fluorine bond that makes them resistant to heat and chemical reactions. Since they comprise such a broad group of chemicals, PFAS can have a wide range of different physical and chemical properties and can exist as gases, liquids or solid polymers. PFAS are easily transported long distances through the environment, and they are not readily degraded, further magnifying their effects on the environment and water systems.

A recent field study noted that sea spray pollutes the atmosphere in coastal areas with PFAS chemicals.

PFAS can now be detected worldwide. Through a field study, scientists recently observed that sea spray pollutes the atmosphere1 with PFAS chemicals in coastal areas. When bubbles containing perfluoroalkyl acids (PFAAs)—a subgroup of the PFAS family—burst at the surface of saltwater, the compounds are ejected as aerosols. Sea spray aerosol particles can travel significant distances in the atmosphere, which suggests that sea spray could be a key route of transport for these persistent chemicals, especially around coastal communities.

Attributes of concern to humans include the bioaccumulation of certain PFAS in organisms, causing toxic effects to reproduction and development. Several PFAS have been demonstrated to cause cancer and some are suspected of having endocrine disrupting effects, although research is ongoing.

Given the concerning properties of this chemical family, it is no surprise that we are seeing regulatory bodies and even some industries around the world begin to aim their attention at controlling the exposure of PFAS to humans and the environment.

Due to their heat-resistant properties, PFAS have become a common ingredient in fire-fighting foams.


EU proposes PFAS ban in firefighting foams
Due to their heat-resistant properties, PFAS have become a common ingredient in fire-fighting foams. This has resulted in many cases of environmental contamination of soil and drinking water in the European Union (EU). The European Chemicals Agency (ECHA) has currently brought forward a proposal2 to restrict all PFAS in firefighting foams in the EU. The goal is to prevent further environmental contamination and mitigate the health risks to humans. ECHA has stated that an EU-wide restriction is justified because the risks posed by PFAS are currently not adequately controlled.

The proposal would ban placement on the market, use and export of all PFAS in firefighting foams with use or sector-specific transition periods that allow time for industry to find suitable replacements. Those still using PFAS-based foams during the transition period will need to ensure releases to the environment are minimized and that any expired or waste foams are disposed of in an appropriate way.

A six-month consultation started on March 23, 2022, which is open for interested parties to give evidence-based comments on the proposal. ECHA also hosted an online info session3 to explain the restriction process and assist stakeholders in taking part in the consultation.

EU moves toward comprehensive restrictions
Several specific, well-known PFAS are already identified in the EU as substances of very high concern (SVHCs) and subject to restriction. These include perfluorooctane sulfonic acid (PFOS), perfluorooctanoic acid (PFOA) and perfluorohexanesulfonic acid (PFHxS). However, since there are so many variations of PFAS, it is not practical to do a substance-by-substance risk assessment.

The EU plans to phase out PFAS for all but essential uses through the “Chemicals Strategy for Sustainability.”4 In addition to the proposed fire-fighting foam ban, five European countries (The Netherlands, Germany, Denmark, Sweden and Norway) are working on a restriction proposal that will cover all PFAS in other uses. The proposal is expected to be submitted in January 2023. The risk assessment pertaining to PFAS in firefighting foams is relevant for all PFAS, and thus it will smooth the path towards evaluating the risks in the broader context of chemical utilization.

Ski waxes flagged for Nordic non-compliance
A joint Nordic enforcement project that inspected articles and chemical products for restricted PFAS found that 15 out of 158 products examined exceeded the limits for PFOS and PFOA established in the EU’s Persistent Organic Pollutants (POPs) Regulation. Ski waxes were responsible for the most cases of noncompliance, as more than a third of ski waxes tested exceeded the limits, with this product group accounting for 14 out of the 15 non-compliant products. The project also searched for PFAS that are not yet restricted in chemical legislation. PFAS were detected in 65% of articles and 40% of chemical products tested. Many products, such as sport jackets, contained PFOS or PFOA at levels below the limit values, or contained other PFAS.

A UK Environmental Audit Committee report concluded that a “chemical cocktail” that includes PFAS and microplastics is polluting rivers across England.


UK river pollution
Earlier this year, the United Kingdom’s (UK) Environmental Audit Committee released a 137-page report on water quality in rivers. In the report, the committee concluded that a “chemical cocktail” that includes PFAS and microplastics is polluting rivers across England, creating a major risk to human health and the environment.

According to the report, PFOS was found in quantities above threshold levels in 46% of English rivers sampled, despite the chemical being prohibited globally under the 2009 Stockholm Convention on POPs. The report recommends that the Dept. for Environment, Food & Rural Affairs (DEFRA) commission a UK-wide survey of emerging pollutants and microplastic pollution in river environments.

The Health & Safety Executive (HSE) is conducting a regulatory management option analysis (RMOA) into PFAS. The call for evidence is now closed and the RMOA is expected in Summer 2022. The UK government is also expected to publish a new chemicals strategy this year.

PFAS added to Prop 65 list; other States pursue rulemaking
Due to industry push-back, PFAS-related legislation at the U.S. Federal level is currently stuck in limbo and significant progress is not expected any time soon. At the State level, it is a different story.

Perfluorononanoic acid (PFNA) and its salts; PFOS and its salts, and transformation and degradation precursors; and PFOA are the latest PFAS to be added to the California Proposition 65 list. Label warnings for these chemicals apply to products sold in the State of California.

Several U.S. States are beginning to implement restrictions to eliminate PFAS in food contact materials (FCMs). New York, Vermont, Connecticut, Minnesota and California have restrictions coming into force between now and 2024. Maine has delayed a similar ban, as regulators seek to first establish access to safer alternatives and ensure that compliance is possible. Additionally, as of Jan. 1, 2022, measures to restrict PFAS in firefighting products are now in effect in Arkansas, California, Illinois and Louisiana.

Canadian PFAS restrictions
In April 2021, the Government of Canada published a Notice of intent to address the broad class of per- and polyfluoroalkyl substances5. In the notice, the Canadian government stated it will continue to invest in research and monitoring of PFAS. It will also collect and examine information
on PFAS to inform a class-based approach and review policy developments in other jurisdictions. In addition, it plans to publish a state of PFAS report in 2023, summarizing relevant information on the class of PFAS. Stakeholders are encouraged to provide feedback on the intent to address PFAS as a class, including any challenges or opportunities they foresee.

Environment & Climate Change Canada (ECCC) is expected to release a proposal to update the Prohibition of Certain Toxic Substances Regulations, which will involve new or additional limits on specific PFAS such as PFOS, PFOA and long chain perfluorocarboxylic acids (LC-PFCA). ECCC is now aiming for a late 2022 release for the proposal.

PFAS regulatory outlook
As PFAS continue to make headlines and pick up new restrictions around the world, they are also receiving increased attention from the public. Consumers are more aware than ever of the negative effects that can be caused by these “forever chemicals” and they will be on the lookout for products boasting safer alternatives.

We are beginning to see industries fold to the pressure of public health campaigns for safer products. For example, Restaurant Brands International (RBI)—parent company of fast-food chains Burger King, Popeyes and Tim Hortons—has recently announced that it will phase out PFAS from its food packaging by 2026. Other fast-food companies have been making similar commitments.

From retailer bans to new government strategies to phase out PFAS, the market will need to adapt and find new chemical alternatives. The reign of PFAS must come to an end to mitigate the human health and environmental hazards posed by this pervasive chemical family.

For more on PFAS and aerosol products, please turn to p. 8 of the Jun 2022 issue of SPRAY.



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During these cold winter months in Canada, many of us often imagine ourselves enjoying the sunny skies and beautiful beaches of South America and Central America. Some of our friends and family members even book trips there to escape the grips of Old Man Winter, away from the continuous snow and chilly wind. This year is a good time to start thinking about the regulation changes taking place in these Latin American countries. While the Globally Harmonized System of Classification & Labeling of Chemicals (GHS) may not be the most exciting reading material for the beach, the rest of us at home can get a hot drink and imagine ourselves in a warmer place.

Chile releases official list of substance classifications
In the December 2021 edition of International Regulatory Influences, my colleague, Cassandra Taylor, discussed Chile’s recent implementation of the GHS under Decree 57 of 2019, Regulation on Classification, Labeling & Notification of Hazardous Chemicals & Mixtures. An important
update to that issue includes Chile’s Ministry of Health publication for its anticipated list of official substance GHS classifications. The data from this list is expected to be used as a minimum reference during substance classification determination by manufacturers and importers. Currently, we estimate that the list has over 4,000 substances present and it’s expected to grow over time; it is therefore a good idea to frequently check for changes, especially since the Ministry will review the list at least every two years. The Chile GHS classifications list may not yet be in all major databases either, so you may need to check the list manually for the time being to ensure the data is considered when authoring a Safety Data Sheet (SDS) or GHS label. Most list entries include the Chemical Abstract Service (CAS) number for easy searching, and chemical names are given in Spanish, which will be helpful for inclusion on the Chilean documents.

Beyond the GHS hazard category and code for the substances, the publication also includes specific concentration limits (SCLs), multiplying (M)-factors, acute toxicity estimates (ATEs) and other appropriate notes (for example: N, P) for consideration. Chile’s list itself does not include the meaning of the notes but they can be acquired in the Resolution 777 (August 2021) publication that announced approval of the official substance classifications. The content of the list appears to follow Europe’s Classification, Labeling & Packaging (CLP) Annex VI harmonized entries, although there could be some deviations, so be sure to confirm the information when classifying products for GHS in Chile.

Substances that are not specified on the official list should be evaluated by the manufacturer for hazards under the Decree 57/2019 classification criteria. The current list is available here.

Any company that manufactures or distributes industrial use substances in Chile will now need to ensure its SDS and workplace labels meet GHS compliance, as the deadline passed last month in February 2022. Non-industrial use substances, industrial use mixtures and non-industrial use mixtures will have additional time to meet compliance with dates of 2023, 2025 and 2027, respectively. It is hard to believe, but Feb. 9, 2023, is less than a year away! Suppliers of non-industrial use substances who have not already done so should start planning their GHS conversion now.

We can expect another joint publication from the Ministry of Health and the Ministry of Environment this year in regards to risk assessment criteria for future chemical notifications. There is speculation that this could come out sooner than the 18-month deadline of August 2022.

Brazil GHS amendments are coming
The GHS has been implemented
in Brazil since 2009; however the Brazilian Association of Technical Standards (ABNT) published its draft GHS amendment in October 2020, called the NBR 14725: Chemicals–Information about Safety, Health & Environment–General Aspects of the Globally Harmonized System (GHS), Classification, SDS & Labeling of Chemicals. This regulation update will move Brazil to the 7th revised edition of the United Nations GHS Purple Book. Given that the 3rd revised edition of the GHS is currently being followed, this means that Brazil will soon implement the category Aerosol 3, non-flammable aerosol hazard classification. The gases under pressure categories will no longer need to be included for aerosol products. Another anticipated change is the creation of just one all-encompassing regulation instead of the four separate parts that currently outline Brazil’s GHS terminology, classification, labeling and SDS criteria.

We expect the revised draft regulation to be released for comment sometime in 2022. Once the next round of public comments is received, the amendment will be finalized, followed by a two-year implementation phase.


Costa Rica GHS implementation end date approaching
This year marks the end of the transition period for Costa Rica’s GHS implementation. Under the Executive Decree No. 40457-S, Technical
Regulation RTCR 481:2015 Chemical Products: Hazardous Chemical Products Labeling, the country had five years to update SDS and labels for hazardous chemical products to the new format by the deadline of Dec. 30, 2022. This regulation has adopted the full hazard classification and SDS communication requirements from the 6th revised edition of the GHS. Unlike in many other countries, the newly adopted GHS did not specify separate transition periods for substances and mixtures in Costa Rica. Additionally, the Executive Decree No. 40457-S, Technical Regulation RTCR 478:2015 Chemical Products: Hazardous Chemical Products, Registration, Import & Control was also published in 2017 and the two regulations complement each other. Potentially dangerous chemical products require registration and must have a GHS-compliant SDS.

It is noteworthy that hazardous product labels in Costa Rica must specify the dangerous ingredients along with the concentration (%), and the statements “In case of poisoning consult a doctor and provide this label” and “Keep out of reach of children” in bold font, among other standard label elements. Of course, the documents must be in the official language of Spanish.

Both regulations outline many exempt product types, including, but not limited to: raw materials for medicines, raw materials for cosmetics, raw materials for food, pesticides for domestic and professional use and food additives.

GHS status of other countries
While researching the GHS status of other Latin American countries, it has become clear that few have been able to implement such regulations in the past several years. While Chile and Colombia were able to pass their new GHS legislations in 2021, many other countries’ regulations remain in consideration or in a draft phase from previous years. Perhaps the COVID-19 pandemic has forced the authorities of these countries to set other priorities beyond their SDS regulations. We are hopeful that 2022 will usher in a new era where hazardous chemical control can become a focus again. Nexreg will be sure to update SPRAY readers with any new developments that take place this year. SPRAY

The Globally Harmonized System of Classification & Labeling of Chemicals (GHS) was developed by the United Nations (UN) to address classification of chemicals by hazard type and propose harmonized hazard communication elements, including labels and safety data sheets (SDS). Despite its name, the GHS is neither completely “global” nor “harmonized” due to the varying implementation approaches enacted by governments around the world. However, GHS does provide a basis for harmonization of rules and regulations on chemicals at a national and international level, which is an important factor in trade facilitation.

This column discusses the latest edition of UN GHS, as well as recent implementation steps taken by some key jurisdictions around the world. While some countries move to implement their first iteration of GHS, others are adopting newer revisions of the system to provide increased worker health, safety benefits and protection.

UN releases 9th Revision of GHS
On Dec. 11, 2020, the Committee of Experts on the Transport of Dangerous Goods & on the Globally Harmonized System of Classification & Labeling of Chemicals adopted a set of amendments to the 8th revised edition of the GHS. The amendments include updates to Chapter 2.1 (Explosives) to better address explosion hazards when products are not in their transport configuration. Other changes include the revision of decision logics, changes to the classification and labeling summary tables in Annex 1, as well as the revision and further rationalization of precautionary statements. References to the Organization for Economic Cooperation & Development (OECD) test guidelines for the testing of chemicals in Annex 9 and Annex 10 were also updated.

The 9th revised edition of GHS, which incorporates these amendments, is currently available for consultation purposes in English and French on the UN Economic Commission for Europe (UNECE) website. The other four official UN languages (Arabic, Chinese, Russian and Spanish) are expected to be posted as they become available.

Chile implements GHS & chemical registration requirements
On Feb. 9, 2021, Chile’s Ministry of Health published Decree 57 of 2019, Regulation on Classification, Labeling &
Notification of Hazardous Chemicals & Mixtures. This new decree marks the formal implementation of GHS in Chile as well as a new chemical reporting system, each with established implementation timelines. Although the decree references the UN Purple Book (a GHS guidance document), it is not based on a specific version of GHS. Product types that are excluded from GHS provisions include hazardous waste, medical devices, pharmaceutical products, food additives and animal feed. The Ministry of Health plans to publish an official list of chemical classifications for substances that will specify the hazard classes and categories. In the future, these official substance classifications will need to be taken into consideration when assessing the hazards of products sold in Chile.

Manufacturers and importers will be obligated to submit a notification to the Chilean government when quantities of a hazardous substance meet or exceed one ton per year.

The deadlines for implementation of GHS in Chile are as follows:
• Substances for industrial use: Feb. 9, 2022
• Substances for non-industrial use: Feb. 9, 2023
• Mixtures for industrial use: Feb. 9, 2025
• Mixtures for non-industrial use: Feb. 9, 2027

Deadlines for registration will come into effect two years after the GHS implementation dates specified above. For example, registration of substances for industrial use will be required by Feb. 9, 2024. Chemical registration is not required for active ingredients in pesticides for agriculture, health and home use.

Columbia moves forward with workplace GHS implementation
On April 7, 2021, Columbia’s Ministry   
of Labor published Resolution 0773/2021, defining the actions that employers must take to implement GHS in the workplace. Implementation of the GHS 6th revised edition was approved in 2018 by Decree 1496/2018 and will proceed based on the timelines established under Resolution 0773/2021.

The transition period for implementation depends on the type of product and the deadlines are as follows:

• Pure chemical substances and diluted solutions: April 7, 2023
• Mixtures: April 7, 2024

Labels and SDS must be in the Spanish language and classified in accordance with Revision 6 of GHS. Employers are required to review the data that SDS and label information is based on every five years, at minimum. The SDS must also include a local or toll-free 24/7 emergency phone number.

According to Resolution 0773/2021, label sizes for containers should align with EU Regulation (EC) No 1272/2008 and be proportional to the size of the container. Components contributing to acute toxicity, skin corrosion or severe eye damage, reproductive toxicity, mutagenicity, carcinogenicity, specific target organ toxicity or skin/respiratory sensitization must be identified on the label.

Australia moves to GHS Revision 7
On Jan. 1, 2021, the two-year transition period for updating from the 3rd edition to the 
7th edition of GHS in Australia began. By 2023, GHS Revision 7 must be used to prepare SDS and labels of hazardous chemicals in Australia.

The key changes involve product classification updates:

• “Flammable aerosols” hazard class becomes “Aerosols” and a new hazard category for non-flammable aerosols is added (Category 3)
• A new physical hazard is being introduced for Desensitized Explosives: Categories 1–4
• Flammable Gas 1 will be divided into Category 1A and 1B and three new flammable gas categories are added:
■ Pyrophoric gas
■ Chemically unstable gas A
■ Chemically unstable gas B
• All Category 2 Eye irritants, including the formerly exempt Category 2B, will now fall under the definition of “hazardous chemical” under the model Work Health & Safety (WHS) laws

There are no major changes to the format of the SDS itself.

New Zealand moves to GHS Revision 7
On April 30, 2021, New Zealand implemented the 7th revised edition of GHS as its official workplace hazard classification system. SDS and labels for new hazardous materials must now be authored according to GHS Revision 7. There is a four-year transition period to update existing labels and SDS to comply with the new classification requirements; this ends on April 30, 2025.

As with the changes for Australia, the new requirements in New Zealand are primarily concerned with the hazard classifications. Revision 7 of the Purple Book applies for classification purposes, except for building blocks that are not adopted in New Zealand, such as the Acute Toxicity 5 and Skin Irritant 3 categories.

There are some differences in the classification cut-offs for New Zealand in comparison to the Purple Book—specifically, the deviations that affect the Skin & Respiratory Sensitizer, Specific Target Organ Toxicant, Carcinogen and Reproductive Toxicant classifications.

Previously, New Zealand managed hazardous substances under several different pieces of legislation. The key regulation was the Hazardous Substances & New Organisms (HSNO) Act, which set criteria that designate a substance as hazardous and assign it an HSNO hazard classification number. The HSNO number determines the nature and level of its conditions of use.

Companies were formerly required to use HSNO classifications on SDS and labels and could additionally choose to include the GHS format. Now, for the first time, the HNSO numbers have been converted to equivalent GHS classifications. All Pre-2021 HSNO classification codes have been revoked, except hazards to the terrestrial environment for agrichemicals, which do not have a GHS equivalent and comprise the following categories:

• Hazardous to soil organisms (9.2A, 9.2B, 9.2C, 9.2D)
• Hazardous to terrestrial vertebrates (9.3A, 9.3B, 9.3C)
• Hazardous to terrestrial invertebrates (9.4A, 9.4B, 9.4C)
• Designed for biocidal action (9.1D)

if you sell hazardous products in Chile, Columbia, Australia or New Zealand, we suggest taking note of the implementation deadlines for the new regulations in each country. This way, you can plan ahead to prepare for any new obligations and ensure that your documentation remains compliant. SPRAY

The global regulatory landscape is constantly evolving to meet the needs of different groups, such as industry, workers and consumers. The needs of different groups, such as industry, workers and consumers. As new health and safety information becomes available, countries must adapt to ensure that product users and producers alike are given the tools and information required to use hazardous chemicals safely and effectively. This column will provide an overview of recent key regulatory updates in several Asian jurisdictions.

China introduces exemption for imported cosmetic animal testing
On March 4, 2021, China’s National Medical Products Administration (NMPA) released the finalized Provisions for Management of Cosmetic Registration & Notification Dossiers. Effective May 1, 2021, “general” cosmetic products can now be imported into China without having to first be tested on animals. Chinese regulations distinguish between “special-use” and “general” cosmetics. Special-use cosmetics include products such as hair dyes, hair perming products, sunscreens and cosmetics “claiming new efficacy.” All other products complying with the definition of cosmetics given by the Cosmetic Supervision & Administration Regulation (CSAR) are classified as “general” cosmetics.

According to the final rule, two documents must be provided in order to benefit from the exemption:

1. A good manufacturing practices (GMP) certificate of compliance issued by a competent authority of the country of origin; and













2. Results of the product’s safety assessment, confirming that the products are safe to use.

In addition to the above requirements, there are a few exceptions when general cosmetics will still require testing on animals for import into China:

• Products that claim they are intended to be used on children/infants;
• Products using new cosmetic ingredients (as defined by the Chinese regulations) during the compulsory three-year monitoring period; and
• Instances where the notifier, importer or manufacturer is listed as a key supervision target according to the results of the quantitative rating system established by the NMPA.

Although there are still some restrictions, this is a good step forward in terms of increasing the accessibility of cruelty-free products in the Chinese market.

South Korea looks to expand definition of existing substances under K-REACH
Earlier this year, South Korea’s Ministry of Environment consulted on a plan to expand the definition of existing substances under K-REACH.

The Act on Registration & Evaluation of Chemicals (K-REACH, also known as ARECs) regulates the designation of hazardous chemical substances in South Korea through registration and evaluation. K-REACH mandates that new chemical substances be registered or notified before production or import. Existing chemical substances need to be registered when the production or import volume exceeds one ton/year.

Existing substances are currently defined under K-REACH as one of the following:

• Chemical substances publicly notified by the Minister of Environment in consultation with the Minister of Employment & Labor, which were domestically distributed for commercial purposes in South Korea prior to Feb. 2, 1991; or
• Chemical substances publicly notified by the Minister of Environment for which, after Feb. 2, 1991, a hazard assessment has been conducted pursuant to the former Toxic Chemicals Control Act.

The draft amendment, which was published on March 2, 2021, adds three new criteria to the definition of existing substances:

1. Isomers of an existing substance;
2. Hydrates or anhydrides of an existing substance; and
3. Reaction products consisting of two or more existing substances.

In cases where an existing chemical substance was notified as a specific isomer, the new definition excludes isomers of the already-notified substance. This means new isomers of an existing substance will still need to be notified if the original substance was a specific isomer rather than mixture of isomers or unspecified. Additionally, reaction products would only be considered “existing” in cases where separation of individual components is technically difficult and therefore the product is distributed on the market as a mixture.

There are currently more than 43,000 substances on the Korea Existing Chemicals List (KECL). This amendment would further expand the group of chemicals considered for listing and therefore distribution in South Korea.

Japan sets preliminary schedule for mandatory SDS, labels
Japan’s Ministry of Health, Labor & Welfare (MHLW) is planning to expand the number of hazardous chemicals that are required to have Safety Data Sheets (SDS) and labels under its Industrial Health & Safety Law (ISHL).

The ISHL requires suppliers to prepare an SDS and label for substances listed in Table 9 of the cabinet order of the ISHL, which currently identifies 633 substances. An SDS and label must also be supplied for mixtures containing designated substances above the applicable cut-offs found in Table 2 of the Ordinance of ISHL.

On Feb. 26, 2021, MHLW published a preliminary five-year schedule outlining the plan to add several hundred new substances to Table 9 each year for the next three years.

According to the interim report from MHLW’s twelfth management of chemical substances in the workplace study group, approximately 700 new substances per year will be added for the first three years. This is followed by a transitional period of two to three years for the new substances.

Additional substances to be listed in Table 9 will be prioritized according to the Globally Harmonized System of Classification & Labeling of Chemicals (GHS) categories assigned by the MHLW, Ministry of Economy, Trade & Industry (Meti) and the Ministry of Environment (MoE). The preliminary schedule appears in the chart at bottom left.

As the table shows, substances classified as GHS Category 1 carcinogens, mutagens and reproductive toxicants (CMRs) will be prioritized for listing this year. These will then be followed by substances with other Category 1 GHS health hazards in 2022 and other hazardous substances in 2023.

Japan GHS chemical classifications are published on the National Institute of Technology & Evaluation (NITE) website as a reference for companies preparing hazard communication documentation. In April, NITE introduced the GHS Mixture Classification & Labeling Creation System (NITE-Gmiccs) web tool to help companies search for GHS classifications and create labels.











Thailand to publish 5th revision of Hazardous Substance Act
Thailand’s Ministry of Industry (MoI) has approved a fifth  revision of the Hazardous
Substances Act, the country’s main chemical control law. The updated regulation, which is anticipated to be published sometime this year, will expand the hazardous substance notification requirements in Thailand.

The new revision is expected to include draft amendments to notification on the declaration of List 5.6 hazardous substances and notification for R&D exemption BE 25XX.

Under List 5.6, the reporting requirements will shift from focus on a product to a single substance. Currently, companies must notify the Dept. of Industrial Works (DIW) if the total accumulated quantity of hazardous substances in all products they manufacture or import exceeds one (1) ton per year. This will change to a requirement to notify if the total amount of a single substance or single mixture exceeds one (1) ton.

The amended notification for R&D exemption will replace the existing MoI Notification on R&D Exemption BE 2559. Anticipated changes under BE 25XX include the following:

• Expansion to include education, testing and analysis;
• Notification and registration for Type 2 (flammable) substances will not be required;
• Licensing and registration for Type 3 (oxidizing agent or peroxide) substances will not be required;
• Substances will need to comply with UN GHS; and
• Exemptions will be valid for six months and are non-renewable.

We will be sure to keep you in the loop as new hazard communication requirements are implemented in Asia and around the world. SPRAY

If you sell hazardous products in Europe or the United Kingdom (UK), you are probably already aware that the chemical regulations are changing. On Jan. 1, 2021, the UK became a “third country” to the European Union (EU). This article will review some recent updates to the EU and UK hazardous materials regulations, and how they relate to each other in the aftermath of Brexit.




EU SDS updates (REACH Annex II)
In July 2020, Annex II of the Registration, Evaluation & Authorization of Chemicals (REACH) Regulation (EC) No 1907/2006 was amended. The new amendment, Commission Regulation (EU) 2020/878, came into force on Jan. 1, 2021. REACH Annex II describes the requirements for the compilation of Safety Data Sheets (SDS), including layout and content.


Amendments to Annex II were necessary to incorporate specific EU requirements for nanoform substances, endocrine disruptors and unique formula identifiers (UFI) into the appropriate subsections of the SDS.

The updated REACH Annex II addresses the following:

• UFI (section 1.1, when it is indicated on the SDS)
• Nanoform properties (sections 1, 3 and 9)
• Endocrine disruptors (sections 2, 11 and 12)
• Additional information for substances included in Part 3 of Annex VI to Regulation (EC) No 1272/2008 (section 3, when available):
• Specific concentration limits (SCLs),
• M-factors,
• Acute toxicity estimate (ATE)
• Section 3 disclosure limits
• Closer alignment with the Globally Harmonized System of Classification & Labeling of Chemicals (GHS) 6th and 7th edition

Among the disclosure changes, skin and respiratory sensitizer 1A chemicals will now have to be disclosed when present at 0.01% or 1/10th of the assigned SCL. Substances that are classified for aspiration toxicity must be disclosed when in the mixture at 1% or more, rather than 10% as previously indicated.

Great Britain (GB) has not officially adopted the Annex II update. This means that there are now differences in the format and content provisions laid out for GB versus EU SDS. As a result of the Annex II amendments, EU SDS are expected to be more comprehensive compared to the current GB and previous European SDS requirements, with additional substance and product data points needed for compliance.

A grace period of until Dec. 31, 2022 has been provided to update all current EU SDS to conform with the new requirements.

EU CLP updates: ATP 14
The 14th Adaptation to Technical Progress (ATP) of the EU Regulation (EC) No 1272/2008 on the classification, labeling and packaging of substances and mixtures (CLP) becomes mandatory on the date of application: Sept. 9, 2021.

ATP 14 includes new classification and labeling requirements for products containing titanium dioxide:

• Liquid products containing 1% or more of Titanium dioxide particles with aerodynamic diameter equal to or below 10μm will need to be classified as Carcinogen 2 and labeled with the EUH211 statement: Warning! Hazardous respirable drop lets may be formed when sprayed. Do not breathe spray or mist.
• Solid mixtures containing 1% or more of Titanium dioxide will need to be will need to be classified as Carcinogen 2 and labeled with the EUH212 statement: Warning! Hazardous respirable dust may be formed when used. Do not breathe dust.

Table 3 of Annex VI to CLP has been amended to include three new notes that relate to the changes for Titanium dioxide. Note V addresses Titanium dioxide fibers and sanctions the assignment of a more severe category (Carc. 1B or 1A) and/or additional routes of exposure when appropriate. Note W describes the particular toxicity of Titanium dioxide as it relates to respirable dust. Note 10 specifies that the carcinogen by inhalation classification applies only to mixtures containing 1% or more of Titanium dioxide in the form of particles with an aerodynamic diameter ≤ 10μm.


Other changes to Annex VI under the 14th ATP of CLP include two deleted substances, 12 updated substances and 17 new substances. Ten new ATEs have been specified in the update as the European Chemicals Agency (ECHA) moves toward inclusion of this relatively new-to-Annex VI data point.

If you are using or supplying substances listed in the ATP 14 update to Annex VI, you will need to re-classify your products and update your SDS based on the new harmonized substance requirements before the date of application.

ATP 14 was adopted before the UK became a third country. Therefore, the new classification and labeling information for Titanium dioxide and the other updated chemicals are also appearing on the GB mandatory classification and labelling list (GB MCL) and must be used for SDS and label generation.

Other ATPs to EU CLP
Several other CLP ATPs are also currently in the works:

• ATP 15 applies from March 1, 2022. Changes to Annex VI of CLP include 37 new entries, 21 revised entries and two deleted entries.
• ATP 16 is currently in draft form. This ATP concerns 15 substances that can be used in cosmetics.
• ATP 17 is currently in draft form. Changes to Annex VI of CLP include 22 new entries, 41 revised entries and one deleted entry. Publication in EU Official Journal is expected soon, with an anticipated application date in mid-2022.
• ATP 18 is currently in draft form. Changes to Annex VI of CLP include 36 new entries and 20 revised entries.

Brexit: EU (Withdrawal) Act 2018 (2020)
Since Brexit, the UK has taken a “lift and shift” approach for all EU chemicals management regulations. The EU (Withdrawal) Act 2018 (2020) converts directly applicable EU law into domestic law in GB. This means that each EU regulation as of Dec. 31, 2020 has been transposed into UK regulation and is applicable in GB from Jan. 1, 2021. For the time being, British legislation remains almost completely aligned with EU legislation. EU regulations implemented this year, such as Regulation 2020/878/EU discussed above, are the exceptions to this rule.

New British regulations transposed from EU regulations include:

• Detergents -> GB Detergents

GB did not directly adopt Annex VI of CLP regulation. The MCL was implemented, which currently matches the harmonized classification and labeling entries found in Annex VI. As GB begins to implement its own requirements, we anticipate that the MCL will begin to deviate from the EU CLP classification requirements.

You might have noticed that UK REACH stands out from the other regulations listed above. Therefore, is it UK REACH or GB REACH? UK REACH is a misnomer. Although the official term is UK REACH, the regulation only applies in GB. This is because Northern Ireland (NI) currently remains under EU REACH regulation.

Due to its geographical location, it is desirable to maintain an open border between the Republic of Ireland (ROI) and NI, even though NI is part of the UK. The Protocol on Ireland/Northern Ireland was established so that NI would remain aligned to EU regulations rather than GB regulations. This means that NI is still subject to EU CLP, EU REACH and so on. The protocol is subject to review every four years.

The Health & Safety Executive (HSE) is the British agency that is taking the place of ECHA in the UK. The HSE is the designated authority responsible for implementing and enforcing GB chemicals management regulations.

In GB, the National Poisons Information Service (NPIS) is the appointed body responsible for receiving specific information from GB importers and suppliers about the ingredients of hazardous mixtures that they place on the GB market. The current scheme of data collection is voluntary and there is no legal obligation to notify NPIS in GB.

The main takeaway is that British hazardous chemicals regulations are still largely the same as the corresponding EU regulations, with technical amendments applied to make them relevant to GB rather than the EU. As we move forward, we can expect to see more divergence as GB shifts towards its own individualized chemicals management scheme. We will be sure to keep you informed on European and British hazardous chemicals regulations as new requirements are implemented. SPRAY

Overview: What is happening?

On Dec. 19, 2020, the Government of Canada published proposed amendments to the Hazardous Products Regulations (HPR) and Schedule 2 of the Hazardous Products Act (HPA). The HPR and HPA set out the requirements for the Workplace Hazardous Materials Information System (WHMIS) in Canada.

The proposed amendments will align the HPR with the 7th Revised Edition of the United Nations Globally Harmonized System of Classification & Labeling of Chemicals (GHS). Additionally, the updates will provide greater clarity or precision regarding certain provisions, include changes to better reflect the original intent of the regulations and address administrative updates. Harmonization with the U.S. will be preserved while advancing worker protections and addressing various issues that have been identified by Health Canada and stakeholders since the HPR came into force in 2015.


Key changes that were made to align the HPR with GHS seventh revision include:
• Updated definitions;
• A new non-flammable Aerosol Hazard category;
• New sub-categories for Flammable Gases;
• A new test procedure for Oxidizing Solids; and
• Updated information elements for safety data sheets (SDS)/labels in Schedule 1

In addition to these key changes related to GHS, a variety of other amendments have been proposed that will address issues identified by Health Canada and stakeholders. Existing provisions relating to classification and labeling of hazardous products will be clarified and adjusted based on the feedback provided by affected parties. There will be a two-year transition period for suppliers to implement the new amendments after they come into force.

Objective: Regulatory cooperation and increased worker protections
The primary objective of the proposed amendment is to meet an international commitment under the Canada-U.S. Regulatory Cooperation Council Joint Forward Plan. The Work Plan for workplace hazardous products aims to coordinate the adoption of GHS updates between the two countries. Canada and the U.S. have pledged to harmonize amendments to their respective regulations as much as possible as they move toward the seventh revision of GHS.










Regulatory cooperation will continue to allow a single label and SDS for a dangerous product to meet the hazard communication requirements in both the U.S. and Canada.

This continued alignment will facilitate trade through common hazard communication requirements and mitigate the economic impacts of disparities in regulatory obligations between the U.S. and Canada.

Aligning with the seventh revised edition of GHS will also provide Candian workers with more comprehensive and detailed occupational safety information, improving their health and safety. This edition of GHS allows for more precise classification of products, such as flammable gases, and includes more detailed information requirements for SDS and labels over the currently implemented fifth revised edition.

Issues identified by stakeholders and Health Canada
The amended regulations aim to address several issues identified by industry stakeholders and Health Canada since the HPR came into force in 2015. Certain provisions are being clarified or made more precise. In some cases, criteria or requirements are being updated to better reflect their original intent such as clarifying exemptions for hazardous products sold to an employer who has filed a confidential business information claim. These changes will result in greater clarity and more appropriate requirements for Canadian workers.

Changes to aerosol classifications
The updates to the aerosol classifications will be of particular interest to SPRAY readers. Under the current WHMIS regime, aerosols intended for workplace use may be classified as either Flammable Aerosols Category 1 or 2 based on their physical characteristics, in addition to the Gases Under Pressure category that also applies to “non-flammable” aerosols.








The amendments will change the hazard name from Flammable Aerosols to Aerosols and include a new Category 3 for non-flammable aerosol products. A new provision will clarify that products in the Aerosols hazard category need not also be considered for the Gases Under Pressure hazard. Although the hazard names are changing, the classification criteria for aerosols are expected to remain the same.

Other key classification changes
Flammable Gases Category 1 will be divided into subcategories: 1A and 1B. The criteria for subcategory 1B will include flammable gases that are not pyrophoric or chemically unstable and have a lower flammability hazard than subcategory 1A products. These changes will go hand-in-hand with new definitions for chemically unstable gas and pyrophoric gas.

The classification criteria for oxidizing solids will be expanded to include test procedure O.3: Alternative test for oxidizing solids. It is still acceptable to use test O.1, which is based on the mean burning time of a mixture of potassium bromate and cellulose. The new O.3 criteria allows for the determination of oxidizing solids using an alternative method based on the mean burning rate of a mixture of calcium peroxide and cellulose.

Definitions and classification criteria for various GHS hazards will be updated and new definitions for germ cell mutagenicity and carcinogenicity will be added. For example, the classification procedures for mixtures with the following hazards will be updated for additional precision:

• Organic Peroxides;
• Acute Toxicity; and
• Specific Target Organ Toxicity–Single Exposure–Category 3

These are a few of the key classification changes that have been proposed, in addition to a variety of other updates, corrections and clarifications to the original provisions of the HPR. The full list of proposed changes can be found in the Canada Gazette here.

When to expect the changes to come into force
As SPRAY goes to press, the amendment is still in the proposed status. The two-year transition period will begin on the date when the HPR revision comes into force, which is expected to happen in the first half of 2021. This means that suppliers will have until 2023 to comply with the updated requirements.

In Spring 2020, the U.S. Office of Information & Regulatory Affairs and the Office of Management & Budget published a rule (here) indicating that they intend to update The U.S. Occupational Safety & Health Administration’s (OSHA) Hazard Communication Standard (HCS) to GHS 7th Revised Edition as well as codify a number of enforcement policies that have been issued since the 2012 standard. Although the objective is in place at the time of writing this article, dates for these changes have not been set. Despite coordination between Canada and the U.S., there is a chance that the timing of implementation may not align perfectly due to regulatory delays and differences in implementation dates. This could result in the need to update SDS and labels in one country sooner than the other.

Suppliers selling products in both Canada and the U.S. will need to ensure their products are compliant with the new regulations by the earliest deadline. Updating products early to comply with new regulations in one country should not result in any compliance issues in the other country. For example, if the HCS update is implemented first, suppliers selling products in the U.S. will need to make sure that their SDS and labels comply with the new requirements. The updated SDS and labels will still be compliant in both countries if the Canada-specific requirements, such as French translations, are also considered.

Health Canada will continue to enforce the requirements for workplace hazardous chemicals according to the provisions of the HPA. Training resources will be developed for inspectors to promote a common understanding and interpretation of the new regulations.

For more information about your obligations under Canadian WHMIS regulations, contact our team at Nexreg Compliance. SPRAY