GPC Newsletter Nov-2024

On October 4, 2024, Canada released a draft plan for the Watch List under the Canadian Environmental Protection Act (CEPA). The Watch List will monitor substances that are potentially harmful to human health or the environment, even if they do not currently meet toxicity criteria under CEPA. Public consultations on the draft will be open for feedback for 60 days before the Watch List is finalized by the end of 2025.

What is the Watch List?

In June 2023, Canada strengthened its environmental protection laws by amending the Canadian Environmental Protection Act, 1999 (CEPA) through Bill S-5. A key element of this amendment is the creation of the Watch List, which is designed to increase transparency and provide the public with insight into substances that may pose a risk to human health or the environment. The Watch List allows for the identification of substances that may become toxic over time, even though they do not currently meet the criteria for toxicity under CEPA, thus allowing for proactive management. Unlike substances listed in Schedule 1 of CEPA, substances on the Watch List are not subject to immediate regulatory restrictions. However, the list provides increased transparency and allows stakeholders to stay informed about substances of concern.

How the Watch List Works

The proposed Watch List approach outlines the processes for adding or removing substances from the Watch List. Environment and Climate Change Canada (ECCC) and Health Canada (HC) are responsible for compiling the list based on scientific data and evaluations. Substances may be added to the Watch List following an assessment or review under Part 5 of CEPA or based on decisions by other jurisdictions that are relevant to Canada.

Substances that may be included on the Watch List are those that do not meet the current definition of toxic under CEPA, but may become harmful if use, exposure or hazard characteristics change in the future. Examples of considerations include:

• The severity or type of health or the environmental effect the substances may have.

• Physical or chemical properties of the substance.

• Potential changes in exposure or use patterns that could increase risks.

• Environmental fate and behavior of the substance in the ecosystem.

Adding Substances to the Watch List

Substances can be added to the Watch List based on several criteria, including:

• A recommendation following an assessment under Part 5 of CEPA.

• A review of decisions by other jurisdictions suggesting that a substance may become toxic.

• Evaluation of new or emerging data that indicate potential risks.

Each addition to the Watch List will go  through a public consultation process to ensure transparency and stakeholder participation.

Removal of Substances from the Watch List

A substance will be removed from the Watch List if:

• It is added to Schedule 1 of CEPA as a toxic substance

• The Ministers of Environment and Health no longer have reason to believe that the substance may become toxic

Public Engagement and Transparency

The Watch List is designed to be a transparent tool for informing the public and stakeholders about substances of potential concern. Information about each substance added to the list, including its Chemical Abstracts Service Reference Number (CAS RN), name, and reason for inclusion, will be made available to the public. This information will be searchable and accessible through the CEPA Registry, ensuring easy access to details of substances on the Watch List.

The proposed Watch List will not impose any legal or regulatory obligations on the substances listed, but will serve as an early warning mechanism for stakeholders, manufacturers, and importers to monitor these substances and consider safer alternatives.

Example Follow-Up Activities for Watch List Substances

While the Watch List does not impose new restrictions, the ECCC and HC may pursue additional activities to monitor and gather information on substances of concern. Examples of such activities include:

• Significant New Activity (SNAc) Provisions: If there is a significant change in the use of a substance, the SNAc provisions may require stakeholders to inform the government of these changes, allowing for further risk assessment.

• Environmental and Biomonitoring: Monitoring the presence of substances in wildlife, air, water, or humans to track trends and potential exposures.

• Section 71 Notices: Mandatory information-gathering notices used to collect data on substance usage, toxicity, and commercial activity.

Public Comment Period and Watch List Finalization

The proposed Watch List approach will be open for public comment for a period of days. Interested parties, including the general public, industry stakeholders, and environmental organizations, are invited to provide feedback. Comments may be submitted through the CEPA Registry and must cite "Proposed Watch List Approach" in the subject line.

Once finalized, the Watch List Approach will be published by the end of 2025, with substances added to the list shortly thereafter. The goal is to provide an early warning system to ensure that potential risks are identified and managed before they become a greater threat to human health or the environment.

On September 30, 2024, the U.S. Environmental Protection Agency (EPA) updated the Safer Chemical Ingredients List (SCIL) to promote transparency and support safer product innovation. The update includes the addition of 27 chemicals, updates to 23 listings, and a planned removal of one chemical after 12 months. Fragrances have also been moved to a more comprehensive list to help manufacturers find approved options for Safer Choice-certified products.

Introduction

The Safer Chemical Ingredients List (SCIL) is a comprehensive compilation of chemicals evaluated by EPA’s Safer Choice program that meet stringent safety criteria. With this latest update, the SCIL now includes 957 chemicals recognized as some of the safest for their intended uses. This list helps manufacturers identify suitable chemicals for products aiming for Safer Choice certification.

Additions to the SCIL

EPA has added 27 new chemicals to the SCIL, increasing the total for 2024 to 29. These additions include colorants, preservatives, processing aids, additives, polymers, solvents, and surfactants, providing manufacturers with more options for creating high-performance products using safer chemicals.

Moving Fragrances from the SCIL

Fragrances may be used in Safer Choice-certified products if they meet the Safer Choice Criteria for Fragrances. EPA is moving fragrances previously listed on the Safer Choice Ingredients List (SCIL) to the Safer Choice Fragrances Palette, which will now serve as the comprehensive source of approved fragrances. The criteria remain unchanged, allowing any fragrance that meets these standards in Safer Choice-certified products. Additionally, for those seeking fragrance-free options, EPA will maintain the Fragrance-Free Safer Choice label on qualifying products, with approximately 300 fragrance-free products currently certified.

Updating SCIL Listings

EPA is updating the status of 23 chemicals on the Safer Chemical Ingredient List (SCIL), using color codes to indicate confidence levels in their safety. As part of this routine maintenance, 20 solvents previously classified as "full green circles" or "yellow triangles" are now reclassified as "half-green circles," indicating low concern but needing more data to bolster their safer status. Additionally, propyl acetate is now designated as a "yellow triangle," meaning it meets Safer Choice Criteria but still has some health and environmental concerns.

EPA has also reclassified methyl ethyl ketone as a specialized industrial chemical, consistent with other chemicals in its hazard profile. Furthermore, ethyl lactate has been changed to a "grey square" status and may be removed from the list in one year if health concerns are not addressed, as no Safer Choice-certified products currently contain this chemical.

EPA is dedicated to regularly updating the SCIL with safer chemical options. They encourage manufacturers to submit their safer chemicals for review and potential inclusion on the SCIL, which will be updated at least annually to reflect advances in safer chemistry.

On October 2, 2024, the U.S. Environmental Protection Agency (EPA) proposed to add 16 individual per- and polyfluoroalkyl substances (PFAS) and 15 PFAS categories, covering over 100 chemicals, to the Toxics Release Inventory (TRI). The proposal would designate them as chemicals of special concern, requiring more robust reporting, even for small concentrations. This move aligns with the Biden-Harris Administration's and EPA's PFAS Strategic Roadmap to address the health and environmental risks of PFAS, boost pollution prevention, and enhance public access to data on environmental releases of these persistent "forever chemicals."

The proposal aims to enhance public and regulatory access to data on toxic chemicals, including those linked to cancer, allowing communities to identify pollution sources and helping facilities reduce or eliminate emissions.

Proposed Rule

1. EPA is proposing to add certain PFAS to the Toxic Release Inventory (TRI) due to their links to health risks such as cancer, liver and kidney damage, and reproductive harm.
2. EPA is proposing a 100-pound reporting threshold for the manufacture, processing, and use of PFAS, aligning with existing TRI reporting requirements established by the National Defense Authorization Act for Fiscal Year 2020. If approved, all PFAS within a category will contribute to the reporting threshold, preventing facilities from avoiding disclosure by claiming that individual PFAS do not meet the threshold. Additionally, EPA plans to reclassify certain PFAS previously added to the TRI individually, consolidating them into 15 broader categories.
3. EPA is also seeking to clarify how PFAS are automatically added to the TRI under the NDAA.

Toxics Release Inventory

The Toxics Release Inventory (TRI) was established to monitor toxic chemical waste management and promote pollution prevention to protect public health. Regulated facilities must report annually to EPA on the quantities of toxic chemicals released into the environment, as well as those managed through recycling, energy recovery, and treatment. Additionally, facilities must disclose practices aimed at minimizing waste generation. EPA makes this data publicly available to aid in decision-making and to promote pollution prevention initiatives.

Rule History

On December 20, 2019, the National Defense Authorization Act (NDAA) was signed into law, adding certain PFAS to the TRI under the Emergency Planning and Community Right-to-Know Act. The NDAA establishes a framework for the annual addition of PFAS to the TRI and requires EPA to consider additional substances for inclusion. The Agency is now proposing to add identified PFAS in accordance with this mandate.

The NDAA allows for the automatic addition of PFAS to the TRI when EPA finalizes a toxicity value. To clarify this process, EPA is proposing a list of toxicity values that would trigger the inclusion of associated PFAS.

Public comments on the proposed rule will be accepted for 60 days following its publication in the Federal Register via docket EPA-HQ-TRI-2023-0538 at Regulations.gov.

UPDATE: The new CLP Regulation (Regulation (EU) 2024/2865) was published in the Official Journal of the European Union on 20 November 2024 and will enter into force on 10 December 2024. The full text can be found here. In addition, ECHA published its updated guidance on the application of CLP criteria on 13 November 2024, to reflect these regulatory changes and provide enhanced support for compliance.

Original text:

On 14 October 2024, the Council of the European Union adopted a new Regulation on the Classification, Labelling, and Packaging (CLP) of Chemical Substances. This update modernises the 2008 CLP Regulation to better reflect evolving chemical hazards and trends in trade and consumer protection.

The adoption marks the final step in the legislative process. Once signed by the President of the European Parliament and the President of the Council, the new CLP Regulation will be published in the Official Journal of the European Union and will enter into force three days later.

CLP Background

The European Commission proposed the CLP revision in December 2022. A provisional agreement was reached between the European Parliament and the Council in December 2023. The adoption concludes the legislative process, aiming to better protect consumers and the environment from chemical hazards.

Key Changes to the CLP Regulation

The newly adopted CLP Regulation focuses on improving chemical safety by:

• Ensuring faster identification and classification of new hazards, including endocrine disruptors.

• Clarifying labelling requirements for both traditional and digital formats.

• Adapting the rules to modern trading practices such as online sales and bulk purchasing.

• Promoting the circular economy through refill stations and more sustainable product handling.

A key feature of the new regulation is the introduction of voluntary digital labelling and specific rules for chemical refill stations. Additionally, the Regulation provides for a five-year grace period for non-modified substances of botanical origin with more than one constituent (MOCS).

Strengthening the Chemicals Strategy for Sustainability

This revision is part of the broader Chemicals Strategy for Sustainability, which supports the European Green Deal. Together with the planned revision of the REACH Regulation, the updated CLP legislation aims to create a more sustainable and toxic-free environment.

On 30 September 2024, the European Commission published the 22nd Adaptation to Technical Progress (ATP) under Regulation (EC) No 1272/2008 (CLP). The 22nd ATP was adopted on 19 June 2024 and published in the Official Journal of the European Union and amend Table 3 of Part 3 of Annex VI to the Classification, Labelling and Packaging (CLP) Regulation by introducing 27 new harmonised classifications, modifying 16 preexisting entries and deleting 7 harmonised classifications. The amendments will come into effect on 1 May 2026.

Compliance Deadlines for 22nd ATP

The new classifications enter into force on 20 October 2024 and will apply from 1 May 2026, giving suppliers sufficient time to adjust their labelling and packaging in line with the new rules. However, suppliers may voluntarily adopt the updated classifications before this date to ensure compliance and to better protect public health and the environment.

New Harmonised Classifications in 22nd ATP

The table below lists the 27 new harmonised classifications added to Part 3, Table 3 of Annex VI to the CLP Regulation. The 16 modified entries can be found here.

For full access to the regulation, visit https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202402564

Deadline for 21^st Adaptation to Technical Progress

The previous ATP (21st ATP) was published in the Official Journal of the European Union on 5 January 2024 and will apply from 1 September 2025. It, however, entered into force on 25 January 2024 and therefore suppliers may already now classify label and package substances and mixtures in accordance with the CLP regulation as amended by the 21st ATP.

On 22 October 2024, the Health and Safety Executive (HSE) published an update on biocide regulation in Great Britain (England, Scotland and Wales), including important deadlines for dossier submissions and renewals in relation to active substance approvals under the GB Biocidal Products Regulation (GB BPR).

Upcoming Dossier Submission Deadlines

In order to keep active substances in the GB Review Programme, specific dossier submission deadlines are approaching. The following active substance/product type combinations, which have already been successfully notified into the Programme, require full dossiers to be submitted by:

• 5 January 2025: N-didecyl-N-dipolyethoxyammonium borate / didecylpolyoxethylammonium (polymeric betaine) (CAS No 214710-34-6) in product type 8.

• 17 April 2025: Active chlorine generated from sodium chloride by electrolysis (CAS No 7782-50-5) in product types 2, 3, 4, 5 and 11.

Only designated notifiers or consortia may submit dossiers for these combinations. Stakeholders with a vested interest are encouraged to engage with notifiers and possibly join them in dossier submissions. Failure to meet the submission deadline will result in a GB non-approval decision, effectively banning these substances from biocidal products in the specified categories within the GB.

Consequences of Non-Approval

Without dossier submissions, the affected active substances cannot be used in biocidal products, nor can articles treated with these products be sold on the GB market. Separate updates will be provided for articles affected by non-approval decisions.

Active Substance Renewal Submission Deadline

Under the GB BPR, active substance approvals require a renewal submission 550 days before expiry. The next critical deadline is:

• 29 April 2025:  Polyhexamethylene biguanide hydrochloride (PHMB (1415;4.7)) (CAS No 1802181-67-4 / 32289-58-0) in product types 2 and 4. 

Any interested party may submit a renewal application, even if they are not the original supporter. Industry members should consult the GB Article 95 List to verify the original supporters and determine if collaboration is feasible.

Failure to renew by the deadline will result in expired approvals and the removal of these substances from the list of approved biocides in the relevant categories for the GB market.

The Turkish Ministry of Environment, Urbanization, and Climate Change, and the Union of Chambers and Commodity Exchange (TOBB) have met with the key companies from the industry to discuss the future of KKDIK and the implementation of the updates that were published in December 2023. The outcome of the privately held meeting is reportedly a draft of the long-awaited circular on procedures and principles.

Draft Circular in the Works

According to the draft, new deadlines for late pre-registrations (LPRs) may be proposed, and new rules would be set for the election of the lead registrant (LR) as well data sharing, two issues on which the Ministry has already received considerable feedback from the industry in public meetings. New rules are expected to set clear boundaries and steps for the election mechanism as well as joint submission.

Work Groups to Improve Support

It is also proposed that new work groups will be formed to put into practise the collaboration between TOBB and the Ministry, as proposed in the 2023 regulation updates. These work groups will be expected to resolve ongoing disputes as well as answer questions to help registrants, something that was difficult for the Ministry to find the time and capacity to do over the past years. leading to much criticism of the Ministry.

The discussion is expected to continue throughout the month of November with a view to finalize the draft and eventually publish the circular before the end of the year.

On 26 September 2024, the Ministry of Environment, Forest and Climate Change (MoEFCC) published the Ecomark Rules, 2024 in the Official Gazette, replacing the Ecomark Scheme of 1991. This update is in line with the ‘LiFE’ (Lifestyle for Environment) mission, which aims to increase demand for eco-friendly products and promote sustainable living. The new rules came into force on the day of their publication.

Objectives of the Ecomark Scheme

The new scheme aims to encourage lower energy consumption, resource efficiency, and the promotion of a circular economy. The scheme seeks to prevent inaccurate labelling, misleading claims and to raise awareness about the products concerned.

Accreditation and Environmental Standards

Products accredited under the Ecomark Scheme will adhere to strict environmental standards, ensuring they have a low impact on environment. This initiative will not only build consumer awareness of environmental issues and encourage sustainable consumption, but will also motivate manufacturers to adopt greener production practices.

Implementation and Global Impact

The Central Pollution Control Board (CPCB) will implement the scheme in partnership with the Bureau of Indian Standards (BIS). This initiative is an important step taken by the government to reduce of carbon footprint and promote environmentally conscious consumption in India. This move is in line with global sustainability goals and underlines the governments’ dedication to environmental management.

The full text of the notification with full details on conditions and procedures can be found here.

India’s Department of Chemicals and Petrochemicals (DCPC) has extended the enforcement date of the Quality Control Orders (QCOs) for six fatty acids. The notifications were published in the Gazette of India on 22 October 2024 in consultation with the Bureau of Indian Standards (BIS). The QCOs were originally published on 27 April 2022. 

The revised implementation dates and corresponding standards for the fatty acids are as follows:    

The Quality Control Order mandates that the substances concerned must carry the Bureau of Indian Standards (BIS) certification mark to ensure compliance with the specified standards until the implementation of the new QCOs.   

On 14 September 2024, China’s Ministry of Industry and Information Technology (MIIT) announced a consultation to revise the national standard on "Regulations on the Preparation of Chemical Safety Labels" to align with the ninth revised edition of the Globally Harmonized System for Classification and Labelling of Chemicals (GHS 9). The Ministry released this announcement on the portal of the National Standards Administration and invited stakeholders to comment on it by 14 October 2024. 

After the official publication of the National Standard on the Provisions on the Preparation of Chemical Safety Labels, the National Technical Committee for Standardization of Hazardous Chemicals Management will work on its implementation. 

Insights of New Labelling Standard 

This new labelling standard will have the following revised information: 

• Alignment with the technical content of the ninth edition of the United Nations GHS, including hazard classification and precautionary statements. 

• Implementation of the "one enterprise, one product, one code" regulation to meet the needs of national safety supervision of hazardous chemicals. Additionally, the means of transmitting hazardous chemical hazard information needed to be strengthened, and the last mile of hazardous chemical hazard information transmission needed to be opened. 

Previous Update  

Previously China’s National Standards Administration revised the Provisions on the Preparation of Chemical Safety Labels in 2009. However, this 2009 version followed GHS 2 while the Ministry has now proposed to align with the provisions of GHS 9. 

Comment Period and Enforcement Date 

Stakeholders are invited to comment on this draft announcement till 14 October 2024. The Ministry has not yet officially announced the enforcement date of the same. 

On October 15, 2024, the Chemical Information Management Support Group in South Korea disclosed the results of the pre-registration of existing chemical substances under K-REACH. This disclosure is in accordance with Article 42 (Disclosure of Chemical Information) of the Act on the Registration and Evaluation of Chemical Substances (K-REACH) and Article 51 (Disclosure of Chemical Information) of the Enforcement Rules of the Act.  

Details of pre-registration results 

A total of 17,502 chemical substances have been pre-registered. The information disclosed results from the pre-registration by substance submitted by companies. This data will be used to organize and operate a joint registration consortium in the future.  

 Key Points:  

• The Chemical Information Management Support Group will periodically update and disclose the results of the (change) pre-registration in the future.  

• The list of pre-registered substances can be accessed here.  

On 18 September 2024, Thailand’s Department of Industrial Works (DIW) introduced new regulatory guidelines on the advertising of hazardous substances under its authority. These regulations which aim to improve public safety and environmental protection, follow the most recent amendments to the Hazardous Substances (No 4) BE 2562 (2019) and will take effect the day after the announcement is published in the Government Gazette. This draft guideline is now subject to public consultation from 18 September to 5 October 2024.  

New Guidelines for Advertising of Hazardous Substances 

Under the new announcement, hazardous substances under the responsibility of DIW must adhere to stringent guidelines when advertised. The guidelines focus on providing clear instructions, safety warnings and relevant hazard symbols to safeguard human health and the environment. 

Key Requirements for Advertising Hazardous Substances: 

1. Product Information: Advertisements must clearly display the name, trade name, ratio, use, importer/distributor details of the hazardous substances. 

2. Safety Warnings: All ads must include appropriate advice and warnings about the dangers of hazardous substances, including the required pictograms, signal words and hazard statements. 

3. Prohibition of Misleading Information: Advertisement must not contain ambiguous or misleading content that could lead to improper use of hazardous substances. 

4. Restricted Media Use: Advertising through electronic media such as radio, television, online platforms and digital platforms is strictly prohibited. 

5. Prohibition of Advertising: Advertising of hazardous substances that are fake, substandard, deteriorated, or unregistered are completely banned. 

List of Regulated Hazardous Substances 

The list of hazardous substances regulated under these guidelines includes various cyanides and other potentially dangerous chemicals. This move by the DIW is in line with Thailand's continued efforts to enhance public safety and ensure that the use of hazardous substances is well regulated. The Department encourages all manufacturers and distributors to strictly adhere to the new regulations to avoid penalties. 

On 19 September 2024, Japan’s Ministry of Economy, Trade and Industry (METI), Ministry of Health, Labour and Welfare (MHLW), and Ministry of Environment (MOE) jointly released the 2025 notification schedule for new chemical substances. METI published this notification schedule on its portal, along with detailed information and a manual. New chemical substances that are manufactured or imported into the Japanese market in quantities exceeding one tonne are subject to this notification. 

Annual Update of the Notification Schedule 

The Ministry updates the notification schedule every year in September. Previously, on 8 September 2023, METI revised the notification schedule for new chemicals for the year 2024. 

Notification Schedule 

For the deadlines of 7 February and 1 August 2025, there is no requirement of preliminary screening if the same substance is notified. Only notifications will be accepted on these dates.  

For preliminary materials, submissions will only be accepted until 3 pm on the respective date. If this deadline is missed, the next deadline will apply. 

Required Information  

The manual for the notification of new chemical substances lists the required information as given below and can be consulted for further information: 

• Company details 

• Name and structural formula of the new chemical substance 

• Physicochemical properties and composition 

• Uses 

• Estimated annual quantity for the manufacture or import of the new chemicals for three years 

• Details of two contact persons 

Next Announcement 

METI has not yet announced the notification schedule for the year 2026, but it is expected to be released in September 2025. 

The Australian Industrial Chemicals Introduction Scheme (AICIS) is reminding businesses to submit their Post-Introduction Declarations (PIDs) for the 2023-2024 period by 30 November 2024. This applies to those who have first introduced an exempted category chemical between 1 September 2023 and 31 August 2024.

Who Needs to Submit?

A PID is required for those who have introduced chemicals from the following exempted categories:

• Polymers of low concern

• Low-concern biological polymers

• Chemicals classified as very low risk to human health and the environment

A separate PID must be submitted for each chemical introduced for the first time during the period.

How to Submit

To submit a PID, businesses must:

1. Log in to AICIS Business Services.

2. Access the PID Dashboard and select the type of introduction.

3. Submit the form by the 30 November 2024 deadline.

For more details, visit the Exempted Introduction Declaration page on the AICIS website's here.

On 24 September 2024, the Australian Industrial Chemicals Introduction Scheme (AICIS) introduced Version 3 of the Industrial Chemicals Categorisation Guidelines. This major update introduces specific revisions to guide chemical importers and manufacturers in Australia, ensuring compliance with current hazard assessment standards and aligning with recent regulatory changes.

Resources and Support for Chemical Introducers

The AICIS has refined its guidance resources, particularly in steps 4.4 (Human Health Hazard Characteristics) and 5.4 (Environmental Hazard Characteristics) of the Categorisation Guidelines, reflecting updates first outlined in March and August 2024. These adaptations clarify test methods, predictive tools and hazard identification criteria, particularly for bioaccumulation and organ toxicity assessments. The updated resources aim to streamline the categorisation process for companies and ensure compliance with current regulatory expectations.

List of Chemicals with High Hazard: Comprehensive Update

The revised AICIS Guidelines includes a significantly expanded list of high-hazard chemicals, adding nearly 600 unique entries for introducers to refer to when categorising chemicals as exempted, reported, or assessed. This list consolidates chemicals recognised as highly hazardous by trusted national and international bodies (e.g. European Chemicals Agency (ECHA), Chemical Substances Control Law of Japan (CSCL)). In addition, the European Commission’s Endocrine Disruptor List (List I) has been added as a source. It is expected that the list will be updated annually. The current version of the list is available here.

Detailed Focus on Hazard Characteristics

To streamline the safety and hazard identification processes, the AICIS has updated its guidance on key hazard characteristics:

• Organ Toxicity (Repeated Exposure): Revised requirements provide companies with clearer pathways to demonstrate the absence of target organ toxicity. This change appears under the category "Human Health Hazard Band B".

• Bioaccumulation Potential: The updated guidance requires more rigorous evidence for chemicals to demonstrate the absence of bioaccumulation, especially in environmental contexts, as detailed under "Environment Hazard Band A".

These refinements will help standardize the data required to establish safer chemical profiles, thereby reducing risks to both human health and the environment.

Vaping Chemicals Reclassified as Therapeutic Goods

From 1 July 2024, the AICIS no longer classifies chemicals used in vaping goods as “industrial chemicals.” Due to recent legislation, these chemicals are now regulated as therapeutic goods under the Therapeutic Goods Act 1989. As a result, the AICIS removed references to personal vaporisers from Version 3 of the Guidelines, and importers or manufacturers of vaping-related chemicals must now comply with Therapeutic Goods Administration (TGA) regulations. The AICIS will only regulate these chemicals if they have other industrial uses beyond vaping.

Version 3  of the Industrial Chemicals Categorisation Guidelines can be found here.

As expected, the Federal Senate has approved Bill 6120/2019, which aims to establish the National Inventory of Chemical Substances. The bill seeks to regulate the use, commercialization, and control of these substances in Brazil, with the aim of reducing harmful impacts on public health and the environment. The bill now awaits presidential approval.

Purpose of the National Inventory

The National Inventory will serve as a strategic tool to identify and monitor chemical substances produced or imported in the country. It will enable more effective risk management of these substances, promote chemical safety, and help align Brazil with international best practices for regulating chemical products.

Legislative Process and Amendments

The bill has passed through several stages in Congress, including consideration of amendments and adjustments to the text. The final version approved by the Senate includes two drafting amendments aimed at improving the clarity of the document without changing its main content.

Expected Timeline for Presidential Approval

The President has 15 business days from the day the bill is officially received by the Executive Branch to make his decision. During this period, the President may either fully sanction the bill, partially or entirely veto it, or allow it to become law by tacit approval if no action is taken within the deadline. It is expected that the approval process will be completed by the end of October 2024, depending on the exact date the bill reaches the President's office.

If sanctioned, PL 6120/2019 will represent a major step forward in Brazil's policy for controlling chemical substances, providing greater protection to the population and the environment from the risks of exposure to hazardous products.

On August 29, 2024, Indonesia’s National Agency of Drug and Food Control (BPOM) released a draft amendment to the Regulation Concerning Cosmetic Labeling, Promotion, and Advertising for public consultation which ended on 2 September 2024. The draft amendment includes business obligations and supervision requirements for the labeling, promotion and advertising of cosmetics.  

Draft to Revoke Existing Cosmetic Labeling and Advertising Regulations 

The draft regulation by BPOM is intended to replace several existing regulations related to cosmetic labeling, promotion, and advertising. Specifically, it will revoke the following regulations once enacted: 

• BPOM Regulation No. 30 of 2020 on Technical Requirements for Cosmetic Labeling. 

• BPOM Regulation No. 32 of 2021 on Cosmetic Advertising Supervision. 

• BPOM Regulation No. 12 of 2023 on Supervision of Cosmetic Manufacturing and Distribution, particularly the sections related to cosmetic labeling and advertising, as well as the supervision of labeling for refillable cosmetics. 

This regulation will take effect on the day of its promulgation. This Agency Regulation will be promulgated by the person in charge by publishing it in the Republic of Indonesia's State Gazette to ensure that everyone is aware of it. 

Comprehensive Labeling Requirements  

The amendment sets out detailed requirements for product labeling, including the following information:  

• Product name  

• Usage  

• Composition  

• Country of origin  

• Full name and address of the Notification Number Owner  

• Batch number  

• Size, content, or net weight  

• Expiration date  

• Notification number  

• 2D barcode  

• Warning and/or caution  

• Benefits or uses   

In addition businesses may include a halal label on the packaging, provided they own the product’s notification number.  

Clear Guidelines for Refillable Cosmetics  

The draft also addresses   

refillable cosmetics, which are cosmetics that are repackaged in containers according to consumer requests made at cosmetic refill facilities. The labeling for refillable cosmetics must include at least the following information:   

• Product name  

• Notification number  

• Name and address of the cosmetic refill facility  

• Batch number  

• Refill date and expiration date  

Promotion and Advertising Rules  

Advertising is a promotion in the form of a communication message regarding cosmetics and/or refillable cosmetics and/or cosmetics and/or refill cosmetics brands to the target audience, in the form of images, writing, sound, audiovisual or other forms delivered by various means for marketing and/or trade of cosmetics and/or refill cosmetics.  

Promotion and advertising may only be carried out for cosmetics that have obtained a distribution permit in the form of a notification from the Head of the Agency. Promotional and advertising publications must be in accordance with the data and information contained in the notifications and comply with advertising ethics.  

On October 25, 2024, the Ministry of Health (MINSA) of Peru issued Ministerial Resolution No. 733-2024/MINSA, introducing crucial updates to Annexes I, II, and III of the "Regulation on Permissible Exposure Limits for Chemical Agents in the Work Environment," initially established by Supreme Decree No. 015-2005-SA. The existing regulation (D.S. No. 015-2005-SA) outlines acceptable exposure limits to chemical agents in workplaces across Peru, ensuring workers are not exposed to harmful levels of hazardous or carcinogenic chemicals. The recent updates are in response to scientific and technological advancements and aim to enhance protections based on the latest health and safety research.

The updated annexes classify permissible exposure limits for various chemical agents to which workers may be exposed, prioritizing quantitative evaluation and control measures, especially for substances primarily absorbed through inhalation. The revisions include newly identified hazardous substances, refined exposure limits, and updated toxicity thresholds, aligning them with global standards.

The new permissible exposure limits will apply to all work environments where chemical or carcinogenic agents pose potential health and safety risks. This update obligates employers to adopt stricter control measures, implement adequate personal protective equipment (PPE), and ensure continuous monitoring of hazardous substances.

The full details of the Ministerial Resolution are available at: Resolution No. 733-2024/MINSA

On 7 October 2024, the South African Minister of Forestry, Fisheries and the Environment (DFFE) introduced new regulations aimed at creating a national framework for compliance with the Rotterdam Convention. These regulations specifically address the Prior Informed Consent (PIC) procedure, which requires countries to be informed and consent before hazardous chemicals are traded internationally. 

Department of Forestry, Fisheries and the Environment  

The DFFE is dedicated to ensuring that all South Africans have the right to a healthy environment. Focusing on sustainability and conservation, the DFFE leads efforts in responsible environmental management, protecting resources for present and future generations. Through these initiatives, the Department aims to promote the wellbeing of communities while contributing to global environmental protection.  

New National Regulations for Trade in Hazardous Chemicals under the Rotterdam Convention  

The National Environmental Management Act (Act No. 107 of 1998) empowers the South African government (DFFE) to regulate the trade of certain chemicals. The new regulations create an appropriate regulatory framework, outlining general prohibitions, notification procedures for chemical commerce, record keeping, and reporting requirements. 

Key Points on New National Regulations for Hazardous Chemicals Trade 

Scope: The regulations apply to chemicals subject to notification under the Rotterdam Convention, covering general prohibitions, notification procedures, record keeping, and reporting. 

Application: The regulations apply to chemicals that are banned or severely restricted as listed in Annexure I. 

Purpose of the Regulations:   

• To implement the provisions of the Rotterdam Convention for hazardous chemicals and pesticides in international trade. 

• To outline the Prior Informed Consent (PIC) procedure for chemicals listed in Annexure I. 

• To promote cooperation in the international movement of chemicals to protect human health and the environment. 

• To facilitate the exchange of information on the safe use of chemicals and ensure international communication of import/export decisions. 

• Exempt chemicals not exceeding 10 kg per year, per country, per chemical. 

Notification Process:   

• Notification Requirement: Importers must notify South African authorities annually of imports from Annexure I, including a Safety Data Sheet (SDS). 

• Documentation: The authorities may request additional documentation after receiving the export notification. 

• Export Notification Form: Complete the official form from Annexure II with the required information. 

• Acknowledgment: The authorities will acknowledge receipt within 10 working days. 

• Processing and Decision Making: Authorities will review notifications and decide whether to grant or deny consent based on the validity of licenses or permits. 

Record Keeping and Reporting:   

• Keep detailed records of quantities, sources, intended use and import/export dates for at least five years. 

• Provide personal and contact details for intended use where applicable. 

• Submit actual amounts imported or exported and customs documents by the end of March each year. 

Penalties for non-compliance :

•  Non-compliance with specific regulations can lead to fines of up to 5 million Rand for first offences and penalties of up to 10 million Rand or imprisonment for subsequent offences. 

Updating of Annexure: Annexure I will be reviewed every two years to align with the Rotterdam Convention. 

Information of Transmission:  The South African Designated National Authority (DNA) must inform the Rotterdam Convention Secretariat of any new regulatory actions within 60 days. 

Repeal of Laws: Previous regulations are repealed, with the new “Prior Informed Consent Procedure Regulations, 2024” taking effect 120 days after publication. 

Prohibition: No import or export of Annexure I chemicals without prior consent under these regulations. 

 Annexes: 

• Annexure I: List of chemicals requiring notification. 

• Annexure II: Rotterdam Convention export notification form. 

 Conclusion 

These new regulations for hazardous chemicals trade represent a significant step towards aligning South Africa's practices with the Rotterdam Convention. By establishing a comprehensive framework for notification, record keeping, and compliance, the DFFE aims to enhance the protection of the environment and public health. These regulations will promote responsible trade in chemicals and ensure that both domestic and international stakeholders are informed and involved in decision-making processes. 

On 2 October 2024, the Jordan Standards and Metrology Organization (JSMO) notified the World Trade Organization (WTO) of a draft standard for the labelling of chemical substances. The second edition of the draft standard, DJS 990:2024, is expected to be adopted on 30 December 2024. 

Previously, Jordan had not formally adopted the Globally Harmonized System of Classification and Labelling of Chemicals (GHS). However, this new standard mandates labelling in accordance with the provisions of the 8th revised edition of the UN GHS and the European CLP Regulation (EC 1272/2008). As a Middle Eastern country, this move marks a significant step towards Jordan’s full implementation of the GHS. 

Jordanian Technical Regulation 119/2022 

Earlier in 2022, the Jordan Standards and Metrology Organization (JSMO) enacted Technical Regulation 119/2022, which outlines the specific requirements for labelling products that are sold or imported into Jordan.  

Scope of DJS 990:2024 

The DJS 990:2024 standard applies to all chemical substances and mixtures, excluding radioactive substances and mixtures, as well as veterinary medicinal products, food or feeding stuffs, cosmetic products, and medical devices. 

Insights from the New Labelling Standard 

As per the draft standard, DJS 990:2024, the label should be in both Arabic and English. The main elements that need to be included on the label are as listed below but more information can be found in standard here. 

• Country of origin and contents 

• Chemical identifier 

• Hazard and precautionary statements 

• Signal word 

• Hazard class and pictogram 

Label and Pictogram Dimensions 

The recommended dimensions for the label and pictogram, depending on the volume of the package are given in the table below. 

Comment Period and Enforcement Date 

The draft is currently open for comment. Stakeholders are invited to comment until 1 December 2024. The standard will come into force on 1 June 2025.