GPC Newsletter Oct-2024

The Department of the Environment, under the authority of the Canadian Environmental Protection Act, 1999, has issued a notice regarding the upcoming implementation of regulations to address benzene emissions from petrochemical facilities in Sarnia, Ontario.

In February 2024, the Minister of the Environment and the Minister of Health published the proposed Reduction in the Release of Volatile Organic Compounds (Storage and Loading of Volatile Petroleum Liquids) Regulations in the Canada Gazette, Part I. In order to expedite the application of certain provisions of these proposed regulations, the Minister of the Environment has issued the Interim Order Respecting Releases of Benzene from Petrochemical Facilities in Sarnia, Ontario under subsection 94(1) of the Act.

As required by subsection 94(5) of the Act, the Ministers must, within 90 days, publish a statement indicating whether they intend to recommend that a regulation with the same effect as the Interim Order be made under section 93. This notice confirms that the Minister of the Environment and the Minister of Health intend to recommend to the Governor in Council that a regulation be made to mirror the effects of the interim order under the Canadian Environmental Protection Act, 1999.

Next Steps

The final version of the Reduction in the Release of Volatile Organic Compounds (Storage and Loading of Volatile Petroleum Liquids) Regulations is expected to be published in the Canada Gazette, Part II, in the winter of 2024-2025. Once finalized, these regulations will require petrochemical facilities to equip storage tanks containing high benzene content with emission controls within specified timeframes. The regulations will apply specifically to standalone petrochemical facilities.

During the 60-day public consultation period from February to April 2024, the Government of Canada gathered input on the proposed regulations from a diverse group of stakeholders, including provinces and territories, industry representatives, Indigenous communities, non-governmental organizations, and the general public. The feedback received is being carefully considered in the development of the final regulations to ensure that they effectively address environmental and public health concerns.

Commitment to Environmental Protection

This initiative underscores the Canadian government's dedication to reducing harmful emissions and protecting both the environment and public health. By targeting releases of benzene - a known hazardous air pollutant - the forthcoming regulations aim to improve air quality and reduce health risks associated with exposure to volatile organic compounds in the Sarnia region.

On September 6, 2024, the U.S. Environmental Protection Agency (EPA) issued an Enforcement Alert under the American Innovation and Manufacturing Act (AIM Act), aimed at phasing down the production and consumption of hydrofluorocarbon (HFC). The Alert highlights common compliance issues with bulk HFC imports and recent enforcement actions and urges companies to follow regulations to avoid potential penalties and support efforts to address the climate crisis.

AIM Act:

The AIM Act, enacted on December 27, 2020, mandates an 85% phasedown of hydrofluorocarbons (HFCs) from historical baseline levels by 2036. EPA is authorized to limit production, consumption, and imports of HFCs; facilitate the transition to next-generation technologies; and minimize releases from equipment that uses HFCs. To implement this, EPA will issue transferable HFC production and import allowances (which producers and importers of HFCs must hold in quantities equal to the amount of HFCs they produce or import). The rule sets baselines, establishes allowance allocations, and outlines recordkeeping and compliance measures. Between 2022 and 2050, this phasedown is expected to prevent the emission of 4,560 million metric tons of HFCs in the U.S. Violations of the requirements established in the AIM Act may be subject to administrative, civil, or criminal enforcement actions. 

Hydrofluorocarbons:

Commonly used in air conditioning, refrigeration, fire suppression, solvents, foam blowing agents, and aerosols, HFCs are potent greenhouse gases with global warming potentials (GWPs) hundreds to thousands of times higher than CO2. Their global use has surged due to the phaseout of ozone-depleting substances and increasing demand for cooling. However, lower GWP alternatives, including non-fluorinated options and HFC blends, are available or under development. EPA’s efforts under the AIM Act contribute to a global HFC phasedown, which could reduce global warming by up to 0.5°C when fully implemented.

Updates:

In fiscal year 2024, EPA has completed nine civil settlements addressing unlawful imports of hydrofluorocarbons (HFCs), including recent actions against five companies. These companies imported HFCs without proper allowances, in violation of the AIM Act. The cases prevented emissions equivalent to more than 24,000 metric tons of CO2, comparable to the annual electricity use of 14,000 homes. The companies will pay a total of $115,551 in penalties. Additionally, criminal enforcement actions have been initiated this fiscal year.

If you suspect illegal HFC imports, please report them to the EPA through its Report Environmental Violations webpage.

On September 5, 2024, the U.S. Environmental Protection Agency (EPA) issued a direct final rule delaying the start of the reporting period for the October 2023 PFAS reporting rule under the Toxic Substances Control Act (TSCA). Originally set to begin on November 12, 2024, the reporting period is now postponed until July 2025 due to resource constraints.

Background:

Under section 8(a)(7) of the Toxic Substances Control Act (TSCA), a reporting rule mandated by the FY2020 National Defense Authorization Act requires all manufacturers, including importers, of per- and polyfluoroalkyl substances (PFAS) and products containing PFAS since 2011 to report detailed information to EPA. This includes data on chemical identity, uses, production and processing volumes, byproducts, environmental and health effects, worker exposure, and disposal practices.

The 2023 reporting rule would have provided EPA, its partners, and the public with the largest dataset on PFAS manufactured and used in the U.S., a critical step in the agency’s PFAS Strategic Roadmap. This data will help EPA and state, local, and Tribal governments understand the uses and quantities of PFAS and support efforts to research, monitor, and regulate these chemicals. However, due to long-standing resource constraints, including a $5 million budget cut in FY 2024, EPA's program has delayed implementation of the rule and reduced its IT operating budget, impacting key initiatives and contractual support for data collection systems.

Due to delays, the agency's software application for collecting PFAS data will not be ready by the originally scheduled November 2024 opening date, making it impossible for submitters to begin submitting data by that date.

Proposed rule:

The proposed rule aims to adjust the data submission timeline by opening the submission period on July 11, 2025, when the Agency anticipates its software reporting application will be fully operational. Most reporters will be required to complete their submissions by January 11, 2026. However, small businesses that report only on the import of articles containing PFAS will have until July 11, 2026, to submit their reports.

To assist those affected by this rule, EPA has made guidance materials available on its website. EPA plans to launch a new guidance webpage on the TSCA GuideME database in the coming months, which will feature additional resources such as video tutorials, fact sheets, and other electronic reporting tools to help with compliance. EPA is also accepting public comments on both the direct final rule and the proposed rules until October 7, 2024, during a 30-day comment period.

The European Commission has that two substances, N,N-dimethylacetamide (DMAC) and 1-ethylpyrrolidin-2-one (NEP), will be added to the Authorisation List (Annex XVII) of the REACH Regulation (Regulation (EC) No 1907/2006) by a new Commission Regulation which will impose significant restrictions on their use. These measures aim to protect the health of workers by addressing the risks associated with exposure to these chemicals.

This Commission Regulation was notified to the World Trade Organization (WTO) on 30 July 2024 and the notification is open for comments for 60 days.

About the Substances

DMAC (CAS No 127-19-5) and NEP (CAS No 2687-91-4) are widely used solvents with various industrial applications, including the production of man-made fibres, films, coatings and chemicals. Both chemicals are classified as toxic to reproduction, based on developmental toxicity studies, making their exposure a particular concern for workers in industries where they are used. NEP is also widely used in cleaning agents, oil field operations and polymer processing.

Proposed Restrictions

The new Regulation imposes strict restrictions on the market availability and use of DMAC and NEP. Specifically, these substances cannot be placed on the market or used in concentrations equal to or greater than 0.3 % unless manufacturers update safety reports and ensure compliance with Derived No-Effect Levels (DNELs). The DNELs for DMAC have been set at 13 mg/m³ for long-term inhalation exposure and 1.8 mg/kg body weight per day for long-term dermal exposure. For NEP, the long-term inhalation DNEL is 4.0 mg/m³ and the dermal DNEL is 2.4 mg/kg body weight per day.

Exposure to DMAC and NEP above these DNELs poses significant risks to the health of workers due to their reprotoxic properties. Prolonged exposure may cause adverse developmental effects, particularly in relation to reproductive health.

Timeline for Compliance

To give industry sufficient time to implement these changes, the Regulation includes a transitional period. For most sectors, the restrictions will come into force 18 months after the Regulation is published in the Official Journal of the EU. However, for the man-made fibres sector, where DMAC is heavily used, the application of the restriction will be postponed for 48 months.

Reasons for the Regulation

The Regulation follows an extensive review process carried out by the European Chemicals Agency (ECHA). Both the Risk Assessment Committee (RAC) and the Socio-Economic Analysis Committee (SEAC) concluded that current measures are not sufficient to reduce the health risks posed by DMAC and NEP. The RAC recommended the proposed DNELs, while the SEAC emphasised the socio-economic benefits of implementing the restriction. The European Commission’s decision also reflects these findings, ensuring that industry prioritises worker safety while adapting to the new requirements.

Conclusion

The inclusion of DMAC and NEP in the REACH Authorisation List is a significant step forward in protecting workers from exposure to harmful chemicals. The transitional periods built into the Regulation will give industry time to comply with the new safety standards, ultimately reducing health risks and ensuring safer working conditions across the EU. The proposed regulation is expected to be adopted in the first quarter of 2025, with the restrictions taking full effect in the following 18 to 48 months.

Today, 19 September 2024, the European Commission adopted new measures under the REACH Regulation to restrict the use of undecafluorohexanoic acid (PFHxA) and PFHxA-related substances, which are a part of the wider group of entire group of per- and polyfluoroalkyl substances (PFAS). These chemicals are highly persistent in water and pose risks to human health and the environment.

Targeted Product Bans Under the PFHxA Restriction

The restriction targets products where risks are not adequately controlled, and bans the sale and use of PFHxA in:

• Consumer textiles such as raincoats

• Food packaging such as pizza boxes

• Consumer compounds such as waterproofing sprays

• Cosmetics such as skin care products

• Firefighting foam applications for training and testing

Other applications such as semiconductors, batteries and green hydrogen fuel cells are not affected by the restriction.

Background on PFAS Chemicals

Per- and polyfluoroalkyl substances (PFAS), often referred to as "forever chemicals", are a large group of synthetic chemicals known for their extreme resistance to degradation in the environment. Due to their unique water- and grease-resistant properties, PFAS have been widely used in various industrial processes and consumer products, including non-stick cookware, waterproof textiles, food packaging and firefighting foams.

However, their persistence means that they accumulate over time in the environment and in living organisms, contributing to widespread contamination of soil and water, including drinking water supplies. This has raised significant concerns about the long-term effects of PFAS on human health, including links to cancer, endocrine disruption and immune system effects.

Key Objectives

The move is part of the EU’s wider effort to reduce PFAS emissions, as PFHxA often replaces the previously banned perfluorooctanoic acid (PFOA). The measure is based on scientific evaluations by the European Chemicals Agency (ECHA) and has been approved by the European Parliament and the Council.

Implementation Timeline

The restriction will enter into force 20 days after its publication in the Official Journal, with transition periods ranging from 18 months to 5 years, depending on the specific use, to allow industry to switch to safer alternatives.

Future Steps

While the current restriction specifically targets PFHxA and related substances, it is separate from the broader EU initiative to address the risks posed by the entire group of per- and polyfluoroalkyl substances (PFAS). The broader PFAS ban is currently being evaluated by the ECHA. This potential ban stems from a 2023 proposal by five European governments - Germany, Denmark, the Netherlands, Sweden and Norway - calling for significant restrictions on all PFAS chemicals due to their persistent environmental and health risks.

On 25 September 2024, the European Union notified the World Trade Organization (WTO) about a Draft Commission Delegated Regulation amending Regulation (EC) No 1272/2008 on classification, labelling, and packaging (CLP) of hazardous substances and mixtures. The Regulation updates Table 3 of Part 3 of Annex VI to the CLP Regulation by introducing and revising the harmonised classification and labelling (CLH) of 32 substances or groups of substances.

Updated Substances

These updates are based on scientific opinions from the European Chemicals Agency’s (ECHA) Committee for Risk Assessment (RAC), which reviewed data on several chemicals. The substances are listed in the table below.

The list of updates with details about hazard classes can be found here. The substances were flagged for potential hazards, such as carcinogenicity, environmental toxicity, or serious health risks, which require stricter regulation in the EU.

Consultation Process 

The proposed changes were informed by public consultations managed by ECHA, where Member States and stakeholders provided feedback. Comments were taken into account in the final RAC opinions. Additionally, expert input was sought through the CARACAL group, which brings together Member States competent authorities responsible for REACH and CLP, as well as industry and regulatory stakeholders.

Main Objectives and Rationale 

The main objectives of the amendments are:

• To ensure the protection of human health and safety.

• Strengthen the protection of the environment by tightening regulations on hazardous substances.

• To facilitate the free movement of substances and mixtures in the EU by harmonising classifications at EU level.

Timeline for Adoption and Application 

The Regulation is expected to be adopted in the fourth quarter of 2024. It will enter into force 20 days after its publication in the Official Journal of the EU, probably in early 2025. A transition period of 18 months is included to allow companies time to adapt their labelling and packaging to the new requirements. However, suppliers will be able to voluntarily apply the new classifications once the regulation enters into force.

Next Steps and Stakeholder Involvement 

Stakeholders are invited to submit comments on the draft Regulation within 60 days of its notification. The final regulation will be shaped by the feedback received during this consultation period to ensure that the amendments address industry concerns while maintaining high safety standards.

Further Resources 

The full text of the Draft Commission Delegated Regulation is available here and the full list of substances is available here.

On 16 August 2024, the UK Health and Safety Executive (HSE) published a bulletin on the export of hazardous chemicals under the Prior Informed Consent (PIC) Regulation. Companies are now invited to submit notifications of their planned exports of PIC chemicals for the year 2025.

Prior Informed Consent

The Prior Informed Consent (PIC) regime in Great Britain (England, Scotland and Wales) regulates the export and import of certain hazardous chemicals on the PIC list. The HSE is the PIC Designated National Authority (DNA) for Great Britain and administers the GB PIC regime including the export notification system and providing information on GB PIC.

Export Notification Requirements

The GB PIC Regulation requires that the first export of a listed chemical to any country in any calendar year must be notified to the HSE at least 35 days before the planned date of export. This includes the transfer of a listed chemical from Great Britain to Northern Ireland. Early notification allows the HSE to process requests and obtain the necessary consent from importing countries.

How to Submit Export Notifications

To submit export notifications, companies should:

• Complete the GB PIC export notification form, available on the HSE PIC website.

• Email the completed form to ukdna@hse.gov.uk.

• Include detailed information in the subject line of the email.

• Attach only one notification form and the relevant safety data sheet (SDS) per email. If available, provide an SDS official language or principal languages of the importing country.

• Describe in detail the intended use of the chemical to ensure proper handling by the importing country authority.

Special Reference Identification Numbers

For exports intended for research or analysis in quantities of 10kg or less, Special Reference Identification Numbers (RINs) are required. These RINs are also required if an importing country has waived its right to receive an export notification. For exports of PIC chemicals to the EU, each Special RIN covers exports of up to 10 kg of the substance for research and analysis purposes to each EU importing country.

Requests for Special RINs for 2025 can now be submitted as follows:

- Complete a Special RIN Request Form or use the BULK Special RIN option for multiple requests.

- Email the form to ukdna@hse.gov.uk with specific details (GB PIC  - Special RIN request - company name – chemical/mixture – importing country name – 2025) in the subject line.

India’s Department of Chemicals and Petrochemicals (DCPC) has extended the enforcement date of the Quality Control Orders (QCOs) for two polymer products. The notifications were published in the Gazette of India on 23 August 2024 in consultation with the Bureau of Indian Standards (BIS) and extend the enforcement dates of the QCOs for Polypropylene (PP) Materials for Moulding and Extrusion and Poly Vinyl Chloride (PVC) Homopolymers. The QCOs were originally published on 26 February 2024 and were due to come into force on 23 August 2024.   

The implementation dates and corresponding standards for the polymer products are as follows:  

The Quality Control Order mandates that the substances concerned to carry the certification mark of the Bureau of Indian Standards, ensuring that the existing rules remain in force until the implementation of the new QCOs.  

On September 13, 2024, the Ministry of Chemicals and Fertilizers issued two important notifications amending the Quality Control Orders (QCOs) related to cement packaging. These amendments are aimed at ensuring safety and quality standards of packaging materials in the industry.

1. Amendment to the HDPE/PP Woven Sacks Order

The Textiles - High Density Polyethylene (HDPE)/Polypropylene (PP) Woven Sacks for Packaging of 50 kg Cement (Quality Control) Second Amendment Order, 2024 (S.O. 3938(E)) has been enacted under the Bureau of Indian Standards Act, 2016.

• Short Title and Commencement:

  • This Order may be cited as the Textiles - HDPE/PP Woven Sacks for Packaging of 50 kg Cement (Quality Control) Second Amendment Order, 2024.

  • It will come into force on the date of publication in the Official Gazette.

• Key Change:
  The commencement date in the original Order has been revised to commence on December 6, 2024.

Note: The Principal Order was published in the Gazette of India, Extraordinary, Part II, Section 3, Sub-section (ii), as S.O. 5178(E) on December 6, 2023, and subsequently amended by S.O. 2181(E) on June 4, 2024.

2. Amendment to the PP Woven, Laminated Sacks Order

The Textiles - Polypropylene (PP) Woven, Laminated, Block Bottom Valve Sacks for Packaging of 50 kg Cement (Quality Control) Second Amendment Order, 2024 (S.O. 3939(E)) has also been introduced.

• Short Title and Commencement:

  • This Order may be cited as the Textiles - Polypropylene (PP) Woven, Laminated, Block Bottom Valve Sacks for Packaging of 50 kg Cement (Quality Control) Second Amendment Order, 2024.

  • It will take effect upon publication in the Official Gazette.

• Key Change:
  Similar to the HDPE/PP sacks, the commencement date in the original order has been revised to take effect on December 6, 2024.

Note: The principal order was published in the Gazette of India, Extraordinary, Part II, Section 3, Sub-section (ii), as S.O. 5179(E) on December 6, 2023, and subsequently amended by S.O. 2182(E) on June 4, 2024.

These amendments reflect the government's commitment to maintaining high standards in cement packaging and ensuring the protection of public interest. Stakeholders are encouraged to consult the official publications for further details.

In a move to strengthen the control over chemicals that can be misused in the production of illicit drugs, China has introduced new regulations that add seven substances to its regulated precursor chemicals list. These substances, including n-phenylpiperidin-4-amine, norfentanyl, and cannabidiol, will be subject to strict oversight from 1 September 2024. The new regulations impact the production, transport, storage, and trade of these chemicals, requiring businesses to adopt tighter compliance measures to align with China's evolving chemical management laws.

Key Points

Overview of the New Substances Added

The seven newly regulated substances include key precursors often used in pharmaceutical and chemical production but with potential for illegal diversion into drug manufacturing. Some notable chemicals include:

• N-phenylpiperidin-4-amine (4-AP): Used in pharmaceutical synthesis, now controlled due to its role in fentanyl production.

• Norfentanyl: A metabolite of fentanyl and a precursor for synthetic opioids.

• Cannabidiol (CBD): Regulated to control non-pharmaceutical uses while allowing research and medical applications under strict supervision.

• Other substances include BMK glycidic acid esters and PMK glycidic acid esters, which are crucial precursors for synthetic drugs such as MDMA and methamphetamine​ (2-methyl-3-phenyl glycidylic acid and its esters, 3-oxo-2-phenybutyric acid and its esters, 2-methyl-3-[3,4-(methylenedioxy)phenyl]glycidyl] glycidyl)

• 1-tert-butoxycarbonyl-4-(N-phenylamino)piperidine which is a precursor to N-phenylpiperidin-4-amine 

Regulatory Framework and Requirements

The Ministry of Public Security, in cooperation with several other agencies, has categorized these substances as Category II precursor chemicals. The key compliance elements include:

• Licensing and Permits: Businesses must obtain licenses to produce, handle, and distribute these chemicals.

• Transportation and Storage: Special approvals are required to transport and store these chemicals to prevent unauthorized access.

• Import and Export Controls: Importers and exporters need to follow specific protocols, including declaring the intended use and obtaining prior approval from the relevant authorities​

Impact on Businesses

The addition of these chemicals to the regulated list creates significant compliance obligations for businesses involved in their manufacture, handling, or distribution. Key impacts include:

• Increased Compliance Costs: Businesses will need to invest in proper documentation, security systems, and monitoring technologies to comply with the new regulations.

• Supply Chain Disruption: Companies handling these substances will face stricter controls on the movement and storage of goods, potentially slowing down operations.

• Enhanced Scrutiny: Regulatory authorities are expected to impose stringent audits and inspections, requiring businesses to maintain comprehensive records of their activities related to these substances​

On August 27, 2024, the National Institute of Chemical Safety (NICS) published Hazard Assessment Results under K-REACH. 

Announcement of Hazard Assessment Results 

In accordance with the Act on the Registration and Evaluation of Chemical Substances, the results of the “Hazard Assessment of Chemical Substances” are published to gather public feedback. This notice is issued in accordance with Article 46 of the Administrative Procedure Act. 

Reason for Revision 

The hazard assessment for registered chemical substances has been completed. The results, including the names, hazards, and toxicity status of these substances, are published. 

Main Content 

A. Notification of Hazard Assessment Results for Registered Chemical Substances 

• New Substances: Examined Substances (Dec 2023 - Mar 2024) - 32 substances, Korean CAS No. 2024-38 to 2024-69 

• Existing Substances: Examined Substances (Apr 2023 - Sep 2023) - 59 substances, Korean CAS No. 2024-463 to 2024-521 

Note: New substances registered between Jun 2023 and Aug 2023. 

This public announcement is made including chemical substances that have secured additional data, such as change registration, and substances that require further review within the same period.

B. Revision of Previously Announced Chemical Substances 

• New Substances: 25 substances were revised for toxicity, name corrections, and hazard information. 

• Existing Substances: 2 substances were revised for hazard information and correction of misinformation. 

Submission of Opinions 

Individuals and organizations are invited to submit their opinions on this Notice by September 19, 2024. Please include: 

• Itemized opinions on the Notice (modifications and reasons). 

• Name, address, and telephone number (for organizations, include the representative’s name). 

Submit to the Director General of the Chemical Safety Agency (Chemical Registration and Evaluation Team) via: 

• Phone: 032-560-7219 / 8493 

• Fax: 032-568-2038 

On September 3, 2024, Representative Paik Jong-heon proposed a bill to amend the Cosmetics Act. The amendment aims to abolish the current government-led certification system and promote a private self-certification system. The goal is to provide more diverse information on natural and organic cosmetics and to align product selection with consumer demand. 

Reason for Revision 

The existing law allows the government to certify natural and organic cosmetics. Internationally, however, such certification systems are typically managed by the private sector. To align with global standards, Korea needs to move to a market-oriented certification system. As the cosmetics industry evolves and consumer values diversify, the government is seeking to abolish the current certification system to better meet consumer demand for natural and organic products. 

Call for Public Input 

If you have an opinion, please fill in the form and send it to jmhan@kcia.or.kr by September 10, 2024. 

On 30 August 2024, Japan’s Ministry of Health, Labour and Welfare (MHLW) amended the New Chemical Substances List by adding 141 new substances. This update follows the Ministry’s previous notice under the Industrial Safety and Health Act (ISHA) which was published on 27 June 2024 and announced the names for these new chemical substances.

The latest additions to the list include details such as the name, ISHA official gazette serial number, chemical and structural formula for the new chemical substances all of which are available on the MHLW Work Safety Portal. Under the Industrial Safety and Health Act, manufacturers, importers or companies must notify the MHLW before manufacturing or importing such chemicals into Japan. The notification, must include the name and hazard evaluation details of the new chemical substance as this is necessary to safeguard the health of workers at the industrial workplace.

The Role of the Industrial Safety and Health Act (ISHA)

An important part of legislation that aims to protect workers' health, safety, and well-being at work is Japan's Industrial Safety and Health Act (ISHA). The Act, which was established in 1972, uses a variety of safety precautions, rules and employer requirements to prevent workplace accidents and health problems.

New Chemical Substances List

The Existing and New Chemical Substances (ENCS) List covers chemicals imported, manufactured and used in the Japanese market. New substances are those approved after 1974 by the regulatory authorities. These new substances are not yet listed on the ENCS database. There are currently over 72,000 compounds on the list.

On 19 September 2024, Japan’s Ministry of Health, Labour and Welfare (MHLW), Ministry of Economy, Trade and Industry (METI) and Ministry of the Environment (MoE) jointly notified the World Trade Organization (WTO) of a draft proposal to designate three chemicals as Class I Specified Chemical Substances. The three chemicals which were mentioned in the draft are Methoxychlor, Dechlorane Plus and UV-328. 

The Act on the Regulation of Manufacture and Evaluation of Chemical Substances regulates these Class I Specified Chemical Substances, which will be amended to add these three chemicals to the list of Class I Specified Chemical Substances. 

The three Class I Specified Chemical Substances are as follows. 

Background 

Earlier in May 2023, at the 11th Conference of the Parties to the Stockholm Convention on Persistent Organic Pollutants (POPs) these three chemicals were added to Annex A of the Convention which can be accessed here. In reply to this, a consultation regarding these designations was held by the three ministries in December 2023. 

Class I Specified Chemical Substances 

Class I Specified Chemical Substances are defined under Japan's Chemical Substances Control Law (CSCL) as substances that have been determined to be persistent, extremely bioaccumulative, or potentially hazardous to the environment and human health over an extended period of time. Manufacturers and importers are required to obtain a permit before manufacturing or importing certain compounds. 

Exemptions 

This order includes some exemptions for the use of Dechlorane Plus in certain applications. 

Comment Period and Enforcement Dates 

Stakeholders are invited to comment on this draft proposal until 18 November 2024. The enforcement order will be adopted in December 2024 and come into force in February 2024. In addition, the importation of products containing Dechlorane Plus and UV-328 (as listed in the table below) will be banned from June 2025. 

It is time for registered importers or manufacturers who introduced industrial chemicals into Australia for commercial purposes between 1 September 2023 and 31 August 2024 to submit their Annual Declaration to the Australian Industrial Chemicals Introduction Scheme (AICIS). This online declaration confirms that chemical introductions were authorized under the Industrial Chemicals Act 2019.

How to Submit                                                                                   

The Annual Declaration form is available on AICIS Business Services and must be submitted by 30 November 2024. The form requires the selection of the categories that apply to the introductions, ensuring that the chemicals meet the criteria for the selected category.

New for 2023-24: Exempted Categories

This year, if introductions fall under the exempted category, all exempted introduction types that applied must be selected on the form:

• Introductions where the highest indicative risk was very low risk

• Polymers of low concern

• Low-concern biological polymers

• Industrial chemicals solely for research and development

• Manufactured soap

• Chemicals imported and subsequently exported

• Chemicals comparable to listed chemicals

• Polymers comparable to listed polymers

• Chemicals resulting from non-functionalized surface treatment of listed chemicals

For more information on submitting the declaration, please visit the annual declaration page.

The Environment Commission (CMA) took another step towards enhancing chemical safety in Brazil by approving Bill PL 6.120/2019 on 11 September 2024. The Bill establishes the National Inventory of Chemical Substances, which will evaluate and control the risks associated with chemical substances used across the country. Originating from the Chamber of Deputies, the proposal received a positive endorsement from Rapporteur Beto Faro (PT-PA), who had also supported the measure in the Commission on Science, Technology, Innovation, and Information (CCT). In the CMA, Senator Fabiano Contarato (PT-ES) served as an ad hoc rapporteur, presenting Faro’s report. The bill now moves to the Social Affairs Commission (CAS) for final analysis, before being sent to the president for sanction.

Creation of Registry to Protect Health and the Environment

The primary goal of the Bill is to reduce the harmful impacts of chemical substances on both human health and the environment. To achieve this, the Bill establishes a Technical Committee for the Evaluation of Chemical Substances and a Deliberative Committee of Chemical Substances, both composed of experts in environmental science, health, chemistry, trade, and metrology. Additionally, the creation of a Chemical Substances Registry will serve as the foundation for the inventory, creating a publicly accessible database of substances that are imported or produced in Brazil.

Key Provisions and Responsibilities

The Bill outlines the criteria and deadlines for including substances in the registry and assigns responsibilities to manufacturers, importers, and professional users of these chemicals. It also introduces penalties for non-compliance, including warnings, fines, and in severe cases, suspension of the substance’s production along with potential seizure. Fines can vary significantly, ranging from 5% of the minimum wage to up to 40,000 times the minimum wage.

The registry will include information about the producer or importer, the quantity produced, the hazard classification based on Brazilian regulations, and usage recommendations. Manufacturers and importers will have up to three years to submit the necessary information after the registry is made public. For newly produced substances, the deadline will be March 31st of the following year.

Substances produced or imported in volumes of one tonne or more per year will need to be registered. However, certain exceptions apply, including radioactive substances, substances in development, those intended for national defense, and products regulated by specific laws, such as food, medicines, pesticides, cosmetics, fertilizers, and veterinary products.

Intellectual Property Protection and Risk Evaluation

For new substances that require unique studies conducted in Brazil to generate necessary information, the bill grants intellectual property rights for up to 10 years over these studies. Third parties may register a substance only if authorized by the study's owner to access the data.

Substances included in the registry will undergo a risk evaluation process led by the Technical and Deliberative Committees. This evaluation will be based on criteria such as environmental toxicity, carcinogenic potential, and effects on human reproduction. The bill also places restrictions on animal testing, only allowing it when all scientifically reliable alternative methods have been exhausted.

Introduction of New Fees

To finance the regulatory process, the Bill introduces a Registration, Evaluation, and Supervision Fee for Chemical Substances. The specific amounts will be determined by the future regulation. The fee will be charged for the registration of substances, those subjected to risk assessments, and in cases where protection of a substance’s identity is requested due to trade or industry secrecy concerns.

On August 1, the Committee on Science, Technology, and Environment held a workshop at the National Assembly Office Headquarters, to provide input on the updated draft Law on Chemicals. Le Quang Huy, the Committee Chairman, presided over the workshop. As a result, a wealth of information was provided, including how the chemical industry is developed, managed, and used to ensure compliance with existing laws and standards. 

Conference Participants 

The workshop was attended by members of many National Assembly committees, as well as representatives of the Nationality Council and the Committee on Science, Technology, and the Environment.. Mr. Phung Manh Ngoc, Director of the Chemical Department (Ministry of Industry and Trade), delegates, specialists, and scientists, as well as representatives from several other key ministries and branches, were present on the side of the drafting agency of the Chemical Law project. 

Scope of the Updated Law 

The updated Law on Chemicals covers agencies, organizations, and individuals involved in chemical activities within the borders of the Socialist Republic of Vietnam; Vietnamese organizations and individuals; foreign organizations and individuals involved in chemical activities; and individuals investing in and building chemical projects. 

Key Objectives  

Based on political, legal, and practical considerations, the Government suggests to amend the 2007 Law on Chemicals in order to: ensure legal consistency; comply with international treaties to which Vietnam is a party; overcome obstacles and shortcomings in the implementation of the 2007 Law on Chemicals; and concretize the Party’s guidelines on the development of the chemical industry as a fundamental industry that meets the demand for basic manufacturing supplies of the economy and serves industrialization and modernization of the nation. 

The 89 articles that make up the updated draft Law on Chemicals are divided into 10 chapters. The regulatory scope of the Law covers chemical activities, industry development, items containing hazardous chemicals, chemical activity safety, rights and obligations of organizations and individuals engaged in chemical activities, and state administration of chemicals. 

On 2 September 2024, the Tanzania Bureau of Standards notified the World Trade Organization (WTO) of a draft standard (DARS 1721:2024) aimed at regulating recycled polyethylene terephthalate (rPET) used for food contact.  The purpose is to enhance Africa’s internal trade capacity, increase Africa’s global competitiveness in edible oil bottles and food containers and improve the welfare of African communities by ensuring the safety and quality of PET and rPET. The notification is open for comments for 60 days from the date of notification.

African Organization for Standardization

The African Organization for Standardization (ARSO) is an African intergovernmental organization established in 1977 by the United Nations Economic Commission for Africa in collaboration with the Organization of African Unity. The fundamental mandate of ARSO is the development and harmonization of African standards, which is carried out through technical committees. The main task of technical committees is to prepare ARSO Standards. Draft ARSO Standards adopted by the technical committees are circulated to the member bodies for voting. Publication of a draft ARSO Standard requires approval by the maximum number of the member bodies casting votes.

PET and rPET Quality Evaluation

In an effort to ensure consumer safety and quality control, the Draft African Standard (DARS 1721:2024 and DARS  1730:2024) has been introduced to provide detailed specifications for requirements, standard test methods, packaging and migration for polyethylene terephthalate (PET) and recycled polyethylene terephthalate (rPET) as recyclates for bottle, flakes and pellets used in the food contact application product.

Key points of the PET and rPET food contact applications Standard

• Scope: Specifies the requirements, methods of sampling and testing for PET and rPET bottles for edible oils, flakes and pellets used for food contact applications.

• Normative References: Refers to other standards that are requirements of the ISO and ASTM (American Society for Testing and Materials), including standards for labelling, test, and packaging.

• Terms and Definitions: Defines terms used in the document that relate to plastic products mentioned in ISO 472 and 21067, such as rPET, blow moulding, recyclate, etc.

• Requirements: Must meet precise quality criteria, including particle size, color, and contamination limits, as well as specific chemical levels and intrinsic viscosity. It also mandates strict migration limits for overall and specific substances, including heavy metals to ensure safety for food contact applications test.

•  Labelling and Packaging: The document outlines packaging and labelling requirements for PET and rPET bottles, including the need for protective coverings to prevent contamination. Each bottle must be marked with the manufacturer's name, date of manufacture, disposal and safety instructions, country of origin, dimensions, batch number and the rPET symbol. Packaging must also display the food grade symbol or the phrase "for food grade”.

• Sampling: Describes the sampling procedure in accordance with ISO standards.

• Tests: Must include leakage, stacking, drop impact, and storage stability tests as specified in the approved draft method.

• Annexes: Includes detailed procedures for the determination of leakage, stacking and drop impact tests.

Conclusion

In conclusion, the document provides comprehensive guidelines for the manufacture, packaging, and labelling of recycled PET (rPET) bottles to ensure safety and quality. It mandates hygienic packaging conditions, clear labelling with essential details such as the manufacturer’s information, production date, and safety instructions, and requires specific markings for food grade suitability. These measures, including strict migration limits and quality checks for contaminants and physical properties, are designed to ensure that PET and rPET bottles meet safety standards and are suitable for their intended use in food contact applications.

Singapore’s National Environment Agency (NEA) has launched a public consultation on the proposed control of six mercury-added products as hazardous substances. This consultation is part of efforts to comply with its international obligations under the Minamata Convention. The consultation period runs from 19 August 2024 to 19 September 2024.

Background on the Minamata Convention

As a Party to the Minamata Convention, Singapore is committed to protecting human health and the environment from mercury emissions. NEA, as the Competent Authority for this Convention, regulates mercury-added products to ensure that the country meets its international obligations.

Proposed Restrictions on Mercury-Added Products

NEA intends to phase out six mercury-added products based on decisions made at the fifth meeting of the Conference of the Parties (COP-5) in November 2023. The manufacture, import and export of certain fluorescent lamps will be prohibited by 1 January 2027 and 1 January 2028, depending on the product type.

Timeline for the Prohibition

From 1 January 2027, compact fluorescent lamps (CFLs) above 30 watts and certain linear and non-linear fluorescent lamps will be prohibited. By 1 January 2028, the restrictions will be extended to triband phosphor non-linear and linear fluorescent lamps. The legislative amendments are expected by 2026, with a two-year transition period before enforcement.

Call for Feedback

NEA is inviting public feedback on the proposal, requesting clear and concise comments with supporting examples or data. Responses can be submitted via an online form or by email by 19 September 2024. Feedback will be reviewed and taken into account when finagling the regulatory measures.

To take part in the consultation, visit the NEA’s online form or send feedback to the email provided. Full details of the proposaland submission guidelines are available on the NEA website here.

The Environmental Protection Authority (EPA) has announced significant changes to reduce the allowable levels of lead impurities in paint and strengthen the safety requirements for art materials marketed to children. The changes, which will take effect from 1 March 2025, aim to align New Zealand’s standards with international standards and protect public health and the environment from lead exposure.

Updated Regulations on Lead Impurities in Paints

The updated regulations will limit lead impurities in all paints, including corrosion inhibitors, to a maximum of 0.009% (90 ppm). These updates are in line with similar regulations in countries such as the US, Canada and Australia. EPA's decision ensures that even trace amounts of lead in paint are tightly controlled to prevent potential exposure, particularly from old lead-containing paint still found in many homes.

Dr Shaun Presow, EPA's Hazardous Substances Reassessments Manager, stated, "Although modern paints no longer contain lead pigments, we are taking these steps to ensure that New Zealand's regulations are as robust as possible. This change eliminates the risk of lead contamination in new paints".

Stricter Controls on Children’s Art Materials

EPA has also introduced stricter rules for children's art materials, such as crayons and chalk, by including them in the Graphic Materials Group Standard. These products must now meet strict safety standards to ensure they do not pose health risks from hazardous substances such as lead. The decision also aligns with global regulatory practices by removing the requirement for importers to report lead leaching test results to EPA.

Summary of Key Regulatory Changes (Effective 2025)

• Lead limits in all paints, including corrosion inhibitors, reduced to 90 ppm.

• Manufacturers and importers must provide test results to demonstrate compliance.

• All art materials marketed to children must comply with the Graphic Materials Group Standard, which prohibits hazardous substances such as lead.

• By 1 September 2025, all products that do not meet these new standards must be removed from the market.

These regulatory updates reflect a precautionary approach to minimizing the harmful effects of lead exposure in everyday products, further contributing to a healthier and safer environment.

On 9 September 2024, Ukraine notified the WTO of the adoption of Order No. 661 entitled "On Approval of the Procedure for Labelling of Controlled Substances, Goods, and Equipment". The Order, issued by the Ministry of Environmental Protection and Natural Resources on 10 June 2024, will come into effect on 1 March 2025.

The Order outlines mandatory labelling requirements for ozone-depleting substances (ODS) and fluorinated greenhouse gases (F-GHG), as listed in Annexes 1 and 2 to the Law of Ukraine "On Regulation of Economic Activities with Ozone-Depleting Substances and Fluorinated Greenhouse Gases", as well as goods and equipment containing them.  It aims to increase transparency and compliance and ensure that consumers and authorities are informed about the environmental impact of these substances.

Alignment with EU Regulations

The procedure is based on the requirements of Article 12 of Regulation (EU) No 517/2014 of the European Parliament and of the Council of 16 April 2014 on fluorinated greenhouse gases, which repealed Regulation (EC) No 842/2006. It also follows Commission Implementing Regulation (EU) 2015/2068 of 17 November 2015, which sets out the format of labels for products and equipment containing fluorinated greenhouse gases. This alignment ensures that Ukrainian regulations are consistent with European standards, facilitating compliance for companies involved in international trade.

Scope and Application

The Order applies to companies involved in the import, export or marketing of products containing controlled substances. Items such as refrigeration equipment, air conditioning equipment, heat pumps, firefighting equipment, electrical switching equipment and aerosol sprays are subject to mandatory labelling.

Specific Labelling Requirements

Products containing controlled substances must be labelled with:

- Information confirming the presence of controlled substances.

- The industrial and chemical name of the substance.

- The quantity of the controlled substance in kilograms and its potential ozone depleting and global warming potential equivalents in tonnes.

For substances intended for special uses, such as military or semiconductor applications, additional text is required, including phrases such as "For disposal only" or "For use in military equipment only".

Packaging and Marking Guidelines

Labels must be durable, clearly legible and placed in visible locations on the product, i.e. near service ports used for filling or collecting of controlled substances or on the part of the product or equipment that contains the controlled substances. Recycled or regenerated substances shall be labelled "100% recycled". For products below 125 ml, this information may be included in the accompanying documentation in lieu of direct labelling.

Implementation and Supervision

The Order, which was registered with the Ministry of Justice on 7 August 2024, will come into force six months after its publication, on 1 March 2025, and its implementation will be overseen by the Department of Industrial Pollution Prevention and Climate Policy.