GPC Newsletter Sep-2024

On August 10, 2024, the Government of Canada,, announced plans to amend the Domestic Substances List under the Canadian Environmental Protection Act (CEPA) of 1999 by unmasking the identities of 198 substances currently listed under Part 3 with confidential status. The Minister of the Environment intends to make these changes to enhance transparency and accountability in the management of chemicals.

Public Engagement and Comment Period

The proposed order, which includes the currently masked names and confidential accession numbers of these substances, has been released for public comment. Stakeholders and the general public have 60 days from the publication of the notice to provide feedback or raise objections. Those wishing to object to the unmasking must submit an application with a masked name that adheres to the Masked Name Regulations and provide a solid justification based on CEPA guidelines.

Confidentiality Considerations

Parties submitting information under this process may request that their information remain confidential. Any such request must identify the data to be kept confidential and provide a justification consistent with CEPA's confidentiality criteria under subsection 313(2).

Next Steps in the Regulatory Process

Following the public consultation period, the feedback received will be reviewed and considered before the order is finalized. Once finalized, the amendments will be published in the Canada Gazette, Part II, and will officially come into force upon registration. The amendments aim to align with Environment and Climate Change Canada’s 2018 initiative to balance transparency with the protection of confidential business information. This move is part of a broader strategy to ensure a more transparent chemicals management framework in Canada, in line with the amendments introduced by Bill S-5, the Strengthening Environmental Protection for a Healthier Canada Act, which became law in June 2023.

Summary of the Proposed Changes

The proposed changes will remove 198 substances from Part 3 of the Domestic Substances List and add them to Part 1 under their Chemical Abstracts Service Registry Numbers. These substances have been listed confidentially on the DSL since 2004 or earlier. The changes support Canada's ongoing commitment to increase transparency and public awareness of substances on the Canadian market, while protecting proprietary business information.

On July 30, 2024, the U.S. Environmental Protection Agency (EPA) published preliminary 2023 Toxics Release Inventory (TRI) data, covering chemical releases, waste management, and pollution prevention from more than 20,000 facilities nationwide. This year, 21 new chemicals were added to the TRI list, including nine per- and polyfluoroalkyl substances (PFAS), following the requirements of 2020 National Defense Authorization Act (NDAA).

Introduction

The Toxics Release Inventory (TRI) monitors the disposal and management of hazardous chemicals to protect human health and the environment. U.S. facilities must annually report the quantities of these chemicals they release, recycle, or treat, along with their waste reduction practices. TRI tracks chemicals that have been linked to cancer, serious health issues, or major environmental damage. The current TRI list includes 794 chemicals and 33 chemical categories.

General Information on the 2023 Preliminary Data

The 2023 preliminary data were reported by facilities in relevant industries that manufactured, processed, or used TRI-listed chemicals in quantities exceeding threshold limits during the year. This data enables the public to:

• Determine the number of TRI facilities operating in specific areas, such as ZIP codes.
• Identify the types and quantities of chemicals managed by these facilities.
• Discover whether any facilities have taken pollution prevention measures in the past calendar year.

While the preliminary data have not yet been fully vetted through the TRI data quality process, the TRI-MEweb reporting software used by facilities includes automated checks to reduce errors. EPA is also performing additional quality reviews to address potential issues and will follow up with facilities as needed. A revised dataset incorporating late and updated submissions will be published in October. This updated data will be used to develop the 2023 TRI National Analysis, which is expected to be released in early 2025.

PFAS-Related Information from the 2023 Preliminary Data

Preliminary data show that facilities handled more than 1.5 million pounds of PFAS-related waste in 2023. In response, EPA has finalized a rule requiring more comprehensive reporting of PFAS by removing previous exemptions for low concentrations. The expanded reporting of PFAS quantities is expected to start with the 2024 TRI data.

Newly Reportable PFAS for the Reporting Year 2023 include:

On 29 July 2024, the California Department of Public Health (CDPH) published its updated reportable ingredients list (RIL) for cosmetics, adding 29 new ingredients to the list.

Reporting Requirements under California Cosmetics Legislation

The California Safe Cosmetics Act of 2005 mandates manufacturers to report products containing carcinogenic ingredients to the CDPH. The Cosmetic Fragrance and Flavor Ingredient Right to Know Act of 2020 mandates reporting of certain fragrance allergens after 1 January 2022.

Fragrance Allergen Reporting Thresholds

Fragrance allergens must be reported when present in a rinse-off cosmetic product at a concentration at or above 0.01 percent (100 parts per million) or in a leave-on cosmetic product at a concentration at or above 0.001 percent (10 parts per million).

California Safe Cosmetics Program Chemical List

The California Safe Cosmetics Program (CSCP) has developed a list of chemicals, including those reportable under the CA Safe Cosmetics Act and the Cosmetic Fragrance and Flavor Ingredient Right to Know Act. The list is available here as a downloadable spreadsheet and includes a fourth tab labelled "Summary of Updates" which shows all ingredients that have been added to or removed from the RIL since the last update.

Manufacturers of cosmetic products in California must report fragrance allergens in Annex III of EU Cosmetics Regulation No. 1223/2009, as required by EU Detergents Regulation No. 21 648/2004, by 2026 or 2028 at the latest, or at any time.

Manufacturers must disclose identified allergens to the California Department of Public Health by the deadlines set by EU law, which are 2026 or 2028, but manufacturers may submit earlier.

The European Commission is seeking public feedback on a draft delegated regulation amending Regulation (EU) 2019/1021, to include UV-328 in the list of persistent organic pollutants (POPs). The aim of the Regulation is to protect human health and the environment by restricting or prohibiting the use of substances listed under the Stockholm Convention on POPs.

The draft Regulation is open for public feedback from 30 July to 27 August 2024. The Commission encourages public feedback, which will be taken into account when finalising the Regulation. Feedback can be submitted via the European Union’s official website.

Decision to Include UV-328

At the eleventh meeting of the Conference of the Parties to the Stockholm Convention (COP11) in May 2023 in Geneva, Switzerland, it was decided to add UV-328 to Annex A of the Convention, with specific exemptions. This amendment requires the inclusion of UV-328 in Annex I of Regulation (EU) 2019/1021. This decision is reflected in the draft Delegated Regulation.

UV-328 is a chemical compound widely used as a UV stabilizer in various plastic and rubber products to prevent degradation from ultraviolet light. Its full chemical name is 2-(2H-Benzotriazol-2-yl)-4,6-di-tert-pentylphenol (CAS No 25973-55-1).

Consultation Process to Date

The Commission consulted with experts from all Member States and relevant stakeholders, including the chemical industry and civil society, at meetings held on 14 June 2023, 29 November 2023 and 7 June 2024. In addition, the European Chemicals Agency (ECHA) conducted a call for information from 31 May to 18 August 2023. Feedback highlighted the need for specific exemptions for articles containing UV-328 imported into the Union.

Proposed Exemptions and Restrictions

The proposed Regulation includes specific exemptions for the use of UV-328 in certain articles, such as mechanical separators in blood collection tubes, polarisers, photographic paper and spare parts for land-based motor vehicles. These exemptions are intended to allow the continued import and use of these articles until suitable alternatives are found. A limit of 1 mg/kg is also proposed for UV-328 as an unintentional trace contaminant in substances, mixtures and articles. Details of the exemptions can be found in the Annex to the draft Delegated Regulation here.

Next Steps

The Regulation will enter into force on the twentieth day following its publication in the Official Journal of the European Union and will apply from 26 February 2025.

For more details and to participate in the consultation process, please visit the European Commission's official website here

An EU initiative will ban the use of Bisphenol A (BPA) in food contact materials in 2024. The EU is set to ban BPA in food contact materials such as packaging and kitchenware. The decision follows a scientific assessment by the European Food Safety Authority (EFSA), which identified potential harmful effects of BPA on the immune system.  

The ban, which was endorsed by Member States after public consultation and discussions, will phase out BPA in items such as coatings of metal cans and reusable plastic bottles. There will be limited exemptions for cases with no safe alternatives, allowing the industry time to adjust and minimizing disruptions.  

European Food Safety Authority on BPA 

Bisphenol A (BPA) is a chemical commonly used in plastics and resins, such as polycarbonate plastics for water dispensers and epoxy resins for can linings. BPA can migrate into food and drink, prompting regular safety reviews by EFSA.  

EFSA’s recent re-evaluation, which considered over 800 new studies since 2013, found potential health risks from BPA, including effects on the immune system, reproductive health and metabolism. The new assessment significantly lowered the tolerable daily intake (TDI) for BPA from 4 micrograms to 0.2 nanograms per kilogram of body weight, a reduction of about 20,000 times. 

The findings suggest that average and high exposures to BPA exceed the new TDI, indicating potential health concerns. EFSA's advice, based on extensive consultation and collaboration with other scientific bodies, will guide EU lawmakers in setting regulatory measures to protect consumer health,.  

Commission Adoption 

On 12 June 2024, EU Member States agreed on the European Commission’s proposal to ban BPA, based on EFSA’s scientific assessment. The proposal will be formally adopted by the European Parliament and the Council following a scrutiny period and will enter into force at the end of 2024.  

On 26 July 2024, the Department of Chemicals and Petrochemicals (DCPC), the statutory body of the Government of India notified the Quality Control Order (QCO) for Vinyl Sulphone to the World Trade Organization (WTO). 

Background on Vinyl Sulphone 

Vinyl Sulphone is an organic chemical used in the production of reactive dyes. These dyes are used in the textile industry to colour fabrics. Vinyl Sulphone-based reactive dyes are also used in paints, plastics, rubber, and pigments. Earlier in August 2023, the Bureau of Indian Standards (BIS) released the specifications for Vinyl Sulphone in the applicable Indian Standard IS 18340:2023. 

Requirements for Vinyl Sulphone 

As per the Indian Standard IS 18340: 2023, Vinyl Sulphone must meet the requirements given in Table 1. 

These requirements must be met when tested according to the methods prescribed in the standard. 

Compliance Strategy 

Chemicals intended for export are exempt from this order. In accordance with the Bureau of Indian Standards (Conformity Assessment) Regulations 2018, specifically Scheme I of Schedule II, all chemicals must adhere to the relevant Indian Standard, IS 18340: 2023, and bear the BIS Standard Mark upon the acquisition of a BIS product certification licence. 

Comments and Enforcement 

The draft is currently open for comments, which will close on 24 September 2024. As it is only a draft, the Vinyl Sulphone (Quality Control) Order, 2024 will come into force six months after it is published in the Official Gazette. 

India’s Central Drugs Standard Control Organization (CDSCO) announced a major improvement to the registration and import procedure for cosmetics on August 9, 2024. Companies submitting applications through the online portal SUGAM will be restricted to 50 products per application under the new policy, but numerous applications can be submitted. This policy was developed in order to handle and dispose of applications within the timeframe specified by the Cosmetic Regulations of 2020.

The proposed restriction took effect on August 16, 2024. All stakeholders are asked to take note of this change when submitting applications via the SUGAM online site.

For further details, please refer to the official CDSCO announcement.

Recent notifications published in the Gazette of India by the Ministry of Consumer Affairs, Food and Public Distribution have announced the adoption of new standards for a  number of substances with specific transition periods for implementation. 

Adoption of Standards for Seven Substances 

Two notifications were issued on 15 July 2024, detailing the adoption of new standards for eleven substances on 11 July 2024. The existing standards for these substances will continue to apply until 11 October 2024. 

Standards Introduced for Eleven Additional Substances 

In addition, a notification published on 6 August 2024 confirms that new standards for seven substances were adopted on 22 July 2024. To ensure a smooth transition, the current standards for these substances will remain in force until 22 January 2025. 

Transition Periods to Facilitate Compliance 

These phased transitions are designed to give industry and stakeholders sufficient time to adapt to the new regulations, ensure compliance and minimize potential disruptions. 

List of Covered Substances 

The substances covered are: 

On July 8, 2024, China’s National Institute for Food and Drug Control (NIFDC) released the "Technical Guidelines for Compatibility Testing and Evaluation of Cosmetics and Packaging Materials". These guidelines aim to enhance regulatory oversight by ensuring that cosmetic products maintain their safety, effectiveness, and stability, and prevent adverse interactions with packaging materials. By evaluating compatibility, potential risks are identified and mitigated, preserving the quality and functionality of cosmetic products throughout their shelf life. This news highlights the key points, evaluation procedures, and results as outlined in the guidelines.

Key Indicators

• Extractables: These are substances present in packaging materials that can be extracted using solvents, such as additives, residual monomers and degradation products.

• Leachables: These are substances that migrate from packaging materials into cosmetics during migration tests or are generated during testing.

Evaluation Procedure

1. Preliminary Data Collection:

• Identify the packaging materials that come into direct contact with the cosmetics.

• Analyze the composition of these materials and understand the conditions under which they interact with the cosmetics.

• Review theproduction process of the cosmetic.

2. Extraction Test:

• Obtain information on extractables to predict potential leachables.

• Choose extraction solvents with properties similar to those of the cosmetic.

• Conduct extraction under conditions that mimic the cosmetic processing environment to extract as many substances as possible.

3. Interaction Study:

• Assess the migration or reaction of packaging components into cosmetics under accelerated and long-term stability test conditions to obtain information on leachables.

4. Evaluation Conclusion:

• Perform a safety assessment of the leachables.

• Determine if the packaging material is suitable for use with the cosmetic.

Critical Parameters/Indicators

1. Extraction Test:

• Solvent selection should consider compatibility with the cosmetic, focusing on pH, polarity and ionic strength.

• Extraction conditions should mimic the processing conditions of the cosmetic.

2. Migration Test: Determine key indicators based on the type of packaging material:

3. Adsorption Test: Conducted if necessary to further assess interaction.

Results

The results are based on the analysis of extractables and leachables obtained from the tests. The types and quantities of leachables are identified, and their safety is evaluated. If the leachables fall within the limits specified in the Cosmetic Safety Technical Specification, the packaging material is deemed suitable. For substances without specified limits, a safety risk assessment ensures that they do not cause harm to human health under normal conditions of use. Stability tests further support the evaluation of the interaction between the cosmetic and the packaging materials, ensuring that the quality and safety of the cosmetic is maintained.

This structured approach ensures comprehensive assessment and compliance with safety standards, safeguarding consumer health and maintaining product integrity.

For more GPC information in Chinese, follow us on WeChat:

On 24 July 2024, GB 30000.1-2024 "Specification for Classification and Labelling of Chemicals—Part 1: General Rules" was officially published on the National Public Service Platform for Standards Information. This updated standard, which aligns with the eighth revised edition of the Globally Harmonized System of Classification and Labelling of Chemicals (GHS 8), will come into force on 1 August 2025 and will replace the existing GB 13690-2009 "General Rules for the Classification and Hazard Communication of Chemicals."

Draft Release and Public Consultation

On 12 March 2024, China's Ministry of Industry and Information Technology (MIIT) released a draft of the revised standard GB 30000.1. This update aims to align China's chemical classification and labelling standards with the UN's GHS 8. Public comments on this draft were invited until 12 April 2024.

Key updates to GB 30000.1

The revised GB 30000.1 introduces significant updates and new categories:

• Terminology and Definitions: Consistency with GHS 8 ensures clear, internationally recognized terminology.

• Hazard Classification: Adds a new category for desensitized explosives, bringing the total number of hazard classes in China to 29.

• Labeling Requirements: Special provisions are made for labeling, particularly for metals and alloys in non-dispersible forms. GHS labels must be used in workplaces, with alternative methods like area-specific labels allowed.

• Safety Data Sheets (SDS): Updated SDS requirements include detailed hazard communication guidelines and cut-off values for different hazard categories.

Exemptions

Certain products, such as pharmaceuticals, food additives, cosmetics, and pesticide residues in food intended for ingestion, are exempt from these labeling requirements unless workers are likely to be exposed during transport.

Implementation and Compliance

The revised GB 30000.1 will replace the existing GB 13690-2009 standard. Once adopted, it will better align China's chemical safety standards with international practices, improve hazard communication and ensure safer handling and transportation of chemicals within China and in international trade.

The adoption of GB 30000.1 is a significant step in enhancing chemical safety and regulatory compliance in China. By aligning with the UN GHS 8, China is demonstrating its commitment to global safety standards, facilitating smoother international trade and improving overall chemical safety management.

For more GPC information in Chinese, follow us on WeChat:  

On June 28, 2024, the National Institute of Chemical Safety (NICS) in South Korea disclosed the results of the hazard assessment of registered chemicals 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. 

Disclosure Targets 

1. Disclosure of information on registered substances for which the hazard assessment has been completed 

- New chemical substances: 37 chemicals that were assessed for hazard between September and November 2023 

- Existing chemical substances: 20 chemicals that were assessed for hazard between January and March 2023 

 
2. Change of information according to additional data such as registration of changes, etc. Re-disclosure of necessary substances 

- 32 new substances  

- 36 existing substances (35 substances reflecting the unique number of toxic substances) 

The list of the results can be found here. 

On July 15, 2024, Rep. Lim I-ja of the People Power Party introduced a bill to amend the ‘Act on the Registration and Evaluation of Chemical Substances’ (K-REACH). This bill aims to allow the use of organoids - artificial organs made from stem cells – in place of animals in experiments. The bill includes provisions for the development and verification of these methods, the establishment of verification and training centres, and the promotion of international cooperation with the OECD. 

Impact on the Biotechnology Industry 

The biotechnology industry is optimistic about the bill and expects it to boost the market for organoids, which are seen as the next generation of bio-industrial technology. The global organoid market is projected to grow significantly, from $1.42 billion in 2023 to $4.38 billion by 2028, with a CAGR of 25.2%. Key players in Korea include CHA Biotech, Cytogen, Gradient, Aligned, JW Shinyak, and T&R Biofab. 

Key Points: 

• Organoids as Animal Substitutes: The bill proposes the use of organoids in place of animals for testing. 

• International Standards: Establishes centres for verification and training to meet international standards. 

• Market Growth: Expected to significantly boost the organoid market, both domestically and globally. 

This bill is poised to create a new ecosystem for the high-tech chemical testing industry, fostering international cooperation and market growth. 

On 16 June 2024, Taiwan closed the comment period for the adoption of the eighth revised edition of the Globally Harmonized System of Classification and Labelling of Chemicals (GHS 8) through the CNS 15030 standard. In order to align with UN GHS 8, the Ministry of Economic Affairs (MOEA) under the Bureau of Standards, Metrology and Inspection (BSMI) of Taiwan is in charge of updating the CNS 15030 serial standards. 21 of the present 29 CNS 15030 series standards will be changed, and a new hazard class for desensitized explosives (CNS 15030-29) will be introduced. 

Similar to China, Taiwan is revising its Chinese National Standard (CNS) to align the GHS framework with GHS 8. Major updates to the CNS 15030 series standards are being worked on in Taiwan, and results are expected by the end of 2024.     

Taiwan transitioning to GHS 8 

Taiwan is currently awaiting the final release of the official standard. Once released, GHS 8 will be adopted in Taiwan and the GHS 4 provisions will be repealed.  

Key Updates to CNS 15030 Standards   

The classification and hazard categories have been updated as follows:  

• Desensitized Explosives: A new hazard class and corresponding new elements for the hazard class and labelling have been added.  

• Flammable Gases: Category 1 has been divided into Category 1A and 1B, with flammable gases, chemically unstable gases and pyrophoric gas classified under Category 1A.  

• Aerosols: Aerosol Category 3 has been added and the name of the class has been changed to ‘Aerosol and Chemicals under Pressure’. The definition of chemicals under pressure has been introduced.  

• Other Revisions: Definitions, classification criteria and OECD testing guidelines for acute toxicity, skin corrosion/irritation and serious eye damage/eye irritation have been revised.   

Previously Taiwan adopted GHS 4  

Since 1 December 2014, Taiwan has been using the fourth revised edition of UN GHS. The Ministry of Labour (MoL) Notice No. 10302007861 of 27 June 2014 and the Environmental Protection Administration (EPA) Notice No. 1030094561 of 10 November 2014, together established the Chinese National Standard CNS 15030: Classification and Labelling of Chemicals, were used to adopt GHS 4. Taiwan has already released 28 CNS standards (CNS 15030-1 to CNS 15030-28) in accordance with GHS 4.   

On 4 July 2024, Japan’s Ministry of Economy, Trade and Industry (METI) and Ministry of the Environment (MOE) jointly notified the World Trade Organization (WTO) of a revision of the Enforcement Order of the Act on Preventing Mercury Pollution of the Environment. This revision updates the list of mercury-added products under Annex A of the Minamata Convention on Mercury. Following the phase-out dates specified in Article 4 of the Minamata Convention, the manufacture of 10 newly added products will be prohibited.  

Currently the draft is open for public comment until 2 September 2024. The revised order will be adopted in October 2024. 

Background on Enforcement Order  

The Enforcement Order which was originally enacted on 11 November 2015 categorizes certain mercury-containing products as specialized goods that require stringent control in accordance with Article 2, Paragraph 1 of the Act on Preventing Mercury Pollution of the Environment. The use of these products as raw materials for the manufacture of other commodities will be restricted. 

Enforcement Dates 

The revised Enforcement Order will come into effect in three phases, starting on 1 January 2026, 1 January 2027 and 1 January 2028 respectively as per the phase-out dates of the Minamata Convention. 

The following products will be subject to the manufacturing ban: 

Rationale 

This strategy will implement the Minamata Convention on Mercury and reduce the risks posed by mercury to human health and the environment. The government will monitor the implementation of the policy and evaluate the long-term effects of these products on the environment and public health. To further contribute to the industry's green transition, the phased prohibition on the manufacture of 10 items will encourage the development and use of low- or no-mercury technology. 

On 1 August 2024, Japan’s Ministry of Health, Labour and Welfare (MHLW), Ministry of Economy, Trade and Industry (METI) and Ministry of the Environment (MOE) jointly released a notice to designate perfluorohexane sulfonic acid (PFHxS)-related chemicals as Class I Specified Chemical Substances. In addition, the notice also specifies a ban on the import of 10 products containing PFHxS-related chemicals. Although there is no deadline for implementation, the ministry stated that more talks will take place after 2025. 

PFHxS designated as Class I Specified Chemical Substances 

The manufacture, import and use of PFHxS-related chemicals will be banned unless deemed needed. PFHxS,,characterised by a branched structure with 6 carbon atoms i.e. perfluoro (hexane-1-sulfonic acid) or perfluoro (alkanesulfonic acid) are derived from compounds with a (tridecafluoroalkyl) sulfonyl group and six carbon atoms. A license is required to manufacture or import these chemicals. 

The Notice provides specific details on the chemicals listed, identified by their CAS numbers: 

Ministry bans import of 10 products containing Class I Specified Chemical Substances 

The following products containing PFHxS-related chemicals will be banned from import: 

1. Fire extinguishers, extinguishing agents for fire extinguishers, and foam extinguishing agents 

2. Etching agents used in metal processing  

3. Surface treatment agents for plating and additives for their preparation 

4. Fabrics treated to impart water- or oil-repellent properties  

5. Clothing treated to impart water- or oil-repellent properties  

6. Floor coverings treated to impart water- or oil-repellent properties  

7. Water-repellent agents, oil-repellent agents, and textile protective agents  

8. Antireflective agents used in semiconductor manufacturing  

9. Etching agents used in semiconductor manufacturing  

10. Resist for semiconductors 

Regulations on the use of Class I Specified Chemical Substances 

According to the Chemical Substances Control Law (CSCL), the use of chemicals is prohibited except for essential use or for testing and research purposes.  

Technical Standards for Handling of Class I Specified Chemicals 

When handling the following products that use Class 1 Specified Chemical Substances, follow the separately prescribed technical handling standards: 

• Fire extinguishers,  

• Extinguishing agents for fire extinguishers 

• Foam extinguishing agents 

Manufacturing Permit 

According to the Notice, manufacturers need to obtain a permit to produce such Class I Specified Chemicals and shall seek permission from the Ministry of Economy, Trade and Industry (METI). The application must include the following details: 

• Name or trade name and address, and in the case of a corporation, the name of its representative 

• Location of business establishment 

• Name of the Class 1 Specified Chemical Substance   

• Structure and capacity of the manufacturing facility. 

After approval of the permit, the manufacturer must immediately notify the Ministry of Environment (MOE). 

Import Permit 

For importers, an import permit is required from the Ministry of Economy, Trade and Industry, with an application containing the following details:  

• Name or trade name and address, and in the case of a corporation, the name of its representative. 

• Name of the Class 1 Specified Chemical Substance. 

• Import quantity 

The Australian Industrial Chemicals Introduction Scheme (AICIS) has announced changes to fees and charges for the 2024-25 registration year, effective from September 1, 2024. These changes will impact industrial chemical introducers, with adjustments to the introduction value thresholds for most registration levels.

Key Changes to Fees and Charges

• Fee Increase: All AICIS service fees will increase by 3.1% to reflect inflationary costs. Details can be found in the 2024-25 AICIS Cost Recovery Implementation Statement (CRIS).

• Registration Charges: Charges and introduction value thresholds will be adjusted. If a company imports or manufactures less than $15 million worth of industrial chemicals, the charges will either remain the same or decrease.

Important Dates

• The next AICIS registration year begins on September 1, 2024.

• Interested parties can view the updated fees and charges for the 2024-25 registration year here.

Updated Registration Level Thresholds

The introduction value thresholds for registration levels have been updated as follows:

Financial Forecasts and Compliance

The adjustments are made following approval by the Assistant Minister for Health and Aged Care. The CRIS transparently outlines how AICIS fees and charges align with the Government’s cost recovery framework, provides financial forecasts and ensures that fees reflect the resources required for various business processes and activities.

Aiming at enhancing efficiency in the agrochemical importation process, Argentina has introduced a new policy that will recognize the equivalency of active substances approved by several leading international authorities. This development, announced through Resolution 694/2024 and published today in the Official Gazette, marks a pivotal shift in the country’s approach to managing agrochemical imports.

A New Era for Agrochemical Imports

The Argentine National Service of Agrifood Health and Quality (Senasa) has formally accepted equivalencies from countries including the United States, Mexico, the European Union, the United Kingdom, Australia, New Zealand, and Brazil. This decision aligns with Argentina’s ongoing efforts to streamline regulatory processes and reduce bureaucratic barriers for businesses.

Under the new resolution, active substances that meet the technical grade criteria and have been approved by the aforementioned authorities will be recognized, provided they come from the same manufacturing establishment and have equal or higher purity levels compared to those registered in these countries. This move is expected to facilitate quicker and more efficient importation of agrochemicals, benefiting both importers and agricultural stakeholders.

Simplification and Deregulation: A Strategic Approach

The adoption of this policy is part of a broader plan to deregulate and simplify the regulatory framework governing agrochemicals in Argentina. Senasa’s initiative is designed to address the challenges faced by the industry and to enhance the overall efficiency of the importation process. By acknowledging international equivalencies, Argentina aims to align its standards with global practices, making it easier for businesses to comply with regulations while ensuring the safety and quality of agrochemical products.

“This is a significant first step in our ongoing efforts to modernize and streamline our regulatory processes,” said a Senasa spokesperson. “We are committed to working closely with the Secretariat of Simplification of the Cabinet of Ministers to further refine and enhance our regulatory framework. Our goal is to clarify regulations, improve efficiency, simplify procedures, and reduce processing times.”

Looking Ahead: Future Developments

The new policy is expected to be the initial phase of a broader regulatory reform process. Senasa has indicated that future steps will involve additional areas of the agency and further collaboration with other governmental bodies. This comprehensive approach is aimed at consolidating the regulatory framework, ultimately benefiting both the agricultural sector and consumers.

As Argentina embarks on this transformative journey, the recognition of international equivalencies represents a crucial advancement in the country’s agrochemical regulation landscape. It not only promises to streamline operations but also reinforces Argentina’s commitment to global standards and practices.

New Zealand is proposing to amend Schedule 2A of the Hazardous Substances and New Organisms Act (HSNO Act) to include three new chemicals: Methoxychlor, Dechlorane Plus, and UV-328. These chemicals were added to Annex A of the Stockholm Convention on Persistent Organic Pollutants (POPs) in May 2023 and must be restricted in New Zealand to comply with international obligations. A public consultation on these proposed amendments is now open and submissions are invited until 4 September 2024.

Background

The Stockholm Convention aims to eliminate or restrict the production and use of POPs, which are highly toxic chemicals that persist in the environment and human bodies, bioaccumulate in the food chain and are transported over long distances. New Zealand implements the Stockholm Convention through the HSNO Act, which lists POPs and any specific exemptions in Schedule 2A.

Proposal: Chemicals to be Restricted

Below are details of the three substances and their proposed restriction, as well as the consultation questions for each substance.

Methoxychlor

• • Uses: Historically used as an agricultural, veterinary, and domestic insecticide.

  • Status in New Zealand: No current approvals or registered products. Not listed in the New Zealand Inventory of Chemicals (NZIoC).

  • Specific Exemptions: None.

  • Consultation Questions

    • Do you agree with the proposal to include methoxychlor in Schedule 2A of the HSNO Act?

    • Do you have information on the use, stockpiles, contamination, imports or exports of methoxychlor in New Zealand?

Dechlorane Plus

• Uses: Flame retardant in adhesives, sealants and polymers. Mainly used in motor vehicles, aerospace, defence, electronics and medical devices.

• Status in New Zealand: Listed in the NZIoC but no specific approvals under the HSNO Act.

• Specific Exemptions: Aerospace, space and defence applications, medical imaging and radiotherapy devices, and replacement parts for specific applications until end of life or 2044.

• Consultation Questions

  • Do you agree with the proposal to include Dechlorane Plus in Schedule 2A of the HSNO Act?

  • Do you have information on the current use, products, imports, exports, stockpiles, waste, or contaminated sites of Dechlorane Plus in New Zealand?

  • Should New Zealand register for specific exemptions for Dechlorane Plus? Which applications should be considered for exemptions?

  • Do you have information on articles in use that contain Dechlorane Plus?

UV-328

• Uses: UV absorber in automotive paints, coatings, adhesives, plastics, rubbers and various other materials.

• Status in New Zealand: Listed in the NZIoC but no specific approvals under the HSNO Act.

• Specific Exemptions: Motor vehicle parts, industrial coating applications, mechanical separators in blood collection tubes, TAC film in polarizers, photographic paper and replacement parts for specific applications until end of life or 2044.

• Consultation Questions

  • Do you agree with the proposal to include UV-328 in Schedule 2A of the HSNO Act?

  • Do you have information on the current use, products, imports, exports, stockpiles, waste or contaminated sites of UV-328 in New Zealand?

  • Should New Zealand register for specific exemptions for UV-328? Which applications should be considered for exemptions?

  • Do you have information on articles in use that contain UV-328?

Imports and Exports (Restrictions) Prohibitions Order (No 2) 2004

In order to align with the Stockholm Convention, methoxychlor, Dechlorane Plus and UV-328 need to be included in Schedule 1 of the Imports and Exports (Restrictions) Prohibition Order (No 2) 2004 to regulate their export and ensure compliance with international obligations.

Consultation Questions:

• Do you agree with the proposal to include Methoxychlor, Dechlorane Plus, and UV-328 in Schedule 1 of the Imports and Exports (Restrictions) Prohibition Order (No 2) 2004?

• Do you have any general comments regarding the inclusion of these chemicals in Schedule 1 of the Imports and Exports (Restrictions) Prohibition Order (No 2) 2004?

Best International Practices, Costs, and Benefits

Including these chemicals in Schedule 2A of the HSNO Act will bring New Zealand into line with international best practices, reduce exposure to these toxic chemicals, ensure compliance with international obligations, and support New Zealand's primary exports. The costs are considered low due to the global phase-out production and use of these chemicals and the availability of alternatives.

Next Steps

The public is invited to comment on the proposals by 5 pm on Wednesday 4 September 2024. The Environmental Protection Authority (EPA) will review the submissions, prepare a report and seek Cabinet approval to amend Schedule 2A of the HSNO Act. The amendments are intended to come into force on 26 February 2025.

On 21 August 2024, the Ministry of Environmental Protection and Natural Resources of Ukraine (MEPNR) announced that the Cabinet of Ministers of Ukraine has approved the procedure for maintaining the State Register of Chemicals. This is an important step towards alignment with European Union standards. This register will contain detailed information on all chemical substances produced, imported or sold in Ukraine in quantities exceeding one tonne per year. It will cover not only industrial chemicals but also those used in everyday products such as detergents, paints, clothing, furniture and electronics.

Database to Provide Information on Chemical Safety to Public

The creation of this register follows a public consultation process that ended on 12 August 2024, during which the draft resolution for the register was open for feedback from stakeholders.

According to Ukraine’s Deputy Minister of Environmental Protection and Natural Resources, Olena Kramarenko, the mandatory registration of these substances is in line with the recently adopted Technical Regulation on the Safety of Chemical Products (also known as Ukraine-REACH), which implements the EU's REACH Regulation. The register, which will be accessible through the national EcoSystem platform, will be a publicly accessible database containing key information on chemical manufacturers, importers and suppliers, as well as details on the potential risks and safety measures associated with these substances.