GPC Newsletter Aug-2024

On July 10, 2024, the U.S. Environmental Protection Agency (EPA) issued a compliance guide for the recently enacted methylene chloride risk management rule under the Toxic Substances Control Act (TSCA). The guide is intended to assist industry, workers, and stakeholders to comply with the regulations designed to prevent injuries, illnesses, and deaths.

In April 2024, EPA finalized a ban on most uses of methylene chloride, citing its links to various cancers, neurotoxicity, and other severe health risks. The regulation, effective from July 8, 2024, aims to protect public health while allowing essential uses to continue safely under a robust Workplace Chemical Protection Program (WCPP).

Affected Stakeholders

The methylene chloride rule affects anyone involved in the manufacturing, importing, processing, distributing, using, or disposing of methylene chloride or products containing it. This includes the use of methylene chloride in laboratories.

Workplace Chemical Protection Program

A Workplace Chemical Protection Program (WCPP) is required in order to continue 13 conditions of use of methylene chloride. These uses include:

1. Domestic manufacturing

2. Import

3. Processing as a reactant

4. Processing in incorporation into formulation, mixture, or reaction product

5. Processing in repackaging

6. Processing in recycling

7. Use as a laboratory chemical.

8. Use in paint and coating removers for safety-critical, corrosion-sensitive components of aircraft and spacecraft

9. Use as a bonding agent for solvent welding

10. Industrial and commercial use as a processing aid

11. Use in the manufacture of plastic and rubber products

12. Use as a solvent that becomes part of a formulation or mixture where the formulation or mixture will be used inside a manufacturing process and the solvent (methylene chloride) will be reclaimed

13. Disposal

The WCPP requires owners and operators of facilities using methylene chloride to comply with new inhalation exposure limits, including a maximum of 2 ppm over an 8-hour period, and must create and enforce an exposure control plan.

Key Phase-Out and Information Deadlines:

• May 5, 2025: Prohibition on distributing methylene chloride for consumer use.
• April 28, 2026: Prohibition on most commercial uses.
• October 7, 2024: Deadline for manufacturers to update Safety Data Sheets (SDS) to spread awareness throughout the supply chain.
• December 4, 2024: Deadline for processors and distributors to update SDSs.

The compliance guide includes special attention to the interests and needs of small businesses. More information on the implemented regulation can be accessed here.

On 18 July 2024, the European Union implemented its latest Eco-design for Sustainable Products Regulation, marking a significant step towards environmental sustainability. The regulation, referred to as ESPR, is a vital component of the Commission’s strategy to promote greener and more circular products. It is part of a comprehensive set of measures integral to realizing the goals set out in the 2020 Circular Economy Action Plan. These initiatives are designed to support the EU's efforts to meet its environmental and climate objectives, including doubling the rate of material circulation and achieving determined energy efficiency targets by 2030. 

Eco-design for Sustainable Products Regulation

The  Eco-design for Sustainable Products Regulation (ESPR) is an approach to sustainable design that operates under a framework, allowing specific product rules to be gradually established either individually or for groups of products with similar characteristics. To ensure transparency and public and stakeholders’ awareness of ESPR initiatives, the Commission will periodically adopt and update working plans. These plans will outline the products to be assessed and the measures to be implemented, over a period of at least three years. 

The Regulation (EU) No 2024/1781, effective from 18 July 2024, establishes this framework for eco-design requirements for sustainable products. It includes amendments to Directive (EU) No 2020/1828 and Regulation (EU) No 2023/1542, while repealing Directive 2009/125/EC, and applies to almost all categories of physical goods. This regulatory framework allows for the setting of performance and information criteria, referred to as ‘eco-design requirements’, which are crucial for advancing sustainability goals within the EU. 

Implementation 

The EU's Eco-design Forum is essential in shaping the ESPR, engaging stakeholders in the development of the post-implementation rules with inclusivity at its core. An open call for membership invites broad participation. The Commission will update working plans to ensure transparency, with the first plan set for mid-2025, covering textiles, steel and more. The ESPR aims to harmonize EU standards and align them with global trade rules to promote sustainability. Ongoing efforts support the transition from the Eco-design Directive, enhancing energy efficiency and labelling. Stakeholders are urged to follow updates on the European Product Registry for Energy Labelling (EPREL) for further details on the implementation of the ESPR. 

Essential Dates to Remember 

The key dates to remember for the ESPR are: 

1. Q3 2024: Establishment of the Eco-design Forum and call for membership applications. 

2. Q4 2024: First meeting of the Forum and consultation on draft first ESPR working plan. 

3. Q2 2025: Adoption and publication of the first ESPR working plan.  

On 19 July 2024, the European Commission launched a consultation on a delegated regulation that will amend the EU’s Prior Informed Consent (PIC) Regulation (EU No 649/2012). The amendment primarily updates the list of chemicals in Annex I, based on recent regulatory developments in the EU and decisions taken under international conventions such as the Rotterdam and Stockholm Conventions.

Understanding PIC

The Prior Informed Consent (PIC) Regulation regulates trade of certain hazardous chemicals that are banned or severely restricted in the EU. It imposes obligations on companies wishing to export these chemicals to non-EU countries or import them into the EU. PIC implements the Rotterdam Convention within the EU and promotes shared responsibility and cooperation in the international trade of hazardous chemicals. It also protects human health and the environment by providing importing countries with information on the safe storage, transport, use and disposal of hazardous chemicals. The PIC Regulation entered into force on 1 March 2014.

What does the PIC Regulation cover?

• Banned or severely restricted chemicals listed in Annex I to the PIC Regulation, including active substances in pesticides and industrial chemicals.

• Chemicals listed in Annex V to the PIC Regulation that are prohibited for export from the EU.

Main Changes in the Delegated Regulation

New Chemicals Added: A total of 42 new chemicals have been added to Part 1 of Annex I, including substances such as abamectin, acrolein, benfluralin and dihexyl phthalate. Part 2 sees the inclusion of 39 new chemicals such as benthiavalicarb, chloridazon, cyanamide and metiram.

Revised Entries: The entries for cyanamide, terbufos and warfarin in Part 1 have been updated with new details. In addition, the entry for polychlorinated biphenyls (PCBs) in Part 3 has been revised.

Deletions and Additions: Terbufos has been removed from Part 2 and added to Part 3 of Annex I with updated details.

New Export Ban: Perfluorohexanesulfonic acid (PFHxS), its salts and PFHxS-related compounds have been added to the list of chemicals subject to an export ban in Annex V. The entry for endosulfan has also been updated.

Consultation Deadline and Regulatory Goals

The consultation on this amendment closes on 16 August 2024 and stakeholders are encouraged to provide their feedback. The proposed amendments aim to improve the regulatory framework for the safe management of hazardous chemicals, ensuring better protection of human health and the environment.

The full text of the draft Delegated Regulation  and its annexes can be downloaded here.

On 26 June 2024, the UK Health and Safety Executive (HSE) announced a significant update to the Great Britain Mandatory Classification and Labelling (GB MCL) list, giving legal effect to the inclusion of 88 chemical substances. This update is in line with the 14th and 15th EU Adaptations to Progress (ATP), updating the Classification, Labelling and Packaging (CLP) Regulation.

Ministerial Approval

The decision, approved by the Minister for Lords (MfL) with the consent of the Scottish and Welsh Ministers, ensures that the 88 substances are now officially listed in the GB MCL under Article 37 of the GB CLP Regulation. This action was necessary to include entries from the EU classification that were not retained in GB law after Brexit ended on 31 December 2020.

Key Changes and Compliance Dates

The updated GB MCL list was published on 26 June 2024 and includes legally binding entries for the 88 substances. The entry into force and compliance date for these substances is also 26 June 2024. This update is critical to ensure that the GB MCL list accurately reflects substances that have not been incorporated into GB law post-Brexit. The detailed GB MCL consolidated summary, which includes the 88 substances, is available here.

Impact on Duty Holders

For most duty holders, this update will not require any additional action. The classifications and labelling requirements for these 88 substances remain unchanged. However, two substances, titanium dioxide (in powder form) and granulated copper, have been removed from the list pending further assessment.

Future Assessments and Notifications

The HSE has indicated that further assessments will be carried out for titanium dioxide and granulated copper under Article 37A of the GB CLP Regulation, as additional information has been identified that requires further assessment. Duty holders affected by the declassification of these two substances should self-classify in accordance with the GB CLP Regulation while the HSE continues to review the GB MCLs for these two substances under the Article 37A procedure. No timetable has yet been agreed for the Article 37A assessment of titanium dioxide (in powder form) and granulated copper.

In India, the Central Pollution Control Board (CPCB) has launched the Extended Producer Responsibility (EPR) portal for used oil management, effective from 1 April 2024.  The online portal, mandated by the Second Amendment to the Hazardous and Other Wastes (Management and Transboundary Movement) 2023, is expected to be fully operational within six months of the date of commencement. Thus, according to the latest update on the EPR portal, producers can now apply for registration. 

Extended Producer Responsibility (EPR) 

The concept of Extended Producer Responsibility (EPR) mandates that producers of base oil, lubrication oil, or importers of used oil under Chapter VII (Extended Producer Responsibility) of the Hazardous and Other Wastes (Management and Transboundary Movement) Second Amendment Rules, 2023 adhere to recycling targets exclusively through authorized recyclers. This measure aims to ensure environmentally sound handling of used oil. The Central Pollution Control Board (CPCB) has introduced an online system for the effective management and enforcement of compliance with the Hazardous and Other Wastes (Management and Transboundary Movement) Second Amendment Rules, 2023. This system acts as a centralized repository for all data related to the implementation of extended producer responsibility for used oil. 

Comprehensive EPR Framework 

The Government has introduced a comprehensive EPR framework aimed at increasing accountability and sustainability in the waste management sector. The framework includes several key functions designed to regulate entities involved in waste management. These functions include: 

1. Registration of entities 

2. Filing returns and submission of information 

3. Issuance of EPR Certificates 

4. Generation and transfer of EPR Certificates 

5. Audit of EPR compliance 

6. Environmental compensation 

These measures are part of efforts to enhance accountability and environmental sustainability in the waste management sector. 

CPCB Adopts Virtual Meetings 

The CPCB is using video conferencing for meetings aimed at resolving concerns regarding the signup and registration of entities. Entities have the option to participate in these meetings via VC on specific days (Monday, Wednesday and Friday) from 4 pm to 5 pm (Click here to join the meeting). 

In June 2024, the Bureau of Indian Standards (BIS) released the first draft standard on ultramarine blue for use as a colourant in plastics for toys and food contact material. The draft is currently open for public comment until 23 August 2024.  

This draft also cites standard IS 9833:2018 which was already released in 2018, which lists colourants that can be safely used in FCMs. But due to the high toxicity risk, there is a strong demand to limit the lead and sulphur content in the ultramarine blue for application in both FCM and children’s toys. For this reason, a new standard specifically for ultramarine blue has been drafted. 

Substance Limits in Draft Standard  

The maximum threshold limits for heavy metals and other restricted substances in ultramarine blue are listed as follows in the draft Standard: 

Good Manufacturing Practices, Testing and Labelling 

The draft Standard emphasizes the importance of Good Manufacturing Practices (GMP). It specifies that whenever testing is conducted as per standard IS 9845 the colourant should not bleed or migrate from a product into food, nor should it show indications of instability or degradation in each process.  

Each container of ultramarine blue shall be labelled with: 

• Name of material 

• Manufacturer’s name 

• Trademark (if available) 

• Net weight  

• Lot/Batch number 

BIS Certification Marking 

Products that meet the requirements of the standard can be certified according to the conformity assessment schemes under the Bureau of Indian Standards Act, 2016, along with its associated Rules and Regulations. These certified products may then be marked with the Standard Mark. 

On July 8, 2024, China’s National Medical Products Administration (NMPA) announced the comprehensive implementation of electronic submission for cosmetics and new cosmetic ingredients, effective from September 1, 2024. This significant regulatory change, outlined in Announcement No. 91 of 2024, aims to enhance efficiency and facilitate the registration process for companies involved in the cosmetics industry.

Background

In accordance with the Cosmetics Supervision and Administration Regulation (CSAR) issued by the NMPA, China applies a registration management system for higher risk new cosmetic ingredients and a filing management system for other new cosmetic ingredients. New cosmetic ingredients are defined as natural or synthetic raw materials used in cosmetics for the first time in China. Registration entities can determine whether an ingredient is a new cosmetic ingredient by consulting the Inventory of Existing Cosmetic Ingredients in China (IECIC).

Key Points of the Announcement

1. Full Implementation of Electronic Submission:

Starting from September 1, 2024, all relevant entities, including registrants, filers, domestic responsible persons and manufacturing enterprises, must submit all documents electronically via the Cosmetics Registration and Filing Information Service Platform. Paper documents will no longer be accepted but must be archived by the relevant domestic entities for future reviews or inspections.

2. Submission of Original Documents:

Original documents, third party certification materials, and other required paper documents must be signed and confirmed for authenticity by the registrant, filer, or domestic responsible person before being submitted electronically through the Information Service Platform.

3. Procedural Adjustments:

The NMPA’s cosmetic technical institutions and provincial drug supervision departments will adjust their submission procedures to optimise the acceptance, technical review and management of registration and filing dossiers.

Recommendations for Enterprises

1. Apply for Certificate Authority Certificates Early:

Companies are advised to apply for Certificate Authority (CA) certificates in advance to facilitate online electronic signing. This preparation will allow efficient handling of multi-page documents with electronic signatures, thereby eliminating the need to print, sign and scan documents and significantly improving workflow efficiency

2. Organize and Archive Documents:

Companies must meticulously organise and archive all electronic documents in accordance with the new regulations. Given that these documents will be critical for future reviews or inspections, it is essential to ensure their completeness and accuracy.

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On July 15, 2024, the Korean Ministry of Food and Drug Safety (MFDS) announced revised guidelines for alternative animal testing methods for cosmetics. The move aims to improve the international competitiveness of the cosmetics industry and non-clinical trial organizations in terms of toxicity tests. The updated guideline includes the OECD TG422E test method (in vitro skin sensitization: genomic allergen rapid detection for assessment of skin sensitizers). 

The guidelines can be found on the website of the Ministry of Food and Drug Safety (www.mfds.go.kr). 

On July 2, 2024, the Korean Ministry of Environment approved a partial revision of the Enforcement Decree of the Act on the Registration and Evaluation of Chemical Substances. From October 10, 2024, chemicals produced by recycling waste will be exempt from registration. This revision aims to eliminate legal uncertainty regarding the registration of recycled chemicals. 

Conditions for Exemptions 

Previously, the recycling industry faced challenges in proving that a manufactured chemical was identical to a chemical already registered in the same supply chain before it became waste. The amendment now includes waste recycled chemicals in the list of exemptions, provided certain conditions are met: 

- Three-Year Gap: The substance must have been registered at least three years ago. 

- Weight Range: It must fall within the weight range of the previously registered chemical. 

- Data Submission: If the previously registered substance is categorized as an intermediate and data submission was omitted, the exemption applies. 

Applicants seeking exemption can submit their confirmation to the Korea Environment Corporation through the Chemical Information Processing System. 

Additional Clarifications and Industry Impact 

Additionally, the revision clarifies the fee collection for the use of hazard test data and aims to reduce the registration burden for the recycling industry. Hwang Kye-young, director of the Environmental Health Department, emphasized the importance of proper waste recycling and chemical safety management. 

On July 12, the Ministry of Environment and the Korea Consumer Agency signed a Memorandum of Understanding (MOU) with home appliance companies to establish an autonomous safety management system for biocides used in home appliances.  

Regulations and Industry Goals 

Starting in 2028, the home appliance industry will be required to use only approved biocidal products and label processed products under the Consumer Chemical Products and Biocides Safety Control Act. The consumer electronics industry aims to reduce the use of biocides and eliminate exaggerated claims, such as “99% antibacterial power”, associated with biocidal products.  

Cooperation and Support 

The Korea Consumer Agency will collaborate with the home appliance industry to create a safer market environment. The Ministry of Environment will support the implementation of chemical-related systems and improve safety management capabilities throughout the supply chain. Vice Minister of Environment Lee Byung-hwa expressed gratitude for the industry’s efforts to improve safety and reduce the hype about antibacterial effects. Yoon So-hyun, head of the Korea Consumer Agency, emphasized the agency’s commitment to eliminating the hype surrounding biocidal products and improving the product use environment for consumers. 

On 21 June 2024, Japan’s Ministry of Health, Labour and Welfare (MHLW), Ministry of Economy, Trade and Industry (METI) and Ministry of the Environment (MOE) notified the World Trade Organization (WTO) of the designation of NPE (polyoxyethylene nonylphenyl ether) as a Class II Specified Chemical Substance under the Act on the Regulation of Manufacture and Evaluation of Chemical Substances (hereinafter referred to as the Act).

Class II Specified Chemical Substances are substances that are specified by Cabinet Order (Order for enforcement of the Act on the Evaluation of Chemical Substances and Regulation of Their Manufacture, etc.), and that are believed to pose a risk of causing harm to humans or damage to flora and fauna in the human living environment, and a significant amount of the substance remains in the environment over a substantially extensive area, or it is reasonably likely that such a situation will arise in the near future.

Regulatory Requirements

This designation necessitates several regulatory requirements:

1. Notification Requirement:
   • Manufacturers and importers of NPE must notify the planned quantity of NPE to be manufactured or imported, as stipulated in Article 35, paragraphs 1 and 6 of the Act.
2. Technical Guidelines:
   • The handling of NPE and NPE-added water-based cleaning agents must comply with the measures outlined in the technical guidelines, as per Article 36, paragraph 1 of the Act.
3. Labelling Requirements:
   • Containers and packaging of NPE and NPE-added water-based cleaning agents must display labels indicating compliance with the prescribed measures, in accordance with Article 37, paragraph 1 of the Act.

Objective and Rationale:
The primary objective of this designation is to protect animal and plant life, ensure public health, and protect the environment. This action reflects Japan's extensive efforts to protect the environment and ensure public health.

Proposed Dates:

• Date of Adoption: October 2024
• Date of Entry into Force: April 2025
• Deadline for Comments: 60 days from notification

Companies are encouraged to review the proposed regulations and provide feedback within the specified comment period. This proactive step is critical to ensuring that the regulations are comprehensive and effective in achieving their intended protective measures.

The Australian Industrial Chemicals Introduction Scheme (AICIS) has released its updated Rolling Action Plan (RAP), which lists ongoing and recently completed chemical evaluations. This initiative is essential to protect human health and the environment.

What is the Rolling Action Plan?

The Rolling Action Plan (RAP) is a strategic work plan used to prioritize chemicals for evaluation based on the results of the Evaluation Selection Analysis (ESA) process. It lists proposed, ongoing and recently completed evaluations, but excludes those with a current assessment certificate.

Update Schedule

The RAP is generally updated as evaluations are completed, with notices published on the AICIS website. Updates may also occur as a result of new information, stakeholder requests, or adverse events requiring evaluation.

Key Details Included in the RAP

• Subject of the evaluation: Chemical name or group name

• Reason for the evaluation

• Estimated date of completion of the evaluation

• Evaluation focus: Human health, environment or both

• Amendments to the evaluation list

Evaluation Process

During the ESA process, chemicals that pose potential risks to human health and/or the environment are identified. Evaluations are prioritized on the basis on these risks, and Evaluation Statements are published for chemicals that do not require further regulation.

Ongoing and Recent Evaluations

The RAP includes lists of ongoing, open for public consultation and recently completed evaluations. A downloadable spreadsheet provides detailed information on chemicals under evaluation.

Chemicals under Evaluation

Chemicals currently under evaluation include:

• 1H-Benzotriazole and its derivatives: Potential risk to human health

• Phenolic benzotriazoles: Potential risk to human health

• Tellurium and its compounds: Potential risk to human health

• Acrylic acid and its salts: Potential environmental risk

• Benzoic acid, 2-hydroxy-, 3,3,5-trimethylcyclohexyl ester (homosalate): Potential health and environmental risk

Recently completed evaluations cover a range of chemicals, including water-soluble zinc salts and acetoin, with results indicating both environmental and human health risks.

Staying Informed

To stay informed on the latest chemical evaluations and RAP updates, stakeholders can subscribe to notifications via email through the AICIS website. For detailed information or to provide input on specific chemicals listed in the RAP, stakeholders are encouraged to contact AICIS directly.

Conclusion

The Rolling Action Plan is a critical component of AICIS' efforts to effectively manage industrial chemical risks. By staying informed and involved, stakeholders can contribute to the continuous improvement of chemical safety and environmental protection.

Effective 1 June 2024, Malaysia has implemented a ban on the import of two medical devices containing mercury: thermometers and sphygmomanometers which are commonly used to measure blood pressure. This prohibition is part of the 'Customs (Prohibition of Imports) (Amendment) (No 2) Order 2024', which was published in the Federal Government Gazette on May 23, 2024.  

New Items Added to Import Prohibition List 

The amendment introduces 'item no 17' into the First Schedule of the 'Customs (Prohibition of Imports) Order 2023'. This category lists various prohibited items, including toxic chemicals and specific minerals that are prohibited from entering Malaysia. Mercury-containing thermometers and sphygmomanometers are now classified under this new item as 'Products under the Minamata Convention'. 

Phase-Out under the Minamata Convention 

Malaysia's decision is in line with its commitment to the UN's Minamata Convention, an international designed to protect human health and the environment from the adverse effects of mercury. The convention mandates the phase-out of certain mercury-containing products, with these specific medical devices being targeted for elimination under the treaty by 2020. 

On July 15, 2024, the Indonesian Halal Product Assurance Agency (BPJPH) of the Ministry of Religion (Kemenag) launched the Overseas Halal Certificate Registration (RSHLN) service. The menu is available at https://ptsp.halal.go.id/.

Import Procedure for Foreign Halal Products

The RSHLN registration service is part of Law Number 33 of 2014, which mandates halal certification for products entering, circulating, and trading in Indonesian territory. It allows foreign halal products imported into Indonesia to be halal-certified without having to apply for a certificate. The certificate must be registered by the BPJPH before distribution in Indonesia. Government Regulation (PP) Number 39 of 2021 also requires halal certificates for raw materials, additives, auxiliary ingredients, and slaughter products.

Documentation Required for RSHLN Registration:

• Application Letter

• Letter of appointment from the company in the applicant's place of origin permitting registration of foreign halal certificates

• Business Licence Number (NIB) of the importer or official representative in Indonesia.

• A copy of the foreign halal certificate must be legalized by the Indonesian representative overseas and signed by an authorized authority for import into Indonesia.

• If the LHLN is in a member country of the Apostille Convention, only an Apostille certificate document is necessary.

• List of items to be imported into Indonesia, with harmonization system code number.

• Confirmation that all provided documents are correct and valid.

Registration process for RSHLN

• The process for RSHLN through the Halal Information System (Sihalal) involves creating an account, filling in applicant data, verifying the application documents, submitting additional documents, making a payment, and publishing the RSHLN Registration Number.

• If the verification results are not met, additional documents and original documents are required.

• If payment is made, an invoice is issued and a payment receipt letter is issued.

• The process ends with the issuance of the RSHLN Registration Number issued.

The halal.go.id page contains all the technical details required for the successful implementation of RSHLN registration.

Update: Public comment period extended till 24 October 2024.

On 26 July 2024, the Peruvian Ministry of the Environment has announced the publication of the draft Regulation of Legislative Decree 1570, which enacts the Comprehensive Chemical Management Law and its annex.

Key Points

The regulation sets out the obligations, powers, and responsibilities of public entities and users of chemicals for their comprehensive management. The primary objective is to protect public health and the environment by implementing measures and mechanisms to reduce the risks associated with the comprehensive management of chemicals throughout their life cycle.

The draft regulation includes:

• Obligations of Public Entities: Defines the roles and responsibilities of government bodies in overseeing and enforcing chemical management practices.

• User Responsibilities: Outlines the duties of individuals and organizations that use chemicals to ensure compliance with safety standards.

• Risk Reduction Measures: Specifies the necessary steps to mitigate potential hazards associated with the handling, use, and disposal of chemicals.

Public Consultation

The draft regulation is available for public review on the Ministry of the Environment’s digital platform (www.gob.pe/1024-consultas-publicas-de-proyectos-normativos-minam). Interested parties are invited to submit their opinions and suggestions within ten (10) business days from the day following the publication of this Ministerial Resolution in the official newspaper, El Peruano.

The proposed regulation is important for enhancing the safety and sustainability of chemical management. By establishing clear guidelines and responsibilities, it aims to minimize the risks to human health and the environment, thus ensuring a safer future for all.

The Department of Employment and Labour in South Africa has announced a new draft Regulation (Notice No. 50431) aimed at controlling exposure to Hazardous Chemical Agents (HCAs). These regulations will implement the 10th revised edition of the Globally Harmonized System (GHS) of Classification and Labeling of Chemicals by June 2025. Interested parties are invited to submit written comments within 90 days from the publication of the draft regulation. The deadline for submission of comments is July 5, 2024.

Regulatory Overview and Exposure Control

The draft regulations aim to ensure the prevention or adequate control of workers exposure to hazardous chemical agents, with a focus on the primary route of inhalation, in addition to ingestion and skin absorption. Compliance with Hazardous Chemical Agents Regulations is detailed, including requirements for risk assessment, exposure monitoring, and maintenance and testing of control measures.

Global Harmonization and Labeling Standards

Compliance with the Globally Harmonized System (GHS) is mandated by the draft Regulation with phase-in periods for the adoption of new revisions (see table below). The UN GHS Purple Book is updated every two years by the United Nations Sub-committee on GHS. To facilitate transition, South African importers and manufacturers are granted a phase-in period of 2 years and 6 months from the date of approval by the UN Sub-committee until 30 June of the relevant year for new revisions. The regulations specify labelling requirements in accordance with the GHS, including pictogram size, inclusion of ingredient information, and specific labelling requirements for carcinogens and specific target organ toxicity.

Phase-in Timeframes for GHS Purple Book New Revisions

Additional Safety Data Sheet Considerations

Safety Data Sheets (SDSs) are essential for mixtures that are not classified for acute toxicity but contain hazardous ingredients. Detailed guidelines ensure all necessary hazard information is provided, respecting the established cut-off values for different hazard classes.

Setting and Implementing Occupational Exposure Limits

The draft Regulation outlines the process for setting Occupational Exposure Limits (OELs), including maximum and restricted limits, and details the methodology for calculating exposure over specified reference periods. It also addresses the need for regular updates to OELs and the establishment of exposure groups to assess compliance effectively.

Special Considerations for Particulates and Confined Spaces

Guidance is provided on managing exposure to particulates and working safely in confined spaces, highlighting the importance of appropriate personal protective equipment and monitoring strategies.

Medical Surveillance and Biological Monitoring

A robust framework for medical surveillance is outlined, detailing the importance of medical screening, biological monitoring, and the management of exposure-related health findings. This comprehensive approach ensures that both individual and collective health risks from hazardous chemical exposures are proactively managed.

Legal and Ethical Considerations

The draft Regulation underscores the legal obligations for reporting occupational diseases and the ethical considerations in conducting health surveillance, including informed consent and confidentiality of medical records.

Engagement with Health and Safety Committees

Employers will be required to engage with health and safety committees to discuss risk assessments, control measures and training related to HCAs, ensuring a collaborative approach to workplace safety.

Conclusion and Deadline Reminder

These draft regulations represent a significant step forward in the management of hazardous chemical agents in the workplace, emphasizing safety, compliance and the protection of the health of all workers. Stakeholders are encouraged to participate in the consultation process to refine and improve the provisions outlined in the draft. Please note that the final date to submit comments is July 5, 2024.

For more details, please refer to the draft Regulation here

On 3 July 2024, five East African countries (Burundi, Kenya, Rwanda, Tanzania and Uganda) notified the World Trade Organization (WTO) that the Draft East African Standard for Henna Powder (DEAS 337:2023) was adopted by the East African Community Council of Ministers on 14 June 2024. This standard, which will replace the 2013 edition, introduces comprehensive specifications to ensure that henna products meet high standards of purity and performance.

Improved Quality Specifications

The updated standard outlines stringent requirements for henna powder, including general and specific quality criteria. Specifically, the new specifications require henna powder to be in the form of a fine, dried powder obtained from fresh leaves of the henna plant and free from extraneous contaminants such as stems, small fruits and other non-plant materials. It also sets precise limits for moisture content, crude fibre, mineral content and the presence of extraneous sand.

Safety and Purity Standards

A key feature of DEAS 337:2023 is its focus on safety and purity. The Standard stipulates that henna powder must not exceed maximum limits for heavy metal contaminants (lead, arsenic and mercury) ensuring the safety of the product for consumer use. In addition, the standard includes microbiological limits to control potential microbial contamination, specifying acceptable levels for several microorganisms including Pseudomonas Aeruginosa and Staphylococcus Aureus.

Updated Labelling Requirements

The Standard also emphasises the importance of accurate labelling. Each package of henna powder must be clearly labelled with the product name and instructions for use, specifically stating that only water should be used as a solvent. The packaging must also be secure and prevent contamination.

Detailed Test Procedures

The standard was developed by the East African Community Technical Committee EASC/TC 071, which oversees cosmetics and related products. The draft has been circulated to stakeholders for feedback to ensure that the final version reflects the needs and concerns of all parties involved.

As part of the implementation of the standard, detailed methods for sampling, testing and analysis are provided, including procedures for determining moisture content, cold water extract levels, and the presence of extraneous dyes by thin layer chromatography.

Moving Towards Harmonization

The introduction of DEAS 337:2023 is a significant step towards harmonising product quality across East African countries, reducing trade barriers and promoting consumer safety. Stakeholders and industry players are encouraged to review the draft and provide feedback to help finalise the standard.

The full text of DEAS 337:2023 can be found here.

On June 12, 2024, the Environmental Protection Authority (EPA) published the Hazardous Substances (Importers and Manufacturers) Amendment Notice 2024 under the Hazardous Substances and New Organisms (HSNO) Act 1996. This notice contains important updates to the regulatory requirements for hazardous substances.

Key Highlights

• Objective of the Notice: The amendment aims to improve the management of hazardous substances by requiring additional information from importers and manufacturers. This includes annual reporting of quantities imported or manufactured, providing New Zealand Business Numbers (NZBN), and specific details for certain explosives.

• Consultation Process: EPA publicly announced its intention on December 13, 2023, and invited comments until March 28, 2024. Feedback from relevant stakeholders was taken into account in finalizing the notice.

• Effective Dates: Certain clauses (13, 14 and 15) will take effect on January 1, 2025, while the remainder of the notice will come into force on January 1, 2026.

Detailed Amendments

• Definitions: New definitions include terms like "agrichemical," "group standard title," "HSNO approval number" and others related to hazardous substances.

• Notification Requirements: Importers and manufacturers must provide prescribed information, including their New Zealand Business Number (NZBN) and HSNO approval number.

• Annual Reporting: Introduces annual reporting requirements for identified substances and certain explosives. These reports must include the name, category, approval number and quantity of the substances.

• Multi-Shipment Import Certificates: EPA may now issue certificates for multiple shipments of explosives, valid for up to 12 months, subject to certain conditions.

Compliance and Enforcement

EPA collects this information to support its regulatory functions, including compliance and enforcement activities, data analysis, and reporting.

Transitional Provisions

Importers and manufacturers who have already complied with the initial notification requirements must update EPA with additional specified information within 30 days of the commencement date of this notice.

Conclusion

The Hazardous Substances (Importers and Manufacturers) Amendment Notice 2024 is a significant step towards better management of hazardous substances in New Zealand. Importers and manufacturers should review the full details of the Notice to ensure compliance with the new requirements. For more information, visit the EPA website or contact their Wellington office.