GPC Newsletter Jul-2024

In a significant move to improve environmental protection and public health, the Canadian government recently updated its regulations on mercury-containing products. These changes, announced on June 19, 2024, mark a critical step in Canada's ongoing commitment to reduce mercury pollution.

Mercury Regulation and Environmental Protection

Mercury and its compounds are recognized as toxic substances under Schedule 1 of the Canadian Environmental Protection Act, 1999 (CEPA). This classification empowers both the Minister of the Environment and the Minister of Health to develop and implement measures to reduce the risks associated with mercury releases, particularly from man-made sources. Over the years, Canada has actively participated in national and international efforts to minimize the environmental and health risks posed by mercury. These include a range of legislative, regulatory and programmatic strategies at federal, provincial, and territorial levels.

Improved Management Practices

Following the publication of the first mercury regulations in November 2014, Canada published the Code of Practice for the Environmentally Sound Management of End-of-life Lamps Containing Mercury in February 2017. This Code, while voluntary, supports best practices among collectors, transporters, and processors of mercury-containing lamps to prevent environmental contamination. It serves to complement existing provincial and territorial initiatives, particularly in regions with limited access to recycling facilities.

Global Commitments

At the global level, the Minamata Convention on Mercury, a legally binding treaty under the United Nations Environment Program (UNEP), entered into force on August 16, 2017. Canada, a signatory since October 10, 2013 and a ratifying member as of April 7, 2017, is committed to a life-cycle approach to reducing mercury pollution. The treaty emphasizes the elimination or reduction of mercury in various products and industrial processes through best environmental practices and restrictions on mercury trade.

Specific Measures under the Minamata Convention

The Minamata Convention mandates the phase-out of certain mercury-containing products such as certain types of lamps by 2020, with additional requirements introduced in subsequent amendments. In particular amendments were adopted in 2022 and 2023 to accelerate the phase-out of compact fluorescent lamps and other mercury-added products to 2026 and 2027, extending beyond the original deadlines due to specific exemptions granted to Canada.

National Strategy and Legislative Actions

In response to the treaty and ongoing environmental concerns, Canada enacted the National Strategy for Safe and Environmentally Sound Disposal of Lamps Containing Mercury Act in 2017. Developed by the Minister of the Environment, the strategy aims to eliminate mercury pollution from lamps, a significant step that was accomplished in collaboration with all relevant Canadian jurisdictions. The strategy encourages the use of mercury-free products and has seen significant compliance, with more than 103 million lamps recycled since 2018.

Health Considerations and Regulatory Amendments

Health Canada's initiatives include the phase-out of bulk dental amalgam powders, which are known to pose risks of mercury exposure risks to dental professionals, reflecting a broader commitment under the Convention to reduce the use of dental amalgam. The comprehensive amendments to the mercury regulations not only seek to align with the Convention's requirements but also aim to address administrative and practical issues, such as labeling, reporting, and recognition of accreditation bodies.

Key Updates in the Mercury Regulations

The updated regulations, which will take effect on June 19, 2024, make significant changes to control the use of mercury in products and underscore Canada's commitment to the Minamata Convention on Mercury. Key updates  to the regulations include:

• Reduced Mercury Limits: The amendments specifically reduce the permissible mercury content in exempted lamps, such as straight fluorescent lamps used for general lighting, a significant reduction from previous levels.

• Phase-out Deadlines Set: Deadlines have been set for the phase-out of certain mercury-containing products. These include popular types of mercury-containing lamps, with deadlines also set for replacement lamps to ensure a smooth transition.

• Elimination of Exemptions: The update removes exemptions for products that are no longer used in Canada or whose exemption period has expired, streamlining the regulations and ensuring relevance and effectiveness.

• Expanded Scope of Accreditation: The scope of accreditation bodies recognized under the regulations now includes signatories to the International Laboratory Accreditation Cooperation Mutual Recognition Arrangement, enhancing the credibility and consistency of compliance assessments.

Implementation and Compliance

These amendments officially came into force on June 19, 2024, with full enforcement starting on the first anniversary of their publication in the Canada Gazette, Part II. This timeline provides stakeholders with sufficient time to adapt to the new requirements.

Conclusion of the Updated Regulations

By reducing the mercury content in lamps and prohibiting specific products, the updated regulations will significantly reduce the risk of mercury releases into the environment. These measures not only meet Canada's international obligations under the Minamata Convention but also position Canada as a leader in global mercury reduction efforts. The amendments demonstrate Canada's proactive approach to environmental protection and public health safety, ensuring a sustainable future with reduced mercury exposure.

On June 5, the U.S. Environmental Protection Agency (EPA) announced a proposed rule under the Toxic Substances Control Act (TSCA) to protect workers and consumers from exposure to the solvent n-methylpyrrolidone (NMP). This proposal is the sixth chemical to be reviewed for the 'first ten' chemicals under the amended TSCA, following actions on asbestos, methylene chloride, trichloroethylene, perchloroethylene, and carbon tetrachloride.

EPA's 2020 risk evaluation found that NMP poses an unreasonable risk to health, with exposure associated with significant adverse effects, including miscarriage, reduced fertility, liver toxicity, kidney toxicity, immunotoxicity, neurotoxicity, skin irritation, and sensitization.

If finalized, the rule would limit NMP concentrations in certain consumer and commercial products, establish strict workplace health controls, and ban some uses where safer alternatives exist.

NMP in Industrial and consumer products

NMP is used in solvent cleaning and surface treatment of metals, textiles, resins, and plastics. In the commercial sector, it is used in the manufacture and removal of paints, coatings and adhesives. Common consumer uses include paints, coatings, glues, adhesive removers, lubricants, and automotive care products.

Proposed rule:

EPA is proposing, under TSCA section 6(a), to:

(i) Ban the manufacture, processing, distribution, and use of NMP for five of 37 evaluated occupational conditions of use (CoU). It also establishes a de minimis threshold of 0.1% by weight below which products would be exempt from the provisions of the rule.

(ii) Establish container size limits and labeling requirements for the manufacture (including import), processing, and distribution in commerce of NMP for seven consumer uses.

The following NMP-containing products cannot be sold in containers larger than 16 ounces and must be labeled 'for consumer use only':

• Paint and coating removers
• Adhesive removers
• Paints and coatings (lacquers, stains, varnishes, primers, floor finishes)
• Paint and coating additives
• Automotive care products
• Cleaning and furniture care products
• Lubricants and lubricant additives

(iii) Require prescriptive controls, including concentration limits and personal protective equipment (PPE), for seven occupational conditions of use. These requirements would be phased in over a two-year period.

(iv) Strict workplace controls, including NMP Workplace Chemical Protection Programs (WCPPs), would be mandated for all other occupational conditions of use.

This includes commercial use of high NMP concentration products essential to the missions of the Department of Defense (DOD) and the National Aeronautics and Space Administration (NASA). These programs are designed to prevent direct dermal contact with NMP.

They would cover approximately 44% of the annual production volume of NMP, including manufacturing, processing, industrial, commercial uses, and disposal. Businesses would have 12 months to establish a WCPP, while federal agencies would have three years to comply.

(v) Require a concentration limit on NMP for the import, processing, and distribution in commerce for a consumer use

(vi) Establish recordkeeping and downstream notification requirements

EPA will accept public comments on the proposed rule for NMP for 45 days following publication in the Federal Register via docket EPA-HQ-OPPT-2020-0744.

The European Chemicals Agency (ECHA) launched a call for evidence on the uses and alternatives for certain hexavalent chromium (CrVI) substances on 5 June 2024. The information will support ECHA’s preparation of an Annex XV Restriction Dossier on Cr(VI) substances, including those listed in REACH Annex XIV (excluding lead chromates) and barium chromate. The call for evidence will be open until 15 August 2024.

First Call for Evidence

To support the preparation of the restriction proposal, ECHA launched a first call for evidence from December 2023 to February 2024. While this first phase aimed to gather comprehensive data, some gaps remained, necessitating a second call for evidence. In addition, on 29 April 2024, the scope of the restriction proposal for chromium (VI) substances was extended by the European Commission to cover a wider range of Cr(VI) substances, further highlighting the need for additional data collection.

Second Call for Evidence

The second call for evidence consists of two separate surveys to collect detailed information for the Restriction Dossier.

Survey 2a focuses on the different uses of Cr(VI) substances, targeting companies in sectors such as transport, aerospace, defence and specialty surface treatment. This survey seeks input from companies that did not respond to the first call and from users of specific Cr(VI) substances, including barium chromate.

Survey 2b targets manufacturers, suppliers, importers, distributors and users of alternatives to Cr(VI) substances, as well as companies that have recently completed or are in the process of replacing Cr(VI) substances.

ECHA encourages participation from a wide range of stakeholders, including private companies, sector associations, scientific organizations, NGOs, and authorities from both EU/EEA and non-EU countries. Information can be submitted on a confidential basis.

For more details and to participate, visit the surveys here and here.

At their June meetings, the European Chemicals Agency's (ECHA) Committee for Risk Assessment (RAC) and Committee for Socio-Economic Analysis (SEAC) have evaluated four key sectors and made provisional conclusions on the impact of the EU-wide proposal to restrict per- and polyfluoroalkyl substances (PFAS) for these sectors. The committees also announced the program for the next sectors to be evaluated and concluded provisionally on the scope of the restriction proposal and the hazards of PFAS.

Sectors evaluated at the June Meeting

At the June meetings, RAC and SEAC reached provisional conclusions on the following sectors:

• Consumer mixtures, cosmetics, and ski wax (initially discussed in the March plenary).

• Metal plating and the manufacture of metal products (discussed in June).

These conclusions remain provisional until the committees complete the evaluation of the entire restriction proposal, encompassing all sectors of use, and formally adopt their opinions. Once finalized, these opinions will be communicated to the public.

Planned Sector Evaluations

Looking ahead, RAC and SEAC have announced the next sectors to be evaluated in upcoming meetings. In September, the focus will be on:

• Textiles, upholstery, leather, apparel, and carpets (TULAC)

• Food contact materials and packaging

• Petroleum and mining

Following the September evaluations, the committees will consider:

• Applications of fluorinated gases

• Transport

• Construction products

PFAS Hazards and Scope               

The RAC also provisionally concluded on the overall scope of the restriction proposal and the hazards posed by PFAS. A primary concern highlighted by the committee is the persistence of PFAS in the environment, which means these substances can remain for a very long time. Additionally, certain PFAS may pose further risks to both the environment and human health. RAC expressed concerns that excluding specific PFAS from the restriction based on their potential environmental degradation is not sufficiently justified.

ECHA’s Commitment to Progress

ECHA is committed to advancing the opinion-making process, in line with updates made to the proposal by five national authorities. The finalized opinions will be submitted to the European Commission as soon as possible.

On 27 June 2024, the European Chemicals Agency (ECHA) announced that bis(α,α-dimethylbenzyl)peroxide has been added to the Candidate List of Substances of Very High Concern (SVHC) by the ECHA Member State Committee (MSC) due to its hazardous properties. The Candidate List now contains 241 entries.

About bis(α,α-dimethylbenzyl)peroxide

Bis(α,α-dimethylbenzyl)peroxide (EC No. 201-279-3) is known to be toxic for reproduction and is commonly used as a processing aid, including. as a flame retardant. More detailed information on the substance can be found in the Member State Support document here.

Suspension of Triphenyl Phosphate Classification

In addition to the update, ECHA has suspended the SVHC classification of triphenyl phosphate (TPhP; EC no. 2024-112-2), which was scheduled for the June MSC meeting. This suspension follows the emergence of significant new information shortly before the meeting that required further evaluation.

Understanding Substances of Very High Concern

Substances of Very High Concern (SVHCs) are substances that may cause serious and often irreversible effects on human health and the environment. A substance identified as an SVHC is placed on the Candidate List for possible inclusion in the Authorisation List. Some of the entries in the Candidate List are groups of chemicals, so the total number of chemicals concerned is higher. The Authorisation List contains 59 entries. If a substance is on the Authorisation List, its use is prohibited unless the European Commission grants an authorisation for continued use.

Legal obligations for Candidate List Substances under REACH

Under the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Regulation there are legal obligations for substances included in the Candidate List.

• Suppliers must inform their customers and consumers if their products contain more than 0.1 % (weight by weight) of a Candidate List substance.

• Consumers have the right to ask suppliers whether their products contain SVHCs.

• Suppliers of Candidate List substances, either on their own or in mixtures, must provide a safety data sheet (SDS)to their customers.

• Importers and manufacturers of articles containing a Candidate List substance must notify ECHA within six months of the substance being added to the list.

In addition, under the Waste Framework Directive, companies must notify ECHA if the articles they produce contain SVHCs in concentrations above 0.1 % (weight by weight). This notification is then made publicly available in ECHA's Substances of Concern in Products (SCIP) database.

New Intentions to Identify Substances for the Candidate List

ECHA also announced on 27 June 2024, that 2 new intentions to identify SVHCs have been received. The two substances are tris(4-nonylphenyl, branched) phosphite (EC 701-028-2) and 6-[(C10-C13)-alkyl-(branched, unsaturated)-2,5-dioxopyrrolidin-1-yl]hexanoic acid (EC 701-118-1). The registry of SVHC intentions until outcome can be found here.

The UK government has extended the deadline of the public consultation on proposals to amend the current transitional provisions under UK-REACH by introducing an Alternative Transitional Registration model (ATRm) until 25 July 2024. Launched on 16 May 2024, the consultation seeks to gather stakeholder opinions on proposed changes to the UK-REACH framework, aiming to reduce costs for businesses transitioning from the EU- REACH regime while maintaining health and environmental protections.

Key Proposals to Improve UK-REACH

Key proposals include reducing duplication, speeding up decision-making, and introducing measures to minimize animal testing. The consultation also addresses changes to the restriction and reporting processes and assesses impacts on trade.

Stakeholders, particularly those from chemical businesses and related sectors, are encouraged to participate and provide their views. The feedback will inform future legislative changes, supported by a Statutory Instrument and impact assessment, to be introduced after a second consultation.

For more information and to participate, visit the Defra website here.

India’s Department of Chemicals and Petrochemicals (DCPC) has extended the enforcement date of the Quality Control Orders (QCOs) for four polymer products. The notifications were published in the Gazette of India on 4 June 2024 in consultation with the Bureau of Indian Standards (BIS). The QCOs were originally published on 6 December 2023 and were due to come into force on 3 June 2024.  

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

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

The Bureau of Indian Standards (BIS) invites public comments on the first revision of the standard for sodium bromide, pure (IS 2780) until 24 June. Sodium bromide is widely used in the chemical industry and laboratories for the preparation of bromides and in medicine. The revised standard specifies the requirements and testing procedures for pure sodium bromide. 

Revised Standard: Specifications and Test Methods 

This standard was originally published in 1964. In this first revision, instrumental test methods for the determination of chlorides, sulphates, iron, lead and arsenic have been added as alternative test methods. In addition, editorial corrections have been made where required. A reference clause has also been incorporated. Furthermore, the clause on packing and marking has been updated. 

According to the notice, pure sodium bromide should be free from impurities and foreign matter. It should appear as tiny, colourless, transparent or opaque crystals or as a white granular powder. The chemical must be stored in tightly sealed containers as it readily absorbs water from the environment.  

 
 
The following table contains requirements for sodium bromide when tested by the methods specified in Annex A of the revised standard 

Packaging and Labelling  

The product must be packaged in clean galvanized iron drums lined with polyethylene or in glass bottles. Each container must be labelled with the following information:  

a) Name and grade of the material;  

b) Net mass of the material;  

c) Date of manufacture;  

d) Manufacturer's name and/or his recognized trade-mark, if any; and  

e) Batch number.  

Containers of analytical reagent grade material should also be labelled with analytical data according to the revised standard.  

BIS Certification Marking  

The product(s) conforming to the requirements of this standard may be certified under the conformity assessment schemes established under the provisions of the Bureau of Indian Standards Act, 2016 and the rules and regulations made thereunder and the products may be marked with the standard mark.  

Starting from June 1, 2024, medical devices listed in the third batch implementation product catalogue in China must complete registration and obtain a Unique Device Identification (UDI) in accordance with the new regulations, according to the National Medical Products Administration (NMPA) Announcement No. 22 of 2023.

Implementation of the UDI System

The Unique Device Identification (UDI) System Rules, which were established by the NMPA on October 1, 2019, aim to standardise the construction of UDIs and strengthen the lifecycle management of medical devices. Each device receives a unique identification code, and registrants must create, maintain, and assign the UDI for devices, upload data, and use the UDI to improve the overall lifecycle management of devices.

First and Second Batch

On January 1, 2021, NMPA decided to implement the UDI system for the first batch of 69 Class III medical devices, and on June 1, 2022, following the implementation for the second batch of other Class III medical devices (including in vitro diagnostic reagents), Order No. 22 of 2023 announced the third batch of products to adopt the UDI system.

Details of the Third Batch

This third batch includes high-demand single-use products, items selected for centralized procurement, and medical aesthetic products, totaling 103 types in 15 categories. The detailed catalogue can be found on the official announcement page here.

Compliance Requirements

The new regulations took effect on June 1, 2024. From that date, new registration applicants are required to submit product identifiers for the smallest sales unit in the registration system. For devices registered before June 1, 2024, registrants must provide these identifiers when renewing or amending their registrations.

On June 4, 2024, the Korean Environmental Corporation (K-ECO) announced that chemical substances that are wholly exported to foreign countries and fall under Article 11, Clause 1 of the Decree (Confirmation of Exemption from Registration and Reporting) will be exempted from registration and reporting. 

The Decree was due to enter into force on August 7, 2025, but the implementation date has been brought forward to May 28, 2024. This is due to the immediate application of Article 11, Clause 1, Number 3 of the Act and is part of an initiative by the Ministry of Environment to improve the active administration system. It will no longer be necessary to submit documents to prove the exporting country and the export volume. 

Relevant Legal Text 

※ Article 11, Clause 3 of the Act on the Registration and Evaluation of Chemical Substances: A person who intends to manufacture or import other chemical substances prescribed by Presidential Decree, such as a chemical substance manufactured or imported to export the whole quantity thereof, in which case he or she has obtained confirmation of exemption from registration or reporting (hereinafter referred to as "confirmation of exemption from registration, etc.") from the Minister of Environment. 

In such cases, the number of goods registered pursuant to Article 10 (1) and (5) or reported pursuant to paragraph (4) of the same Article shall be excluded from the calculation of the quantity for which registration, etc. has been exempted. 

Effective June 6, 2024, the Occupational Safety and Health Administration (OSHA) under the Ministry of Labour  in Taiwan has implemented amendments to the "Regulations for Governing Designating and Handling of Priority Management Chemicals." These revisions aim to further develop the safety protocols and management practices for hazardous chemicals in workplaces, focusing on strict reporting requirements to improve safety measures to protect workers’ health and the environment.

Key Changes to the Regulations

The revised regulations prioritise the management of hazardous chemicals. These include carcinogens, mutagens, reproductive toxicants, respiratory sensitizers, substances causing serious eye damage and specific target organ toxicants (STOT). These classifications follow national standards (CNS 15030).

Reporting Requirements

Operators must submit detailed reports to the Central Authority. There are three types of reporting.

• Initial Reporting: Submit comprehensive details about operations, including chemical quantities and handling practices, including any changes in operations.

• Periodic Reporting: Provide annual updates on the use and management of chemicals.

• Dynamic Reporting: Report any significant changes in chemical quantities within 30 days of the change to ensure data is kept up to date.

Enforcement and Penalties

The amendments impose strict penalties for non-compliance, including fines for false information, failure to report or errors in submissions. Products that are exempted from the updated priority manager measure are industrial waste, tobacco, food, beverages, medicines, cosmetics, finished products, fire extinguishers and consumer goods for non-industrial use.

Safety Measures

Operators are required to maintain accurate records and follow strict safety measures when handling hazardous chemicals. By enforcing stricter reporting requirements and improving safety protocols, the Ministry of Labour aims to reduce the risks associated with hazardous chemicals to protect workers and the environment.

Conclusion

The updated regulations highlight the government's dedication to maintain high workplace safety standards by imposing a stricter chemical management system.

The Taiwan Food and Drug Administration (TFDA) has announced significant regulatory changes for the cosmetics industry, set to take effect on 1 July 2024. These changes primarily involve the restructuring of cosmetic ingredient lists and the reclassification of specific purpose cosmetics to general cosmetics, as well as enhanced reporting and compliance requirements. These updates are designed to ensure the safety and quality of cosmetic products.

Restructuring of Ingredient Lists

The TFDA will abolish the current List of Specific Purpose Ingredients and the List of Antibacterial Ingredients Allowed in Cosmetic Products. A new List of UV Filters will be established, and changes will be made to the List of Ingredients Restricted in Cosmetic Products. This includes the addition of 122 new ingredients, the revision of 31 ingredients and the deletion of 2 ingredients from the restricted list.

Reclassification of Cosmetics

Starting 1 July 2024, specific purpose cosmetics (e.g., sunscreen, hair dye, tooth whitening) will be reclassified as general cosmetics. This transition will shift the regulatory requirements from pre-market registration to a more streamlined notification process and the establishment of a Product Information File (PIF). This change aims to simplify the compliance process for cosmetic companies, reduce the administrative burden and expedite product launches.

Compliance and Reporting Requirements

Cosmetics manufacturers and importers must comply with the new notification system and prepare PIFs for inspection by the TFDA. The notification system will require detailed information about the product, including safety assessments and compliance with Good Manufacturing Practices (GMP).

Phased Compliance Schedule

To facilitate a seamless transition, the TFDA has established a phased compliance schedule:

• Specific Purpose Cosmetics: Must comply by 1 July 2024.

• Non-Specific Purpose Cosmetics for Infants, Lips, or Eyes: Compliance required by 1 July 2025.

• Other Non-Specific Purpose Cosmetics: Compliance required by 1 July 2026.

The new regulations are designed to improve the safety and quality of cosmetic products. Cosmetics companies are advised to prepare for these changes to ensure seamless compliance by the 1 July 2024 deadline.

On 21 June 2024, Japan took a significant step in chemical safety management by releasing an updated list of new and revised Globally Harmonized System (GHS) classifications for 160 chemical substances. This update was published by the National Institute of Technology and Evaluation (NITE) on behalf of the Ministry of Health, Labour and Welfare (MHLW), the Ministry of the Environment (MOE) and the Ministry of Economy, Trade and Industry (METI).

This GHS classification was performed based on the information sources and guidance for classification and evaluation which are described in the GHS Classification Guidance for the Japanese Government etc.

Details of the Update:

• New Classifications: The update includes 48 newly classified substances such as Oxiran-2-ylmethyl neodecanoate (CAS 26761-45-5) and Cycloaliphatic epoxy resin (CAS 2386-87-0).
• Revised Classifications: It also revises the classifications for 112 existing substances, including 1,2-Dichloropropane (CAS 78-87-5) and Cellosolve acetate (CAS 111-15-9).

Comprehensive Information:

The detailed list is available in both Japanese and English. It includes the following critical information for each substance:

• Hazard Class
• Pictogram
• Signal Word
• Hazard and Precautionary Statements
• Classification Rationale
• CAS Numbers
• Reference Materials

The classifications were finalized during the fiscal year 2023, from 1 April 2023, to 31 March 2024.

Implications for Companies:

While companies are encouraged to use this updated list as a reference when preparing GHS-based labels or Safety Data Sheets (SDS), it is not mandatory. Companies may choose to use other test results and information sources to support their labels and SDS content.

Japan follows the sixth revised edition of the UN Globally Harmonized System of Classification and Labelling of Chemicals. Currently, Japan's GHS list includes a total of 3376 substances. This update reinforces Japan's commitment to chemical safety and aligns with global standards for chemical classification and labelling. Companies involved in the production, handling or use of these substances should review the new classifications to ensure compliance and safety.

The Brazilian federal government launched the "Selo Verde Brasil" (Green Seal Brazil) Program to promote sustainable development and reduce greenhouse gas emissions. The decree establishing the program was officially published on 18 June 2024, signalling Brazil's renewed commitment to responsible environmental practices.

Program Objectives

The Green Seal Brazil Program aims to certify products and services that meet pre-defined sustainability requirements. This certification will provide consumers and businesses with accurate and verifiable information, thus encouraging informed choices and promoting sustainable consumption. Another important objective is to strengthen sustainable public procurement processes in the country.

Implementation and Standards

According to the decree, the program will follow both national and international environmental certification standards, ensuring reciprocity and mutual recognition with similar global initiatives. This strategy aims to facilitate the acceptance of Green Seal Brazil in international markets, thereby enhancing the global competitiveness of Brazilian products.

Integration with Existing Initiatives

Green Seal Brazil will be integrated with existing certification programs and sustainability initiatives. It will be aligned with public policies that promote sustainable products and services and support the Ministry of Finance's Ecological Transformation Plan. This comprehensive integration is designed to strengthen the country's green economy and promote transparency, social inclusion and income generation.

Role of the Conformity Assessment Bodies

The certification process will be carried out by conformity assessment bodies accredited by the National Institute of Metrology, Quality and Technology (Inmetro). These bodies will verify that products and services comply with the sustainability requirements set out in specific Brazilian technical standards.

Future Impact and Commitment

In order to ensure the effective implementation of the program, the Ministry of Development, Industry, Commerce and Services may enter into contracts, technical cooperation agreements or adjustments with public and private entities. The visual identity of the Green Seal Brazil will be established by an act of the Minister of State for Development, Industry, Commerce and Services.

Conclusion

The launch of the Green Seal Brazil represents a significant step forward in the promotion of a green economy in Brazil. It reaffirms the country's commitment to sustainability and environmental protection, aiming at a greener and more prosperous future. This decree will take effect on the date of its publication, marking a new era of sustainable and conscious practices in Brazil.

The Federal Office of Public Health (FOPH), in collaboration with the Federal Office for the Environment (FOEN) and the State Secretariat for Economic Affairs (SECO), has announced significant amendments to the Ordinance on the Protection against Dangerous Substances and Preparations (ChemO). These amendments were notified to he World Trade Organization (WTO) on May 27, 2024. The amendments, The aim of the amendments which will come into force on September 1, 2024, is to improve safety standards for chemical products in Switzerland.

Key Amendments

Updates to Annex 2:

• Classification, Labelling, and Packaging: The European Union’s CLP Regulation (Regulation (EC) No 1272/2008) Annexes I to VII are now applicable to Swiss standards. This alignment ensures that the classification, labelling, and packaging of substances and preparations are consistent with international guidelines.

• New EU Hazard Classes: The new EU hazard classes according to Delegated Regulation (EU) 2023/707 for endocrine disruptors and chemicals that are persistent, bioaccumulative, or may reach surface water, groundwater or drinking water due to their mobility, will become applicable in Switzerland. These hazard classes will become mandatory in stages, first for substances, and subsequently for preparations.

• Testing Methods: The testing methods for determining the properties of substances and preparations have been updated. Acceptable methods include those defined in EU Regulation (CE) No. 440/2008, OECD Guidelines for the Testing of Chemicals (as of June 2024), and the UN Manual of Tests and Criteria.

Updates to Annex 3:

• List of Substances of Very High Concern: Seven news entries have been added to the list and one entry has been updates. This list, effective September 1, 2024, contains 240 substances and groups of substances that have been identified as being of very high concern due to their hazardous properties. This update aims to improve the safety of public health and the protection of the environment by regulating these high-risk chemicals.

Transitional Provisions

In order to facilitate a smooth transition, the Ordinance provides for specific deadlines for compliance:

• Non-compliant substances: Substances that do not comply wjth the new regulations can be marketed until October 31, 2026.

• Non-compliant preparations: Preparations that do not meet the new criteria can be marketed until April 30, 2028.

• Harmonized classification and labelling: Substances listed in Delegated Regulation (EU) 2024/197 and their preparations must comply by August 31, 2025.

Implementation and Compliance

The FOPH emphasizes that these amendments are essential to align Swiss chemical safety standards with international regulations, thereby improving the protection of human health and the environment. Companies dealing with chemical substances and preparations are advised to review the updated requirements and ensure compliance by the specified deadlines to avoid disruptions in their operations.

The Occupational Safety and Health (Amendment) Act 2022 (OSHA 2022), which amends the Occupational Safety and Health Act 1994, will come into effect on June 1, 2024, according to a notification issued by the Malaysian Department of Occupational Safety and Health (DOSH) on April 2, 2024. Although the Act was promulgated on March 16, 2022, its implementation was pending until now.  

A notice of the enforcement date of the Factories and Machinery (Repeal) Act 2022, which repeals the Factories and Machinery Act 1967, was also issued on April 2. In addition, two new regulations based on OSHA 2022 will be introduced: 

• Occupational Safety and Health (Licenced Person) Order 2024  

• Occupational Safety and Health (Plant Requiring Certificate of Fitness) Regulations 2024.  

All these Acts and regulations will come into effect on June 1, 2024. 

Occupational Safety and Health (Amendment) Act 2022 

The following are the main changes to the Act that affect employers.  

• Obtain permit from the Director-General of the Department of Occupational Safety and Health (DOSH) before constructing or operating a specified facility. Then, issue a Certificate of Fitness (refer to the guidelines below). 

• In businesses with five or more employees where the appointment of a safety and health officer is not required, a safety and health coordinator should be appointed. If an employer fails to appoint a coordinator, the employer could be fined up to RM50,000, face six months in prison or both.   

• A person must register as a competent person if he or she carries out any of the tasks listed in Appendix 5 (installation, operation, disassembly, maintenance, etc. of a plant, medical surveillance, assessment of exposure to hazardous substances, noise, etc.) 

• Occupational safety and health training is required for designated workers; details are set out in separate laws and regulations, which have not yet been published.

Occupational Safety and Health (Plants Requiring a Certificate of Fitness) Regulations 2024 

The main points of the regulation are: 

• Applies to steam boilers, pressure vessels, and lifting gear. 

• Requires inspection by a licensed individual before installation. 

• Information on the design of the installation must be submitted to the Director General of DOSH for a Certificate of Fitness, which is valid for 15 months. 

• A periodic inspection is required to renew the certificate before it expires. 

Occupational Safety and Health (Licenced Person) Order 2024 

The main content of this Order is: 

• Details the appointment and duties of licensed individuals responsible for plant inspections. 

• Lists the verification requirements for plant inspections. 

Factories and Machinery (Repeal) Act 2022 

 This The Factories and Machinery Act 1967 is to be repealed in order to maintain consistency between laws and regulations as it contains requirements similar to those in the Occupational Safety and Health Act of 1994. It will be replaced by the Factories and Machinery (Repeal) Act 2022. 

Presidential Regulation No. 14 of 2024 on the Implementation of Carbon Capture and Storage Activities was enacted by the Government of the Republic of Indonesia on January 30, 2024. This regulation outlines a methodology for the capture and processing of carbon produced by upstream oil and gas business activities, power plants, industries, and other emission-producing activities. It also defines procedures for transporting carbon from collection and/or processing facilities to injection and storage locations. 

Although Carbon Capture Storage, or "CCS," is not a novel concept, this regulation signals an exciting phase in Indonesia’s history. This strategy will revolutionize the country's economy by creating new business opportunities and expanding the market for low-carbon goods worldwide. 

Objectives

The main focus of the recently released Presidential Regulation No. 14 of 2024 (PR No. 14/2024) is to facilitate the execution of CCS operations highlighting Indonesia's potential as a hub for carbon storage. The regulation provides two main plans for CCS operations: 

• CCS inclusion: This requires cooperative alterations to contracts for integration with oil and gas operations. 

• Licensing: Licenses will be needed for exploration and storage operations in regions that are designated as non-working areas. 

A more detailed procedure for CCS implementation plans is described in PR No. 14/2024, which includes examination by SKK Migas's ((Oil and Gas Upstream Business Activities Operational Agency) and approval by the MoEMR (Ministry of Energy and Mineral Resources). While carbon-storage licenses are not a requirement for implementing CCS in accordance with MoEMR Reg No. 2/2023, the regulation prioritizes domestic storage capacity and international collaboration. 

In order to encourage investment in CCS projects, the regulation emphasizes tax incentives and introduces a carbon transport licence. PR No. 14/2024 complements MoEMR Reg No. 2/2023 and is detailed enough for businesses to begin thinking about developing CCS projects. 

Outcome

Indonesia stands to gain greatly from the application of CCS both the environmentally and economically. In addition to promoting innovation and creating highly skilled jobs, the development and application of CCS can attract investment, particularly from abroad. Indonesia has the geographical advantages that make it even more likely to make a big impact on the global CCS scene. 

On 27 May 2024, the Chilean Agriculture and Livestock Service (SAG) published a draft regulation that establishes the conditions and requirements for authorising the importation and use of pesticide samples. This draft, which aims to improve processes for research and development in the agricultural sector, reflects the SAG's commitment to improving the efficiency and safety of pesticide evaluation. If adopted the resolution will repeal Resolution No. 92 of 2002. It is open for comments until 24 July 2024.

Streamlined Process for Innovation

The new regulations propose a structured framework for the management of pesticide samples, which is crucial for innovation in pest control solutions. By providing clear guidelines, the SAG aims to facilitate scientific research and product development, while ensuring that safety and environmental standards are maintained. The regulations specify the documentation required for importing samples, including detailed information on chemical composition, intended use and safety data sheets. This transparency is expected to streamline the approval process and reduce the administrative burdens for researchers and companies.

Ensuring Safety and Compliance

Safety is the core of the proposed regulation. The draft requires strict safety measures to be followed during the handling, storage, and application of pesticide samples. These measures include proper labelling, safe storage conditions and protocols for emergency situations. Additionally, the regulations emphasise the importance of complying with international safety standards, bringing Chile's practices in line with global best practice.

To ensure thorough oversight, the SAG will require detailed reporting from companies that import and use pesticide samples. These reports must include data on the use, efficacy and any observed environmental or health impacts. This information will be essential for ongoing monitoring and assessment to ensure that the use of these samples does not pose undue risks.

Facilitating Research and Development

One of the main objectives of the new regulations is to support research and development in the agricultural sector. By simplifying the process of obtaining and using pesticide samples, the SAG hopes to encourage innovation and the development of more effective and safer pest control solutions. The regulations will make it easier for researchers to conduct field trials and laboratory experiments  accelerating the discovery of new products and practises that can improve agricultural productivity and sustainability.

The draft regulations also include provisions for the import of pesticide samples for educational purposes. Universities and research institutions will have easier access to these samples, supporting academic research and the training of future scientists. This educational component is seen as an important part of fostering a culture of innovation and scientific inquiry within Chile's agricultural sector.

Public Consultation and Feedback

The SAG has opened the draft regulations for public consultation, inviting feedback from stakeholders including farmers, researchers, industry representatives and environmental groups. This inclusive approach aims to gather diverse perspectives and ensure that the final regulations are robust, practical and widely accepted.

Stakeholders are encouraged to review the draft and provide input on various aspects such as documentation requirements, security measures and reporting protocols. The SAG will carefully consider this feedback before finalizing the regulations, with the aim of creating a regulatory framework that supports innovation while protecting public health and the environment.

The consultation is open for comments until 24 July 2024.

Conclusion

The proposed regulations for the import and use of pesticide samples represent a significant step forward for Chile's agricultural sector. By establishing clear guidelines and robust safety measures, the SAG aims to facilitate research and development, support innovation, and ensure the safe and effective use of pesticides. The public consultation process underscores the importance of stakeholder engagement in shaping policies that will impact the future of agriculture in Chile.

For more details, please see the draft resolution (in Spanish) here.

On 21 May 2024, the Gulf Cooperation Council (GCC) notified the World Trade Organization (WTO) of a second draft standard, i.e. GSO/TC01 /DS2/ GSO2654:2023, aligned with the seventh revised edition of the Globally Harmonized System of Classification and Labelling of Chemicals (GHS 7). The draft was prepared by the GCC Standardization Organization (GSO) Technical Committee No. GSO/TC01. This GSO draft aims to ensure the safe production, transport, handling, use and disposal of hazardous substances in line with GHS requirements. In addition to the GCC members United Arab Emirates (UAE), Kingdom of Bahrain, State of Kuwait, Oman, State of Qatar and Kingdom of Saudi Arabia), Yemen has also notified this draft standard to the WTO.

Overview and Scope

GSO Standard GSO2654:2023 establishes comprehensive criteria for classifying substances and mixtures according to their health, environmental, and physical hazards. It also details elements of hazard communication, including requirements for Safety Data Sheets (SDS) and labelling.

The regulation applies to all substances and mixtures supplied, used or manufactured in GCC countries, with certain exceptions such as radioactive substances, non-isolated intermediates and products such as cosmetics, detergents and foodstuffs. The standard ensures that all chemical products, regardless of their manufacturing stage, comply with GHS requirements without any exemptions.

Previous GCC Draft Standard

On 6 November 2023, the Gulf Cooperation Council (GCC) notified the World Trade Organization (WTO) of the first draft standard GSO 2654:2023 for the implementation of GHS 7. This Gulf Standardization Organization (GSO) standard is based on a previous draft published on 30 August 2018.

Insights from the Second Draft Standard

Compared to the first draft of the standard, the following new provisions have been added to the second draft:

• Safety Data Sheets (SDS) must be revised within 18 months if new information becomes available

• Specific provisions for human health and environmental safety have been added.

• New definitions have been added for:

3.21 Supplier

3.22 Hazardous materials

3.23 Mixture

3.24 Hazard

3.25 Risks

3.26 Accident

3.27 Near miss

3.28 Labels

3.29 Risk classification

Key Elements of the Draft Standard

1. Requirements for Safety Data Sheets (SDS):

   - Language and Format: SDSs must be clear, concise, and available in English and Arabic. They should follow a 16-section format covering identification, hazard identification, composition, first aid measures, fire-fighting measures, accidental release measures, handling and storage, exposure controls/personal protection, physical and chemical properties, stability and reactivity, toxicological information, environmental information, disposal considerations, transport information, regulatory information, and other relevant details.

   - Updates and Confidentiality: The SDS should be updated promptly with any new significant information affecting health and environmental protection. Confidential business information shall be made available to competent authorities on request without compromising safety details.

2. Labelling Requirements:

   - Content and Presentation: Labels must be bilingual (Arabic and English) and include product identifiers, supplier details, hazard pictograms, signal words, hazard statements, precautionary statements and additional information. Labels should be legible and of an appropriate size for easy reading.

   - Precedence and Exemptions: In the case of multiple hazards, precedence rules for symbols, signal words and statements must be followed to avoid redundancy. Small packages and certain product forms may have reduced labelling requirements under certain conditions.

3. Hazard Classification:

   - Substances and Mixtures: Classification is based on available data on physical, health and environmental hazards. Self-classification and harmonized classification are used, with specific rules for determining concentration limits and cut-off values for hazardous components.

   - Physical, Health, and Environmental Hazards: Detailed criteria and communication elements are provided for different hazard categories to ensure comprehensive coverage of potential risks.

4. Implementation and Compliance:

   - Training and Responsibilities: Suppliers must ensure that SDS authors are competent and well trained. Regular refresher training programs are mandatory to maintain compliance.

   - Regulatory Alignment: The draft aligns with international standards such as the Classification, Labelling and Packaging (CLP) Regulation and GHS, facilitating global trade and improving chemical safety management in the GCC region.

Target Audience

This standard is essential for consumers, workers, transport personnel, and emergency responders dealing with chemical products in the GCC countries. It provides a consistent approach to hazard communication and promotes safer handling and use of hazardous substances throughout the region.

Deadline for Comments

Interested stakeholders and parties are invited to submit comments by 20 July 2024. The date of adoption and entry into force are yet to be decided.

Future Developments

The GSO invites comments on this draft regulation, emphasizing its status as a working document subject to revision. Once approved, GSO2654:2023 will become a formal Gulf Technical Regulation and will significantly improve the management of hazardous materials in the GCC countries.

On 6 May 2024, Singapore’s National Environment Agency (NEA) announced revised compliance dates for Dechlorane Plus, Methoxychlor, and UV-328 under the Stockholm Convention.

Chemicals Added to Annex A to the Stockholm Convention

At the 11th Conference of the Parties (COP) to the Stockholm Convention in May 2023, the Parties agreed to include Dechlorane Plus, Methoxychlor and UV-328 in Annex A for elimination, subject to certain exemptions. Following this decision, the NEA issued a circular to industry stakeholders on 24 July 2023 that the manufacture, import and export of these chemicals and products containing them would be prohibited in Singapore with effect from 12 May 2024.

Revised Compliance Date

However, the listing of Dechlorane Plus, Methoxychlor and UV-328 in Annex A to the Stockholm Convention was not officially communicated via a Depositary Notification until 26 February 2024. According to the rules of the Stockholm Convention, amendments to the Annexes take effect for all Parties one year after the date of notification. Consequently, the effective date for Singapore to cease the manufacture, import, and export of Dechlorane Plus, Methoxychlor and UV-328 has been revised to 26 February 2025 to meet the Convention deadline.

Details on Exemptions and HS Codes to Follow

The NEA will provide further details on specific exemptions in due course. Industry stakeholders are advised to refer to the annex attached to the announcement for the list of applicable Harmonized System (HS) and Product Codes required for the declaration of  import and export TradeNet® licence applications. All such applications will be subject to approval by the Chemical Control and Management Department (CCMD).

On 29 May 2024, the Ministry of Environmental Protection and Natural Resources of Ukraine announced the completion of the public consultation process on the draft Resolution of the Cabinet of Ministers of Ukraine "On the Approval of the Technical Regulation on the Safety of Chemical Products" by, commonly referred to as Ukraine-REACH or UA-REACH.

Ukraine-REACH Consultation

I accordance with the established procedure for public consultations on issues of state policy in Ukraine, the draft Resolution was initially published on the official website of the Ministry on 22 March 2024. The public was invited to submit written suggestions and comments for a two-month period.

During this period, feedback was received from various stakeholders, including the European Business Association (EBA), the Ukrainian Association of Tobacco Manufacturers "UKRTTYUTYN", the Association of Manufacturers and Formulators of Enzyme Products (AMFEP), the European Chemical Industry Council (Cefic), the Japan Chemicals Exporters and Importers Association (JCEIA) and the American Chamber of Commerce in Ukraine.

The Ministry has reviewed all submissions and published the results on its official website, providing a table summarising the comments and suggestions from these entities and organisations.

Revisions and Recommendations for REACH Implementation in Ukraine

A general concern of stakeholders participating in the consultation was the proposed timelines for chemical registration. There are significant concerns about the feasibility of the currently proposed deadlines for each tonnage band. This concern is based on past experience with e.g. KKDIK (Turkey REACH), which required significant extensions to allow industry to comply.

The Ministry of Environmental Protection and Natural Resources has responded to the concerns by revising the compliance deadlines. The revised deadlines, based on the tonnage of existing chemicals produced or made available on the market, are as follows:

Other recommendations by stakeholders:

• Simplify the registration process, especially for substances already registered under EU REACH.

• Adopt models from other countries (e.g. Switzerland or Türkiye) to reduce redundancy and administrative burden.

• Ensure clear and consistent regulations that in line with existing legislation and international practice to facilitate implementation and compliance.

For more details on the results of the public consultation, please visit the Ministry's official website here.

On 21 June 2024, the Ministry of Environmental Protection and Natural Resources (MEPNR) of Ukraine announced that the Cabinet of Ministers of Ukraine has approved the procedure for the creation and operation of the Information System for Chemical Safety. This is an important step towards modernising regulatory oversight in Ukraine. The platform will be launched as part of the national online platform EcoSystem, which provides up-to date information on the state of the environment.

Services for Companies and Improved Public Access

The new information system will provide a range of administrative services for companies and open registers for public access. Companies will be able to:

• Submit documents for registration of chemical substances.

• Obtain permits for the use of poisonous and particularly hazardous chemicals that are withdrawn from the market.

• Notify authorities of the use of alternative names for chemical substances.

• Report on the hazard classification of chemical products.

In addition, the system will provide comprehensive information on:

• Chemical products, their market volumes and hazardous properties.

• Potential risks associated with the use of chemicals and related safety measures.

• Manufacturers, importers, and suppliers of chemical products.

• Chemical incidents and identified threats to chemical safety.

Meeting EU Integration Obligations

The initiative stems from Ukraine's commitment to harmonise its chemical safety regulations with EU standards, required by the Law on Ensuring Chemical Safety and Management of Chemical Products, which will come into force on 29 June 2024. This legislation sets the framework for the adoption key EU technical regulations, including CLP (Classification, Labelling, and Packaging) and REACH (Registration, Evaluation, Authorization, and Restriction of Chemicals).

CLP and REACH in Ukraine

On 10 May 2024, the Ukrainian government adopted the Technical Regulation for the Classification of Hazards, Labeling and Packaging of Chemical Products. The Technical Regulation will enter into force on 15 November 2024, except for some parts which will enter into force on 1 January 2025

Regarding the implementation of Ukraine-REACH, the MEPNR has already developed the draft Technical Regulation on the Safety of Chemical Products, which will be submitted to the Government for consideration in the near future.

The MEPNR recently announced the completion of the public consultation process on the draft resolution for Ukraine-REACH. A significant outcome of the public consultation is the MEPNR’s decision to revise the deadlines for registration under Ukraine-REACH, allowing industry additional time to prepare. The revised deadlines, based on the tonnage band are as follows:

• 1 October 2026 for tonnages over 1000 TPA

• 1 June 2028 for the 100-1000 TPA tonnage band.

• 1 March 2030 for the 1-100 TPA tonnage band.

Chemical products on the market before the entry into force of the Regulation that do not comply with all or some of the requirements of the Technical Regulation may continue to be sold for up to one year after entry into force of the Regulation.