GPC Newsletter May-2024

The Canadian Department of the Environment announced on April 20, 2024, an enhanced regulation under the Canadian Environmental Protection Act, 1999, that will now require industries involved with plastic resins and products to report extensively to the Federal Plastics Registry. This initiative, rooted in subsection 46(1) of the Act, underscores Canada's commitment to reducing plastic waste through improved transparency and accountability.

The regulation requires all entities, including manufacturers and importers of plastic resins and products to maintain detailed records documenting their compliance for three years (2024-2026),. These records should include calculations, measurements and any other data supporting the information provided and should be stored at the parent company’s head office in Canada. The information must be submitted by September 29 of the following year.

The mandate details a comprehensive list of 24 specific plastic resins classified under the North American Product Classification System (NAPCS) Canada 2022 Version 1.0, which includes commonly used plastics such as polyethylene terephthalate (PET) and polyvinyl chloride (PVC). The notice also covers a wide range of plastic products in various sectors such as electronic and electrical equipment, transportation, construction and agriculture, as well as items intended for single use or disposal.

Key components of the regulation include:

- Recordkeeping and Reporting: Companies are required to keep and report data on the volume and types of plastics produced or managed. This includes details such as the resin types, their sources (virgin fossil-based, virgin bio-based, post-consumer recycled, and post-industrial recycled), and detailed categorization of plastic products in terms of their applications in various industries.

- Confidentiality Requests: In response to the Notice, companies may requests that their information be treated as confidential, on the basis of section 52 of the Act. However, the Minister retains the authority to disclose such information as necessary under subsection 53(3).

- Penalties for Non-Compliance: The Notice explicitly states that non-compliance may result in penalties under the applicable offence provisions of the Act, underscoring the strict enforcement of these environmental regulations.

This regulation extends to detailed reporting of plastic packaging, both filled and unfilled, within specific sub-categories such as rigid and flexible packaging types, covering a range of products from beverage containers to packaging for hazardous materials.

Through this initiative, Canada aims not only to monitor and reduce the environmental impact of plastic production but also to improve recycling and disposal processes. This is part of a broader national effort to ensure a sustainable future through responsible environmental stewardship and industrial practices.

The Environmental Protection Agency (EPA) is proposing Significant New Use Rules (SNURs) under the Toxic Substances Control Act (TSCA) for chemicals previously reviewed in premanufacture notices (PMNs). These chemicals have been deemed "not likely to present an unreasonable risk" under TSCA. The SNURs require notification to EPA at least 90 days before manufacturing or processing any of these chemicals for a newly proposed significant use.

Proposed Rule:

Under TSCA, EPA must make a determination and take necessary action prior to the manufacture or processing of a new chemical substance or for a significant new use. A SNUR is not a risk determination itself but requires notification for “significant new uses” so that EPA can review and assess the risk. Following EPA's review of a pre-manufacture notice (PMN), a Microbial Commercial Activity Notice (MCAN), or a Significant New Use Notice (SNUN) under TSCA Section 5, it may take appropriate action. Manufacturers must await EPA's review and decision before commencing manufacturing or processing for a significant new use.

Potentially affected entities may include manufacturers or processors of one or more subject chemical substances such as chemical manufacturing and petroleum refineries. For exporters of substances subject to SNURs, a single notification to EPA is required for the first export to a specific country.

Costs:

Submitting a Significant New Use Notice (SNUN) has an estimated cost of $26,700 for large companies and $11,000 for small companies. These costs cover preparation and submission of the SNUN, including registration on EPA's Central Data Exchange (CDX), along with payment of user fees. Large companies pay a user fee of $19,020, while small companies, as defined in 13 CFR 121.201, pay a reduced fee of $3,300 per fiscal year.

The total expenses for export notification will vary based on the requirements of the chemical and the number of countries involved.

Factors assessed while determining that the use of a chemical substance is a significant new use include:

• The projected volume of manufacturing and processing of a chemical substance.
• The extent to which a use changes the type or form of exposure of human beings or the environment to a chemical substance.
• The extent to which a use increases the extent and duration of exposure of human beings or the environment to a chemical substance.
• The reasonably anticipated manner and methods of manufacture, processing, distribution in commerce, and disposal of a chemical substance.

Submission of Significant New Use Notifications (SNUNs) requires completion of EPA Form No. 7710-25, which is generated using e-PMN software, and compliance with the procedures outlined in 40 CFR 720.40 and 721.25. The e-PMN software can be accessed electronically at https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca.

This proposed rule is assigned Docket Number EPA-HQ-OPPT-2021-0228. It was notified to the World Trade Organization (WTO) on April 9, 2024. The deadline for submitting comments is May 8, 2024.

On April 19, 2024, the US Environmental Protection Agency (EPA) published a rule designating perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS), along with their salts and structural isomers, as hazardous substances under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA), also known as Superfund. This amendment to Title 40 of the Code of Federal Regulations will become effective 60 days after publication in the Federal Register.

Background

PFOA, PFOS, their salts, and structural isomers are considered hazardous substances under CERCLA due to their prolonged accumulation and persistence in the human body. Studies on both laboratory animals and human populations have revealed a correlation between exposure to these substances and adverse health effects including cancer, immune system disruption, cardiovascular issues, liver damage, and harm to developing fetuses. Failure to address these contaminants will lead to continued migration, increased exposure risks and potential cleanup expenses.

CERCLA aims to identify and prioritize sites that pose unreasonable risks to human health, ensure the prompt cleanup of contaminated areas and hold responsible parties accountable for significant pollution. This approach aligns with CERCLA's core objectives of cleaning up contaminated sites and enforcing the "Polluter Pays" principle, which enables EPA to require responsible parties to cover the costs for cleanup.

Reporting Requirements

The direct effects of the rule require:

• All releases of PFOA and PFOS surpassing the one-pound Reportable Quantity (RQ) within a 24-hour period must be reported to the National Response Center (NRC). A subsequent written report should be submitted to the State Emergency Response Commission (SERC) or Tribal Emergency Response Commission (TERC), as well as the Local Emergency Planning Committee (LEPC) or Tribal emergency planning committee (TEPC), at the earliest opportunity after the release.
• Federal entities that transfer or sell property must notify storage, release, or disposal of PFOA or PFOS. They must also include a covenant in the deed, committing to clean up any resulting contamination as per CERCLA 120(h).
• The U.S. Department of Transportation must list and regulate these substances as hazardous materials under the Hazardous Materials Transportation Act.

• Vessel or facility owners/operators must give reasonable notice of any release of these substances to potentially affected parties by publication in local newspapers about.

This rule may impact various entities including, but not limited to:

1. Manufacturers (including importers) of PFOA and/or PFOS, and articles containing these substances.
2. Processors of PFOA and/or PFOS.
3. Manufacturers of products containing PFOA and/or PFOS.
4. Downstream users of PFOA and PFOS.
5. Downstream users of products containing PFOA and/or PFOS.
6. Waste management facilities.
7. Wastewater treatment facilities.

The pre-publication of final rule can be accessed here. 

In a plenary session on 23 April 2024, the European Parliament adopted a provisional political agreement with the EU countries to update the Classification, Labelling and Packaging (CLP) regulation. This revision aligns with the EU's broader Chemicals Strategy for Sustainability, aiming to strengthen and simplify the legal framework for chemicals and promote a sustainable and competitive environment.

As part of the revision a delegated regulation implementing new hazard classes for chemicals and criteria for classification, labelling and packaging of substances and mixtures entered into force on 20 April 2023.

Key highlights of the updated CLP regulation include:

• Mandatory uniform and adequate classification of all hazardous chemicals in the EU.

• Implementation of more accessible and understandable labels, including for products sold online.

• Improved identification and classification of hazardous chemicals to better communicate chemical hazards and address legal gaps and non-compliance issues.

The full text of the update can be found here.

Next Steps

The law is now set for adoption by the Council, followed by publication in the EU Official Journal. It will enter into force 20 days after publication, marking a significant increase in the level of consumer and the environment protection.

On 23 April 2024, the European Parliament approved new EU rules to initiate a more sustainable era of product design and consumption. 

Key Highlights: 

Ecodesign Directive: The European Parliament has adopted new regulations aimed at embedding sustainability into product design and manufacturing processes. These rules will revolutionize the way products are made and used, promoting a more circular economy and reducing environmental impact. 

Ambitious Targets: The new regulations set ambitious targets for products across a range of sectors, including electronics, textiles and construction. These targets will encourage manufacturers to prioritize sustainability and longevity in their designs, leading to products that are more energy -efficient, durable, and recyclable. 

Consumer Benefits: Consumers can expect a number of benefits from these new rules. From reduced energy bills to longer-lasting products and increased access to repair services, the changes are designed to empower consumers and encourage more sustainable consumption habits. 

Global Impact: The EU's commitment to sustainable product design not only benefits European citizens, but also sets a precedent for global environmental action. By leading the way in eco-friendly product regulation, the EU is encouraging other countries to follow suit and prioritize sustainability in their own industries. 

What's Next: 

With these new rules in place, the EU is poised to make significant strides towards a more sustainable future. By embracing eco-friendly product design and manufacturing practices, we can create a world where sustainable products are the norm rather than the exception. 

On 22 April 2024, the European Commission adopted criteria outlining what constitutes ‘essential uses’ of the most harmful chemicals (‘Guiding Criteria and Principles for the Essential Use Concept in EU Legislation Dealing with Chemicals’). This move aims to improve health and environmental protection by accelerating the phase-out of non-essential uses while allowing time for substitution in essential cases.

What is an essential use

In the Communication published on 22 April, the Commission defines that a use of a most harmful substance is essential only if both of the following two criteria are met:

1. Its use is necessary for health or safety or is critical for the functioning of society.

2. There are no acceptable alternatives.

The concept of essential use will only have legal effect if it is included in specific legislation which is currently not the case in the EU.

Most harmful chemicals

A most harmful substance has one or more of the following hazard properties:

• Carcinogenicity Category 1A and 1B.

• Germ cell mutagenicity Category 1A and 1B.

• Reproductive/developmental toxicity Category 1A and 1B.

• Endocrine disruption Category 1 (human health).

• Endocrine disruption Category 1 (environment).

• Respiratory sensitisation Category 1.

• Specific target organ toxicity – repeated exposure (STOT-RE) Category 1, including immunotoxicity and neurotoxicity.

• Persistent, bioaccumulative and toxic/very persistent and very bioaccumulative (PBT/vPvB).

• Persistent, mobile and toxic/very persistent and mobile (PMT/vPvM).

• Hazardous to the ozone layer Category 1.

Use necessary for health and safety

The use of a most harmful substance is necessary for health or safety if the use and the technical function of the substance in that use are necessary in order to:

• Prevent, monitor or treat disease and similar health conditions.

• Maintain essential conditions for human or animal life and health.

• Manage health crises and emergencies.

• Ensure personal safety.

• Ensure public safety.

These elements are described in the Annex to the Communication (Table 2).

Uses critical for the functioning of society

The use of a most harmful substance is critical for the functioning of society if the use and the technical function of the substance in that use are critical in order to:

• Provide resources or services that need to be maintained for society to function (e.g. ensure the supply of energy and critical raw materials or resilience to supply disruptions).

• Manage societal risks and impacts of natural crises and disasters.

• Protect and restore the natural environment.

• Undertake scientific research and development.

• Protect cultural heritage.

These elements are described in the Annex to the Communication (Table 3).

Definition of ‘use’

In the context of the essential use concept, 'use' applies to substances in various forms, including mixtures, articles, products or processes. It covers activities such as processing, formulation, consumption, storage, treatment and production. The assessment of essentiality takes into account both the technical function of the substance and the context of its use. A substance may be essential for one product, but not for another.

Integrating essential use into legislation

The Communication outlines the guiding principles and criteria for the concept of essential use, with the aim of incorporating it into EU legislation in a harmonised way. The legal effect of the concept will only be achieved through its inclusion in legislation, a process which depends on impact assessments.

At present, the essential use concept is not part of the REACH regulation and therefore does not influence initiatives such as the restriction of PFAS. Nevertheless, the Communication reaffirms the Commission's commitment to phasing out harmful substances while recognising their essential societal role, particularly in the green and digital transition.

On 10 April 2024, the UK Department for Business and Trade formally notified the World Trade Organization (WTO) of its intention to amend the GB Cosmetics Regulation (Regulation (EC) No 1223/2009), which applies in England, Wales and Scotland. The proposed amendments aim to regulate the use of certain chemical substances in cosmetic products. The amended regulations will be known as the Cosmetic Products (Restriction of Chemical Substances) (No. 2) Regulations 2024.

The Notice is open for comment for 60 days from the date of notification.

Proposed Regulatory Amendments

Among the proposed amendments, the UK plans to allow the use of kojic acid at a maximum concentration of 1% in certain cosmetic products, namely face and hand products. This follows the publication of the Final Opinion of the Scientific Advisory Group on Chemical Safety in Consumer Products (SAG-CS).

In addition, the amendments will prohibit the use of 52 chemicals that are classified as carcinogenic, mutagenic and reprotoxic (CMR) under the GB Classification, Labelling and Packaging (CLP) Regulation (Regulation (EC) No 1272/2008). The list of chemicals is available here.

The aim of these amendments is to ensure the safety of cosmetic products on the market by adjusting the permitted use of certain chemicals.

Timetable

The amendment is expected to be adopted on 25 June 2024.  Cosmetic products placed on the market on or before 20 April 2025 may continue to be made available on the market until 20 August 2025.

On March 15, 2024, the Ministry of Environment, Forest and Climate Change (MOEFCC) notified the rules further amending the Plastic Waste Management Rules, 2016 namely the Plastic Waste Management (Amendment) Rules, 2024 in the Gazette of India.  

The amendment came into force from the date of publication in the Gazette. With this amendment India is taking a significant step towards tackling plastic pollution. 

The draft rules to amend the Plastic Waste Management Rules, 2016, were first published in the Gazette of India on October 16, 2023, inviting objections and suggestions from the public within a period of sixty days. 

Amendments Introduced 

In the amended rules, a few sections have been replaced with new clauses, including for biodegradable plastics under Extended producer Responsibility (EPR). 

 EPR is a waste and pollution management concept that encourages companies to design more sustainable and recyclable products and manufacturing processes. It also places the responsibility on manufacturers to minimize the environmental impact of their products throughout their lifecycle.  

In Rule 3, a few clauses are replaced and added relating to biodegradable plastics, importers, manufacturers, producers and sellers. Similarly, amendments are introduced in the several rules of the Plastic Waste Management (Amendment) Rules, 2016. 

The following amendments are also included: 

• Requirements for labelling and certification of compostable or biodegradable plastics. 

• Requirements for reporting on quantities of goods placed in the market and pre-consumer waste generated. 

• Responsibility of manufacturers, producers, importers and brand owners for the collection of plastic packaging introduced. 

• Guidelines for working with local authorities on a voluntary basis. 

• Annual reporting mechanisms for various entities involved in plastic waste management. 

Extended Producer Responsibility Targets 

In Schedule II of the Rules, the Extended Producer Responsibility target, category-wise, is given in the table below, as follows:

Minimum level of recycling (excluding end-of-life disposal) of plastic packaging waste 

                                                    (% of Extended Producer Responsibility target) 

The categories are defined as follows: 

Category I: Rigid plastic packaging 

Category II: Flexible plastic packaging of single layer or multilayer, plastic sheets or like and covers made of plastic sheet, carry bags, plastics sachet or pouches. 

Category III: Multilayered plastic packaging (at least one layer of plastic and at least one layer of material other than plastic). 

Further details of the amendments introduced can be found here: 

https://moef.gov.in/wp-content/uploads/2024/03/GSR201(E)-[14032024]-Plastic-Waste-Mangement-Rules-2024.pdf 

On 13 April 2024, the Department of Chemicals and Petrochemicals (DCPC) of India published the Ortho Phosphoric Acid (Quality Control) Amendment Order, 2024.

Background to the Amendment

The Ortho Phosphoric Acid (Quality Control) Order, 2021 was published in the Gazette of India, Extraordinary, Part II, Section 3, Sub-section (ii), vide number S.O. 2335(E), dated 15 June 2021 and subsequently amended vide notification numbers S.O. 4914(E), dated 29 November 2021 and S.O. 2225(E), dated 13 May 2022.

Key Provision of the Amendment

The following provision shall be inserted after the table in the Ortho Phosphoric Acid (Quality Control) Order, 2021: "Provided that, nothing in this Order shall apply to the Ortho Phosphoric Acid when used as a raw material in the production of fertilizers for a period of ninety days from the date of publication of this notification."

Application and Enforcement

The QCO applies to export chemicals and requires them to conform to IS 798: 2020 Orthophosphoric Acid — Specification and bear the Compulsory Registration Scheme (CRS) Mark under the licence of the Bureau of Indian Standards (BIS). Violations will result in penalties under the BIS Act, 2016.

The published draft came into force on 13 April 2024.

On 22 April 2024, the National Medical and Pharmaceutical Administration of China (NMPA) announced an updated Technical Guidelines for Cosmetic Safety Assessment, which will be implemented from 1 May 2024. This update will further assist companies currently preparing Cosmetic Product Safety Reports (CPSRs) to achieve faster registration.

Details of Rules 2024 nr 50 (updated on 22 April 2024 based on Rules 2021 nr 51):

• The updated technical guideline for cosmetics has published examples of both the detailed and simplified format. This change will further facilitate the process of submitting CPSRs.

• Before 1 May 2025, the legal representative or recordation of the registration can follow the officially published technical guideline to provide the required information for CPSR directly in the simplified format.

• All the registration and recordation shall follow the Safety Evaluation Capacity and Standard proposed by the Cosmetic Safety Evaluation Measures. This Cosmetic Safety Evaluation Measures addresses the importance of the following matters: strengthening technical instruction and providing a safer foundation for the supervision of cosmetic-related products.

For more information on how to comply with China’s cosmetic regulations, please contact GPC regulators  jingyan@cn.gpcregulatory.com or annie@cn.gpcregulatory.com.

On March 26, 2024, the South Korean Ministry of Environment (MoE) notified the World Trade Organization (WTO) of its decision to designate certain consumer chemical products subject to safety verification and to establish standards for their safety and labeling.

Reason for the Revision

The reason for the revision is that in the case of products with ambiguous judgment as to whether they are food misunderstood or confused, it is necessary to prepare devices such as a committee to finally determine whether they meet safety standards, and if the weight and capacity of living chemicals decrease while the price of consumer chemical products remains the same, consumers cannot easily know the change.

The partial amendment includes the following:

- Establishment of a Committee to assess consumer chemical products that are mistaken for food

- Indication of changes in product weight and capacity, etc.

Timeline

The amendment is open for comments until April 16, 2024. The proposed date for adaptation of the amendment is May 31, 2024, and the enforcement date of the amendment is January 1, 2025.

The National Institute of Chemical Safety (NICS) has launched an initiative to distribute an “Information Book for Chemical Accident Site Response” to relevant organizations such as firefighting units, local governments, and police departments from April 9.

The book contains specialized information needed for on-site response in the event of chemical accidents.

Expanded Material Information and Comprehensive Coverage

Originally containing 97 types of material information, the book has now been expanded to 150 types.

These 150 types of material information are selected based on chemical substances that have caused accidents in Korea over the past 10 years. They include substances such as hydrochloric acid (hydrogen chloride), ammonia, and sulfuric acid.

The book provides details on chemical characteristics, risks, countermeasures, personal protective equipment, detection equipment, evacuation distances, acceptable exposure standards, and emergency measures. To facilitate understanding, key response information is presented using pictograms and photos.

Use of Technology and Future Plans

An “accident situation sharing app” operated by the Korea Chemical Safety Institute provides real-time material information to responders. The app significantly reduces the time required to provide material information, ensuring optimal response time.

The full text of the material information book will be available as a PDF on the Korea Chemical Safety Institute’s website.

The Institute plans to create 150 types of material information each year, with a total of 900 types by 2028. The aim is to help emergency responders take prompt initial action in the event of a chemical accident.

Park Bong-kyun, head of the Ministry of Environment’s Chemical Safety Institute, emphasized the importance of providing accurate information to effectively respond to chemical accidents.

On April 11, 2024, Taiwan’s Food and Drug Administration under the Ministry of Health and Welfare announced the types of cosmetics and implementation dates for which product information files (PIFs) should be established.

About the Cosmetic PIF

The cosmetic PIF must contain the following (according to Article 3 of the Cosmetic Product Information File Management Regulations):

1. Basic information about the product: the name of the product, the category of the product,
2. dosage form, purpose, the names and addresses of manufacturing facilities, information
3. of product manufacturers or importers.
4. Evidentiary documents of completing product notification.
5. Full ingredient names and the individual content.
6. The outer packaging of the products, containers, labels, or leaflets.
7. GMP compliance certificates or self-declarations which the manufacturing facilities
8. comply with cosmetic Good Manufacturing Practice Regulations.
9. Manufacturing methods and procedures.
10. Usage methods, body parts, dosage, frequencies, and the targeted population.
11. Adverse effects of the product application.
12. Physical and chemical characteristics of the products and individual ingredients.
13. Toxicological data of the ingredients.
14. The product stability test reports.
15. The microbiological test reports.
16. The antimicrobial effectiveness test reports.
17. Supporting information on the functional assessments.
18. Information about the packaging materials which have contact with the products.
19. Product safety information

The Cosmetic Hygiene and Safety Act requires companies to establish a PIF before launching a product in Taiwan, according to the Cosmetic Hygiene and Safety Act.

On 12 April 2024, Japan's Ministry of Health, Labour and Welfare (MHLW), Ministry of Economy, Trade and Industry (METI) and Ministry of the Environment (MOE) formally notified the World Trade Organization (WTO) of the revision of the Order for Enforcement of the Act on the Regulation of Manufacture and Evaluation of Chemical Substances (the Act).

Key Revisions to the Act

5. Designation of Class I Specified Chemical Substances: Pursuant to Articles 17 and 22 of the Act, the following substances will now require authorization for manufacture or import:

   • PFOA isomers or their salts and PFOA related compounds.

5. Designation of Permitted Chemical Substances and Uses: Article 25 of the Act allows the use of the following substances for a specified period of time.

   • 8:2 fluorotelomer alcohol, used in the manufacture of invasive and implantable medical devices, permitted until 3 December 2025.

   • Perfluorooctyl iodide, for the manufacture of pharmaceutical products, permitted until 31 December 2036.

5. Prohibition on Import of Products: Under Article 24 of the Act, the import of following products containing PFOA isomers or their salts, and PFOA-related compounds will be prohibited.

Addressing Environmental Concerns: Objective of the Revision

The objective of the revision is to address environmental concerns arising from the non-biodegradability, bioaccumulation potential and chronic toxicity of PFOA isomers or their salts and PFOA-related compounds. The decision is in line with the decisions taken at the Ninth Conference of the Parties to the Stockholm Convention on Persistent Organic Pollutants in 2019.

Timeline and Procedure:

Proposed Adoption Date: June 2024.

Proposed Entry into Force: The revised regulations will take effect in two phases. Firstly, the designation of PFOA isomers or their salts is proposed to take effect in August 2024. Subsequently, the designation of PFOA-related compounds and the addition of banned products are scheduled to take effect in December 2024.

Deadline for Comments: Stakeholders have 60 days from the date of notification to provide feedback.

The revision underscores Japan's commitment to environmental protection and public health by regulating hazardous chemical substances and their uses.

The Australian Department of Climate Change, Energy, Environment and Water (DCCEEW) is seeking public input on proposed Industrial Chemicals Environmental Management Standard (IChEMS) decisions on internationally recognized chemicals of concern and lower-concern chemicals. The newly proposed standards aim to optimize the management of the use, storage, handling and disposal of chemicals within industrial sectors. IChEMS is dedicated to providing a consistent national framework that ensures environmentally sound practices and promotes the adoption of safer chemical alternatives across Australia.

The IChEMS Register classifies chemicals into one of seven categories based on their environmental risks, increasing transparency and guiding industry towards effective risk management. These classifications, along with specific risk management measures aim to protect natural ecosystems and promote sustainable industrial practices.

Public feedback is essential to refine the proposed standards and will directly influence the scheduling of chemicals on the IChEMS Register. Supporting documents for the consultation include indicative lists of chemicals with their respective Chemical Abstracts Service (CAS) Registry Numbers, providing essential data for stakeholders to identify and manage chemicals more efficiently.

Key Proposals for Feedback:

Internationally Recognized Chemicals of Concern:

- Dechlorane Plus® and UV-328: These chemicals are part of the Stockholm Convention on Persistent Organic Pollutants (POPs), indicating a high level of environmental threat requiring stringent controls.

The consultation is on inclusion in Schedule 6 of the IChEMS Register. Inclusion in Schedule 6 will prohibit their import, manufacture, use and export in Australia, with limited exceptions for unintentional trace contamination, research, environmentally sound disposal and articles in use before the date the decision takes effect. The proposed effective date is 1 July 2026.

Chemicals with Lower Environmental Risks:

- Melamine, boric acid and its precursors, and β-alanine: These are considered to pose a lower risk, but still require careful management to prevent environmental damage. The consultation is for inclusion in Schedule 2 (melamine and boric acid) and Schedule 3 (β-alanine) of the IChEMS Register.

Participation and Submission Process

Stakeholders are encouraged to review the detailed proposal and accompanying Q&A document to fully understand the scope and implications of the standards. To submit feedback:

- Access the online survey here (scroll down). The survey allows for comprehensive feedback and the option to attach relevant documents.

- Deadline for Submissions: Feedback must be submitted by 5pm (AEST) on Monday 13 May 2024.

Moving towards environmental preservation, Brazil has recently issued a draft rule for public comment outlining the requirements and procedures aimed at controlling the import, export, recycling, recovery, trade, use, and transportation of metallic mercury within its borders. This decision, based on Decree nº 97.634, issued on 10 April 1989 and in alignment with the Minamata Convention on Mercury, represents an important moment in Brazil's commitment to sustainability and environmental responsibility.

Strengthening Environmental Regulations

The implementation of these regulations underscores Brazil's commitment to protecting its natural resources and ecosystems. By establishing stringent requirements and procedures for mercury waste disposal, Brazil aims to mitigate the harmful effects of mercury pollution on both human health and the environment.

Brazil's Role in Global Environmental Governance

This initiative not only positions Brazil as a leader in environmental governance but also demonstrates its proactive approach to addressing global environmental challenges. Through adherence to international standards and active participation in the Minamata Convention, Brazil is making a valuable contribution to the global effort to reduce mercury pollution and promote a healthier planet.

Vietnam's main chemical management law, the Law on Chemicals, has a draft update that has been finalized by the Ministry of Industry and Trade (MOIT). MOIT is currently seeking input on the proposed revisions. 

Background on the Law on Chemicals 

The 12th National Assembly, in its second session, passed the Law on Chemicals No. 06/2007/QH12 on November 21, 2007. It became operative on July 1, 2008, institutionalizing, implementing, and expeditiously concretizing the principles and policies of the Party and the State. The enactment of the Law on Chemicals is a significant turning point in the process of formalizing and establishing a national legal corridor for chemical-related activities. 

Current Amendments 

On March 7, MOIT stated that the Ministry's Department of Chemicals should work with the Department of Legal Affairs and other relevant agencies to make further changes to the draft before it is published,. A drafting board and editorial team would be established, MOIT advised, to urgently organise the implementation of the law. 

The Ministry plans to propose an amended draft law at the eighth session of the 15th National Assembly in October 2024, which it hopes will be passed at the ninth session in May 2025. 

Policy development Objectives 

• Create a legal framework that supports the growth of the chemical sector in line with the Party's Ten-Year Socio-Economic Development Strategy, which outlines its goals and directions for 2021–2030. 

• Pay attention to the growth of a number of basic industries, such as energy, mechanical engineering, metallurgy, and chemistry, to meet the economy's needs for basic production materials. 

• Consider the prudent, cost-effective, efficient, and long-term management, utilization, and accumulation of resources. 

• Consider the preservation of the quality of life and public health as primary objectives. 

• In order to "build a green, circular, environmentally friendly economy" and preserve biodiversity and ecosystems, the Party must resolutely reject projects that pollute the environment. This will further consolidate the Party's leadership in chemical management and the chemical industry. 

• Establish a framework of legal documents to stabilize the management of basic chemical activities in the coming years. 

• Align the legal framework for chemical management with international standards to encourage investment from multinational companies and big chemical companies that can expand their operations in Vietnam by utilizing technology, cutting-edge management techniques, and high-value products. This will also help Vietnamese companies to engage in international trade by providing favourable conditions. 

Compared to the 2007 Chemical Law, the draft has one additional chapter and 24 articles, bringing the total to 11 chapters and 95 articles. 

Evaluating the policy impact:  

The following issues will be assessed by the Ministry of Industry and Trade: 

Policy 1: The sustainable growth of the chemical industry as a key sector today. 

Policy 2: Coordinated management of chemicals throughout their life cycle. 

Policy 3: Management of hazardous chemical in products. 

Policy 4: Increasing effectiveness in ensuring the safety of chemicals. 

The Ministry of Industry and Trade analyses each policy using the following procedure: 

1. Identification of the problem (explaining the current state of the problem and examining its causes, effects, and implications). 

2. Aim of the problem solution. 

3. Proposed solution (some of which leave things as they are). 

4. Analysis of the effects of the suggested solution (counting the advantages and disadvantages of each policy option for the state, its citizens, and its companies). 

5. Recommendations and choice of solutions based on effect analysis and evaluation advantages and disadvantages of each solution. 

Submitting Comments 

Comments from agencies, units, organizations, and individuals should be sent in writing to the Ministry of Industry and Trade by email (at KienNV@moit.gov.vn, ThanhNT@moit.gov.vn) or through the Department of Chemicals, No. 21 Ngo Quyen, Trang Tien Ward, Hoan Kiem District, Hanoi City, by April 10, 2024. 

On April 2, 2024, the Malaysian Department of Occupational Safety and Health (DOSH) announced in the Federal Government Gazette that Malaysia's Occupational Safety and Health (Amendment) Act 2022 (OSHA 2022) will come into effect on June 1, 2024. The Factories and Machinery (Repeal) Act 2022 and the Occupational Safety and Health (Licensed Person) Order 2024 will also come into force on the same date. 

The Factories and Machinery (Repeal) Act 2022, provides general guidance for the handling and storage of chemicals and equipment in the  workplace. The Occupational Safety and Health (Licenced Person) Order 2024, outlines the duties and obligations of the licensed person who inspects premises to ensure that  equipment and working conditions meet the required standards.  

Amendments in OSHA 2022 

The current OSHA 1994, which covers only ten industries, i.e. manufacturing, mining and quarrying, construction, and agriculture—will be amended by OSHA 2022. OSHA 2022 was passed in Parliament on March 16, 2022, and as mentioned above, will enter into force on June 1, 2024. 

In order to increase worker safety, OSHA 2022 will apply to all industry sectors and all places of work throughout Malaysia. Among the amendments are:  

• Inclusion of a new provision to enhance the protection for employees, allowing them to remove themselves from danger (Section 26A) 

• Compulsory risk evaluations aimed at  identifying suitable risk control strategies.;  

• Ensuring protection and well-being of labourers throughout the storage and transportation of chemicals. 

• Providing knowledge, guidance, education, training, and oversight to safeguard employees'’ health and safety (Section 31A). 

• Establishing a secure working environment to protect employees'’ health.

• Establishing and carrying out of emergency protocols 

• Designating a coordinator for workplace health and safety (Section 29A).  

• Revised fines for non-compliance. Employers can be fined a maximum penalty of RM 500,000 as opposed to RM 50,000 under OSHA 1994. Fines for employees will also increase from the current RM 1,000 to a maximum of RM 2,000.  

In an effort to streamline regulations and improve environmental protection, member countries of the Andean Community are proposing to synchronize standards for household cleaners and absorbent personal hygiene products. The initiative aims to establish a consistent framework across the four countries that make up the trading bloc– Bolivia, Colombia, Ecuador, and Peru. 

Proposed Regulations for Household Products 

Under the proposed draft, a unified set of regulations would govern the production, processing, packaging, importation, storage, sale and marketing of various products including soaps, detergents, fabric softeners, air fresheners, sanitary towels and diapers. Key measures outlined in the draft include the mandatory submission of health notifications to national authorities prior to import, export, and marketing of these items. 

Focus on Environmental Integration 

Furthermore, the draft requires national authorities to seek approval from the General Secretariat of the Andean Community before imposing restrictions or bans on ingredients used in covered products. The overarching goal of these measures is to integrate the principles of circular economy into production and commercial processes, thereby balancing environmental protection and product safety. 

Andean Community Seeks Feedback 

The draft Regulation, which has been submitted to the WTO, invites feedback from stakeholders until the deadline of June 15. This collaborative effort underscores the Andean Community's commitment to promoting sustainable practices while ensuring the safety and quality of everyday consumer products. 

On 8 April 2024, the Ministry of Environmental Protection and Natural Resources of Ukraine notified to the World Trade Organization (WTO) a revised draft Technical Regulation "On Approval of the Technical Regulation on Safety of Chemical Products" to. The revised version includes suggestions and technical modifications compared to the previous version notified on 20 September 2023 (G/TBT/N/UKR/179/Rev.1).

Stakeholders and interested parties now have a 60-day window from the date of notification to provide their input on this draft regulation and help shape Ukraine's chemical safety landscape.

Harmonisation with EU Standards

This draft Technical Regulation is based on the provisions of Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals, commonly known as EU-REACH.

By aligning with these European standards, Ukraine aims to synchronise its chemical safety practices with those of the European Union.

Key Elements of the Revision

The draft Technical Regulation has been drafted in accordance with the provisions of the Law of Ukraine "On Ensuring Chemical Safety and Management of Chemical Products." Its main objective is to ensure a high level of protection of human health and the environment, while facilitating the free circulation of chemical products, promoting alternative methods of assessing chemical hazards, and encouraging innovation to improve competitiveness. The Regulation sets out requirements for the safety of chemicals at all stages of production, distribution, and use stages, including chemicals in mixtures and products.

At the heart of the Regulation is the precautionary principle, which requires manufacturers, importers and users to ensure that their chemicals do not pose a risk to human health or the environment. Chemical products that do not meet the requirements of this Technical Regulation cannot be placed on the market in Ukraine.

Transitional Provisions and Timeline

A transitional period of one year from the date of entry into force of the Regulation is provided for chemical products already in circulation that do not comply with the requirements of the Regulation.

The date of adoption of the Technical Resolution is yet to be determined, and its enforcement is scheduled to take place six months after its publication.