GPC Newsletter Nov-2023

On 18 November, in a significant move to protect both the environment and public health, the Government of Canada unveiled the Certain Products Containing Toxic Substances Regulations. This groundbreaking initiative is part of the broader Chemicals Management Plan (CMP), which aims to evaluate and reduce  risks posed to the environment and human health by potentially harmful chemical substances. 

Upgraded Management of Harmful Chemicals 

Under the Canadian Environmental Protection Act (CEPA), substances that are considered toxic to the environment or human health are subject to strict regulations. The CMP, backed by CEPA, gives the Governor in Council the authority to enact regulations to reduce the risks associated with these toxic substances. 

Focus on Coal Tars and their Distillates 

The proposed regulations particularly focus on coal tars and their distillates. These substances, which consist of  complex mixtures of hydrocarbon and other chemicals, are essential for the production of various materials like creosote, crude naphthalene, and coal tar pitch and oils. They are also used in certain veterinary and human pharmaceuticals. 

Key Objectives of the New Regulations 

The primary goal of these new regulations is to ban the manufacture, import, and sale of specific coal tar-based sealant products and sealants containing Polycyclic Aromatic Hydrocarbons (PAH) above 1,000 ppm. This is a proactive measure to prevent ecological damage and reduce health risks associated with these toxic substances in Canada. 

Implementation Timeline and Exceptions 

By January 1, 2025, the regulations will prohibit the manufacture and import of certain sealant products containing coal tars and PAHs above the 1,000 ppm threshold. Exemptions include products manufactured for export only or in transit through Canada, and those manufactured under a specific permit. The ban extends to pavement and roofing sealant products and, for coal tars, includes industrially applied sealants on various materials. 

The sale and offer of these products will be prohibited by June 30, 2025, with certain temporary exemptions. Notably, coal tar-based industrial sealants will be exempt until January 1, 2028. 

Integration of 2-BE Regulations 

The new regulations will also incorporate the existing 2-Butoxyethanol Regulations (2-BE Regulations), to improve their consistency with the current legislative draft. However, the core requirements for permitting and record-keeping under the 2-BE Regulations will remain unchanged. 

Enforcement Measures 

Enforcement of these regulations, under CEPA's Compliance and Enforcement Policy, will be stringent to ensure compliance with the new standards. This move reflects Canada's commitment to a healthier environment and public safety and underscores the government's proactive approach to chemicals management. 

On October 19, 2023, the U.S. Environmental Protection Agency (EPA) introduced a new rule aimed at improving the evaluation of chemical risks under the Toxic Substances Control Act (TSCA). This proposal seeks to align EPA procedures with legal requirements, ensuring comprehensive assessments that safeguard workers and communities.

Key Changes Proposed in the New Rule:

1. Environmental Justice Emphasis: The rule commits to considering disproportionate harms in overburdened communities, including multiple exposure pathways and combined risks from multiple chemicals.
2. Comprehensive Evaluations: Risk evaluations must cover all conditions of use and exposure pathways.
3. Worker Protection: Clear provisions to ensure that risks to workers are properly assessed.
4. Scientific Rigor: EPA will use the best available science for evaluations and base decisions on scientific evidence.
5. Unified Determination: Risk evaluations will culminate in a single determination of unreasonable risk; not individual chemical uses.
6. Transparency and Procedural Requirements: New requirements for transparent risk evaluation document revisions.
7. Adjusted Manufacturer Requested Evaluations: Aligns the process with EPA-initiated evaluations and data collection.

These changes, previously announced in 2021, aim to provide certainty and predictability for EPA and stakeholders. Public comments on the proposed rule will be accepted for 45 days at docket EPA-HQ-OPPT-2023-0496 on www.regulations.gov. This proactive approach is part of a broader effort to ensure the safety of chemical substances and protect the environment and public health.

Background: The Three-Step Process

EPA's risk evaluation process for existing chemicals under TSCA is a structured, three-step procedure that begins with Prioritization, followed by Risk Evaluation, and concludes with Risk Management. The primary objective of the Risk Evaluation step is to determine whether a chemical substance poses an unreasonable risk to human health or the environment under its specific conditions of use.

During this evaluation, several key principles guide the assessment:

1. Hazard and Exposure Assessment: EPA examines both the hazards associated with the chemical, which may include factors such as toxicity and the extent of exposure. This approach disregards non-risk-related factors and ensures that scientific methods align with the best available science and a weight-of-scientific-evidence basis.
2. Initiation of the Risk Evaluation: Risk evaluations can be initiated by the EPA either through the Prioritization process or by accepting a manufacturer's request.
   • EPA-Initiated Risk Evaluations: The EPA, pursuant to the Lautenberg Act, initiated evaluations for the first 10 chemicals in December 2016, chosen from the 2014 Update to the TSCA Work Plan. Subsequently, EPA continues to conduct evaluations on High-Priority Substances designated through the Prioritization process.
3. Components of a Risk Evaluation: The risk evaluation process comprises several key components:
   • Scope of the Risk Evaluation: A draft scope is published in the Federal Register within three months of initiating the risk evaluation, followed by a 45-day public comment period. A final scope is published no later than six months after the evaluation's initiation, as required by law.
   • Hazard Assessment: EPA identifies the adverse health or environmental effects of exposure to the chemical, encompassing areas like cancer, mutation, reproductive, developmental, and respiratory impacts.
   • Exposure Assessment: This phase delves into the extent and nature of exposure under various conditions of use, as well as the populations exposed.
   • Risk Characterization: EPA integrates available information regarding hazards and exposure, including assessments of information quality and alternative interpretations.
   • Risk Determination: EPA produces a draft determination regarding whether the chemical poses an unreasonable risk to health or the environment.
4. Publication of the Risk Evaluation: The final risk evaluation is released within 3 to 3.5 years after identifying the chemical as a high priority for risk assessment.

Find the docket numbers, problem formulations, scope documents and supplemental documents for each chemical substance undergoing risk evaluation under TSCA here.

The U.S. Environmental Protection Agency (EPA) on October 26, 2023, unveiled a comprehensive plan to improve the assessment of pesticides to quickly and effectively assess potential endocrine-disrupting effects in humans. This initiative will strengthen the Agency's ability to safeguard against such effects when making pesticide-related decisions under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and to implement the Endocrine Disruptor Screening Program (EDSP) under Section 408(p) of the Federal Food, Drug, and Cosmetic Act (FFDCA).

Understanding Endocrine Systems and Disruptors

Endocrine systems, which regulate hormones in various living organisms, play a central role in processes ranging from development and reproduction to metabolism. Endocrine disruptors are chemicals that interfere with the natural functions of hormones. EPA established the EDSP in 1996 to evaluate how pesticides and other chemicals might affect the estrogen, androgen, and thyroid systems. However, challenges have hampered its effective implementation. EPA lacked efficient methods to rapidly test numerous chemicals for endocrine-disrupting effects and often did not provide clear explanations for collecting the necessary endocrine data.

The Path Forward

EPA's strategic plan involves using its FIFRA process to collect human health endocrine data to improve the efficiency of endocrine-related decision-making. The Agency will prioritize around 400 conventional pesticide active ingredients that are either being registered for the first time or are under registration review. In cases where existing data align with the findings of the FFDCA EDSP, EPA will use this information to expedite decisions and reduce the need for additional testing.

EPA is releasing a scientific paper to clarify which existing data can be used to support endocrine disruption findings. For 403 conventional pesticides, EPA has established sufficient estrogen and androgen data for 86 chemicals to make EDSP decisions regarding their potential effects on human systems. Additionally, 52 pesticide chemicals are now part of this plan, and EPA is communicating its final EDSP decisions regarding their potential effects on the human endocrine system.

Remaining Challenges

As the science on the human endocrine system, especially the thyroid, continues to evolve, EPA anticipates seeking scientific peer review in 2025 to assess advances and its current approach to thyroid assessments.

In the short term, EPA has identified 30 high-priority pesticides that require additional data on potential human estrogen and androgen effects. Preliminary data suggest that these pesticides may affect the endocrine system. The Agency is inviting the public to submit data or comments on these chemicals during a 60-day public comment period. To fill the remaining data gaps, EPA intends to issue FIFRA human health data requests for these pesticides in the spring of 2024. For a second group of 126 conventional pesticides with limited endocrine data, the Agency is seeking information to evaluate their endocrine data needs. Moreover, EPA will determine which of the 161 additional conventional pesticides will require updated endocrine data in the coming years during the registration review process.

The public comment period for this initiative opened on Friday October 27, and stakeholders are encouraged to submit their contributions via Docket EPA-HQ-OPP-2023-0474 at www.regulations.gov.

On 20 October 2023, the United States Environmental Protection Agency (EPA) issued a rule that strengthens reporting requirements for per- and polyfluoroalkyl substances (PFAS) to the Toxics Release Inventory (TRI). The rule eliminates an exemption that allowed facilities to withhold information on PFAS when the chemicals were used in low concentrations.  

PFAS are commonly referred to as "forever chemicals" and are found in low concentrations in a variety of products. By removing of the reporting exemption, the rule applies to all industry sectors, including metal mining and chemical manufacturing, as well as federal facilities that manufacture or use any of the 189 PFASs listed in the TRI. This rule ensures that facilities can no longer withhold information regarding the amounts of PFAS that they manage or release into the environment. 

Toxics Release Inventory 

EPA’s TRI Toxics Tracker (TRI) compiles annual data from various industries, including manufacturing, mining, power generation and chemical production. It includes information on the quantities of chemicals released into the environment or managed as waste.  

This data helps communities understand how local facilities handle listed chemicals and supports informed decisions by businesses, governments, non-governmental organizations (NGOs), and the public. EPA's updated online TRI tools, such as the TRI-listed chemicals, allow communities to map reporting facilities, view chemical releases, waste management, and pollution prevention efforts. 

PFAS in the Toxics Release Inventory 

The 2020 National Defense Authorization Act (NDAA) initially added 172 PFAS chemicals to the TRI for reporting in 2021, with a framework for adding more in the future. Facilities were required to report if they used more than 100 pounds of these substances, a lower threshold than most other TRI-listed chemicals.  

However, the previous administration's codification of the NDAA did not address the availability of the de minimis exemption or other reporting burden reduction provisions, which had allowed facilities reporting to TRI to avoid reporting minimal concentrations of PFAS chemicals.  

The new rule nullifies the prior exemption for all chemicals on the TRI list of chemicals of special concern, including lead, mercury, and dioxins that accumulate in the body over time. 

On November 20, 2023, the U.S. Environmental Protection Agency (EPA) unveiled a proposed rule designed to enhance protection against two toxic chemicals—decabromodiphenyl ether (decaBDE) and phenol, isopropylated phosphate (3:1) (PIP (3:1)). These persistent, bioaccumulative, and toxic (PBT) chemicals, previously subject to risk management provisions under the Toxic Substances Control Act (TSCA), are now the focus of enhanced workplace safety measures and water release restrictions.

The proposed rule aims to protect workers, communities, and critical industries such as nuclear energy, transportation, construction, agriculture, forestry, mining, life sciences, and semiconductor production.

The 2021 Rule

In response to TSCA, EPA moved quickly to address five PBT chemicals to protect human health and the environment, finalizing risk management rules in January 2021. In February, a review was initiated to ensure adherence to science and law, considering feedback from manufacturers who anticipated compliance challenges. In March, prompted by Biden-Harris Administration directives, EPA sought public input on the PBT rules, leading to proposed amendments for two of the five chemicals. Notably, the regulations for the remaining three PBT chemicals (2,4,6-tris(tert-butyl)phenol (2,4,6-TTBP), hexachlorobutadiene (HCBD) and pentachlorothiophenol (PCTP)) remain unchanged.

Details of the proposed rule

Under the proposed rule, EPA is targeting two specific PBT chemicals:

DecaBDE: A flame retardant widely used in nuclear power and aerospace applications, decaBDE has been linked to adverse health effects. EPA's 2021 rule prohibited its manufacture, processing, and distribution, with exceptions. The new proposal introduces further measures by requiring personal protective equipment (PPE) for specific decaBDE activities, prohibiting water releases during production, and extending the compliance date for certain applications crucial for nuclear facilities.

PIP (3:1): This versatile chemical found in hydraulic fluids, coatings, electronics, and various industries poses risks to aquatic life and human health. The proposed rule extends compliance dates for certain applications, introduces worker protections, and outlines a phase-out approach for certain uses of PIP (3:1). EPA will host a public webinar to provide an overview of the proposed rule, with a 45-day comment period after publication.

The proposed measures will strengthen protection against these hazardous chemicals while ensuring that essential uses can continue safely.

For more details and to provide public comments, visit www.regulations.gov (Docket: EPA-HQ-OPPT-2023-0376).

In a recent development, the U.S. Food and Drug Administration (FDA) has announced a six-month extension of the enforcement deadline for cosmetic product facility registration and product listing requirements under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). The previous deadline of December 29, 2023, has been pushed back to July 1, 2024, providing the cosmetics industry with additional time to comply with these regulatory obligations.

This decision comes in the wake of the FDA's commitment to facilitating a smooth transition for industry stakeholders in complying with the new regulatory landscape mandated by MoCRA. The Agency recognizes the importance of ensuring that cosmetic manufacturers and processors have adequate time to submit facility registration and product listing information.

Background and Timeline:

1. Suspension of Voluntary Cosmetic Registration Program (VCRP): In March 2023, the FDA announced the suspension of submissions to the Voluntary Cosmetic Registration Program (VCRP) due to the imminent implementation of the facility registration and product listing authorities mandated by MoCRA.
2. Draft Guidance on Cosmetic Product Regulations: By August 2023, the FDA issued draft guidance on cosmetic product facility registration and product listing, aligning with the requirements set forth by MoCRA. This draft, once finalized, will offer crucial recommendations and instructions for individuals submitting cosmetic product facility registrations and product listings to the FDA.
3. Introduction of Electronic Submission Portal: In September 2023, the FDA introduced an opportunity for public comment on its newly developed draft electronic submission portal named "Cosmetics Direct," along with the paper forms (Forms FDA 5066 and 5067). Emphasizing the importance of electronic submissions for efficiency, the Agency anticipates the availability of electronic submission options and supporting documentation in early December 2023.

Details of the Delayed Enforcement:

The FDA's decision to delay enforcement aims to provide regulated industries with the necessary time to comply with MoCRA's new authorities, which include facility registration and product listing requirements. Specifically, the delay extends to July 1, 2024, for both the statutory deadline of December 29, 2023, and specific registration and listing requirements.

This extension also includes a grace period for owners or operators of facilities that commenced manufacturing or processing a cosmetic product after December 29, 2022, and for cosmetic products first marketed after that date.

MoCRA Authorities and Exemptions:

Cosmetic product manufacturers and processors are required to register their facilities, update information promptly, and renew registrations every two years. Responsible persons, such as manufacturers, packers, or distributors, must list each cosmetic product marketed, including ingredients, and provide annual updates.

Exemptions are granted to certain small businesses. However, such exemptions do not apply to facilities that manufacture or process, or to responsible persons for, the following cosmetic products:

• Products that regularly come into contact with the mucus membranes of the eye under customary or usual conditions of use.
• Products that are injected.
• Products that are intended for internal use.
• Products that are intended to alter appearance for more than 24 hours under customary or usual conditions of use and removal by the consumer is not part of such conditions of use. 

Exemptions also exist for certain products and facilities that are subject to requirements for drugs and devices.

As the FDA extends the MoCRA implementation deadline, industry stakeholders are encouraged to take advantage of the additional time granted to ensure a seamless transition to compliance with the new regulations.

On 31 October 2023, the European Chemicals Agency (ECHA) published an investigation report on the use and presence of CMR 1A or 1B substances in childcare products. The report was prepared to support the European Commission in preparing an EU-wide restriction under the REACH regulation with the aim to protect children from exposure to CMR substances.

Results of the investigation

The investigation carried out by ECHA gathered data from 48 sources and showed that childcare products may contain substances known to be carcinogenic, mutagenic, or toxic for reproduction (CMR). It focused on substances that have a harmonised classification under the Classification, Labelling and Packaging (CLP) Regulation as a CMRs in category 1A (known human carcinogen, mutagen or reproductive toxicant) or 1B (presumed human carcinogen, mutagen or reproductive toxicant).

The most common CMRs found in these products include metals such as cobalt and lead, as well as phthalates such as di(2-ethylhexyl) phthalate (DEHP). These hazardous substances were commonly found in products such as car seats, bibs, products related to toiletry, bedding, and mattresses.

Children are at risk of exposure to these harmful substances through skin or oral contact when using these products. They are particularly vulnerable to the harm caused by such chemical substances because their small size, developing physiology, and behaviour make them more susceptible to the effects of these substances.

During the investigation, ECHA carried out two public calls for evidence and held a consultation on the draft report. The Agency contacted 233 different stakeholders to inform them about the work and took their feedback into account.

The full text of the report can be found here.

Next steps

ECHA's report provides key insights to assist the European Commission in the preparation of a possible future restriction. It covers the definition of childcare articles, the possible scope of the restriction, recommended concentration limits, timeframes for implementation and potential derogations. It also includes perspectives from ECHA's Enforcement Forum on the feasibility of such a restriction.

The report will be submitted to the European Commission to enable the preparation of a restriction proposal under Article 68(2) of REACH without direct involvement of ECHA's Scientific Committees.

The European Chemicals Agency (ECHA) published its third report on the operation of the Prior Informed Consent (PIC) Regulation in October 2023. In the report, ECHA recommends more transparency in the trade of hazardous chemicals.

About the PIC Regulation

The PIC Regulation regulates the export and import of hazardous chemicals and pesticides between the European Union (EU) and non-EU countries. Within the EU, the Regulation implements the Rotterdam Convention on the prior informed procedure in international trade and it places obligations primarily on companies exporting these chemicals to non-EU countries.

Findings of ECHA’s Report

ECHA’s report shows that despite a slight decrease in export notifications the workload for implementing the PIC Regulation is still increasing. This increase is attributed to the continuous addition of new chemicals subject to PIC and the growing number of substances that require explicit consent from non-EU importing countries prior toexport.

The report highlights the challenges posed by newly added chemicals, such as substances containing benzene (the first "substance in substance") and neonicotinoids harmful to bees, resulting in numerous notifications and new types of exports. There has also been an increase in public requests for data on the trade of hazardous substances collected under the PIC Regulation.

In response to these findings, ECHA recommends that future revision of the PIC Regulation should include:

• Definition of which parts of export notifications should be made public.

• Clarification of the trade information to be included in the annual reports at EU level.

• Improving the predictability and clarity through amendments to the legal text and implementation practices.

Sharon McGuinness, ECHA’s Executive Director, highlights the growing interest in the export of hazardous chemicals from the EU in recent years. She says "The ongoing evaluation of the regulation offers a good opportunity to improve the impact and transparency of PIC." McGuinness adds, "Our recommendations aim at a more transparent and effective implementation of the regulation, which controls the trade of hazardous chemicals."

The full report is available here.

On 15 November 2023, the European Chemicals Agency (ECHA) published a news report that identifies areas where research is needed to protect human health and the environment. The report entitled "Key areas of regulatory challenges” also highlights areas where new methods are needed to support the move away from animal testing.

Background

The implementation of the Chemicals Strategy for Sustainability (CSS) calls for ECHA to review its advisory role on the issues where it can provide the most valuable input. Therefore ECHA has started to map its Key Areas of Regulatory Challenge (KARC) as part of the European Partnership for the Assessment of Risks from Chemicals (PARC) project.

The PARC project is a seven-year EU-wide research and innovation project that aims to advance research, share knowledge, and improve skills in chemical risk assessment. ECHA’s role in PARC is to ensure that the scientific research funded addresses current challenges in chemical risk assessment and adds value to EU regulatory processes.

Priority areas for research

In order to improve chemical safety in the EU, it is essential that scientific research provides data relevant to the rregulation of chemicals. ECHA has identified the following priority areas for research to improve the regulatory relevance of scientific data.

• Protection against the most harmful chemicals. Hazard identification for critical biological effects for which specific and sensitive test methods are currently lacking, i.e. developmental and adult neurotoxicity, immunotoxicity and endocrine disruption.

• Addressing chemical pollution in the natural environment. Key areas include bioaccumulation, extending biodiversity protection, and exposure assessment.

• Moving away from animal testing. Development of New Approach Methods (NAMs) to facilitate reduction of animal testing for read-across under REACH, move away from fish test to determine fish toxicity, and mechanistic support for toxicology studies e.g. carcinogenicity).

• Improve the availability of chemical data in particular for polymers and nanomaterials.  Development of analytical methods to ensure proper assessment of hazardous substances.

Mike Rasenberg, ECHA’s Director of Hazard Assessment, emphasised the urgency of aligning scientific research with regulatory needs "ECHA believes that to achieve the ambitions of the European Green Deal and the EU’s Chemicals Strategy for Sustainability we need more scientific research with regulatory relevance." He added: "There is a growing need for new test methods that do not rely on animals, and a better understanding of the toxicological mode of action of certain hazardous chemicals. Generating the necessary data without animal testing while protecting health and the environment cannot be achieved without scientific progress."

 The full text of the report is available here.

On 15 November 2023, the Swedish Chemicals Agency (KEMI) expanded its PRIO database by adding 5700 new per- and polyfluoroalkyl substances (PFAS). This update brings the total number of PFAS substances in the database to nearly 11,000. The comprehensive database serves as a valuable resource to help producers and purchasers identify which substances to avoid.

The PRIO database

The PRIO database is a web-based tool that contains more than 16,500 hazardous substances. It lists chemical substances with properties that are hazardous to human health and the environment. Although it is not a complete list of all hazardous or banned substances present in products on the market, PRIO primarily helps users to identify hazardous substances that are not yet banned in the EU. The database can be searched here.

Substances in the PRIO database are categorised into the following two priority levels:

• Phase-out substances: These are the substances with the most hazardous properties, recommended by KEMI for substitution by less hazardous substances or alternative technical solutions. The criteria include:

  • CMR category 1A or 1B

  • Fluorinated greenhouse gases

  • Endocrine disrupting

  • Highly allergenic (Respiratory sensitising category 1A or skin sensitising category 1A)

  • Ozone depleting             

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

  • Particularly hazardous metals (mercury, cadmium, lead, and their compounds)

  • PFAS

• Priority risk-reduction substances: These are less hazardous but require proper handling to reduce the risk of unnecessary exposure. Criteria for priority risk-reduction substances can be found here.

PFAS in PRIO

The list of PFAS substances in PRIO should not be considered as an exhaustive inventory of all PFAS substances found worldwide, but it contains nearly 11,000 PFAS substances that are consistent with the OECD's 2021 definition of PFAS. The list of PFASs in PRIO can be downloaded here.

The OECD's definition of PFAS was also used in the EU’s PFAS restriction proposal to ban the manufacture and sale of PFAS in the EU, which was submitted to the European Chemicals Agency (ECHA) by Sweden, Denmark, Norway, Germany, and the Netherlands in February 2023.

In an effort to achieve net-zero emissions by the middle of the century, the European Commission is planning to propose a system for certifying the removal of carbon dioxide from the environment. 

How does carbon removals work? 

Activities that remove carbon dioxide from the atmosphere and store it permanently are known as carbon removals.  

There are numerous approaches to accomplish this, such as: 

• Removing carbon directly from the air and storing it in a stable state for permanent storage. 

• Carbon farming, or practises that improve carbon sequestration in soil and forest (e.g., wetland and peatland management, forest restoration). 

• Carbon storage in products (for instance, wood-based structures store carbon that is sequestered by trees). 

In addition to increasing carbon reductions, the EU must accelerate its 2050 climate neutrality goal in order to compensate for residual emissions that are anticipated from industries like manufacturing and agriculture. 

Today, the natural carbon cycle is carried out by nature, mostly by forests, soils, and oceans, which absorb CO2. Reforestation and "carbon farming" techniques, which capture CO2 from the atmosphere and store it in soil or plant material, can promote these natural processes. 

EU carbon removal certification scheme 

In November 2022 the European Commission suggested the creation of an EU-wide carbon removal certification programme to promote and accelerate the implementation of efficient, high-quality carbon removal operations. 

Certification would guarantee precise measurement of carbon removal activities, long-term storage of carbon, and support, or at the very least not hinder, other environmental objectives such as biodiversity, zero pollution, and the circular economy. 

A unified certification programme would build confidence and direct funding from public and private sources towards carbon reduction initiatives. 

Members of the European Parliament (MEPs) stressed the need to create an "EU registry" to maintain openness, disseminate information to the public, reduce the possibility of fraud, and prevent duplicate counting of carbon reductions, The system must also comply with international standards. 

Additionally, MEPs believed it is necessary to differentiate between the definitions, quality standards, and regulations for carbon removals, carbon farming, and carbon storage in products, due to their differences and environmental impacts. 

Next decisions 

Now that the Parliament is ready, talks with EU member states can begin. 

On 22 November 2023, the European Chemicals Agency (ECHA) published an investigation report on PVC and PVC additives. The investigation was carried out by ECHA at the request of the European Commission to help the Commission determine how to control potential risks from PVC additives and PVC. The investigation found that some substances such as plasticisers, that are added to polyvinyl chloride (PVC) plastic, can potentially pose risks to human health and the environment. It also concluded that regulatory action is needed to limit the use of such additives and to minimise the release of PVC microparticles.

PVC additives

The polymer PVC needs to be combined with specific additives before it can be converted into products. The additives play an important role in determining the flexibility, stability, colour, clarity, and electrical properties of PVC products.

Some additives used in PVC such as stabilisers containing cadmium- and lead and certain phthalates have been found to pose an unacceptable risk to human health and the environment. As a result, these additives are now restricted under REACH. In addition, studies are underway to assess the risks associated with other additives such as medium-chain chlorinated paraffins and flame retardants.

Conclusions

The study focused on 63 PVC additives selected from an initial list of 470 substances. The 63 substances are plasticisers, heat stabilisers and flame retardants (the full lists can be found here). The main findings of the report suggest that regulatory action is needed in the following areas:

• To minimise risks from plasticisers, in particular ortho-phthalates which have already been confirmed to be reprotoxic or endocrine disruptors. Suitable regulatory action is REACH restriction.

• To reduce risks from organo-tin substances (such as DOTE) used as heat stabilisers, which can cause developmental malformations and reproductive problems. Suitable regulatory action is REACH restriction in combination with other measures.

• To ensure that releases of PVC microparticles and prioritised PVC additives are minimised. Technologies to minimise emissions of PVC microparticles at recycling facilities and landfills must be implemented and improved. The microparticles contain the harmful additives so minimising the emissions would consequently reduce emissions of the additives.

• To reduce emissions of flame retardants, which contribute significantly to the emission of the prioritised additives, as proposed in ECHA’s strategy on flame retardants.

The risks posed by PVC resin to workers and the environment are considered to be adequately controlled by the current operating conditions and safety measures implemented by companies. This conclusion follows an analysis of the materials used to produce of PVC resin, the production process itself, waste management practises, and exposure to PVC dust.

The full text of the report can be accessed here.

Next steps

ECHA’s investigation report has now been sent to the European Commission. The Commission will evaluate the report and decide whether there is a need to formally request ECHA to prepare a proposal for a restriction under REACH.

The UK Minister for Social Mobility, Youth and Progress (MfSMYP) has, taken a key decision on the classification and labelling of 98 chemical substances in Great Britain (England, Scotland and Wales). This decision was taken after the Secretary of State accepted the recommendations of the Health and Safety Executive (HSE), with the agreement of the Scottish and Welsh Ministers. This move brings significant changes to the GB Mandatory Classification and Labelling (GB MCL) list, which was officially updated on 20 October 2023 under Article 37 of the GB CLP Regulation.

Details of the decision

The Ministerial decision, taken in consultation with the devolved governments, falls under Article 37 of the GB CLP Regulation. This process primarily involves the administrative task of incorporating new and revised GB MCLs into the existing list. Summaries of these updated classifications are now available in the GB CLP publication table which can be found here together with the date of entry into force (20 October 2023) and the date of compliance (20 April 2025).

This decision is based on the scientific and technical evaluation of the available information which identified the intrinsic hazards of these 98 substances. The technical reports of the Health and Safety Executive (HSE) have highlighted these intrinsic hazards, while the impact and policy assessments outlined in the Agency's opinions have not identified any significant impacts.

First proposal

This is the first batch of substances added to the GB MCL after Brexit. The classifications are based on opinions published by the European Chemicals Agency’s (ECHA) risk assessment committee (RAC) in 2019 and 2020 before the end of the Brexit transition period. The proposal was notified to the World Trade Organisation (WTO) in April 2023.

Future proposals

On 24 August 2023, the HSE notified the WTO of their intention to add a second batch of 26 substances to the GB MCL. The list of substances can be found here. The proposed date of adoption for these substances is the first quarter of 2024. The classification would come into force on a voluntary basis at the time of adoption and become mandatory in the third quarter of 2025. A third proposal is expected to come soon.

On 9 November 2023, the UK Department for Environment Food & Rural Affairs (DEFRA) published a policy paper introducing an alternative transitional registration model (ATRm) for chemicals which aims to reduce costs for businesses while maintaining DEFRA’s commitment to protecting human health and the environment.

UK-REACH

Following UK’s withdrawal from the EU, a regulatory framework for chemicals in Great Britain (England, Scotland and Wales), known as the UK Registration, Evaluation, Authorisation and Restriction of Chemicals (UK-REACH), was put in place. UK-REACH retains the key principles of EU-REACH and aims to maintain high standards of protection of human health and environmental in Great Britain. EU-REACH continues to apply in Northern Ireland under the terms of the Northern Ireland Protocol.

The Alternative Transitional Registration Model

DEFRA, in collaboration with the Health and Safety Executive (HSE) and the Environment Agency, has introduced an Alternative Transitional Registration Model (ATRm) in response to concerns from UK industry about the financial burden of accessing EU data packages for UK-REACH transitional registrations. The ATRm aims to reduce business costs while prioritising the commitment to protect human health and the environment.

The ATRm is the result of an intensive review process involving industry experts and stakeholders. DEFRA’s aim is to take a more targeted approach using existing information already available in the EU and globally to develop the detailed information held on chemical substances in a more focused way. The review has shown that UK regulators do not need to maintain a full replica of all chemical registration data under EU-REACH in order to carry out their regulatory work effectively.

The Government's ambition is to have a comprehensive view of the use of chemicals in Great Britain to ensure that industry complies with the safe use of chemicals. This approach will enable regulators to assess the risks associated with chemicals and take targeted action where risks are deemed unacceptable. The success of the strategy was demonstrated by the release of the risk management analysis for per- and polyfluoroalkyl substances (PFAS) earlier this year.

DEFRA’s progress to date

DEFRA has made progress in the areas listed below. Proposals are being developed and will be subject of consultation.   

• Refining the details of the 'use and exposure' information required from Great Britain registrants.

• Reducing the hazard information required for transitional registrations and intermediates to the essential minimum so that UK-REACH registrants will not generally need to access and pay for data packages from the EU.

• Significantly reduce the cost to industry associated with buying or accessing EU hazard information.

• Improve the powers of regulators to quickly request and receive data from registrants for regulatory or risk prioritisation purposes, ensuring the ability to respond quickly to new or emerging risks.

• Undertake a review of the current fee structure for UK-REACH to establish a more sustainable funding model, including a possible reduction in the current level of UK-REACH registration fees.

• Revise the UK-REACH restriction processes to provide greater flexibility to respond quickly to identified risks.

Conclusion

The introduction of the ATRm and associated changes will provide a stronger basis for identifying and managing high risk chemicals in Great Britain while addressing the financial burden on businesses during the transition to UK-REACH. Consultations on the detailed policy are expected to take place in early 2024.

The UK’s Health and Safety Executive (HSE) has launched two public consultations on two substances, Pigment Red 83 and Solvent Violet 13, used in tattoo and permanent make-up (PMU) inks. The two substances have been proposed for mandatory classification and labelling (MCL) under Great Britain’s Classification, Labelling and Packaging (CLP) Regulation and scientific or technical information and/or wider policy and impact considerations can be submitted via the HSE’s comment webform by 2 January 2024.

Restriction Proposal for Tattoo Inks

In its capacity as the Agency for UK-REACH, the HSE has prepared a proposal under Article 69(1) of UK­-REACH to restrict certain hazardous substances found in inks used for tattooing and permanent make-up (PMU). The proposed restriction applies to substances with a mandatory classification for various hazards, such as skin sensitisation (H317). It also includes substances that are banned for use in cosmetic products in the EU under Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (as amended), commonly known as the Cosmetics Regulation.

The proposed restriction includes a derogation for 19 substances including Pigment Blue 15:3 and Pigment Green 7. Initially Pigment Red 83 and Solvent Violet 13 were also included in the derogation, but these two substances were removed because a review by the HSE identified data indicating potential concerns for skin sensitisation for these substances.

Pigment Red and Solvent Violet

The HSE has reviewed the available hazard information and found that there is a potential concern for skin sensitisation for two substances: Pigment Red 83 and Solvent Violet 13. Mandatory classification for skin sensitisation category 1B (H317) would bring the substances within the scope of the proposed restriction.

Therefore, the HSE as the Agency for GB CLP has prepared targeted reports to propose the mandatory classification and labelling of Pigment Red 83 and Solvent Violet 13 for skin sensitisation. The MCL reports are available here and here.

Information on the two substances is given in the table below:

Anyone with relevant information is encouraged to share it with the HSE. Relevant information includes scientific or technical information associated with the proposed classification, as well as information on the potential effects of the classification both positive and negative.

On 14th November 2023, the Ministry of Environment, Urbanization, and Climate Change of Turkey announced the additional responsibilities of the registrants under KKDIK. These include changing the company status or the identity information. 

As stated in the initial section of Article 22 of the KKDIK Regulation, companies undergoing registration are required to promptly revise their registration details in the event of any alterations to their status, such as transitioning to a manufacturer, importer, or goods producer. This includes updating identification information like address and company name. Article 59 (1) of the KKDIK Regulation specifies that registrants are liable to incur fees for essential changes to their approved registration documents.

Therefore, businesses that make changes to the information provided after submitting the registration dossier must obtain an application number from https://donersermaye.csb.gov.tr/.

To find out more about your responsibilities and to get support you are more than welcome to contact us!

KKDIK (aka Turkey REACH) came into force on 23 June 2017 as a result of the EU Adaptation policy. The regulation provides the means of registration, evaluation, authorization, and restriction of chemicals and safeguarding human health and the environment. 

The KKDIK registration period started on 1 January 2021 and the registration deadline is 31 December 2023. On the other hand, the current number of registrations is much lower than expected. Since the deadline is approaching, industry representatives addressed their concerns during the latest meeting with the Ministry about completing KKDIK chemical substance registrations by 31 December 2023. 

The TOBB (Union of Chambers and Commodity Exchanges of Turkey) and the Ministry discussed proposed timelines for the chemical substance registrations under KKDIK. After that, a draft was published on 14th November 2023 for consultation and obtaining insights from industry representatives. The discussions between govermental stakeholders is still ongoing. 

The main objective of this draft for KKDIK is to determine different deadlines for different tonnage bands as the UK is experiencing with UK REACH. 

Key points from this KKDIK draft:

Ministry representatives explained that the deadlines for pre-registration will most likely to be extended until the end of the timeline.

31 December 2026:

Substances manufactured or imported in an annual amount of 1000 tonnes or more.

Substances falling within the Aquatic Acute 1 and Aquatic Chronic 1 (H400, H410) hazard categories in an annual amount of 100 tonnes or more.

Substances falling within the Carcinogenic, Mutagenic, and Reprotoxic Category 1A and 1B hazard categories in an annual amount of 1 tonne or more.

31 December 2028:

Substances manufactured or imported in an annual amount of 100 tonnes or more.

31 December 2030:

Substances manufactured or imported in an annual amount of 1 tonne or more.

At GPC, we are always ready to act on your behalf for your compliance needs with our worldwide team of experts and professionals to ensure the safety of your trade in Türkiye.

Stay tuned for updates on the KKDIK! 

On 11 October 2023, India's Ministry of Environment, Forest and Climate Change (MoEFCC) notified the draft Ecomark Certification Rules, 2023. The final day for comments is 60 days from the date of notification. These rules apply to all products produced or supplied for distribution, or use in the market, unless otherwise excluded under the Ecomark Certification Rules. 

Introduction: 

The Ecomark Certification Rules, 2023 ('the Ecomark Rules') provide for the labelling of products designed to minimize their environmental impact. The primary objective is to encourage consumer acceptance of such products and to motivate manufacturers to move towards producing Ecomark certified products, thereby promoting sustainability. 

The Ecomark Rules aim to promote environmentally friendly products and ensure the level of environmental performance of such products in terms of consumption of resources and environmental effects. This includes effects on climate change, effects on nature and biodiversity, energy consumption, waste production, discharges into all environments, pollution caused by physical effects and the use and release of hazardous substances. 

The Ecomark Rules will provide labels for products that meet approved environmental criteria. 

Purpose: 

The purpose of the Ecomark Rules is to increase demand for environmentally friendly products that have less negative environmental impacts, in line with the principles of LiFE (Lifestyle for Environment). The rules promote resource efficiency and the circular economy and aim to prevent misleading information on the environmental aspects of products. 

The following are the key objectives of the Ecomark Rules: 

1. To raise consumer awareness regarding environmental issues and the consequences of their choices, thereby encouraging a shift towards more environmentally friendly behaviors and consumption patterns. 

2. To encourage manufacturers to switch to the production of Ecomark certified products. 

3. Take measures to avoid deceptive or misleading information about the fraudulent use of the EcoMark label. 

On 19^th October, China MIIT published a notification which announced 60 standards relating to chemical industry. 

Among the 60 standards, there are 20 standards which were made to replace the previous standards, covering the area of determination of isocyanate group content in polyurethane prepolymer, the testing for industrial phosphorous acid, industrial strontium carbonate, industrial sodium chlorite, etc. The rest 40 standards are new standards governing the testing for polypropylene series chemical substances and etc. 

The publicity period is from 19^th October 2023 until 19^th November 2023. During this period, if you have any suggestion, you are welcome to contact GPC China via compliance@gpcregulatory.cn. GPC China can help you to report your suggestion to the official. 

The Ministries of Environment and Commerce of China published a revised list of hazardous chemicals for priority control as part of the country’s obligations under the Stockholm and Rotterdam Conventions. Currently, there are nine substances included in this list. 

Under this notification, two substances were added to the hazardous chemicals list: decaBDE and perfluorootanoic acid (PFOA). The list now requires stricter controls on short-chain chlorinated paraffins (SCCPs) and updates to their CAS numbers. 

Additionally, the use of following chemicals has been restricted: 

• Flame retardant hexabromocylododecane (HBCDD)
• Perfluorooctane sulfonic acid (PFOS) and its salts
• Perfluorootane sulfonyl fluoride (PFODF), excluding for the production of firefighting foams. 

The updated list took effect from 18^th Oct. 2023. It will replace the 2020 version.

For companies who are seeking to export the listed chemicals, they need to first apply to MEE for a release order. Once the order is released, it will be valid for 6 months. If you have any questions to this notification, please contact GPC China via compliance@gpcregulatory.cn.

The Ministry of Environment and Ecology of China (MEE) has consulted on the inclusion of four chemical substances to its Inventory of Existing Chemical Substances (IECSC) under MEE Order No.12. 

The concerned substances are: 

• 4-chlorobenzophenone;
• 1,8-naphthalimide;
• (2S,4S)-2-(dimethyl-amino carbonyl)-4-mercapto-1-(p -nitrobenzyloxycarbonyl)- 1-pyrrolidine; and
• cerium (III) acetate hydrate.

These four substances were nominated by the industry on the legal basis that these substances were manufactured in or imported into China before 15^th October 2003 as provided in MEE Order No.12.

The nomination was done on 23^rd October, and it will be opened for consultation for two weeks. From now on, there are no registration or record filling obligations for these four substances under China REACH. For more information regarding China REACH, please contact GPC China via compliance@gpcregulatory.cn. 

The South Korean Ministry of Food and Drug Safety (MFDS) announced a new guideline for animal testing on October 18, 2023, entitled Guideline of Alternative Animal Testing Methods for Cosmetics: Eye Irritation (Acute Eye Damage or Irritation) Test using Reconstructed Human Cornea-like Epithelium (RhCE).

Animal testing

Many countries prohibit animal testing. Since 2013, South Korea has also been a pioneer in the protection of animal rights. According to the South Korean Cosmetics Act, no cosmetics or cosmetic materials that have been tested on animals may be supplied in the country. The ban on animal testing also applies to imported cosmetics.

The MFDS has previously issued twenty-nine recommendations previously on alternative animal testing methods to help cosmetic companies conduct safety tests efficiently.

RhCE model

The reconstructed human corneal-like epithelial model (RhCE) is a model created by culturing immortalized human-derived corneal epithelial cells that have a lamellar structure and a highly differentiated squamous epithelium. It consists of at least four living cell layers and measures survival after topical exposure to a test substance. RhCE tissue viability measures the extent to which the bioluminescent dye MTT is converted to formazan dye by living cells and predicts the overall ocular damage/irritation response to chemicals.

Guidelines

The recently published guidelines explain alternative testing methods for eye irritation in cosmetics using the RhCE model. It describes the position of the Food and Drug Administration (FDA) and is based on scientific evidence and laws in effect as of October 18, 2023. It may be applied differently depending on recent amendments.

"Eye damage or irritation" refers to adverse effects such as damage or irritation caused by the test chemical coming into contact with the eyes. The RhCE eye irritation test technique is anticipated to assist companies in developing safer cosmetic products without the use of animal testing.

This test guideline applies to single substances, mixtures, solids, liquids, semi-solids, and waxes. It is applicable to water-soluble or water-insoluble liquids and highly soluble or insoluble solids. It is not appropriate to apply this guideline to gases and aerosols, and scientifically meaningful results should be considered when testing difficult-to-test substances or mixtures not covered by this guideline.

On October 31, 2023, the South Korean Ministry of Environment (MoE) notified the World Trade Organization (WTO) of the draft partial amendment to the Enforcement Rule of the Act on Registration and Evaluation of Chemical Substances. The amendment aims to reduce trade barriers and facilitate trade. 

The amendment is open for comments for 60 days from the date of notification. The proposed date for adaptation and enforcement of the amendments is January 30, 2024. The partial amendment contains the following: 

For the chemical substances under Article 11(1) of the Act on Registration and Evaluation of Chemical Substances (hereinafter referred to as "the Act"), it is allowed to waive some of the data required for chemical registration under Article 10 of the Act, the Ministry of Environment requests to submit the reason of waiving and the evidence data under Article 5 of the Enforcement Rule of the Act.  However, at present, the MoE requests the submission of the evidence data even when it is possible to justify waiving some data based on the hazard evaluation results of overseas governments, etc. Therefore, this partial amendment aims to specify the cases in which the submission of evidence data is not required. 

On November 17, 2023, the National Institute for Environmental Research (NIER) in South Korea published a partial amendment to the “Regulations on Classification and Labelling of Chemicals.” This amendment will take effect from the date of notification. 

The key changes in this partial amendment include: 

1. Revised Toxic Substances: 

• 15 toxic substances, 2 restricted substances, and 6 substances requiring preparation for accidents have been updated. 

• The chemical names of these substances have been modified, and specific requirements regarding import declaration, business license, labeling of hazardous chemicals, and transitional measures have been established for the newly designated toxic substances. 

2. Addition of New Chemicals: 

• A total of 55 new chemicals have been added to the list. The chemicals are listed in the table below.  

On October 2023, Taiwan Food and Drug Administration (TFDA) Taiwan updated its guidance for Product Information File (PIF) for cosmetics. It includes guidelines on the preparation of PIF, manual for the establishment of PIF, and PIF checklist. The main revision are on the documents of terminology and references for documents, PIF documents, and the alternatives to animal testing. All the documents came into force upon their release on 2 October 2023. 

If you have any further inquiry regarding Taiwan REACH TCCSCA or cosmetic registration, please contact GPC via compliance@gpcregulatory.cn or zhengmin@cn.gpcregulatory.com. 

On 27 October 2023, the Japanese Ministry of Economy, Trade and Industry (METI) issued a proposal to classify poly(oxyethylene) nonylphenyl ether (NPE) as a Class II specified chemical substance according to its Chemical Substance Control Law (CSCL). The proposal mandates that manufacturers and importers to label their packaging with environmental protection guidelines and to submit reports detailing both expected and actual annual quantities.

Class II specified chemicals are chemicals that have been detected (or are expected to be detected) in significant amounts in the environment and are believed to represent a risk of long-term adverse effects to humans and/or the ecosystem. Currently, there are 23 substances in this class, including trichloroethylene, tetrachloroethylene, carbon tetrachloride, and triphenyltin N,N-dimethyldithiocarbamate.

In Japan, NPE is widely used as:

• Wetting, emulsifying, and dispersing agent in textile processing.
• Detergents, dishwashing liquids, and floor cleaners in household and industrial cleaning products.
• Defoaming agent in paper and pulp production.
• Emulsifier and wetting agent in the production of pesticides and herbicides.
• Emulsifier and surfactants in cosmetic products such as shampoos, body washes, facial cleansers, etc.

The consultation on the draft will end on 26 November 2023.

On 1 November 2023, Japan's Ministry of Economy, Trade and Industry (METI) issued a directive requiring companies to submit detailed information on two priority assessment chemicals (PACs) under the country's Chemical Substances Control Law (CSCL).

The substances in question, sodium alkenesulfonate and sodium hydroxyalkanesulfonate, have been listed as PACs, indicating their potential risks to the environment or human health. Companies are now required to submit comprehensive data with their annual reports for the financial year 2024. The information required includes:

Name and Contact Details of Notifier: Companies must provide their name and contact details as the notifier of the substances in question.

Name and CAS Number of the Substance: The specific identification of the substances with their Chemical Abstracts Service (CAS) numbers is crucial for accurate reporting.

Chemical Structure, Composition, and Weight Percentage: Detailed information about the chemical structure, composition, and weight percentage of the substances is required for a thorough assessment.

Volume: Companies are required to disclose the volume of the substances being manufactured or imported, especially if the volume exceeds one tonne per year.

Uses: METI is requesting information on the intended uses of sodium alkenesulfonate and sodium hydroxyalkanesulfonate, as understanding the potential exposure scenarios is essential for risk evaluation.

Priority assessment chemicals are subject to increased scrutiny due to their potential adverse effects. The National Institute of Technology and Evaluation’s (NITE) Chemical Risk Information Platform shows that there are currently 218 substances listed under the PAC category.

Companies engaging in the manufacture or import of these substances in quantities exceeding one tonne per year are required to submit their annual reports, ensuring compliance with METI regulations and contributing to the overall safety and accountability in the handling of chemicals.

The President of Ibama (Brazilian Institute of environment) has issued a groundbreaking resolution regarding the control of Hydrofluorocarbons (HFCs) imports. 

The resolution outlines stringent measures to regulate the importation of HFCs and HFC-containing mixtures. This action is taken in compliance with the Kigali Amendment of the Montreal Protocol on Substances that Deplete the Ozone Layer. 

The key provisions of the resolution include: 

• Definition of Terms: The resolution provides comprehensive definitions, including those for substances that deplete the ozone layer (SDO), the Montreal Protocol, Global Warming Potential (GWP), ton of CO2 equivalent, and various categories related to HFCs. 

• Import Quotas: The resolution establishes a quota system for the import of HFCs, delineating annual maximum limits in CO2 equivalent tons. These quotas are assigned based on various criteria, including the importer's historical activities and the type of HFCs involved. 

• Control Mechanisms: Companies involved in importing HFCs are required to submit electronic forms detailing their activities by April 30 of the subsequent year. Failure to provide accurate information will result in penalties. 

• Reduction Targets: The resolution outlines a phased reduction in the national quota for HFC imports, with a freeze for the year 2024 and subsequent annual reductions from 2029 onwards. 

• Performance and Technical Reserves: The national quota will be divided into performance and technical reserves, ensuring responsible import practices. The technical reserve is set aside for new market entrants and those who have exhausted their specific quota. 

• Utilization of Quotas: Importers must adhere to strict procedures for utilizing their quotas, including registration with Ibama and the Unique Foreign Trade Portal. The resolution emphasizes the importance of accurate information and compliance with the stipulated regulations. 

• Transfer of Quotas: The resolution permits the transfer of quotas between companies under specific conditions, subject to Ibama approval. This measure aims to foster collaboration and responsibility within the industry. 

• Cessation of Import: Companies choosing not to utilize their import quotas for two consecutive years will have their quotas permanently transferred to the technical reserve. 

This landmark resolution reflects Brazil's commitment to international environmental agreements and signals a proactive approach to mitigating the impact of HFCs on the ozone layer and global warming.  

The MMA (Ministry of Environment of Brazil) is calling for non-governmental entities to join their National Commission for Chemical Safety (Conasq).
Published on Monday (Nov 13th), this notice invites organizations from civil society, the private sector, academia, and professional entities to be a part of this crucial commission. The deadline for registration is November 24th!
The Conasq is dedicated to fostering integrated actions for the environmentally responsible management of chemical products. Its mission is to proactively address health and environmental risks associated with these substances. By promoting the safe use of chemicals, the commission aims to minimize their presence in consumer products while advocating for safer alternatives.
Brazil is making strides towards a safer and healthier future!

Malaysia launched the newly redesigned MyEHS Environmentally Hazardous Substance (EHS) registration system was introduced on September 5, 2023. The website has been redesigned, and organisations can now register, log in, and complete the required steps. As part of the new MyEHS, companies will be asked to provide information on the production and import of chemicals that are subject to certain frameworks, mostly international treaties.

Objective of the MyEHS system

The objective of the MyEHS system is to ensure that manufacturers and importers notify the authorities about the production and import of EHS, and provide the information required for the safe and sound management of EHSs to protect the environment and public health.

Malaysian EHS Reference List

The Malaysian EHS Reference List will be established by the Department of Environment (DOE) based on data provided by industry. The list will include the names of the substance reported to DOE, their uses in Malaysia, their hazard classification, and the total amount of these chemicals sold in Malaysia. The public will have access to the data stored in this system.

The EHS Reference List contains the following list of chemical compounds that are covered by MyEHS:

• Substances included in the Rotterdam Convention's Annex III
• Chemicals regulated by the Minamata Convention on Mercury
• Chemicals listed in Annexes I and V of the EU PIC Regulation (Regulation (EU) No 649/2012) 
• Chemicals included in Annexes A, B, and C of the Stockholm Convention
• Additional substances designated by the DOE Director General as substances  of concern (such as chemicals included in the Customs (Prohibition of Import) Order 2023 and the Customs (Prohibition of Export) Order 2023)

Moreover, substances covered under the following Acts are excluded from MyEHS because the relevant authorities have previously received the information separately:

• Pesticides Act (1974)
• Poisons Act (1952)
• The Atomic Energy Licensing Act (1984)
• The Chemical Weapons Convention Act (2005)

Colombian companies handling polychlorinated biphenyls (PCBs) are racing against the clock to meet the 30 November deadline set by the Ministry of Environment and Sustainable Development. The regulatory mandate requires these companies, already listed in the national inventory, to submit comprehensive reports detailing their PCB usage throughout the 2022 calendar year.

The looming deadline stems from Resolution 222/2011, enacted in 2011, which mandates annual registration and updates of PCB inventories for companies within its purview. The resolution not only emphasizes meticulous record-keeping but also outlines specific responsibilities for the identification, analysis, and a gradual phase-out of equipment and waste containing PCBs by the year 2028.

The Ministry of Environment and Sustainable Development has been vigilant in monitoring and enforcing compliance with these regulations to mitigate the environmental impact of PCBs, which are known for their harmful effects on ecosystems and human health.

Companies subject to the resolution are urged to expedite the submission of their 2022 reports, ensuring accurate and transparent documentation of their PCB-related activities. The ministry emphasizes that timely reporting is essential to assess the progress made in the gradual elimination of PCB-containing equipment and waste.

Failure to meet the 30 November deadline may result in penalties and legal consequences for non-compliant companies, as the government underscores its commitment to environmental conservation and sustainable development. As the clock ticks down, Colombian businesses are working diligently to fulfill their reporting obligations and contribute to the country's collective efforts in creating a cleaner and healthier environment.

In a strategic move to prevent the illicit introduction of specific chemicals aimed at evading taxes on fuel, Mexico has announced robust regulatory measures. The temporary ban on 68 listed substances, coupled with recent updates to the List of Substances regulated by the Secretary of Energy, signals a comprehensive effort to secure the nation's energy landscape.

Under the revised list, the 68 substances implicated in fuel adulteration are now subject to heightened scrutiny. Notably, entities looking to import these substances must file for temporary import authorizations within 30 business days through the online system, VUCEM.

This development holds significant implications for companies operating in Mexico reliant on these substances for their daily operations. Staying informed and adapting to these new processes is crucial as Mexico fortifies its regulatory framework to safeguard against tax evasion tactics in the fuel sector.

The non-governmental organization (NGO) Zero Mercury Working Group (ZMWG) has conducted a market monitoring of skin lightening products sold online and found that toxic mercury cosmetics are still being marketed as a ‘solution’ for dark skin. The ZMWG is urging the negotiators at the Fifth Conference of the Parties (COP5) to the Minamata Convention to address the enforcement gaps and implementation failures related to mercury-containing cosmetics. 

African proposal 

In May 2023, Botswana, and Burkina Faso on behalf of the African Parties to the Minamata Convention, proposed an amendment to eliminate the use of mercury in cosmetics, removing the current 1ppm threshold for mercury in cosmetics and phasing out the substance completely by 2025. Mercury is used in products such as skin lightening products (SLPs) which are predominantly used by people of colour to obtain lighter skin. The text of the proposal can be found here.

The African amendment seeks to strengthen the Minamata Convention provision by: 

• Banning the production and sale of all ‘mercury-added’ cosmetics, not just those containing more than 1 ppm of mercury.  

• Restricting the trade of ‘mercury-added’ SLPs, including sales, offers for sale, marketing, advertising, and display. 

• Coordinating inter-ministerial, bilateral, and/or regional strategies to phase-out mercury SLPs  

• Increasing public awareness regarding the risks associated with mercury SLPs. 

Report by Zero Mercury Working Group 

On 12 October 2023, the NGO Zero Mercury Working Group (ZMWG) released its report on ‘Online Marketing of Toxic Skin Lighteners’. In the report they state that they have found mercury levels ranging from 1.18 ppm to 74,800 ppm in 191 out of 213 SLPs purchased from online platforms.  

The report highlights the current lack of adequate measures to stop the production and online sale of mercury-added SLPs. Online platforms, continue to avoid their duty to stop unethical sellers from advertising, marketing and selling illegal SLPs. 

Based on information from the packaging of these products ZMWG said that most of these products are manufactured or distributed from Pakistan (34 %), Thailand (17%) and China (13%) and sold on various online platforms such as Amazon, eBay, Shopee, and Flipkart 

In addition, ZMWG has highlighted some other issues with the information on the packaging of SLPs: 

1. The information on the packaging is often inaccurate and misleading information. 

2. Mercury-added SLPs that did not list mercury as an ingredient  

3. Country of origin is not always listed. 

4. Obscure name of manufacturer 

5. Web links that lead to unsafe or unrelated webpages. 

6. Phone numbers that do not connect to the manufacturer. 

On November 6, 2023, the Gulf Cooperation Council (GCC) countries notified a draft standard (GSO 2654:2023) for the implementation of the seventh revised edition of the Globally Harmonized Standard of Classification and Labelling of Chemicals (GHS7) to the World Trade Organization. The notifying countries were the United Arab Emirates, the Kingdom of Bahrain, the State of Kuwait, Oman, Qatar, the Kingdom of Saudi Arabia, and Yemen i.e. the Gulf Cooperation Council (GCC) countries.

The objective of GSO 2654:2023

The draft standard has been published by the GCC Standardization Organization (GSO). The GSO technical regulation (GSO 2654:2023) aims to ensure the safe production, transport, handling, use, and disposal of hazardous substances in line with GHS requirements, including classification of substances and hazard communication elements like safety data sheets and labels.

Content of the standard document

In accordance with the GHS regulations, the proposed Gulf technical rule aims to ensure the safe production, transportation, handling, use, and disposal of hazardous substances:

1) The standard for categorizing compounds and Mixtures according to their physical, chemical, and health risks; and

2) The components of hazard communication, such as the specifications for safety data sheets and labels.

Deadline and Implementation

The comments are accepted by WTO for the notification in the next 60 days (i.e. until January 5, 2024). The date of adoption is yet to be determined. The Standard will come into force 180 days after publication in the official gazette.

On October 27, 2023, the New Zealand Environmental Protection Authority (EPA) released a set of proposals with the aim to protect people’s health and safety by reducing the maximum allowable levels of lead in paint. The proposals are open for comment until January 26, 2024. 

Toxicity of Lead 

Lead, a metal known for its high toxicity, poses significant health risks. It accumulates in the body, and no level of exposure is considered safe. Health issues resulting from lead exposure include irreversible damage to the brain and nervous system, anaemia, kidney damage, and impaired reproductive function. 

The environmental harm caused by lead extends beyond human health. This toxic element adversely affects plants, animals, and micro-organisms, demonstrating a universally detrimental effect. 

Historical Use of Lead in Paint 

The use of lead in paints dates back to at least the 4th century BCE. It was incorporated for colouring, drying enhancement, and as a corrosion inhibitor. Common lead pigments in paints include lead(II) chromate (chrome yellow), lead(II,IV) oxide (red lead), and lead(II) carbonate (white lead). Lead is also found in various coatings like varnishes, lacquers, enamels, glazes, and primers. 

Lead is released into the environment during the production, application, and degradation of paint. Lead dust from chipping or peeling paint poses a risk of inhalation, ingestion, or skin contact. 

EPA's Proposed Regulations to Limit Lead Exposure 

The Environmental Protection Agency (EPA) has outlined proposals to reduce lead hazards. These include: 

1. Capping lead in paints at 90 ppm under the Surface Coatings and Colourants Group Standards and the Aerosols Group Standards. 

2. Implementing lead limits in the Corrosion Inhibitors Group Standards. 

3. Requiring evidence of compliance with relevant lead levels. 

4. Revising element migration limits in graphic materials. 

5. Updating the AS/NZS ISO 8124.3 standard, which governs lead leaching from toys to the latest version. 

6. Amending the standards so that children's graphic materials only comply with the Graphic Materials Group Standard. 

7. Remove the notification requirement from the Graphic Materials Group Standard. 

8. Implement these changes 6 months after the Gazette notification. 

9. Disposing of non-compliant products within 6 months of the amendment. 

EPA's primary goal is to protect public health by reducing permissible levels of lead in paint. Additionally, the Agency is seeking to minimize lead risks in children's graphic materials, such as finger paints, crayons, and felt-tip pens. 

Public Participation Opportunity 

EPA is seeking public feedback on these proposals to lower lead levels in paint and graphic materials. The community can submit their responses until 26 January 2024 and play a crucial role in shaping these health-protective measures. 

At the fifth meeting of the Conference of the Parties to the Minamata Convention (COP-5), significant progress was made by adopting 21 decisions to further protect human health and the environment from the harmful effects of mercury. COP-5 was held in Geneva from 30 October to 3 November 2023 and the meeting attracted more than 800 participants and 900 online viewers.

Background on the Minamata Convention

The Minamata Convention on Mercury, adopted in 2013, is the most recent global agreement on environment and health. It is named after the bay in Japan where, in the mid-20th century, mercury-contaminated industrial wastewater poisoned thousands of people, causing severe health damage that became known as the “Minamata disease”. Since the Convention entered into force on 16 August 2017, 147 Parties have been working together to control the supply and trade of mercury, reduce mercury use, emissions and releases of mercury, raise public awareness, and build the necessary institutional capacity.

Decisions taken at COP-5

New phase-out dates:

• By 2025, the use of all mercury-added cosmetics must be phased out, with the exception of products intended for use around the eyes area due to the unavailability of safe substitute preservatives. This includes skin-lightening soaps and creams.

• Certain batteries, switches, relays, and fluorescent lamps will be phased out between 2025 and 2027, depending on the type.

• The use of mercury as a catalyst in polyurethane production will be phased out by 2025.

Dental amalgam:

• Parties that have not yet phased out dental amalgam will now be required to submit a national action plan every four years on their progress in phasing out or phasing down dental amalgam.

• Further action on dental amalgam will be considered at COP-6 in 2025.

Mercury waste:

• Guidance on BAT (best available techniques) and BEP (best environmental practices) for controlling mercury releases to land and water was adopted.

• Parties were encouraged to continue to advance their efforts to control mercury emissions to the atmosphere and to develop emission inventories.

• A threshold value of 15 mg/kg total mercury concentration was established for for waste contaminated with mercury or mercury compounds.

Artisanal and small-scale gold mining (ASGM):

• Advocate for greater involvement of indigenous peoples and local communities in Convention projects on artisanal and small-scale gold mining, to promote broader participation.

• The importance of protecting and strengthening traditional livelihoods and cultural practises was highlighted and further action was called for in the development and implementation of National Action Plans.

Conclusion

This progress at COP-5 underlines a collective commitment to a healthier, more sustainable future and marks critical steps forward in the global fight against mercury pollution. The decisions taken not only reflect immediate actions but also set the stage for ongoing strategies, emphasising the importance of continued cooperation and commitment to environmental protection.

On 25 October 2023, the Persistent Organic Pollutants Review Committee (POPRC) of the Stockholm Convention, issued a call for information on a number of proposed persistent organic pollutants (POPs) in advance of its upcoming meeting in September 2024. The POPRC is seeking information on chlorpyrifos, medium-chain chlorinated paraffins (MCCPs) and long-chain perfluorocarboxylic acids (LC-PFCAs).

Stockholm Convention

The Stockholm Convention is a global treaty that aims to protect human health and the environment from the effects of Persistent Organic Pollutants (POPs), which are substances that persist in the environment, accumulate in living organisms and pose a risk to human health and the environment. 

POPs can be transported across international borders by air, water or by migratory species, reaching regions where they have never been produced or used. The substances listed in the Convention are generally banned from production, marketing or use, unless specific exemptions or acceptable purposes for continued use are agreed. 

Parties to the Convention may propose a substance for listing if they have gathered evidence suggesting that it may be a POP. The technical scientific committee of the Stockholm Convention (POPRC) will then review and further develop the evidence that the substance has POP characteristics. 

If there is evidence that a substance has POP characteristics, the POPRC then considers the social and economic impacts of banning or restricting that substance and makes recommendations to the Conference of the Parties of the Stockholm Convention, which meets every two years. 

Medium-chain chlorinated paraffins

Chlorinated paraffins are used as plasticisers for polyvinyl chloride, as extreme pressure additives in metal-machining fluids, as additives to paints, coatings, and sealants to improve their resistance to chemicals and to water, and as flame retardants in plastics, fabrics, paints, and coatings.

Medium-chain chlorinated paraffins (MCCPs) were recommended for listing as POPs under the Stockholm Convention at the 19^th meeting of the POPRC (POPRC-19) in October 2023. The Committee decided to recommend that the Conference of the Parties to consider listing chlorinated paraffins with carbon chain lengths in the range C14–17 and chlorination levels of 45 % chlorine or more by weight in Annex A to the Convention with specific exemptions for some applications.

The Committee has invited Parties and observers to provide information that would assist it in possibly strengthening of the recommendations. The deadline for submissions is 24 January 2024 and the information submission forms for MCCPs can be found here.

In particular, the POPRC is specifically asking for the following:

• Information to enable the specification of the chemical identity.

• Information to enable the determination of concentration limits.

• Any other information, including information on the applications relating to specific exemptions.

Long-chain perfluorocarboxylic acids

Long-chain perfluorocarboxylic acids (LC-PFCAs), their salts and precursors have water, oil, dirt and grease repellent properties and are used in a wide range of products, including personal care products, cleaning products, and surface treatments for textiles, upholstery, leather, automotive parts, carpets and paper products, and packaging. They belong to the group of per- and polyfluorinated substances (PFAS). 

The POPRC has adopted the Risk Management Evaluation of LC-PFCAs, their salts, and related compounds, and recommended that the substances be listed for elimination in Annex A to the Stockholm Convention. The Committee invited Parties and observers to provide information that would assist in the possible definition of specific exemptions for the production and use of LC-PFCAs, their salts and related compounds. The deadline for comments is 24 January 2024 and the information submission forms for LC-PFCAs can be found here.

Chlorpyrifos

Chlorpyrifos is an organophosphate pesticide widely used as an agricultural insecticide and as a biocide to control non-agricultural pests. After completing a risk profile for chlorpyrifos, the POPRC has adopted a risk profile and decided that chlorpyrifos is likely to cause significant adverse human health and environmental effects, as a result of its long-range environmental transport and that global action is therefore warranted.

The Committee has requested additional information on the socio-economic considerations for chlorpyrifos to support the preparation of a risk management evaluation as specified in Annex F of the Stockholm Convention. The deadline is 1 December 2023.

On 19 October 2023, the Ministry of Health of Ukraine introduced an important draft law aimed at regulating and supervising the state registration of hazardous factors, with a particular focus on chemical and biological elements. The draft law, entitled the “On Approval of the Procedure for State Registration of Hazardous Factors”, outlines a comprehensive procedure for the state registration of these potentially harmful elements. The draft law was notified to the World Trade Organization (WTO) on 3 November 2023. The WTO is accepting comments for 60 days from the date of notification.

Details of the draft law

The main focus of the draft law is to establish a structured process for the state registration of chemical and biological hazardous factors. All individual chemicals, substances of biological origin as well as those present in mixed products are subject to registration. This is the case regardless of whether the substances are produced, used within Ukraine's borders, or imported into the country. The full text can be found here in Ukrainian.

Scope of registration: All individual chemical and biological hazardous factors, either as single substances or as part of mixed products, are subject to state registration in Ukraine. A hazardous factor that is part of a product or mixed product is subject to registration under the following conditions:

• Intentional release during use of the product or mixed product

• The concentration of the hazardous factor that is part of the product or mixed product is 0.1 % or more

• Impurities formed during the process of production or use of a substance are registered as individual substances.

Application and registration procedure: Applications for state registration of a hazardous factor may be submitted to the Ministry of Health, either in writing or electronically. In addition, if several manufacturers and importers are involved in the production or import of a particular hazardous factor, a joint application for registration is required.

Confirmation of registration: The registration of a hazardous factor is confirmed when the registration is recorded in the State Register of Hazardous Factors. Subsequently, the Ministry of Health issues a certificate confirming the registration.

State Register of Hazardous Factors: The following information on the substances is entered into the State Register:

• Name of the substance

• Source of origin (production

• Data on the purpose of the substance

• Characteristics of the biological action of the substance

• Hazard class

• Nature of action of the substance in the environment

• Methods of indication

• State medical and health standards established for the substance

• State medical and health rules for use (if necessary)

Hazard classification: The hazard classification of chemicals and chemical products follows the Globally Harmonized System of Classification and Labelling of Chemicals (GHS). The procedure for classification and labelling of chemicals and chemical products is established by the technical regulations approved by the Cabinet of Ministers of Ukraine.

Timeline: The proposed date of entry into force is 1 January 2024.