GPC Newsletter Oct-2023

In a move to enhance public safety, Health Canada has recently released information on six Hazardous Substance Assessments (HSAs). These assessments, fundamental for suppliers of hazardous products under the Hazardous Products Act (HPA) and its regulations, serve as indispensable educational tools. The Health Canadahas meticulously compiled comprehensive reports on the following substances: 

1. 4,4'-Methylenediphenyl Diisocyanate 

2. Diethylene Glycol 

3. d-Limonene 

4. EDTA Tetrasodium Salt 

5. Morpholine 

6. Toluene 

These technical documents provide critical insight into the safe handling and use of these substances to ensure compliance with regulatory standards. Health Canada's commitment to public well-being is demonstrated through the release of these detailed assessments, which provide valuable information to both manufacturers and consumers alike. 

On 20 September 2023 the US Consumer Product Safety Commission (CPSC) published a request for information on per- and polyfluoroalkyl substances (PFAS) that are in commerce or may be used in consumer products, potential exposures linked to such use, and potential adverse consequences on human health from the use of PFAS in consumer products. The request was notified to the World Trade Organisation (WTO) on 21 September. The notification is open for comments until 20 November 2023.  

Information requested  

The request for information is open to all stakeholders, including consumers, manufacturers and importers, government and non-government groups, and researchers. Stakeholders are asked to focus the information on consumer products considering the data that the CPSC already has access to in the contract report and related supporting materials. The report from the contractor is not a risk assessment and does not list all potential data sources that might be used in a risk assessment. 

The Consumer Product Safety Commission (CPSC) is specifically seeking information regarding the presence and use of per- and polyfluoroalkyl substances (PFAS) in consumer products, the potential human exposure to PFAS associated with the consumer product use, the potential exposure of highly exposed populations, and the potential adverse effects on human health derived from toxicological data sources. 

The CPSC seeks comment on all significant aspects of this issue. More details can be found here:  https://www.govinfo.gov/content/pkg/FR-2023-09-20/pdf/2023-20332.pdf 

On 28 September 2023 the U.S. Environmental Protection Agency (EPA) finalised a rule that will result in the most comprehensive collection of data on per- and polyfluoroalkyl substances (PFAS) produced and used in the United States. This rule is the culmination of more than two years of progress on the Government's initiative to tackle PFAS pollution, protect public health, and promote environmental justice, and is a major step in the EPA's PFAS Strategic Roadmap.

Per- and Polyfluorinated Substances

Per- and Polyfluorinated Substances (PFAS) are a class of manufactured chemicals that are widely used in industrial and consumer products. They have been manufactured since the 1940s and have properties that allow them to be used in a wide range of products, from non-stick cookware to waterproof clothing and firefighting foam. They are also used in some manufacturing processes.

PFAS are known as 'forever chemicals' as they are extremely persistent in our environment and bodies. They can lead to health problems such as liver damage, thyroid disease, obesity, fertility issues and cancer.

EPA’s Final Rule

The final rule expands the scope of the proposed rules definition of PFAS to include 41 additional PFAS identified as being of concern. The Environmental Protection Agency (EPA) has determined that a minimum of 1,462 PFAS have been produced or manufactured in the United States since 2011 will be subject to the final rule. It is important data to protect human health and the environment from these chemicals.

The Toxic Substance Control Act (TSCA) reporting rule is part of the FY2020 National Défense Authorization Act (NDAA), which requires all manufacturers (including importers) of PFAS-containing products in a given year from 2011 to submit information to the Environmental Protection Agency (EPA) including chemical identity, volume of products manufactured and processed, byproducts, environmental and health effects, worker exposure, and disposal.

This rule will provide the ability to understand and effectively protect people from PFAS and to conduct research on who is using the substances and in which quantity.  This rule will produce actionable data that can be used by the EPA and governments to craft policies and laws to protect people and the environment from PFAS.

Timeline

Companies will have 18 months from the effective date of the final rule (30 days after publication in the Federal Register) to report data online. Small companies that only report data on the import of PFAS in articles will have an additional 6 months to complete their online submissions.

On September 29, 2023, the U.S. Environmental Protection Agency (EPA) expanded the Safer Chemical Ingredients List (SCIL) by adding ten chemicals. The SCIL is a dynamic compilation of chemicals that meet the safety criteria of the Safer Choice program and now includes 1,071 chemicals that are considered the safest for their intended purposes.

Background

The Safer Chemical Ingredients List (SCIL) is a comprehensive compilation of chemical ingredients classified according to functional-use categories. These ingredients have been assessed by the Safer Choice Program and have been deemed to be safer alternatives to conventional chemical ingredients. The primary objective of this list is to assist manufacturers in identifying and adopting chemical alternatives that meet the exacting standards of the Safer Choice Program.

Selection Criteria

Prior to the inclusion of a chemical on the Safer Chemical Ingredients List (SCIL) by the Safer Choice program, an independent third-party profiler, such as NSF International, or ToxServices, is responsible for collecting hazard information. This process involves a comprehensive examination and assessment of all available data on the chemical's toxicological properties and environmental behavior. Subsequently, the third-party profiler compiles a detailed report for submission to Safer Choice, together with a recommendation as to whether the chemical meets the criteria for Safer Chemical Ingredients. Additionally, Safer Choice may conduct supplementary literature reviews and consider data from confidential sources, such as the Environmental Protection Agency's New Chemicals Program.

The Safer Choice program certifies products containing ingredients that meet the program’s criteria for human health and environmental safety and allows companies to use its label on products that meet the Safer Choice Standard. EPA encourages manufacturers to submit their safer chemical formulations for EPA evaluation and potential listing on the SCIL, which the EPA revises at least once annually to reflect advances in the field of safer chemistry.

The latest additions to the SCIL are: 

• Fats and Glyceridic oils, vegetable, hydrogenated; 
• Tocopherols; 
• Sulfuric acid, dimethyl ester, compd. with .alpha.,.alpha.',.alpha.'',.alpha.'''-[1,6-hexanediylbis(nitrilodi-2,1-ethanediyl)]tetrakis[.omega.-hydroxypoly(oxy-1,2-ethanediyl)]; 
• Glycolipids, sophorose-contg., Candida bombicola-fermented, from D-glucose and mahua Madhuca longifolia fats and glyceridic oils; 
• 1,4-Benzenedicarboxylic acid, 1,4-dimethyl ester, polymer with 1,2-ethanediol, .alpha.-hydro-.omega.-hydroxypoly(oxy-1,2-ethanediyl) and 1,2-propanediol, ester with .alpha.-methyl-.omega.-hydroxypoly(oxy-1,2-ethanediyl); 
• Dodecanoic acid, ester with 1,2-propanediol; 
• Diisopropyl succinate; 
• Diisopropyl sebacate;  
• Methyl propanediol; and 
• Methyl ethyl ketone. 

You can access a downloadable spreadsheet of the Safer Chemical Ingredients List (xls). Additionally, the U.S. EPA has initiated efforts to eliminate per- and polyfluoroalkyl substances from the program and to explore the possibility of expanding the scope of the program to include categories that are presently outside its scope.

The US Environmental Protection Agency (EPA) has opened a 60-day public comment period on the draft Toxicological Review of Inorganic Arsenic under the Integrated Risk Information System (IRIS). This draft, prepared by the Center for Public Health and Environmental Assessment (CPHEA) within EPA's Office of Research and Development, evaluates the toxicological effects of inorganic arsenic. The public comment period, which opened on October 16, 2023, will remain open until December 15, 2023.

BACKGROUND:

Inorganic arsenic is used in various industrial applications, including the hardening of copper and lead alloys, glass manufacture, and as a catalyst in the production of ethylene oxide. Given its widespread use, understanding its potential health risks is of paramount importance. The draft IRIS assessment, if finalized, could lead to stricter federal regulations on the use of inorganic arsenic in these industries.

KEY ASPECTS:

The latest evaluation introduces an overall reference dose of 0.031 µg/kg per day, which is well-supported by evidence that links inorganic arsenic to circulatory system disorders. The potential adoption of this reference dose has significant implications for the regulation of inorganic arsenic in various products and processes. While the EPA's Integrated Risk Information System program previously classified arsenic as carcinogenic, this classification remains unaltered in the latest draft.

However, the draft assessment looks more closely at the risks beyond cancer, including new data on noncancerous effects. These include effects on the cardiovascular system, neurodevelopment, pregnancy, and diabetes. The draft assessment conveys a high level of confidence in the role of inorganic arsenic compounds in the development of cardiovascular disease and diabetes, and a moderate level of confidence in their association with pregnancy, birth, and neurodevelopmental effects.

This comprehensive evaluation of the health effects of inorganic arsenic underscores the critical importance of regulating the use of this compound in various industries. To participate in the public comment process and have your say on these proposed regulations, visit the IRIS website or the public docket, with Docket ID No. EPA–HQ–ORD–2012–0830. The EPA welcomes input from stakeholders, scientists, and the public to help shape the future regulation of inorganic arsenic.

PFDA Review

The EPA also published a report detailing an external peer review of its preliminary IRIS assessment of perfluorodecanoic acid (PFDA), a long-chain PFAS. The reviewers generally agreed with the EPA's initial findings on the effects of PFDA on the immune system and development, but also provided additional perspectives. In the preliminary draft, a provisional overall reference dose of 4*10-10 mg/kg/day was established, based on considerations of immunotoxicity and developmental toxicity. However, the report underscores that the information currently available is insufficient for a comprehensive evaluation of the risks associated with PFDA.

On October 23, 2023, the U.S. Environmental Protection Agency (EPA) unveiled a major proposal aimed at prohibiting the use of trichloroethylene (TCE), an exceptionally dangerous chemical known to be associated with serious health risks, including cancer, neurotoxicity, and reproductive toxicity.

Background-

Trichloroethylene (TCE) is a substance found in various cleaning and furniture maintenance products, degreasers, brake cleaners, and tyre repair sealants. Several safer alternatives are readily available for most of these consumer applications. Commercially, TCE is used in vapor degreasing of components such as aircraft parts and machinery, as an intermediate in the production of specific refrigerants (which are already being phased out in the US), and in the production of battery separators for electric vehicles, transportation, security, and defense systems.

For decades, TCE contamination has plagued numerous communities, causing adverse health effects. This harmful substance is often found as a contaminant in soil and groundwater at Superfund sites. EPA has been actively involved in cleanup efforts, but the regulations proposed today, as part of the revamped 2016 Toxic Substances Control Act (TSCA), would potentially have spared many communities from the harmful effects of TCE exposure.

EPA's research has identified TCE as a causative agent of liver cancer, kidney cancer, and non-Hodgkin’s lymphoma. Moreover, TCE adversely affects the central nervous system, liver, kidneys, immune system, reproductive organs, and poses a threat to fetal development, even at minute concentrations. People residing near TCE production and use facilities face an elevated risk of developing these health conditions.

Proposal-

Under the Toxic Substances Control Act (TSCA), this initiative seeks to protect the public by prohibiting the manufacture, processing, and distribution of TCE for all uses. The proposed risk management rule will take effect within one year for consumer products and most commercial uses. It will also enforce strong protections for workers in the limited remaining commercial and industrial applications, with a longer phase-down period.

The anticipated reductions in exposure from this proposal aim to prevent cancer before it takes root, in line with President Biden’s Cancer Moonshot initiative.

Details of the Proposal-

EPA's proposed risk management rule would restrict most uses of TCE within a year, including its manufacture and processing for most commercial and consumer products. During this period, most individuals at risk of exposure to TCE such as workers in various sectors, consumers, and communities, will benefit from the protections in place. Safer alternatives are already available for most uses of TCE as a solvent

For limited uses of TCE, such as critical uses by federal agencies, the production of battery separators for electric vehicle batteries, and the manufacturing of specific refrigerants that are subject to national phase-down in favor of environmentally friendly alternatives, the proposal will grant an extended transition period. Strict worker protection measures will be mandated to minimize near-term exposures.

Furthermore, EPA's proposal includes provisions for essential laboratory use and proper disposal of TCE wastewater at sites with historic TCE contamination, extending up to 50 years, subject to workplace safety protocols.

The EPA is inviting public input on this proposed TCE rule for 45 days following its publication in the Federal Register via docket EPA-HQ-OPPT-2020-0642 at www.regulations.gov. The Agency also plans to conduct a public webinar for employers and workers to provide insight into the proposed regulatory measures.

This initiative represents a significant step towards safeguarding public health and promoting a cleaner, safer environment for all.

The European Chemicals Agency (ECHA) has received a mandate from the European Commission to prepare a restriction proposal in accordance with the requirements of Annex XV of the REACH Regulation targeting at least two Chromium (VI) substances. The proposal is expected to be submitted by 4 October 2024. The full text of the request can be found here.

Chromium (VI) substances

Within the EU-REACH Authorisation list (Annex XIV), there are 11 entries for Cr (VI) substances (entries 16-22 and 28-31). These substances are classified as carcinogenic (1A or 1B) and exposure to them poses a risk to both workers and the general population when exposed via the environment.

The proposed restriction will cover at least the following two Cr(VI) substances:

• Chromium trioxide (CrO3) - Annex XIV entry 16

This particular Cr(VI) substance is responsible for the majority of applications for authorisation.

• Chromic acid (H2Cr2O4) - Annex XIV entry 17

This is a group of acids produced from chromium trioxide and therefore needs to be included in the scope of the restriction proposal.

One of the main applications of these substances is in electroplating, a common surface finishing process for coating materials.

Background

The European Commission has received a substantial number of applications for authorisation of the use of the Cr(VI) substances listed in Annex XIV. This has stretched the capacity of the Committee for Risk Assessment (RAC) and the Committee for Socio-Economic Analysis (SEAC) and has affected their ability to regulate other hazardous substances.

The situation also undermines one of the objectives of the authorisation provisions which is the gradual substitution of this type of substance by economically and technically viable alternative substances or technologies.

The Commission’s Mandate

As part of the restriction proposal the Commission has requested that ECHA carries out a short analysis of the availability of alternatives. ECHA should also assess whether there is a potential risk of substitution of other chromium (VI) substances. If this is the case an extension of the mandate is possible.

The preparation of the restriction proposal and its evaluation by the RAC and SEAC will follow the standard REACH restriction process. In preparing the proposal, ECHA will take into account the knowledge and experience gained from handling applications for authorisation for these substances during the preparation of the proposal.

Once the Commission adopts the restriction, the substances within the scope will be removed from the Authorisation List. This action would be a historic first under EU-REACH.

Timeline

In the best case scenario, the Commission expects that a restriction could be adopted approximately 3 years after the receipt of the mandate by ECHA.

Help for companies

The Commission has published a Q&A document to clarify the situation for affected companies. This document also addresses the main issues related to the judgment of the European Court of Justice annulling the authorisation of a consortium comprising many downstream users of chromium trioxide.

On 16 October 2023, the European Commission presented a proposal for a Regulation on the prevention of pellet losses to reduce microplastic pollution. The aim of the proposal is to ensure that all operators handling plastic pellets in the EU take the necessary precautionary measures. This is expected to reduce pellet release by up to 74 % contributing to plastic-free rivers and oceans, cleaner ecosystems, and a reduction in potential risks to human health.

Background on Plastic Pellets

Plastic pellets, also known as nurdles, nibs, and resin pellets, are the primary raw material used in the production of all plastics. The majority of these pellets are considered microplastics, measuring up to 5mm in size, although a small proportion may be slightly larger. Plastic pellets represent one of the largest sources of unintentional microplastic pollution.

Current practices for handling plastic pellets result in losses at all stages of the supply chain, in particular during production, processing, transport and waste management operations. Once released into the environment, these small particles do not biodegrade and cannot be removed. Microplastics accumulate in animals including fish and shellfish, and eventually end up in human food. The continued release of microplastics contributes to persistent contamination of our ecosystems and food chains.

Proposed Measures

The measures proposed by the European Commission are as follows:

• Best handling practices for operators: Depending on the size of the facility or transport activity, operators will be required to follow certain best handling practices.

• Mandatory certification and self-declaration: To assist national competent authorities in verifying compliance, larger operators will be required to obtain a certificate from an independent third party, while smaller operators will be required to self-declare their compliance.

• A harmonised methodology to estimate losses: To help operators monitor their losses and fill some of the remaining data gaps, a harmonised methodology will be developed by standardisation bodies. This methodology is expected to increase accountability by increasing awareness of the environmental and human health impacts of different practices. 

• Reduced requirements for SMEs: Given the large share of small and medium-sized enterprises (SMEs) in the pellet supply chain, reduced requirements will apply in particular to micro and small operators.

Who is affected by the proposal?

The proposal sets minimum requirements for all operators, with additional conditions for medium and large companies handling more than 1,000 tonnes of plastic pellets per year. For SMEs and for medium and large companies handling less than 1,000 tonnes of plastic pellets per year the following less stringent requirements will apply:

• No obligation to carry out an internal assessment.

• No requirement for certification but of self-declaration of compliance.

• No obligation of reviewing at formal management meetings certain compliance information.

• No requirement to establish an awareness and training programme. 

• No requirement to establish procedures for informing drivers, suppliers and subcontractors of the relevant procedures to prevent, contain and clean up spills and losses.

Medium-sized companies handling more than 1,000 tonnes of plastic pellets per year will have a longer transition period compared to larger companies (36 months instead of 24 months) and a longer validity of the certificate (four years instead of three). There will also be specific requirements for transporters of plastic pellets.

Other EU Action on Microplastics Pollution

The European Union has taken a number of regulatory initiatives to address the pollution caused by plastic products that ultimately degrade into microplastics in the environment. These initiatives, including the Single-Use Plastics Directive and the proposal for a new EU Packaging Regulation, play a significant role in reducing the production of plastic waste, improving its collection and recycling, and promoting the incorporation of recycled materials in new products.

In addition, the EU adopted restrictions on intentionally added microplastics on 25 September 2023. These restrictions together with the newly proposed measures are the first EU instruments specifically designed to tackle microplastic pollution at the source and contribute to the Zero Pollution Action Plan’s target of reducing microplastic releases into the environment by 30 % by 2030.

The full text of the proposed Regulation on preventing pellet losses to reduce microplastic pollution can be found here.

Importers and downstream users of industrial-use-only mixtures need to be aware of the upcoming second poison centre compliance date. From 1 January 2024, all newly submitted poison centre notifications (PCNs) will have to comply with the harmonised information requirements set out in Annex VIII of the Classification, Labelling and Packaging (CLP) Regulation. 

Industrial-use-only mixtures

Industrial-use-only mixtures are used exclusively within industrial premises and remain inaccessible to both consumers and professionals, whether in their final product form or through any dilution achieved by reformulation, such as mixtures within mixtures (MiM). An example of an industrial-use-only mixture (as a final product) could be an automotive paint that is only used on an industrial site and is only available to industrial end-users.

Transitional period

There will be a one-year transitional period. Notifications for industrial-use-only mixtures that are on the market and notified before 1 January 2024 will remain valid until 1 January 2025. This means that after this date, all notifications, regardless of the use type, will have to be submitted in the harmonised format.

If changes are made to the product during the transitional period (e.g. changes to the mixture composition, toxicological properties, or product identifiers), a notification in the harmonised format must be submitted before the modified mixture can be placed on the market.

Information requirements

According to Annex VIII of the CLP Regulation, the harmonised information requirements include:

• The full chemical composition

• The toxicological information

• Product information

• The unique formula identifier (UFI)

However, for industrial use mixtures, there is an option to make a "limited submission" where compositional information from the Safety Data Sheet can be used. If this option is used, the notification must include a contact person who can quickly access the full compositional details 24 hours per day in case of an incident.

PCNs can be prepared and submitted to the European Chemicals Agency (ECHA) using the International Uniform Chemical Information Database (IUCLID). More information is available on the ECHA Poison Centre Website: https://poisoncentres.echa.europa.eu/.

The EU Regulation on the Registration, Evaluation, Authorisation and Restriction of Chemicals (EU-REACH) is the EU’s main legislation to protect human health and the environment from the risks that chemicals can pose.  

The REACH regulation is due for a revision to promote sustainable chemicals and simplify the regulation. The revision was originally promised in 2020 as part of the European Commission’s Chemicals Strategy for Sustainability, which aims for a toxic-free environment, and was scheduled for adoption at the end of 2022.

The complexity of the REACH regulation, which has not been revised since it came into force, is a major factor contributing to the delay. Parallel efforts to revise the Classification, Labelling, and Packaging (CLP) Regulation have also added to the complexity of the process.

On 17 October 2023, the Commission’s work programme for the period until the European Parliament elections in June 2024 was adopted. The revision of REACH is not included in the work programme ,so it can be assumed that the revision will be postponed until after the elections.

The UK government published the Guidance on the Management of CMR substances under the UK Cosmetics Regulation, on 5 October 2023. The regulation was published under the guidance of the Office for Product Safety and Standards (OPSS) and consists of a guidance document on the management of CMR (carcinogenic, mutagenic, or toxic for reproduction) chemicals present in cosmetics and the application for the exemption process for their continued use. England, Scotland, and Wales come under the scope of these regulations.

The UK Cosmetics Regulation can allow the use of CMRs in cosmetic products with an exemption from the Secretary of State. The regulation essentially covers the exemption procedure and associated timescales for the continued use in cosmetic goods of compounds categorized as carcinogenic, mutagenic, and toxic for reproduction (CMR) under the GB CLP Regulations. These exemptions are granted under the UK Cosmetics Regulation and can only be granted by the Secretary of State (SoS).

The Health and Safety Executive (HSE) has published the two procedures for GB mandatory classification and labeling under Article 37 and Article 37A. The deadline for applications to OPSS for cosmetic product chemicals is 18 months after the Technical Report is published on the HSE GB CLP Publication table. If the submitted exemption dossier needs to be updated, then interested parties can continue to check the data using the following links:

• ECHA website

• ECHA Registry of CLH Intentions until outcome

• ECHA Weekly Newsletter

• HSE GB CLP e-Bulletin

• HSE GB CLP publication table

The OPSS will not send a separate notification for this.

OPSS requests that the original report study and literature review be submitted with the application. OPSS is also committed to maintaining the confidentiality of submitted data.

Exemption applications can be submitted to cmrenquiries@beis.gov.uk via email.

On 11 October 2023, the UK’s Health and Safety Executive (HSE), in collaboration with the Environment Agency published its risk assessment analysis of the risks to humans and the environment from lead in ammunition. The publication follows a consultation to which the HSE received more than 2500 responses. In the risk assessment, the HSE recommends a restriction on the use of lead shot and lead bullets, with some exceptions, for example for outdoor target shooting in international competitions.

Following the publication of the analysis, the HSE's draft socio-economic opinion on the issue has been opened for a 60-day public consultation, and public comments can be submitted via the HSE’s official website.

HSE conclusions

The HSE has concluded that the following risks are not adequately controlled:

• Environment: lead shot (primary and secondary exposure), lead bullets (secondary exposure), and airgun ammunition (primary exposure and secondary exposure).

• Humans: for people who frequently consume large quantities of game shot with lead ammunition (shot or bullets), there is a health risk to vulnerable people, particularly young children and women of childbearing age, which is not being effectively managed.

The HSE is therefore recommending measures to restrict the use and placing on the market of some types of lead ammunition.

Uses and proposed restriction measures

The table below summarises the different uses of lead ammunition and the measures proposed by the HSE. The HSE emphasises that these restrictions do not amount to a total ban on live quarry shooting or target shooting in Great Britain.

Transitional periods

A transitional period of five years is proposed for the placing on the market and use of lead shot cartridges. This will give the manufacturers time to scale up production to replace the quantity of lead shot currently on the market. A transition period of 2 years is proposed for lead bullets for target shooting.

As the KKDIK deadline is rapidly approaching, we have gathered some insights for you to understand this process better.  

On the 21st of September, we had a meeting with the Turkish Ministry of Environment, Urbanization, and Climate Change (MoEUCC) regarding the KKDİK deadline (Türkiye REACH). After that, the Ministry and sector representatives had another meeting that addressed their concerns about the completion of KKDIK chemical substance registrations by December 31, 2023. In this meeting, TOBB (Union of Chambers and Commodity Exchanges of Turkey) and the Ministry discussed proposed timelines for the chemical substance registrations under KKDIK. 

In summary, there has been no official announcement from the Ministry regarding the postponement of the final registration date for KKDIK. However, the latest updates indicate that a draft plan to extend the deadline for KKDIK pre-registration notifications and registration dossier processes is being considered.

Stay tuned for updates on the postponement of the KKDIK process and current information!

On 30 September 2023, India’s Central Board of Indirect Taxes and Customs (CBIC) issued a new Circular (No. 23/2023) regarding mandatory additional qualifiers in import/export declarations in respect of certain products. This Circular amends a precious Circular (No.15/2023) dated 7 June 2023 following consideration of various representations and consultations with stakeholder. The Circular will enter into force on 15 October 2023, two weeks later than originally planned.

The amendment primarily affects paragraphs 4.1 and 4.2 of Circular No. 15/2023. The key changes are described below.

Chemical Category Details

The orginal Circular No. 15/2023, introduced changes that required additional qualifiers in import/export declarations for certain products. The Circular required these qualifiers for goods imported under chapters 28, 29, 32, 38, and 39. In the amended circular only heading 3808 of Chapter 38 ‘Insecticides, rodenticides, fungicides, herbicides, antisprouting products and plant-growth regulators, disinfectants and similar products, put up in forms or packings for retail sale or as preparations or articles’ is included.

For goods imported under the above-mentioned chapters, importers will now be required to provide additional details in the following categories:

Declaration of Non-Availability

In cases where importers are unable to obtain information on even one ingredient due to supplier confidentiality, a declaration of non-availability of CAS and IUPAC details must on the Bill of Entry as follows:

I certify that the information related to IUPAC & CAS number is not in my possession as the same is not provided by my supplier due to confidentiality.

Effective Date and Implementation

The revised requirements specified in Circular No. 23/2023 will be mandatory for imports under the mentioned chapters for all bills of entry filed on or after 15 October 2023. These additional qualifiers will supplement the existing declaration made by importers. 

It is important to note that the mandatory additional qualifiers for exports under the specified Customs Tariff Headings (CTHs) of the mentioned chapters will remain the same, with effect from 1 October 2023.

In a significant step towards enhancing transparency and efficiency in the chemical and petrochemical sector, the Department of Chemicals and Petrochemicals (DCPC), Government of India, is in the process of launching the Indian Chemical Inventory through its platform, ChemIndia. This platform, which is set to redefine the industry landscape, aims to facilitate the requirements of the chemical and petrochemical industries while collecting vital statistics on production, capacity, exports, imports, purchases, sales, and various chemical properties. 

Comprehensive Chemical Inventory 

The primary objective of compiling this database is to create a comprehensive chemical inventory that includes all pertinent information related to the sector. As part of this initiative, the DCPC has mandated the inclusion of additional qualifiers, such as CAS and IUPAC names in addition to the Harmonized System (HS) codes, for import-export data. This requirement, effective from 15 October 2023, applies to imports falling under Chapters 28, 29, 32, 38 (3808 only) and 39 for all bills of entry filed on or after 1 October 2023. More details on these requirements can be found here). 

Empowering Industries Through the Indian Chemical Inventory 

The Indian Chemical Inventory is as a testament to the DCPC's commitment to revolutionise data management in the chemical industry. This ambitious project provides real-time data collection, analysis, and compilation from the chemicals and petrochemical industry, presented on a monthly/annual basis. By streamlining data collection and storage, the Indian Chemical Inventory drastically reduces the cost, time, and administrative burden associated with manual processes. 

Benefits  

The Indian Chemical Inventory initiative is a significant development in providing access to information based on geographical location, enabling rapid decision making and responses based on current market knowledge. The focus is on improving accuracy and efficiency in managing and interpreting data, promoting knowledge generation, and encouraging innovation within the industry. It will enable researchers and various stakeholders to carry out effective research and analysis. In addition, this inventory would provide valuable data insights to policy makers at national and regional levels, promoting collaboration and partnerships within the chemical sector ecosystem. Additionally, there's a shift towards the use of cutting-edge technologies for data collection, analysis, and storage, allowing remote data entry, monitoring, and analysis.  

Features  

Key features of this platform include: A GIS Dashboards that provide location-based insights through interactive data visualisations, ensuring fast and intuitive analysis.  It also provides real-time data availability, enabling rapid access for in-depth analysis and making it a valuable asset for businesses, researchers, and policy makers.  

In addition, the Indian Chemical Inventory serves as a hub for sharing research material and data, promoting collaboration among industry stakeholders and facilitating industrial policy development. Leveraging advanced technologies such as artificial intelligence, machine learning, and big data analytics, the Inventory enhances data processing capabilities, enabling detailed analysis of hazard classifications, exposure routes, and environmental impacts. It also provides a systematic overview of the industry, enabling companies to make informed decisions and strategic plans for sustainable growth.  

More information on how to use this Platform can be found here. 

If you have any questions, please write a message to our team via this email: indiareg@gpcregulatory.com 

In order to control the presence of heavy metals in specific cosmetics, the Bureau of Indian Standards (BIS) has opened the comments area for three Draft Indian Standards for face wash, shower gel, and face/body scrub. The comment sections will be accessible until October 28, 2023.

Contents of the draft Standard

The draft Standard contains the methods for the determination of pH, heavy metals with their restricted amount in cosmetics, and sampling methods for cosmetics. The draft also elaborates on the packing and marking requirement for cosmetic products as per the Bureau of Indian Standards Act, 2016.

The proposed limits for lead, arsenic, and mercury in surfactant-based and soap-based face wash, shower gel, and face/body scrub are as follows:

A limitation on the total microbiological count for products as defined by Indian Standard (IS) 14648 is also included in the proposal. According to the current Indian Standard (IS) 4011, safety assessments would be necessary for any newly developed or unusual ingredients used in the production of the products.

According to the requirements, substances used to make body gel and face wash should adhere to the list of chemicals that are generally recognized as safe (GRAS) as per Indian Standard (IS) 4707 and be subject to limitations under the Drugs and Cosmetics Act 1940.

BIS certification marking

The Bureau of Indian Standards Act, 2016, and the Rules and Regulations established thereunder allow conformity assessment methods, the application of the Standard Mark on the product(s), and certification of the product(s) complying with the requirements of this standard.

Packing and marking

According to the draft Standard, the products should be packed in suitable well-closed containers and marked with the following information:

• Name of the material

• Manufacturer’s name and its recognized trade-mark, if any

• Net content

• Batch number

• Use before or expiry date as per statutory requirements

• List of ingredients, as per statutory requirements

• Any other information required by statutory authorities

The Bureau of Indian Standards (BIS) is seeking feedback on a draft revision of the standard that restricts the amount of lead and cadmium in porcelain crockery that comes into contact with food and drink till 10 November 2023. 

Background 

The standard for porcelain crockeryware (IS 3505) was first released in 1965 and has been amended several over the years. It was revised in 1979, 1994, and then a third time in 2002. In the third revision, the limits for lead and lead-dioxin release had been changed to be in line with the standards set by the International Organization for Standardization and Disarmament (ISO/DIS) for Ceramicware, Glass Ceramicware and Glass Dinnerware in Contact with Food-Release of Lead and Cadmium. Part 2 of the standard is called the 'Permissible Limit', which includes current regulations from major world bodies. It's designed to make sure there are no non-tariff barriers, and to protect people from any potential risks arising from the use of incorrectly manufactured or handled crockeryware that comes into contact with food and drink. 

Fourth revision of the porcelain standard 

The draft of the fourth revision of the standard specifies the standards and techniques for sampling and testing porcelain crockery. The draft lists the test techniques from IS 14179:1999 used to guarantee that products are resistant to detergents, citric acid, and hairline cracking of the surface glaze. As porcelain has a low thermal conductivity, the test methods used to assess possible migration of harmful elements differ from those used for ceramic items. 

The test method for lead and cadmium is specified in IS 9806:2001 and the release of these elements must not exceed the limit values given in the table below. 

The draft of the fourth revision also lays out provisions for marking and packing. It mandates that each article of porcelain crockeryware must be indelibly and legibly marked on its underside with the manufacturer’s name.  

In addition, each package of products must be marked with the following details: 

• Indication of the source of manufacturer 

• Description of the items 

• Quantity 

• Batch and lot number 

• Grade and type 

• Decoration quality number if any 

• Month and year of manufacture 

Further consultations 

The BIS also is consulting on revised standards for earthenware crockeryware (deadline 3 November 2023), fine (bone) china crockeryware (deadline 10 November 2023), and stoneware crockeryware (deadline 20 November 2023). 

On October 13, 2023, the Bureau of Indian Standards (BIS) opened a public consultation on a standard for plastic bottles and containers used for packaging natural mineral water and drinking water.  The last date for comments is December 12,2023. 

This standard specifies the raw material requirements, dimensional and performance requirements, and test methods for plastic containers used for packaging natural mineral water and packaged drinking water, excluding flexible pouches, polymeric layers inside metal cans, and paperboard-based packaging materials. 

Scope: 

This standard covers the specifications for the raw materials, dimensions, performance requirements, and test procedures applicable to plastic containers, such as bottles, jars, and cups, including their respective closures fabricated from materials like Polyethylene (PE), Polyethylene Terephthalate (PET), Polypropylene (PP), or Polycarbonate (PC). 

Materials for containers and lids: 

The standard requires that the plastic containers shall be made of the materials listed below which must conform to the relevant Indian Standards. 

• Polyethylene (PE) – IS 10146 

• Polyethylene Terephthalate (PET) – IS 12252 

• Polypropylene (PP) – IS 10910 

• Polycarbonate (PC) – IS 14971 

The container must have a lid made of one of the following materials: 

• Aluminium sheets coated with food grade lacquering on the inside. 

• Plastic such as High-Density Polyethylene (HDPE) or Polypropylene 

• A combination of plastic and metal  

Each container and lid must be marked with the name of the material (PET, PE, PP, or PC), as well as the batch and code number. In addition, it should be marked with its recycling symbol and recycled content as required by IS 14535. 

Polymer film used to coat aluminum foil must meet IS 8970:1991 and IS 10910:1994 criteria for safe usage in contact with food and drinking water.  

The guideline excludes biodegradable and compostable plastics, as well as flexible pouches used as water containers.  

Migration limits:

The standard establishes the following permitted limits for heavy metals in containers and lids. The limits are set by the Food Safety and Standards (Packaging) Regulations, 2018. 

Timeline: 

Last date for submitting comments is December 12, 2023. 

On 12 October 2023 the Ministry of Environment, Forest and Climate Change (MoEFCC) officially promulgated the Green Credit Rules, 2023. The Rules were published in the Gazette of India and came into force on the same day.  The Green Credit Rules are being implemented to promote the Green Credit Program which aims to promote environmental preservation and sustainability through market-driven strate. 

LIFE campaign 

The Government of India has initiated the 'LiFE' (Lifestyle for Environment) - 'Environmentally Sustainable Development Policy' as a movement to promote environmental protection and sustainable lifestyles based on the traditions and values of conservation by motivating consumers and the public to adopt behavioural changes that promote environmentally friendly actions. 

The Green Credit Rules, 2023, may provide derive cost benefits to environmentalists who reduce such carbon emissions and to the green credit breeding industry. 

Green Credit programme 

Any person or entity may take any measure for the purpose of protecting, preserving or conserving the environment. The measures referred to may include the following activities, namely:  

1. Tree plantation 

2. Water management 

3. Sustainable agriculture 

4. Waste management 

5. Air pollution reduction 

6. Mangrove conservation and restoration 

7. Eco mark label development 

8. Sustainable building and infrastructure 

Green Credit Certification 

The process for obtaining Green Credits for the activities mentioned above is as follows: 

• A person or entity wishing to obtain green credit shall register the activity with the Administrator. 

• An application for registration shall be submitted to the Administrator electronically through a website established by the Central Government for this purpose. 

• The Administrator shall arrange for verification of the activity by a designated agency. 

• Upon successful verification the Administrator will issue a Green Credit Certificate to the applicant. 

Methodology 

The Administrator determines the formula for calculating green credits and the process for generating them. It is based on the equivalent use of resources, size, scope, and other relevant factors required to achieve the intended environmental result. The Administrator shall also specify the process for reviewing and verifying activities. 

Trading 

The Administrator will create and manage a trading platform where green credits can be bought and sold in order to facilitate trading. A Green Credit Registry has also been developed to track the issuance of Green Credits. 

The full text of the Green Credit Rules, 2023 can be found here. 

On 21 September 2023, the Central Pollution Control Board (CPCB) of India published a notification to establish the framework for generation of EPR certificates for key metals recycled from e-waste under E-Waste (Management) Rules, 2022. EPR stands for Extended Producer Responsibility and means that obligated producers are responsible for the end-of-life collection and treatment of certain products. 

In the notification the key metals are grouped into three categories as mentioned below. 

Under the EPR Scheme, certification for rare earths and other precious materials will be considered and encouraged. However, in the first two years the EPR certification will be limited to gold, copper and aluminium, and iron (including steel and galvanized iron). 

The target for EPR Certificates for gold has been comparatively reduced as it has been determined that the annual capacity for gold recovery is less than the EPR obligation of producers. In the first year of implementation, the EPR obligation for gold will be 20% of the total gold obligation, increasing by 10% for the following year, 15 % for the next two years, afterwards by 20% in the subsequent two years. This means that by 2028-29 the recycling obligation for gold will be 100 % and that the gap between total EPR Obligation in respect of gold and gold recycling capacity will be bridged in five years. 

The EPR obligation of Producers in terms of non-ferrous and ferrous metals will be 100% of the obligation. 

The average material composition of key metals in terms of weight can be found here. 

On 16 October 2023 the Indian Ministry of Environment, Forest and Climate Change (MoEFCC) published a draft notification in the Gazette of India for rules on plastic waste management. The rules can be referred to as the Plastic Waste Management (Second Amendment) Rules, 2023. The draft notification is open for comments for 60 days from the date of publication in the Gazette of India.  

According to the draft, the manufacturers and importers of plastic packaging, products with plastic packaging, carrier bags, multi-layer packaging, or plastic sheets should comply with the registration of the concerned State Pollution Control Boards (SPCB) or Pollution Control Committee. 

Plastic Packaging 

Plastic packaging means packaging material made from plastics for the protection, preservation, storage, and transport of products in a variety of ways and includes the following categories: 

The thickness requirement does not apply to carrier bags and commodities made from compostable plastic and biodegradable plastics. Carrier bags and commodities made from compostable plastics shall conform to the Indian Standard: IS/ISO 17088:2021 titled Specifications for Compostable Plastics, as amended from time to time. The manufacturers or sellers of compostable plastic and biodegradable plastic, carrier bags and/or commodities or both shall obtain a certificate from the Central Pollution Control Board before marketing or selling. 

Extended Producer Responsibility 

Producers, importers and brand owners, shall comply with the Extended Producer Responsibility (EPR) for plastic packaging of following criteria: 

• Compostable and biodegradable plastics 

• Multi-layered plastic sachets or pouches 

The EPR targets for minimum levels of recycling (excluding end-of-life disposal) of plastic packaging waste for each category are listed in the table below: 

                                             (% of Extended Producer Responsibility Target)

BIS Report 

In cases where the sample testing was started, before the laboratory was recognized/certified by BIS (Bureau of Indian Standards) or NABL (National Accreditation Board for Testing and Calibration Laboratories), and the report is complying with IS 17899 T:2022, the production sample should be sent to BIS for re-testing to verify the biodegradable properties.  

According to BIS regulations any plastic packaging should be  labelled as “compostable” or “recycled” or “biodegradable” (with a specific number of days for the product to degrade) in terms of its properties. 

Registration 

Any person engaged in the business of selling, manufacturing or producing raw materials or plastic products should apply for one- time registration on the CPCB web portal.  

The registration guidelines are mentioned on the official website of CPCB: https://cpcb.nic.in/registration-for-brand-owner/ 

Every local body shall be responsible for developing and setting up infrastructure for segregation, collection, storage, transportation, processing and disposal of plastic waste either by itself or by engaging agencies or producers by undertaking assessment of plastic waste generated in a year, including legacy plastic waste, by 30th June of the next financial year and taking necessary steps to prevent stocking, distribution, sale and use of banned single-use-plastic items within its jurisdiction. Also by assessing the plastic waste management infrastructure available for collection, segregation and processing and reporting it on the CPCB website. 

The report must include the following points:  

1. Plastic waste generated in a year, including legacy plastic waste. 

2. Plastic waste management infrastructure available for collection, segregation, and processing. 

3. Forecast of plastic waste to be generated. 

4. Status of development and implementation of byelaws. 

5. Measures taken to prevent the stocking, distribution, sale and use of prohibited single-use-plastic items. 

Every registered person should complete the annual report. The report can be filled by submitting details on the CBCP web portal. Below are the forms that can be submitted by the respective obligated entities: 

The full text of the draft Plastic Waste Management (Second Amendment) Rules, 2023 can be found here. 

On 25 September 2023, the National Medical Products Administration (NMPA) published a notification on the enforcement of toothpaste regulation and simplified the information requirements for toothpaste products which have already done registration and record filing. 

1. The enforcement of toothpaste regulation 

According to this notification, since 1 December 2023, imported toothpaste can only be registered via NMPA, while domestic toothpaste registration can be done via provincial MPA. The product label sample and other relevant information in the toothpaste registration materials should comply with the requirements of the CSAR, Cosmetic Label Management Measures and other regulations. Toothpaste filers should, while filing toothpaste, upload through the filing platform the literature, research data or summary of product efficacy evaluation data on which efficacy claims are based, and accept social supervision. Toothpaste products that only claim to have cleaning effects are exempt from uploading and publishing abstracts.

This notification emphasized again that Children's toothpaste refers to toothpaste claimed to be suitable for children under the age of 12 (including 12 years old). The efficacy categories that children's toothpaste can claim are limited to cleaning and preventing caries. Children's toothpaste should be marked with the children's toothpaste logo on the sales package display surface. Children's toothpaste should also be marked with relevant warnings such as "Use under adult supervision", "Not edible", "Beware of swallowing" and other relevant warnings on the visible side of the sales package.

2. Simplify the information requirements for toothpaste products which have already done registration 

From 1 October 2023 to 30 November 2023, toothpaste filers can submit the following simplified information through the registration platform to register toothpaste products that have been on the market:

1. Basic information of toothpaste filer. Include the name, address, contact information, etc. of the filing person. If production is commissioned, the name, address, contact information, etc. of the actual production enterprise must also be submitted at the same time;
2. Basic product information. Including product name, product formula, product sales packaging label pictures, etc.;
3. Relevant information proving that the product has a history of safe use. This includes, but is not limited to, production and material input records, sales invoices, inspection reports and other relevant information since the product was launched, as well as the filing party’s commitments to product safety and the authenticity of the filing materials.

Toothpaste filers should complete the corresponding product registration materials in accordance with relevant laws and regulations before 1 December 2025. If the first batch of products are put on the market before 1 January 2021, the product registration materials can be kept on file by the filer for future reference; if the first batch of products are put on sale after that, the filer should submit complete filing materials through the filing platform.

For toothpaste products with simplified filing, the content of the label must comply with the requirements of the CSAR and Measures for the Administration of Cosmetic Labels. If only the format of the label needs to be adjusted, the already marketed sales can be used during the simplified filing. Packaging labels, and complete product label updates as required before 1 July 2024. In addition to those that only claim to have cleaning efficacy, toothpaste products subject to simplified registration must also upload and publish a summary of the basis for product efficacy claims through the registration platform before 1 December 2025.

For any China related inquiries, please contact GPC China via compliance@gpcregulatory.cn. 

On September 26, 2023, the Ministry of Employment and Labor (MoEL) announced the names, hazards, and risks of 55 new chemical substances manufactured and imported in the third quarter of 2023, as well as measures to prevent workers’ health problems related to these substances. 

Manufacturers and importers of new chemicals must submit a Hazard and Risk Investigation Report to the Ministry of Employment and Labor (MoEL) 30 days before the date of manufacture or import of the new chemical, and the MoEL regularly announces the name, hazards, and risks of the new chemicals. 

20 of the 55 new chemicals announced this time, are classified as either acutely toxic, skin and eye irritating, skin sensitising, or hazardous to the aquatic environment including (S)-Nornicotine and diphenylphosphine. 

Accordingly, the Ministry of Employment and Labor notified employers who manufacture or import the substance of measures to prevent health problems among workers who handle harmful or dangerous chemicals. 

Choi Tae-ho, director of the Industrial Accident Prevention and Supervision Policy Bureau, said, "It should not stop at knowing the harmfulness and risks of new chemicals and measures to protect workers". He emphasized, "It is important for employers to install local exhaust systems and provide and wear personal protective equipment such as respiratory protection, protective gloves, and safety glasses, while implementing basic safety and health rules, such as thoroughly wearing personal protective equipment when handling chemicals." 

Companies in South Korea that manufacture or import 10 to 100 tonnes of chemicals per year are required to submit their Material Safety Data Sheets (MSDSs) to the MSDS portal before the grace period ends on January 16, 2024. 

This mandatory submission is part of the country’s efforts to ensure the safety and health of workers handling these chemicals. The MSDS provides detailed information on the physical and chemical properties of these substances, including potential hazards and instructions for safe handling. 

In cases where the MSDS contains trade secrets, workplaces must undergo a non-disclosure approval review with the Occupational Safety and Health Agency (OSHA). This process allows for alternative names and content to be entered, protecting proprietary information while still ensuring safety compliance. 

Failure to meet this deadline could result in penalties, so companies are encouraged to start preparing their MSDS submissions as soon as possible. 

Grace periods for submitting MSDSs 

From 16 January 2021, Korean authorities require manufacturers, importers, or Only Representatives (ORs) appointed by non-Korean manufacturers to submit an MSDS before manufacturing or importing chemical substances. The MSDS must be submitted in Korean Language and follow the fourth revision of the UN GHS. If a chemical substance has been placed on the Korean market and an MSDS has been prepared before 16 January 2021, there are grace periods for submitting MSDSs based on the tonnage bands as listed in the table below. The grace periods for the tonnage bands above 1000 tonnes per annum (TPA) and 100-1000 TPA have expired.  

On 20 September 2023, the Ministry of Health, Labour, and Welfare (MHLW), the Ministry of Economy, Trade and Industry (METI), and the Ministry of Environment (MOE) jointly issued a Notice requesting hazard information on a ‘default candidate substance’. The notice sets a deadline of 30 November 2023 for submitting hazard information or an offer to conduct a study. Companies planning to conduct studies in 2024 should also notify the ministries by the same deadline.

A 'default candidate substance' refers to a general chemical substance for which the government ministries lack sufficient hazard data to carry out a screening assessment for its classification as a priority assessment chemical (PAC).

The three ministries have requested the following hazard information on the substance alpha-(2-ethylhexanoyl)-omega-[(2-ethylhexanoyl)oxy]poly(oxyethylene) (CAS no: 9004-93-7):

•  Algae growth inhibition test
•  Daphnia magna acute swimming inhibition test
•  Fish acute toxicity test

 If the collected information is found to be insufficient or the obtained data is deemed unreliable for the screening assessment, the ministries will classify the substance under the default hazard class, with hazard class 1 for ecological effects and hazard class 2 for human health effects.

Subsequently, a joint ministerial council will assess the hazard and toxicity of the substance and use this information to determine whether it should be officially designated as a priority assessment chemical. This thorough evaluation process is essential to protect both the environment and public health by ensuring proper attention and scrutiny for potentially hazardous substances.

The full Japanese text of the Ministerial Notice which includes guidelines for submitting hazard information and conducting studies can be found here.

In Japan, the Ministry of Health, Labour and Welfare (MHLW) has taken significant steps to improve workplace safety by updating the list of substances that require safety data sheets (SDSs) and labels in accordance with the United Nations Globally Harmonized System of classification and labelling (GHS). This move, in line with Japan's Industrial Safety and Health Act (ISHA), aims to improve the transparency of hazard information throughout the supply chain.

Revised list

On 31 August 2023, the MHLW published the revised list, which now includes a total of 667 substances. These substances are listed in both Japanese and English, along with their Chemical Abstracts Service (CAS) numbers and specified cut-off values. The cut-off value, designates the concentration threshold of a chemical substance within a product. If a listed chemical falls below this threshold, companies are exempt from providing SDSs and GHS-based labelling.

The revised list of substances requiring SDSs and GHS-based labels can be found here.

Manufacturers and importers are urged to thoroughly examine their products to determine whether they contain any of the listed chemicals above the specified cut-off values, thereby requiring SDSs or GHS-based labelling. Compliance with these regulations is essential to maintaining a safe and transparent working environment in Japan.

Earlier announcement

This development follows an earlier announcement on 16 March 2023, when Japan said it would add an additional 1,469 substances to the list, further strengthening the country's commitment to workplace safety and risk assessment. The 1,469 substances will be added in two stages in April 2025 and April 2026. More details on this addition can be found here. Transparent dissemination of hazard information throughout the supply chain remains a cornerstone of Japan's strategy.

Implementation of GHS in Japan

In Japan, the GHS is implemented under three laws, which include the Industrial Safety and Health Act (ISHL), the Pollutant Release and Transfer Register (PRTR) Law, and the Poisonous and Deleterious Substances Control Act (PDSCL).

As Japan continues to refine its workplace safety measures, the aim is to create a safer, more transparent environment for workers and companies alike, to encourage responsible handling of hazardous substances and to promote global harmonization of safety standards.

It is time for registered importers or manufacturers who introduced industrial chemicals into Australia during the previous registration year to submit their annual declaration to the Australian Industrial Chemicals Introduction Scheme (AICIS). The deadline for submission is 30 November 2023. This applies to all chemical introductions, regardless of category, quantity, or number of chemicals. The annual declaration covers activities from 1 September 2022 to 31 August 2023.  

The annual declaration should include: 

• The introduction categories for the chemicals imported or manufactured during the registration year. 

• A declaration that all introductions were authorised in accordance with sections 25 to 30 of the Industrial Chemicals Act 2019. 

• It should also be noted that an agent or consultant cannot submit the annual declaration on behalf of a company.  

• A separate post-introduction declaration (PID) must be submitted for each chemical categorised as very low risk for human health and the environment that is introduced in a registration year. 

• A separate post-introduction declaration must be submitted for the total number of polymers of low concern (PLCs) introduced during the registration year and a separate declaration must be submitted for the number of low-concern biopolymers introduced during the registration year. 

For more information you can contact us via the following email: compliance@gpcregulatory.com 

On 9 October 2023, the Australian Department of Climate Change, Energy, the Environment and Water (DCCEEW) opened consultations on the proposed scheduling decisions for short chain chlorinated paraffins under the Industrial Chemicals Environmental Management Standard (IChEMS).  

The substances in question are all classified as Persistent Organic Pollutants (POPs) under the Stockholm Convention. These substances have the potential to inflict significant or irreversible damage to the environment unless they are appropriately controlled. The consultations are open for feedback until 8 November 2023 and submissions can be made here. Providing feedback on the proposed decisions will help the Australian governments and businesses manage the environmental risks associated with these chemicals. 

Short chain chlorinated paraffins 

Short-chain chlorinated paraffins (SCCPs) refer to a category of chlorinated paraffin chemicals composed of straight-chain alkanes. It is important to note that SCCPs have never been manufactured in Australia, but have been used in a variety of  industries. They have been used as a dual-purpose flame retardant and plasticizer in polyvinyl chloride (PVC) products, as lubricants in metalworking, and in the leather treatment process. 

The DCCEEW is seeking feedback on short-chain chlorinated paraffins (SCCPs). The scheduling decision is for Schedule 7 of the IChEMS Register. If adopted, the import, manufacture, use and export in Australia will be prohibited from 1 July 2024.  

The Industrial Chemicals Environmental Management Standard 

IChEMS is a national approach in Australia that aims to efficiently manage the use, storage, handling and disposal of chemicals. By establishing standardised environmental protocols for the handling of industrial chemicals, IChEMS streamlines the process for industry to choose less hazardous alternatives. Under IChEMS, chemicals will be listed on the IChEMS Register in one of seven schedules based on their risk characteristics to provide information on their relative environmental risk. The IChEMS Register will also include risk-based controls that should be applied to protect the environment. Industrial chemical uses that pose a greater risk to human health and the environment will be subject to more stringent controls. 

IChEMS Register Schedules 

In the IChEMS Register, Schedules 6 and 7 list the industrial chemicals of greatest environmental concern, e.g. chemicals that are persistent, bioaccumulative and toxic, such as POPs. All uses of chemicals in Schedules 6 and 7 are being phased out, except for essential uses. Schedules 2 to 5 list industrial chemicals of medium environmental concern. They are subject to controls that are proportionate to the nature and level of risk. Schedule 1 lists the industrial chemicals of lowest concern. 

Previous consultations 

In July 2023 the DCCEEW held consultations on the proposed scheduling decisions for perfluorooctanoic acid (PFOA), perfluorooctane sulfonic acid (PFOS), perfluorohexane sulfonate (PFHxS), and pentachlorobenzene (PeCB). Those consultations closed on 1 September 2023. Furthermore, in September 2023, the DCCEEW  also held consultations on the proposed scheduling decisions for brominated flame retardants (BFRs) and these consultations are still open till 25 October 2023.  

Food Standards Australia New Zealand (FSANZ) proposes to amend its Food Standards Code to align residue limits (MRLs) for agricultural and veterinary chemicals with other national regulations. 

Regulatory Authority involved:

• Food Standards Australia New Zealand (FSANZ)

• Australian Pesticides and Veterinary Medicines Authority (APVMA)

APVMA sets maximum residue levels that are not likely to be exceeded if agricultural or veterinary chemicals are used in accordance with approved label instruction. In considering maximum residue levels (MRLs) and variations to MRLs, the APVMA considered studies on chemistry, metabolism, analytical methodology, residues, toxicology, good agricultural practice, and dietary exposure.

The following substances in particular plant and animal commodities are the subject of the proposed amendments:

Plant commodities: Fenpropidin, florylpicoxamid, abamectin, acibenzolar-S-methyl, benzovindiflupyr, chlorantraniliprole, cyanamide, cyantraniliprole, difenoconazole, dimethoate, fenpropidin, fluxapyroxad, isocycloseram, isopyrazam, omethoate, pyraclostrobin, spirotetramat, tebuconazole, tetraniliprole, trifloxystrobin, and trifludimoxazi Australian Pesticides and Veterinary Medicines Authorityroln.

Animal commodities: Fenpropidin, halauxifen-methyl, and trifluralin

Key highlights of amended version of MRL standard:

• New MRLs have been established for a variety of pesticides and veterinary compounds, including those used on new crops or to combat novel pests and diseases.

• MRLs for various pesticides and veterinary chemicals have been increased to reflect the latest scientific research on their safety.

• MRLs for various pesticides and veterinary compounds have been reduced to ensure that dietary exposure remains safe.

FSANZ has assessed the scientific data on chemicals and concluded that the proposed MRLs are safe for consumers.

Public is invited to comment on proposed amendments until 14 November 2023.

Proposed date of adoption and publication anticipated in January 2024.

In a significant move towards enhancing the safety assessment of pesticide products, the Brazilian Health Regulatory Agency, Anvisa, has introduced a user-friendly and entirely electronic pesticide indication form. This innovative step aims to streamline the process of toxicological safety reassessment, making it more accessible and efficient for all stakeholders.

The new pesticide indication form marks a departure from the conventional paper-based submissions. Instead, it allows users to submit their suggestions electronically, eliminating the need to send documents via email. This transition to a fully electronic platform is expected to expedite the collection and evaluation of crucial data in the reassessment of pesticide active ingredients.

One of the primary objectives of the revised process is to compile a more robust risk matrix for ranking and selecting active ingredients that warrant re-evaluation. This initiative builds upon the last list of active ingredients for re-evaluation published in 2019, which prioritized seven compounds. Among these, the re-evaluation of carbendazim led to its eventual ban, underlining the significance of this endeavor in safeguarding public health.

Currently, four active ingredients are undergoing technical analysis by Anvisa, while two are awaiting the publication of a notice to commence re-evaluation. The revised pesticide indication form ensures that stakeholders, including representatives from the regulated sector and ordinary citizens, can contribute to the nomination process. However, it is important to note that providing technical-scientific information to support the suggested nominations is a prerequisite.

The toxicological reassessment of pesticides is a crucial post-market action undertaken by Anvisa to review the registration of products with potential health risks that were not initially identified during the registration process. Re-evaluation becomes necessary when there are concerns about the unacceptable risks posed by a particular active ingredient in a pesticide. The results of this re-evaluation can lead to various outcomes, including the suspension, ban, or maintenance of pesticide registrations, often with the adoption of health protection measures.

Anvisa invites all interested parties to contribute to the new matrix for selecting and prioritizing active ingredients for re-evaluation. This collaborative approach underscores the agency's commitment to ensuring the safety of pesticide products and protecting public health.

For those seeking further information on the toxicological re-evaluation process of pesticides, Anvisa's re-evaluation page provides comprehensive insights into the criteria used to prioritize active ingredients, the toxicological aspects evaluated, the complete list of active ingredients slated for re-evaluation, and much more.

This groundbreaking step by Anvisa in introducing a more accessible and efficient pesticide indication form promises to enhance the safety assessment of pesticide products, reinforcing the agency's dedication to safeguarding the health and well-being of the Brazilian population. Stakeholders are encouraged to actively engage in this important process to contribute to the ongoing improvement of pesticide safety standards.

More information at: Brazilian Health Regulatory Agency (Anvisa) — Agência Nacional de Vigilância Sanitária - Anvisa (www.gov.br)

In a considerable move towards combating climate change and protecting the environment, Brazil has enacted the Kigali Amendment to the Montreal Protocol on Substances that Deplete the Ozone Layer. This milestone was achieved through Decree No. 11.666 in August, and it marks a vital step in addressing the high potential of Hydrofluorocarbons (HFCs) to intensify global warming. HFCs may not deplete the ozone layer, but their contribution to climate change cannot be ignored.

The Kigali Amendment, named after the Rwandan city where it was adopted in 2016, is an extension of the Montreal Protocol, which has been hailed as one of the world's most successful environmental agreements. The original Montreal Protocol focused on phasing out ozone-depleting substances (ODS) like chlorofluorocarbons (CFCs) and halons. Its remarkable success in achieving its goals has been pivotal in protecting the Earth's ozone layer.

However, as the world reduced its use of ODS, there was a surge in the production and consumption of HFCs, hydrochlorofluorocarbons (HCFCs), and other related compounds. These chemicals, used primarily in air conditioning, refrigeration, and other applications, are potent greenhouse gases, with global warming potentials thousands of times greater than carbon dioxide (CO2).

The Kigali Amendment, therefore, aims to address this unintended consequence by phasing down the production and consumption of HFCs. Signatories to the Montreal Protocol are required to reduce their HFC usage over time, ultimately leading to a significant reduction in their contribution to global warming.

Brazil's Commitment to the Kigali Amendment

Brazil's commitment to combating climate change has taken another step forward with the enactment of the Kigali Amendment. By aligning with the goals of the amendment, Brazil acknowledges the importance of mitigating the impacts of HFCs on the climate.

To implement the Kigali Amendment domestically, Brazil's environmental agency, the Brazilian Institute of the Environment and Renewable Natural Resources (Ibama), will play a pivotal role. Ibama will publish a Normative Instruction (IN) that will establish the requirements and procedures related to the import control of HFCs and mixtures containing HFCs. This regulation will set annual import limits in compliance with the Protocol, ensuring that Brazil meets its obligations under the Kigali Amendment.

Public Engagement and Transparency

Ibama's commitment to transparency and public participation is commendable. The Institute has announced its intention to open a public consultation on the Normative Instruction (IN) through the Participa + Brasil platform. This initiative allows all interested sectors, including industry, environmental organizations, and the public, to access the proposal and make their contributions on the subject. This inclusive approach ensures that a wide range of perspectives and expertise are considered in the development of the regulation, promoting fairness and effectiveness in its implementation.

More info in Portuguese about it: Ibama informa sobre Implementação da Emenda de Kigali para controle dos HFCs no Brasil — Ibama (www.gov.br)

A public consultation on the Draft Circular on Technical Regulations for Measurement, Reporting and Verification of Greenhouse Gas Emission Reduction and Greenhouse Gas Inventory in the Industry and Trade Sectors (hereinafter referred to as "the Draft") was launched on September 6, 2023, by the Ministry of Industry and Trade of Vietnam (MOIT). The call for comments can be found here.

The Draft offers technical guidance on greenhouse gas (GHG) inventory and GHG emission reduction at the facility level in the industrial sector under the control of the MOIT's. It does so by implementing Decree No. 06/2022/ND-CP Providing Regulations on Reduction of Greenhouse Gas Emissions and Protection of the Ozone Layer. Prime Minister's Decision No. 01/2022/QD-TTg, of January 8, 2022, lists the companies that are required to submit a GHG inventory. This list includes 1,662 facilities in the commercial and industrial sectors.

Emission Sources        

GHG emission sources include direct emissions from stationary equipment such as boilers, furnaces, burners, turbines, heaters, and incinerators resulting from the combustion of fuel. Additionally,  there are mobile emission sources, resulting from the burning of fuel in vehicles etc Indirect emission sources include emission sources resulting from the consumption of electrical energy as well as emission sources related to the use of steam and heat energy. Also, to be considered are emission sources related to purchased raw materials, fuels and waste treatment processes, and others.

GHG Inventory

The latest recommendations issued by the United Nations Intergovernmental Panel on Climate Change (IPCC) will be implemented for specific emission sources. Annex II of the Draft contains the calculations for determining the GHG emissions from each source. The Ministry of Natural Resources and Environment's (MONRE) list of specified emission factors are essentially what the calculation's emission factors follow.

Every two years starting in 2024, facility-level GHG inventories must be created and submitted to the People's Committee of the province or city for review together with any pertinent data. Form 06 in Annex II of Decree No. 06/2022/ND-CP shall be used as the reporting format for the GHG inventory. The deadline for submitting the first report for 2024 is March 31, 2025.  

Reporting of GHG Emission results

In contrast to the GHG inventory procedure, the reporting of GHG emission reduction results will start in 2026, and the first report must be submitted to MONRE and MOIT by March 31, 2027, together with the findings of any third-party verification. Regarding these reporting formats, Form 02 in Annex III of Decree No. 06/2022/ND-CP is to be used for the GHG emission reduction results report and Annex II.2 of the Draft is to be used for the verification results report.

The full Draft can be downloaded here.

On 10 October 2023, the Vietnamese Ministry of Health notified to the World Trade Organisation (WTO) a Draft Circular promulgating the list of chemicals and insecticidal and disinfectant products for household and medical use which are under the state management of the Ministry of Health and whose HS codes can be identified according to Vietnam’s nomenclature of exports and imports. The final date for comments is 60 days from the date of notification.

The Draft Circular was published together with Circular No. 31/2022/TT-BTC of the Minister of Finance, dated June 8, 2022 which published the List of Vietnam's export and import items.

Relevant documents

• Circular No.  65/2017/TT-BTC dated  June  27,  2017  of  the  Minister  of  Finance promulgating Vietnam's nomenclature of exports and imports.
• Circular No.  09/2018/TT-BYT dated April 27, 2018 promulgating the list of chemicals and insecticidal and disinfectant products for household and medical use which are under the state management of the Ministry of Health and whose HS codes can be identified in accordance with the Vietnamese Nomenclature for Exports and Imports.
• Circular No.  31/2022/TT-BTC of the Minister of  Finance promulgating  Vietnam's  nomenclature  of   exports and imports, replacing Circular No. 65/2017/TT-BTC.

The tariff classification of imported and exported commodities under the ASEAN Harmonized Tariff Nomenclature (AHTN) 2022 is revised by Circular No. 31/2022/TT-BTC (Circular 31). Based on the most recent version of the World Customs Organization's Harmonized Commodity Description and Coding System (HS), the AHTN is updated every five years (WCO). Every five years, the HS is  updated to reflect advances in product technology, engineering, and marketing.

This Circular is applicable to create import and export tariffs, create lists of goods to serve government administration in accordance with government regulations and Clause 4 Article 26 of the Customs Law, to compile state statistics on import and export, and to assist the state in managing the import and export of goods and other areas.

Purpose and timeline

The purpose of this circular, its justification, and the types of urgent issues it addresses are to protect human health and safety, the environment, and the standards of quality. The proposed date of adoption is 15 December 2023 and is likely to come into force on 15 January 2024.

On 6 September 2023, the Malaysian Department of Occupational Safety and Health (DOSH) published its proposed amendments to the Industry Code of Practices of Chemicals Classification and Hazard Communication (ICOP), Parts 2 and 3. The consultation on the proposed amendments is open until 10 November 2023. The eighth revised edition of the UN’s Globally Harmonized System (GHS) for Classification and Labelling of chemicals served as a building block for the development of these changes.

ICOP Regulation

In order to comply with the Occupational Safety and Health (Classification, Labelling and Safety Data Sheet of Hazardous Chemicals) Regulations 2013 (CLASS Regulations), the Industry Code of Practices of Chemicals Classification and Hazard Communication, 2014 (ICOP) is a legally binding document that must be followed. Generally speaking, the CLASS Regulations provides guidance on chemical classification and hazard communication, as well as a list of chemical substances that have been officially classified.

The following four Parts along with an Appendix create the ICOP:

Part 1: Classified Chemicals List

Part 2: Chemical classification

Part 3: Hazard Communication, labelling and SDS,

Part 4: Confidential Business Information (CBI)

Amendments to Part 2 (Classification of Chemicals) of ICOP

In Part 2 of the ICOP, the main amendments to the hazard classes in terms of definitions and classification methods are as follows:

• Physical Hazards: Explosives/Flammable gases/Flammable liquids/Flammable solids/Oxidizing gases/Oxidizing solids/Gases under pressure/Self-reactive substances/Substances which in contact with water emit flammable gases/Organic peroxides/Substances corrosive to metal
• Environmental Hazards: Hazardous to the aquatic environment/Hazardous to the ozone layer
• Health Hazards: Acute toxicity/Skin corrosion or irritation/Serious eye damage or eye irritation/Respiratory sensitization/Skin sensitization/Germ cell mutagenicity/Carcinogenicity/Reproductive toxicity/Specific target organ toxicity (single exposure)/Specific target organ toxicity (repeat exposure)/Aspiration toxicity

Amendments to Part 3 (Hazard communication) of ICOP

In addition to amendments related to labelling, the guidance for the creation of Safety Data Sheets (SDS) has been amended. Some of the changes are as follows:

• Section 1: The following paragraph was added: The product identifier used for the chemical shall match with the product identifier used on the label (3.7.1.1.4)
• Section 4:  Guidance on first-aid measures was added.
• Section 6: Advice related to suitable fabric for personal protective clothing was added (3.7.6.1.2).
• Section 8:  Guidance on air monitoring procedures was added (3.7.8.1.1). ‘Exposure monitoring’ has been modified to ‘air monitoring’.
• Section 9:  Advice on the properties that should be included and the appropriate units of measure and/or reference conditions was added.
• Section 11:  Guidance on hazard information to be provided was corrected
• Section 14: Guidance on bulk transport was added

Amendments to the ICOP Appendix

In addition, with regard to Parts 2 and 3, the Appendix was also amended as follows:

• Appendix 2.2 Guidance on classification of carcinogenicity.
• Appendix 2.3 Example of Classification Record
• H315 + H320 (causes skin and eye irritation) were removed from Appendix 3.1 (List of hazards).
• Appendix 3.2 (List of Precautionary statements) several entries were deleted, replaced or amended, and new entries were added.
• Appendix 3.3 has been replaced by instructions for choosing precautionary statements for labelling.
• Appendix 3.4: Label elements for each hazard class
• Appendix 3.5: Examples of label element arrangements

Argentina has introduced fresh technical guidelines for the storage of mercury in line with the Minamata Convention. The issued Resolution delineates the particulars concerning storage and management, encompassing explicit stipulations for labeling. These updated regulations are applicable to any entity or individual within Argentina who is in possession of mercury under the following conditions:

Those who have sought exemption in accordance with Resolution MAyDS No. 299/21;

Those who have had their Reconversion Plans approved under the Minamata Convention on Mercury as per Resolution MAyDS No. 503/22;

Those subject to the provisions of Law No. 24,051. 

On 2 November 2023, the 90-day deadline set by the Argentine National Administration of Medicines, Food, and Medical Technology (ANMAT) for companies to make the required revisions and begin the process of changing formulations and labeling required under Provision 5978 / 2023 will expire.

The Provision was released by the ANMAT on 4 August 2023. The article prohibits the use of certain substances in cosmetics, personal hygiene, and perfume products, including 4-Amino-3-hydroxytoluene, 1,2,4-Trihydroxybenzene, and 2-[(4-amino-2-nitrophenyl)-amino]-benzoic acid.

The EU’s Scientific Committee on Consumer Safety (SCCS) has already issued opinions on the safety of these ingredients when used in hair and eyelash dyes. The SCCS found that 4-amino-3-hydroxytoluene and 1,2,4-Trihydroxybenzene are genotoxic, while 2-[(4-amino-2-nitrophenyl)-amino]-benzoic acid is mutagenic. According to the findings, the use of these chemicals in cosmetics is not safe. Based on the quality of the scientific evidence provided, the European Commission modified Annex II of Regulation No. 1223/2009 to include these compounds in the list of substances restricted for use in cosmetics. ANMAT cites the EU's findings as the proof required to ban the chemicals in Argentina.

Provision 5978 / 2023 also forbids the marketing of cosmetic products containing these chemicals. Companies that own, produce, or import cosmetic items affected by this clause have 90 calendar days (until 2 November 2023) to make required revisions and commence the process of changing formulations and labeling. Penalties for non-compliance will be imposed in accordance with Law 6.463 and Decree No. 341/92. The Provision entered into force on the day of its publication in the Official Gazette, and it must be filed with the National Directorate of the Official Registry, the Argentine Chamber of the Industry of Personal Hygiene, Cosmetics, and Perfumery Products, and other organizations.

On 12 September 2023, five East African countries (Burundi, Kenya, Rwanda, Tanzania, and Uganda) notified the World Trade Organisation (WTO) of a Draft East African Standard for alkaline thioglycollic based hair removers. The Draft is open for comments for 60 days from the date of notification.

Scope of the Standard

The Draft East African Standard specifies the various sampling and test methods for alkaline thioglycolic based hair removers. The product can also be referred to as chemical depilatory. Hair removers of the epilator type and those containing metallic sulphides or of stannite composition are not covered by the Standard.

Requirements for alkaline thioglycolic based hair removers

Alkaline thioglycolic based hair removers must comply with all requirements in the East African Standard for Cosmetics and cosmetic products (EAS 337). Moreover, these products must fulfil some additional requirements:

1. It should convert human hair into a soft plastic mass which can be easily removed from the skin by rinsing or wiping.

2. It should be non-toxic and non-irritating to the skin even after prolonged contact with the skin.

3. It must not stick to cloths and be stain free.

Furthermore, the alkaline thioglycollic based hair removers must comply with the specific requirements given in the table below when tested with the specified test methods.

The alkaline thioglycollic based hair removers must not contain heavy metals beyond the limits listed in the following table.  The total combined amount of these metals must not be excess of 10 mg/kg in final formulation.

In addition to this the hair remover products must comply with the specific microbiological limits listed in the table below when tested according to the specified test methods.

Packing and labelling requirements for hair remover products

The final formulation must be packed in sealed containers from which the product cannot leaked out and that do not react with the product.

Before entering the market the product must be labelled as required in the East African Standard for Labelling of Cosmetics (EAS 346). In addition each package must be marked with the following:

• Product name as “Alkaline thioglycollic based hair remover” or ”Hair remover X” where “X” denotes the form/presentation of the product.

• Contact time permitted for the product to completely remove hair from the body

• Instruction for use including the following:

  • • never use the product  beyond the time as specified on the package by the manufacturer.

    • never use the product on inflamed or broken skin or near the eyes. Should this occur, rinse with running water If symptoms persist, seek medical advice.

    • if used for the first time, carry out the following patch test: Use a little hair remover over 5 cm2 of skin on the inner elbow. If 24 h later the skin is normal, the material may be safely used.

• With proper cautions such as:

  • Contains thioglycolate.

  • Follow the instructions

  • Keep out of reach of children

Reference documents

The following documents are referred to in the Standard.

• EAS 346, Labelling of cosmetics — General requirements

• EAS 377 (all parts), Cosmetics and cosmetic products

• EAS 846, Glossary of terms relating to the cosmetic industry

• EAS 847-16, Cosmetics — Analytical methods — Part 16: Determination of lead, mercury and arsenic content

• EAS 847-17, Cosmetics — Analytical methods — Part 17: Determination of pH

• EAS 847-18, Cosmetics — Analytical methods — Part 18: Determination of thermal stability

• ISO 18416, Cosmetics — Microbiology — Detection of Candida albicans

• ISO 21149, Cosmetics — Microbiology — Enumeration and detection of aerobic mesophilic bacteria

• ISO 21150, Cosmetics — Microbiology — Detection of Escherichia coli

• ISO 22717, Cosmetics — Microbiology — Detection of Pseudomonas aeruginosa

• ISO 22718, Cosmetics — Microbiology — Detection of Staphylococcus aureus

• ISO 24153, Random sampling and randomization procedures

The full text of the Draft East African Standard can be found here.

The trade bloc of South America (Mercosur) has released a preliminary regulatory proposal aimed at modernizing the roster of permissible additives for food contact materials.

Should the proposal gain approval, it would result in an update to technical regulation No 02/12. The key addition would be the inclusion of tetramethyl bisphenol F diglycyl ether in the 'positive list' for food contact materials, which specifies authorized plastics and polymeric coatings.

Additionally, the proposal would impose restrictions on the use of polyamide-imide 2, confining it to being a binding agent exclusively for high-temperature resistant cookware.

For these changes to become legally binding in each of the Mercosur countries, namely Argentina, Brazil, Paraguay, and Uruguay, they would need to integrate this standard into their national legislations.

Interested parties are invited to submit their comments on the proposal by the 30th of October.

In a progressive step to improve consumer safety and align with international standards, New Zealand’s Environmental Protection Authority (EPA) recently announced ambitious proposals to overhaul the cosmetics industry. These proposals come after the EPA received feedback from a range of stakeholders, including 20 submissions from industry players, representatives of industry groups, international organizations, government bodies, and individual submitters. 

The proposed changes cover a wide range of aspects within the cosmetics sector. In the following the key highlights of the EPA’s proposals and the areas where disagreements arose during the consultation process are listed. 

Proposed Changes: 

1. Aligning the definition of PFAS: The EPA proposes to align the definition of PFAS with the proposed rules in Europe while retaining the plan to phase out PFAS ingredients by December 31, 2025. 

2. Transition period: To address the concerns from the cosmetics industry, the proposed transition period for compliance with the new rules is extended to December 31, 2025, with an additional year for the sale of products. 

3. Scope and clarification of rules: The scope modifications remain unchanged, but the EPA has clarified its expectations concerning the simplicity of rules assignment to the Group Standard. 

4. Amendments to Schedules 4 to 8: Several changes are proposed, including the requirement to print the fluoride concentration on the label for fluoridated toothpastes, the retention of zinc pyrithione as a cosmetic ingredient, alterations in the presentation of the rules for specific ingredients, and alignment of the definition of maximum concentration with European standards. 

5. Exceptions for nanomaterials: Exceptions from the notification requirements for nanomaterials are proposed for ingredients already approved as colorants, preservatives, and UV filters, in order to reduce the burden on the industry. 

6. Additional proposals: The EPA also plans to phase out cosmetics containing PFAS by December 31, 2025, require compliance for products containing hazardous components, introduce clear record-keeping requirements for nanomaterials, update fragrance regulations, and consolidate the main text and Schedules 4 to 8 into a single document for improved usability. 

These proposed changes are designed to align New Zealand's cosmetics regulations with the evolving standards in the European Union (EU) and ensure a safer, more transparent industry. The transitional provisions have been carefully structured to allow the industry sufficient time to adapt to the forthcoming changes to the Group Standard. 

Food Standards Australia New Zealand (FSANZ) proposes to amend its Food Standards Code to align residue limits (MRLs) for agricultural and veterinary chemicals with other national regulations. 

Regulatory Authority involved:

• Food Standards Australia New Zealand (FSANZ)

• Australian Pesticides and Veterinary Medicines Authority (APVMA)

APVMA sets maximum residue levels that are not likely to be exceeded if agricultural or veterinary chemicals are used in accordance with approved label instruction. In considering maximum residue levels (MRLs) and variations to MRLs, the APVMA considered studies on chemistry, metabolism, analytical methodology, residues, toxicology, good agricultural practice, and dietary exposure.

The following substances in particular plant and animal commodities are the subject of the proposed amendments:

Plant commodities: Fenpropidin, florylpicoxamid, abamectin, acibenzolar-S-methyl, benzovindiflupyr, chlorantraniliprole, cyanamide, cyantraniliprole, difenoconazole, dimethoate, fenpropidin, fluxapyroxad, isocycloseram, isopyrazam, omethoate, pyraclostrobin, spirotetramat, tebuconazole, tetraniliprole, trifloxystrobin, and trifludimoxazi Australian Pesticides and Veterinary Medicines Authorityroln.

Animal commodities: Fenpropidin, halauxifen-methyl, and trifluralin

Key highlights of amended version of MRL standard:

• New MRLs have been established for a variety of pesticides and veterinary compounds, including those used on new crops or to combat novel pests and diseases.

• MRLs for various pesticides and veterinary chemicals have been increased to reflect the latest scientific research on their safety.

• MRLs for various pesticides and veterinary compounds have been reduced to ensure that dietary exposure remains safe.

FSANZ has assessed the scientific data on chemicals and concluded that the proposed MRLs are safe for consumers.

Public is invited to comment on proposed amendments until 14 November 2023.

Proposed date of adoption and publication anticipated in January 2024.

The 19th assembly of the Persistent Organic Pollutants Review Committee (POPRC-19), presided over by Dr. Peter Dawson of New Zealand, convened at the Food and Agriculture Organization of the United Nations in Rome, Italy, from October 9 to 13, 2023. During this meeting, POPRC-19 recommended the inclusion of two groups of chemicals in Annex A of the Stockholm Convention for elimination.

Stockholm Convention

The Stockholm Convention on Persistent Organic Pollutants, established in 2001 and ratified in 2004, is a global treaty committed to reducing or eliminating the release of Persistent Organic Pollutants (POPs) into the environment. This Convention aims to protect human health and the environment from chemicals characterized by their long-lasting persistence, wide geographical distribution, accumulation in the fatty tissues of humans and wildlife, and adverse effects on health and the environment.

Groups of substances included

The two groups of chemicals recommended for inclusion in Annex A of the Stockholm Convention are 'medium-chain chlorinated paraffins' (MCCPs), with carbon chain lengths in the range C14–17 and chlorine content of 45 percent by weight or more, and long-chain perfluorocarboxylic acids, along with their salts and related compounds.

MCCPs have multiple applications, from serving as lubricants and coolants in metalworking fluids to plastic softening additives. They are used in products like polyvinyl chloride (PVC), paints, sealants, rubber, and more. Nevertheless, the scientific consensus is that these substances present significant risks to human health due to their persistent presence in the human body, potentially leading to health complications, including cancer.

Long-chain perfluorocarboxylic acids which belong to the family of 'forever chemicals' or PFAS are recommended for elimination under the Convention. PFAS chemicals have found wide applications in both industrial and consumer products due to their water, stain, and grease-resistant properties.

The elimination recommendations allow for specific exemptions, which will be further discussed at the next Conference of the Parties to the Stockholm Convention in 2025.

Future action on Chlorpyrifos

In addition to these key decisions, the POPRC-19 endorsed the risk assessment profile for 'chlorpyrifos,' a highly toxic pesticide widely used in agriculture. Chlorpyrifos poses significant health hazards, particularly to children and pregnant women, and has adverse effects on the nervous system. Over the coming year, the Committee will examine socio-economic considerations, and potential control measures, and formulate recommendations regarding the inclusion of chlorpyrifos during its risk management evaluation.

On 2 October 2023, the Ministry of Health of Ukraine published a draft Law ‘On the supply and use of biocidal products on the market’. The draft law was notified to the World Trade Organization (WTO) on 12 October 2023. The WTO is accepting comments until 11 December 2023.

The draft Law has been developed with the aim of implementing the Regulation of the European Union No. 528/2012 of the European Parliament and the Council of 22 May 2012, regarding the supply and use of biocidal products on the market (BPR Regulation) in the Ukraine. It aims to regulate the placing on the market and use of biocidal products while ensuring a high level of protection of human and animal health and the environment against harmful organisms, such as pests or bacteria, and against the effects of active substances contained in biocidal products.

Provisions of the Draft Law

The Draft Law provides for the regulation of legal relations in relation to:

• Approval of active substances of biocidal products.

• Obtaining authorisation to place biocidal products on the market.

• Production, trade, and safe use of biocidal products for human, animal and environmental health.

• Placing treated articles on the market.

• Defining the rights and obligations of companies, organisations, and individuals.

• Defining the powers of government bodies and officials in this area.

In order to ensure a high level of protection for human health, animal welfare, and the environment, active substances with the worst hazard profiles will not be authorise for use in biocidal products unless they qualify for a derogation. Possible reasons for a derogation are:

• Low risk of exposure to the substance

• Disproportionate adverse effects in case of non-approval

• Disproportionate negative impact on society in case of non-approval

When deciding on the approval of such active substances, the availability of suitable and sufficient alternative substances or technologies will also be considered.

The Draft Law will not apply to the following areas:

• Medicinal feeds

• Medical devices

• Medicinal products and veterinary drugs

• Feed and feed additives for animals

• Food hygiene products

• Food additives

• Food flavorings and ingredients with flavoring properties intended for use in and on food products.

• Phytosanitary products

• Plant protection products

• Cosmetic products

Timeline

The law will enter into force the day after its publication and will be enacted after 12 months. The proposed date of adoption has not yet been set.

The full text of the draft law in Ukrainian can be found here.