GPC Newsletter Apr-2024

Health Canada and Environment and Climate Change Canada (ECCC) are currently seeking feedback from industry stakeholders and interested parties on the regulation of low boiling point naphthas (LBPNs). The deadline for comments is May 15, 2024. 

Understanding Low Boiling Point Naphthas: Key Considerations and Regulatory Assessment 

In the realm of petrochemicals, low boiling point naphthas (LBPNs) are emerging as a complex group of hydrocarbons that are essential for a variety of industrial applications. Derived from the distillation of crude oil, LBPNs include a wide range of hydrocarbons from C4 to C14 in the carbon chain spectrum. These substances include alkanes, cycloalkanes, alkenes, and aromatic hydrocarbons and their chemical diversity makes them invaluable in the production of gasoline, solvents, and numerous consumer and industrial products. 

Classified as UVCBs (Unknown or Variable Composition, Complex Reaction Products or Biological Materials), the intricate nature of LBPNs presents challenges to their consistent characterization. However, their significant role in fuel blending processes and as components in manufacturing underscores their industrial relevance. 

Health Canada and Environment and Climate Change Canada (ECCC) have classified LBPNs into four distinct subgroups, based on their health effects, presence in consumer products, and aromatic content. These include: 

- Subgroup 1: C9-C14 hydrocarbon solvents 

- Subgroup 2: C9 aromatic hydrocarbon solvents 

- Subgroup 3: C6-C9 aliphatic hydrocarbon solvents 

- Subgroup 4: LBPNs not used in consumer products 

LBPNs are used in a wide range of solvents, viscosity adjustors, and fuel additives, and play a central role in petroleum production, industrial processing and products ranging from lubricants to personal care products. Despite their widespread use, the health and environmental impacts of certain LBPNs require careful management and regulation. 

In a recent draft assessment by Health Canada and the ECCC, 17 out of 27 LBPN substances have been provisionally identified as meeting toxicity criteria under the Canadian Environmental Protection Act (CEPA). This assessment further divides LBPNs into four main categories for regulatory focus and risk management. 

Current Regulatory Landscape and Risk Management Initiatives 

In Canada, regulatory action on LBPNs spans several areas including cosmetics, food additives, food packaging, pest control products, and consumer safety. In particular, certain LBPNs are highlighted for their absence from the Cosmetic Ingredient Hotlist and the List of Permitted Food Additives, emphasizing their restricted use in these sectors. Additionally, their use in food packaging and pest control underline the nuanced approach towards ensuring public health and safety. 

Internationally, the regulation of LBPNs varies, with specific restrictions and approvals in the United States and Europe, particularly regarding their use in cosmetics, food-related applications, and environmental emissions. These regulatory frameworks reflect a concerted effort to mitigate health risks while recognizing the essential industrial applications of LBPNs. 

Invitation for Stakeholder Engagement 

As the assessment progresses, industry stakeholders, and interested parties are encouraged to participate in the consultation process. The input received will be critical in refining risk management strategies and ensuring a balanced approach to regulating the use of LBPNs use and addressing potential health and environmental impacts. The deadline for comments is May 15, 2024, providing a valuable opportunity to contribute to informed decision-making. 

In summary, the evolving landscape of LBPN regulation underscores the importance of these substances in various sectors, while highlighting the need for vigilant risk management to protect public health and the environment. Stakeholder engagement remains a critical component of this process, ensuring comprehensive and effective regulatory action. 

On February 20, 2024, the U.S. Environmental Protection Agency (EPA) announced the latest update to the Toxic Substances Control Act (TSCA) Inventory. 

Key Findings of the Update 

The TSCA Inventory includes all existing manufactured, processed, or imported chemicals in the United States. As part of its regular release of non-confidential TSCA Inventory data, EPA updates the public TSCA Inventory every two years. 

The most recent TSCA Inventory contains a total of 86,741 chemical substances, with 42,293 substances classified as active. Updates to the TSCA Inventory also include data on unique identifiers, commercial activities, and regulatory flags including test orders and significant new use requirements (SNURs). 

Transition from Confidential to Public Information 

Furthermore, as part of EPA's ongoing review of TSCA confidential business information, certain substances remain on the list with their unique chemical identities after being moved from the confidential part of the Inventory to the public part. Since the last update of the TSCA Inventory in August 2023 EPA has moved approximately 900 chemicals from the confidential part to the public part of the Inventory.  

For more information on the TSCA Inventory, please visit: https://www.epa.gov/tsca-inventory. 

The U.S. Environmental Protection Agency (EPA) is introducing a rule under Section 8(d) of the Toxic Substances Control Act (TSCA), mandating manufacturers (including importers) of 16 chemicals to submit to the Agency data from unpublished health, safety, environmental, as well as occupational, general population and consumer exposure studies. These submissions will help in EPA's prioritization, risk evaluation, and management of chemicals under TSCA, reinforcing its commitment to protecting human health and the environment.

Chemicals Covered by the Proposed Rule

The proposed rule includes 13 chemicals listed in the 2014 TSCA Work Plan, curated by EPA for additional assessment based on their identified hazards and potential exposures. To effectively prioritize, evaluate risks, and manage these chemicals, EPA needs information on their hazards and potential exposure pathways.

Priority Chemicals Identified for Risk Evaluation

EPA proposed to prioritize five of the chemicals included in the proposed rule for risk evaluation in December 2023, all of which have been linked to cancer and used to make plastics: 

• 4,4’-Methylene bis(2-chloroaniline) (MBOCA) (CASRN 101-14-4), 
• Acetaldehyde (CASRN 75-07-0), 
• Acrylonitrile (CASRN 107-13-1), 
• Benzenamine (CASRN 62-53-3), and 
• Vinyl chloride (CASRN 75-01-4). 

Additional Chemicals Covered by the Proposed Rule

The proposed rule additionally covers 10 chemicals that EPA initially identified as candidates for prioritization but did not include in its prioritization action initiated in December 2023. However, these chemicals are currently under consideration for inclusion in the prioritization action scheduled to begin in December 2024:

• 4-tert-octylphenol(4-(1,1,3,3-Tetramethylbutyl)-phenol) (CASRN 140-66-9), 
• Benzene (CASRN 71-43-2), 
• Bisphenol A (CASRN 80-05-7), 
• Ethylbenzene (CASRN 100-41-4), 
• Hydrogen fluoride (CASRN 7664-39-3), 
• N-(1,3-Dimethylbutyl)-N’-phenyl-p-phenylenediamine (6PPD) (CASRN 793-24-8), 
• Naphthalene (CASRN 91-20-3), 
• Styrene (CASRN 100-42-5),  
• Tribomomethane (Bromoform) (CASRN 75-25-2), and 
• Triglycidyl isocyanurate (CASRN 2451-62-9). 

EPA’s Response to Specific Concerns

In November 2023, EPA responded to a petition from certain tribes regarding the use of the chemical 6PPD in tires. 6PPD reacts with ozone air pollution, to form a compound known as 6PPD-quinone (2-anilino-5-[(4-methylpentan-2-yl) amino]cyclohexa-2,5-diene-1,4-dione)(CASRN: 2754428-18-5), which has been shown to be lethal to coho salmon when present in stormwater. As a result, EPA finalized a rule to collect additional data on 6PPD. This proposed rule now includes provisions for 6PPD-quinone.

In a significant step towards environmental protection, the European Union published Regulation (EU) 2024/590 on Substances that Deplete the Ozone Layer in the Official Journal of the European Union on 20 February 2024. This Regulation which aims to limit emission of substances that deplete the ozone layer, will enter into force on 11 March 2024 and will repeal the existing Regulation (EC) No 1005/2009. The new regulation is a key step in protecting the Earth's stratospheric ozone layer, which is crucial for protecting the planet from harmful UV radiation.

Tackling Twin Threats: Ozone Depletion and Greenhouse Gas Emissions

Ozone-depleting substances (ODS) not only contribute to the formation of the so-called 'hole in the ozone layer', but also play a significant role in increasing greenhouse gas emissions. When these man-made chemicals reach the upper atmosphere they deplete the ozone layer, causing adverse effects on human health, ecosystems, as well as significant financial costs.

Prohibitions and Exemptions

The new Regulation lays down comprehensive rules covering the entire life cycle of ODS. It prohibits the production, import, export, placing on the market, storage, and subsequent supply of the substances listed in Annex I to the Regulation. It also addresses the critical aspects of their use, recovery, recycling, reclamation, and destruction, emphasising responsible practices throughout the supply chain. The legislation also requires detailed reporting of information on ozone-depleting substances.

The Regulation allows exemptions for the following purposes:

• Feedstock i.e. any ozone-depleting substance that undergoes chemical transformation in a process in which it is completely converted from its original composition and whose emissions are insignificant.

• Process agents i.e. any ozone-depleting substance used as chemical process agents in the applications listed in Annex III to the Regulation.

• Essential laboratory and analytical uses

• Critical uses of halons e.g. fire extinguishers on military vehicles.

• Emergency use of methyl bromide when unexpected outbreaks of certain pests or diseases requires it.

A Step Towards a Greener Future: Regulation in Line with European Green Deal

The adopted regulation, part of the Emissions and Pollutants Package, is aligned with the European Green Deal (2019), reflecting the EU's commitment to environmental sustainability.

A thorough Regulatory Fitness and Performance (REFIT) evaluation by the European Commission found that the previous regulation, Regulation (EC) No 1005/2009, was generally fit for purpose, but that improvements were needed to better align it with evolving environmental objectives.

The legislative process involving the European Parliament, the Council of the European Union, and the European Commission, culminated in the adoption of the new Regulation on 7 February 2024, marking a decisive step towards a greener and more sustainable future for the European Union.

The full text of the Regulation can be accessed here.

On 13 March 2024, the European Chemicals Agency (ECHA) published on its official website the next steps in the evaluation of the proposal to restrict per- and polyfluoroalkyl substances (PFAS).

Outcome of the public consultation

Following the public consultation on the PFAS restriction dossier, submitted jointly by Germany, Denmark, the Netherlands, Norway, and Sweden, where a record-breaking 5642 comments were received between March and September 2023. Following a thorough initial review by both the submitting authorities ECHA, the comments will now undergo sector-specific processing by ECHA's Scientific Committees, namely the Committee for Risk Assessment (RAC) and the Committee for Socio-Economic Analysis (SEAC), in addition to review by the dossier submitters. The submitting countries will use the feedback to revise the original restriction report, which will serve as the basis for the Committees' opinion, together with the comments.

Upcoming Committee meetings

The upcoming RAC and SEAC Committee meetings will address the following topics and sectors:

March 2024 Meetings:

• Consumer mixtures, cosmetics, and ski wax

• Hazard properties of PFAS (RAC only)

• General approach (SEAC only)

June 2024 Meetings:

• Metal coating and manufacturing of metal products

• Additional discussion on hazard properties (RAC only)

September 2024 Meetings:

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

• Food contact materials and packaging

• Petroleum and mining

ECHA will continue to provide updates on the timetable and planned discussions in the committees as work progresses. Information releases will be timed to coincide with the committee meetings.

Next steps

Once the ECHA Committees have finalised their opinions, the European Commission together with the EU Member States will decide on the restriction.

On 26 February 2024, the Swedish Chemicals Agency (KEMI) announced the latest update of its PRIO tool. The update extends the tool's criteria to include the new hazard classes in the latest update of the EU Regulation for Classification, Labelling and Packaging of Chemical Substances and Mixtures (CLP Regulation). The PRIO tool is a valuable resource to help manufacturers and purchasers identify substances to avoid.

The PRIO tool

The web-based PRIO tool is based on a database containing more than 16,500 hazardous substances. The database lists chemical substances with properties that are hazardous to human health and the environment. For example, it contains nearly 11,000 per- and polyfluoroalkyl substances (PFAS). PRIO serves is an important resource for identifying substances that are harmful to health or the environment. While it is not legally required to be used, it’s designed for companies that want to go beyond existing regulatory standards.

The PRIO tool contains criteria for evaluating the health or environmental hazards of substances, based on Sweden's environmental quality objectives, EU chemicals legislation, and international conventions.

Latest updates to PRIO

The latest updates to PRIO introduce two new criteria and update three existing criteria in line with the latest hazard classifications in the CLP Regulation. The two new criteria are:

• PMT (persistent, mobile, toxic) / vPvM (very persistent, very mobile)

• ED HH2 (suspected of causing endocrine disruption in humans) / ED ENV2 (suspected of causing endocrine disruption in the environment)

The following existing criteria descriptions have been updated:

• PBT (persistent, bioaccumulative, toxic) / vPvB (very persistent, very bioaccumulative)

• Suspected PBT/vPvB

• Endocrine disruptors for human health and environment.

For more information and to access to the PRIO tool, please visit the Swedish Chemicals Agency website here.

On 25 March 2024, the European Chemicals Agency (ECHA) announced that enforcement authorities will check poison centre notifications (PCNs) of hazardous chemical mixtures in order to improve emergency preparedness. This initiative, agreed at the March meeting of ECHA’s Enforcement Forum, aims to ensure that suppliers are complying with the regulations requiring the notification of such substances.

Aim of the Checks

The main objective of these inspections is to protect human health by enforcing the obligation of chemical suppliers to inform national authorities about hazardous mixtures. This information is essential for poison centres to provide accurate advice in emergencies and to enable informed decisions by citizens and medical professionals.

Inspectors will verify the submission of notifications and examine mixture labels, along with Safety Data Sheets where necessary. The full scope of these inspections will be defined in the coming months.

Project Timeline

The inspections, scheduled to begin in January 2025 and run for six months, are designed to ensure that poison centres have accurate information for effective emergency response. A detailed report of the project's findings will be published by the end of 2025.

Background on the Enforcement Forum

The Enforcement Forum including its Biocides subgroup (BPRS), is a network of enforcement authorities from the European Union (EU) and the European Economic Area (EEA). They are responsible for coordinating the enforcement of the REACH, CLP, PIC, POPs and the Biocidal Product Regulations. The overall aim of these initiatives is to protect human health and the environment while ensuring a level playing field for companies across the EU market.

On 12 March 2024, the UKs Health and Safety Executive (HSE) announced that 25 chemical substances have been added to the Great Britain Mandatory Classification and Labelling List (GB MCL). These additions came into force on 2 March 2025 and summaries have been published in the GB CLP publication table. The compliance date for the 25 substances is 2 September 2025. The additions were made after the Secretary of State accepted HSE’s recommendations, with the agreement of the Scottish and Welsh Ministers. The GB MCL list now contains a total of 123 entries.

Scientific Basis

The inclusion of these substances is based on the scientific and technical evaluations that identified the intrinsic hazards of these 25 substances. Whilst the HSE’s technical reports highlighted these intrinsic hazards, the impact and policy assessments set out in the Agency's opinions did not identify any significant impacts.

Post-Brexit Additions to the GB MCL

This is the second batch of substances to be added to the GB MCL after Brexit. The first batch of 98 substances was added on 20 October 2023. The HSE notified the World Trade Organization (WTO) of its intention to add this second batch on 24 August 2023. A list of the substances can be found here.

India’s Department of Chemicals and Petrochemicals, under the Ministry of Chemicals and Fertilizers, has officially launched a major data collection initiative for the chemicals and petrochemicals industry. This initiative, announced in the Gazette of India on 19 February 2024, aims to use the ChemIndia Webportal to collect detailed statistics on a variety of metrics including production, capacity, exports, imports, and sales figures. 

Creating a Robust Database for Sectoral Analysis 

The move is part of a broader effort to create a robust, authentic database for the sector, facilitating comprehensive analysis and real-time data compilation from registered entities. This data will play a key role in the monthly and annual compilation of the Index of Industrial Production (IIP), contributing to the broader economic analysis conducted by the National Statistical Office. 

Leadership and Compliance 

Shri Ganga Kumar, Deputy Director General of the Statistics and Monitoring Division, has been appointed as the Statistics Officer in charge of this project. He will oversee the collection, verification, and analysis of the industry data and ensure compliance with the Collection of Statistics Act, 2008, and its rules. 

This initiative aims not only to improve policy formulation and industry monitoring but also to support a transparent and data-driven approach to sectoral development. By requiring submissions on both a monthly and annual basis, the Ministry is positioning itself to gain a deeper understanding of sector dynamics, ultimately facilitating informed decision-making at both government and industry levels. 

Key Points of the Initiative: 

- Mandatory Data Submission: All registered chemical and petrochemical industries are required to submit comprehensive data through the ChemIndia Webportal (https://chemindia.chemicals.gov.in/). 

- Comprehensive Data Collection: The initiative covers production, installed capacity, exports, imports, sales, and other relevant data. 

- Monthly and Annual Reports: Data will be collected on a monthly and annual basis to support the compilation of the Index of Industrial Production and the annual publication "Chemical and Petrochemical Statistics at a Glance". 

- Enhanced Policy and Industry Monitoring: The data will help policy makers and researchers to design policies that promote best practices and optimal industrial development. 

This data collection policy is a significant step towards leveraging technology for sectoral development and ensuring that the Ministry of Chemicals and Fertilizers remains at the forefront of informed policy-making and industry support. 

The complete text of the notification can be accessed here. 

On February 23, 2024, the Central Drugs Standard Control Organization (Cosmetics Division) of India issued a circular outlining the import regulations for cosmetics. The CDSCO has issued the Circular urging importers to comply with the requirement to provide annual import details for cosmetics as per Form COS-4A to avoid potential regulatory penalties.

Details of the Circular

The Government of India has issued an Import Registration Number (lRN) under Form Cos-4A for cosmetics already registered under Rule 13 for import and sale in the country. Importers are required submit an annual declaration to the Central Licensing Authority of cosmetics imported und the IRN conditions specified in Form 4A. However, the Central Licensing Authority has not received the details of cosmetics imported annually by these importers, under the Cosmetics Rules, 2020.

Import Registration Number

An import registration number issued under sub-rule (2) is valid for three years unless suspended or cancelled. If an importer fails to meet conditions, the Central Licensing Authority may suspend or cancel the number, with cause given.

Information required

Every applicant is required to provide the following details of the cosmetic product:

• Number of consignments/bill of entries of each consignment

• Imported quantity in each consignment

• The total cost of imported cosmetics in each consignment

• Warehouse details where those are stored for further distribution

• Sale

The CDSCO encourages importers to comply with the cosmetic import restrictions and submit their annual reports.

The Bureau of Indian Standards (BIS) is seeking comments until 20 April 2024 on the third revision of the standard for iron oxide pigments used in paints. The standard (IS 44) was first released in 1950. 

The draft standard proposed by BIS aims to address health and safety concerns and restrictions related to lead and toxic heavy metals in paint ingredients. 

Changes to the revised standard:  

The aim of this third revision is to improve the acceptability and relevance of the product by bringing it into compliance with current market requirements. Notable changes include:  

1. The material classification has been reorganized into color-based groups, categories (represented as iron (III) oxide), grades based on sieve residue, types based on water soluble matter content and total water soluble chlorides and sulfates (represented as Cl^– and SO₄^2– ions), and classes based on the origin of the material. By replacing the previous seven classes, this change brought the criteria into line with current market practice.  

2. Furthermore, requirements of each classification and associated test procedures have been revised. For example, new standards have been added to the colour measurement, staining power, and undertone test methods.  

3. Restrictions have been introduced for lead and toxic heavy metals to address health and safety concerns. 

4. Finally, several revisions and updates to references have been made to make the updated standard more accurate and relevant. 

According to the proposed standard, iron oxide pigments are classified as follows:  

• By groups depending on their colour.  

• By categories depending on their iron content, expressed as iron (III) oxide.

• By types depending on their content of water-soluble matter and their total content of water-soluble chlorides and sulfates, expressed as the ions Cl^– and SO₄^2–.

• By grades depending on their residue on sieve. 

• By classes depending on their origin. 

Furthermore, according to the draft, the substance should not contain more than 90 ppm of lead, lead compounds or mixtures of the two,. Also, the following substances, separately or in combination, are limited to a maximum of 0.1 percent by weight: 

• mercury

• mercury compounds

• cadmium

• arsenic

• chromium VI

• antimony

• and their oxides 

The draft recommends that packaging be marked or labelled with the following information: 

• The name of the substance

• Group, Category, Type, Grade and Class of the substanc

• Source of manufacture 

• The month and year of manufacture

• Expiry date/shelf life/best before  

• The substance’s net mass

• The batch and lot number 

• The maximum lead content 

• The toxic heavy metals content 

• Cautionary notes (‘Keep out of reach of children’ or ‘This product may be harmful if swallowed or inhaled’). 

Timeline  

The Bureau of Indian Standards (BIS) is consulting on the revised standard for iron oxide pigments used in paints until 20 April 2024 

On 12^th March 2024, The Ministry of Industry and Information Technology of China (MIIT) published a notification soliciting public comments on the draft standard of GB 30000.1: Rules for classification and labelling of chemicals—Part 1 General specifications. According to the notification, once the new standard is approved, it will be effective 12 months after the publication and the previous standards GB 13690-2009 will be appealed. 

Basis for technical requirements in GB 30000.1 

The technical content of this standard is mainly derived from the GHS system. This standard specifies the terms and definitions involved in the classification and labeling of chemicals, categories of hazardous properties of chemicals, classification standards for substances and mixtures, guidance on the preparation of chemical safety labels, and guidance on the preparation of chemical safety data sheets (SDS). regulations etc.

The main content of this standard consists of the following parts: 

1. Terms and definitions 
2. Chemical hazard classification
3. Label 
4. Chemical Safety Data Sheet

Main changes to GB 13690-2009

Firstly, the name of this standard is changed to Rules for classification and labelling of chemicals—Part 1:General specifications. 

Secondly, it added "United Nations Globally Harmonized System of Classification and Labeling of Chemicals (Eighth Revised Edition)" and "United Nations Model Regulations on the Recommendation on the Transport of Dangerous Goods (Twenty-second Revised Edition)" as cited documents, deleted Referenced documents "GB/T 22272~ GB/T 22278". 

Thirdly, it adjusted the regulations on chemical hazard classification: 4.1.1 Hazard Category a) Added desensitizing explosives to physical hazards. 

Fourthly, it deleted sample sheets in the appendix: 

1. Deleted Informative Appendix A "Examples of Precautionary Statements", while added Informative Appendix A "Definitions and Abbreviations Specified in GHS". 
2. Deleted Informative Appendix B "Pictograms of Protective Measures". 
3. Deleted Informative Appendix C "Sample GHS Label"; 
4. Deleted informative Appendix D "Minimum Information on Safety Data Sheets". 

For more information regarding China GHS and China REACH related inquires, please contact GPC via compliance@gpcregulatory.cn or zhengmin@cn.gpcregulatory.com. 

On 12 March 2024, the National Health Commission of China (NHC) released a new standard GB 4806.15-2024 for adhesives in materials used for food preparation and storage. This new standard introduces controls on food contact materials (FCMs) including composite materials and pressure-sensitive adhesives.

Categorization of Adhesive

The standard divides adhesives into two categories: direct and indirect food contact applications. Direct food contact applications which have a higher migration risk will be more strictly regulated. For indirect food contact applications which have lower migration risks, the requirements will be less stringent.

Requirements and Implementation

The new standard also includes a list of substances that can be used for direct and indirect food contact and the requirements for their use in the annexes. According to the annexes, 51 raw materials are approved for direct food contacts and 341 substances are permitted for indirect food contact materials. Materials approved for direct contact applications are also approved for indirect contact materials.

Adhesive products must indicate on the label which category they fall into. Additionally, additives used in adhesives must meet the requirements of standards GB 4806.1-2016, GB 9685-2019, and any further announcements.

Implementation Date and Contact Information

The new standard will come into force on 8 February 2025. For further information, please contact Global Product Compliance (GPC) at compliance@gpcregulatory.cn or zhengmin@cn.gpcregulatory.com.

On March 14, 2024, the South Korean National Institute of Food and Drug Safety Evaluation published a draft of the ‘Guidelines for Alternatives to Animal Testing Methods’ to help improve the international competitiveness of the domestic cosmetics industry and non-clinical testing institutions related to toxicity tests. The draft contains the guidelines for the two test methods as follows. 

• Guidelines for Test No. 498: In vitro Phototoxicity - Reconstructed Human Epidermis Phototoxicity test method Skin phototoxicity for Cosmetics, etc. 

• Guidelines for ARE-Nrf2 Luciferase Keratinocyte Activation Test Method (OECD 442D) KeretinoSens TM for skin sensitization for Cosmetics, etc. 

Companies that have an opinion on the draft guideline, please reply to our association (email: jenko@kcia.or.kr ) by March 18, 2024. 

On March 14, 2024, the Ministry of Environment (MoE) in South Korea published the Administrative Notice of Partial Revision of Regulations on prescribed quantities of toxic substances, restricted substances, prohibited substances, and permitted substances. 

Content of the Notice 

The notice aims to establish the prescribed quantity for each substance to classify the subject of submitting a chemical accident prevention management plan (first group, second group, exemption) for toxic substances additionally designated by the revision of the "Description of Toxic Substances (National Institute of Environmental Research, January 10, 2024)”. 

For new toxic substances (39 types in total), the upper and lower prescribed quantities have been specified.  

Stakeholder Feedback 

Organizations, institutions, or individuals who have opinions on this amendment should review the amendment on the website of the Ministry of Environment  by April 2, 2024, and submit a written opinion to the Minister of Environment (Director of Chemical Safety) stating the following: 

1. Whether you agree or disagree with the notice (give reasons if you disagree) 

- Revision (draft) 

- Correction (draft) 

- Reasons for correction 

2. Name (for an institution or organization, the name of the institution or organization, and the name of its representative), address, and phone number 

On 2 February 2024, the Thai Food and Drug Administration (FDA) submitted two draft notifications to the World Trade Organization (WTO). The goal of both drafts is to protect human health and provide an update on the overall proportion of alcohol in alcohol-based hand sanitizers.  

Notification 1: Determining the Characteristics of Cosmetics Containing Alcohol for Hand Sanitizing Prohibited for Manufacture, Import, or Sale 

The draft notification prohibits the manufacture, import, or sale of cosmetics containing alcohol for hand sanitizing purposes if they have a concentration of either ethanol, isopropanol, n-propanol, or a mixture thereof of less than 70% by volume or less than 65% by weight. These products are intended to clean hands without the use of water. 

Notification 2: Determining the Criteria for Deviation Limits of Main Ingredients in Cosmetics Containing Alcohol for Hand Sanitizing 

This draft notification sets out the criteria for deviation limits of alcohol in cosmetics containing alcohol for hand sanitizing, specifying that they must contain not less than 15% and not more than 18% as notified to the Regulatory Body. 

In both notifications "alcohol" refers to ethyl alcohol (ethanol), isopropyl alcohol (isopropanol), and n-propyl alcohol (n-propanol) in cosmetics containing alcohol for hand sanitizing. 

The drafts will be available for public comment for the next sixty days. The day following their publication in the Government Gazette will mark the effective date which has not yet been determined. 

The Australian Industrial Chemicals Introduction Scheme (AICIS) will implement significant changes to the Industrial Chemicals (General) Rules 2019, from 24 April 2024. These modifications are the result of extensive consultation and feedback from stakeholders and reflect a concerted effort to streamline processes and improve environmental and health protection in the chemical industry. 

Key Updates to the General Rules: 

- Transition from Written Undertakings to Simplified Records: In an effort to simplify compliance, AICIS will replace written undertakings with simpler recordkeeping practices. 

- Wider Acceptance of INCI Names: The reporting and record-keeping framework will now broader accept International Nomenclature of Cosmetic Ingredients (INCI) names, facilitating a more standardized global approach. 

- Refined Categorisation Criteria: Adjustments to the categorisation criteria will benefit several sectors, including: 

  - Local soap manufacturers 

  - Introducers of chemicals in flavour and fragrance mixtures 

  - Introducers of hazardous chemicals, with controlled introduction and use 

Further, the rules will introduce stricter criteria and/or reporting requirements specifically designed to prevent persistent organic pollutants (POPs) from being categorized as exempted or reported introductions. 

Feedback and Adjustments: 

The initial proposals received broad support from stakeholders. However, based on valuable feedback, some adjustments were made in order to: 

- Simplify record keeping for listed introductions 

- Expand the circumstances where INCI names can be used for both reporting and record keeping 

- Broaden the eligibility criteria for chemicals used in flavour and fragrance mixtures 

These adjustments aim to reduce regulatory burden while ensuring that the necessary protection remains in place. 

Upcoming Guideline Changes: 

Further changes to the Industrial Chemicals Categorisation Guidelines are on the horizon with announcements expected soon. These adjustments, set to take effect on 24 April 2024, will align with the commencement of the amended rules. Additional changes, expected in September 2024, will address the need for companies to have more time to prepare, as indicated by industry feedback. 

Transitional Provisions for NICNAS Introducers: 

Temporary recordkeeping provisions will be available until 23 April 2024, for chemical introducers transitioning from the National Industrial Chemicals Notification and Assessment Scheme (NICNAS) to AICIS. This accommodation is specifically for eligible introducers who continue to import or manufacture chemicals previously listed on the NICNAS Inventory. 

The upcoming changes reflect the AICIS’s commitment to regulatory excellence, which aims to promote innovation and safety in the chemical industry while minimizing administrative burdens. Stay tuned for detailed updates on these important changes, which promise to shape the future of chemical management and safety standards in Australia. 

In its continuous efforts to ensure the safety of food contact materials and promote sustainability in the industry, the Brazilian Health Regulatory Agency (Anvisa) recently published the 6th edition of its "Questions and Answers" document. This update addresses changes resulting from regulatory updates and aims to provide clearer guidance on materials in contact with food.

New Inclusions and Sustainability Focus

The updated document includes new questions covering a range of topics such as chemical recycling of plastic materials, biodegradable or compostable packaging, references for updating positive lists, and more. One particularly relevant aspect highlighted in Question 22 centers around sustainability, aligning with the broader goals of the National Solid Waste Policy (Law 12.305/2010) and the National Solid Waste Plan (Planares).

Circular Economy and Recycling Initiatives

The Planares emphasizes actions related to the circular economy, which prioritizes reduction, reuse, and reintroduction of materials, reducing pressure on natural resources, greenhouse gas emissions, and waste generation. Despite a 22.10% recycling rate of plastic waste from packaging in 2018, challenges persist, especially in the flexible materials category.

The Brazilian Chemical Industry Association (Abiquim) notes the success of mechanical recycling in Brazil but highlights obstacles, particularly in the food and beverage market, which represents almost 30% of the global polyolefin market. To address these challenges, the document advocates for the essential role of chemical recycling in recycling all types of plastic waste, aligning with global initiatives in the United States and the European Union.

Chemical Recycling Processes and Regulatory Clarifications

Anvisa received inquiries about the utilization of chemical recycling processes in the production of plastic packaging for food. The updated document clarifies that processes of complete depolymerization, resulting in monomers indistinguishable from original monomers and meeting purity standards, can be used without specific petitioning or authorization. However, processes obtaining mixtures, oligomers, or intermediates require specific evaluation and petitioning.

Contributing to Sustainable Goals

The adoption of chemical recycling processes in the production of food packaging aligns with Planares' objectives, particularly Goals 4 and 6. Goal 4 aims to reduce waste and rejections sent for environmentally appropriate final disposal, with an indicator to recover 48.1% of the total mass of Urban Solid Waste nationwide by 2040. Goal 6 focuses on increasing the recovery of the dry fraction of waste, with indicators targeting the recovery of 20% of dry recyclables by 2040 and the recovery of 50% of general packaging through reverse logistics systems by 2040.

Conclusion

Anvisa's commitment to regulatory quality and sustainability is evident in this latest guidance. The agency acknowledges the importance of addressing challenges in the recycling landscape and emphasizes the role of chemical recycling in achieving sustainable practices.

For further inquiries or to stay updated on Anvisa's guidance, you can contact the agency's Central Assistance or refer to the latest version of the "Questions and Answers" document.

On 15 March 2024, Singapore has announced plans to phase out the use of firefighting foams containing per- and polyfluoroalkyl substances (PFAS) listed under the Stockholm Convention. Singapore is a party to the Stockholm Convention which aims to eliminate Persistent Organic Pollutants (POPs) such as PFAS.

Implementation and Threshold Limits

Effective from 1 January 2026, Singapore will phase out the import and use of fire-fighting foams containing perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS), along with their salts and related compounds. However, companies can continue to use these foams after 1 January 2026 if the concentrations of trace contaminants in them are below certain threshold limits: 25 ppb for PFOA and 10,000 ppb for PFOS. For perfluorohexane sulfonic acid (PFHxS) and related compounds the threshold limit is 100 ppb.

Mandatory Compliance Measures

Companies storing or using firefighting foams containing PFOA, PFOA and PFHxS above the threshold concentrations are required to engage Toxic Industrial Waste Collectors (TIWCs) licensed by the National Environment Agency (NEA) for the safe collection and disposal of these chemicals. Traders are also advised to use appropriate Harmonized System (HS) and product codes when declaring imports and exports of affected materials in TradeNet® permit applications. Applications will be subject to processing and approval by the Chemical Control and Management Department (CCMD).

A list of HS and product codes of the affected materials can be found in the table below:

Conclusion

This announcement demonstrates Singapore's commitment to environmental protection and is in line with global efforts to reduce the use of harmful chemicals in fire-fighting foams. For further enquiries, stakeholders can contact Ms. Nikki Lee via email at Nikki_Lee@nea.gov.sg.

On 22 February 2024, the Ministry of Environmental Protection and Natural Resources of Ukraine published the Draft Law of Ukraine on Plant Protection Products and Fertilizers. The draft law was notified to the World Trade Organization (WTO) on 27 February 2024. This legislative initiative is a proactive step to ensure Ukraine’s compliance with EU standards.

Alignment with EU Standards for Plant and Fertilizer Products  

The proposed draft law aims to establish comprehensive procedures for introducing plant protection products (PPPs) and fertilizers to the market in line with current EU regulations. In particular, it aims to align with Regulation (EU) 2019/1009, which sets out rules for the availability of fertilizer products in the EU and Regulation (EC) No 1107/2009 on the placing of plant protection products on the market.

The purpose of the draft law is to:

- Define terminology and basic concepts for the authorisation of active substances, antidotes, and synergists in preparative forms of plant protection products.

- Specify unacceptable co-formulants that cannot be included in plant protection products.

- Harmonise procedures for making fertilizers available on the market.

- Define the procedure for the management of hazardous waste arising from the use of plant protection products.

Conformity Assessment

The legislation sets out the obligations of companies in carrying out conformity assessments and managing the placing of fertilizers on the market. In addition the legislation announces the forthcoming adoption of a separate government resolution on the Technical Regulation on conformity assessment of fertilizing products.

Current Legislation on Pesticides and Agrochemicals

Currently fertilizers and PPPs in Ukraine are regulated by Law No. 86/95-BP on Pesticides and Agrochemicals. This law will be repealed when the draft law enters into force. However, all valid pesticide registrations made in accordance with the Law on Pesticides and Agrochemicals and in force on the date of the draft law's enactment, will remain valid until the expiry of the registration period without requiring approval for antidotes or synergist substances within the preparative form.

Timeline

The date of adoption of the draft law has not yet been determined. The law will enter into force the day after its publication and will be enacted 24 months later, except for certain provisions which will enter into force after 36 months.