GPC Newsletter Mar-2024

On February 1, 2024, the U.S. Environmental Protection Agency (EPA) announced its initiatives aimed at protecting communities and the environment from the health risks associated with some per- and polyfluoroalkyl substances (PFAS). These chemicals, known for their widespread use and persistence, pose health concerns as they degrade slowly over time and have been used in various consumer, commercial, and industrial products.

To comprehensively address PFAS pollution, EPA is proposing two regulatory updates.

1. EPA is proposing to modify the definition of hazardous waste for cleanups at permitted hazardous waste facilities. This modification aims to ensure that EPA's regulations accurately reflect its authority under the Resource Conservation and Recovery Act (RCRA), to mandate cleanup of chemicals including emerging chemicals of concern, such as PFAS.

2. EPA is proposing to amend its RCRA regulations to designate multiple PFAS compounds as hazardous constituents. These additions would prompt the inclusion of PFAS in facility assessments and, where necessary, further investigation and cleanup through the corrective action process at hazardous waste treatment, storage, and disposal facilities.

These proposed rules are designed to strengthen protections for communities and drinking water supplies near the 1,740 permitted hazardous waste facilities nationwide. Under RCRA's corrective action provisions, hazardous waste facilities must investigate and clean up hazardous releases to soil, groundwater, surface water, and air to protect human health and the environment.

EPA plans to publish these proposals in the Federal Register in the coming weeks. The proposed rule entitled "Definition of Hazardous Waste Applicable to Corrective Action from Solid Waste Management Units" will be open for public comment for 30 days, while the proposed rule entitled "Listing of Specific PFAS as Hazardous Constituents" will be open for public comment for 60 days. Upon publication, EPA encourages public comment on each proposal.

On February 16, 2024, the U.S. Environmental Protection Agency (EPA) announced an extension of the submission deadline for the annual electronic reporting mandated under the Toxic Substances Control Act (TSCA). Specifically, this extension applies to polymers manufactured under the terms of the polymer exemption for new chemicals. The new deadline for submission is March 31, 2024.

EPA cites technical difficulties with the launch of the new electronic reporting tool as the primary reason for the extension. The Agency aims to give manufacturers sufficient time to submit their reports and accompanying claims using the updated tool.

Reporting Requirements:

Under the polymer exemption, companies may manufacture polymers that meet the exemption criteria without the need for a premanufacture notice or exemption notice under the TSCA New Chemicals Program.

While exemption from certain notices is granted, there are still recordkeeping requirements to ensure compliance. Manufacturers of exempted polymers must submit an annual report on the number of exempted polymers manufactured or imported during the preceding calendar year.

Under EPA regulations, manufacturers (including importers) of polymers manufactured under the exemption must submit a report of manufacture or import by January 31 of the following year. In June 2023, EPA amended the reporting requirement to require electronic submission. To determine if your company is subject to this regulation, it is advised to review the applicability criteria outlined in 40 CFR 723.250.

Submission Process:

Reports and accompanying claims must be submitted electronically through EPA's Central Data Exchange (CDX) using the TSCA Section 5 Notices and Supports—ePMN application.

On 30 January 2024, the European Chemicals Agency (ECHA) published its Strategy Statement for the years 2024-2028, emphasising its commitment to protecting human health and the environment through robust chemical safety measures. Aligned with the EU’s goals on chemical safety, the strategy outlines key objectives to address challenges related to climate change, biodiversity loss, and pollution, while contributing to the EU’s broader green, digital, and sustainable growth agenda.

Expanding Legal Mandate and Policy Landscape

ECHA acknowledges a broadening legal mandate, influenced by the Chemicals Strategy for Sustainability and EU Green Deal initiatives. Despite policy changes, the agency remains dedicated to ensuring the protection of health, promoting the free circulation of substances in the internal market, and fostering competitiveness and innovation. Proactively preparing for new tasks and responsibilities, ECHA maintains a strong focus on transparency, independence, and the quality of scientific opinions and decisions. Additionally, efforts are directed towards supporting industries, especially Small and Medium-sized Enterprises (SMEs), in meeting their legal obligations.

Collaboration and Expertise

Dr. Sharon McGuinness, ECHA Executive Director, highlighted the importance of collaboration with the Commission, Member States, agencies, and stakeholders. The strategy underscores the Agency's role in advancing scientific knowledge and data to deliver chemical safety in the present and future. She stated, "I am happy to present our new Strategy Statement, which will drive ECHA’s direction and priorities for the next five years. Our new vision, chemical safety through science, collaboration and knowledge will guide us as we deliver our strategy and our values of integrity, transparency, collaboration and innovation will inform our actions. We look forward to working with our staff, partners and stakeholders in delivering our strategy.”

Paul Krajnik, Chair of ECHA’s Management Board, highlighted the significance of the updated strategy, stating, "The new ECHA Strategy reflects the broadening of our legal mandate in support of the European Union’s ambitious goals on chemical safety, and its commitment to the protection of health and the environment. This new strategy equips ECHA to continue its successful implementation of its agenda into the future."

Key Elements of ECHA's Strategy for 2024-2028:

1. Be a trusted chemicals agency: ECHA aims to strengthen its position as a reliable and trusted authority in the field of chemical safety, reinforcing confidence in its actions and decisions.

2. Respond to emerging challenges and changes in the legal landscape: The strategy underscores ECHA's commitment to addressing new challenges and adapting to changes in the legal landscape, ensuring a dynamic and effective response to evolving circumstances.

3. Communicate and engage: ECHA places a strong emphasis on transparent communication and active engagement with stakeholders, fostering a collaborative approach in its mission to protect health and the environment.

4. Lead on chemical knowledge and expertise: The agency aspires to take a leadership role in advancing chemical knowledge and expertise, contributing significantly to the scientific understanding of chemical safety.

5. Invest in people and organisational excellence: Recognizing the critical role of its workforce, ECHA plans to invest in the development of its personnel to ensure they are well-prepared for the challenges and tasks ahead, promoting organizational excellence.

With these strategic goals and priorities in place, ECHA is poised to make significant strides in chemical safety over the next five years, aligning its efforts with the broader objectives of the European Union. The agency looks forward to collaborative efforts with its staff, partners, and stakeholders to achieve its vision for a safer and more sustainable future.

The complete text of the Strategy Statement 2024-2028 can be found here.

On 20 February 2024, negotiators from both the Parliament and the Council reached a preliminary political agreement focused on ensuring cleaner air within the EU. The overall objective is ambitious yet vital: complete elimination of air pollution by 2050, protecting human health, preserving natural ecosystems, and promoting biodiversity. 

Background: A Call for Change 

Air pollution remains the primary environmental factor contributing to premature deaths in the EU, claiming approximately 300,000 lives each year. In an urgent response, the Commission proposed a revision of the EU’s air quality rules in October 2022, setting more robust targets for 2030 with the ultimate aim of achieving zero pollution by 2050, aligning with the Zero Pollution Action Plan. 

Stricter Guidelines for Cleaner Air 

The recently introduced rules set significantly stricter limits and target values for 2030, surpassing existing regulations. Notably, key pollutants such as particulate matter (PM2.5, PM10), NO2 (nitrogen dioxide), and SO2 (sulphur dioxide) will face tighter controls. For PM2.5 and NO2, the annual limit values will be more than halved. Regular reviews of air quality standards are incorporated to ensure that they are kept in line with the latest scientific discoveries. 

Flexibility and Accountability for Member States  

Acknowledging the challenges of meeting air quality limit values, Member States will be able to request an extension of up to ten years under specific conditions. The agreement strives for transparency by standardizing air quality indices, making them clear and accessible across the EU. Furthermore, it gives citizens and environmental NGOs the right to challenge the implementation of the directive, fostering accountability. Citizens will also be entitled to compensation if their health is adversely affected due to violations of the new national rules. 

Citizen Protection: Access to Justice and Compensation 

In a noteworthy development, affected citizens and environmental NGOs will now have the right to access justice to contest the directive's implementation.  

Roadmaps to Cleaner Air 

In addition to air quality plans for nations surpassing limits, every Member State commits to developing air quality roadmaps by 31 December 2028. These roadmaps will outline both short- and long-term measures to meet the new 2030 limit values, emphasizing a holistic strategy for cleaner air. 

What's Next? 

While this agreement is a significant step forward, it still needs final adoption by the Parliament and Council. Once ratified, the new law will be published in the EU Official Journal, taking effect 20 days later. Member States will then have two years to implement these transformative rules. 

The Lithuanian government has taken a significant step towards amending the country's chemical management laws, to strengthen safety and environmental protection measures related to chemicals and chemical mixtures. In a resolution dated February 14, 2024, the Government approved amendments to several key articles of the Law on Chemical Substances and Chemical Mixtures (No. VIII-1641), which will now be submitted to the Seimas, the Lithuanian Parliament. 

The proposed amendments concern Articles 1, 5, 14, 15, 17, 19, 20, and the Appendix of the existing law and reflect the government's commitment to align national regulations with practical needs and EU standards, in particular the implementation of Article 5(2) of EU Regulation 2019/1021 on persistent organic pollutants (POPs). 

Key Highlights of the Amendments: 

1. Scope clarification: The amendments aim to clarify the application of the law to chemicals used in various sectors, including waste management, cosmetics, and pharmaceuticals, to ensure legal clarity and prevent misinterpretations that could hinder environmental protection efforts. 

2. Representation and authority: Environment Minister Simonas Gentvilas, or his deputies if he is unavailable, is authorized to represent the government in the legislative process, ensuring informed and responsive advocacy of the amendments in the Seimas. 

3. Improved management of POPs: Concerning the management of persistent organic pollutants (POPs), the amendments aim to improve the national regulatory framework for reporting and management of POPs stockpiles, thereby enhancing environmental safety and compliance with international obligations under the Stockholm Convention. 

4. Streamlining compliance and monitoring: The proposal includes provisions to harmonize compliance timelines and clarify supervisory roles, thereby facilitating more effective enforcement and reducing the administrative burdens on companies involved in chemicals management. 

5. Legislative and regulatory adjustments: The amendments will be accompanied by the necessary adjustments to the related legal and regulatory framework to ensure coherence and alignment with EU legislation, in particular on concerning the management of hazardous substances. 

Expected Results: 

The adoption of these amendments is anticipated to bring significant positive outcomes, including improved safety and health protection, enhanced environmental sustainability, and alignment with EU standards on chemical management. By clarifying the legal provisions, the amendments aim to eliminate ambiguities, reduce legal disputes, and streamline the management and control of chemicals and chemical mixtures throughout Lithuania. 

Public and Institutional Engagement: 

The drafting process involved consultations with relevant stakeholders, to ensure that the amendments address practical challenges and reflect the needs of both the public and the affected industries. The proposed legislative changes underscore Lithuania's proactive stance on environmental protection and public health, and emphasize the government's dedication to upholding and enhancing standards in chemical management. 

Next Steps: 

Following its submission to the Seimas, the draft law is expected to be discussed during the spring session of Parliament, with potential adoption in March or April 2024. The law is expected to come into effect on November 1, bringing Lithuania's legal framework in line with contemporary environmental and health standards. 

This legislative initiative marks a crucial step forward in Lithuania's environmental governance, reinforcing the country's commitment to sustainable development and the well-being of its citizens. 

On 19 February 2024, the UK Health and Safety Executive (HSE) announced the postponement of active substance expiry dates for all biocidal active substance/product type combinations due to expire between 1 January 2024 and 31 December 2026. The new deadline for these expirations will be 31 January 2027.

The decision follows challenges beyond the control of the applicants, where approvals were at risk of expiring before a renewal decision could be taken under the GB Biocidal Products Regulation (GB BPR). In addition, this extension will allow time to consider possible reforms to the GB BPR. The HSE plans to publish detailed information on this development in the near future.

Impact on Active Substances/Product Type Combinations

Up to 110 active substance/product type combinations will be affected by this decision, subject to timely submission and acceptance of renewal applications. Currently, 46 combinations listed on the HSE website have met the renewal requirements, resulting in their expiry dates being postponed to 31 January 2027.

For those wishing to introduce new biocidal products containing these active substances, applications for GB BPR product authorisation are still open. However, it is emphasised that new products, including those with new trade names, should not be supplied in Great Britain (England, Scotland and Wales) until proper product authorisation has been granted.

Future Updates

The HSE assures stakeholders that there will be future updates on future postponements of expiry dates under this umbrella decision as they become relevant.

On February 12th, the Ministry of Environment, Urbanization, and Climate Change in Türkiye made an announcement regarding Safety Data Sheets from the Chemicals Help Desk.

Key points from this announcement:

• You can continue to use existing safety data sheets compliant with previous regulations unless there are changes in substance-related information or processes.
• Depending on the requests of your downstream-users, safety data sheets may need to be reviewed.
• Attention should be paid to ensuring that the classification in safety data sheets is similar to the classification in KKDIK registration files.
• All newly prepared safety data sheets must comply with the KKDIK regulation.
• If your existing safety data sheets are not compliant with previous regulations, they must be updated as soon as possible.
• If you have any doubts about the completeness of your safety data sheets in any of the above, reviewing them would be the best course of action.

In January the Bureau of Indian Standards (BIS) released for public consultation the revised draft Indian Standard for Specification of Polyethylene Terephthalate (PET) Bottles for Packaging of Alcoholic Beverages (First Revision of IS 14537). 

Scope of the Standard 

This standard specifies the conditions, procedures, and test methods for poly(ethylene terephthalate) (PET) bottles used in the packaging of both distilled and non-distilled alcoholic beverages. Distilled alcoholic beverages include brandy, gin, whiskey, and rum. Non-distilled alcoholic beverages can be carbonated (i.e. beer and sparkling wine) or non-carbonated (i.e. wine). 

Main changes in the revised Standard 

This standard (IS 14537) was first released in 1998. This revision takes into account editorial alignment and compliance with several relevant rules. The main changes in this revision are the following: 

•  The material requirement has been changed.  

•  Recyclability and other requirements for plastics must be in compliance with the Plastic Waste Management Rules, 2016, as amended.  

• Specific migration limits as per Food Safety and Standards (Packaging) Regulation 2018 and its amendments have been incorporated. 

• The marking/labelling clause has been revised to a marking/packing clause with labelling requirements in accordance with the Food Safety and Standards (Labelling and Display) Regulation, 2020 and its amendments and Part 5 (Specific Labelling Requirements for Alcoholic Beverages) of the Food Safety and  Standards (Alcoholic Beverages) Regulations, 2018. 

Migration test 

Overall migration: When tested in according to  IS 9845, the total migration limit must not be exceeded and must be 60 mg/kg or 10 mg/dm2 with no discernible colour migration. In the case of colored plastics, colour that has migrated into the simulant shall not be visible to the naked eye (see IS 9833). Even if the extraction value is below the overall migration limit, such materials are not suitable if the colour migration is clearly visible.Specific migration: Specific migration is tested to determine the amount of a specific substance that can migrate from a food packaging material or food container into food. Specific migration limits are usually expressed as mg/kg of food. The migration limits for the specified substances in the simulant are given in the table below. 

Timeline 

The Bureau of Indian Standards (BIS) is consulting on the revised standard for polyethylene terephthalate (PET) bottles, used for packaging alcoholic drinks until 8 February 2024. 

On January 30, 2024, India’s Ministry of Environment, Forest and Climate Change (MoEFCC) released the draft End-of-Life Vehicles (Management) Rules, 2024, signalling a commitment to sustainable practices in the automobile industry. Comments on the draft are invited for 60 days from the date of publication. 

Key Highlights of the Draft: 

1. Extended Producer Responsibility System: 

The draft rules propose the implementation of an Extended Producer Responsibility (EPR) system for car manufacturers and other entities from April 2025. This system aims to ensure the responsible and environmentally friendly disposal of End-of-Life Vehicles (ELVs). 

2. Inclusion of Electric Vehicles: 

Notably, the regulation covers electric vehicles (EVs), including e-rickshaws and e-carts, under its purview. This signifies a comprehensive approach to the management of the life cycle of vehicles, in line with the growing importance of electric mobility. 

3. Registration and Reporting Obligations: 

Producers falling under the definition outlined in the draft, including manufacturers, assemblers, and importers, will be required to register on a dedicated portal within six months of the promulgation of the Rules. They will also be required to submit annual reports detailing vehicles placed on the market, steel usage, and compliance with recycling targets. 

4. Recycling Targets: 

The draft sets ambitious steel recycling targets for private and commercial vehicles, calculated on the basis of steel used in vehicles placed on the market 20 years ago for private vehicles and 12 years ago for commercial vehicles. 

5. Environmental Compensation for Violations: 

In case of violations, the draft introduces environmental compensation as a penalty, with a unique feature. A partial refund may be granted if the violation is addressed within three years of the imposition of the penalty, thus providing an incentive for timely compliance. 

The draft rules represent a milestone in the promotion of sustainable practices within the car industry, in line with global efforts to build a greener future. Stakeholders are encouraged to fully review the draft and prepare for the forthcoming changes. 

A detailed overview of the draft can be accessed here the document.

The Solid Waste and Chemicals Management Center (SCC) under the Ministry of Ecology and Environment of China (MEE) published a notification to remind new chemical substance registrants to submit 2023 annual reports before 30th April via the online registration system. 

According to MEE Order No.12, the following types of new chemical substance registration have annual report obligation. 

• Certificates obtained under MEP Order No.7, and the new substance belongs to key environmental management categories; and 
• Certificates obtained under MEE Order No.12, and the annual report obligation was specified in the regular registration certificate. 

As required, registrants shall include the following information in the annual report.  

• Actual production in 2023.
• Import volume of chemical in 2023.
• Environmental release details, the implementation status of environmental risk control measures.
• Environmental management requirements.

The registrants or their agents in China shall log into the system and fill in the report form online. SCC also disclosed a list of registrants subject to annual report obligation. If you are not sure if you have annual report obligation, please submit a query to GPC via compliance@gpcregulatory.cn or zhengmin@cn.gpcregulatory.com, we will help to you to check. 

On February 7, 2024, the South Korean Ministry of Food and Drug Safety (MFDS) announced a partial revision to the Cosmetics Act, adding 1,2,4-Trihydroxybenzene (CAS 533-73-3) to the list of prohibited raw materials for cosmetics. This revision aims to include harmful ingredients in the list of raw materials prohibited for use in cosmetics. The decision, made under Article 8 of the Cosmetics Act, is based on risk assessments, considering factors such as the status of foreign powers. 

The amendment seeks to strengthen safety management in the cosmetics industry and protect public health. Cosmetics manufactured or imported before the enforcement of this notice must be sold, displayed, or stored for sale by October 1, 2024. 

Thailand notifies WTO of draft regulation to restrict mercury in electrical and electronic equipment

On 12 February 2024, the Thai Industrial Standards Institute (TISI) notified the World Trade Organization (WTO) of a draft Ministerial Regulation Prescribing Industrial Products for Mercury-Added Electrical and Electronic Equipment to Conform to the Standards B.E. The deadline for comments is 60 days from the date of notification.

Objective:

The proposed draft Ministerial Regulation aims to ensure the protection of human health and the environment by restricting the use of mercury in certain electrical and electronic equipment. With a focus on public wellfare, this regulation aims to reduce potential health risks associated with mercury exposure and to reduce environmental contamination.

Rationale:

Mercury, a toxic heavy metal, poses significant risks to human health and the environment. Exposure to mercury can lead to serious health problems, including neurological disorders, developmental disorders, and environmental pollution. By restricting the use of mercury in specific electrical and electronic equipment, the Regulation aims to address urgent concerns public health and environmental safety concerns.

Responsible Agency:

The Thai Industrial Standards Institute (TISI), under the Ministry of Industry, will be responsible for overseeing the implementation and enforcement of the proposed regulation. As a regulatory body, TISI plays a crucial role in ensuring compliance with industrial standards to protect public health and environmental integrity.

Description of Content:

According to the WTO notification released on 12 February 2024, the draft Ministerial Regulation mandates adherence to the TIS 3604–25XX (20XX) Mercury-Added Product – Restriction of the Use of Mercury for the following electrical and electronic equipment:

• Button zinc silver oxide batteries
• Button zinc air batteries
• Inclination switches
• Temperature switches
• Electronic acceleration switches (G sensors)
• Overcurrent protection switches
• Switches and relays for measurement, control, and transmission
• Compact fluorescent lamps (CFLs)
• Linear fluorescent lamps (LFLs)
• Cold cathode fluorescent lamps (CCFL) and external electrode fluorescent lamps (EEEL)

Timeline:

The adoption date for the regulation is yet to be determined. The regulation will enter into force 270 days after publication in the Government Gazette.

On 9 January 2024, the Japanese Ministry of Health, Labour, and Welfare (MHLW) issued a key notice to guide companies in complying with new requirements for safety data sheets (SDSs) and Globally Harmonized System (GHS) based labels for hazardous substances under the Industrial Safety and Health Act (ISHA). These requirements are set to become mandatory from 1 April 2024.

Key requirements outlined by the MHLW include:

A. Safety Data Sheets (SDS) must include:

• CAS numbers and substance names
• Physical and chemical properties of the substance, including colour, odour, melting/freezing point, boiling point and flammability.
• Information on appropriate protective equipment and storage/handling precautions.
• Specific information on human health effects following exposure, such as acute toxicity, serious eye damage/irritation, respiratory/skin sensitization, reproductive toxicity, and germ cell mutagenicity.
• Accident and emergency management procedures in case of leakage and other incidents, including evacuation measures and use of protective equipment.
• Description of the content in terms of concentration or weight percentage, or provision of a conversion formula to enable users to convert to weight percentage.
• Recommended uses and restrictions on use including conditions to avoid and incompatible materials.
• Product ingredients classified as confidential must be clearly identified with a summary description; companies may use non-disclosure agreements for such information. Exceptions apply to substances regulated by specific ordinances.

B. Packaging labels must include:

• The name of the substance (must be identical to the name in the SDS). The product name may be used if it allows identification.
• GHS hazard classifications (according to standard JISZ7252:2019) with details for each substance in a mixture if the mixture itself is not classified
• Possible harmful effects on the human body
• Hazards with pictograms and warnings
• Storage and handling instructions, including measures to prevent exposure.
• Name, address, and telephone number of the person making the label and information on the domestic manufacturer/importer.
• Emergency contact telephone numbers
• Signal word
• Information on the stability and reactivity of the substance, including storage conditions, handling precautions, decomposition, and mixing with incompatible substances.

Companies are urged to bring their practices into line with these regulations without delay to ensure compliance by the specified deadline. Failure to do so may result in penalties or legal consequences. The MHLW emphasizes the importance of these measures in improving workplace safety and minimizing the risks associated with hazardous substances.

The Brazilian Association of Technical Standards (ABNT) has taken an important step forward in enhancing safety measures concerning chemical substances with the introduction of the new standard "NBR 17160 - Safe Storage and Incompatibility of Chemical Products." This standard, which entered National Consultation on 02/19/2024 and is accessible until 03/19/2024, signifies a crucial development in the field of chemical storage and compatibility.

Background: This standard is built upon the foundation of the German international standard "TRGS 510 - Storage of hazardous substances in non-stationary containers." The primary focus of NBR 17160 is to establish criteria for determining storage classes of chemical products. This is achieved by utilizing hazard classifications according to NBR 14725 and transport classifications according to Resolution 5998/ANTT, which was the prevailing standard during the document's formulation.

Objective: The core objective of NBR 17160 is to provide a comprehensive framework for segregating chemical products based on their respective chemical incompatibilities. This approach is crucial in minimizing the risk of hazardous reactions between substances, ensuring the safety of storage facilities and personnel.

Key Features:

1. Creation of Storage Classes: The standard introduces a system of classes to facilitate the segregation of chemical products. This categorization is designed to align with the classifications of hazards according to NBR 14725, creating a standardized approach to storage.

2. Rules for Safe Storage: NBR 17160 establishes explicit rules for the safe storage of chemical products within each class. This includes specific guidelines for handling various groups of substances, such as explosives, flammable liquids, and oxidizing agents. These rules contribute to maintaining a secure environment and preventing accidents.

3. Alignment with International Standards: Drawing inspiration from international standards like TRGS 510 ensures that Brazil remains in sync with global best practices. This alignment enhances the country's ability to participate in international trade while upholding high safety standards.

Accessing the Standard: To gain insights into the intricacies of the NBR 17160 standard, interested individuals can access the full text on the ABNT website through this link. The document is located under the ABNT/CB-010 Chemistry committee, titled "PROJETO ABNT NBR 17160 Armazenamento seguro e incompatibilidade de produtos químicos." However, it's essential to note that the window for accessing and providing improvement comments closes on 03/19/2024.

The introduction of NBR 17160 marks a stride in ensuring the safe storage and compatibility of chemical substances in Brazil. This standard not only establishes clear guidelines for storage but also reflects a commitment to international standards, emphasizing the importance of safety in handling and storing chemical products. As stakeholders engage in the National Consultation, their input and feedback will contribute to refining and implementing a standard that sets a benchmark for safety in the chemical industry.

The Vietnamese Ministry of Health (MoH) announced on December 13, 2023, that a new decree on cosmetics management is being drafted.

Background information

Currently, after more than 12 years of implementation of Circular No. 06/2011/TT-BYT and 7 years of implementation of Decree No. 93/2016/ND-CP, the evaluation report on law enforcement in the cosmetics industry shows that the regulations in the two aforementioned documents have resulted in several shortcomings that hinder and cause difficulties for management agencies affecting aesthetic management products as well as the production and trade of cosmetics within the enterprise. These shortcomings include the following:

•           Regarding cosmetic product announcement

•           Concerning cosmetic post-inspection work

•           Organization of cosmetic sampling for quality control

•           Concerning the production of cosmetics

Content of the new decree

The purpose of the drafting and implementation of this Decree is to swiftly remove barriers and challenges pertaining to law and policy, as well as to address real-world issues that come up in the context of Vietnam's rapidly expanding cosmetics industry.

It is expected that the draft Decree will contain 15 chapters and 63 articles related to 3 policies including:

Policy 1: Strengthen regulations on cosmetic product declaration to ensure uniformity in considering the declaration and use of cosmetic product in accordance with international practices and the ASEAN Cosmetic Harmonization Agreement.

Policy 2: Strengthen the post-inspection work on cosmetics management in accordance with the trend of the 4.0 revolution (the ongoing fourth industrial revolution marked by integration of digital technologies, automation, and artificial intelligence) and promote the use of information technology in the state management of cosmetics; streamline and simplifying administrative procedures, creating favorable conditions for businesses while ensuring consumers’ rights.

Policy 3: Improving the quality of domestically produced cosmetics.

The Draft Decree covers organizations and persons involved in the announcement, production, import, export, and trade of cosmetic products in Vietnam, as well as functional agencies involved in the management of cosmetics.

On 31 January, the Ministry of the Environment approved the draft regulation of Law No. 21.368, which regulates the disposal of single-use plastics and plastic bottles and modifies the legal bodies it indicates—better known as the Single-Use Plastics Law—and submitted it for public consultation.

In Chile, approximately 23,000 tonnes of waste from single-use plastics are generated, with a significant percentage ending up in the sea or left in landfills, rivers, parks, and public roads. The Single-Use Plastics Law, enacted in August 2021, aims to protect the environment and reduce waste generation by limiting the supply of single-use products in plastic and regulating disposable plastic bottles.

The Act primarily regulates two matters. Firstly, the dispensing of single-use products in food establishments, and secondly, the management of both returnable and disposable plastic bottles for beverages.

The regulation aims to establish requirements and procedures for the granting of the certificates outlined in the Law, as well as to specify other obligations established in the Law.

The preliminary draft will be open for public consultation for a period of 35 working days (until 27 March) through the public consultation platform https://consultasciudadanas.mma.gob.cl/portal. During this time, all those interested in the regulation are invited to inform themselves, participate, and incorporate their opinions or observations on the aforementioned platform or in writing at the Office of Parties of the same or at the corresponding Regional Ministerial Secretariats of the Environment.

This citizen consultation process includes webinars and talks to provide information about the Law and the draft regulation in particular.

On 26 January 2024, the Ministry of Health of Chile published Law No. 21646 in the Diario Oficial de la Republica de Chile, which prohibits animal testing in the preparation of cosmetics. 

The law adds the following text to Article 108 of the Sanitary Code: 

The use of animals for the safety and efficacy testing of cosmetic, hygiene, and personal odorization products, and each of the ingredients, combination of ingredients, or final formulations is prohibited.    

To ensure the protection of human health, by the standards of this code, manufacturers must use alternative testing methods that do not involve animals to demonstrate the safety and effectiveness of cosmetics, personal care, and odorization products and all of their ingredients.  

Amended Clauses in Law No. 20.380 on the protection of animals:

An exception to the prohibition on animal testing is made if the following conditions are met: 

1. There is no alternative method or strategy to the use of animals recognized by the Public Health Institute or by the Organization for Economic Cooperation and Development to demonstrate safety parameters. 

2. The ingredients are subject to restriction in their concentration for cosmetic use. These ingredients are listed in the database of cosmetic ingredients used by the Public Health Institute. 

3. The cosmetic ingredient is widely used and cannot be replaced by another ingredient that can perform a similar function. 

The law will take effect twelve months after its publication in the Official Gazette (27 January 2025).

New Zealand, a pioneer in environmental protection, has taken a significant step to improve consumer safety and safeguard the environment by banning the use of per- and polyfluoroalkyl substances (PFAS), commonly known as 'forever chemicals', in cosmetic products from 31 December 2026. This was announced in a press release on 30 January 2024. 

PFAS in cosmetic products 

PFAS can be found in a variety of consumer products, including nail polish, shaving cream, foundation, lipstick, and mascara. These compounds are added to improve skin smoothness and product durability, as well as impart water-resistant properties to cosmetic products. 

International research indicates that PFAS are present in a limited number of products. However, New Zealand's Environmental Protection Agency (EPA) is taking a precautionary approach to the  risks posed by PFAS. This approach includes banning these chemicals in cosmetics as part of an ongoing response that includes phasing out PFAS-containing firefighting foams and monitoring background levels of PFAS in the local environment. 

Comprehensive update of the Cosmetic Products Group Standard 

The decision to regulate PFAS is just one aspect of a comprehensive update to the Cosmetic Products Group Standard. This update aims to ensure the safety of cosmetic products and to bring the rules in line with global developments. 

EPA says it has also strengthened the regulations, to cover non-hazardous cosmetic products that contain hazardous ingredients. This will enable them to effectively enforce the rules governing banned and restricted ingredients in such products. 

Public consultation and industry feedback 

In 2023, EPA initiated a public consultation on the proposed rule changes and received 20 submissions, including 14 from the cosmetics industry. EPA’s Hazardous Substances Reassessments Manager, Dr. Presow, acknowledges the significance of this feedback, stating, " The feedback from our consultation was particularly important for us to better understand how widespread PFAS use is in cosmetics, and was supportive of the changes." 

EPA remains committed to engaging with the industry to ensure a smooth transition before the ban on PFAS ingredients and other regulatory adjustments come into force. 

Harmonizing Regulations with European Union Standards 

The recent updates focus primarily on aligning Schedules 4 to 8 of the Group Standard with the stringent requirements of the European Union, which is  as the global benchmark for quality and safety standards. 

Phasing Out PFAS Ingredients 

Perfluoroalkyl and polyfluoroalkyl substances (PFAS), often referred to as 'forever chemicals,' will be phased out of cosmetics, with a target date of the end of 2025. 

Expanding the Scope of the Group Standard 

Certain cosmetic products currently contain minute concentrations of hazardous substances that do not cause the entire product to be classified as hazardous. The proposed changes will require these products to comply with the Group Standard, ensuring consumer protection, clearer industry regulations, and improved enforcement. 

Other Proposed Updates Include: 

1. Mandatory recordkeeping for nanomaterials 

2. Updates to fragrance requirements 

3. Consolidation of the main text and Schedules 4 to 8 into a single document 

4. Improvements in the presentation and usability of the group standard. 

EPA remains committed to its mission of protecting the well-being of consumers and the environment through vigilant regulatory measures. 

 On 2 February 2024, the Ministry of Health of Ukraine notified the World Trade Organization (WTO) that Order No 2104 ‘On Approval of Special Requirements for Plastic Materials and Articles Intended to Come into Contact with Foodstuffs’ was adopted on 11 December 2023 and will enter into force on 19 November 2025. At the same date the Law of Ukraine No 2718 - IX "On Materials and Articles Intended to Come into Contact with Food" of 3 November 2022 will come into force.

Order No 2104

The purpose of Order No 2104 is to validate specific requirements for plastics intended to come into contact with food by incorporating the provisions of European Union Regulation (EU) 10/2011 (on plastic materials and articles intended to come into contact with food). Key points of the Order include:

• Defining the scope of food contact plastics

• Specifying that ion exchange resins, rubber, silicones, printing inks, adhesives, and varnishes/coatings are exempted.

• Outlining the compositional requirements for food contact plastics including the use of authorised monomers, starting substances, macromolecules from microbial fermentation (listed in Appendix 1) or substances included in the State Register for the manufacture of food contact plastics.

• Establishing general requirements, restrictions, and technical specifications, such as specific migration limits (SML), overall migration limits (OML), and limits for primary aromatic amines (PAA)

• Providing regulations for plastic multi-layer materials and articles, as well as multi-material multi-layer materials and articles.

The Order provides that plastic materials and articles intended to come into contact with food and manufactured before the entry into force of the Order, may be in circulation until their expiry date.

The full text of the Order (in Ukrainian) can be found here.

Law No 2718

Ukraine introduced Law No. 2718-IX of 3 November 2022, 'On Materials and Articles Intended to Come into Contact with Food,' effective from 20 November 2022, with key provisions applicable from19  November 2025. This law incorporates elements from EU regulations on materials and articles intended to come into contact with food and includes the following:

Section I - General provisions:

• Scope: Covers food contact materials (FCMs) and articles.

• Exemptions: Antiques, protective coatings, fixed water supply equipment.

• Defines: Terms, powers of government agencies.

Section II - Requirements for materials and articles:

• Compliance: FCM must comply with Good Manufacturing Practice (GMP).

• Safety Requirements: General safety, non-deceptive labelling.

• Special Requirements: 18 FCM groups may have specific criteria.

• Recycled Plastics: Allowed if obtained through a state-registered process.

Section III - State registration of articles:

• Outlines requirements and procedures for state registration.

Section IV - Marking, declaration of conformity and ensuring traceability of materials and items:

• Labelling: Information for materials not yet in contact with food.

• Active and Intelligent Materials: Special labelling requirements.

• Declaration of Conformity: For materials with special requirements.

• Traceability: Ensures traceability at all stages for control and recall.

Section V - Good manufacturing practices:

• Details: GMP requirements, quality assurance, and control systems.

Section VI - State control and responsibility:

• Defines: Powers granted to government agencies.

The full text of Law No. 2718-IX of 3 November 2022, can be found here.   

On 16 February 2024, the Ukrainian Cabinet of Ministers published a draft resolution aimed at improving chemical product safety standards. The proposed legislation, entitled "On the Approval of the Technical Regulations for the Classification of Hazards, Labelling, and Packaging of Chemical Products," aims to align Ukraine's chemical safety protocols with European Union standards and United Nations guidelines.

Developed under the provisions of the Law of Ukraine on Ensuring Chemical Safety and Management of Chemical Products and other relevant national laws, this draft resolution is an important step towards harmonising Ukraine's chemical safety regulations with international benchmarks, in particular the EU Regulation No. 1272/2008 on Classification, Labelling and Packaging of Substances and Mixtures (the CLP Regulation) and the UN Globally Harmonized System (GHS) on the Classification and Labelling of Chemicals.

The draft resolution was notified to the World Trade Organization (WTO) on 27 February 2024.

Key Highlights of the Draft Resolution

- The resolution mandates the adoption of the Technical Regulation for the Classification, Labelling, and Packaging of Chemical Products, ensuring compliance with both EU legislation and UN standards.

- The Ministry of Environmental Protection and Natural Resources will be tasked with overseeing the implementation of these technical regulations.

- A transition period is proposed to allow chemical products that do not fully comply with the new regulations to remain on the market for a period of time to ensure a smooth transition for businesses.

- Amendments to existing laws and executive orders will be required to bring them into line with this resolution, underlin the comprehensive approach to chemical safety.

- The resolution is scheduled to enter into force on 29 June 2024, with certain provisions coming into force on 1 January 2025 to address implementation logistics.

Objective and Scope

The primary objective of this Regulation is to protect public health and the environment by establishing strict criteria for the hazard classification, labelling, and packaging of chemical products. By setting clear requirements for the identification and communication of chemical hazards, Ukraine aims to facilitate the safe handling of chemical substances and mixtures, thereby ensuring the well-being of its citizens and the ecological integrity of its territories.

The draft resolution covers a wide range of chemical products, excluding only those explicitly listed, such as radioactive materials, non-isolated intermediates, and certain products used exclusively in scientific research, among others.

Public and Stakeholder Engagement

The Cabinet of Ministers is inviting public feedback and stakeholder input on the draft resolution, underscoring the government's commitment to transparency and collaborative policymaking. This participatory approach is expected to refine the regulations and ensure their effectiveness in protect human health and the environment. The deadline for comments is 16 March 2024.

Conclusion

Ukraine's proactive measures to update its chemical safety standards reflect its commitment to protecting the environment and public health. By aligning with international regulations, Ukraine is not only improving its domestic safety protocols but also facilitating the smoother cross-border trade and handling of chemical product.