ELEMENTS by H2 Compliance - October 2024

News from H2 Compliance

Nearing the end of 2024, various jurisdictions are ramping up their environmental and chemical regulatory actions and even planning for the year ahead.

In this newsletter, we highlight:

NEWLY PUBLISHED REPORTS FROM H2

·??????? Tea Tree Oil – Recent Developments in the EU

THE LATEST DEVELOPMENTS IN ENVIRONMENTAL COMPLIANCE

·??????? Important changes for Non-UK sellers of WEEE

·??????? Extended Producer Responsibility (EPR) Developments in North America: Colorado PRO registration deadline & California deadline for expanded polystyrene producers

THE LATEST DEVELOPMENTS IN CHEMICAL COMPLIANCE

·??????? EU Developments

o?? EU finalizes a new PFHxA restriction

o?? The publishing of the 22nd Adaptation to Technical Progress (ATP) to the EU Classification, Labelling, and Packaging regulation (CLP)

o?? ECHA’s report on Integrated Regulatory Strategy

·??????? APAC Developments

o?? Australia changes categorisation, reporting, and record-keeping requirements under AICIS

o?? Thailand embarks on a comprehensive review of its Hazardous Substance Act

·??????? US Developments

o?? Maine eliminates the January 2025 general notification deadline for PFAS

·??????? South America Developments

o?? Peru introduces draft regulations for classifying, reporting, and prioritizing hazardous substances

·??????? Global Chemicals Framework offers support to developing nations

H2 NEW STAFF HIGHLIGHT: CHEMICAL TEAM

NOTABLE UPDATES FROM H2

As always, our articles complement the extensive content we post to our website regularly and we invite you to visit our website and get in touch with us ([email protected]) to help you navigate the complex and ever-evolving chemical and environmental compliance space.

New Reports

Tea Tree Oil – Recent Developments in the EU

Melaleuca alternifolia (Tea Tree Oil) is used extensively in cosmetics and personal care products. Tea Tree Oil is known to have skin conditioning, insecticidal, repellent and anti-bacterial properties and therefore is used in pharmaceutical products for treatment of wounds, acne and insect bites. In addition, Tea Tree Oil is comprised of more than 100 chemicals and is a substance of unknown/variable composition, complex reaction products or of biological materials (UVCB).

Recently, the EU has adopted an opinion that Tea Tree Oil is a Category 1B reproductive toxicant. Any substance classified as a CMR (carcinogenic, mutagenic, and reprotoxic) in the EU Classification, Labelling and Packaging (CLP) regulation, which includes those classified as Category 1B (H360), are banned for use in cosmetics in the EU, unless industry members receive an exemption by demonstrating safe use according to specific criteria as per Article 15 of the EU Cosmetics Regulation (EC) 1223/2009. A total ban will have significant consequences.

For more details on the new classification for Tea Tree Oil and its implications, please read on at our website here: TEA TREE OIL - RECENT DEVELOPMENTS - H2 Compliance

Environmental Regulatory Updates

Important Changes for Non-UK Sellers of WEEE

Following new guidance from the UK’s Environment Agencies, overseas companies who are not established in the UK placing electrical and electronic equipment (EEE) on the UK market via indirect selling only will no longer be obligated as EEE producers from the 2025 Compliance Year.

Previously, some non-UK companies selling EEE products indirectly to the UK market could register as EEE producers in place of the local UK-based importers and/or distributors. This change has been made in an attempt to align policy with the producer definitions set out in the UK WEEE regulations.

For more information on what to do if you’re impacted by these developments, please read on at our website here: WEEE UK: Important Changes for non-UK sellers - H2 Compliance

PRO Registration & Upcoming Obligation Deadlines

Producers in Colorado subject to the Producer Responsibility Program for Statewide Recycling Act had until 1 October 2024 to register with the PRO, Circular Action Alliance (CAA). The deadline for participation (e.g. sharing data, paying fees) is 1 July 2025.

Additional regulatory deadlines for PRO registration for Oregon, Minnesota, and California have also been published. For more information on these deadlines, visit our website insights here: News Update: Colorado PRO registration deadline just days away - H2 Compliance

If you need support or have any questions, please contact us at [email protected].

Upcoming Deadline for California Producers of Expanded Polystyrene (EPS) Products to Comply with Recycling Rate

CalRecycle recently issued a reminder that Producers of EPS packaging and food service ware will have until 1 January 2025 to demonstrate compliance with SB54 (The Plastic Pollution Prevention and Packaging Producer Responsibility Act). It requires reporting for recycling rates of not less than 25 percent.

Producers who do not comply will not be able to sell, offer for sale, distribute, or import EPS products in or into California.

EPS reporting requirements for recycling rates will increase in the future as follows:

? Not less than 30 percent on and after January 1, 2028

? Not less than 50 percent on and after January 1, 2030.

? Not less than 65 percent on and after January 1, 2032

As per SB54, the reporting / demonstrating of compliance with EPS recycling rates is not something a producer responsible origanization (PRO) is required to do. This information must come from EPS product Producers and be sent directly to CalRecycle. The full article can be found here on our website: News Update: California deadline for Producers of expanded polystyrene (EPS) products to comply with recycling rate is this January - H2 Compliance. If you need support or have additional questions, please contact us at [email protected]

Global Chemical Regulatory Updates

EU finalizes a new PFHxA restriction

The EU has reached a major milestone in the regulation of PFAS, as the European Commission (EC) has finalised a new restriction on a subgroup of PFAS - undecafluorohexanoic acid (‘PFHxA') and PFHxA?related substances on 19 September 2024. This restriction was narrowed to focus on uses where the risk is not adequately controlled or outweighed by the benefit. The use of PFHxA in?consumer textiles, food packaging including paper and cardboard, consumer mixtures?& cosmetics; along with some?firefighting foam applications?will now be banned. The PFHxA restriction has entered into force 20 days after publication, and will take effect after transitional periods varying from 18 months to 5 years, allowing time for substitution. The EC press release can be found here: Commission restricts use of a sub-group of PFAS chemicals

For further guidance on navigating the PFHxA restriction and the future of PFAS restrictions in the EU, please contact [email protected].

The publishing of the 22nd Adaptation to Technical Progress (ATP) to the EU Classification, Labelling, and Packaging regulation (CLP)

On 30th September 2024, the Commission Delegated Regulation (EU) 2024/2564 amended Regulation (EC) No 1272/2008 with regards to the harmonised classification and labelling of certain substances (CLP) which was published in the Official Journal of the European Union.

The regulation entered into force on 20th October 2024. To ensure a high level of protection of human health and the environment, suppliers can apply the new or updated harmonised classifications and adapt the labelling and packaging on a voluntary basis before the date of application 1st May 2026. After that time, the new requirements become mandatory.

For more specific information on the updates to the ATP, please read on at our website here: The 22nd ATP to CLP has been officially published - H2 Compliance

ECHA’s report on Integrated Regulatory Strategy

On 23 October 2024, the European Chemical Agency (ECHA) released the final report of its Integrated Regulatory Strategy (IRS) 2019-2023. The IRS achieved its original goal of screening chemicals manufactured in or imported to the EU above 100 tonnes in 2018, and to prioritise them for regulatory risk management or data generation, and has increased overall knowledge of chemicals on the EU market. Among the highlights:

·??????? ECHA has grouped and screened 6,000 substances, and addressed almost all the 4,100 high tonnage ones

·??????? Around 1,900 substances may potentially require regulatory risk management, mostly harmonised classification & labelling (CLH) or restriction under REACH

·??????? For over two thirds, more data is needed to confirm the relevant hazards, and

·??????? Around 60% of all substances screened did not require further action

Several substance groups flagged for further action, such as bisphenols, ortho-phthalates, flame retardants, hydrocarbyl siloxanes and hydrocarbylphenols, became part of the EU’s Restrictions Roadmap, published in April 2022 (see H2 Compliance's article here).?

The integrated risk strategy approach, which addresses chemicals in groups, has proven successful in accelerating data generation, review and action. The reviewed IRS for 2024-2028, which will focus on risk management and continue to improve the protection of human health and the environment from risks posed by hazardous chemicals, is in line with the EU’s ambitious Chemical Strategy for Sustainability?released in 2020.

Australia changes categorisation, reporting, and record-keeping requirements under AICIS

Earlier this year the Australian Industrial Chemicals Introduction Scheme (AICIS) implemented amendments that aim to lower the regulatory burden for companies.

The changes include:

·??????? Replacing the requirement for companies to obtain written undertakings from suppliers or manufacturers with five alternative record-keeping options.

·??????? Accepting International Nomenclature of Cosmetic Ingredients (INCI) names more widely for reporting and record keeping;

·??????? Amending the categorisation of fluorinated chemicals and persistent organic pollutants (POPs) to ensure substances of high concern are not designated as low or very low risk;

·??????? Expanding eligibility criteria for flavour or fragrance blend chemicals;

·??????? Establishing criteria for hazardous chemicals to be classified as low risk if they are strictly controlled; and

·??????? Reducing regulatory obligations for small-scale soap makers.

The amendments entered into force on the 24 April. Specific details can be found on the AICIS website.

Thailand embarks on a comprehensive review of its Hazardous Substance Act

Thailand's Hazardous Substance Act is a law designed to regulate the production, importation, exportation, and possession of hazardous substances within the country. It aims to protect public health and the environment by setting standards and guidelines for the handling, storage, and transportation of these substances.

The country's law has had some amendments since its enactment in 1992. However, the Department of Industrial Works (DIW) - a government agency responsible for overseeing the industrial sector - noted before that the law has been in force for a long time and some provisions may no longer align with current realities. As a result, Thailand is reviewing its Hazardous Substance Act to ensure its effectiveness and relevance. The review aims to examine potential overlaps with other laws, social justice principles, and the necessity of legal provisions. The DIW looked for input from industry and stakeholders to assess the law's implementation and alignment with its original objectives. Key areas for feedback included:

-????????????? Definitions in section 4 of the act for: hazardous substances, production, import, export, sale, possession and labelling

-????????????? Structure of the nine ministries of DIW operations

-????????????? The structure, powers and duties of the Hazardous Substance Committee

-????????????? the Hazardous Substance Information Centre and its role in coordinating government agencies and the private sector.

As a result, the DIW has identified several failings in the law's implementation, such as:

-????????????? Inconsistent interpretations of the regulation

-????????????? Enforcement delays due to involvement of multiple agencies

-????????????? Unclear responsibilities between agencies

-????????????? Inadequate supervision of hazardous substance containers

-????????????? Inefficiencies of the Hazardous Substance Committee

Thailand will now work with these finding to ensure the laws effectiveness and relevance.

Maine eliminates the January 2025 general notification deadline for PFAS

Maine’s ‘An Act to Stop PFAS Pollution’ (LD 1503) was recently amended by LD 1537, effective August 9, 2024. The amended legislation still requires notification of PFAS containing products, but it eliminates the general notification deadline that was previously scheduled as January 1, 2025. This is a further step back for Maine after it delayed and narrowed the PFAS notification in April 2024.

The notification requirement was amended with the focus on the manufacturer’s responsibility to identify “currently unavoidable uses” (CUU) of PFAS in products. Some categories of products will still be subject to sales ban if they contain PFAS that are not CUUs.

A list of products subject to sales ban are provided in the image table below:

For more information, read the official notice here: PFAS in Products, Maine Department of Environmental Protection

Peru introduces draft regulations for classifying, reporting, and prioritizing hazardous substances

In late July Peru introduced draft regulations for classifying, reporting, and prioritizing hazardous substances under its national chemicals law. These regulations aim to implement Decree No 1570, which established a framework for a chemicals management system and created the National Registry of Chemical Substances (RENASQ).

The draft regulations mandate that manufacturers and importers register hazardous substances following the guidelines of the sixth revision of the Globally Harmonized System (GHS 6). The draft also features an “anticipated chemical hazard classification” list, which includes well over 4,000 substances. Registration timelines will vary based on whether the substances align with the classifications in this anticipated list.

For more information on the regulatory deadlines that vary by hazard classification, please read more on our website here: Peru Introduces New Draft Regulations - H2 Compliance

Global Chemicals Framework offers support to developing nations

The Global Framework on Chemicals (GFC) is an international agreement aimed at preventing or minimizing the harm caused by chemicals and waste. It was agreed in September 2023 after eight years of negotiations and sets out a vision, objectives, and funding system to "free the world of harm from chemicals."

Earlier this month the GFC launched its fund to help countries implement the international agreement on chemicals. The funding is now open to developing countries, small island developing states, countries with economies in transition, and civil society networks. The aim of the funding is to help prevent or minimise the harm caused by chemicals and waste.

Contributions to the GFC are voluntary and donors include Germany, the Netherlands, Switzerland, Spain, the United Kingdom, and the International Council of Chemical Associations. The secretariat stated that it will finance and prioritize proposals that:

-??????? Strengthen national and regional capacities for the implementation of the GFC

-??????? Implement programmes that promote the safe and sustainable management of chemicals and waste,

-??????? Promote policies that enable countries to unlock and secure funding for managing chemicals and waste, and

-??????? Address issues of concern as well as cross-cutting themes.

Countries and other stakeholders can apply for funding until 31 January. You can find further information here: Overview of the Global Framework on Chemicals Fund | UNEP - UN Environment Programme

H2 New Staff Highlight: Chemical Team

Welcome Catalina & Adrienne!

The H2 Chemical team has welcomed two new esteemed colleagues in 2024! With their addition to the team, we have yet again extended our capabilities in the areas of regulatory software solutions and toxicology.

Please read more about Catalina and Adrienne below.

Catalina Dobre

Originally from Romania, where she studied Law (including Public International Law, as well as Business Law & Legal Technology), Catalina is based in Amsterdam, Netherlands. Since qualifying, Catalina has worked in the area of chemical compliance in Bucharest, before working in Environmental Compliance and more recently, leading SCIP, regulatory training and efficiency improvement.

Catalina has joined H2 as a Compliance Solution, Senior Consultant,?to oversee our element1 software platform (internally and externally) as well as enhancement of our systems to improve our process efficiency (SharePoint, KPI’s, Document and Contract management).

Adrienne Black, PhD, DABT

Adrienne Black is a board-certified PhD toxicologist serving as a Senior Regulatory Toxicology Consultant in the H2 Compliance Chemical Compliance and Stewardship service area. Her experience includes global product stewardship for consumer, nanomaterial, cosmetic and food products as well as laboratory research for assessing toxicological and chemical hazards and collegiate faculty instruction.

As a corporate toxicologist, Dr. Black supplied expert subject matter knowledge to both company personnel and clients, enabling the completion of GHS-compliant classifications, extensive chemical toxicological assessments of consumer, cosmetic and food product ingredients, pharmaceutical agents and industrial chemicals as well as evaluation of regulatory guidance documents for North America, Europe and throughout Asia. She has also assessed the potential toxicological hazards and exposure to nanomaterials in the occupational setting and determined the appropriate measures and control banding necessary to ensure worker safety.

In addition, Dr. Black has served as an adjunct faculty member with New York Medical College, Rutgers University, and the University of Maryland, providing in-person and online undergraduate and graduate-level instruction in toxicology fundamentals and applications, industrial hygiene and environmental risk assessment. She is also a member of several professional societies including Society of Toxicology, American College of Toxicology, American Chemical Society, American Society for Cellular and Computational Toxicology and Society of Chemical Hazard Communication.

In her spare time, Adrienne enjoys cooking, baking bread, sewing, reading and watching sci-fi. She is based out of Vonore, Tennessee, USA.

Notable Updates from H2

Fall Conference Blitz

September and October were busy for H2’s North America teams as we participated in the Canadian Stewardship Conference, Society for Chemical Hazard Communication Annual Meeting, and Product Stewardship Exchange (PSX) Conference.

In addition to exhibiting at each conference and speaking with many talented individuals, H2 presented at both the Canadian Stewardship Conference and PSX.

At the Canadian Stewardship Conference, Thomas Fischer participated in a session dedicated to the global EPR landscape, focusing on the EU, and John Hayes shared his experience in a panel discussing how best to work with PROs.

At PSX, Claire Mathis co-presented as part of the Introduction to Product Stewardship education workshop prior to the conference as well as co-presented a session on achieving the Certified Professional Product Stewardship (CPPS) credential; Domonick Zanarini and Jim Mo presented a session on the EU’s Digital Product Passport and ongoing regulatory requirements; and Domonick also presented on a framework for product stewardship gap assessment.

We so enjoyed meeting with many new and familiar faces at these events and look forward to the future networking opportunity provided from each event.