ELEMENTS by H2 Compliance - December 2024

Season’s Greetings from H2 Compliance

As we approach the end of the year, may we take the opportunity to wish you an enjoyable holiday season, and hope you take time to rest and reflect during a holiday break. We want to thank our customers for allowing us support your business activities throughout the year and look forward to our collaborations in 2025.

On reflection, 2024 has been a year of quiet progress, rather than one driven by concrete regulatory deadlines.

Slow but steady progress:

-??????? EU: The revision of REACH remains mired in delays, partly due to a change of parliament, though due to uncertainty in the extent of the revision. PFAS remain controversial, Polymers registration is unresolved, but simplification of Restrictions and Authorisation to reduce burden, while accelerating decision making has progressed. EPR regulations in various Member States have taken the form of eco-modulation and new specific regulations for novel waste streams, including textiles.

-??????? UK: Difficulties remain on how to move forward with their version of REACH. Costs for legitimate access to data is proving difficult to resolve. The 2026/2028/2030 deadlines remain, though there are suggestions of some further modifications.

-??????? INDIA: A further year has passed without any real resolution on their REACH-like plans. The most recent draft (India’s 5th revision) was over 4 years ago, with no real insight as to direction or timing from here.

?

While elsewhere…:

-??????? North American EPR: States and provinces in the US and Canada continue to author and pass new EPR legislation, with a significant focus on packaging in 2024.

-??????? South America is embracing Chemical regulations with Brazil and Chile joining Colombia and Peru with progressive programs now in place.

-??????? Ukraine, despite its plight, is moving forward with its version of REACH, and with a first deadline for pre-registration in January 2025. Subsequent Registration deadlines, like Turkey and the UK, and slated for 2026/2028/2030.

-??????? PFAS and Microplastics continue to attract column-inches around the world, particularly in the USA and the EU.

-??????? Substances of Concern, Green Chemistry, Safe and Sustainable by Design, and Digital Product Passports gather further momentum in the EU in particular.

-??????? The US and Canada are moving to GHS revision 7, which will drive SDS conversion activity in advance of December 2025 (Canada) and July 2026 (substances) and Jan 2028 (mixture) (US) deadlines.

-??????? The EU decide on enforcement themes annually. Online Sales will be the 2025 focus, aimed to reduce the incidence of inaccurate/incomplete data provision to aid customers with their purchasing decisions

These regulatory developments require continued and focused efforts for companies selling domestically and internationally.

A data-first approach is important to allow you make timely decisions to keep your markets open and your customers satisfied.

Best wishes on the close of 2024 and beginning of 2025,

Kevin Hoban

Director, H2 Compliance

In this Newsletter:

WE ARE HIRING A US-BASED PRODUCT STEWARD!

THE LATEST DEVELOPMENTS IN ENVIRONMENTAL COMPLIANCE?

·??????? Canada Developments

o?? Saskatchewan transitions to full EPR program

·??????? US Developments

o?? US News Update – Prepping for 2025 EPR Laws and Regulations

o?? Massachusetts takes steps toward packaging EPR

o?? Maine packing EPR implementation rules published

THE LATEST DEVELOPMENTS IN CHEMICAL COMPLIANCE??

·????????????????? EU Developments?

o??????? New EU Environment Commissioner Committed to REACH Revision

o??????? Latest Update from ECHA on the EU Restriction Proposal

o??????? New EU CLP Regulation Enters into Force on December 10, 2024

o??????? European states to inspect the compliance of chemical products sold on-line in 2025

o??????? Ukraine REACH enters into force in January 2025, with pre-registrations lasting till January 2026 and first registrations due October 2026; Ukrainian CLP already in force: C&L notifications for phase-in substances to be submitted by 15 November 2025

·????????????????? APAC Developments?

o?? K-REACH Compliance: Upcoming Deadlines for 100-1,000 Tonne Substances

o?? New Zealand Regulatory Update

·????????????????? US Developments?

o?? US TSCA Update – Section 5

o?? Developments for California Proposition 65 Short-Form Warning Labels

·????????????????? South America Developments?

o?? Brazil Enacts REACH-Inspired Chemical Law

?

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.?

We are Hiring a US-Based Product Steward!

This is an excellent opportunity to join our growing US team as a Product Stewardship Senior Consultant. If your passion and experience matches what we are looking for, please review the details for application here: Product Stewardship Senior Consultant (m/f/d) - Landbell Group

Environmental Regulatory Updates?

Saskatchewan transitions to full EPR program

Saskatchewan transitioned to a full EPR program for packaging and paper products on December 1, 2024. The program will be implemented in 3 phases starting with large urban communities and incrementally expanding until December 1, 2027, when all collectors should have transitioned.

The new regulation aligns the definition of a producer with most other provinces, extending it to include all Canadian residents above a certain revenue threshold. In the same vein, it modifies its de minimis exemption revenue and/or volume thresholds as well as abandons the single point of retail exemption.

For more information on the regulatory timelines and scope of the new EPR program, read on at our website here: Saskatchewan transition to full EPR program - H2 Compliance.

Prepping for 2025 EPR Laws & Regulations

2025 will be here sooner than you think, as will new EPR laws and regulations. H2 Compliance understands that anticipating what might come next is a step in the right direction.?We help you look ahead via three key tasks and the regulatory expertise and experience to back it up:

1.??????? Tracking new proposals and bills

2.??????? Checking state and industry news

3.??????? Verifying how it applies

To read more about what's involved in each of these steps and how we can help you stay ahead of the regulatory changes ahead, read on at our website here: https://lnkd.in/eSVJNX2G.

Massachusetts takes steps toward packaging EPR

At the end of November, Massachusetts Governor Healey signed into law An Act promoting a clean energy grid, advancing equity, and protecting ratepayers.? It’s a climate law of considerable scope primarily focused on clean energy, its infrastructure, and costs.? Tucked away in Section 108 is a requirement to establish a commission to recommend EPR policies for The Commonwealth.

To read about what tasks this new commission will be responsible for and how they will impact EPR adoption in Massachusetts, read the full article on our website here: Massachusetts takes steps toward packaging EPR - H2 Compliance.

Maine packaging EPR implementation rules published

On December 5, 2024, the Maine Board of Environmental Protection finalized implementation rules for the packaging extended producer responsibility (EPR) program, as part of the implementation of the Act To Support and Improve Municipal Recycling Programs and Save Taxpayer Money. Maine was the first state to make producers solely and fully responsible for the cost of collection and recycling of in-scope materials. In-scope materials are defined as packaging materials used for the containment, protection, delivery, presentation, or distribution of a product supplied to consumers, whether it is paid for at the time of receipt or not. For more information on the regulatory timelines and further details on the regulation, please read on at our website here: https://lnkd.in/etfctPBv.

Global Chemical Regulatory Updates?

New EU Environment Commissioner Committed to REACH Revision

Swedish EU minister, Jessika Roswall, was recently approved for the post of EU Commissioner for Environment, at which time she committed to moving forward with long awaited REACH Review in 2025. In terms of REACH Revision, Commissioners-designate have highlighted the following focus areas:

·??????? Review authorisation and restriction processes, to reduce the need for individual authorisations and allow faster and more transparent decision making without jeopardising chemical safety.

·??????? Strengthen enforcement?to level the playing field, including for online sales, to maintain the competitive position of compliant EU companies and ensure compliance of imported products.

·??????? Improve information requirements?such as on endocrine disruptors to close information gaps and improve risk control.

·??????? Promote non-animal testing

·??????? Ease regulatory burden on companies, particularly SMEs, through digitalisation.

·??????? In terms of PFAS, focus on banning the consumer uses of PFAS, such as in cosmetics, food contact materials and outdoor clothing.

For more details on the REACH Revision and the roles of the new Commissioners-designate in its implementation, please read on at our website here: https://lnkd.in/ebKYMPeb

Latest Update from ECHA on the EU Restriction Proposal

ECHA & the relevant Member States (Dossier Submitters) released a progress update on the 20th of November. They indicated that alternative restriction options are being considered, outside of the full ban or a ban with time-limited derogations.

It was suggested that the alternative option could allow the continued manufacture, placing on the market or use of PFAS, for uses where evidence suggests that a ban could lead to disproportionate socio-economic impacts. In particular, the assessment is currently underway for batteries, fuel cells; and electrolysers, with assessments for medical devices and semiconductors to follow. In addition, Fluoropolymers are of particular interest, and specific attention is being given to this group in the opinion development process.

For the full text from ECHA refer to the link provided here: https://lnkd.in/dJgTFQuB

For more details on the EU Restriction Proposal updates, please read on at our website here: https://lnkd.in/dsg_aF_z

New EU CLP Regulation Enters into Force on December 10, 2024

On 20 November 2024, the new CLP Regulation (EU) 2024/2865 was published. It introduces significant changes to existing legislation on the classification, labelling and packaging of substances and mixtures (Regulation (EC) No 1272/2008). The aim of the revision is to better adapt the law to technological and societal changes, to increase health and environmental protection and to improve risk management of chemicals. This regulation entered into force on 10 December 2024. Key changes include:

·??????? Introduction of new hazard classes

·??????? Adaptation to e-commerce

·??????? Digital labels

·??????? New regulations for multi-component substances

·??????? Safety at filling stations

·??????? Clear deadlines for updating labels

·??????? Packaging adaptation

A full breakdown of the changes to the regulation and timeline details are provided at our website: https://lnkd.in/eJMps4rT

Now is a good time to check if your products are ready for the upcoming changes!

European states to inspect the compliance of chemical products sold on-line in 2025

Throughout 2025, the chemical inspectors in all EU countries will focus on the online sales – chemicals products compliance as well as the responsibility of the sellers, suppliers, marketplace platforms. Online sales have been attracting a lot of attention due to higher levels of non-compliance compared to other, more traditional sales channels.

The inspections will cover a variety of common household products and toys, and focus on fulfilling the following duties:

-??????? mixtures being classified, labelled and packaged according to the revised CLP

-??????? online offers to include the required hazard information (equivalent to the label when sold to general public)

-??????? compliance with restrictions under REACH, Persistent Organic Pollutants (POPs) and the Restriction of Hazardous Substances (RoHS) Directive.

Besides the ‘traditional’ chemical compliance duties, the recently updated General Product Safety Regulation as well as Digital Services Act tighten the rules for the online sales, place responsibility on the marketplace platforms, require safety information to be clearly presented, and more innovations to make compliance stronger.

We will follow with more detailed reviews of how the product safety regulations affect online sellers and marketplaces at the start of the New Year. In the meantime, we recommend reviewing your online inventory across all platforms and check:

-??????? Have you recently revised your product classifications and labels?

-??????? Does the online product offer match your product compliance documents?

With more responsibility placed on the online marketplaces, you may also need to be prepared to them updating their Terms & Conditions to comply with the regulations.

Ukraine REACH enters into force in January 2025, with pre-registrations lasting till January 2026 and first registrations due October 2026; Ukrainian CLP already in force: C&L notifications for phase-in substances to be submitted by 15 November 2025

Ukraine’s EU-aligned chemical products safety law – ‘Ukraine REACH’ – enters into force on 26 January 2025. The national Technical Regulation on the Safety of Chemical Products mirrors the EU REACH thus the main provisions and requirements are already familiar to our clients active in the European market.

Ukraine’s REACH Regulation requires mandatory registration of all chemicals produced, imported or placed on the market in Ukraine at one tonne or more per year. It also provides for the creation of a database containing information on the properties, risks and safe use of chemicals.

Ukraine’s CLP Regulation, Technical Regulations on Hazard Classification, Labeling and Packaging of Chemical Products, has already entered into force on 15 November 2024. It mirrors the EU CLP and implements the international GHS classification and labeling system for chemicals.

We published an extensive article on our website that details the timelines, requirements, and process for compliance here: Ukraine REACH and Ukraine CLP enter into force - H2 Compliance

K-REACH Compliance: Upcoming Deadlines for 100-1,000 Tonne Substances

The Ministry of Environment (MoE) in South Korea has published an updated list of over 17,000 pre-registered substances under the K-REACH regulation. Notably, 3,001 of these substances fall into the 100 to 1,000 tonne annual volume category, which necessitates full registration by?December 31, 2024. This registration is essential for the continued importation or manufacturing of these substances within this volume range.

For substances exceeding 1,000 tonnes, the registration deadline was at the end of 2021, and there are still 96,000 active applicants for these substances, highlighting their importance in the market.

For more information, please read the full article on our website here: K-REACH Compliance: Upcoming Deadlines for 100-1,000 Tonne Substances - H2 Compliance.

New Zealand Regulatory Update

Following the election of a new government back in October 2023, there have recently been several regulatory updates within the country. This includes the establishment of a new ministry, namely the Ministry of Regulation. The country has also had a reorganization of their Environmental Protection Authority (EPA).

Following this, the EPA has announced that it is implementing significant legislative changes to align with global best practices. The key changes include a new requirement for manufacturers and importers of hazardous chemicals to report the tonnage of substances entering New Zealand.

Companies will be required to submit annual reports on the total tonnage of hazardous chemicals, this is required if the substance is imported under individual approvals or if the substance falls under specific classes, such as explosives. This requirement does not apply to substances imported under group standards. The amendment will become effective in 2026, at which point companies must comply with these updates.

For more information, please read on at our website and get in touch: New Zealand Regulatory Update - H2 Compliance

US TSCA Update – Section 5

On December 4, 2024, U.S. Environmental Protection Agency (EPA) finalized amendments to the regulations for the review of new chemicals under Section 5 of the Toxic Substances Control Act (TSCA) to improve efficiency and align with the 2016 bipartisan TSCA amendments. These amendments are intended to promote both innovation while ensuring the safety of any substance prior to entering commerce. The final rule ensures that new per- and polyfluoroalkyl substances (PFAS) and persistent, bioaccumulative and toxic (PBT) chemicals are always subject to a full, robust safety assessment process prior to manufacture. This would be accomplished through the elimination of all eligibility exemptions for PFAS and PBT substances for a low volume exemption (LVE) or low release and exposure exemption (LoREX), requiring a full safety review.

The new rule also requires a formal safety determination for all chemical determinations as part of submission process for premanufacture notices (PMNs) for new chemical substances, significant new use notices (SNUNs) for significant new uses, and microbial commercial activity notices (MCANs) for microorganisms with commercial applications.?

For a more detailed summary of the new Section 5 rule, read the full article on our website here: US TSCA Update - Section 5 - H2 Compliance

Developments for California Proposition 65 Short-Form Warning Labels

On December 6, 2024, California’s Office of Environmental Health Hazard Assessment (OEHHA) issued final modifications to the Proposition 65 short-form warning requirements for consumer product labels via amendments to Title 27 of the California Code of Regulations.

The modifications have already been approved and take effect January 1, 2025.

The new short-form requirement mandates the listing of at least one chemical by name on the label, similar to that in the long-form requirements.

Any business that currently uses the existing short-form warnings has 3-years to transition to the new short-form content (until January 1, 2028). The regulation also provides an unlimited sell-through period for any product manufactured and labeled with the existing short-form warnings before or during the 3-year transition period. Online retailers also have a 60-day transition time to modify their online short-form warning content from the time they are notified by the manufacturer of a revised safe harbor warning.

For more information on the revised regulation, read on at our website: https://lnkd.in/ecz8KYfh

Brazil Enacts REACH-Inspired Chemical Law

Brazil’s Senate approved a REACH-like chemicals management framework earlier this year. Following this, the?Law 15.022?was published on the 15th?of November 2024. This becomes Brazil’s REACH-inspired chemical management law.

This makes Brazil the largest country in Latin America to adopt such a framework, joining Chile, Colombia, Costa Rica, and Peru. This move could inspire other nations within the region to follow suit.

For a more detailed summary on what will be required under the new bill and proposed timelines, read on at our website here: Brazil Enacts REACH-Inspired Chemical Law - H2 Compliance