Chemical & Product Regulatory Outlook – Focus on the EU market

  • July 30, 2025
  • Reachlaw Marketing

Discover the key regulatory drivers shaping chemical and product compliance in the EU – and the smart moves companies must make in 2025 to stay ahead of the 2026 wave of change!

REACH Registration: A continuing Priority for EU Market Access

Under REACH, chemical substances that fall within the scope of the regulation must be registered with ECHA before they are manufactured in or imported into the EU at quantities of 1 tonne or more per year – unless specifically exempt. This makes REACH registration not only a regulatory obligation, but a critical gatekeeper to market access in the European Union.

We have recently received a significant number of inquiries related to REACH registration, highlighting the continuing complexity and importance of compliance. Companies intending to place such substances on the EU market must ensure that their substances are registered in accordance with REACH before they are placed on the EU market. Registration is not optional, nor can it be postponed until after market entry.

Whether you are new to the EU market or expanding your range of substances to be registered, now is the time to assess your portfolio and ensure that every applicable substance is fully compliant. The following key actions will help guide your next steps and safeguard your ability to operate within the EU.

Key Action Points:

  • Review your substance portfolio, including potential exemptions and projected annual volumes.
  • Reassess substance classifications considering new hazard classes introduced under the revised CLP regulation, such as Endocrine Disruptors (ED), Persistent, Bioaccumulative and Toxic (PBT/vPvB), and Persistent, Mobile and Toxic (PMT/vPvM).
  • Confirm your supply chain role (e.g., Manufacturer, Formulator, Importer, Non-EU Manufacturer/Formulator, Distributor) to understand your obligations
  • Evaluate your internal capacity to manage registrations effectively and consider engaging external expertise if needed.
  • Non-EU manufacturers/formulators wishing to register substances under REACH must appoint a trusted and experienced Only Representative (OR) in the EU for REACH compliance
  • Develop a realistic budget that covers all costs, including testing, ECHA fees, and Letters of Access
  • Start the registration process early to avoid potential fines or bottlenecks as 2026 approaches.

REACH Restriction Proposal: Chromium (VI) Public Consultation

The European Chemicals Agency (ECHA) has announced a public consultation for its restriction proposal on certain Chromium (VI) substances, inviting industry feedback until late 2025. This initiative could significantly impact sectors such as aerospace, defense, hydraulics, automotive, and energy, all of which heavily rely on chromed components.

Substances Targeted:

  • Chromium trioxide
  • Acids generated from chromium trioxide and their oligomers
  • Sodium dichromate
  • Potassium dichromate
  • Ammonium dichromate
  • Potassium chromate
  • Sodium chromate
  • Dichromium tris(chromate)
  • Strontium chromate
  • Potassium hydroxyoctaoxodizincate dichromate(1−)
  • Pentazinc chromate octahydroxide
  • Barium chromate

What You Should Do:

If your company is impacted, it’s critical to act now. Assess the proposal’s implications by considering the following:

  • Are the proposed limits achievable for your operations?
  • Are vital use cases missing from the exemptions?
  • Is the proposed timeline realistic for your business?

The public consultation, which opened on June 18, 2025, provides companies with a vital opportunity to shape the outcome of this restriction. Don’t let your voice go unheard! If you’re unsure how to craft effective comments or require guidance, consider partnering with a professional consultancy to ensure your input is impactful during this pivotal window of opportunity

REACH Revision: Preparing for Possible Expanded Obligations

A targeted revision of the EU REACH Regulation is expected to be proposed by the Commission by Q4 2025, it will include proposals for new compliance obligations for companies placing chemical substances on the EU market. As the proposed Revision will be high on the EU’s legislative agenda for potential adoption in 2026 or 2027, businesses should already familiarize themselves with these potential requirements and begin developing an action plan to address these possible upcoming challenges.

Possible Changes being discussed:

  • Polymers Notification: An estimated 200,000 polymers might require notification under REACH, with around 30,000 high-concern polymers potentially subject to full registration obligations.
  • Stronger Risk Controls: the Generic Risk Management Approach would be standardised and generalised for so-called substances of concern, including endocrine disruptors and persistent, mobile, and toxic (PMT/vPvM) chemicals—potentially leading to faster adoption of REACH restrictions.
  • Accelerated Regulatory Processes: The authorisation and restriction procedures might be streamlined to allow for quicker regulatory response and enhanced public health protection.

Key Preparation Steps for 2025:

  • Review Polymer Inventories: Identify polymers in your product portfolio that may fall within the revised scope to mitigate risks and take proactive steps.
  • Safety Documentation: Review Safety Data Sheets (SDS) to prepare for possible future updates in hazard classification and label requirements. Changes to the SDSs are not required at this time but should be anticipated 
  • Supply Chain Management: Proactively engage with suppliers and downstream users to ensure a unified approach to potential upcoming obligations.

Early awareness and planning will be critical to managing the possible expanded requirements effectively and avoiding supply chain disruptions.

Updates on the EU PFAS Restriction Proposal

The European Chemicals Agency (ECHA) is advancing its opinion development on the proposal of five EEA Member States to restrict more than 10,000 per- and polyfluoroalkyl substances (PFAS) under the REACH Regulation. These substances are deeply embedded in numerous products, ranging from consumer products to industrial applications in sectors such as automotive, electronics, medical devices, aerospace and defence, and many more.

During their June 2025 meetings, ECHA’s Committees for Risk Assessment (RAC) and Socio-Economic Analysis (SEAC) advanced their evaluations. Both committees have now reached provisional conclusions on the use of PFAS in medical devices. Additionally, RAC finalized provisional views on PFAS in lubricants, while SEAC focused on the transport sector.

During the meeting in June, the committees have also outlined their tentative agenda for the September and December 2025 meetings, which will cover electronics and semiconductors and the continued evaluation of energy and lubricants sectors.

The further ECHA schedule for 2026 to finalise the RAC/SEAC opinion is not known yet. The second 60-day ECHA public consultation on the draft SEAC opinion is planned before the finalization of the SEAC opinion.

The final decision on the restriction will then be taken by the Commission with the Member States (comitology). The Commission has already stated that it supports restricting the use of PFAS in consumer uses, like cosmetics, food contact materials and outdoor clothing. Where adequate alternatives in terms of performance and safety are not available, the continued use of PFAS in industrial applications, in particular critical ones, should be ensured. Such continued use should take place under strict conditions for limiting the risks until acceptable substitutes are found.

Earlier in 2025, the Commission has also announced a (further) clarification of policy intentions on PFAS for Q4 2025, as part of the Chemicals Industry Package.

What does this mean for the Industry?

The phased evaluation process highlights the complexity of regulating PFAS, substances found in a wide variety of applications from consumer goods to industrial processes. For companies and end users involved in affected sectors, these developments highlight the importance of:

  • Conducting thorough inventories of PFAS use and presence in their products and supply chains
  • Engaging with suppliers and customers to anticipate regulatory impacts and substitution needs
  • Closely monitoring the restriction process and prepare for the second ECHA public consultation on the draft SEAC opinion which could occur as early as 2026.  

Industries may also apply to attend RAC/SEAC meetings for their concerned uses as ECHA accredited stakeholder organisations. If you need any support on that matter, please reach out to REACHLaw. 

“Substances of Concern” – Latest developments

“Substances of Concern” (SoC) are currently addressed in a number of more recent EU laws governing environmental sustainability, extending the need for sound chemicals management beyond EU REACH and CLP.

SoC definitions

The main reference definition of SoCs is contained Regulation (EU) 2024/1781 of the European Parliament and of the Council of 13 June 2024 establishing a framework for the setting of ecodesign requirements for sustainable products (ESPR). According to ESPR Article 2(27) an SoC is a substance that:

  1. has been identified as a Substance of Very High Concern (SVHC) (Article 57 of REACH) and added to the Candidate List
  2. is classified (harmonised classification for chronic effects) according to CLP
  3. is a Persistent Organic Pollutant (POPs Regulation); or
  4. negatively affects the reuse and recycling of materials in the product in which it is present (“circularity-based SoC”)

The main extension in scope of substances to be tracked – compared to SVHCs – comes from the relevant CLP harmonized classifications, which comprise several thousand substances!

Other EU laws use the same definition (e.g. the new Packaging and Packaging Waste Regulation (EU) 2025/40 (PPWR)). According to ECHA keeping an eye on the ESPR definition is also very important for the on-going assessment of SoCs in batteries, even though the Batteries Regulation (EU) 2023/1542 does not have a clear definition. The reference to the POPs Regulation is missing in the definition of SoCs in the European Sustainability Reporting Standards (ESRS) under the Corporate Sustainability Due Diligence Directive (CSRD).

Implications for industry  

Generally speaking, the broad inclusion of the SoC concept in various EU laws means that companies have to take into account this broader definition in their chemicals management.

Main possible impacts for industry include:

  • Compliance requirements, e.g. disclosures under CSRD / ESRS E2, future reporting in the Digital Product Passport for ESPR-regulated products
  • Possible future product-specific restrictions, e.g. under the Batteries and PPWR Regulations. ECHA is currently preparing reports on SoCs in batteries (due by December 2026) and packaging (due by September 2026)
  • New source of possible obsolescence of materials and processes

The precise impact of the SoC concept for industry depends on your company and product portfolio and requires close monitoring of Commission and ECHA activities. ECHA also invites stakeholders to provide information on substances in batteries and packaging by participating to its Calls for Evidence.

——

This blog post has highlighted significant regulatory developments within the EU, offering actionable steps to help companies prepare for compliance as we approach 2026. By remaining proactive – whether through reassessing your substance portfolio, managing registrations, or anticipating potential restrictions or supply chain disruptions – you can transform these chemical and product regulatory challenges into strategic opportunities to gain a competitive edge.

If you need expert support or tailored guidance on any of the topics discussed in this newsletter, our team is ready to assist you! Contact us at sales@reachlaw.fi

Useful links to explore:

Share this Post: