Petra Rönnholm: When regulation reshapes markets

Meet Petra Rönnholm – a Senior Regulatory Affairs Advisor and PhD in Chemistry with deep expertise in EU REACH, regulatory affairs, pharmaceutical and chemical compliance.

Her career spans global senior regulatory roles at AstraZeneca, Wintzell & Fried and Fisher Scientific, where she has led clinical trial regulatory work, global submissions and compliance systems across complex international regulatory environments.

Petra works where scientific precision meets regulatory strategy – helping organisations navigate evolving compliance requirements while safeguarding product approvals and market access.

Her experience includes:

• Leading regulatory operations for clinical trials and global dossier submissions at AstraZeneca

• Establishing and leading the global regulatory function at Wintzell & Fred, achieving full REACH compliance

• Designing regulatory systems and training programmes across European markets

• Delivering regulatory submissions across EU, US and Rest-of-World jurisdictions

• Supporting companies navigating chemicals, pharmaceutical and MedTech regulatory frameworks

  
  

She operates with a clear principle: regulatory compliance is a capability that protects long-term market access.

INSIGHT by Petra Rönnholm

Below, Petra outlines the key EU REACH regulatory updates expected in 2026, including expanded SVHC listings, the upcoming microplastics restriction and the proposed PFAS ban.

When regulation reshapes markets

The European Union’s Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation remains a cornerstone of chemical safety and environmental protection. Designed to ensure the safe use of chemicals across their lifecycle, EU REACH places clear responsibilities on manufacturers, importers, suppliers and downstream users operating in the EU market.

As the regulatory landscape continues to evolve, several important REACH updates are expected to take effect in 2026, with significant implications for the chemicals, pharmaceutical and manufacturing sectors. This article provides an overview of upcoming regulatory changes, a practical compliance checklist, sector‑specific impacts, and a clear readiness timeline to help companies prepare proactively.

Key upcoming EU REACH regulatory updates

The European Chemicals Agency (ECHA) and the European Commission regularly amend REACH to address emerging risks and reflect advances in scientific knowledge. Key developments to watch in the coming months include:

• Expanded Candidate List (SVHCs): Additional Substances of Very High Concern (SVHCs) are expected to be added to the Candidate List, increasing authorisation, notification and communication obligations across supply chains.

• Microplastics restriction (Annex XVII): The Restriction on Intentionally Added Microplastics under REACH Annex XVII is expected to be finalised and published in early 2026. This will require manufacturers to reformulate certain products and update labelling and reporting practices.

• Data sharing and digitalisation: Strengthened requirements for electronic submissions, data sharing and dossier updates will improve transparency but will also place greater demands on IT systems and data management processes.

• Updates to REACH Annexes: Technical amendments to Annex XVII (Restrictions) and Annex XIV (Authorisations) may limit or condition the use of specific substances in both industrial and consumer applications.

• PFAS restriction proposal: A wide‑ranging proposal to restrict per‑ and polyfluoroalkyl substances (PFAS, "forever chemicals") remains under review. If adopted, it could affect a broad range of uses across manufacturing, pharmaceuticals and speciality chemicals.

Compliance checklist: Preparing for EU REACH changes

A structured and proactive approach will be essential for maintaining compliance. Organisations should consider the following key actions:

1. Monitor regulatory developments: Assign responsibility for tracking updates from ECHA and the European Commission, with a focus on Candidate List additions and new restriction proposals.

2. Conduct substance and product inventories: Review all substances, mixtures and finished products for potential exposure to new SVHC or restriction categories.

3. Update Safety Data Sheets (SDS): Ensure SDS documentation reflects updated classifications, labelling and reporting obligations.

4. Strengthen supplier communication: Engage suppliers to confirm compliance status, data accuracy and traceability for affected substances.

5. Assess reformulation needs: Identify products containing microplastics or PFAS and evaluate substitution or reformulation options early.

6. Enhance digital compliance systems: Upgrade IT and data management infrastructure to support electronic filings, dossier updates and data sharing.

7. Deliver internal training: Provide targeted training for regulatory, R&D, procurement, sales, and quality teams on new EU REACH requirements.

8. Audit and review compliance status: Conduct internal audits to identify gaps, define corrective actions and mitigate regulatory risk.

9. Prepare ECHA reporting: Ensure readiness for notifications, annual updates and other required submissions.

Sector impact overview

Chemicals sector

Producers and importers of chemicals will face increased reporting and authorisation obligations, especially as the Candidate List expands. Restrictions on microplastics and PFAS may require substantial changes in formulations and supply chains. Investment in digital compliance tools will be essential for managing new data requirements. These regulatory changes can also significantly affect Marketing Authorisation Applications (MAAs), as updates may become necessary to reflect altered formulations, new safety data, or revised supplier, manufacturer or process information. The process of updating MAAs is typically prolonged as it depends on the intended application of the chemical and requires comprehensive safety and efficacy data, coordination among regulatory authorities and manufacturers, potential additional toxicological or stability studies, and often involves extended review timelines. Furthermore, any modifications to excipients, packaging, or supply chain components - often resulting from new restrictions – may require supplemental submissions and regulatory approvals, potentially delaying product launches or continued market access. 

Pharmaceutical sector

Pharmaceutical companies may need to review excipients, packaging, and auxiliary substances for new SVHCs and PFAS restrictions. While active pharmaceutical ingredients (APIs) are often exempt, changes in ancillary materials could affect product registration and marketability. Additionally, Marketing Authorisation Applications (MAA) might need to be updated to reflect these changes, ensuring continued access to market opportunities and regulatory compliance. It is important to note that the timeline for updating MAAs can be quite lengthy, as it often involves gathering new data, revising documentation, coordinating with regulatory authorities, and potentially addressing follow-up questions or requirements. Companies should plan accordingly to allow sufficient time for these updates and to avoid disruptions to existing market authorisations. For CMC Regulatory Affairs, updated technical documentation and safety data sheets, etc., in the Drug Master File (DMF) will be necessary to reflect any changes in formulations or processes. Hence, CMC Regulatory teams will need to closely monitor regulatory developments to ensure timely submissions and compliance with new reporting or authorisation requirements, potentially impacting product registration timelines and ongoing regulatory maintenance. 

Manufacturing sector

Manufacturers using chemicals as part of their processes or in finished goods must assess whether any substances are newly restricted or subject to authorisation. The microplastics ban will impact manufacturers of plastics, coatings, paints, and adhesives, necessitating product reformulation and updating technical documentation. These regulatory changes could significantly affect CMC (Chemistry, Manufacturing, and Controls) Manufacturing. For CMC Manufacturing, reformulating products to comply with new restrictions on microplastics and other substances may require changes in raw materials, process validation, and production protocols. This could lead to increased workload and the need for additional resources to ensure the continued quality and consistency of products and production. 

2026 Timeline for readiness and audits

To ensure compliance with the upcoming EU REACH regulatory updates, organisations should follow a quarterly action plan throughout 2026. In the first quarter, the focus should be on monitoring regulatory developments, assigning compliance responsibilities, and initiating an inventory review with supplier engagement. The second quarter is dedicated to updating Safety Data Sheets (SDS), revising technical documents, starting reformulations for regulated substances, and improving digital compliance infrastructure. During the third quarter, companies should conduct staff training, analyse any compliance gaps, and prepare draft reporting materials. By the fourth quarter, it's essential to carry out internal audits, finalise any necessary product changes, and submit all required notifications and reports to the European Chemicals Agency (ECHA).

This structured approach will help organisations remain proactive, minimise compliance risks, and ensure smooth adaptation to the evolving EU REACH requirements:

Q1 2026 - Monitor regulatory updates, assign compliance leads, begin inventory assessment and supplier outreach.

Q2 2026 - Update SDS and technical documentation, initiate product reformulation for affected substances, upgrade digital systems. 

Q3 2026 - Conduct internal training, perform compliance GAP analysis, prepare draft reporting templates. 

Q4 2026 - Schedule and complete internal audits: finalize product changes - submit required notifications and reports to ECHA. 

Conclusion

As EU REACH continues to evolve, early planning, robust governance and strong digital capabilities are essential. By closely monitoring regulatory developments, updating documentation, engaging suppliers and investing in compliance systems, companies can ensure continuity of operations and market access. Regular internal audits and targeted training further strengthen compliance readiness, enabling businesses in the chemicals, pharmaceutical and manufacturing sectors to respond confidently to new and emerging requirements. Communication and staying informed, proactive and prepared are key to successful EU REACH compliance in 2026 and beyond. Ultimately, maintaining compliance safeguards the environment, human and animal health, while also driving sustainable business growth and preserving market opportunities. 

INSIGHT by Petra Rönnholm, Senior Advisor at Advisory on demand