Michael J Kujawinski, International Business Development Manager at Ricardo (a member of WSP) explains how regulatory compliance in an era of enforcement, penalties and commercial risk can be leveraged positively to support resilience, efficiency and growth.

The chemical sector is entering a decisive phase whereby regulatory compliance is no longer a background obligation, it is a frontline business risk with direct consequences for revenue, market access and brand reputation. Across the EU, UK and globally aligned jurisdictions, authorities are increasing inspection frequency, tightening enforcement cooperation, and applying more meaningful penalties for non-compliance. The result is a shift from largely administrative oversight to active regulatory policing.

Fines for breaches of REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals), CLP (Classification, Labelling and Packaging) and related frameworks have become more substantial and more consistently applied. In parallel, enforcement actions now extend beyond financial penalties to include forced product withdrawals, shipment holds and restrictions on market placement. For many companies, the more immediate and damaging consequence is not the fine itself, but operational disruption, delayed product launches, halted supply chains and lost customer confidence. In sectors where speed to market and continuity of supply are critical, even short compliance gaps can translate into significant commercial losses.

At the same time, compliance expectations are broadening. Regulators are no longer satisfied with static documentation or “checkbox” submissions; they are increasingly scrutinising data quality, update frequency, and internal governance processes. Digitalisation is enabling authorities to cross-reference submissions across systems (e.g. Safety Data Sheets [SDS], Poison Centre Notifications, REACH dossiers), exposing inconsistencies that may previously have gone unnoticed.

The cumulative effect is clear: compliance failures are becoming more visible, more measurable, and more consequential.

Against this backdrop, chemical companies face a strategic crossroad. They can continue to approach compliance reactively, addressing issues as they arise and managing each jurisdiction in isolation, or they can transform compliance into a structured, integrated capability that supports resilience, efficiency and growth. The latter requires investment in systems, data governance, scientific rigour and operational discipline, but it positions organisations not only to avoid penalties, but to move faster, operate more reliably, and build trust with regulators and customers alike.

SDS: The Cornerstone of Hazard Communication
SDS remain the cornerstone of regulatory compliance and workplace safety. However, the modern compliance environment demands much more than simply producing a legally valid SDS at a single point in time.

Companies must now ensure that SDS content is aligned with evolving product formulations, supplier inputs, toxicological insights, and jurisdiction-specific requirements. These requirements vary significantly ranging from language and formatting to hazard statements, exposure scenarios, and mandatory emergency contact details. Inconsistencies across regions can quickly lead to non-compliance and shipment rejection.

Best-in-class organisations treat SDS management as a governed lifecycle rather than a documentation task. Centralised digital platforms, automated change triggers, and systematic version control enable rapid updates and reduce the risk of outdated information circulating in the supply chain. Routine cross-checks against product inventories ensure that all marketed products have current and compliant SDS documentation.

Crucially, access and usability matter as much as accuracy. Employees must be able to retrieve and interpret SDS quickly in operational settings. Training programmes that build understanding at the frontline significantly reduce misinterpretation risks and improve incident response outcomes.

When embedded effectively, SDS governance becomes both a compliance safeguard and an operational asset enhancing Environment, Health and Safety (EHS) performance, audit readiness, and organisational confidence.

24/7 Emergency Response: An Evolving Strategic Asset
The requirement for a 24/7 emergency contact number has evolved from a regulatory detail into a fundamental expectation across the chemical value chain. Increasingly, regulators, carriers and downstream customers demand demonstrable, reliable and locally relevant emergency response provision.

Compliance difficulties often arise due to the complexity of rules: some jurisdictions require local telephone numbers, others mandate specific languages, and transport regulations such as the European Agreement concerning the International Carriage of Dangerous Goods by Road (ADR; Accord européen relatif au transport international des marchandises Dangereuses par Route), the International Maritime Dangerous Goods (IMDG) Code, and the International Air Transport Association (IATA) add modal-specific nuances. Logistics providers are now less tolerant of ambiguity, with many refusing to handle shipments without validated and compliant emergency contact details.

Beyond compliance, however, the real value lies in operational readiness. A professionally delivered emergency response service provides immediate access to technical expertise, helping to contain incidents, protect personnel, and minimise environmental impact. Multilingual capability and alignment with Cefic (European Chemical Industry Council) and Responsible Care® principles further strengthen credibility and effectiveness.

Organisations that invest in high-quality emergency response infrastructure consistently demonstrate better incident outcomes, faster resolution times, and stronger stakeholder trust. In a high-scrutiny environment, this capability serves as both a risk mitigator and a reputational differentiator.

PCN: New Normal for Mixtures
Poison Centre Notification (PCN) requirements under the EU’s CLP Regulation have now matured into a fully embedded compliance obligation. Companies placing hazardous mixtures on the EU market must submit detailed information covering composition, toxicology, intended use and emergency response guidance, linked via a Unique Formula Identifier (UFI).

Recent regulatory tightening, particularly through 2024 and into 2025, increased enforcement focus on both the completeness and accuracy of submissions. Authorities are specifically targeting discrepancies between PCN filings, SDS content and product labels, as well as failures to update notifications following formulation changes.

Non-compliance can have immediate and severe consequences, including the inability to sell products in specific Member States, forced withdrawal from the market and financial penalties. For multinational organisations, managing confidentiality while meeting data-sharing requirements adds further complexity, often necessitating the use of EU-based representatives.

Effective PCN management requires integration into broader product lifecycle processes. Automated triggers for updates, clear ownership, and alignment with SDS and REACH data are all critical to maintaining compliance and avoiding costly disruptions.

Global Echoes of Extended REACH
REACH remains the global benchmark for chemicals regulation, anchoring the principle of “no data, no market.” However, its influence is now echoed across multiple jurisdictions, each introducing its own variant.

UK REACH continues post-Brexit with evolving timelines and potential divergence. Turkey’s KKDIK and Korea’s K-REACH replicate many core elements while introducing local requirements and deadlines. Ukraine’s UA REACH, effective from 26th January 2025, introduces pre-registration and phased compliance obligations aligned with EU hazard classification frameworks.

The challenge for companies is no longer simply understanding each regulation individually, it is orchestrating compliance across all of them simultaneously. Data must be harmonised, but submissions must reflect national nuances. Deadlines differ, documentation expectations vary, and local representation requirements must be fulfilled.

Early strategic planning is essential. Portfolio scoping, substance prioritisation and the appointment of experienced Only Representatives or Authorised Representatives can prevent bottlenecks and last-minute compliance risks. Companies that adopt a coordinated global approach are far better positioned to maintain uninterrupted market access.

Raising the Scientific Bar
Scientific expectations around environmental fate and persistence are increasing rapidly, particularly for complex and “difficult-to-test” substances. Regulatory scrutiny now extends beyond test results to the methodologies used and the interpretation of data.

Poorly soluble substances, UVCBs (Unknown or Variable Composition, Complex Reaction Products, or Biological Materials), volatile compounds and highly sorptive materials often fall outside the reliable scope of standard biodegradation tests. Without appropriate methodological adaptations, results can be misleading, potentially triggering unnecessary regulatory constraints or misclassification.

Current best practice emphasises a tiered testing strategy, starting with screening tests (e.g., OECD 301/310) and progressing to more realistic simulation studies where needed. Advances supported by organisations such as the Cefic Long-range Research Initiative (LRI) and the European Centre for Ecotoxicology and Toxicology of Chemicals (ECETOC) are helping refine approaches, including improved test delivery techniques and better handling of variability.

Companies must invest in robust study design, quality assurance, and transparent reporting. A defensible scientific position is not only critical for regulatory approval but also for enabling innovation and sustainable product development.

Best Practice Anchors
Voluntary frameworks such as Cefic guidance and Responsible Care® are increasingly influential in shaping expectations across the industry. They provide structured approaches for implementing best practice across safety, sustainability and supply chain management.

Programmes like SQAS (Safety and Quality Assessment for Sustainability) offer tools for evaluating logistics and operational performance, while Responsible Care® promotes continuous improvement through auditable management systems.

Customers and partners are increasingly using these frameworks as benchmarks when selecting suppliers. Companies that actively engage with them signal a commitment to high standards and transparency – qualities that are becoming commercially decisive.

COSHH in the UK
Under COSHH (Control of Substances Hazardous to Health), UK businesses must assess and control risks associated with hazardous substances. However, regulatory expectations go beyond initial compliance, assessments must be continuously updated to reflect real-world conditions.

Too often, COSHH documentation becomes static, failing to evolve with changes in processes, formulations, or exposure scenarios. This creates both compliance risks and safety gaps.
Integrating COSHH with digital SDS systems, exposure monitoring data, and incident reporting enables organisations to maintain “living” risk assessments. This dynamic approach supports continuous improvement and aligns with broader Responsible Care® principles.

From Compliance Burden to Competitive Edge
Leading organisations distinguish themselves by treating compliance as a strategic function:
1. Data discipline: Establish a single, authoritative source of product and regulatory data, enabling consistency across SDS, PCN, and REACH processes.
2. Response readiness: Position emergency response capabilities as part of the company’s value proposition.
3. Scientific rigor: Ensure testing strategies are robust, defensible, and aligned with regulatory expectations.
4. Global orchestration: Coordinate compliance activities across jurisdictions to minimise duplication and risk.

Top 10 Compliance Pitfalls in the Chemical Sector
1. Outdated SDS Content: Failure to update SDS following formulation changes, regulatory updates, or new hazard data is one of the most frequent compliance breaches. Even minor discrepancies such as incorrect classification or outdated emergency numbers can lead to shipping delays or regulatory action. Companies often underestimate how quickly SDS content becomes obsolete without automated update mechanisms.
2. Fragmented REACH Strategy: Managing REACH obligations across different jurisdictions in silos leads to duplication, inconsistency, and missed deadlines. Without a harmonised strategy, companies risk submitting conflicting data sets, failing to update dossiers, or overlooking post-registration obligations such as substance evaluation responses.
3. Incomplete Emergency Response Coverage: Relying on non-compliant emergency contact numbers such as those lacking a local number, language capability, solely displaying a Poison Centre number or not having 24/7 availability can result in shipment refusal by carriers and breaches of transport regulations. This issue is especially prevalent in global supply chains.
4. Late or Inaccurate PCN Submissions: Delays in PCN notifications or failure to update UFIs after formulation changes can prevent products from being legally sold. Inaccurate compositional data may also undermine emergency medical response, increasing both regulatory and ethical risk.
5. Underestimating Ecotoxicology Complexity: Applying standard test methods without considering substance-specific challenges often produces misleading results. This can lead to over-classification, regulatory restrictions, or costly retesting exercises.
6. Poor Data Governance: Without a “single source of truth,” inconsistencies inevitably arise between SDS, labels, REACH dossiers, and PCN submissions. These discrepancies are increasingly detectable by regulators using digital tools, making data governance a critical compliance priority.
7. Static COSHH Assessments: Treating COSHH assessments as one-off exercises rather than dynamic tools leads to outdated risk controls and potential worker exposure. Regular reviews linked to operational changes are essential.
8. Ignoring Cefic & Responsible Care® Frameworks: Companies that overlook these frameworks miss opportunities to adopt proven best practices and may appear less credible to customers and regulators. Increasingly, such standards are treated as baseline expectations rather than optional extras.
9. Reactive Compliance Culture: Organisations that wait for audits or enforcement actions to trigger compliance improvements inherently operate at higher risk. A reactive approach typically results in higher costs, rushed remediation efforts, and reputational damage.
10. Neglecting Training & Communication: Even the best systems fail if employees do not understand them. Lack of training leads to incorrect SDS usage, poor implementation of COSHH controls, and ineffective emergency response turning compliance gaps into real safety incidents.

The Bottom Line
Compliance is no longer just a legal obligation, it is a core business capability. As enforcement intensifies and regulatory expectations evolve, companies must move beyond reactive approaches and build integrated, forward-looking compliance systems.

Those that succeed will not only avoid fines, delays, and disruption they will gain a measurable competitive advantage through improved efficiency, stronger stakeholder trust, and more resilient operations.

In today’s environment, the choice is clear: treat compliance as a constraint or leverage it as a catalyst for sustainable growth and operational excellence.

Contact:
Michael J Kujawinski
International Business Development Manager
Ricardo (a member of WSP)
Telephone: +44 (0)1235 836016
Email: michael.kujawinski@wsp.com
Website: www.wsp.com/en-gb/services/chemical-regulatory-compliance

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