Product Compliance and Regulatory Support

The product compliance obligations under EU chemicals legislation are specific, interconnected and require constant work. A new classification decision affects what goes into the SDS. An SDS update in turn affects downstream customer communication. A new entry on ECHA's Candidate List can require Article 33 notifications, SCIP submissions and SDS revisions at the same time. Compliance is not a static objective, but it's rolling-basis work that requires precise and knowledgeable efforts. Lirk Nor covers this as a connected body of work, for individual tasks and on an ongoing basis across your full product portfolio.

Safety Data Sheets

We author SDS for substances and mixtures to Annex II of REACH under Commission Regulation (EU) 2020/878, in both EU and UK formats. For registered substances, this includes extended SDS documents integrating the exposure scenarios developed in the chemical safety report. For mixtures containing SVHC-listed substances, it means correctly identifying them in Section 3 and ensuring the communication obligations toward downstream users are met.

We also review incoming SDS from suppliers. Classification errors, outdated hazard statements, missing exposure scenarios and incorrect regulatory status information appear in supplier documents more often than most companies expect, and the company relying on an inaccurate SDS carries compliance risk it may not be aware of. Where corrections are needed, we communicate them directly to the supplier.

Multilingual SDS are prepared across all official EU languages and UK English, reviewed for chemical and regulatory accuracy rather than purely translated. Version control and update management across a full-language set is handled alongside the regulatory content work.

CLP classification and labelling

Under Reg. (EC) No 1272/2008 (CLP), the classification of a substance or mixture determines what appears on the label, what enters the SDS, which downstream notification obligations apply and, in some cases, whether authorisation or restriction requirements come into effect. We classify substances and mixtures against current CLP criteria, including the new hazard classes for endocrine disruptors and persistent, bioaccumulative and mobile (PBT/PMT) substances that have been phasing in since 2023.

When harmonised classification decisions are adopted under Annex VI of CLP, we assess the impact on your portfolio and manage what follows: SDS updates, label changes and classification and labelling (C&L) notifications to ECHA under Article 40 of REACH. We also handle standalone C&L notifications for manufacturers and importers of substances who are not yet subject to full REACH registration.

Poison centre notifications

Mixtures placed on the EU market for consumer, professional or industrial use require notification to national poison centres before sale, under Annex VIII of CLP. The obligation covers a wide range of product types, from cleaning products and paints to adhesives, lubricants and professional-use cosmetics. The November 2024 CLP revision (Reg. (EU) 2024/2865) has extended the duty to distributors who relabel or rebrand hazardous mixtures across member state borders.

We manage the full notification workflow: generating Unique Formula Identifiers (UFIs), preparing formulation data to the standard required by ECHA's CPNP portal, and submitting notifications across one or multiple EU member states. Notifications must stay aligned with the product as sold. Formulation changes, classification changes and new trade names all require updates, and we handle those as part of ongoing portfolio management rather than as separate engagements.

EU REACH registration

Manufacturers and importers of substances at one tonne or more per year must register them under Reg. (EC) No 1907/2006 (REACH) before placing them on the EU market. We support the registration process from initial substance identification through Substance Information Exchange Forum (SIEF) participation, endpoint data gap analysis, IUCLID dossier preparation and submission to ECHA.

Registration is not a one-time event. Dossiers require updating when tonnage bands change, when ECHA issues evaluation or compliance check outcomes, or when new endpoint data becomes available. We manage ongoing dossier maintenance alongside initial registrations, and advise on the implications of ECHA's updated dossier quality requirements as they apply to existing submissions.

SVHC and supply chain obligations

ECHA's Candidate List of Substances of Very High Concern is updated twice a year and currently contains over 250 entries. When a substance is added, obligations follow depending on whether it is present in a mixture, an article or a registered substance. For article producers and importers, an SVHC above 0.1% w/w in an individual article triggers disclosure obligations under Article 33 of REACH and, in some cases, a notification to ECHA. The SCIP database under the revised Waste Framework Directive requires parallel notifications for SVHC in articles above the same threshold, to support end-of-life treatment of materials.

We track Candidate List developments, assess which parts of your portfolio are affected when new substances are added, and manage the communication and notification obligations that follow. For companies with large article portfolios or complex supply chains, we help establish systematic tracking approaches that scale as the list grows.

PFAS

Per- and polyfluoroalkyl substances are addressed by several existing REACH restrictions and by the proposed EU universal restriction, which would cover thousands of PFAS compounds in a single broad entry. Some PFAS are already subject to authorisation requirements or existing Annex XVII restrictions. Others are currently unrestricted but within the proposed scope.

We assess portfolios, formulations and processes for PFAS content, map them against the restriction scope and available exemptions, and support the decisions that follow where reformulation or substitution is required within the regulatory timeline.

RoHS

Directive 2011/65/EU (RoHS, recast) restricts ten hazardous substances in electrical and electronic equipment placed on the EU market: lead, mercury, cadmium, hexavalent chromium, polybrominated biphenyls (PBB) and polybrominated diphenyl ethers (PBDE), plus four phthalates (DEHP, BBP, DBP and DIBP) added in 2019. The restriction applies to manufacturers and importers of EEE and, in practice, to the supply chains feeding into them, since compliance documentation must be traceable to component and material level.

RoHS exemptions are time-limited and subject to renewal applications. When an exemption lapses or is not renewed, uses that were previously permitted become non-compliant without necessarily triggering automatic notification through the supply chain. We advise on substance compliance across EEE product categories, assess which exemptions apply to specific uses and when they expire, and support the technical documentation that underpins a Declaration of Conformity. Where RoHS and REACH address the same substances, we ensure the obligations under each framework are mapped together rather than managed independently.

POPs

Reg. (EU) 2019/1021 (EU POPs Regulation) implements the obligations of the Stockholm Convention in EU law, setting concentration limits for persistent organic pollutants in substances, mixtures, articles and waste. The regulation covers a broad range of compounds, including polychlorinated biphenyls (PCBs), certain brominated flame retardants and, increasingly, PFAS compounds that have been added to the Stockholm Convention annexes in recent years. PFOS was listed under the Stockholm Convention in 2009, PFOA in 2019, and PFHxS in 2022, with each listing reflected in the EU POPs Regulation.

The POPs Regulation and REACH interact in places. Some substances are controlled under both frameworks, but with different concentration thresholds, different scope definitions and different obligations depending on whether the substance appears in a product, an article or a waste stream. We advise on POPs content in product portfolios and supply chains, assess compliance with the applicable concentration limits, and clarify the relationship between POPs obligations and REACH restrictions for substances addressed under both.

ELV regulation

The EU End-of-Life Vehicles framework is in transition. Directive 2000/53/EC is being replaced by a new directly applicable regulation following the European Parliament's vote on 15 June 2026, with Council approval still pending. The existing directive has restricted lead, mercury, cadmium and hexavalent chromium in vehicles and vehicle components since 2000, with a set of exemptions that are periodically reviewed and revised. Those substance restrictions are carried forward in the new regulation.

The new regulation goes further, introducing a Circularity Vehicle Passport that will require manufacturers to document restricted substance information, recycled content and circularity strategies for each vehicle type. That documentation requirement will push substance transparency requests up through the supply chain to chemical and materials suppliers. The regulation also sets mandatory minimum recycled plastic content targets, which create new compliance considerations under REACH: SVHC obligations apply to recycled polymer feedstocks in the same way as virgin materials, and Article 33 communication requirements and SCIP notifications apply regardless of a material's recycled origin. We advise on compliance with the existing vehicle substance restrictions, the interaction with REACH, and the obligations introduced by the new regulation as it enters into force.

Biocidal products

Biocidal products, including disinfectants, preservatives, pest control formulations and process biocides, are regulated under Reg. (EU) No 528/2012 (BPR). Active substances must be approved at EU level before products containing them can be authorised in member states. Articles treated with biocides carry their own labelling and communication obligations. We advise on product type categorisation, active substance authorisation status, the regulatory obligations applicable to treated articles, and the interaction between BPR and REACH for substances that appear across both frameworks.

Conflict and responsible minerals reporting

Three standardised templates from the Responsible Minerals Initiative (RMI) have become the primary instruments for minerals due diligence in global supply chains. The Conflict Minerals Reporting Template (CMRT) covers tin, tantalum, tungsten and gold (3TG). The Extended Minerals Reporting Template (EMRT) covers cobalt and mica. The Additional Minerals Reporting Template (AMRT) extends to materials including aluminium, chromium, lithium and others relevant to battery and electronics supply chains. Customers, OEMs and procurement teams across automotive, electronics and aerospace sectors request completed templates from their suppliers as a standard part of qualification and annual due diligence cycles.

The EU Conflict Minerals Regulation (Reg. (EU) 2017/821), which came into force in January 2021, gives the CMRT a direct legal footing for EU importers of 3TG originating from conflict-affected and high-risk areas (CAHRAs), requiring due diligence aligned with the OECD Due Diligence Guidance. We collect CMRT, EMRT and AMRT responses from suppliers on behalf of clients, review the data for completeness and accuracy, follow up on non-responses, and identify smelters or refineries outside the RMAP conformant list. We also help clients prepare and maintain their own outward-facing template responses for submission to their customers.

UK REACH

Downstream user obligations

Companies using registered substances in their own processes are downstream users under REACH and must verify that those uses are covered by the exposure scenarios in the extended SDS provided by their supplier. Where uses fall outside the communicated scenarios, the downstream user must either communicate the use up the supply chain or notify ECHA under Article 38. We map chemical use portfolios against current SDS documentation, identify where the coverage gaps are, and manage the options available under the regulation.

Authorisation and restrictions

Substances on the Authorisation List (Annex XIV of REACH) cannot be placed on the market or used after their sunset date without a specific authorisation or an applicable exemption. Authorisation applications are use-specific and require a chemical safety assessment, an analysis of alternatives and, where the risk cannot be adequately controlled, a socioeconomic justification. We assess whether your uses are covered by existing authorisations already in the supply chain, support preparation of new applications, and advise on the available options when a sunset date is approaching and alternative substances or processes are not yet qualified.

Restrictions under Annex XVII of REACH prohibit or limit the manufacture, use or placing on the market of specific substances in specific applications. The scope is broad, covering substances in consumer products, textiles, articles and industrial settings, and the list is amended periodically as ECHA's restriction process produces new outcomes. We assess product and supply chain compliance against current Annex XVII entries and monitor the restriction pipeline for upcoming obligations affecting your portfolio.

Packaging and Packaging Waste Regulation (PPWR)

The Packaging and Packaging Waste Regulation (PPWR) introduces EU-wide requirements on recyclability, recycled content and packaging minimisation that will affect manufacturers, importers and packers placing goods on the EU market. For chemical companies, one immediate compliance consideration is the restriction on PFAS in food contact packaging above 25 ppm total fluorine. The regulation also introduces recyclability-by-design criteria, mandatory minimum recycled content targets for plastic packaging, and restrictions on certain formats. We advise on PPWR compliance for packaging used with chemical products, assess PFAS content in packaging materials, and advise on the interaction between PPWR obligations and REACH for substances present in packaging components.

EU food contact materials

Food contact materials (FCM) are regulated under the framework of Reg. (EC) No 1935/2004, with material-specific measures covering authorised substances and migration limits. Plastic FCMs are covered by Reg. (EU) No 10/2011, which maintains a positive list of authorised monomers, additives and other starting substances, each with specific migration limits and, in some cases, use category restrictions. EFSA authorises new substances following a safety assessment requiring toxicological data, migration testing and a technical dossier. We advise on FCM compliance for substances used in or constituting food contact materials, assess positive list status, review migration testing requirements and support regulatory submissions for substances seeking authorisation.

Drinking water contact materials

Materials in contact with drinking water are subject to a compliance regime separate from food contact. Commission Implementing Decision (EU) 2024/367 establishes a positive list of starting substances authorised for use in plastic materials in contact with drinking water, and parallel measures are in development for metals, cementitious materials and organic coatings. Substances not on the positive list require assessment and authorisation before use in drinking water contact applications. We advise on positive list compliance for drinking water system materials, assess substance authorisation status under the applicable implementing decisions, and support the testing and documentation required for market access.

Nanomaterials

REACH requires separate registration dossiers for nano forms of substances, with specific information requirements on physico-chemical characterisation, dissolution rates and nano-specific toxicological and ecotoxicological endpoints that differ substantially from those for bulk forms. The EU Cosmetics Regulation requires notification of nanomaterials in cosmetic products under Article 16, with a six-month notification window before market placement. Additional sector-specific nano rules apply in food and food contact materials. We advise on nano form registration requirements under REACH, prepare and review nano-specific dossier sections, and advise on notification obligations across the Cosmetics Regulation and other applicable sector frameworks.

PAH restriction

Polycyclic aromatic hydrocarbons in rubber and plastic components of consumer articles and in tyres are restricted under Entry 50 of REACH Annex XVII, as established and amended by Reg. (EC) No 835/2011. The restriction sets concentration limits for eight specific PAHs, including benzo[a]pyrene and benz[a]anthracene, in rubber or plastic parts of articles intended for prolonged skin or oral contact. We assess product compliance with Entry 50 concentration limits, advise on applicable testing methods and documentation requirements, and monitor for amendments to the substance list or thresholds.

Endocrine disruptors - new hazard classes

Commission Delegated Regulation (EU) 2023/707 introduced two new CLP hazard classes: endocrine disruptor for human health (ED HH) and endocrine disruptor for the environment (ED ENV), each with category 1 and category 2. Transition periods apply, with mandatory use of the new classes for substances from 1 May 2025 and for mixtures from 1 May 2026. Classification as a category 1 endocrine disruptor under either hazard class can lead to identification as a substance of equivalent level of concern under REACH, opening the pathway to SVHC listing and potential authorisation requirements. We review substance and mixture portfolios against the new ED classification criteria, prepare self-classification assessments, and advise on the downstream regulatory consequences including potential SVHC identification.

Phthalates

Phthalates are addressed across several EU regulatory instruments. Entry 51 of REACH Annex XVII restricts DEHP, DBP, BBP and DIBP in articles and certain mixtures. Entry 52 restricts DINP, DIDP and DNOP in toys and childcare articles. RoHS restricts DEHP, BBP, DBP and DIBP in electrical and electronic equipment. Several phthalates are SVHCs on the REACH Candidate List. Restriction proposals targeting a broader range of applications for DINP and other phthalates are advancing, and a group restriction approach covering the wider phthalate family is under development at ECHA. We assess product and formulation portfolios for phthalate content, map findings against current restriction entries and SVHC status, and advise on the implications of group restriction proposals for substitution planning.

Siloxanes

Cyclic siloxanes D4 (octamethylcyclotetrasiloxane) and D5 (decamethylcyclopentasiloxane) are restricted under REACH Annex XVII in wash-off personal care products above 0.1% w/w. D4, D5 and D6 (dodecamethylcyclohexasiloxane) are listed on the SVHC Candidate List due to their PBT or vPvB properties, triggering Article 33 communication obligations for articles containing them above threshold. Restriction activity for linear siloxanes and additional cyclic siloxanes is progressing. We advise on siloxane content in formulations and articles, assess compliance with current Annex XVII restrictions and SVHC communication obligations, and monitor restriction proposals affecting the broader siloxane family.

Bisphenols

Bisphenol A (BPA) is restricted under REACH Annex XVII in food contact materials, thermal paper and a range of consumer articles, and is an SVHC due to its endocrine disrupting properties. Bisphenol AF (BPAF) was added to the SVHC Candidate List in February 2026 on grounds of reproductive toxicity. Bisphenol S (BPS) and Bisphenol F (BPF) are under active ECHA assessment as potential SVHCs. The bisphenol family is expanding as a regulatory concern, with each new SVHC listing carrying Article 33 communication obligations and potential downstream restriction consequences. We assess bisphenol content across product portfolios, advise on current restriction entries and SVHC obligations, and monitor the regulatory trajectory for the substance family.

ODS regulation

Ozone-depleting substances are controlled under Reg. (EU) 2024/590, which replaced Reg. (EC) No 1005/2009 and aligns EU law with updated obligations under the Montreal Protocol. The regulation restricts or prohibits the production, import, export, placing on the market and use of substances that deplete the stratospheric ozone layer, including CFCs, HCFCs, HBFCs, halons, methyl bromide and related substances. Controlled uses require authorisation, and records of purchases, sales and quantities must be maintained. We advise on ODS compliance for companies manufacturing, importing or using controlled substances, assess whether specific uses qualify for permitted exemptions, and support the documentation and reporting obligations under the regulation.

F-Gas regulation

Fluorinated greenhouse gases, including hydrofluorocarbons (HFCs), perfluorocarbons (PFCs) and sulphur hexafluoride (SF6), are regulated under the EU F-Gas Regulation, which introduced a phase-down quota system for HFCs and prohibits F-gas use in specific equipment categories where alternatives are available. Operators of equipment containing F-gases above specified charge sizes are required to conduct regular leak checks and maintain service records. We advise on F-gas compliance for manufacturers, importers and users of F-gas-containing equipment, assess which application-specific prohibitions apply to products in your portfolio, and support record-keeping and operator obligations.

EU CSRD

The Corporate Sustainability Reporting Directive (Directive (EU) 2022/2056, CSRD) requires companies above applicable thresholds to report on sustainability-related impacts, risks and opportunities across their operations and value chains. For chemical companies and manufacturers with significant chemical use, the primary relevant standard is ESRS E2 (Pollution), which requires disclosure on substances of concern, hazardous chemicals, SVHC and restricted substances present in the value chain, and the policies and targets governing their management. We advise on the chemical and substance dimensions of CSRD reporting, support double materiality assessments where chemicals are a relevant topic, assist with gap analysis against ESRS E2 requirements, and help develop the underlying chemical management data that supports compliant disclosure.

TSCA

The US Toxic Substances Control Act (TSCA) governs the manufacture, import, processing, distribution, use and disposal of chemical substances in the United States. Section 5 requires pre-manufacture notification (PMN) to the EPA at least 90 days before manufacturing or importing a new chemical substance not already on the TSCA Inventory. Section 6 authorises EPA to take risk management action on chemicals posing unreasonable risk; Section 6(h) specifically targets persistent, bioaccumulative and toxic (PBT) substances, and EPA has issued final rules restricting or prohibiting the manufacture, processing and distribution of several PBT chemicals including decabromodiphenyl ether (DecaBDE) and phenol, isopropylated phosphate (PIP (3:1)). Section 8 sets reporting and record-keeping requirements, including the Chemical Data Reporting (CDR) rule for manufacturers and importers above volume thresholds. We support non-US companies entering the US chemical market, advise on PMN requirements, TSCA Inventory status, SNUR applicability and Section 6(h) compliance, and assist with Section 8 reporting obligations.

California Proposition 65

California Proposition 65 (the Safe Drinking Water and Toxic Enforcement Act of 1986) requires businesses to provide a clear and reasonable warning before knowingly exposing Californians to chemicals listed by OEHHA as known to cause cancer, birth defects or other reproductive harm. The list currently contains over 900 chemicals and is updated regularly. Enforcement is primarily citizen-suit driven, with penalties of up to USD 2,500 per day per violation. We assess product compositions against the Prop 65 list, advise on safe harbour levels (No Significant Risk Levels for carcinogens and Maximum Allowable Dose Levels for reproductive toxicants), and help companies develop compliant warning strategies for products distributed in California.

FDA evaluation and support

For companies placing chemical products, food contact substances, cosmetic ingredients or combination products on the US market, FDA regulatory requirements apply alongside or in place of EU frameworks. We advise on FDA pre-market notification requirements for food contact substances under the Food Contact Substance Notification (FCN) programme, assess ingredient regulatory status for cosmetic products under FDA jurisdiction, and support companies navigating the regulatory interface between EU and US requirements for products distributed in both markets.