Why Manufacturers Struggle to Align REACH, RoHS, and PFAS Compliance Data

Three separate requests. The same substance. Three different answers.

A compliance manager is preparing a response to a customer's chemical compliance questionnaire. The customer wants to know whether the product contains DEHP (di(2-ethylhexyl) phthalate), a phthalate present in PVC components.

The REACH answer: DEHP is on the Candidate List of SVHCs. It is present in a PVC seal at 0.12% w/w of the homogeneous material. Under Article 33, the customer must be notified. The substance is also on REACH Annex XIV (the Authorisation List). A downstream use authorisation applies.

The RoHS answer: DEHP was added to the RoHS restricted substance list in 2019 under RoHS 3 (Directive 2015/863). It is restricted to 0.1% w/w in homogeneous materials in EEE. At 0.12%, the component is non-compliant under RoHS unless a valid exemption applies. The product is electronic equipment, so RoHS applies.

The PFAS answer: DEHP is not classified as a PFAS under EPA's structural definition or under the EU's PFAS restriction framework, because it does not contain a fully fluorinated carbon structure. No PFAS obligation applies to DEHP specifically.

Three frameworks. Three different scopes, thresholds, reporting mechanisms, and compliance statuses. For the compliance manager, this is not a theoretical complexity: it is a practical problem that has to be resolved, documented, and communicated, for every substance in every product, across every regulatory framework that applies. And DEHP is just one substance among thousands.

This is why manufacturers struggle to align REACH, RoHS, and PFAS compliance data. Not because any one of the frameworks is incomprehensible in isolation, but because the overlaps, conflicts, and gaps between them create a data alignment challenge that no single compliance programme was designed to handle.

The Three Frameworks and Why They Don't Map Cleanly Onto Each Other

REACH: horizontal, substance-level, continuous

REACH (Regulation (EC) No 1907/2006) is a horizontal regulation covering all chemical substances in all products placed on the EU market (with limited exclusions). Its obligations are triggered by substance identity and concentration, not by product category. The key compliance instruments are:

Candidate List (Annex XV SVHC): Substances of very high concern. Triggers Article 33 communication obligations and SCIP notifications when present above 0.1% w/w in articles. Updated roughly twice a year. Currently at 253 entries (February 2026).

Authorisation List (Annex XIV): Substances requiring authorisation to use. Companies must hold a valid authorisation or rely on an existing downstream use authorisation.

Restriction List (Annex XVII): Substances prohibited or restricted for specific uses. Over 80 entries, including phthalates in toys, nickel in jewellery, and PFAS in firefighting foams. Conditions vary: some restrictions are concentration-based, others are use-specific.

REACH compliance is a continuous obligation that responds to regulatory updates without a defined cycle. Every Candidate List addition immediately triggers new obligations for affected products.

RoHS: sector-specific, homogeneous-material-level, threshold-based

RoHS (Directive 2011/65/EU as amended by 2015/863) applies exclusively to electrical and electronic equipment (EEE) placed on the EU market. It restricts ten specific substances at defined maximum concentration values (MCVs) in homogeneous materials:

Lead, mercury, hexavalent chromium, PBB, PBDE: 0.1% w/w per homogeneous material Cadmium: 0.01% w/w per homogeneous material Four phthalates (DEHP, BBP, DBP, DIBP): 0.1% w/w per homogeneous material (added 2019)

RoHS exemptions (Annex III and Annex IV) permit specific applications where substitutes are unavailable. These exemptions have expiry dates and are periodically revised.

RoHS is not a continuous obligation in the same way as REACH. The restricted substance list changes infrequently (the phthalate addition in 2019 was the most recent). But exemption changes create compliance volatility even when the substance list is stable.

PFAS: class-based, multiple instruments, globally fragmented

PFAS (per- and polyfluoroalkyl substances) are not a single regulatory instrument. They are a class of substances regulated through multiple parallel frameworks simultaneously:

Under EU REACH: Several PFAS subgroups are already restricted in Annex XVII (PFHxA from April 2026, PFAS in firefighting foams (Entry 82, in force October 2025, with mandatory labelling from October 2026 and a full use ban phasing in through 2030. A universal restriction proposal covering 10,000+ PFAS has cleared the RAC/SEAC process: RAC adopted its final opinion in March 2026 and SEAC is expected to finalise its opinion by end of 2026, after which the European Commission will prepare a legislative proposal. A Commission decision is unlikely before 2027. Multiple PFAS are already on the Candidate List (PFOS, PFOA, and related substances).

Under the Stockholm Convention (incorporated into EU POPs Regulation): Long-chain PFCAs (C9-21) are being banned globally from December 2026.

Under TSCA (US): Section 8(a)(7) reporting rule requiring manufacturers and importers to report on PFAS use in any year from 2011 to 2022. The submission window has been repeatedly delayed — EPA postponed the start of submissions in April 2026, with reporting now expected to begin no later than January 31, 2027. EPA has also designated several PFAS as hazardous substances under CERCLA.

Under national bans: France (January 2026), Denmark (July 2026), Minnesota (reporting July 2026, ban by 2032), Maine, and others.

The PFAS class definition itself differs across regulatory instruments: EPA's structural definition covers three specific fluorinated sub-structures; the EU universal restriction proposal covers any substance with at least one fully fluorinated carbon; national bans use varying definitions. A substance that is regulated as PFAS under one instrument may not be regulated under another.

Six Specific Conflicts That Make Alignment Difficult

1. The same substance at the same concentration can be compliant under REACH but non-compliant under RoHS (or vice versa)

Take hexavalent chromium. Under REACH Annex XVII, hexavalent chromium compounds are restricted in leather articles used in clothing (Entry 47), in cement (Entry 10), and in specific other uses. Under RoHS, hexavalent chromium is restricted to 0.1% w/w in all homogeneous materials in EEE.

A leather-covered electronic product might have hexavalent chromium in the leather at a concentration that triggers the REACH Annex XVII restriction for leather but doesn't violate the RoHS threshold in the EEE context. Or it might violate both. Or it might violate neither if an exemption applies. The compliance answer depends on which framework governs, what the concentration is, which homogeneous material is assessed, and what exemptions are in play. These cannot be determined by checking a single substance list.

2. PFAS sits simultaneously under REACH, the POPs Regulation, and national bans, each with different scope and thresholds

A manufacturer using PTFE (polytetrafluoroethylene) coatings in a product that is sold in the EU, US, and Denmark faces three simultaneous PFAS questions. Under the EU universal restriction proposal, PTFE may eventually be regulated (though large fluoropolymers may be derogated). Under the PFHxA restriction (Entry 79, REACH Annex XVII), PTFE is not in scope. Under Denmark's national ban, large fluoropolymers are currently excluded. Under TSCA Section 8(a)(7), PTFE use in products imported into the US since 2011 may require reporting.

Four different answers to "does this PFAS require action?" for the same substance in the same product sold across four markets.

3. REACH addresses article-level obligations; RoHS addresses homogeneous-material-level obligations

REACH Article 33 communication and SCIP notification obligations are triggered when an article contains an SVHC above 0.1% w/w of the article. The compliance calculation starts at the article level.

RoHS obligations are triggered when a homogeneous material within the product contains a restricted substance above its MCV. The compliance calculation starts at the homogeneous material level.

For a complex product, these two calculations can produce different outcomes. An SVHC present at 0.08% w/w of the total article might be present at 0.15% w/w in a specific homogeneous material within it. The product is compliant under REACH Article 33 (below the article-level threshold) but non-compliant under RoHS (above the homogeneous material threshold). A supplier declaration that says "REACH compliant, RoHS compliant" without specifying the calculation methodology for each is not verifiable.

4. Phthalates sit on both the REACH Candidate List and the RoHS restricted list with different obligations under each

DEHP, BBP, DBP, and DIBP are restricted under RoHS at 0.1% w/w in homogeneous materials in EEE. They are also on the REACH Candidate List and the Authorisation List. For an electronics manufacturer, a phthalate above 0.1% w/w creates simultaneous obligations under both regulations: RoHS non-compliance (restricted substance above MCV), REACH Article 33 communication (SVHC in article above 0.1%), REACH SCIP notification, and potentially REACH Annex XIV authorisation (if no downstream use authorisation covers the specific use).

Managing a single phthalate finding requires four simultaneous regulatory responses. Most compliance programmes handle them as separate workstreams, generating duplicate supplier outreach, duplicate documentation, and duplicate reporting for what is operationally the same substance problem.

5. RoHS exemptions and REACH authorisations don't align

When a substance requires an exemption under RoHS and an authorisation under REACH, the two instruments don't share a common process or timeline. A RoHS exemption permits the use of a restricted substance in a specific application until the exemption's expiry date. A REACH authorisation permits the use of an Annex XIV substance for a specific use, often for a defined review period.

For lead in certain solder applications, a manufacturer may hold a valid RoHS exemption (until the exemption's expiry, which post-2025 may require attention to the restructured sub-exemptions ) and simultaneously be required to hold or rely on a downstream use authorisation under REACH Annex XIV. If either lapses independently, the product becomes non-compliant under the corresponding regulation regardless of the other instrument's status.

6. PFAS substance-level data required for TSCA reporting may not match REACH SVHC data collected for EU compliance

TSCA Section 8(a)(7) requires reporting using EPA's structural PFAS definition, which identifies CAS numbers and structural identities at a level of specificity that most REACH compliance programmes don't capture. A REACH supplier declaration noting "no SVHCs present" covers the Candidate List substances (which includes some PFAS like PFOS and PFOA). But TSCA requires reporting on PFAS that aren't on the Candidate List and aren't restricted under REACH. The two data sets are not equivalent, and a company that collected REACH-sufficient PFAS data may still lack TSCA-sufficient PFAS data for the same substances and products.

Why Separate Compliance Workstreams Make This Worse

Most manufacturers manage REACH, RoHS, and PFAS as separate compliance programmes: different teams, different supplier questionnaires, different data repositories, different reporting calendars. When the same substance appears in multiple frameworks simultaneously, three things happen:

Duplicate supplier outreach. The REACH team sends a questionnaire asking about SVHCs. The RoHS team sends a questionnaire asking about restricted substance concentrations. The PFAS team sends a third questionnaire about fluorinated chemistry. The supplier receives three separate requests for substance data that could have been collected in a single interaction.

Inconsistent data. The supplier's REACH declaration, RoHS declaration, and PFAS disclosure may use different CAS numbers for group entries, different homogeneous material breakdowns, and different measurement dates. When the compliance team tries to reconcile the three data sets for a single part, they find three versions of the same substance story that don't match.

Compliance gaps in the intersections. A substance finding in one workstream doesn't automatically trigger a review in the other. A phthalate identified through RoHS screening may not be flagged for REACH Article 33 review. A PFAS substance identified through TSCA screening may not be assessed for REACH Annex XVII restriction status. The gaps between the workstreams are where undetected non-compliance accumulates.

Building Integrated Chemical Compliance Intelligence

1. Maintain a single substance database mapped across all three frameworks

The foundation of cross-framework alignment is a substance database that, for every CAS number, shows its status simultaneously under the REACH Candidate List, REACH Annex XIV, REACH Annex XVII, RoHS restricted substance list (with MCVs), and applicable PFAS regulatory instruments.ECHA's CHEM database (which incorporated regulatory lists including SVHC and Annex XVII data in September 2025) is now the authoritative single source for EU substance classifications.Build your internal substance database as a derivative of ECHA CHEM, supplemented with TSCA inventory data for US obligations.

2. Send consolidated substance questionnaires to suppliers

Request substance data in a single interaction that covers all applicable frameworks. A well-designed questionnaire asks: substance identity (CAS number), concentration per homogeneous material, the article-level context, and any applicable exemptions or authorisations. The compliance platform maps the response to REACH, RoHS, and PFAS obligations simultaneously, rather than routing the data to three separate workstreams.

3. Apply threshold calculations at the correct level for each framework

Maintain explicit logic for threshold calculations: REACH Article 33 is calculated at the article level; RoHS is calculated at the homogeneous material level; REACH Annex XVII restrictions may be use-specific or concentration-based depending on the entry. These calculations must be applied correctly and independently for each framework against the same underlying substance data.

4. Trigger cross-framework reviews when a substance finding is identified in any single framework

If the REACH workstream identifies an SVHC in a component, automatically trigger a review of whether the same substance is restricted under RoHS (and at what MCV), whether it is subject to any PFAS regulatory instrument, and whether any applicable exemptions or authorisations are in place. The finding in one framework is the trigger for review in all applicable frameworks, not a separate finding.

5. Monitor the CMR Annex XVII update pipeline

In 2026, a CMR (carcinogenic, mutagenic, reprotoxic) update to REACH Annex XVII adds 22 new substances with compliance obligations expected later in 2026. These new restrictions will intersect with existing REACH Candidate List, Authorisation List, and RoHS obligations for the same substances. Monitoring the Annex XVII update pipeline as part of a unified regulatory intelligence function prevents the update from arriving as a surprise that each workstream handles separately.

A Self-Check for Cross-Framework Alignment

Six questions to test your chemical compliance integration:

• Single substance view: For any given CAS number, can you immediately see its status across REACH (Candidate List, Annex XIV, Annex XVII), RoHS restricted list, and applicable PFAS instruments?
• Duplicate outreach audit: How many separate questionnaires does your average supplier receive annually covering REACH, RoHS, and PFAS data for the same components?
• Threshold methodology: Do your compliance calculations apply the correct threshold logic for each framework (article-level for REACH Article 33, homogeneous-material-level for RoHS MCVs)?
• Cross-trigger workflows: When a substance finding is identified in one framework, is there an automatic workflow that reviews its status across all other applicable frameworks?
• Phthalate reconciliation: For the four RoHS phthalates (DEHP, BBP, DBP, DIBP), does your programme manage their simultaneous REACH Candidate List, REACH Annex XIV, RoHS, and SCIP obligations in a unified workflow?
• PFAS data equivalence: Is the PFAS substance data you collected for REACH compliance sufficient to meet TSCA Section 8(a)(7) reporting requirements, or are they two separate, non-equivalent data sets?

If more than two answers reveal gaps, your cross-framework compliance programme has intersections where undetected non-compliance is accumulating.

Where Regilient fits in

The REACH, RoHS, and PFAS compliance problem is not three separate problems. It is one problem: getting accurate, current, substance-level data from your supply chain and applying it correctly against multiple regulatory frameworks simultaneously. Regilient's agentic sustainability platform treats it as the single problem it is:

• Unified substance intelligence that maps every CAS number against REACH Candidate List, Annex XIV, Annex XVII, RoHS MCVs, and PFAS regulatory instruments simultaneously, using ECHA CHEM as the authoritative reference database
• Cross-framework supplier questionnaires that collect substance data once and apply it to all three frameworks, eliminating duplicate outreach and inconsistent data sets
• Correct threshold logic per framework applied automatically: article-level for REACH Article 33, homogeneous-material-level for RoHS, use-specific for REACH Annex XVII restrictions
• Cross-trigger compliance reviews that automatically assess a substance finding across all applicable frameworks when it is identified in any single workstream
• Regulatory update integration that incorporates REACH Candidate List additions, Annex XVII CMR updates, and PFAS restriction milestones into cross-framework re-evaluation workflows

The three frameworks share more underlying data than most compliance programmes recognise. The supplier who can tell you the CAS number and concentration of every substance in a homogeneous material has given you everything you need to assess compliance under REACH, RoHS, and PFAS simultaneously. The programmes that collect that data once and apply it across frameworks will outperform the programmes that collect it three times and still miss the intersections.

Book a Regilient demo to see how agentic chemical compliance intelligence unifies REACH, RoHS, and PFAS data into a single, cross-framework compliance view.

Regilient provides agentic sustainability software for product compliance, supplier engagement, and regulatory intelligence across REACH, RoHS, PFAS, CMRT, SCIP, and global chemical regulations.