REACH and SVHC readiness guide for specialty chemical suppliers
A working guide for raw-material and specialty-chemical suppliers keeping REACH registration numbers, SVHC declarations, safety data sheet versions, and CAS/EC substance identity current and customer-ready. It follows the obligations that ride with a substance from ECHA registration through the Candidate List, Authorisation, Restriction, and the 16-section SDS that carries hazard data into both EU and US supply chains.
Operational guide, not legal advice
Answer for the substance, not the paperwork
Under REACH the substance is what is regulated, and the "no data, no market" rule means an unregistered substance cannot legally be manufactured or placed on the EU market. Valent keeps a supplier's global compliance status by CAS number review-ready and turns it into customer-ready declaration documents on request, so a coverage question resolves to a current answer instead of a document hunt.
Why this matters
Your customers are regulated at the substance level, so every registration number, SVHC statement, and SDS version you send becomes their proof too. When those artifacts drift out of date, the request lands back on your regulatory-affairs desk in the middle of a market-access window.
A substance is registered with ECHA, but the registration number is scattered across dossiers, emails, and PDFs instead of tied to its CAS and EC identity.
A substance lands on the Candidate List, but the SVHC declaration and Section 15 of the SDS are never updated to reflect it.
An SDS is revised, but customers keep receiving an older version and no one can say which release they hold.
An Article 33 request arrives, but the 45-day consumer-response clock starts before anyone can confirm content above 0.1% w/w.
REACH and SVHC readiness map
Registration threshold
Any company that manufactures or imports a substance into the EU at or above one tonne per year must register it with ECHA; below one tonne, no registration is required.
No data, no market
An unregistered substance is illegal to manufacture or place on the EU market, so registration is a market-access gate, not a filing formality.
SVHC / Candidate List
Once ECHA places a substance on the Candidate List, obligations apply immediately, including confirming content above 0.1% w/w and updating Section 15 of the SDS to identify it as an SVHC.
Authorisation and Restriction
Annex XIV substances need an authorisation to stay in use past their sunset date; Annex XVII restrictions can limit or ban manufacture, placing on the market, or use under stated conditions.
Article 33 communication
Suppliers of articles containing a Candidate List substance above 0.1% w/w must pass at least the substance name to recipients and answer a consumer request within 45 days.
The safety data sheet
A 16-section document required under REACH Article 31 / Annex II in the EU and OSHA HazCom in the US (aligned to UN GHS, primarily Revision 7), the same artifact across both supply chains.
Regulatory-affairs action plan
Use this sequence to keep registration numbers, SVHC declarations, SDS versions, and substance identity current and releasable when a customer, auditor, or regulator asks.
01
Build the substance identity file
Create one controlled record per substance keyed to its identifiers, because customers confirm coverage by matching identity, not product name. This record is what every declaration and SDS points back to.
Substance name, CAS number, and EC numberREACH registration number and co-registrant groupingRegistration status against the one-tonne-per-year thresholdOwner for identity and registration changes
02
Track dossier and registration status
The registration number is issued once the dossier is complete, and the dossier carries the hazard data and, where relevant, a chemical safety assessment and risk controls. Keep its status and update triggers visible so a lapse surfaces before a customer notices.
Dossier completeness and registration numberChemical safety report and exposure scenarios where requiredTonnage-driven registration obligationUpdate trigger for new data or new uses
03
Monitor Candidate List, Annex XIV, and Annex XVII
SVHC listing creates obligations the day a substance joins the Candidate List, ahead of any authorisation step. Watch the Authorisation List for sunset and latest application dates, and Annex XVII for restriction conditions that can limit or ban a use.
Candidate List (SVHC) status and 0.1% w/w contentAnnex XIV sunset date and application for authorisationAnnex XVII restriction conditions for substances, mixtures, and articlesTrigger to refresh declarations on any status change
04
Keep SVHC declarations and Article 33 responses ready
Once a substance is on the Candidate List, customers ask you to confirm content above 0.1% and update Section 15 of the SDS. For articles containing a Candidate List substance above 0.1% w/w, communication must reach recipients, and a consumer request must be answered within 45 days.
SVHC statement of content above or below 0.1% w/wSDS Section 15 update identifying the SVHCArticle 33 communication to industrial and professional recipients and distributors45-day consumer-request response path
05
Version-control the SDS and CLP label
CLP classification feeds the SDS, and hazardous substances and mixtures must be classified and labelled before being placed on the market. Manage SDS revisions so every customer holding an older version receives the current release.
16-section SDS with a version and effective dateCLP classification, pictograms, signal word, and hazard and precautionary statementsEU (REACH Annex II) and US (OSHA HazCom) content in one artifactRe-issue trigger and record of who holds which version
Anchor everything to substance identity
REACH regulates the substance, and customers confirm coverage by matching the name, CAS number, EC number, and REACH registration number. Keep those identifiers on one controlled record per substance so a coverage question resolves without reopening the dossier.
Substance name, CAS number, and EC number
REACH registration number issued once the dossier is complete
Registration status against the one-tonne-per-year threshold
Co-registrant grouping for the same substance
Track Candidate List, Authorisation, and Restriction status
SVHC listing triggers legal obligations the moment a substance joins the Candidate List, before any authorisation step. Annex XIV substances need an application for authorisation and a positive Commission decision to stay in use past the sunset date, while Annex XVII restrictions can limit or ban a use outright.
Candidate List (SVHC) status and content above or below 0.1% w/w
SDS Section 15 updated to identify a Candidate List substance as an SVHC
Annex XIV authorisation status, sunset date, and latest application date
Annex XVII restriction conditions for the substance, mixtures, and articles
Keep the SDS current as one artifact across two regimes
The safety data sheet is a 16-section document required under REACH Article 31 and Annex II in the EU and under OSHA's Hazard Communication Standard in the US. It carries hazard data into both supply chains with regime-specific content, so a version change has to reach every customer still holding the old one.
16-section GHS structure, from Identification through Other information
CLP classification and label elements feeding the EU SDS
OSHA-enforced Sections 1-11 and 16; Sections 12-15 included but outside OSHA's jurisdiction
Exposure scenarios annexed to the extended SDS where a chemical safety report applies
Checklist
Keep the REACH file current before the request arrives
Use these checks to keep registration, SVHC, SDS, and identity evidence releasable before a customer, auditor, or regulator asks, shared through permissioned, gated access while upstream sources stay private.
01
Maintain one controlled record per substance with name, CAS number, EC number, and REACH registration number.
02
Confirm registration status against the one-tonne-per-year threshold and keep the dossier and any chemical safety report current.
03
Monitor the Candidate List, the Annex XIV Authorisation List, and Annex XVII restrictions, and refresh SVHC declarations and SDS Section 15 on any status change.
04
Version-control the 16-section SDS and CLP label so every customer receives the current release, with EU and US content in the one artifact.
05
Keep Article 33 communication and the 45-day consumer-request response ready for articles containing a Candidate List substance above 0.1% w/w.
06
Preserve reviewer identity, decision rationale, and the release record behind each declaration, shared through permissioned, gated access.
Be ready before the next customer asks
See how Valent keeps supplier evidence, review decisions, and release records ready, so proving compliance never holds up the business.
