EU REACH Readiness: Registration, SDS and Article Information
Track tonnage per substance and legal entity, keep SDS versions tied to customers and collect article declarations above 0.1%.
In Short
- Register at 1 tonne a year.
- Articles: SVHC over 0.1% w/w.
- Keep REACH records 10 years.
REACH, Regulation (EC) 1907/2006, applies to substances manufactured in or imported into the EU, on their own, in mixtures and in some articles. Its core principle in Article 5 is 'no data, no market'. Registration is required at 1 tonne or more per year, safety data sheets travel down the supply chain, and suppliers of articles must pass on information about candidate-list substances above 0.1% weight by weight. This guide covers the duties a chemical maker should organise; it is orientation, not legal advice. Sources checked 4 Oct 2026.
Who must register, and at what tonnage
Article 6 requires a manufacturer or importer of a substance, on its own or in mixtures, in quantities of 1 tonne or more per year to submit a registration. Article 5 says substances that have not been registered where required shall not be manufactured or placed on the market.
What tonnage changes
| Annual volume per registrant | Key consequence |
|---|---|
| Under 1 tonne | No registration duty under Article 6 |
| 1 tonne or more | Registration required (Article 6) |
| 10 tonnes or more | Chemical safety report (Article 14) |
| Higher bands | More data required (Article 12, Annexes) |
- Under 1 tonne
- Key consequence
- No registration duty under Article 6
- 1 tonne or more
- Key consequence
- Registration required (Article 6)
- 10 tonnes or more
- Key consequence
- Chemical safety report (Article 14)
- Higher bands
- Key consequence
- More data required (Article 12, Annexes)
More on who must register, and at what tonnage
Article 12 links the information required to tonnage bands, and Article 14 requires a chemical safety report from 10 tonnes per year. Track annual tonnage per substance and legal entity, because the bands decide your data obligations.
Non-EU manufacturers and the only representative
Article 8 allows a manufacturer established outside the EU to appoint an only representative in the EU to fulfil importers' registration obligations. Importers covered by that appointment are then treated as downstream users.
More on non-EU manufacturers and the only representative
Keep the appointment, the covered substances and the importers it covers on record. Without an only representative, each EU importer registers in its own name, which can mean several registrations for the same substance and different data access.
Safety Data Sheets
Article 31 requires suppliers to provide a safety data sheet for substances and mixtures meeting the hazard criteria and in certain other cases. The SDS must be consistent with the chemical safety report where one is required and must be updated when new hazard information or a restriction or authorisation becomes available.
More on safety Data Sheets
Keep SDS versions linked to the formulation and to every customer who received each version, so an update can be sent to the right people.
Candidate-List Substances in Articles
Article 33 requires any supplier of an article containing a candidate-list substance above 0.1% weight by weight to give recipients sufficient information to allow safe use, including at least the substance name. Consumers can request the same information and must receive it free of charge within 45 days.
Worked Example: Candidate List Update Review CL-2026-07
- Update publishedRegulatory lead logs new entries
- +5 daysSupplier declarations requested for affected articles
- +20 daysArticle PK-118 found above 0.1% w/w
- +25 daysCustomer information sent with substance name
- +10 yearsEarliest disposal of the review record
More on candidate-List Substances in Articles
This affects plastics, packaging and component suppliers, not only chemical makers. Collect supplier declarations and re-check them each time the candidate list is updated.
Records, and where V5 fits
Article 36 requires manufacturers, importers, downstream users and distributors to keep the information they need for their REACH duties for at least 10 years after they last manufactured, imported, supplied or used the substance or mixture. V5 keeps formulations, supplier declarations, SDS versions and customer shipments linked, with revision history.
More on records, and where V5 fits
It does not prepare registration dossiers or classify substances. Your regulatory team and registrants decide registration strategy, classification and SDS content.
Questions
When is REACH registration required?
Article 6 requires registration by the manufacturer or importer for substances at 1 tonne or more per year, unless an exemption applies.
Can a non-EU manufacturer register directly?
No, but under Article 8 it can appoint an EU-established only representative to fulfil the importers' registration obligations.
What is the 0.1% article threshold?
Article 33 requires suppliers of articles containing a candidate-list substance above 0.1% weight by weight to give recipients information for safe use.
How long must REACH information be kept?
Article 36 requires at least 10 years after the actor last manufactured, imported, supplied or used the substance or mixture.
Practical orientation, not legal advice. Rules differ by jurisdiction; your quality and compliance team decides what applies.
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