The EU REACH Regulation (EC) No 1907/2006 governs the Registration, Evaluation, Authorisation and Restriction of Chemicals placed on the European Union market. For buyers importing chemicals from outside the EU, including from India, REACH is not only the supplier's problem: in many cases the EU importer carries the legal obligations. This article explains the basics. It is a general overview. For decisions on specific substances, consult the regulation, European Chemicals Agency (ECHA) guidance or a regulatory specialist.
The core principle: no data, no market
Under REACH, substances manufactured in or imported into the EU in quantities of one tonne or more per year per legal entity must generally be registered with ECHA before they can be placed on the market. Registration requires a dossier of information on properties, uses and safe handling, with data requirements increasing by tonnage band.
| Tonnage band (per year, per registrant) | Information requirements |
|---|---|
| 1 to 10 t | Annex VII: basic physicochemical, toxicological and ecotoxicological data |
| 10 to 100 t | Annex VIII, plus a Chemical Safety Report |
| 100 to 1,000 t | Annex IX, including longer-term studies |
| ≥ 1,000 t | Annex X, the most extensive requirements |
Registration applies to substances on their own, in mixtures, and in some cases in articles where the substance is intended to be released.
Who is responsible when you import
REACH obligations fall on legal entities established in the EU. A manufacturer in India cannot register directly. That leaves two routes:
- The EU importer registers. Each importer that brings in one tonne or more per year of a substance must hold its own registration, typically by joining the existing joint submission for that substance and paying for access to the shared data.
- The non-EU manufacturer appoints an Only Representative (OR). Under Article 8, a non-EU manufacturer, formulator or article producer may appoint an EU-based OR to register on its behalf. Importers buying from that manufacturer's covered supply chain are then treated as downstream users and do not need to register those volumes themselves.
If you are importing, ask your supplier whether an OR registration covers the substance, the tonnage and your company. Obtain written confirmation, including the registration number and the OR's details.
Exemptions that matter for laboratory and research buyers
Below one tonne
Imports below one tonne per year per legal entity are outside the registration obligation, though other REACH and CLP duties, such as SDS and labelling requirements, still apply. Many laboratory reagents fall into this category.
Scientific research and development
Substances used in scientific R&D, meaning experimentation, analysis or chemical research under controlled conditions, in volumes below one tonne per year, are exempt from registration.
PPORD
Product and process orientated research and development (PPORD) exemptions allow larger volumes to be used in development for up to five years, extendable in some cases, after notification to ECHA and under specified conditions.
Other exemptions
Substances used in medicinal products within the scope of the relevant EU medicines legislation are exempt from registration for that use, as are certain food and feed uses. Polymers are exempt, although their monomers may need registration. Isolated intermediates used under strictly controlled conditions have reduced information requirements. Each exemption has conditions, so check them carefully.
Beyond registration
Substances of very high concern
Substances meeting certain hazard criteria, such as carcinogens, mutagens, reproductive toxicants or persistent and bioaccumulative substances, can be identified as substances of very high concern (SVHC) and placed on the Candidate List. Candidate List status triggers communication duties in the supply chain.
Authorisation
SVHCs moved to Annex XIV of REACH can be used after the sunset date only with an authorisation for a specific use, unless an exemption applies.
Restrictions
Annex XVII lists restrictions on manufacture, use or placing on the market of certain substances, mixtures and articles, such as concentration limits in consumer products.
Safety Data Sheets and CLP
Suppliers placing hazardous substances or mixtures on the EU market must provide a Safety Data Sheet compliant with Annex II of REACH, in an official language of the member state. Classification, labelling and packaging are governed by the CLP Regulation (EC) No 1272/2008, which implements the GHS in the EU. As an importer, you become the supplier to your own customers and must ensure the SDS and label meet these requirements.
The United Kingdom
Since leaving the EU, Great Britain has operated its own regime, UK REACH, administered by the Health and Safety Executive, with its own registration deadlines and requirements. Northern Ireland remains within EU REACH under separate arrangements. EU registrations do not automatically cover Great Britain.
Practical checklist for EU buyers
- Estimate your annual import volume per substance, per legal entity.
- Check whether the substance is exempt for your use, for example scientific R&D below one tonne.
- If above one tonne, confirm whether your supplier's OR registration covers you, or plan your own registration.
- Check Candidate List, Annex XIV and Annex XVII status.
- Obtain an EU-compliant SDS and ensure labels meet CLP.
- Keep records of volumes and communications for at least ten years, as REACH requires for relevant information.
How we support EU buyers
When you request a quotation for delivery to the EU, tell us the expected annual volume and use. We will tell you what we know about the registration status of the manufacturer's supply chain, and provide the SDS and documentation available. Registration decisions ultimately rest with the importer, so confirm the position before placing volume orders.
FAQs
Do I need to register laboratory chemicals under REACH?
Usually not if volumes are below one tonne per year per legal entity, or if they are used for scientific R&D under one tonne. SDS and labelling rules still apply.
What is an Only Representative?
An EU-based entity appointed by a non-EU manufacturer to register substances under REACH on its behalf, so that EU importers in that supply chain are treated as downstream users.
Does EU REACH registration cover the UK?
No. Great Britain has its own UK REACH regime administered by the HSE, with separate registration requirements.