EU REACH COMPLIANCE

Practical Guide for Indian Chemical and Article Exporters

This guide provides a comprehensive practical reference for Indian exporters of chemicals, mixtures, and articles (manufactured goods containing chemicals) on their obligations under EU REACH — Regulation (EC) No 1907/2006 — as amended. It covers registration, SVHC obligations, restrictions, Safety Data Sheets, and the Only Representative system.

1. REACH — Scope and Core Principle

REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) is the EU's primary chemicals regulation, in force since 1 June 2007. Its core principle is "no data, no market" — chemical substances manufactured in or imported into the EU above defined volume thresholds must be registered with the European Chemicals Agency (ECHA) before they can be placed on the EU market.

REACH applies to:

Substances on their own (e.g. pure chemicals, solvents, dyes).

Substances in mixtures (e.g. paints, cleaning products, adhesives, lubricants).

Substances in articles (e.g. textiles, furniture, electronics, machinery, plastic goods) — to the extent the substance is present above 0.1% w/w and is on the SVHC Candidate List.

Who bears REACH obligations? REACH obligations fall primarily on EU-established manufacturers and importers. Indian exporters are not directly subject to REACH — but their EU buyers (importers) are, and cannot fulfil their REACH obligations without data and cooperation from Indian suppliers. In practice, REACH obligations flow down the supply chain to Indian exporters through contractual requirements and information requests.

2. REACH Registration — The Tonnage Trigger

Substances manufactured in or imported into the EU must be registered with ECHA if the volume meets or exceeds 1 tonne per year (per manufacturer or importer). Registration is phased by volume:

For Indian exporters supplying substances to EU importers at volumes above 1 tonne per year, the EU importer must either: (a) hold a valid REACH registration for the substance; or (b) appoint an Only Representative (OR) — a legal entity established in the EU — who registers the substance on behalf of the non-EU manufacturer.

3. The Only Representative (OR) — Key Tool for Indian Exporters

The Only Representative (OR) is a legal entity established in the EU appointed by a non-EU manufacturer (the Indian exporter) to fulfil the REACH registration obligations that would otherwise fall on the EU importer. Key points:

The OR must be a natural or legal person established in the EU — not the EU importer themselves.

The OR registers the substance with ECHA in its own name, on behalf of the Indian manufacturer.

Once an OR is appointed, the EU importers who import the substance from that manufacturer are exempt from REACH registration obligations for that substance (they become "downstream users").

The Indian manufacturer retains full control over its REACH registration data — the EU importers cannot access the registration dossier details.

The OR does not need to be in any particular EU country — most OR service providers operate EU-wide.

When to use an OR: The OR system is most useful when the Indian manufacturer supplies to multiple EU importers, or when the manufacturer wishes to protect its REACH registration data from being shared with competitors among its EU buyer base. The OR acts as a single point of registration, regardless of how many EU buyers the Indian supplier has.

Finding an OR: Several specialised consultancies provide Only Representative services — including REACH regulatory consultancies, law firms, and subsidiaries of large testing/inspection companies (SGS, Intertek, Bureau Veritas all offer OR services). The cost typically includes a registration fee plus an annual maintenance fee.

4. SVHC — Substances of Very High Concern

4.1 What Are SVHCs?

SVHCs are substances identified by ECHA as having serious and often irreversible effects on human health or the environment. They include:

CMR substances (Carcinogenic, Mutagenic, or Toxic for Reproduction) Category 1A or 1B.

PBT substances (Persistent, Bioaccumulative, and Toxic).

vPvB substances (very Persistent and very Bioaccumulative).

Substances of equivalent concern (e.g. endocrine disruptors).

SVHCs are added to the ECHA Candidate List (officially: List of Substances of Very High Concern for Authorisation) through an ongoing process. As of 2024, the Candidate List contains over 240 substances and is updated twice per year. The full current list is available at echa.europa.eu/candidate-list-table.

4.2 SVHC Obligations for Articles

If an article (manufactured product) imported into the EU contains an SVHC at a concentration above 0.1% by weight of the article, the EU importer must:

Notify ECHA if the annual volume imported exceeds 1 tonne per year. Notification is made through ECHA's SCIP database.

Provide information to downstream users (business customers) upon request, within 45 days — sufficient information to allow safe use of the article, at minimum the name of the SVHC and its concentration.

Provide information to consumers (end users) upon request, within 45 days — same minimum information.

What does this mean for Indian exporters? EU buyers will typically include a REACH SVHC clause in their supply contracts, requiring Indian suppliers to: (a) declare whether the supplied product contains any SVHC above 0.1% w/w; (b) provide an updated declaration whenever the ECHA Candidate List is updated; and (c) cooperate with any REACH substance information request from the EU buyer within the 45-day response window.

5. REACH Restrictions — Annex XVII

REACH Annex XVII contains restrictions on the manufacture, use, or placing on the market of certain hazardous substances, mixtures, and articles in the EU. Restrictions apply regardless of REACH registration status. Key restrictions relevant to Indian exporters include:

Asbestos: Total prohibition — all forms of asbestos and articles containing asbestos may not be placed on the EU market.

Lead in PVC: Restrictions on lead compounds as stabilisers in PVC.

Cadmium: Restrictions on cadmium in plastic articles, brazing alloys, and plating.

Certain phthalates (DEHP, DBP, BBP, DIBP): Restricted in consumer articles, toys, and childcare items.

Polycyclic aromatic hydrocarbons (PAHs): Restricted in rubber and plastic articles intended for consumer use (e.g. tyres, handles, tools).

Nonylphenols and nonylphenol ethoxylates: Restricted in textiles and leather products.

Certain azo dyes: Restricted in textiles and leather articles where they may release carcinogenic aromatic amines upon reduction.

Formaldehyde: Restrictions in certain wooden articles.

This list is not exhaustive. The full Annex XVII restriction list must be reviewed for any substance present in your product above the applicable concentration limit.

6. REACH Authorisation — Annex XIV

Substances on the REACH Authorisation List (Annex XIV) may only be used in the EU if the manufacturer or downstream user has obtained specific authorisation from ECHA for that use. For Indian exporters, this is most relevant where the EU importer processes or uses the imported substance in an industrial application and requires authorisation for that use. Indian suppliers of Annex XIV substances should be aware that their EU buyers may face authorisation timelines that could affect demand.

7. Safety Data Sheet (SDS) Requirements

A REACH-compliant Safety Data Sheet (SDS) must accompany every shipment of a hazardous substance or mixture supplied to EU buyers. The SDS must:

Comply with Annex II of REACH (as amended by Regulation (EU) 2020/878 — the new SDS format effective from January 2023) — 16 sections covering identification, hazard identification, composition, first aid, firefighting, accidental release, handling and storage, exposure controls, physical and chemical properties, stability and reactivity, toxicological information, ecological information, disposal, transport, regulatory information, and other information.

Be in the language of the EU member state of receipt — not just in English. A translated SDS is required for each country of destination.

Be kept up to date — revised when new information on hazards or risk management becomes available, when authorisation is granted or refused, or when a restriction is adopted.

Include the REACH registration number in Section 1 (where the substance is registered).

Include exposure scenarios in the extended SDS (e-SDS) where a Chemical Safety Report has been prepared.

8. REACH Compliance Checklist for Indian Exporters

Doc 57 — EU REACH Compliance Guide — Neutral Template