🌍 Introduction: Why REACH Compliance Is Non-Negotiable for EU Exports
If you’re a chemical manufacturer in India (or any non-EU country) planning to export to the European Union, then REACH is the most important regulation you need to comply with.
REACH stands for:
Registration, Evaluation, Authorisation and Restriction of Chemicals
Managed by ECHA (European Chemicals Agency), REACH ensures that chemicals sold in the EU do not harm human health or the environment.
Since 2007, REACH has impacted over 30,000 chemicals. In 2025, it’s stricter than ever—with penalties, bans, and rejections for non-compliant shipments.
This guide gives you a complete REACH compliance checklist, step-by-step process, documents, deadlines, and costs—tailored for Indian chemical exporters.
🧾 Who Needs to Be REACH Compliant?
You must comply with REACH if you are:
✅ Exporter / Manufacturer / Formulator outside the EU who wants to:
- Sell raw chemicals (solvents, dyes, APIs, acids)
- Sell finished mixtures (like adhesives, agrochemicals, paints)
- Export chemicals above 1 tonne/year to the EU
❌ You don’t need REACH if you only export:
- Machinery (non-chemical)
- Non-EU destinations
- Under 1 tonne/year per substance
🧪 What Does REACH Involve?
REACH requires you to:
- Register each chemical substance (not product) with ECHA
- Submit a technical dossier + safety data
- Ensure proper labelling, SDS, and packaging
- Partner with an EU-based Only Representative (OR)
- Keep track of annual tonnage and uses
✅ REACH Compliance Checklist for 2025
Let’s break it down step-by-step. Here’s your REACH roadmap:
✅ 1. Know the Substance You’re Exporting
Start by identifying the chemical substance (not the formulation):
- Trade name
- IUPAC name
- CAS number
- EC number
- Purity (%), impurities
- Annual volume exported to EU
👉 Example:
- Trade name: Isopropyl Alcohol
- CAS: 67-63-0
- Volume: 15 tonnes/year
✅ 2. Check If the Substance Is Already Registered
Use the ECHA database:
🔗 https://echa.europa.eu/information-on-chemicals
Search by:
- CAS No
- EC No
- Chemical name
👉 If someone else already registered it, you can join a SIEF (Substance Information Exchange Forum) and share data.
✅ 3. Choose a REACH Registration Path
Tonnage/Year | Requirement |
---|---|
<1 T | No registration |
1–10 T | Basic registration + reduced data |
10–100 T | Full technical dossier + safety data |
>100 T | Extended study and CSR (Chemical Safety Report) |
✅ 4. Appoint an ‘Only Representative’ (OR) in the EU
Non-EU companies must appoint an EU-based legal entity as their Only Representative (OR).
The OR:
- Registers substances on your behalf
- Submits SDS and compliance files
- Acts as your legal contact point with ECHA
⚠️ Tip: Choose a reliable OR. Their credibility affects your shipment acceptance.
🔍 Popular OR service providers:
- REACHLaw
- ToxMinds
- Yordas Group
- Lisam Systems
✅ 5. Prepare and Submit a Technical Dossier
A REACH dossier includes:
Section | Details |
---|---|
Identity | CAS, EC number, name, impurities |
Manufacture | Process, scale, location |
Use | Industrial, consumer, intermediate, etc. |
Classification | Hazard classes under CLP |
Physico-chemical | Boiling point, flash point, solubility |
Toxicology | Acute/chronic tests, reproductive, etc. |
Ecotoxicology | Aquatic, soil, bioaccumulation |
Guidance | Safe use, risk mitigation |
SDS | Safety Data Sheet (Section 1–16) |
💻 Submit via ECHA’s REACH-IT platform
🧪 If you’re a small manufacturer, you can use IUCLID software to prepare the file.
✅ 6. Pay the ECHA Fees
2025 REACH fee structure:
Volume | SME Fee (EUR) | Regular Fee (EUR) |
---|---|---|
1–10 T | €1,200 | €3,300 |
10–100 T | €3,000 | €8,300 |
100–1,000 T | €8,000 | €21,500 |
>1,000 T | €22,000 | €59,000+ |
💡 Tip: MSMEs in India can claim 35–50% subsidy for REACH-related compliance under Technology Upgradation schemes
✅ 7. Labeling + SDS + Packaging Compliance
For every REACH-compliant shipment, ensure:
- CLP Compliant Labels with hazard pictograms
- EU-format SDS (16-section Safety Data Sheet)
- Tamper-proof packaging with REACH reference
- OR’s contact on the label
🚫 Mistakes here can lead to:
- Rejection by EU customs
- Blacklisting
- Fines up to €50,000 in certain EU countries
✅ 8. Track Tonnage & Uses Annually
Every year, update your:
- Volume exported per substance
- Usage category (industrial, end-user, etc.)
- Supply chain tracking
Use software tools like:
- Chemeter
- IUCLID
- Yordas Hive
✅ 9. Follow Authorization & Restriction Lists
REACH includes two key lists:
List | Meaning |
---|---|
SVHC (Substance of Very High Concern) | Needs authorisation for use |
Annex XVII Restricted List | Prohibited uses (e.g., phthalates, heavy metals) |
📍 Check if your product contains any SVHC or restricted substance.
🔗 SVHC List: https://echa.europa.eu/candidate-list-table
✅ 10. Be Prepared for Audits and Inquiries
Your OR or buyer may request:
- REACH certificate copy
- Pre-registration number
- Safety study summaries
- ECHA confirmation
Keep all records updated and ready to submit.
📦 Documents Required for REACH Registration
Document | Purpose |
---|---|
Chemical name + CAS | Basic identity |
SDS | Safety information |
Impurity profile | For classification |
Test data | Physical, toxic, eco-toxic |
Lab reports | OECD compliant preferred |
Use map | How buyers will use it |
Only Representative Agreement | Legal proof |
📈 High CPC Keywords You Can Target
Keyword | CPC (INR) |
---|---|
“REACH compliance India” | ₹240 |
“how to register for REACH” | ₹260 |
“EU chemical export rules 2025” | ₹200 |
“appoint REACH only representative” | ₹290 |
“REACH SDS format” | ₹220 |
Monetize through:
- Export consultants
- REACH compliance agencies
- SDS software providers
- International freight forwarders
🧠 Bonus: Common Mistakes to Avoid
Mistake | Risk |
---|---|
Wrong tonnage estimate | Higher fees or non-compliance |
No OR appointed | Legal rejection |
Outdated SDS | Customs rejection |
Missing impurity data | Labeling mismatch |
Ignoring SVHC list | Total ban in EU |
✅ Conclusion: Start REACH Compliance Early to Save Time and Money
If you’re serious about exporting your chemicals to Europe in 2025, then REACH is not optional. It’s a legal and safety requirement that builds trust with European buyers, importers, and regulators.
Start early — REACH registration can take 3–6 months depending on the complexity and volume.
A REACH-compliant exporter:
- 🏭 Wins long-term buyers
- 🌍 Accesses 27+ EU countries
- 💼 Avoids legal trouble
- 💰 Commands higher margins