The European Union treats SDIC and TCCA as biocides — a category with tighter regulation than pesticides. Non-compliance means product seizure, fines up to €50,000, and blacklisting. This guide walks EU importers through the 4-pillar compliance framework.
1. Biocidal Products Regulation (BPR) – The Main Framework
Regulation (EU) 528/2012 (BPR) governs all antimicrobial products sold in the EU. For SDIC and TCCA:
- Active substance approval: both SDIC (Product Type 1-5) and TCCA (PT 2, 3, 4, 5, 11, 12) are on Union List of approved active substances
- Article 95 List: your active substance supplier (or you) must be on Article 95 List of Approved Suppliers. Chinese TCCA producers like Occidental, Novum Alva, and Shilan are on Article 95 List.
- Product Authorization: the finished biocidal product needs authorization at either EU Union level (Union Authorisation) or Member State level (National Authorisation)
2. Product Types (PT) Relevant to SDIC/TCCA
| PT | Description | SDIC | TCCA |
|---|---|---|---|
| PT 1 | Human hygiene | ✓ | – |
| PT 2 | Disinfectants for private and public health areas | ✓ | ✓ |
| PT 3 | Veterinary hygiene | ✓ | ✓ |
| PT 4 | Food and feed area | ✓ | ✓ |
| PT 5 | Drinking water | ✓ | ✓ |
| PT 11 | Preservatives for cooling systems | – | ✓ |
| PT 12 | Slimicides (pulp/paper) | – | ✓ |
3. REACH Registration
Under REACH Regulation (EC) 1907/2006:
- Imports > 1 tonne/year require REACH registration with ECHA
- Both SDIC (EC 220-767-7) and TCCA (EC 201-782-8) are pre-registered
- Full registration cost: €5,000-50,000 per substance (varies by tonnage band)
- Alternative: buy from Only Representative (OR) or Downstream User model
Most importers use their supplier’s OR to avoid registration cost. Shilan Chemical’s designated OR in Belgium covers customer registrations.
4. CLP Labeling (GHS-Based)
Every SDIC/TCCA package must carry CLP-compliant label:
For SDIC:
- Signal word: WARNING
- Hazard pictogram: Oxidizer flame (GHS03), Exclamation (GHS07), Environment (GHS09)
- H-statements: H272 (may intensify fire), H302 (harmful if swallowed), H319 (eye irritation), H335 (respiratory irritation), H410 (very toxic to aquatic life)
- P-statements: full list per formulation
For TCCA:
- Signal word: DANGER
- Hazard pictograms: Oxidizer flame (GHS03), Corrosion (GHS05), Environment (GHS09)
- H-statements: H272, H302, H319, H335, H410
- Additional: EUH031 (contact with acids liberates toxic gas)
5. Language Requirements
Labels must be in the official language(s) of the destination Member State:
- Germany: German
- France: French
- Spain: Spanish (Basque, Catalan in some regions)
- Italy: Italian
- Poland: Polish
- Netherlands: Dutch
- Multi-language accepted if distributed across borders
6. Import Duties and VAT
| Item | Rate |
|---|---|
| MFN Customs Duty on Chinese TCCA | 5.5% |
| Anti-dumping duty on Chinese TCCA | 7.3-42.6% (varies by producer) |
| Standard VAT (Germany) | 19% |
| Standard VAT (France) | 20% |
| Standard VAT (Italy) | 22% |
| Standard VAT (Poland) | 23% |
VAT is reclaimable if you are a B2B importer registered for VAT in destination country.
7. Customs Documentation Package
- Commercial invoice with EORI number of importer
- Packing list
- Bill of Lading
- Certificate of Origin (Form A for GSP if applicable, or standard CO)
- MSDS in destination language
- CLP-compliant label preview
- REACH registration number or OR letter
- Article 95 List declaration from active substance supplier
- National biocidal product authorization (or transitional derogation letter)
8. National Biocidal Product Authorization
Even with approved active substance, each finished product needs national authorization. Timeline and cost vary:
| Country | Timeline | Fee |
|---|---|---|
| Germany (BAuA) | 18-30 months | €10,000-30,000 |
| France (ANSES) | 12-24 months | €8,000-25,000 |
| Netherlands (Ctgb) | 12-18 months | €6,000-18,000 |
| UK (HSE, post-Brexit) | 18-24 months | £8,000-20,000 |
9. FAQ
Q: Can I sell TCCA on Amazon.de without authorization?
A: No. Amazon EU marketplaces require BPR-compliant listings. Non-compliant sellers face account termination and product removal.
Q: What about UK post-Brexit?
A: UK operates its own GB BPR (parallel to EU BPR). Need separate UK REACH + GB BPR authorization. Northern Ireland still follows EU BPR.
Q: Are transitional derogations available?
A: Yes, for products with active substance under review. Check your specific PT and country. This is why many Chinese TCCA is currently sold in EU under transitional letters.
Q: How to verify a supplier is on Article 95 List?
A: Check ECHA website: https://echa.europa.eu/information-on-chemicals/active-substance-suppliers
EU-Compliant SDIC/TCCA
Shilan Chemical is Article 95-listed and provides EU importers with REACH OR support, CLP-compliant labels in 12 languages, and multi-country BPR documentation. Read our MSDS/COA verification guide or request EU compliance package.