What is the tonnage threshold for REACH on phthalic anhydride?

Registration required for any importer or manufacturer placing >1 t/year on the EU market

CAS 85-44-9 · REACH · European Union

Phthalic anhydride under REACH

C8H4O3 · 邻苯二甲酸酐

Status: Registered. Phthalic anhydride is fully registered under REACH at the highest tonnage band (>1,000,000 tonnes/year). **Distinguishing pattern: closes ortho-xylene (batch 21 OX isomer ~15%) chain via OX oxidation route + Resp. Sens. 1 (H334) (similar to MDI batch 30 + TDI batch 31 sensitiser pattern) + downstream phthalate-plasticizer cascade (DOP / DEHP SVHC + DINP + DIDP) + unsaturated polyester resin (UPR) + alkyd resin chains + Aoxing Yangzhou + Sinopec + Tianjin Petrochem leadership (NEW combined).** Reg (EC) 1272/2008 harmonised: Acute Tox. 4 oral / inhalation + Eye Dam. 1 + Skin Sens. 1 + Resp. Sens. 1 + STOT SE 3. NOT SVHC. NOT Annex XIV. NOT a drug precursor. NO active EU AD case on Chinese-origin phthalic anhydride currently.

Phthalic anhydride is fully REACH-registered with **Acute Tox. 4 + Resp. Sens. 1 + Skin Sens. 1 hazard profile**. **Closes ortho-xylene batch 21 OX isomer chain via OX oxidation route** (~95% globally). NOT SVHC despite Resp. Sens. 1. NO active EU AD case. NOT in CBAM Phase 1. Major Chinese producers: **Aoxing (Yangzhou Jiangsu; verify the most recent phthalic anhydride nameplate against the Aoxing corporate site before relying)**, Sinopec (Yangzi + Shanghai + Beijing), Tianjin Petrochem, Wanhua Chemical Yantai. China dominates global PA capacity (~50%, ~3-4 Mt/yr). **Downstream phthalate-plasticizer cascade**: DEHP / DOP + DBP + BBP + DIBP all on REACH SVHC + Annex XIV; phthalic anhydride is upstream feedstock. End-use mix: phthalate plasticizers (~55%, DOP / DEHP / DINP / DIDP for flexible PVC), unsaturated polyester resin / UPR (~25%, gel coat + composite), alkyd resin (~15%, paint), other (~5%). Phthalate plasticizer transition to non-phthalate alternatives (DOTP, DINCH, DPHP) post-EU SVHC + Annex XIV.

Listing and threshold

Substance	Phthalic anhydride (CAS 85-44-9), C8H4O3
Regime	EU Regulation (EC) No 1907/2006: Registration, Evaluation, Authorisation and Restriction of Chemicals
Jurisdiction	European Union (EU-27 plus EEA: Iceland, Liechtenstein, Norway)
Status	Registered
Tonnage threshold	Registration required for any importer or manufacturer placing >1 t/year on the EU market

Classifications under this regime

Harmonised CLP classification: Acute Tox. 4 oral (H302), Acute Tox. 4 inhalation (H332), Eye Dam. 1 (H318), Skin Sens. 1 (H317), Resp. Sens. 1 (H334), STOT SE 3 (H335)
Signal word: DANGER
GHS pictograms: GHS05 (corrosion / eye damage), GHS07 (exclamation mark), GHS08 (health hazard, sensitiser)
IARC: nitric acid itself is not separately classified; occupational exposure to strong-inorganic-acid mists containing sulfuric acid was classified IARC Group 1 (laryngeal cancer) in Monograph Volume 54 (1992) (verify the current classification and Monograph volume against https://monographs.iarc.who.int/list-of-classifications before relying on the inorganic-acid-mist read-across for nitric acid)
NOT subject to Drug Precursors or Explosives Precursors scheduling
ADR / RID transport classification: Class 8 (corrosive substance) for some packaging configurations

Restrictions and conditions of use

NOT on REACH Annex XIV (Authorisation list)
NOT classified as SVHC
**Downstream phthalate-plasticizer cascade**: DEHP / DOP (CAS 117-81-7) IS SVHC + Annex XIV entry 4 (sunset 21 February 2015); BBP (CAS 85-68-7) IS SVHC + Annex XIV entry 5 (sunset 21 February 2015); DBP (CAS 84-74-2) IS SVHC + Annex XIV entry 6 (sunset 21 February 2015); DIBP (CAS 84-69-5) IS SVHC + Annex XIV entry 7 (sunset 21 February 2015). Verified against ECHA Annex XIV list at https://echa.europa.eu/authorisation-list. Phthalic anhydride is upstream feedstock for these phthalate plasticizers
NO active EU AD case on Chinese-origin phthalic anhydride currently
NOT in CBAM Phase 1 scope
EU Reg 10/2011 food-contact: phthalic anhydride monomer specific migration limit (SML applies)

Importer obligations

A non-EU producer cannot register directly under REACH. The EU importer of record must hold a registration or rely on an Only Representative (OR). **Resp. Sens. 1 + Skin Sens. 1 + Acute Tox. 4 hazard profile** drives substantial workplace exposure-control overhead + occupational asthma surveillance. Major Chinese producers: **Aoxing (Yangzhou Jiangsu; verify the most recent phthalic anhydride nameplate against the Aoxing corporate site before relying)**, Sinopec (Yangzi + Shanghai + Beijing), Tianjin Petrochem, Wanhua Chemical Yantai. EU domestic producers: Lanxess Krefeld, ExxonMobil Antwerp.

Required documents

REACH registration number on the EU side (registrant or OR-appointed)
Safety Data Sheet (SDS) compliant with REACH Annex II reflecting H302 / H317 / H318 / H332 / H334 / H335 classification
CLP-compliant labelling with GHS05 + GHS07 + GHS08 pictograms and DANGER signal word
Customs entry with HS code 291735 (phthalic anhydride)
ADR consignment note for transport (Class 8 or unclassified depending on form)

Common compliance traps

The pitfalls that have bitten importers on this lane in the past. None of these is theoretical.

**Closes ortho-xylene (batch 21 OX isomer ~15%) chain** via OX oxidation route
**Resp. Sens. 1 (H334)** drives workplace exposure-control + occupational asthma surveillance (similar to MDI batch 30 + TDI batch 31 sensitiser pattern)
**Downstream phthalate-plasticizer cascade**: DEHP / DOP + DBP + BBP + DIBP all on REACH SVHC + Annex XIV with sunset dates passed; phthalic anhydride is upstream feedstock for these plasticizers
NO active EU AD case on Chinese phthalic anhydride currently
NOT in CBAM Phase 1
Major Chinese producers: **Aoxing (Yangzhou Jiangsu; verify the most recent phthalic anhydride nameplate against the Aoxing corporate site before relying)**, Sinopec (Yangzi + Shanghai + Beijing), Tianjin Petrochem, Wanhua Chemical Yantai. China dominates global PA capacity (~50%, ~3-4 Mt/yr)
Production: ortho-xylene + air oxidation (~95% globally; Lurgi / SCM licensed catalysts); naphthalene oxidation legacy route (~5%)
End-use mix: phthalate plasticizers (~55%, DOP / DEHP / DINP / DIDP for flexible PVC + automotive + construction), unsaturated polyester resin / UPR (~25%, gel coat + composite + automotive + marine), alkyd resin (~15%, paint + coating), other (~5%)
**Phthalate plasticizer transition to non-phthalate alternatives** (DOTP, DINCH, DPHP) post-EU SVHC + Annex XIV listings

Where to read next

For substance-level identifiers (formula, molecular weight, SMILES, InChIKey), GHS hazard profile, IMDG transport class, and full sourcing reference for phthalic anhydride, see the CAS 85-44-9 sourcing reference.

For grade-by-grade buying notes, freight maths, supplier-tier pricing, and a worked landed-cost example, the phthalic anhydride cornerstone hub covers the full sourcing chain.

For the structure and history of REACH, see the REACH glossary entry.

Need cross-jurisdiction compliance support on this substance? Run it through the REACH / TSCA / IECSC / AICIS / K-REACH checker, or send us the substance and the destination and we will quote FOB China and CIF / DDP landed including the regulatory work on the destination side.

Cross-jurisdiction profile and sourcing references

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