As an industrial polar solvent, Sulfolane's compliance is centered on chemical supervision. Internationally, REACH registration (≥1 ton/year) and compliance with CLP classification and labeling requirements are mandatory in the EU; the US requires compliance with TSCA declaration specifications. In China, it is classified as a general industrial chemical with no hazardous chemical license required, but basic documents such as MSDS and COA shall be provided. Supplier qualifications shall include chemical business scope, ISO 9001 and regional compliance certificates. Packaging and transportation shall comply with GHS labeling and airtight leak-proof requirements. Strict control over SVHC and impurity residues shall be implemented. Contracts shall clearly stipulate quality standards, compliance guarantees and recall clauses. Detailed explanations are given below from the aspects of international regulations, supplier qualifications, packaging & transportation, restriction & risk control, contract & traceability.
EU REACH: Classified as a conventional non-SVHC substance. REACH registration is mandatory for exports of ≥1 ton per year, to be handled by an EU Only Representative (OR).
EU CLP: Classified as GHS07 (Harmful) with hazard statement H302 (Harmful if swallowed). Labels must be affixed with GHS pictograms, signal word Warning, as well as hazard and precautionary statements.
US TSCA: Listed in the TSCA Inventory. Importation shall comply with TSCA declaration requirements with SDS and ingredient statement provided.
China: Not included in the Catalogue of Hazardous Chemicals, categorized as a general industrial chemical. MSDS, COA and production qualifications are required; it is not subject to precursor explosive/precursor drug control.
Business License (business scope covering chemical raw materials / solvents)
Production License / relevant hazardous chemical qualifications (if applicable)
ISO 9001; REACH Registration Certificate (EU market); TSCA Compliance Statement (US market)
Complete 16-section MSDS (GHS standard + local language), COA (purity ≥ 99.5%)
Packaging: 200L galvanized iron drum / 1000L IBC tank, airtight and leak-proof, stored away from oxidants and strong acids.
Labeling: GHS standard + Chinese-English bilingual, including product name, CAS number, purity, hazard identification, emergency contact number, batch number and validity period.
Transportation: Non-dangerous goods but transported in accordance with IMDG/IATA regulations; No UN number assigned, SDS must be accompanied with the shipment.
SVHC Screening: Check the ECHA Inventory every six months to ensure SVHC content does not exceed 0.1%.
Impurity Control: Focus on controlling moisture, free acid, heavy metals and sulfur oxide residues.
Environmental Compliance: Comply with RoHS and restrictions under REACH Annex XVII; Discharge of sulfur-containing waste gas is prohibited.
Clarify quality standards (≥99.5%), testing methods, batch traceability and liability division.
Agree on REACH/TSCA compliance guarantee, authenticity and validity of SDS/COA, and recall provisions for non-conforming products.
As a polymer additive, its compliance focuses on additive supervision and food contact scenarios. It enjoys polymer registration exemption under EU REACH, but SVHC screening (≤0.1%) and RoHS 2.0 compliance are required. Approved by US FDA for indirect food contact with a compliance letter required. Suppliers shall hold relevant polymer additive qualifications, ISO certifications and RoHS/FDA documents. Product heavy metal residues and food contact migration shall be strictly controlled; packaging shall be moisture-proof and light-shielding. Contracts shall specify compliance requirements and recall liabilities for non-conforming products. Detailed explanations are as follows.
EU REACH: Exempted from polymer registration, but monomer/impurity assessment is required; SVHC screening (≤0.1%) is mandatory.
EU RoHS 2.0: Full compliance (lead/cadmium/mercury/hexavalent chromium/phthalate-free) with RoHS test report provided.
US FDA: Approved under 21 CFR 178.2010 for indirect food contact (packaging/tableware), FDA compliance letter is required.
China: Comply with GB 38400 (RoHS) and GB 2760 (Food Contact); No mandatory license for industrial grade, MSDS/COA are required.
Business License (polymer additives / additives)
ISO 9001, ISO 14001; REACH Compliance Statement, RoHS Report, FDA Food Contact Letter.
GHS-standard MSDS, COA (active ingredient ≥98%, volatile matter ≤0.5%).
Packaging: 25kg paper bag / paper drum, moisture-proof and light-shielding, kept away from heat sources and UV rays.
Labeling: GHS standard + bilingual labeling, including product name, CAS number, batch number, purity, RoHS/FDA marking and storage conditions.
Transportation: General chemical goods with no UN number; Avoid exposure to sunlight, rain and high temperature.
Strict SVHC Control: Free of SVHC exceeding 0.1% (e.g. heavy metals, phthalates, polycyclic aromatic hydrocarbons).
Heavy Metal Residue: Pb＜10ppm, Cd＜1ppm, Hg＜1ppm (RoHS limit values).
Food Contact Migration: Overall migration ≤18mg/dm², specific migration ＜0.05mg/kg.
Clarify RoHS/FDA compliance, food contact grade, batch traceability and quality objection period.
Agree on recall and compensation liabilities for excessive SVHC or unqualified migration volume.
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