Paraffin Solids EU REACH Compliance Test Report Process
Date：2026-08-31 10:04:26 Classification
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EU REACH Compliance Testing Report Process for Solid Paraffin Wax
Solid paraffin wax (CAS 8002-74-2) is a common industrial raw material. Exporting it to the EU requires REACH compliance depending on its intended use and tonnage. The following is the core process:
I. Compliance Assessment Beforehand
1. Identity Confirmation: Paraffin wax is generally classified as a substance; a few refined products may be considered mixtures.
2. Annual Import Volume: ≥1 ton/year requires registration (tonnage determines testing data requirements; >10 tons requires a Chemical Safety Report (CSR)).
3. Use Classification: Industrial (candles, packaging, rubber) vs. Cosmetic/Food Grade (subject to additional regulations).
II. Registration/Notification Path
| Situation | Process
| Annual imports ≥1 ton (>10 tons require CSR) | Submit registration dossier to ECHA through a Sole Representative (OR)
| Pre-register existing substances | Complete pre-registration during the transition period and enjoy the grace period.
| Annual imports less than 1 ton | No registration required, but must comply with the restricted list and SVHC obligations.
III. Core Testing Items
As a hydrocarbon mixture, paraffin wax is primarily tested for the following aspects:
1. Physicochemical Properties: Melting point, flash point, viscosity, oil content
2. 3. Toxicological Testing: Acute toxicity, skin irritation, sensitization (GLP testing required for tonnage ≥ 10 tons)
4. Ecotoxicity: Impact on aquatic organisms, biodegradability
5. Impurity Analysis: Focus on restricted substances such as polycyclic aromatic hydrocarbons (PAHs), heavy metal residues, and polycyclic aromatic hydrocarbons (PAHs)
6. SDS (Safety Data Sheet): Compliant with Annex II requirements (16 items)
IV. Application Process
| Steps | Content
| ① Appoint a Sole Representative (OR) | Must be appointed for non-EU companies
| ② Data Gap Analysis | Assess existing data vs. REACH requirements
| ③ Test Execution | Data issued by an EU-certified laboratory (DEZW Testing CNAS Registration No.: L8083)
| ④ Dossier Preparation | Complete IUCLID software, ensuring completeness of technical documentation
| ⑤ ECHA Submission | Submit registration and pay fees online
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