Importation of cyclohexanone into the European Economic Area triggers a bifurcated compliance obligation under Regulation (EC) No 1907/2006 (REACH) and Regulation (EC) No 1272/2008 (CLP). The substance, assigned CAS 108-94-1, EC 203-631-1, and Annex VI Index 606-010-00-7, is a six-member cyclic ketone with a normal boiling point of 155.6 °C at 101.3 kPa and a closed-cup flash point of 44 °C. The compliance workflow commonly designated REACH Registration & SDS for Cyclohexanone Imports requires the EU importer to ascertain whether the annual imported volume reaches the 1 t/a registration threshold, to determine whether an Only Representative has been appointed under Article 8 of REACH, and to obtain a Safety Data Sheet conforming to Annex II of REACH before first supply. Transport labelling under ADR does not substitute for registration and SDS transmission.

What registration duty arises when cyclohexanone is imported into the EEA?

Where cyclohexanone is imported as a substance on its own or in a mixture at or above 1 t/a, the importer becomes a registrant under Article 6 of REACH unless the non-EU manufacturer has appointed an Only Representative under Article 8. A new registration requires an inquiry dossier through REACH-IT under Article 26; the dossier must identify the imported tonnage band, the legal entity, and the exact composition of the cyclohexanone grade. Registration obligations are tonnage-dependent and are not removed by the existence of a harmonised CLP entry. A non-EU supplier SDS or a TSCA-based safety document does not satisfy REACH Article 6 because the registration dossier must be generated by an EU-established legal entity for the imported quantities.

When an Only Representative is appointed, the non-EU manufacturer must identify the EU importer in the registration dossier, and the importer is classified as a downstream user. The downstream user must verify that its use is covered in the registration exposure scenario and that the supplier SDS carries the registration number in Section 1. If the use is outside the exposure scenario, the downstream user may be obliged to submit a downstream user chemical safety report under Article 37. In the absence of an Only Representative, the EU importer becomes the registrant and should participate in the existing Substance Information Exchange Forum for cyclohexanone rather than duplicating vertebrate tests; this is a data-sharing obligation under Article 29 and Article 30.

Safety Data Sheet content obligations for imported cyclohexanone cargoes

For cyclohexanone, the SDS is mandatory because the harmonised classification includes Flammable Liquid 3, Acute Toxicity 4 via oral, dermal and inhalation routes, Skin Irritation 2, Eye Irritation 2, and Specific Target Organ Toxicity Single Exposure 3; corresponding hazard statements H226, H302, H312, H332, H315, H319, H335, and H336 must be reproduced in Section 2. The SDS must follow Annex II to REACH as amended by Regulation (EU) 2020/878. Section 1.3 should carry the REACH registration number only after the number has been issued through REACH-IT; a pending registration cannot lawfully state a registration number before the ECHA decision is confirmed.

The SDS must be supplied in the official language of the Member State where the cyclohexanone is placed on the market, in accordance with Article 31(5) of REACH. An English-language SDS is insufficient for workplaces in France, Germany, Poland, Spain, or Italy that require the national-language version. For transport, the accompanying dangerous goods transport document must include UN 1915, Class 3, Packing Group III, and the proper shipping name “Cyclohexanone.” Section 14 of the SDS should not be used as the transport document itself. Section 7 should define storage separation from strong oxidizers and strong bases because the ketone can undergo exothermic condensation and oxidation reactions; Section 10 should state the potential heat release from aldol condensation if the stored liquid is contaminated with alkaline residues.

When strictly controlled intermediate status applies to caprolactam processors

Cyclohexanone imported for immediate conversion to cyclohexanone oxime and subsequently to caprolactam may qualify as an isolated intermediate under strictly controlled conditions under Article 17 or Article 18 of REACH. In that configuration the registrant may submit reduced information under Annex VII rather than the full Annex X dataset, provided that closed-system handling, containment of fugitive emissions, and separation of residual substance are documented. Strictly controlled conditions must be demonstrated with equipment specifications such as sealed pump types and closed sampling loops, not merely claimed. If the same batch is later diverted to solvent blending or adhesive formulation, the intermediate exemption is not applicable and full registration obligations attach to the solvent or formulation use volume.

Registrations above 10 t/a for cyclohexanone require a chemical safety report with exposure scenarios. The importer or downstream user must match imported quantities against use descriptors such as industrial use in coating formulation, use as a process solvent, or manufacture of caprolactam. Cyclohexanone is also used in polyvinyl chloride solution preparation, nitrocellulose lacquers, epoxy resin viscosity adjustment, and metal degreasing. Each use must be covered by an exposure scenario in the registration. If the EU importer formulates cyclohexanone into a thinner mixture, the mixture classification must be calculated under CLP and the SDS for the mixture must include the cyclohexanone concentration and the mixture-specific acute or irritation classifications. Poison centre notification under Annex VIII to CLP applies at the mixture level, not to the neat solvent import.

Because the closed-cup flash point is 44 °C, normal storage at ambient warehouse temperatures below the flash point does not remove vapour flashback risk in warmer zones. The lower explosive limit in air is reported at approximately 1.1 vol% and the upper explosive limit at approximately 9.4 vol%. Tanks for bulk cyclohexanone should be inerted or vented to a closed flare if the headspace temperature cannot be maintained below 38 °C. Loading and unloading should use dry-break couplings and vapour balancing to reduce vapour drift. Water solubility of approximately 8.7 g/100 mL at 20 °C means that spill containment should not rely solely on water dilution; the dissolved fraction can pass through drainage if not intercepted. Section 6 of the SDS should specify alcohol-resistant foam, dry chemical, or carbon dioxide extinguishing media, and Section 13 should identify sealed incineration or licenced solvent recovery as disposal routes.

Commercial cyclohexanone imported for solvent or intermediate service typically has a minimum purity specification of 99.5 wt%; residual cyclohexanol and water levels must be reported in Section 3.1 of the SDS because both influence downstream polymer solubility and oxime formation stoichiometry. In solvent applications such as nitrocellulose lacquers and vinyl chloride copolymer coating formulations, low water content reduces phase separation during high-shear mixing. In caprolactam production, the molar ratio of hydroxylamine to cyclohexanone must account for residual cyclohexanol; deviations in feed ketone content shift oximation conversion and increase ammonium sulfate recycle load in the Beckmann rearrangement step. These process-specific impurity boundaries are included in the registration dossier only when the importer or Only Representative has provided measured batch data across the supply chain.