ECHA’s Guidance on Intermediate Substances

The chemical industry uses different categories of substances. On one hand are those placed on the market on their own or in mixtures while on the other hand, substances that are manufactured and subsequently transformed into other substances which are then placed on the market.

Both of these substance categories can pose risks to human health and the environment. As a result, the EU REACH regulation requires them to be registered should they meet the registration thresholds under the regulation. Substances used in the manufacture of other substances are technically referred to as intermediates.

While the chemical industry agreed that substances that are placed in the market on their own or in mixtures and which met the registration requirements under the REACH regulation were to be registered, the thought of subjecting intermediates to REACH registration did not appeal to the industry. The regulation however takes care of this, noting when and how an intermediate should be registered. The ECHA also published a guidance document on intermediates to steer the industry through the compliance process.

Article 3(15) of the REACH regulation defines an intermediate as:

A substance that is manufactured for and consumed in or used for chemical processing in order

to be transformed into another substance

Article 3 (Definitions) also defines the types of intermediates recognized by the regulation; non-isolated, on-site isolated and transported isolated intermediates. The ECHA guidance offers detailed explanations on what each of the intermediate categories entail.

According to the ECHA guidance on intermediates, all non-isolated intermediates are out of the scope of the REACH regulation in line with Article 2 (1)(c) of the regulation. Appendix IV of the guidance however notes that isolated intermediates are covered by the regulation, albeit with significant reduction of the general registration requirements.

Manufacturers of isolated intermediates in quantities from 1 tonne annually should submit a registration dossier to the agency under a different regime in line with REACH’s chapter 3 of Title II. However in case of an earlier notification under Directive 67/548/EEC (the Dangerous Substance Directive, also known as the DSD) had been submitted, no registration is required. The agency will instead assign a registration number.

Monomers used as on-site isolated intermediates in the production of polymers do not benefit from reduced registration requirements, manufacturers must submit a standard registration dossier. All isolated intermediates subject to registration must also meet C&L requirements where the producers are required to notify the C&L inventory as provided for in articles 39, 40 of the Regulation (EC) No 1272/2008 if:

  • he places the intermediate on the market (i.e. he makes it available to another

legal entity on the same site), and

  • the substance meets the criteria for classification as hazardous.

It is clear that there is a very blurred line separating when a substance is used either as an intermediate or as a final substance. Manufacturers/ importers should familiarize themselves with the defining conditions in order to comply with the environmental safety regulations appropriately.

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