For EU importers, please pay attention to the Intermediate registration in the monitor page.
There are two types of registration under REACH: Full registration and Intermediate registration. Intermediate registration costs significantly less but has strict requirements to meet. ECHA and competent authorities from respective countries are under extensive inspection on the intermediate registrations. If the requirements can not be met, you will on longer be able to use the REACH registration number otherwise be considered violating the regulation.
There are 2 requirements for intermediate registration that need to be met at the same time:
- 1.Through chemical reaction, the substance (to be registered) transfers into another chemically different substance (please see more details in article below);
- 2.The above chemical reaction complies with Strictly Controlled Conditions (In practice, companies of the chemical reaction taking place within EU is requested to sign this document. Please check if you have this document ready which is requested during inspection).
REACH 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(15)).A non-isolated intermediate is an intermediate that during synthesis is not intentionally removed (except for sampling) from the equipment in which the synthesis takes place. Such equipment includes the reaction vessel, its ancillary equipment, and any equipment through which the substance(s) pass(es) during a continuous flow or batch process as well as the pipework for transfer from one vessel to another for the purpose of the next reaction step, but it excludes tanks or other vessels in which the substance(s) are stored after the manufacture (Article 3(15)(a)).On-site isolated intermediate means an intermediate not meeting the criteria of a nonisolated intermediate and where the manufacture of the intermediate and the synthesis of (an)other substance(s) from that intermediate take place on the same site, operated by one or more legal entities (Article 3(15)(b)).
For on-site isolated intermediates, the manufacturer confirms that the substance is only manufactured and used under strictly controlled conditions (Article 17(3)).For transported isolated intermediates, the manufacturer or importer confirms himself or states that he has received confirmation from the user that the synthesis of (an)other substance(s) from that intermediate takes place on other sites under strictly controlled conditions detailed in Article18(4). For transported isolated intermediates that are manufactured in the EU the strictly controlled conditions shall apply both to the manufacture and use of the substance.
To assess if the intermediate is manufactured and used under strictly controlled conditions during its whole lifecycle, the registrant should evaluate if all the Article 18(4) conditions apply:
- 1.the substance is rigorously contained by technical means during its whole lifecycle including manufacture, purification, cleaning and maintenance of equipment, sampling, analysis, loading and unloading of equipment or vessels, waste disposal or purification and storage; (see chapter 2.1.1);
- 2.procedural and control technologies shall be used that minimise emission and any resulting exposure; (see chapter 2.1.2);
- 3.only properly trained and authorised personnel handle the substance; (see chapter 2.1.3);
- 4.in the case of cleaning and maintenance works, special procedures such as purging and washing are applied before the system is opened and entered;
- 5.in cases of accident and where waste is generated, procedural and/or control technologies are used to minimise emissions and the resulting exposure during purification or cleaning and maintenance procedures; (see chapter 2.1.4);
- 6.substance-handling procedures are well documented and strictly supervised by the site operator.
Doc 0 - Statement of compliance with SCC condition - Importer to non-eu manufacturer.doc