Why does my supplier ask me to declare compliance with strictly controlled conditions?
If your supplier also manufactures or imports the substance, he has the obligation to register the substance (if the manufactured or imported quantity is larger than 1 tonne per year).
Registrants who register their substances as (transported) isolated intermediate, can provide reduced registration information, if they confirm that the substance is manufactured and used under strictly controlled conditions. In order for conditions to be considered as strictly controlled, the following criteria must be met:
- 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;
- Procedural and control technologies are used that minimise emission and any resulting exposure;
- Only properly trained and authorised personnel handle the substance;
- In the case of cleaning and maintenance works, special procedures such as purging and washing are applied before the system is opened and entered;
- 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; and
- Substance-handling procedures are well documented and strictly supervised by the site operator.
The reduced data requirements apply only when the registrant confirms that he himself or his clients use the intermediate under controlled conditions. To this end, registrants of (transported) isolated intermediates will ask the downstream users of the substance to sign a statement of compliance with transported isolated intermediates under strictly controlled conditions.
Please note: by signing such statement, you confirm that you:
- Use the substance as an intermediate; and
- That your activities take place under controlled conditions.
If your chemical process does not lead to the manufacture another substance, but instead produces mixtures or articles or results in a specific function or property, you are not using the substance as an intermediate. In such case, in order to be compliant, you must source the substance from a supplier who has completed a full REACH registration.