According to the REACH Regulation (1907/2006), an intermediate is defined as a substance manufactured, consumed, or used to be transformed, through a chemical process, into another substance. REACH further distinguishes three types of intermediates:
- Non-isolated
- On-site isolated
- Transported isolated
Of the three types, only the latter two are subject to registration if manufactured or imported in quantities exceeding one tonne per year.
Under Article 2(8) of REACH, intermediates are subject to reduced information requirements at the registration stage. However, in order to benefit from this simplification, they must be manufactured and used under strictly controlled conditions (SCC).
Since the first registration deadline in 2010, many substances have been registered as intermediates—about 35% of all registrations in Italy—but no systematic inspection plan has ever been implemented by the authorities to verify actual compliance with SCCs (with the exception of an ECHA pilot project between 2012 and 2013).
To address this, in 2019 the REACH & CLP inspection programme REACH-EN-FORCE 7 (REF 7) was launched. One of its key objectives is to verify whether manufacturers and users of intermediates are complying with SCCs as defined by the Regulation.
Failure to meet these conditions could result in the registrant losing the right to maintain a registration as an intermediate, unless technical or procedural measures are taken to comply with legal requirements.
TEAM mastery, in its commitment to fully supporting companies, is available to carry out on-site inspections and provide targeted consultancy to assess companies’ compliance with SCCs and to suggest practical actions aimed at addressing any discrepancies.
For more information on these services, you can contact the head of the Product Safety division, Mattia Pavan.