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Getting intermediates right
During the summer, ECHA launched a practical guide which gives advice to registrants on how to report information on intermediates in their registration dossiers. The guide also helps downstream users who need to provide information to their suppliers on intermediate uses of substances. The guide gives examples of the information that needs to be shown in intermediate dossiers.
Intermediates are substances that are manufactured for and used solely in chemical processing. As a result of the processing, they are transformed into another substance. Registrants of intermediates are able to benefit from reduced information requirements if their intermediates are manufactured and/or used under strictly controlled conditions. Intermediates that are not used under strictly controlled conditions must have full registration dossiers.
|The practical guide gives advice to registrants on how to report information on intermediates in their registration dossiers. The guide also helps downstream users who need to provide information to their suppliers on intermediate uses of substances. Image: ECHA.|
Inadequate intermediate dossiers
"We began checking intermediate dossiers in 2009 to find out what kind of information was being included. Our findings showed that the majority of the dossiers were lacking basic information about the use of substances and their conditions of use," says Augusto Di Bastiano from ECHA's Risk Management Unit. "This made it difficult to know whether the registrations should really benefit from the exemptions foreseen for intermediates or not," he continues.
A news alert was published in 2010 to inform registrants that there were significant issues with intermediate dossiers. ECHA then wrote to registrants of intermediates asking them to submit more information on their use of intermediates. "These letters asked for two things from the registrants. The first was how the substance is used and whether it is being used as an intermediate in the manufacture of other substances. The second was to ask for some documentation of the strictly controlled conditions that were being applied," Mr Di Bastiano states.
It became clear from the deficiencies identified in the registration dossiers and from the responses to the letters, that more advice was needed for the registrants of intermediates. This is where the practical guide comes in.
Is the substance really an intermediate?
"Before thinking about the conditions of use for the substance, it is important to know whether it is actually being used as an intermediate," Mr Di Bastiano says. The practical guide devotes a section to this issue and gives registrants and downstream users a checklist to help them.
The checklist includes the key things to think about when deciding if the substance is an intermediate. It then gives three practical examples: clearly defined substances; substances of unknown or variable composition, complex reaction products or biological materials (UVCBs); and the manufacture of multiple substances from the same intermediate. The key considerations are:
- What are the process and steps involving of the substance?
- What chemical transformations does the substance go through during the process?
- What is the technical role of the substance in the process (i.e. is the substance chosen for any reason other than to manufacture the transformation products)?
- What are the chemical identity and registration obligations for the transformation products (i.e. the final substances created using the intermediate during the chemical process)?
"We tried to focus on examples for registrants, and also to give support to downstream users," Mr Di Bastiano remarks and continues, "downstream users have to notify to the registrant and confirm that they are using the substance only as an intermediate and that they are using it only under strictly controlled conditions."
Guidelines on how downstream users can provide this information are also contained in the practical guide. Registrants can then have a clear understanding of how the substance is used throughout the supply chain and declare this in their dossier.
Are the conditions strictly controlled?
"To benefit from the reduced information requirements, registrants need to prove that the manufacture and/or use of the intermediate substance is strictly controlled," says Mr Di Bastiano.
Strictly controlled conditions are technical measures supported by operating procedures and management systems. These include:
- Containment of the substance to avoid emissions and exposure of the intermediate.
- Handling of the substance by trained and supervised personnel according to documented procedures.
- Procedures being in place for cleaning and maintenance.
- Control technologies to deal with accidents and waste management.
If registrants of intermediates can show that these conditions are met at their own site and, where the intermediate is transported, at their downstream users' sites, they are able to benefit from reduced information requirements for their registrations.
Other exemptions for intermediates
Intermediates are also exempt from some REACH processes. Not only are there reduced registration information requirements and a reduced fee but also:
- If the substance is an intermediate and is used under strictly controlled conditions, it is exempt from dossier and substance evaluation.
- If the substance is used as an intermediate, that use does not require authorisation. On-site intermediates (i.e. those manufactured and used at the same site) are also exempt from restriction under REACH.
These exemptions exist for intermediates because they normally undergo a limited number of steps before they transform into the manufactured new substance. This manufactured substance is then subject to the standard REACH requirements.
Implications of getting "intermediates" wrong
Registrants wrongly registering an "intermediate" are in breach of their registration obligation. They may also miss the opportunity to apply for authorisation to use the substance in time if it is included in the Authorisation List.
On the other hand, if the registration dossier does not show clearly which uses are intermediate, the substance may be prioritised for risk management which could be unneccessary given the strictly controlled conditions.
Interview by Paul Trouth
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