ECHA has recently published a factsheet that provides further guidance on toll manufacturing, as toll manufacturers are not specifically addressed by the REACH Regulation. ECHA highlights how a company procuring toll manufacturing services and a toll manufacturer with REACH obligations can allocate liability for these obligations between themselves in order to facilitate compliance with REACH whilst sharing the administrative and financial burdens involved.
As per previous ECHA guidance, ECHA explains in the factsheet that any EU-based toll manufacturer may have responsibilities under REACH because it could be considered to be a “manufacturer” undertaking “manufacturing” of substances within the REACH definitions. Upon our inquiry, the UK REACH Helpdesk has clarified that whether these definitions apply to a toll manufacturer is determined by its role in the supply chain. Specifically, toll manufacturers undertaking a process not involving the manufacture of a new substance are not likely to have many obligations under REACH.
However, when REACH obligations apply, their scope may vary depending on the circumstances. As a minimum, toll manufacturers who in fact manufacture substances will have to register such substances on their own or present in a mixture for the company procuring the toll manufacturing services. Further responsibilities under REACH may include:
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reviewing and/ or updating an existing registration;
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ensuring that the manufacture/ placing on the market/ use of substances is not restricted under REACH;
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applying for authorisation for the placing on the market/ use of substances if this is required under REACH;
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providing safety data sheets if supplying a substance;
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collecting and retaining all information required to carry out REACH obligations; and
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notifying ECHA in the event of a change of toll manufacturer. (This may involve updating the registration dossier and paying an update fee, or completing a new registration).
ECHA further explains in the factsheet that even if the registration obligations in most cases cannot be shifted from a toll manufacturer, the process of registration (including the generation, sharing and compilation of data) may be transferred to the company procuring the tolling services using contractual arrangements. Such a solution may become necessary for a number of reasons. For example, toll manufacturers may not possess the financial and/ or administrative resources to bear the burden of registration and/ or other REACH obligations. Additionally, the company procuring toll manufacturing services may prefer to control registration for the sake of convenience (being the holder of the requisite data) and because of the desire to protect confidential business information about a substance and its uses. Therefore, parties involved in toll manufacturing could benefit from pre-defined contractual arrangements for the registration obligations and other responsibilities listed above.
ECHA also addresses other issues arising from involvement in toll manufacturing. Toll manufacturers requiring an authorisation for certain uses of a substance may be able to benefit from authorisations previously granted within the supply chain. Confidential business information may be retained in relation to the involvement and/ or identity of toll manufacturers by an EU toll manufacturer appointing an EU company to act as a Third Party Representative during discussions with other registrants within the SIEF.
In light of the above, companies procuring toll manufacturing services should consider whether existing contractual arrangements with toll manufacturers appropriately address REACH obligations. When new toll manufacturing services are procured, care should be taken in allocating the responsibilities under REACH.
The factsheet “Information for parties involved in contractual arrangements for toll manufacturing” can be found by clicking here.
Should you require further guidance on toll manufacturer obligations under REACH, K&L Gates’ REACH team is well positioned to assist your business, including the review of contractual arrangements between manufacturers/ importers and toll manufacturers.
