The role of the Only Representative
See also our guidance on what to look for when choosing an Only Representative.
The responsibilities for REACH rest with the person within the EU responsible for placing the substance on the market there. This means that non-EU companies cannot fulfil the requirements of REACH themselves, but instead must work with their supply chain partners and customers to make sure that the requirements are met and their substances can continue to be supplied.
The supply lines for chemical substances can be complex, with many organisations sourcing from EU and non-EU suppliers and in turn, many non-EU suppliers selling to multiple importers. To try to simplify the process for registration, and for subsequent hazard and risk communication, it is possible for non-EU manufacturers to appoint an ‘Only Representative' who will be responsible for fulfilling the registration and hazard communication duties that would otherwise fall upon the importers of specific substances into Europe. This will also help non-EU manufacturers to protect confidential business information that would need to be shared with the importers if registration duties were left to them.
It is stated in the regulation that a ‘natural or legal person' in the EU (or European Economic Area) may take on the role as nominated Only Representative (OR). A natural person is a citizen of the EU, while a legal person is a legally registered company within the EU. This requirement is intended to identify the person who can be prosecuted in Europe if things go horribly wrong. In other words, 'off-shore' companies will not suffice. It is suggested that such a person must have sufficient background in the handling of substances and information related to them (although ‘sufficient' is not itself defined - but a definition is suggested later in this document).
The OR may be a subsidiary of the non-EU supplier, an importer themselves, a legal representative, a consultant or even your cousin's mother in law. Twice removed. In other words, any person who is a citizen of a Member State may be appointed by the non-EU supplier. It is important to note that if the OR is a named individual person and there is a change of personnel or responsibilities within the organisation, the conditions of the OR arrangements will need to change.
The REACH Regulation implies that there is a simple supply line of supplier - importer - user. In reality, the user may purchase from several sources, the importer may source from more than one supplier and the supplier themselves may be an export company buying from various sources before shipping off to Europe. From current guidance and from experience with the pre-REACH New Substance Notification system, we can see some scenarios being considered ‘pragmatic' even if there is no direct guidance from the Regulation and supporting documents.
The OR must be appointed by the non-EU producer and their role must be agreed by the importers. Drawing a parallel with the Sole Representative under New Substance Notification, three stages are involved:
1 Letter from supplier naming their OR
2 Letter from importers covered by the OR arrangement recognising the OR
3 Letter from OR to supplier and importers agreeing to their role
The concept of writing ‘letters' is not explicitly implied in the Regulation, but there needs to be a defined recognition of roles between the relationships and this written documentation needs to be added to the IUCLID 5 Registration document during submission.
The legal text suggests that the OR can only be appointed by the manufacturer, formulator or processor and by this, implies that traders or export agents cannot make such an appointment. It is certainly best if the appointment is made as far up the supply line as possible as these organisations will have a better understanding of the substance.
The OR is the legally responsible person for the registration and hazard communication for the specified substance. The work can be done behind the scenes by the supplier (ie. the non-EU supplier sends technical specialists to work on SEIFs, organises testing, prepares the CSR, completes the IUCLID file etc) but the final submission is done by the EU based OR. Certainly, this scenario is likely in the case of organisations appointing legal consultants (lawyers) to be the OR or where the OR is just an import agent with no technical skills. This can be done legally, but the advice given is that before accepting to be an OR, the person must have some idea of what they are letting themselves in for.
Not in any particular order, the responsibilities can be summarised:
· Accept the role as Only Representative following appointment by the supplier
· Make the pre-registration on behalf of the supplier
· Accept official role on SIEFs
· Agree hazard assessment for single registration (CSA)
· Agree on data gaps
· Agree on costs of sharing data
· Agree on new testing strategies
· Identify and agree to work with importers (DUs)
· Consider exposure scenarios of DUs (and in turn, their customers etc)
· Organise CSR (either prepare themselves or helps DUs)
· Organise and agree on SDSs to be consistent with Registration details
· Make Registration (pay fees !)
· Monitor supply patterns (volumes of import by each importer, SDS checks etc)
· Check Risk Management Measures are being communicated and complied with
And this list does not include all the work associated with control or Authorisation.
The main qualification of an OR is a good organiser and communicator, with at least enough basic knowledge of the REACH process to understand whether others working with them are doing their job.
Ideally, the qualities of the OR will include not only technical and communication skills, but an ability to hold their own when dealing with other Registrants in a SEIF and to be able (and willing) to negotiate on cost sharing for test work or to value data held by the supplier or importers who they are working with.
REACH does not end when the Registration is made. This obviously applies to all those involved in REACH and not just the OR. The exposure scenarios, CSR and CSA are on-going ‘live' documents that need updating with new test data or new exposure details as necessary and obviously the SDS is a live document that will need update and revision as required.
Currently, Denehurst Chemical Safety Ltd is not offering to act as an Only Representative as this could have potential conflict of interest with advisory roles, especially relating to the work with REACHReady. REACHReady offers a 'Matchmaker' service to help find service providers, including potential Only Representatives
Denehurst Chemical Safety Ltd