REACH : Only Representatives

Introduction

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 taking subsequent hazard and risk communication responsibility, it is possible for non-EU manufacturers to appoint an ‘Only Representative’ who will be responsible for the supplies of specific substances into Europe. 

Who can be Only Representative

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).  This includes individuals who are residents of the EU or registered companies - however, in any case, there need sto be a named individual 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 appropriate levels of skill (although ‘appropriate’ 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. 

Complex supply routes

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.

Appointment of an Only Representative

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 or roles between the relationships and this written documentation to demonstrate acceptance of roles needs to tbe 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 certianly best if the appointment is made as far up the supply line as possible as these organsiations will have a better nderstanding of the substance.

Role of Only Representative

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 this list does not include all the work associated with control or Authorisation. 

Qualifications of the Only Representative

The main qualifications 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 you 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.

On-going duties of Only Representative

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.

Role of Denehurst