Denehurst Chemical Safety Ltd

Only Representative choice

 

Choosing the right Only Representative is an important decision. It is important to remember that non-EU suppliers who appoint the Only Representative can do a lot of the technical work themselves if they wish and the choice of OR will depend largely on the level of support required.

 

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). The official guidance has been updated a number of times to provide clarification on the role of the Only Representative, and further changes may be expected as the guidance is reviewed in the light of experience.

 

This guidance does not dwell on the legal issues as such guidance is available from ECHA, but instead, it is hoped that guidance is offered to help choose the right sort of OR for your own specific requirements.

Some key facts need considering to put the advice in context :

 

  1. The OR must be in the EU and appointment is by the non-EU manufacturer / processor of the substance(s)

  2. The non-EU supplier may choose to do most of the technical work themselves and can take part in SIEF discussions.

  3. The OR and importers using the OR Registration must be in contact with each other and tonnage band information exchanged

  4. The OR can be sacked from their position by the non-EU appointee, but commercial contract arrangements are important for all parties involved.

Making the right choice of OR will save money and hopefully enable supply into the EU market without any delays.

 

Legal details

The OR must be appointed by the non-EU producer (manufacturer, formulator or processor) 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 appointing 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. This is the first stage of setting up the OR and this written evidence needs to be attached to the IUCLID Registration file when the OR makes the full registration.

Example letters are attached as Annexes to this guide.

 

Role of the 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.

 

The choice of OR will depend largely on the level of work to be undertaken by the non-EU appointee themselves. To make this easier, it is necessary to split the type of OR into categories that reflect the service offered; the categories are :

 

  1. Full service

  2. Technical consultant

  3. Legal advisory

  4. Basic nominated legal entity

This is a very simplistic division of roles, but example of types of organisations are be summarised below.

 

Full Service

Service offered by testing laboratory with active regulatory department that can offer a full service ‘one-stop-shop’ that includes the testing and generation of data.

 

Advantages : little input required; give substance details and identify importers and sit back to let the OR do all the work. Useful if the non-EU supplier has little technical capability or has no time to get involved.

Disadvantages : can be expensive and control is perhaps lost to the OR

 

Technical Consultant

The technical consultant can take on all activities except the actual testing. However, most good technical groups can arrange testing and monitor such work

 

 

Advantages : if no testing is planned (eg. if not the lead registrant and taking on a minor role in the SIEF) these consultants can do everything that the full service can offer except the integrated testing. Again, the non-EU supplier can sit back and let the OR get on with it.

Disadvantages : giving all the work to the consulting organisation may result in reduced control and consultant may be doing ‘easy’ activities that you could do in-house

 

Legal

Legal firms are offering OR services and will provide excellent service to ensure correct approach is take for difficult substances or that legal arrangements for registration are met.

 

Advantages : Can ensure compliance to regulations and provide a solid base for SIEF negotiations. Ideal if the non-EU supplier has good technical base and can handle a lot of the work themselves.

Disadvantages : when the SIEFs get technical and test data needs assessing, support may be weak, but many legal firms have links to technical support.

 

Basic

This term describes the minimum role by an OR and is perhaps the role being taken on by traders and importers to support their non-EU supplier.

 

Advantages: least expensive and will let the supplier keep in control of the registration process

Disadvantages : These organisations may not be able to give support if things are going badly.

 

Summary

The roles taken on by the OR can include a number of activities and the following table tries to summarise the roles and activities.

 

The symbol ‘√’ indicates a role expected of the relevant type of OR, ‘O’ is optional and ‘X’ suggests a role not necessarily suitable for such an OR category.

 

Role

Full Service

Technical

Legal

Basic

Accept position of OR and prepare commercial contract

Identify precise REACH requirements

O

X

Make pre-registration

O

O

Accept official role on SIEF

Identify and agree to work with importers (DUs)

Agree hazard assessment for single registration

X

X

Agree on data gaps and new testing strategies

X

X

Agree on legal make-up of SIEF

O

X

Agree on costs of sharing data

X

Propose testing strategies

X

X

Perform testing

X

X

X

Consider exposure scenarios of DUs (and in turn, their customers etc)

X

X

Prepare CSR

X

X

Prepare SDSs to be consistent with registration details

X

X

Work with SIEF on IUCLID dossier (lead registration?)

O

O

Make registration

O

O

Monitor supply patterns (volumes of import by each importer, use patterns, SDS checks etc)

Check risk Management Measures are being communicated

 

This is a very simplistic approach, but it aimed to help those seeking Only Representatives ask the right questions to ensure they have the right partner.

 

What can the non-EU supplier do?

It is important to realise that the non-EU supplier can do almost all the work themselves. From outside the EU. The only thing that cannot be done is being the named registrant and thereby taking on the legal role. The items marked as ‘√’ in the table above under the ‘basic’ role are the activities not possible to do from outside the EU.

 

The non-EU supplier can therefore actually make the pre-registration (with the OR’s log-in details from REACH IT) and can complete all the registration process including the CSR, SDS etc. The testing can be done outside the EU as long as it meets the correct guidelines and the IUCLID documents completed. The SIEF discussions can be held by any person representing the substance supplier and if meetings are held, specialists from outside the EU can obviously attend.

 

Therefore, for organisations outside the EU with good technical facilities, almost all the work can be done ‘in-house’.

 

Contracts

Getting the right contract is important as the OR will ‘own’ the registration and if the non-EU appointee wants to sack the OR, there needs to be safeguards in place. The importers cannot sack the OR, but they can opt out of the arrangement by finding a new supplier or making their own registration. Although OR relationships need to be long term, they can be terminated and all parties need to be careful in setting out working arrangements.

 

A basic contract should cover the following:

 

 

The fact that the relationship will need to go on far beyond the registration phase needs to be taken into account.

 

Changing OR

The Only Representative can be sacked and the OR can stop working with their non-EU appointee. Guidance on the precise implications to the SIEF and registration process are being discussed by ECHA, but facilities to ease the change in relationships by appointing new ORs are considered. This enhances competition between potential ORs and allows great flexibility for suppliers and importers.

 

On-going duties

REACH does not end when the Registration is made. 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. The OR will continue to have an essential role long after the registration is complete

 

Annex 1

Example texts for use in letters between importers and the OR

 

1 Text for letter from importer xxx to OR yyy.

As importer of [the substance] sss, we [the company] xxx, recognises the role of yyy as Only Representative for the registration of this substance imported from the non-EU supplier zzz.

We are aware of our responsibility to keep yyy informed of the tonnage band imported under the scope of this registration. We also agree to keep yyy informed of any adverse effects noted during use of the substance by ourselves or our customers.

 

2 Text for letter from OR yyy to importer xxx

The company yyy has been appointed by the non-EU exporter zzz of [substance] sss to act as their Only Representative for Registration under REACH. It has been agreed that you may import the substance directly from zzz without making your own Registration, but you have the duty to inform us of the annual tonnage so that we can maintain records to ensure that the Registration is valid.

 

It is also your obligation to inform us of any adverse effects noted in the use of the substance by yourself or your customers. It is also noted that it is our obligation to keep you informed of any changes in the status of the Registration with respect to recognised uses and also to make available any hazard data that may impact on recommended risk management measures.