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Denehurst Chemical Safety Ltd

Trustee - Confidential data exchange for Only Representatives

The role of 'trustee' is a service to help two or more parties involved in SIEFs or Registration activities to agree on data share or to share commercially sensitive information, such as exposure estimates, tonnage bands and product composition. By reviewing information from different parties, the trustee can judge whether the substances are equivalent to allow data share or that exposure patterns are close enough to share exposure scenarios without each party having to provide competitors with commercial details.

A further role for a trustee involves Only Representatives; if a non-EU manufacturer is making use of an Only Representative, and offering this facility to non-EU customers to allow their products to be imported in parallel, it needs to be accepted that all importers must know who the Only Rep is and must exchange a minimal amount of information with them.  If the parallel importer is a competitor or if the non-EU customer wants to keep the identity of their customers confidential, this can cause a problem.

The use of a 'trustee' (a third party organsiation bound by commercial confidentiality agreements) is a solution to many situations where commercial sensitivities makes direct exchange of information impossible.

The Only Rep Trustee Role

Introduction
Using an Only Representative (OR) is perhaps the best option to ensure that the European customers importing chemicals do not need to register. For non-EU manufacturers and formulators, it also allows you to help your non-EU customers who sell your substances into Europe as their customers can also make use of the OR facility.

The OR must be appointed by the non-EU producer(manufacturer, formulator or processor) and their role must be agreed by the importers. Three mandatory points of communication are involved and there is no way around this:

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.

This means that every importer who makes use of the OR facility must have a point of contact with the OR and vice-versa. Therefore, if a non-EU manufacturer sells a substance to a non-EU customer, who then re-sells in the EU, the OR will know who the customers in Europe are. The legal requirement rests with the importer to have this permission to make use of the OR pre-registration /registration.

There is also other mandated communication requirements, but these can be commercially sensitive and although this communication must take place, it is possible to set up a trusted intermediary - this Trustee can act in a central role, bound by confidentiality agreements and ensuring flow of mandatory information.

Mandated communication
As well as the mutual recognition of each other and the roles they play in the supply line, there is further mandated communication. Note that the term ‘importer' is used to describe the EU customer, who is technically a ‘Downstream User'.

The communication requirements can be summarised as being:

OR to importer:
Chemical hazard data (SDS and/or Robust Summary)
Details of Exposure Scenarios acceptable for use that is covered by the registration
Risk Management Measures determined by the Chemical Safety Report

Importer to OR:
Any adverse effects to users or the environment as a result of use
Tonnages of the substance imported

To meet these requirements, it is implied that the customer importing the substance must know its precise identity and if importing it in a preparation, would need to know its concentration in that preparation to estimate tonnage. Unless it is hazardous, the supplier would not normally give the customer details of the chemicals in a mixture and especially not the proportions or even who they buy the components from.

The REACH legal text does not state that this commercial related information has to be shared directly; all it states is that the OR must be made aware of the total imported tonnage and that the importer / user is provided with sufficient information for them to manage risks.

It is therefore possible to use a trusted intermediary to ensure that commercially confidential information is filtered so that mandated information is exchanged but commercial details remain confidential. This is the envisaged role of the ‘trustee'.

It must also be noted that to avoid the importer being identified by the Only Rep, the responsibility for import can be passed to a chemical trader - in other words, the exporter can use an import agent to take the responsibility of import. However, this could add to costs for supply.

The Trustee
The term ‘trustee' will not be found in the legal text and is only once referred to in official guidance. However, such a role is considered vital to retain commercial confidentiality between the importers of chemicals and the OR who is covering their registration.

The best way to view this is with the following scenario;

A company in the US makes a non-hazardous wetting agent that can be used in paints. They have two customers in the US who use the substance to formulate into specialist proprietary products that are considered commercially confidential. The manufacturer also sells the substance directly into Europe through a sales office in the EU who will be both importer and OR.

The US customers sell their competing paints into Europe, and their customers have been given permission to use the OR established by the manufacturer. Each of these customers (importers) need to write to the OR to make contact and the OR must write back to give permission. This part cannot be avoided.

However, so that the importers do not find out what the wetting agent is chemically, they need only be given a code name; ie, they are told that the formulation contains substance ‘X' and they are told to contact the OR of the manufacturer. The OR obviously needs to know what the real identity of Substance A is, but the US customers and their EU importers do not have to know - the EU importers just need the assurance it is compliant with REACH.

The importers nor the US manufacturer know what percentage of the Substance A is present in the paint and indeed, it may vary between products - this is a trade secret of the formulator in the US. The importer therefore knows how much paint they import, but not the tonnage of Substance A. The formulator does not want the OR to know either as this is confidential.

To solve this scenario, a Trustee is appointed by the OR to liase with all parties under separate confidentiality agreements; the Trustee therefore knows the formulation details, the substance identity, the code name, the identity of all importers and their tonnage imports.

Using this information, the Trustee can prepare a report for the OR to give them the grand total of import of Substance A and the OR will not know the breakdown between the importers and if there are two paint manufacturers in the EU exporting, they need not know the relative market sizes of these companies in the EU.

Hazardous substances
Note that if hazardous, and if present in a formulation above thresholds of concern (1% for many hazardous materials and 0.1% if very hazardous), the substance needs to be identified on the SDS and label, even if it is considered commercially confidential. This has not changed with REACH and has been a legal requirement in Europe for many years. Therefore, the need for a Trustee is less pressing if hazardous substances are involved, but it still makes sharing tonnage information more confidential.

If hazardous, the OR has a duty to make the hazard data, exposure scenarios, SDS etc available to the importers making use of the OR facility; this can be done through the Trustee, but as it is so important to do this, it is probably best done by the OR as they are the ones legally responsible for passing on these details. Likewise, if the user finds adverse effects from use, they are best contacting the OR direct as, again, they are legally responsible to do this.