Companies nowadays act globally. They might have several sites both within and outside the European economic area (EEA) and have substantial numbers of suppliers and customers, which also may have sites within or outside the EEA. Since December 2006, many manufacturers within the EEA have been obligated to comply with REACH regulation.

Regulation (EC) No. 1907/2006 of the European Parliament and of the Council is well-known as REACH regulation, or Registration, Evaluation, Authorization and Restriction of Chemicals. It requires all manufacturers within the European economic area - currently 28 EU member states plus Norway, Iceland and Liechtenstein - producing a substance in volumes of one ton or more per year to submit a registration to the European Chemicals Agency (ECHA) in Helsinki. In general the same applies to importers established in the EEA if they buy from manufacturers established outside the EEA, but there may also be exemptions from that obligation under special circumstances.

Each business relationship of a company requires that somebody within the supply chain take care of REACH registration obligations. In some cases the registrant has several options. The role of the registrant within a certain supply chain defines the role of further actors in that supply chain. Therefore it is important to know the roles under REACH and the obligations connected to each single role.

A short overview on important roles under REACH is given in figure 1.

Manufacturer within the EEA

In REACH regulation Article 3(9) it is defined: "Manufacturer means any natural or legal person established within the Community who manufactures a substance within the Community." According to Article 3(8), "Manufacturing means production or extraction of substances in the natural state."

Manufacturer outside of EEA

Each manufacturer producing outside of the EEA is a "Non-EU Manufacturer" (more precisely one would have to call it a "Non-EEA Manufacturer"). A Swiss company is on the European continent, but because Switzerland is not a member of the EEA this company will have the role of a Non-EU Manufacturer in regard to REACH. A Non-EU Manufacturer is not allowed to submit registration dossiers to ECHA on its own. However, if a Non-EU Manufacturer intends to offer already registered substances to its customers within the EEA as all EU Manufacturers do, it may involve an Only Representative.

Importer

Article 3 (11) of REACH defines: "Importer means any natural or legal person established within the Community who is responsible for import."

Only Representative

An Only Representative needs to be established within the EEA and operates on behalf of a Non-EU Manufacturer. The Only Representative acts formally as the Importer under REACH and fulfills the registration obligations. Customers of the Non-EU Manufacturer then will be Downstream Users.

Downstream User

Article 8 (13) of REACH defines the role of a Downstream User as follows: "A Downstream User is any natural or legal person established within the Community, other than the manufacturer or the importer, who uses a substance, either on its own or in a preparation, in the course of his industrial or professional activities." Distributors and consumers are not Downstream Users, whereas a re-importer is considered to be a Downstream User. That means whenever a company established within the EEA buys a substance or preparation from a European source, it will benefit from being a Downstream User since it does not have any registration obligation. In case of imports from Non-EEA sources, the company benefits from being a Downstream User only if the Non-EU Manufacturer fulfills the registration obligation via an Only Representative.

Trader Or Distributor

A Trader does not manufacture a substance itself, but purchases this substance from somebody else and sells either the whole volume as it is or after repacking it into smaller portions. In regard to REACH it makes a difference whether the Trader or Distributor is established within the EEA or outside. A Trader or Distributor located within the EEA may act as an Importer under REACH and therefore is allowed to be a registrant, whereas a competitor located outside the EEA is not allowed to submit a registration dossier to ECHA. Furthermore, a Trader or Distributor established outside the EEA is not allowed to appoint an Only Representative as Non-EU Manufacturers can.

Who Is Obligated to Register?

Fig. 2 shows that three roles under REACH may have an obligation or at least the opportunity to register. Each EU Manufacturer has registration obligations under REACH. An Importer has registration obligations only if he buys from a supplier outside the EEA that has not appointed an Only Representative. If a Non-EU Manufacturer takes care of the registration obligations by appointing an Only Representative, the former Importer becomes a Downstream User without any registration obligation.

Therefore companies established within the EEA must consider the situation in regard to REACH for any substance they intend to purchase from a supplier. Figure 3 shows the roles that, e.g., a German company may have when purchasing raw materials. If a raw material is purchased from a European source, the company will be unequivocally a Downstream User. If the company purchases from a Non-EU source it should ask whether the Non-EU Manufacturer has appointed an Only Representative. If the Non-EU Manufacturer has appointed an Only Representative, the German company benefits from being a Downstream User. If the company buys from a Non-EU source that does not take care of the registration obligations via an Only Representative (either Non-EU Manufacturer who has not appointed an Only Representative or a Non-EU Trader), the German company will be responsible for registration for volumes of one ton or more per year.

The German company also might consider doing its own registration for strategic reasons. If the German company has concerns about informing the supplier of its uses of a substance, which must be included in the registration dossier, it will have the chance to do the registration on its own when it buys from Non-EU sources. In this case, the German company will also have the possibility to buy from different Non-EU sources, whereas each registration dossier from an Only Representative covers exclusively the substance imported from the company that had appointed the Only Representative.

Also read:

Roles under REACH - Part 2
Roles under REACH - Part 3
Roles under REACH - Part 4