What are the obligations?

REACH applies to everyone in the European Union who occupationally produces, imports, distributes or uses chemical substances or preparations. REACH distinguishes different obligations for manufacturers, importers, downstream users and distributors of substances as such, in preparations or articles. They each have a different role and different obligations under REACH. A company involved with REACH will therefore first have to determine which role it plays.

The following is an example in which the different roles are clarified:

• A manufacturer produces titanium dioxide, for instance, a non-toxic good-covering pigment.
• He sells this to a first formulator who makes a pigment paste with this titanium dioxide that is used by a next formulator to make paint.
• This formulator can sell his paint to three different users.
  • An industrial user: for instance a carpenter who makes windows and uses the paint.
  • Professional users (painters) who use the paint for their work.
  • Directly to consumers who use the paint to repaint their windows.

Role

A company can also have more than one role. A manufacturer of a chemical substance can also itself be a user (for instance the formulator in the example above) of chemical substances. In the supply chain of a chemical substance companies therefore have different roles with specific responsibilities for the risk management of substances. Depending on the use of the substance the following obligations can be distinguished for the different roles (if you want to read the specific obligations click on one of the parties):

• Manufacturer
• Importer
• Downstream user
• Distributor

After the role has been determined companies must decide if:

• A substance must be registered
• Which activities they carry out with a substance that must be registered
• What the obligations are in that case.

They can preregister phase-in substances. On preregistration these companies automatically become compulsory participants of the Substance Information Exchange Forum (SIEF). Exchanging information avoids work having to be done repeatedly and unnecessary testing on animals for the actual registration of a substance. After registration companies must keep the registration file up to date. This means that all new information about a substance, but also address changes, must be notified to the European Chemicals Agency (ECHA).

For each potential registrant of a ‘non-phase-in substance’ or potential registrant of a ‘phase-in substance’, who has not affected preregistration there is the obligation to gain information from the European Chemicals Agency prior to registration. The potential registrant then finds out if registration has already been submitted for the specific substance.

If the substance has not yet been registered he will be informed of this by the European Chemicals Agency. This therefore means that the European Chemicals Agency has not yet received information about the substance. The potential registrant cannot use information from a previous registrant and may therefore have to carry out tests to be able to compile a full registration file.

If the substance was registered fewer than 12 years earlier, the European Chemicals Agency submits the contact details of previous registrants and informs the potential registrant of any relevant research results already submitted by them. The previous registrants will also receive the contact details of the potential registrants. The potential registrant then asks the previous registrant(s) for the information (research results) he requires for registration. After this request both parties will do all they can to agree that the information will be shared. They also do everything to ensure that the costs of the joint use of the information are established in a fair, transparent and non-discriminatory way. The guidelines for sharing the costs are still being developed at present. As soon as agreement has been reached about joint use of the information, the previous registrant makes the agreed information available to the new registrant and gives him permission to refer to the full study report. If no agreement is reached, the potential registrant informs the European Chemicals Agency and the previous registrants of this. Within one month of the Agency receiving this information, the Agency grants the potential registrant permission to refer to the information required by him in his registration file. This is provided that the potential registrant, on the request of the Agency, demonstrates that he has paid the previous registrant(s) for the information as a share of the costs made.

Information provision throughout the product chain:

• REACH is to result in intensive communication in the supply chain through the obligation to exchange information both downstream (from manufacturer/importer, through any distributor to a user) and upstream (from user, through any distributor to the manufacturer/importer).
• The exchange of information downstream takes place particularly by means of safety data sheets (SDS) or in another way if no safety data sheet is required. The SDS will also continue to exist under REACH. It will indeed become even more important.
• The exchange of information upstream concerns information about use of the substance, preparation or article that user’s pass on to the supplier or distributor for the preparation or adaptation of registration. Sometimes users will also submit information about danger aspects, other characteristics and labelling.
• It is not sufficient for the manufacturer or importer to merely know which safety measures exist concerning the use of a certain chemical substance.  The users of the chemical substance must also take appropriate measures to reduce the risks.
• To ensure that the industry (manufacturers, importers and downstream users), the Commission, the European Chemicals Agency and the Member States can implement the Regulation practically, the Commission (in co-operation with experts from groups of parties concerned) has started drawing up REACH implementation projects (RIPs). Some projects are aimed at drawing up guidelines and the development of resources (manuals and IT tools) to increase workability so that everyone can fulfil his obligations.