CHEMICAL PRODUCT DEVELOPMENT AND DEFENSE

The Registration Process

The core of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) is its registration requirement, which mandates that all substances manufactured or imported into the European Union (EU) in quantities of one metric ton or more per year be registered with the European Chemicals Agency (ECHA). The registration obligation applies to legal entities -- all manufacturers and importers of substances on their own or in preparations (i.e., mixtures) and all producers and importers of articles meeting certain criteria -- that are established within the EU and that meet the one metric ton/yr threshold. Failure to register a substance that is required to be registered means that the substance cannot legally be manufactured, imported, or otherwise placed on the EU market -- a REACH principle often referred to as the “no data, no market” principle.

REACH Article 4 affords EU entities -- manufacturers, importers, and downstream users -- the ability to appoint a Third Party Representative (TPR) and thereby maintain anonymity in the context of data- and cost-sharing discussions with other parties (e.g., other Substance Information Exchange Forum (SIEF) participants). This convention is particularly useful for companies that, for commercial or other reasons, do not wish to signal to potential or actual competitors their company’s interest in a particular substance.

Although the appointing company retains full responsibility for complying with its REACH obligations -- for example, it remains the pre-registrant and potential registrant and must share, through its TPR, any existing data in its possession -- REACH makes clear that when a TPR has been appointed, the company’s identity shall not normally be disclosed by ECHA.

According to ECHA guidance, data holders wishing to participate in a SIEF for the purpose of sharing their data and seeking compensation also may appoint a TPR.

Non-EU companies do not have any registration (or other) obligations under REACH, but because their products are imported into the EU, they are greatly impacted by the regulation, particularly when the proprietary aspects of those products (e.g., compositional details) are taken into account. Non-EU companies can rely on the actual EU importers or even establish a “friendly” EU legal entity through which all product imports would flow, but each of these approaches is fraught with shortcomings. Perhaps most significantly, relying on EU importers to undertake the requisite registrations (assuming, of course, the importers are willing and able to do that) means that potentially sensitive information must be disclosed to them, while establishing a friendly EU legal entity presents a number of administrative, financial, and commercial difficulties. Fortunately, a third option is available to non-EU entities whose substances are imported into the EU.

REACH Article 8 enables a non-EU substance manufacturer, preparation formulator, or article producer to appoint an Only Representative (OR) to carry out the registration of a substance imported into the EU. The appointment of an OR relieves the actual EU importers of their registration and other importer obligations under REACH and transforms them instead into downstream users. Not anyone, though, can serve as an OR and bring about this result. REACH specifies that an OR must be “a natural or legal person established in the Community” and “have a sufficient background in the practical handling of substances and the information related to them.”

Decisions on whether to appoint a TPR or OR should be made in advance of the pre-registration period.

Registration under REACH will commence on 1 June 2008, and will take up to 10 years to complete. In brief, the process will entail the collection and perhaps generation of substance-specific health and safety data, preparation of a technical dossier, and, for those substances manufactured or imported in quantities of 10 metric tons or more per year, a Chemical Safety Report that assesses the risks posed by the substance, including relevant exposure scenarios, and the development and communication of appropriate risk management measures.

For non-phase-in substances, the registration obligation applies from 1 June 2008, while for phase-in substances, the registration process will proceed in phases, as depicted in the diagram below.

To obtain the benefit of the extended registration deadlines -- 1 December 2010, 1 June 2013, or 1 June 2018, depending on the annual volume and hazard of the substance -- companies must pre-register their substances between 1 June 2008 and 1 December 2008. More information is available on the ECHA website at http://reach.jrc.it/about_reach_en.htm.