In our previous issue, we addressed how chemical companies have been preparing for compliance with the European Union’s Registration, Evaluation, and Authorisation of Chemicals (REACH) legislation, which went into effect June 1. In this issue, we outline the phases of a REACH compliance effort.
The Due Diligence Phase Part 1 – Identify the Substance
The due diligence phase is primarily aimed at identifying the substances that a company handles and associated data. The starting point should be the company’s product inventories of raw materials and finished products. Once the substances have been identified, it is important to categorize them under the REACH terminology according to the nature and function of such substances. Indeed, substances have different regulatory regimes depending on their qualification under REACH (e.g., “isolated intermediate,” “on-site transported intermediate,” additive, polymer, etc.).
Annex VI of REACH provides the parameters for substance identification and the European Commission is developing further guidance for the industry on this subject in the so-called “RIP 3.10” project.
The Due Diligence Phase Part 2 – Identify Information Available and Compare Against Information Requirements
Once substances have been identified, companies should identify the information that they have on such substances, starting with information on annual volumes handled, hazard information, classification and labeling (C&L), uses, suppliers and their customers. This information should be checked against the information requirements under REACH, particularly those required under the socalled “Chemical Safety Reports” (which are required for substances imported or manufactured in quantities of 10 tons or more), which include exposure scenarios covering all identified uses of a particular substance and related risk management measures.
The next logical step is to decide how to fill in any identified information gaps. Here, companies will look at published literature, databases and databanks that are already available, but will also have to consider the generation of new data, possibly through the creation of consortia with industry peers.
The Due Diligence Phase Part 3 – Identify Roles and Obligations
In connection with each substance, companies will have to assess their role (for example, manufacturer/importer, downstream user or manufacturer of finished articles). This will be decisive in determining the company’s obligations regarding each of the substances it handles. It will also be good to establish a “duties calendar,” spreading compliance activities over a precise timeline.
Once substances, related data requirements and obligations have been assessed, companies will be faced with important strategic decisions. Clearly, it will be key to identify risk factors such as the potential authorization or restriction requirements in connection with specific substances as these requirements might lead to substance discontinuation or to increased costs in their procurement or supply. If this is the case, potential alternatives for reformulation might be considered.
The REACH Regulation is now approved, together with its annexes. However, it would be a mistake to consider this piece of legislation as forever “cast in stone.” As with all pieces of legislation, REACH too may be changed. Most importantly, while amending the body of the regulation would require the same legislative procedure that led to its adoption, and would therefore be subject to a complicated and presumably very lengthy process, the REACH annexes can be changed in a much simpler way, called the new “regulatory with scrutiny” committee procedure. Indeed it is already envisaged that several annexes will be amended in order for REACH to be reconciled with other pieces of legislation like the proposed implementation of the Globally Harmonised System (GHS) in the EU or to rectify recognized mistakes in such annexes. It will be essential for industry to not only monitor such developments but also to take an active role in contributing to them.
Equally important in the framework of a compliance program is to monitor the development of guidance tools, such as the REACH implementation projects (RIP) guidance documents that are being developed under the auspices of the European Commission.
The Implementation/Ongoing Compliance Phase
Ongoing compliance will require a number of actions including the drafting of correspondence and agreements with customers, industry peers (and potentially competitors) and suppliers, as well as the drafting and preparation of regulatory filings and correspondence including the potential filing of appeals to regulatory decisions.
A last key element of a REACH compliance effort will be a careful monitoring of compliance with antitrust rules, particularly in light of the increased likelihood that information will be shared with competitors as a result of the new rules.
We have published a white paper outlining basic information about REACH that includes the information above and more. It can be found at http://www.ssd.com/publications/pub_detail.aspx?pubid=9918.