This post was written by David Wagner, Lou Naugle, Nick Elliot and Todd O. Maiden.
With REACH Pre-Registration closed for existing substances, the European Union’s new chemical regime has shifted to the stage called pre-SIEF or Pre- Substance Information Exchange Forum. Following a relatively brief pre-SIEF phase for each substance, a SIEF will form from a pre-SIEF after potential registrants have agreed they intend to register the same substance. Keep in mind that after a substance is Pre-Registered, an extended deadline for Registration, based on volume and nature of the substance, is established ranging from 2010 to 2018. In preparing for Registration, the key issues for potential registrants to understand include collaborating efficiently when sharing data, understanding the roles of the SIEF and consortia, protecting confidential business information, and complying with European Community competition law.
As an initial step, a Pre-Registrant should see who else has pre-registered the same substance. The information should be displayed on a substance specific pre-SIEF page available through the European Chemicals Agency’s REACH-IT portal. A substance’s pre-SIEF page should include information on substance identification and company contact information for each Pre-Registrant (e.g., the company contact person or the only representative. Companies that have pre-registered a substance will automatically become listed on the pre-SIEF page of this substance. The information on the substance’s pre-SIEF page may also identify the SIEF formation facilitator for that substance or provide contact information to initiate discussions on pre-SIEF organization or on the “substance sameness” assessment (discussed below). If you pre-registered through an only representative and do not have access to this information, you may want to contact your only representative for log-in and password information.
A short posting cannot discuss all of the issues in depth so what follows is an overview of key REACH considerations and requirements. Please feel free to contact the authors of this posting for more details.
The initial task of the group of Pre-Registrants is to agree that they intend to register the same substance, based on chemical identity and the substance sameness assessment. The exchange of this information within the group of Pre-Registrants and the decision to form a SIEF will be led by a SIEF facilitator (if available). In addition to substance and company information on the pre-SIEF page found in the REACH-IT portal, the European Chemicals Agency published a list of Pre-Registered substances on Dec. 19, 2008 (http://apps.echa.europa.eu/preregistered/pre-registered-sub.aspx).
Agreement on substance identity may in some cases require the exchange of detailed technical information on the composition of the substance, the raw materials used, the substance impurities, and possibly on the manufacturing process. Given that agreeing on substance sameness may in some cases involve the disclosure of confidential data, companies may want to preserve confidentiality in a secure exchange.
Moving to the next stage, a SIEF is formed from a pre-SIEF after the potential registrants have agreed they intend to register the same substance. As a potential registrant, obligatory participation in the SIEF following Pre-Registration is a means to (1) facilitate the exchange of information between potential registrants, thereby avoiding the duplication of studies, and (2) agree on classification and labeling. REACH provides for potential registrants to share information and work together to prepare a joint registration submission.
Participants in a SIEF are free to organize themselves in consortia or other forms of agreements as they see fit to carry out their obligations under REACH. Consortia are intended to provide a legal framework to deal with cooperation among SIEF participants and may include elements such as:
- Adopting competition law compliance rules
- Preserving the confidentiality of business information and data
- Defining classification and labeling
- Facilitating data-sharing and coordination
The activities of consortia may potentially give rise to EC competition law issues. Article 81 of the European Community Treaty prohibits any agreements or concerted practices that may result in the prevention, restriction or distortion of competition within the common market. In complying with data sharing and registration obligations, potential registrants should limit exposure to anti-competitive behavior by avoiding or carefully managing the exchange of commercially sensitive information and discrimination regarding consortium entry or sharing of costs. Adherence to a strict antitrust policy, including a well-thought out and transparent approach to dealings with competitors, is advisable.
Moreover, Article 82 of the EC Treaty prohibits the abuse of a dominant position, which can include a collectively dominant position, as may be held by a consortium. Article 82 EC is therefore aimed at preventing any undertaking, which holds a dominant position in a market, from abusing that position, by, for instance, directly or indirectly imposing unfair purchase or selling prices or other unfair trading conditions or limiting production, markets or technical development to the prejudice of consumers. The exclusion of a competitor from a consortium without objectively justified reasons may potentially be problematic under both Articles 81 and 82 EC, and so it is recommended that the admission of undertakings to any consortia be carefully managed in a way that avoids such risks.
Reed Smith's experience in this area suggests that information exchange, particularly in relation to future volumes, is regarded by the European Commission as being particularly sensitive – the Commission’s Directorate General for Competition has previously referred specifically to REACH as an area of interest to it and is currently consulting on the issue of information exchange.
