REACH: Taking Steps to Register Preregistered Substances

Jan 13, 2009 | Contact Author | By: Annelie Struessmann, PhD, CONUSBAT
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Title: REACH: Taking Steps to Register Preregistered Substances
  • Article

The preregistration of phase-in chemicals, which ended on Dec. 1, 2008, allows preregistrants to benefit from extended registration deadlines. However, to ensure sufficient time to organize data-sharing and prepare registration dossiers, potential registrants are recommended to perform the necessary follow-up steps as soon as possible. This is particularly important for the three substance categories whose first registration deadline is Nov. 30, 2010:

1) CMR substances: Substances classified as carcinogenic, mutagenic or toxic to reproduction (Categories 1 and 2) in quantities of 1 ton/year or more;
2) Substances classified as R50-53: Very toxic to aquatic organisms and may cause long-term adverse effects in the aquatic environment in quantities of 100 ton/year or more; and
3) High volume substances of 1,000 ton/year or more.

The testing requirements for these substance categories are described in the Annexes VII, VIII, IX and X of the REACH Regulation. Additionally a Chemical Safety Report (CSR) is necessary for registration, according to Article 14. REACH mandates that all available in vitro and in vivo data, historical human data, data from valid (Q)SARs and from structurally related substances (read-across approach) must be assessed before new tests are conducted to determine the properties listed in these annexes.

Concerning the exchange of data, Substance Information Exchange Forums (SIEFs) will be formed for each preregistered substance with the same chemical identity. Several arrangements are possible for companies to organize their cooperation in a SIEF. Companies may decide for a loose approach, e.g. using IT tools to communicate between all SIEF members. More structured and binding arrangements include consortia; several of these have been founded already and their cooperation is usually based on firm, contractual agreements. Another cooperation structure may be that a manufacturer within a SIEF provides a full data set to the other manufacturers in the SIEF and authorizes their access to the data in a simple written statement.

REACH does not require formal legal agreements; however, ECHA advises that parties should agree in writing on the main rules of data sharing. The practice for determining the costs of sharing information is a part of the provisions of REACH in Article 30, and is requested to be determined in a fair, transparent and non-discriminatory way.

The participants in the SIEF will be the potential registrants and data holders, which includes early registrants. Potential registrants are manufacturers, importers and only representatives of non-EU manufacturers. Any manufacturer or importer may appoint a third party representative, especially when a company does not want to disclose commercial secrets.

The third party representative is responsible for tasks relating to data and cost sharing, while the responsibility for the registration remains with the nominating legal entity. The third party representative should not be confused with only representatives, who are legally responsible for the registration.

In addition, the role of an independent third party exists and is different than a third party representative. Independent third parties act as trustees for a consortium or a group of companies in cases where participants need to preserve information, such as confidential data on know-how and figures for cost sharing, or where areas are tangent to the EC competition rules.

Key Summary:
• The first deadline for registration of preregistered substances is November 30, 2010;
• This deadline applies to high volume substances and substances constituting high risks to humans and the environment;
• The subsequent step to preregistration is identification of the SIEFs since REACH requires the exchange of existing test data;
• The organizational form of a SIEF is left to the participants;
• REACH requires the costs of sharing information to be fair, transparent and non discriminatory;
• Any manufacturer or importer may appoint a third party representative for data and cost sharing in a SIEF;
• When appointing a third party representative the legal responsibility for the registration remains with the nominating entity;
• Independent third parties and third party representatives should not be confused;
• Independent third parties act as trustees for a consortium or a group of companies where confidential data is exchanged or where areas are tangent to the EC competition rules.

Do you have further questions? Visit C&T magazine's REACH Round Table.

Readers are reminded that the text of the REACH Regulation (EC) No 1907/2006 is the only authentic legal reference. The information in this document does not constitute legal advice.