Substance Information Exchange Forum (SIEF) is a platform for data sharing and Classification & Labeling Agreement for all pre-registrants of the same phase-in substance under the REACH Regulation (Articles 29 & 30). The main aim of a SIEF is to reduce the registration cost burden through sharing available test data, thus avoiding study (in particular animal) duplication. Recent ECHA figures released after the 1st December 2010 deadline revealed that there were a high proportion of joint member registrant submissions (82%); this illustrates how important the industry-led SIEF initiative is for successful registration to the European Chemicals Agency.
SIEF participants encompass a variety of stakeholders, which may be divided into the following 2 main categories: (1) Potential Registrants and (2) Data Holders
(1) Potential Registrants
Potential Registrants have pre-registered information (according to Article 28) on a phase-in substance. These following parties are considered potential registrants:
- Manufacturers and Importers who have pre-registered a phase-in substance
- Producers and Importers who have pre-registered a phase-in substance in an articles if it is of intended release from the article.
- Only Representatives who have pre-registered a phase-in substance on behalf of a non-EU Manufacturer
If it is deemed necessary, the manufacturers, importers and producers described above may appoint a Third Party Representative (TPR; Article 4). This may be for reasons of corporate or commercial confidentiality and a TPR can be utilised to protect sensitive information. In this case, 'the identity of a manufacturer or importer or downstream user who has appointed a representative shall not normally be disclosed by the Agency to other manufacturers, importers, or, where relevant, downstream users' (Article 4). However, the legal entity appointing a TPR still retains ' full responsibility for complying with his obligations under this Regulation' (Article 4). The TPR is not considered a potential registrant and therefore carries none of the legal responsibilities associated with that role. The TPR role is primarily associated with negotiation of data-sharing obligations.
(2) Data Holders
Those who retain relevant information with regards to a phase-in substance may be willing to share it with other SIEF members. If they wish to do so, they can either contact ECHA directly to communicate their wish to be a SIEF member, or submit to ECHA the information in Article 28.1.
Data holders may be:
- Manufacturers and Importers of phase-in substances who have not pre-registered and manufacture and import in quantities of less than 1 tonne per annum.
- Downstream Users of phase-in substances. They may have useful information concerning quantification of exposure and estimation of risks.
- Third Parties who retain information on phase-in substances, e.g. Trade or industry federations, Non Governmental Organisations (NGOs), laboratories, universities, international agencies.
Two other groups are considered automatic SIEF participants, as they have previously submitted information to ECHA either as:
(i) Any party that has registered a phase-in substance (i.e. registrants) with intended release from an article before 1 June 2018
(ii) Any party that has submitted information under the Plant Protection Product Directive (91/414/EC) or the Biocidal Product Directive (98/8/EC)
Note: there is a mandatory requirement to share animal testing data
Important Considerations as a SIEF Member
- Confidentiality - Preserve Confidential Business Information as appropriate, Appoint a Third Party Representative, or Opt out
- Type of Cooperation – SIEF alone or member of a Consortium
- Cost Allocation, Sharing and Compensation – Based on Data Quality and Valuation
- Data Sharing Rules – Collective or Individual Route for Data Gathering, Evaluation, Data Gap Analysis, Testing Proposal Generation
- EC Competition Law Applies: 'this Regulation should be without prejudice to the full application of the Community competition rules' (Recital 48). This applies to the exchange, frequency of exchange, misuse, scope and type of information between REACh actors.
