The purpose of substance information exchange forums (SIEFs) is to facilitate the exchange of information, to avoid duplication of studies and animal testing, and to agree on classification and labelling of chemical substances. Members in a SIEF are the manufacturers, or their appointed third party representatives; importers; and only representatives of non-EU manufacturers who have submitted the pre-registration information on the same substance. Other parties that may submit this information and become a member in the SIEF (Article 28(7)) include: manufacturers or importers of phase-in substances in quantities of less than 1 ton per year, downstream users of those substances and third parties holding information on the substance.
Companies, that register phase-in substances directly become data holders and will have to respond to data requests from SIEF members.
The purpose of a SIEF is laid out in Article 29 of the REACH regulation where the forums will not be further managed by the ECHA or the EU Commission. Consortia are additional agreements amongst companies approaching the needs of registrants within the REACH processes. The consortia management can be provided by industry associations or by external consultants, and the rules applicable in such consortia must be agreed upon among the consortia members. It is expected that in some industries the consortia will be set up already before June 2008.
Interview with Peter Ungeheuer, PhD, secretary general of EFfCI about consortia formation and the activities of his organization.
The European Federation for Cosmetic Ingredients (EFfCI) represents the manufacturers of chemical and natural ingredients for the cosmetic industry. Established in 2000, EFfCI advocates the collective interests of more than 100 cosmetic ingredient companies in Europe. A key activity of EFfCI is to provide timely and comprehensive information on international cosmetic regulations and on important regulatory, legal, technical and scientific developments, including the support on REACH. For more information abotu the group, visit www.effci.com.
1. For how many substances from the ‘cosmetic ingredients’ sector do you expect SIEFs or consortia to be formed?
A: It is difficult to estimate this at this point. Most of the substances used as cosmetic ingredients are used in other application areas as well and the tonnages used for these other applications may be even larger. Therefore, I believe that for REACH processes, the substances used as cosmetic ingredients will be covered more often by other industry associations than by EFfCI. These associations will establish consortia for the substances. At this point, we assume that this will be the case for most of the cosmetic ingredients.
2. What will the procedure be for the exchange of data and the implicit financial compensation?
A: There are ongoing activities on an industry level to establish an electronic platform for the exchange of information within a SIEF. There will be no tools provided for this on behalf of the authorities. With respect to the financial compensation, it is requested in the REACH Regulation that this should be accomplished in a fair, transparent and non-discriminatory manner. Basically, the mode is open to be decided amongst the potential registrants from the industry. In a case of no agreement, the REACH regulation foresees a sharing of costs in equal parts.
3. How will confidentiality be ensured?
A: Within consortia the confidentiality rules will be defined amongst the participants. In order to achieve confidentiality within a SIEF a company can appoint a third party representative. In this case the identity of the company shall not be disclosed to the other registrants.
4. Will EFfCI take an active role in the REACH process and/or for the SIEFs?
A: The EFfCI board of management has decided to offer to its members support in the formation of consortia, if this is wanted. It is up to the member companies to nominate substances, where a common interest exists for the cooperation in relation to REACH requirements. The federation will get clarification on the interest and, where required, initiate the cooperation.
5. If consortia will be established for defined substances before June 2008, how will other suppliers of these substances be informed about the existence of the consortia?
A: Consortia are formed based on private agreements. According to REACH there is no request to form consortia and similarly there is no obligation to disclose the formation of a consortium to third parties.
• The purpose of SIEFs is to facilitate the exchange of information and to agree on classification and labelling of chemical substances;
• The working structures of the forums are not laid out in the REACH regulation, there will be no further management by the ECHA or the EU Commission;
• Consortia are additional agreements amongst companies approaching their needs within the REACH processes.
Next month’s topic: Specific provisions for naturals and polymers
If you have questions towards REACH, visit www.CosmeticsandToiletries.com/reachroundtable, and get an answer.
REACH fees regulation: The REACH fees regulation was agreed at the comitology meeting on Dec. 10, 2007, and will be published in the Official Journal of the European Communities. A draft version can be found under: www.euractiv.com/29/images/Commission%20draft%20REACH%20fees_tcm29-168130.pdf.
Germany’s government passed national adaptation statutes for REACH on December 12, 2007, including regulations for sanctions. Fines of 100, 000 are described when infringing upon core requirements of REACH at: www.bmu.de/files/pdfs/allgemein/application/pdf/reach_anpassungsgesetz_entwurf.pdf.
The guidance document for downstream users was published and can be found at: http://reach.jrc.it/docs/guidance_document/du_en.pdf.
THE ECHA WORK PROGRAMME 2008 describes the priorities and goals of the agency for 2008. REACH stakeholder information activities include a conference foreseen to be held in April 2008, addressing (pre-)registration. http://echa.europa.eu/doc/FINAL_MB_18_2007_Work_Programme_2008.pdf.
REACH IT - Helpful information and learning tools from the REACH IT Workshop on Oct. 5, 2007, is available under: http://echa.europa.eu/news/workshop_en.html
-Annelie Struessmann, PhD, CONUSBAT
Disclaimer: Readers are reminded, that the text of the REACH Regulation (Regulation (EC) No 1907/2006) is the only authentic legal reference. The information in this document does not constitute legal advice.