IUCLID 5 – International Uniform Chemical Information Database (Version 5.0)
IUCLID 5 is the essential software & tool to submit and exchange data on chemical substances with the European Chemical Agency (ECHA) for the purpose of REACH registration. In addition, the IUCLID 5 software is also used for submitting the ELINCS Enquiry, notification for Authorization as well as notification for the presence of substances of very high concern (SVHC) with REACH.
ELINCS - European List of Notified Chemical Substances (ELINCS)
Certain chemical substances were notified with the relevant European enforcement authorities within Directive 67/548/EEC on the “approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labeling of dangerous substances”.
The final edition of ELINCS (2009) is comprehensive of all notified substances, concluded by expiry of the Directive on 31st May 2008, and contains 8433 notifications, representing 5292 substances in total. On 1st June 2008 the notification scheme was revoked and replaced by Regulation (EC) No 1907/2006 concerning the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH). The complete list is available by clicking the Pdf document
EINECS - European Inventory of Existing Commercial Substances
The European Inventory of Existing Commercial Substances lists and defines those chemical substances that were available in the European Community market between Jan. 1st 1971 and Sep. 18th 1981. An EINECS number is a seven-digit system number of the form 2XX-XXX-X or 3XX-XXX-X, starting at 200-001-8.
Chemical Safety Report (CSR)
The chemical safety report will document the chemical safety assessment for either each substance on its own or in a preparation or in an article or a group of substances and is required for substances exported at > 10 ton/annum. The chemical safety report documents the results of the chemical safety assessment (CSA) which include results of exposure scenarios carried out for the various uses of a particular substance.
Within REACH, it is important that the European buyers (who are the downstream users of the “only representative”) convey their uses either to their non-European supplier or to the “only representative” to cover in the registration dossier (technical dossier). If they do not want to share the use with their supplier or is “only representative”, they shall have to perform the CSA and prepare the CSR for their use individually.
Technical dossier
Every potential registrant within REACH has to prepare and submit a technical dossier in order to register his substance with the ECHA. The technical dossier can be said to comprise of two parts.
The mini dossier compromises the details that shall be company specific and hence each potential pre-registrant has to prepare and submit the mini dossier through the “only representative” individually. The main dossier comprises information on the physico-chemical, toxicological and eco-toxicological properties of the substance to be registered and shall ideally be submitted by the lead registrant to ECHA at least 2 months before the first REACH deadline of 30th November’ 2010.
Lead Registrant (LR)
The lead registrant is assumed to be a very important player in the substance information exchange forum (SIEF). Ideally he is a pre-registrant who has the first REACH registration deadline to meet, is a major market player for that substance and should also ideally be having substantial ownership data related to the physico-chemical, toxicological and eco-toxicological properties of the substance. Since REACH warrants “one substance one registration (OSOR), it is expected that all the members of the same SIEF (i.e. pre-registrants who have pre-registered the same substance) will submit a joint registration to the ECHA through the lead registrant.
Letter of Access (LoA)
Letter of access is a document that shall have to be procured by the potential registrants from the data owners in order to fulfill their information requirements for REACH registration, by providing some compensation, which shall be known as the cost of the letter of access. The letter of access only enables the potential registrant who has bought it from the data owner to use the data for REACH purposes. There will be no ownership issue involved in this case compared to when a potential registrant pays a higher cost to the data owner and decides to become co-owner of the data which he wants to use, possible for compliance with other regulations. The cost of LoA is expected to much lower as compared to the cost of co-ownership of the data. LOA is part of the data sharing process within REACH. |