In order to benefit from extended deadlines for phase-in substances, potential registrants under REACH may pre-register their substances with ECHA between 1st June 2008 and 1st December 2008 (inclusive).
As described in the Guidance on Data Sharing, starting from 1 June 2008, there will be two possibilities to submit pre-registration information:
- by direct encoding of the information on the REACH-IT Portal (On-line pre-registration)
- by submitting a pre-registration prepared separately in a computer file format specified by ECHA in accordance with Article 111 of the REACH Regulation.
On-line pre-registration via the REACH-IT Portal
REACH-IT Portal is the tool to be used to enter data for on-line pre-registration.
Detailed information on the pre-registration process is available in the pre-registration section of the ECHA website explaining the different options to submit a pre-registration.
IUCLID 5 Pre-registration plugin
IUCLID 5 offers the possibility to create pre-registration XML files
with the help of a plug-in software.
A plugin is an extension of the IUCLID 5 application, which has to be installed separately. The pre-registration plugin adds the functionality of creating single and bulk pre-registration XML files in a format that can be submitted to the European Chemicals Agency.
With the pre-registration plugin you will be able to enter the required data, or extract the available information relevant for pre-registration, from your existing IUCLID 5 data sets. You will also be able to pre-register multiple substances under certain conditions.
If you have more than a few substances to pre-register we would recommend you using this plugin for preparing your pre-registration.
IUCLID 5 Pre-registration plugin Training Material
IUCLID 5 Pre-registration Presentation
Pre-registration plugin Presentation
IUCLID 5 Pre-registration Video Tutorial - Part I
The videos can be watched with subtitles in your language. In order to do so, users need to download the video and save it into a local folder. The subtitles file need to be saved to the same folder. Using Windows Media Player, subtitles are enabled by selecting "On if Available" in the Menu bar "Play >> Captions and Subtitles". After having checked this option close the media player and launch it again.
The following video shows how to prepare a basic mono constituent substance for pre-registration.
IUCLID 5 Pre-registration Video Tutorial - Part II
The next video shows how to prepare a multi constituent substance for pre-registration.
Pre-Registration XML Format
Pre-registrants who do not want to use IUCLID 5 for pre-registration, still need to comply with the same data format as produced by the IUCLID 5 pre-registration plug-in. In order to enable you to develop your own tool for creating valid pre-registration files for submission to REACH-IT, the format specifications are published here.
A specific format is necessary in order to facilitate and validate the submission of your pre-registration data. This pre-registration XML format is produced by a IUCLID 5 plug-in. Alternatively, pre-registration files may also be created by other applications, as long as they use the same format for submission, as the one produced by IUCLID 5.
The XML documents containing data for pre-registration must follow a specific format for submission to REACH-IT. The format is described by a set of XSD documents, specified using the W3C XML Schema.
The majority of pre-registrants need not concern themselves with these technical documents as the IUCLID 5 Pre-registration plug-in will implement this format.
The XML Format is intended for companies that need to register a large number of phase-in substances and prefer to develop their own tool for creating the XML files.
The IUCLID 5 Support Team has developed a set of examples to demonstrate the use of the pre-registration XML format. These examples can be used as a template for creating your own tools.
One example of third party software developed for pre-registration is an
Excel based tool
developed by CEFIC and CONCAWE that can be used to transform your existing data.
The tool can be downloaded free of charge from the CEFIC and CONCAWE websites.
Please note that the European Commission or ECHA can not provide support for this external software. If you have any question you should contact CEFIC or CONCAWE.
Guidance on registration:
- Section 2.2 (Main principles of pre-registration of phase-in substances)
- Section 1.7 (When to register?)
Guidance on data sharing:
- Art. 111 (Formats and software for submission of information to the Agency)
- Art. 23 (Specific provisions for phase-in substances)
- Art. 3.20 (Definitions, phase-in substance)