The essential guide to Reach IT systems
The massive increase in data that chemical firms will have to generate and share under Reach has forced regulators to develop equally ambitious information technologies to help them. Paul Kaye reports on the tools firms will be using
With its new Reach regulation, the EU has embarked on the world’s most ambitious programme of collecting, sharing, analysing and publishing information on chemicals.
The obligations placed on companies and regulators by the new policy are of a different order to anything that has come before it, and European officials have had to develop correspondingly ambitious information technology (IT) tools to enable firms and regulators to rise to the challenge.
The first product of this effort was released in mid-June: Iuclid 5 is a new and much-expanded version of the chemicals database used for previous EU chemical policies, and will be an essential software application for all firms dealing with Reach. Next year will see the publication of Reach-IT – the main IT glue that the European Chemicals Agency (Echa) will use to hold together all Reach activities.
Complementing these main elements will be other specific IT applications aimed at different parts of the process.
For the thousands of companies that must register substances under Reach, Iuclid 5 will be their central IT focus. This will be where they store the information Reach requires on the substances they sell. It will be the means for sharing data with other makers of the same substance, and the mandatory format for submitting to Echa the “technical dossier” that is the basis of every substance registration.
Iuclid – the International Uniform ChemicaL Information Database – was developed in the early 1990s by the European Chemicals Bureau to ease implementation of the EU’s 1993 “existing substances” regulation, which set out the chemical risk assessment framework used in the EU before Reach entered force. It was modified several times, mainly to cater for the launch of a separate EU risk assessment programme for biocides.
The fifth incarnation of Iuclid is the first for six years. It contains significant improvements and expanded functions.
Iuclid 5 is free to download to any organisation or individual, but users must register with the Echa as a legal entity. All data remains linked to the name of the legal entity entering it.
Firms engaging external service providers to help them complete their registration will be able to allow access to the database on their behalf. User support comes in the form of a 2,000-page manual, a ‘getting started’ guide and online video tutorials.
Iuclid 5 consists of a multitude of data entry ‘forms’ for each substance, based on templates developed by the Organisation for Economic Co-operation and Development’s chemicals programme. Using these forms, a firm will create a “substance dataset” for each chemical it produces or imports.
Each dataset will be made up of two types of information, arranged into 13 categories. The first three cover general information. This is where firms will log a substance’s chemical identity and its ‘business relationships’ – the identity of suppliers, recipients, membership of a registration consortium, the substance’s hazard classification and labelling status, manufacturing methods, estimated production quantities, waste production, intended uses and exposure scenarios.
The other ten categories cover ‘endpoint data’ – information on the chemical’s health and environmental effects. Here firms will record basic information on a substance’s physical and chemical properties, environmental pathways, toxicological information and guidance on safe use. This is where the results of substance testing required by Reach will be entered, and if necessary proposals for further testing.
Many firms already hold Reach-relevant data in various forms. Iuclid 5 comes with a “migration tool” so that users of previous versions of the database will not need to re-enter their substance information.
Meanwhile, under the Reach implementation projects (RIPs) EU industry group Cefic is developing software to allow producers and importers using other databases to extract the relevant details and import them into Iuclid.
Firms will be able to share with other producers or importers of the same substance their entries in the relevant sections. This will enable the coordination of parts of the substance registration dossier that must be submitted jointly, such as the classification and labelling status and the presentation of certain test results.
This joint submission of information under Reach will force inter-company collaboration on a scale previously unknown. Iuclid 5 will be essential for it to work properly.
“Iuclid 5 is very important for us,” says Andrea Paetz of German firm Bayer, which has had a hand in developing the new database. “We can exchange data files with other companies and so joint submissions are easier – one company can work on one part of the dossier, and a different one on another.”
SIEFs and CSRs
Iuclid 5 will be the tool for sharing information, but discussions between companies on the selection of information and extra testing to fill data gaps will be coordinated through substance information exchange forums, or Siefs. Every producer of a substance must join a Sief, and since some Siefs will have several hundred members, efficient communication will be vital.
Cefic is working under the RIPs on software to allow Sief members to liaise on the joint sections of the registration dossier. It is also developing a electronic questionnaire for gathering information from other parts of the supply chain.
Iuclid 5 will have many other advantages. For example, it will allow firms to group together similar substances and share common information between them. The use of OECD templates in Iuclid 5 means firms will be able to use the database to comply with the information requirements in other parts of the world, including the US and Japan.
Once a producer or importer has assembled all the information required of it under Reach, Iuclid 5 will generate a technical dossier that they can send to Echa to complete the registration. The last of the 13 database categories will be used for firms to attach to the technical dossier a chemical safety report (CSR) if they are required to do this according to the nature and production volume of their substance.
The CSR itself, an initial mini risk assessment of the substance, will be generated outside Iuclid. Again, specific software is being developed in the RIPs to help firms carry out the chemical safety assessment for a CSR. This will include an application to help them generate the exposure scenarios for their substance and its uses.
At Echa the data received from companies covered by the regulation will be merged into the master Iuclid database of all Reach substances. This central database will underpin all the agency’s work, which will itself be coordinated by Reach-IT.
Due to be launched next year, Reach-IT will be used internally to manage the agency’s workflow, and externally for all communication with other Reach actors.
The agency will use Reach-IT to extract administrative information on firms and substances to begin the work of evaluating substances. Reach-IT will also hold several other databases maintained by the agency: the classification and labelling inventory, rolling plans for substance evaluation work, and the list of substance authorisations and restrictions.
For firms, Reach-IT will be the interface for all interaction with the agency. They will use it to submit the Iuclid-generated registration dossier, to complete the pre-registration task (through an add-on module to be developed for Iuclid 5), to notify the agency of substances contained in articles and to apply for substance authorisations.
In the other direction the agency will use it to update them on the status of their dossier and to send requests for further information and registration fee invoices.
The agency will use Reach-IT to coordinate substance evaluation work with member state authorities. And an open-access branch of the application will be used to extract and disseminate all publicly available substance and company information via a public website.
For companies that are only starting to dip a toe in the Reach pool, one final IT tool has been developed. The Reach Navigator guides firms through a questionnaire helping them to determine their obligations and directing them to the appropriate guidance documents. For many firms the Navigator will be just the start of a new IT adventure that EU regulators hope will make Reach compliance go smoothly.
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