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Tender Specifications - ECHA - Europa

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• testing<br />

• support of operation in production<br />

• information security tasks as interwoven part of the above services<br />

The above list of services is not exhaustive. Other services may be requested provided they are in<br />

the scope of the framework contract.<br />

4.2.2 Current status of the related IT systems<br />

A short description of the status of the systems for which the services will be provided follows:<br />

REACH-IT (LOT 1)<br />

It is the Agency’s central IT system that provides support for REACH. It is used by companies in<br />

registering substances, by the Agency and Member States in evaluating dossiers and to help public<br />

in accessing information on chemicals. The REACH-IT system has been in operational use for a<br />

number of years, and is currently under active development. During the coming years, the foreseen<br />

tasks focus mostly on implementation of new submission type and processes, integration with other<br />

systems and improving user experience; in addition maintenance activities will continue to be vital<br />

for the quality of the service to the users of the system.<br />

The development of the REACH-IT was assigned to the first Contractor on early 2007 to be<br />

performed at the Contractor’s premises. After the completion of the contract in April 2011 the work<br />

for the continuation of the project was assigned to the second Contractor (based on the results of<br />

the relevant procurement process), who is currently working on further developing and maintaining<br />

the system. During the execution of the project and until now, the development and the testing<br />

regarding unit, integration, performance, security and functional testing has been performed at the<br />

Contractor’s site, while the acceptance testing, final production and security testing are being<br />

performed at <strong>ECHA</strong> premises by <strong>ECHA</strong> personnel and intra muros consultants.<br />

BIOCIDES (LOT 1)<br />

Regarding biocides regulation, the exact scope of <strong>ECHA</strong>’s role is still subject to the finalisation of<br />

the legislative process between the Commission, the Council and European Parliament. It is<br />

probable that <strong>ECHA</strong> will undertake the responsibility of receiving and checking applications for the<br />

approval of active substances and Union authorisation for biocidal products. Applications will be<br />

submitted through an IT portal (the Registry for Biocidal Products - R4BP).<br />

The scientific evaluation will be taken care of by Member State Competent Authorities who submit<br />

an assessment report to <strong>ECHA</strong>. <strong>ECHA</strong> will have to build up a Biocidal Products Committee which<br />

will process these assessments. The Commission will then decide on the approval of the<br />

substances and/or grant authorisation. There will also be other processes: helpdesk, data sharing<br />

and dissemination (similar to REACH), the assessment of technical equivalence and the publishing<br />

of a list of applicants who wish to continue on the market.<br />

R4BP is currently hosted and maintained by the Commission to serve the current Biocidal Products<br />

Directive (98/8/EEC). In preparation for its role under the new Biocidal Products Regulation, <strong>ECHA</strong><br />

has started business analysis work in Q3 2011 to implement a new version of R4BP. The<br />

development of the new R4BP is planned to start in Q2 2012 and will be outsourced to an external<br />

Contractor. The target for <strong>ECHA</strong> site acceptance test and completion of the new R4BP is Q2 2013.<br />

PIC (LOT 1)<br />

Regarding the prior informed consent (PIC) regulation, the European Commission has set up a<br />

software tool, the EDEXIM database (European Database for the Export and Import of dangerous<br />

chemicals). EDEXIM database is currently hosted and maintained by the Commission to serve the<br />

current Regulation (EC) No 689/2008 of the European Parliament and the Council concerning the<br />

export and import of dangerous chemicals (EDEXIM is used by industry and national authorities for<br />

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