ECHA issues technical completeness check tool for PPORD

The agency has developed a software tool that allows companies to check the technical completeness of Product and Process Orientated Research and Development (PPORD) notification submissions. The tool, which if free, aims to help companies prepare complete technical dossiers for PPORD data submission according to REACH Articles 9(3) and 20(2).

• PPORD Completeness Check
• PPORD Notification System

ECHA publishes guidance on elements of evaluation, authorisation

The European Chemicals Agency, on 11th August, 2008, has published two news guidance documents. Guidance on Annex XIV (list of substances subject to Authorisation) Inclusion describes how the agency, working in co-operation with Member State Competent Authorities, will include substances in the authorisation system. Meanwhile, Guidance on Priority Setting for Evaluation details different methods that have been developed to prioritise dossiers, testing proposals or substances for evaluation and provides guidance for the Agency and Member State Competent Authorities on how to apply these approaches.

ECHA has also published Templates for a Chemical Safety Report (CSR) along with related guidance note on 30th July 2008.

EU REACH pre-registration moving fast

Pre-registrations application number had reached 56,000 by 5 August, told Greet Dancet Executive Director, ECHA. ECHA executive director, Geert Dancet believes the number of pre-registrations could top 200,000, particularly considering these potential new product entities. The six month pre-registration period runs until the end of November. Full registration under Reach begins in 2010.

It is to be noted that companies have only been able to pre-register substances in bulk with the European Chemicals Agency (ECHA) from 22 July. 

Companies also appear to be forward-looking and submitting registrations not simply for products in their current portfolio but also for potential products. 
 
By 28 July 32,191 pre-registrations had been created by 4,627 companies signed up for the REACH-IT system. These covered 13,883 substances. Most substances were registered using the European EINECS registry number but 3.5% of the number up to 28 July were registered by name only. 

Europe’s new chemicals agency faces the huge task of logging the pre-registration and ultimately registration documents as the EU’s Reach scheme moves into full gear.  The Reach process thus far seems to have has run surprisingly well with few complaints from industry. Producers and others appear to have knuckled down and simply got on with the job.
 
Pre-registration is a relatively simple process requiring little substance data. Registration itself is another matter and the number of consortia established to facilitate the registration and data gathering process for either individual or groups of substances is growing. 

The Reach scheme faces some critical tests this year as the first lists of substances of greatest concern are published. An unofficial list from NGOs (non-governmental organisations) is expected to cause most of a stir. An early official list of 16 substances has already been published.
 
The lists and how individual chemicals on them are then treated will test the Reach procedures – which ultimately involve the sanction of EU member sates. A solid scientific base should allow more rapid regulatory decisions – or so the official thinking goes – as Reach replaces a raft of earlier chemicals control legislation. But the proof of Reach effectiveness will ultimately be in its implementation. 

 The challenge for the ECHA is to balance expectations whilst maintaining its scientific and technical integrity. “I think that those chemicals which need controlling will be controlled,” the man who has been involved with Reach since the very beginning says, “It will take 20 years to get this system comprehensively up and running and in some cases chemicals will have to leave the market. If the use of a nasty chemical is necessary, Reach gives a possibility to keep it, but industry needs to show why it is necessary to use that chemical and not another one.”