SUNIVO REACH Newsletter(9)

ISSUE 9-19th May 2009

SUNIVO has already taken part in the consortium to discuss within SIEFs to facilitate the exchange of information that is needed for registration between potential registrants of the same substance to avoid duplication of studies.

Recently CEFIC director general Alain Perroy has called on the European Chemicals Agency (ECHA) to take action to kick-start the Substance Information Exchange Forum (SIEF) process. Although the agency has consistently stated that industry should be responsible for the initiation and operation of SIEFs, Mr Perroy suggested that ECHA should provide clearer direction on what companies should do. This could, he mooted, include telling companies which communication systems to use.

He cited the fact that there were 2.8 million pre-registrations of 146,000 substances; and that the agency had estimated around 55,000 substances might be registered by 2010. From CEFIC’s experience it is aware of 100 consortia that have formed to prepare registration dossiers for 1,600 substances. Via REACHlink it is aware of 7,400 SIEFs that have been formally established. “There is a big gap,” he notes, “which says the SIEF phase of REACH is not working, or not working yet.”

The other news from the UK REACH Competent Authority, it has published a new information leaflet giving a step-by-step guide to companies' registration duties and the processes involved from participating in substance information exchange forum (SIEFs) to making inquiries about previous registrations.

And Belgian law firm Nauta Dutilh has published a paper describing the many potential conflicts that may arise between members of a substance information exchange forum (SIEF) and between SIEF members and external actors. Partner Philippe Péters describes the requirements of the REACH Regulation relevant to each type of dispute and offers advice on how to bring about efficient solutions.

A Substance Information Exchange Forum (SIEF) will be formed automatically within REACH-IT, comprising all the relevant stakeholders (see below) for each substance. You can view all the members of the SIEF through the REACH-IT system where you made your pre-registration. There is no option to opt out of a SIEF, but you can decide how active you wish to be within it.

Before a SIEF can operate effectively two things need to happen. Firstly, the pre-registrants need to find some way of working together to discuss how the SIEF will operate (who will coordinate it, methods of communications, who will be the lead-registrant, rules for late joiners, etc). Secondly, once the initial SIEF has formed, its members will need to compare the entity each has pre-registered to find out if there is sufficient similarity (e.g. the form, purity and impurity profile) in the nature of the substance each has pre-registered to allow data sharing and a valid joint submission of data. During this stage, the pre-SIEF exists. The Pre-SIEF was not foreseen in the REACH Regulation, but this concept was introduced, with support from industry, in order to bring pre-registrants together to facilitate SIEF formation.

SUNIVO Recommendation: If you failed to meet the pre-registration deadline of 1 Dec. 2008 for your substances, you still can pass through us to continue your business in Europe. And our pre-registration is totally free.

Sources: Chemical Watch，UK REACH Competent Authority

If you have any issue facing with REACH or trade in Europe,