Share |


ECHA requests 574 registrants to update their intermediate dossiers.

14 Sept 2012, ECHA has sent letters to 574 registrants to request them to review and update their intermediate dossiers with correct information over the next three months.  ECHA has screened approximately 5 500 registrations for intermediates and 2388 dossiers included uses that do not, or are very unlikely to, fulfil the definition of intermediates and/or are used under strictly controlled conditions. 

ECHA has also added to this letter practical advice for registrants on how to better report intermediates in IUCLID 5.4 or how to update the registration to a full Article 10 Registration.

After the end of the three month period, ECHA will undertake a new screening of dossiers and identify those that require regulatory action.

Background Information

On 11 May 2011 ECHA announced that most (86%) of the more than 400 dossiers on intermediates it screened do not seem to meet the conditions imposed by REACH for them to benefit from the reduced information requirements. ECHA encourages registrants of intermediates to proactively reassess and, where necessary, update their registration dossiers.

According to REACH, two critical conditions need to be met for an on-site or transported isolated intermediate to benefit from the reduced data set provisions of articles 17 and 18 of REACH:

  • the use of the substance must meet the definition of intermediates as described in article 3 (15) of REACH; and
  • the substance must be manufactured and/or used under strictly controlled conditions (SCC).

 

Manufacturers and importers who have submitted reduced registration dossiers for isolated intermediates under SCCs are indeed advised to review their dossier to determine whether they are likely to face criticism from authorities on the fact that their substance either does not meet the definition of “intermediates” or is not manufactured or used under SCCs.

Reference

http://echa.europa.eu/view-article/-/journal_content/0d1a14fe-9c63-4807-a3de-380c0dbffdf5

To follow more events, free regulatory updates and publications from CIRS, please subscribe our monthly newsletter:

Email Newsletter icon, E-mail Newsletter icon, Email List icon, E-mail List icon Sign up for Newsletter
For Email Marketing you can trust