Planning for registration in 2013 The initial deadline for large (>1000 tonnes per year) organisations to register their products for REACH has long since passed, on 1st December 2010. Now the focus shifts to those in the lower tonnage band of 100 -1000 tonnes per year. This applies to manufacturers or importers of substances in the EU, or those who have been appointed as an only representative. If you are in this category for 2013 registration, what do you need to do now? The first thing to do is not to wait until the last minute! The deadline of 1st June 2013 is just that – a deadline. It does not mean that you have to wait until then before acting. You can register at any time - it is far better to start thinking now of what you need to do. This of course assumes that you have in fact pre-registered your substance already – something that you should have done some time ago! So what should you have done already? When you pre-registered your substance, you would have entered a SIEF – a Substance Information Exchange Forum. For some substances, there were consortia which developed out of the SIEFs, which were used to facilitate the initial registration, but for many in the lower tonnage bands, there has been little activity. Nevertheless, even if you did not need to register in 2010, you still needed to have notified your substance under regulation 1272/2008 (the classification, labelling and packing regulation), which should have been carried out by January 2011. If you need to register in 2013, what must you do next? If the substance has already been registered in 2010 in the large tonnage band, then there will have been a REACH dossier submitted by the Lead Registrant, and the other registrants will have joined a ‘joint submission’ to enable their own registration. For 2013, you can then register as a ‘co-registrant’ and essentially link your registration to the main dossier of the Lead Registrant. You should check REACH-IT to find out who the SIEF formation facilitator is, if you do not know who the Lead Registrant is, or how to purchase a letter of access. If your substance has not been covered in this way, then a completely new registration is required, and you may even need to act as a Lead Registrant yourself. Again, first check REACH-IT to see if there is a SIEF formation facilitator identified. If there is, contact them – it is likely that there is already someone else working toward registration. The data requirements for the lower tonnage bands are less onerous than for the >1000 tonnes per year band, but only marginally. For less widely used substances, however, less data may be available to cover the endpoints required by REACH. Strategies such as read-across and QSAR (Quantitative Structure-Activity Relationships) can be used, but it may be that additional toxicological testing may be needed. Through ReachSupport.eu we can offer a range of services to assist you in securing the successful registration of your product. This can be through assisting you on a particular aspect of your registration, through to preparing the full IUCLID dossier ready for your submission. Our expert support can include: -
IUCLID dossier preparation -
CSR preparation -
Literature searches and toxicological data review -
Analysis of testing requirements and organisation of test protocols -
Advice on analytical data needed and provision of data on your product -
Classification and labelling proposals -
Use mapping -
Exposure assessment including PNEC and DNEL derivation -
Exposure scenario preparation for your particular uses
For all aspects of support for your 2013 registration, please contact us. |