Denehurst Chemical Safety Ltd

EU and UK REACH Registration

 


The first and perhaps most obvious point is not to leave everything to the last minute and to be ready to have a Registration in place prior to the need to register.

 

It is possible to rush through simple Joint Submissions (where someone has already successfully submitted a data set and is the 'Lead registrant') and an Inquiry plus purchase of a Letter of Access can be done in 4 - 6 weeks depending on the time needed to obtain the analytical evidence (See Inquiry page).

 

However, if the Inquiry indicates you are on your own, it can take substantially longer to prepare a full dossier as Lead Registrant.  Some data sets can be deferred by 'proposals' or using 'study planned' options, but before the first tonne of a substance is manufactured or imported in the UK or EU, you will need a reasonable understanding of potential hazards to at least prepare a suitable SDS and correctly label.

 

If the substance is developmental or trials are needed, a PPORD is possible (see PPORD page).  This allows quick options for import or manufacturer, but there are limitations and the lifecycle needs to be known, making supply to wider professional or consumer applications impossible.

 

Either way, do not delay if import or manufacturer is known and even if making an Inquiry or PPORD, there is certainly no future obligation to move on to a full Registration.

 

Joint Registration

 

The most contentious issue is the payment for access. REACH legal text states that cost sharing and compensation for costs of data generated previously should be ‘fair and equitable’. What is fair for one organisation is very likely not going to be fair for another. There needs to be flexibility in cost sharing and lessons from 2013 demonstrate that disputes can cost more in legal fees and management time than the letter of access costs. 

If buying a ‘letter of access’, the key item for EU REACH is the ‘token’. The electronic token to allow access to joint submissions is provided by ECHA and is obtained by the Lead Registrant.

 

When working as part of a Joint Registration, it is important to ensure that a balance is struck between constructive cooperation and caution. Those joining in an existing consortium or existing Joint Submission may find established rules, systems and relationships. However, any new member has the same rights as existing members with respect to REACH and data sharing and can also attempt to make changes to existing systems; the commercial part of SIEFs, Joint Submissions and consortia are subject to the same rules as any other industry group.

However, it is recommended to try to fit into existing frameworks where possible, remembering time and effort (and perhaps legal costs) making changes to agreements diverts resources away from the more pressing need to register and assess safety of substances.

Note that data access will be free 12 years after it is submitted to ECHA, but there may still be some cost sharing issues for access to additional data, collective exposure scenarios etc. Any SIEF or Joint Submission agreement should take into account future activities and refunds may be applicable as new income from later registrants is disbursed among earlier registration – check these details in any agreement.

 


Lead Registration

 

If not already registered, the data endpoints that need to be addressed are linked to respective tonnage bands, as described in Annex VII, VIII, IX and XI of EU REACH and is mirrored in UK REACH.

 

Note that Annex XI tels us that we must consider alternatives to new testing and Article 25 of EU REACH reminds us that new animal testing is only as a last resort.

 

UK REACH is even stronger on avoidance of animal testing and in the UK it is illegal to perform animal tests on substances where data is already available, even if data owners are refusing to share.

 

It is possible to cover many endpoints by using read-across or modelling or justify not testing by requesting a waiver. 

In a surprisingly large number of cases, the amount of testing required can be quite low thanks to alternatives to testing. Guidance provided by ECHA describes the ‘intelligent’ testing strategy to reduce the burden of testing and to specifically avoid animal experiments.  

 

Denehurst can provide support on waivers  and testing if needed.

 

Advice on methods to avoid new animal work is provided without charge.