REACH Statement

Registration, Evaluation, Authorisation and Restriction of Chemicals, or in short REACH, is an EU regulation with the aim to protect the health and environment from risk associated with improper use of chemicals. Subject to various exemptions REACH is applicable to all chemicals that are produced or imported into EU, and in a recent ruling from ECHA, ozone is also subjected to registration, if manufacture or import is at 1 tonne per year or more.

 

REACH is implemented in four tonnage bands with registration deadlines for phase-in substances between 2010 and 2018. The last two tonnage bands, production or importation volumes between 1-10 and 10-100 tons annually, both have a registration deadline of 31st of May 2018. Before this date registrants need to submit a compliant registration dossier to ECHA in order to maintain supply.

 

In order to benefit from the 31st May 2018 registration deadline it is necessary for registrants to pre-register the substance. This pre-registration needs to be completed by 31 May 2017 at the latest. If pre-registration is not undertaken then the registration requirement is immediate once supply exceeds 1 tonne per year.

 

REACH is applicable for your company if you provide ozone generators to one legal entity that produce more than 1 ton ozone annually. 1 ton annually is equal to continuously operating at 114 g/h ozone per hour. Production volume is additive; if one legal entity uses 2 pieces 60 g/h ozone the REACH tonnage band will be exceeded and registration is necessary. Please be aware that the legal obligation to register under REACH lies with the entity that is actually producing the ozone within the EU. YOUR CUSTOMERS NEED TO REGISTER BEFORE 31ST MAY 2017.

 

Registration is undertaken by means of a joint submission  between all companies that wish to register the substance . The registration group is led by a “lead registrant” that is preparing the full registration dossier and submits this to ECHA. Subsequent registrants are obliged to become part of the joint submission process and submit their own non-lead dossiers.
All pre-registrants are placed in a SIEF. (see explanation sheet). This is in effect a working group.
We plan to register the following substance under REACH prior to the May 2018 deadline (Phase III):

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The pre-SIEF is formed automatically within REACH-IT when you pre-register a substance.  Once you have pre-registered a substance you are a member of the pre-SIEF.  There is no option to opt out of a SIEF, but you can decide how active you wish to be within it, which is where the roles of lead/active/passive etc. are relevant.

 

Generally, the pre-SIEF becomes known as the SIEF once the registrants agree how they will work together and what they will register, i.e. if there is sufficient similarity (e.g. the form, purity etc.) to allow data sharing and a valid joint submission of data.  If you do nothing at all you are still a member of the SIEF, just a dormant one.
The role of lead registrant has to be agreed within the SIEF.  The list of pre-registrants is available to all pre-registrants in REACH-IT.

 

Whoever ultimately becomes the Lead Registrant will need to ensure that the cost sharing is transparent, non-discriminatory and fair.  There cannot be preferential treatment of one group over another.  It is essential to ensure that records of all correspondence is kept, as in the event of a dispute over costs, ECHA will rely entirely on the correspondence from each party.
Full details of the REACH regulations can be found at the ECHA (European Chemicals Agency) web site: https://echa.europa.eu/guidance-documents/guidance-on-reach