Are you still unsure whether or not you need to pre-register, then later register, for the REACH Regulations?
All pre-registration must take place before 1 December 2008.
Failure to pre-register means that the substance cannot be manufactured or put on the market until it has been fully registered. This would require the compilation and submission of a technical dossier which could take months for large volumes or hazardous substances.
Pre-registration is optional but failure to do this means that after 1 December 2008 the substance will be treated as a non phase-in substance and from that point the requirement to register becomes immediate.
Without
the required information the European Chemicals Agency (ECHA) would
reject the registration and so it would be illegal to manufacture,
import or supply the substance.
So, who may need to pre-register / register?
An equipment manufacturer
imports materials such as alloy, paint, adhesives etc from a supplier
outside the European Union (EU). If any of the chemicals contained
within these materials exceeds 1 tonne per annum (tpa) then the
manufacturer will need to pre-register, and then register, these
substances.
Importers of equipment will need to register if equipment releases more than 1 tpa of a substance.
Distributors
who are also importers will be responsible for pre-registration and
registration as exporters located outside of the EU cannot register.
One
option is that companies outside the EU can appoint an "only
representative" who pre-registers and registers these substances
instead of the distributor.
Pre-registration ensures that the chemical will be included in a staggered assessment and registration programme.
This
will start with substances of more than 1000 tpa or those of highest
concern. These must be registered along with the required data and
information by 30 November 2010.
100-1000 tpa must be registered by 31 May 2013 and finally 1-100 tpa by 31 May 2018.
Pre-registration is via the ECHA website at http://echa.europa.eu/reachit_en.asp where various options of how to pre-register are outlined.
Fees
for the actual registration process vary from a standard fee, with
increasing levels of discount for medium, small and micro enterprises.
As an example, the cost of registration for a substance of 10-100
tonnes would start at a standard rate of €4300 reducing to €3010 for a
medium enterprise and as low as €430 for a micro enterprise.
However, the cost of authorisation of substances of high concern comes with a base fee of €50000, reducing to €25000 for a small enterprise. Under normal circumstances it will be necessary to re-apply for authorisation and pay the relevant fee again every five years. Fees will also be adjusted in line with inflation.
A more comprehensive list of fees can be found on the Farnell website.
Substances of very high concern will be included gradually in Annex XIV of the REACH regulation and cannot be placed on the market or used after a date (known as a "sunset" date) set by the ECHA unless the "use" is authorised.
At present, no substances of very high concern have been formally identified but a "candidates" list will be published late in 2008 or early 2009. The first list of substances to be included in Annex XIV is expected by 1 June 2009.
Restrictions and authorisations on use can apply to these substances irrespective of volume.
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