REACH: Pre-registration-time running out for India?

BANGALORE, INDIA & UK: Are you still unsure whether or not you need to pre-register, then later register, for the REACH (Registration, Evaluation, Authorisation (and restriction) of CHemicals) Regulations?

US companies must pre-register 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.

Indian companies 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 program.

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.

The 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, 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.

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.

The author is Customer Support Manager, Legislation and Environmental Affairs, Premier Farnell.