BANGALORE, INDIA: REACH is a European Union (EU) regulation governing the Registration, Evaluation, Authorisation (and restriction) of CHemicals.

About 280 pages long, with some 2,000 pages of guidance notes and replacing 40 other pieces of legislation, REACH is one of the most complex regulations to come out of the EU.

Of the 30,000 most popular chemicals in use only 3 percent of them have been fully tested. There is still no data for 21 percent of them and inadequate data on a further 65 percent.

At the same time, the number of incidents of allergies, asthma, certain types of cancer, and reproductive disorders, including low sperm counts, are on the increase in Europe. Chemicals are thought to be responsible for 1 percent of all diseases in the EU.

REACH requires the registration of these popular chemicals, as well as new ones, along with the adequate safety data. Substances considered of very high concern (SVHC) may need to have their use authorised, at significant cost. Dates for registration vary over some 10 years with obviously chemicals of highest use, and greatest concern, under review as a matter of priority.

Indian firms intending EU exports
If Indian companies intend to export in to the EU, they will require either a distributor, or “only representative”, to register their products as appropriate, depending on the tonnage exported.

It is not yet clear how Indian companies will establish, and maintain, relationships with only representatives. Under REACH, an only representative should have sufficient background in the handling of substances as well as an awareness of the safety data required. Therefore, it appears that such a representative would probably need to be a chemicals professional based in the EU.

Registration is dependent on the tonnage imported into the EU, but can vary from around US$2,000 to over US$40,000. Authorisation of use of SVHC can be even more significant, over US$70,000.

These prohibitive costs may well have an impact on Indian companies when looking to import goods from the EU. As a result of these costs, certain substances may be phased out by EU manufacturers. At very least, Indian companies are likely to find that products and raw materials purchased from the EU will become more expensive as EU companies comply with the REACH regulations.

Indian companies with operations in the EU are likely to be affected by REACH regulations that require EU importers, manufacturers, producers and downstream users to comply with a variety of procedures including, in some cases, registration of substances where certain weight thresholds are met.

Indian companies with EU operations should now be looking into their potential obligations. For example, does their EU operation use substances imported from outside the EU, and are there substances in products they import from outside the EU that are intended to be released, or any that are likely to be categorised as substances of very high concern? If so, these factors could trigger various burdensome registration and notification obligations.

However, there are obvious benefits to health. The European Commission estimates that, once REACH is fully implemented, there will be 4,500 fewer cases of cancer each year, and 90,000 less allergies, skin disorders, etc., in Europe.

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