After REACH deal, the hard work really begins

This month has brought to an apparent end three years of arguing over the best way to regulate the thousands of chemicals used in Europe. Put simply, the deal adopted by ministers and MEPs makes compulsory the registration of 30,000 chemicals produced or imported in quantities of more than one tonne per year.

MEPs voted last week to approve a compromise text on the chemicals regulation, known as REACH, which will replace 40 older laws on EU chemicals, and governments rubberstamped it at an environment council this Monday (18 December).

But the culmination of talks is not the end of the story. Chemical companies now have to tackle new and complex rules, while governments and the European Commission continue to hear complaints from businesses and environmentalists that REACH will not work in its current form.

REACH will come into force on 1 June but is not expected to cover all chemicals until 2018.

The first challenge will be to get the new European Chemicals Agency, the ECHA, up and running in Helsinki. The agency will process all registration and authorisation applications over the next 11 years.

A preliminary pre-registration process is expected to be completed in 18 months, winding up on 30 November 2008. The first year will also be used to organise and staff the agency, leaving just six months clear to tackle pre-registrations.

Conservation groups say that registration through the agency will be too opaque. Industry groups say it will be too burdensome. Small- and medium-sized enterprises say there are still legal questions about sharing registration costs.

The Commission is now drawing up guidance documents and IT tools to respond to these fears. The tools and documents are supposed to be available when the agency opens in June.

The majority of chemicals can be registered in Helsinki as long as the registration application meets information and safety requirements. But about 3,000 chemicals considered the most dangerous face a more complex procedure: their manufacturers will have to apply for authorisation. Permission to use these chemicals in Europe will only be granted if no alternative exists and the socio-environmental benefits of using them outweigh the risks.

Even then, the authorisation will only be for a limited time period while the manufacturer pays for research to identify an alternative. If one already exists, manufacturers will have to produce a substitution plan setting out how the switch will be made.

Most of the 3,000 chemicals affected by the authorisation rules are known as persistent, bio-accumulative and toxic (PBTs) or very persistent and very bio-accumulative (vPvBs).

Environmentalists say this definition is not strict enough. In particular, they claim that REACH will allow hormone-disrupting chemicals in common consumer products. After six years the Commission could propose adding these ‘endocrine disrupters’ to the most dangerous list. Under the current agreement they can be registered if the producer guarantees ‘adequate control’.

After seven years the EU will also decide whether extensive safety data requirements should be extended to chemicals linked to cancer, mutations and infertility even when they are produced in quantities of less than 10 tonnes per year. After 12 years the Union must decide whether these safety requirements should apply to all chemicals in this lower production bracket.

One of the many goals of REACH is to promote the use of alternatives to animal testing. The Commission will produce a report every three years on the use of such alternatives. The Commission might also draw up a new quality labelling system for EU chemicals.

The registration of several thousand chemicals, however complicated, is a one-off. It has a 2018 deadline and could one day fade to memory. The same cannot however be said for the worries and tensions that led to REACH being proposed in the first place, on 29 October 2003.

Environmentalists’ fears about chemicals exposure have not been allayed, even if REACH is one of the most comprehensive environmental laws ever passed in Europe. And on the other side of the equation, late concessions to the concerns of chemicals producers about the workability of the legislation have not convinced industry that REACH will be good for European business. The arguments will continue.

This month has brought to an apparent end three years of arguing over the best way to regulate the thousands of chemicals used in Europe. Put simply, the deal adopted by ministers and MEPs makes compulsory the registration of 30,000 chemicals produced or imported in quantities of more than one tonne per year.