From the moment it was tabled until its eventual adoption in 2006, the REACH regulation gave rise to one of the most epic lobbying battles in the EU's history, pitting green campaigners against the powerful chemicals industry.
Five years on, the European Commission is preparing to review the controversial piece of legislation, which sought to protect consumers' health and the environment from the dangerous effects of toxic chemicals.
"I think it is a start and a very important start," said Jamie Page from the Cancer Prevention and Education Society, a non-profit group that supports REACH's objectives.
Adopted in 2006, REACH sought to review the 100,000-odd chemical substances which are currently on the market and screen them for potential threats to human health or the environment.
Since then, only a small number of chemicals have actually been reviewed, starting with a list of 47 Substances of Very High Concern (SVHC), which are suspected of causing cancer or disturbing the human reproductive system.
But there are a lot more substances out there, said Page, who is calling for the screening process to be accelerated. "Obviously, there are a lot of chemicals on the market – people estimate between 80,000 and 100,000 – so it is like a few down, a lot to go."
ChemSec, an environmental lobby group, has recently accused the EU of delaying action on "endocrine-disrupting" chemicals such as phthalates, calling on regulators to speed up work. ChemSec wants 378 substances included in the list of "substances of very high concern".
"There are a lot of controversial products," Page concurred, citing Bisphenol A, a compound which has recently been banned in plastic baby bottles but which some scientists believe could be harmful in other guises, such as coatings for food cans.
Some dangerous chemicals have been removed from the market, said Page, but "there is an issue of whether those [substances] can be evaluated properly," he added, pointing out that a full ban on Bisphenol A was still being discussed at EU level.
"The methodologies which are being used to justify that they are kept on the market – we would like to see more transparency on that."
Within the chemicals industry, efforts have focused on complying with the complex EU regulation while protecting legitimate business interests. Companies that want to sell chemicals must register them with the European Chemicals Agency (ECHA) in Helsinki, including details on toxicity, which the agency publishes on its website.
One contentious issue is whether ECHA should make all the toxicity data available to the public or whether parts of it should remain confidential to protect company's patents.
Cefic, which represents European chemicals firms, complained recently that publishing company names against toxicity data sheets might give overseas rivals an insight into their innovation strategies.
Anti-toxics campaigners have countered that such information is crucial to hold companies to account over the safety of their products.
The REACH review, due in 2012, will assess whether changes here are necessary.
Others have criticised the law for targeting the wrong substances. The REACH regulation was initially designed to protect consumers from exposure to hazardous chemicals, but the bureaucracy it created ended up encompassing metals such as cobalt, which hardly comes into contact with consumers at all.
David Weight, from the Cobalt Development Institute, an organisation representing major producers of the metal, said REACH had "very laudable ambitions" but criticised it for its unintended consequences.
"Where we have misgivings is in the implementation," Weight explained, saying that there is "no consumer exposure" to cobalt and that it is therefore "not really the sort of substance that should fall under the spotlight".
"This is where we should have much closer discussion," Weight said, referring to the opportunities that a review would offer to fine-tune the legislation.
"At the end of the day, the changes for health and for the environment will be imperceptible," Weight argued, referring to a possible restriction on cobalt. Meanwhile, the heavy bureaucratic burden imposed by REACH "may well have damaged the economy," he warned, saying the regulation had introduced new trade barriers for cobalt.
Andrew Miller, a Labour MP who chairs the science and technology committee in the UK parliament, agreed. He said policymakers should adopt different approaches for substances that aren't dangerous and those "that are known to be harmful to human health".
In June, the committee produced a report, which said REACH had introduced "de facto import tariffs" on some strategic raw materials by requesting importers to submit registration dossiers for all kinds of substances.
Anthony Lipmann, of Lipmann Walton & Co Ltd., a small company importing various strategic metals, told the committee that he had to spend "a lot of money" to register products with the European Chemicals Agency (ECHA).
In one instance, Lipmann said his company had to purchase a letter of access (LOA) to import 1,000 tonnes of titanium, which cost him €40,000. Although he only needed to import 100 tonnes of titanium, he still had to pay €40,000.
"If you translate that across the 20 elements that I trade, it is untenable," he told the committee.
'Be careful what you wish for'
A senior EU official dealing with REACH seemed to agree with critics, saying the value of the regulation lies in making sure that only hazardous substances are screened, not those that pose no health or environmental threat.
But he also played down expectations, saying the review would be fairly limited in scope. Speaking on condition of anonymity, the official cautioned that a full-blown revision could open up "a can of worms".
"Be careful what you wish for," warned the official, who was speaking at a stakeholder workshop organised by EurActiv in London last June.
The Commission review will be based on a report drawing on lessons learned from the implementation of REACH, "with special attention to the costs and administrative burden and other impacts on innovation". This will include a review of registration requirements for lower tonnage substances.
Other aspects of the review will include:
- A review of the amount and distribution of funding made available by the Commission for the development and evaluation of alternative test methods (Art. 117.4 of REACH).
- Whether or not to amend the scope of REACH in order to avoid overlaps with other EU legislation (Art. 138.6).
- A review of the European Chemicals Agency (Art. 75.2).