Public health first
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 Substances of Very High Concern (SVHC), which are suspected of causing cancer or disturbing the human reproductive system.
This has led campaigners to call for an acceleration of the screening process. 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," said Jamie Page from the Cancer Prevention and Education Society, a non-profit group. Page cited 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," Page said.
Review limited in scope, big changes unlikely
The European Commission has sought to play down expectations, indicating that the REACH review will be based on a report drawing on lessons learned from the legislation's implementation.
EU officials told EURACTIV that the review was more likely to focus on better enforcing existing rules rather than introducing major changes to the legislation, which took effect in 2007 after years of heated debate.
Janez Poto?nik, the EU's environment commissioner, stressed that the review was only a legal requirement and that the Commission would "only put forward a legislative revision if it were really needed and necessary".
An EU official dealing with REACH said the review will pay "special attention to the costs and administrative burden" placed on companies as well as "other impacts on innovation". This will for example include a review of registration requirements for substances produced in lower quantities. 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).
The EU official said the value of the regulation lies in making sure that only hazardous substances are screened, not those that pose no health or environmental threat. The REACH review will therefore more likely focus on enforcing the existing rules, he said, warning that a full-blown revision could open up "a can of worms".
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. Some of this data may actually be withheld and kept confidential when companies can demonstrate that disclosure would hurt their bottom-line.
CEFIC, a trade group which represents European chemicals companies, 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, will assess whether changes there are necessary.
Meanwhile, not all companies seem to be playing by the rules and ECHA said it was investigating whether all confidentiality claims filed until now were legitimate.
Producers and downstream users of chemicals
Part of the review will focus on simplifying the rules and making sure they do not hurt the European manufacturing sector – whether the chemical firms themselves or others that use chemicals as a key component of their supply chains.
These worries were expressed chiefly by Slovakia and the Czech Republic, which they have outlined in a document submitted to the EU Council of Ministers.
“The competitiveness of the European chemical industry is weakening compared to emerging economies such as China, India or South America,” warned Martin Kuba, the Czech minister of Industry and Trade, urging European leaders to reconsider “excessive” safety regulations on the chemicals industry.
On the business side, a major concern relates to REACH's impact on the companies that use chemicals as part of their manufacturing process – the so-called downstream users of chemicals.
The current regulation includes inherent disadvantages for European companies, which must comply with the rules while imported goods do not always have to live by the same rules.
Downstream sectors affected by REACH include aerospace and defence companies, which use chemicals to manufacture aeroplanes (see "positions"). In the Czech Republic, the industrial sectors affected include automotive and machinery manufacturing. Slovakia is an important auto and electronics producer, which are heavy users of chemicals.
Their view is that REACH “not only has an impact on the chemical industry but also on all manufacturing industries” especially small-to-medium firms which represent 96% of the EU’s chemicals concerns.
Small businesses in focus
For the Czechs, smaller businesses that use chemicals need particular attention and should be given more leeway in complying with the regulation. “REACH imposes excessive administrative and financial burden on SMEs, and might threaten the very existence of many companies,” Kuba warned in a statement.
Thomas Fischer, chemical policy advisor for UEAPME, the EU's small business organisation, concurred. SMEs, he said, have no time to cope with hundreds of pages of guidance and elaborate registration dossiers.
Regulators have attempted to make life easier for SMEs by encouraging companies to submit a joint registration – mainly to reduce costs and avoid unnecessary testing on animals. However, few companies are making use of that possibility and most prefer to register alone, in order to prevent competitors from peaking into their trade secrets.
But Geert Dancet, executive director of ECHA, said it was not evident in some cases why the registrant did not join with other manufacturers of the same substance. Those companies would be investigated in priority, he indicated.
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".
Meanwhile, potential restrictions imposed by REACH "may well have damaged the economy," Weight 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 2011, 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.
Commission targets deceivers
However, not all companies seem to be acting in good faith when registering substances, with some putting in place elaborate systems to circumvent the rules.
Geert Dancet, the executive director of the European Chemicals Agency (ECHA), remarked that 25% of the 25,000 chemicals substances submitted in 2010 were registered as "intermediates", thereby benefitting from reduced fees. However, some of these substances may actually not qualify as intermediates, Dancet noted.
"Companies must not erroneously benefit from the reduced requirements of REACH," Dancet told a conference in September 2011. "A substance that is not intermediate should be fully registered and not unduly benefit from exemption from eventual authorisation obligation," he stressed.
According to the ECHA official, some companies have also sought to deceive regulators by unduly declaring themselves small businesses, which benefit from simplified procedures under REACH.
"We have evidence that a proportion of companies have mistakenly claimed to be small or medium," said Dancet, promising a follow-up of these dossiers to make the companies pay the full cost, plus a surplus charge to cover the administrative expenses.
The agency is also tracing some 1,500 "missing" substances it expected to be submitted by the 2010 deadline following company's declared intentions.
Leena Ylä-Mononen, ECHA director of evaluation, stressed that companies "need to provide detailed reasoning and supporting data" to support their submissions. ECHA wants "no vague sentences" in the dossiers and companies need to clearly state the identity of chemical substances they submit for approval, she added.