REACH chemical safety review: Re-opening a can of worms?

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Five years after its adoption, the European Commission is preparing to review the controversial REACH regulation, which for the first time required chemical manufacturers to justify that their products are safe for consumers before placing them on the market.

Background

From the moment it was tabled in 2003 until its eventual adoption three years later, REACH gave rise to one of the most epic lobbying battles in the EU's history, pitting green campaigners against the powerful chemicals industry.

Adopted in 2006, the REACH regulation requires chemical manufacturers to register the 100,000 or so substances currently on the market and submit them for safety screening and subsequent authorisation (>> read our LinksDossier).

Those that are considered to pose an unacceptable threat to human health or the environment may be phased out and eventually replaced.

The regulation is due for review in 2012, setting the stage for a lobbying offensive by industry groups that say the rules hurt competitiveness, and consumer and health organisations that want stronger measures.

Meanwhile, the REACH screening process continues as the European Commission pursues a revision of the law in parallel.

EU member states have proposed a number of chemicals for inclusion on a list of Substances of Very High Concern (SVHC), which should be examined as a priority. These include substances that cause cancer, birth defects or which accumulate in human bodies and in the environment.

The European Chemicals Agency (ECHA) published the first candidate list of 15 such substances in October 2008. The list has since been updated several times and now includes dozens more (see updated candidate list of Substances of Very High Concern).

Issues

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".

Confidentiality matters

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.

Unintended consequences

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.

Positions

Rather than lobbying to get the rules changed, the European Commission urged chemical firms to focus their efforts on submitting clearer and more truthful dossiers in the future. Environment Commissioner Janez Poto?nik stressed that the review was a legal requirement and that the Commission would "only put forward a legislative revision if it were really needed and necessary".

The Czech Republic and Slovakia have taken the lead in demanding a simplification of the REACH regulation, saying it hurts smaller businesses and undermines economic growth. “We recognise the importance of protecting people, but on the other hand we also have to think about the competitiveness of our small and medium enterprises,” said Dušan Jurík, competitiveness attaché in Slovakia’s mission to the EU. "We know it is difficult to find a compromise between health protection and environment, but also competitiveness. This is the role of the Commission, to find this compromise,” he said.

The European Chemical Industry Council argues that REACH has undermined production of chemicals in the EU, saying emerging economies are overtaking both Europe and North America in chemicals production. China and the rest of the Asia-Pacific region have attracted more than three times the investment in the chemicals sector than Europe and North America in 2010, CEFIC pointed out, warning of a risk of de-industrialisation.

Dow Chemicals, a US firm with large operations in Europe, has recommended greater harmonisation of REACH to ensure "consistent enforcement" among the relevant authorities in the EU's 27 member states, which can all submit substances for inclusion in the candidate list of substances of very high concern. It also suggested "greater industry involvement in the legislative process" and a clearer definition of REACH to reduce administrative burden and confusion.

The European metal industry has had particular misgivings regarding REACH as several metals such as cobalt have ended up on the list of priority substances although they hardly ever come in contact with consumers and therefore do not represent an immediate risk to human health.

Eurometaux, an umbrella group representing the European metals sector, called on regulators to recognise the specificities of metals, saying they should be treated differently from organic substances used in chemical products. It also called on policymakers to ensure that REACH is made more "coherent" with other EU policies such as the initiative to secure better access to raw materials for industry. "REACH needs to be viewed as supportive of the sustainability and competitiveness of the metals sector in Europe," Eurometaux said, calling on ECHA to apply "the principle of proportionality" in its deliberations.

The Nickel Institute, an EU trade association representing the sector, said the REACH review process provides an opportunity to look again at the prioritisation criteria for the selection of substances which should be evaluated in priority and for the Substances of Very High Concern to be included in the Authorisation list. It underlined the need to have a risk-based instead of a hazard-based approach.

BEUC, the European consumer organisation, says the EU regulatory landscape on chemicals is "opaque as a jungle", with many EU regulations including REACH, but also many other sector specific rules on toys, food medical devices, construction products, biocides, pesticides, cosmetics, textiles, electronic devices and so on.

"Despite this truckload of regulation, consumers and the environment are insufficiently protected from hazardous chemicals. We are in daily contact with a cocktail of chemicals in the food we eat, the water we drink, the air we breathe, the cosmetics we apply to our skin and the textiles we wear.”

BEUC believes the REACH review can bring opportunities to close "a key loophole" in the regulation of nanomaterials. "First, we see a need to lower the tonnage threshold which triggers registration obligations from one tonne to 10 kilogramme. Second, REACH should contain a legal definition for the term ‘nanomaterial’ which is currently lacking. Third, all nanomaterials should be considered as new substances and should require safety testing before they can be used. Finally, there is insufficient transparency for the consumer in which products and services nanomaterials are used." BEUC called for a mandatory reporting scheme for manufacturers in which they specify which nanomaterial they use, in which quantities and in which consumer articles.

BEUC also called for tighter regulation of hormone disrupting chemicals, and said REACH should introduce ‘endocrine disrupter’ as a separate category of concern in article 57f. "This would allow putting chemicals with endocrine disrupting properties on the candidate list more quickly and give consumers the right to ask producers or suppliers if a product contains this chemical.”

Finally, BEUC warns of a lack of enforcement, saying the capacities of national market surveillance authorities are too low to control consumer products before they are placed on the market. "It is a worrying reality that a lot of toys and childcare articles still contain harmful phthalates although their use is restricted. In addition to considerably stepping up enforcement activities, we see an urgent need for a horizontal approach to chemicals which would allow banning certain groups of hazardous chemicals across product groups.”  

Cristian Samoilovich from the Aerospace and Defence Industries (ADS) drew attention to so-called "downstream users" who use chemicals as part of their manufacturing processes. Small companies relying on niche chemicals for their operations might go out of business once the manufactures or importers of those substances find REACH compliance requirements too costly compared to the amounts sold and stop dealing them, ADS noted.

ADS also regretted that REACH's compliance burden is costing much more than it should to downstream users, who are investing millions in IT systems and consultancy to track substances just "to please ECHA and tell them what's in a product". Instead, he said the money could be spent on R&D for new substances that are more environmentally-friendly.

Jacqueline Henshaw from the Aerospace Defence & Security Trade Association said that in the run up to the 2010 registration "we were in a position where our supply chain completely dried up of two chemicals used in flight critical situations". She called for help in managing the REACH process and making sure that downstream users are not be forgotten in the process, she added. 

Several groups, including the European consumers' organisation BEUC, have called for tougher chemicals disclosure rules. The Standing Committee for European Doctors and the Sweden-based International Chemical Secretariat have called for much more stringent regulations and the replacement of chemicals that pose potential health risks.

In a 2011 study, the Swedish Society for Nature Conservation drew attention to chemicals that are present in ordinary household dust, underlining that "several of them" can affect the human endocrine system.

The International Chemical Secretariat (ChemSec), a green NGO, used the study to call for REACH amendments to protect consumers against endocrine disruptors. "It is alarming that chemicals with negative effects on the environment and health that have long been known are present in household dust under our beds […]. They do not belong in the environment and should not be in the dust in bedrooms!"

ChemSec has criticised chemical companies, saying they do not always make use of the best available methods to test the safety of their products. "Due to the hard resistance from industry and subsequent lack of action from the European Commissions side, [...] registrants are currently not using the best methods to perform tests to spot endocrine active substances," said Jerker Ligthart, Senior Chemicals Advisor at ChemSec.

In e-mailed comments sent to EURACTIV, Ligthart said he suspected chemical companies of intentionally submitting bad quality registration dossiers. "The quality of registration dossiers have been really poor," he said, adding that a vast majority of all registration dossiers are incomplete or misleading. This, he said, meant that "95% of the dossiers will not be checked at all, undermining the credibility of the REACH motto 'No data - No market'". According to Ligthart, at least 50% of the dossiers should be checked in order to avoid free-riders in the registration process.

"Hefty fines and immediate withdrawal of registration numbers should be used to reduce the temptation of submitting a bad quality dossier intentionally," Ligthart said.

Besides, ChemSec agreed with BEUC in saying more attention should be given to nanomaterials in the REACH review.

Timeline

  • 31 Nov. 2010: First REACH registration deadline for:

    • Substances manufactured in the EU or imported in quantities of 1,000 tonnes or more per year per manufacturer or per importer
    • Substances classified as carcinogenic, mutagenic or toxic to reproduction (CMR) and imported in quantities reaching 1 tonne or more per year per manufacturer
    • Substances classified as very toxic to aquatic organisms and manufactured or imported in quantities reaching 100 tonne or more per year per manufacturer or per importer
  • Sept. 2012: European Commission expected to launch REACH review with a series of reports examining how the regulation has worked so far. It may decide to table a legislative proposal to amend REACH at a later stage.
  • 31 May 2013: Second REACH registration deadline for:

    • Substances manufactured or imported in quantities of 100 tonnes or more per year per manufacturer (100 to 1,000 tonnes)
  • June 2018: Third REACH registration deadline for:

    • Substances manufactured or imported in quantities of 1 tonne or more per year per manufacturer (1 to 100 tonnes)

Further Reading

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