The next major REACH deadline is 31 May 2013. John Barwise examines the ongoing challenges facing the regulation of chemicals
EU Regulation 1907/2007 came into force on 1 June 2007. Commonly known as REACH, the regulation governs the registration, evaluation, authorisation and restriction of chemicals in Europe. Its primary purpose is to protect human health and the environment from the potential risks associated with the use of chemicals.
The European Commission published its five-year review of REACH in February . It concluded that the system is functioning well, but that the quality of registration documents was a concern. More than 30,600 dossiers on chemicals have now been registered with the Helsinki-based European Chemicals Agency, (ECHA), which was created to help implement REACH.
The scope of REACH broadens on 31 May 2013 as it extends to low-tonnage chemicals that currently fall outside the regulation. There is concern, however, that many companies are ill-prepared for its expansion.
In 2003, WWF mounted one of the environment movement’s most ambitious and successful campaigns. Blood samples were taken from more than 350 people, including leading EU politicians, as part of the organisation’s detox biomonitoring programme.
Chemical analysis of the blood samples was unequivocal: all those who took part in the tests were contaminated with chemicals whose long-term effects were largely unknown. Backed up by hard scientific evidence, the campaign received wide publicity across Europe and did much to persuade policymakers in Brussels that the principles of protecting human health and the environment should be enshrined in legislation.
The chemicals industry at the time was concerned that the cost of implementing REACH would undermine international trade, particularly with the US, which could result in significant job losses across the EU. There was concern too that access to information rules might breach confidentiality, leading to a loss of business and intellectual property.
The sector vigorously opposed WWF’s campaign and lobbied hard against some REACH requirements, arguing that chemicals are an integral part of daily life and that proof of exposure was not proof of harm, adding that chemical properties in some products, such as penicillin, actually save lives, and that anything taken in excess can be harmful.
But the detox campaign was much more than a publicity stunt. Biomonitoring is essential to better understand the pervasive characteristics of some chemicals in the environment.
Tony Long is director of the European policy office at WWF and helped lead the detox campaign. He says: “The biomonitoring of politicians, officials and three generations of the same families pushed the draft REACH legislation to the forefront of political debate in Brussels and the national capitals in 2005 and 2006.
“It wasn’t always comfortable locking horns with industry on blood testing, especially with accusations that NGOs were engaging in scaremongering. But the chemical industry had failed to do biomonitoring of its own; it was therefore somewhat defenceless in the face of this new exposure information.”
Threats fail to materialise
The initial concerns of the chemicals industry have proved to be largely unfounded and, in many ways, the benefits of implementing REACH have outweighed the costs. Guy Thiran, director-general of Eurometaux, the body for the non-ferrous metals industry in Europe, acknowledges that REACH has been a valuable, though resource-hungry, exercise. The industry has always considered REACH a “responsible” investment, he says.
Since the introduction of the regulation, global chemical sales have continued to grow and although the EU share of the market is now 21%, compared with 30% in 2003, it remains the world’s largest exporter of chemicals. Furthermore, turnover among European chemical companies has risen in absolute terms.
The loss of export trade has not really materialised because similar regulations were introduced in the US under the high-production volume (HPV) challenge programme. This initiative too was influenced by environmental campaigners seeking an international response to growing concerns about the impacts of hazardous chemicals in the environment.
The HPV programme and the subsequent chemical assessment and management programme have helped to harmonise international legislation on the production, labelling and use of hazardous chemicals.
In Europe, REACH has streamlined chemicals management by replacing 40 pieces of legislation and creating a level playing field for existing and new substances. The hazards and risks associated with chemicals are now systematically identified, closing the knowledge gap for thousands of existing substances and providing valuable risk-management information on their acute and long-term effects.
Furthermore, the supply chain and downstream users receive relevant information on the safe use and application of chemical substances in production processes, which ensures safer working conditions.
In its summary assessment of REACH’s positive impact on occupational and public health, the commission’s enterprise and industry directorate concluded that it would lead to a reduction in respiratory and bladder cancers, mesotheliomas, skin disorders, respiratory diseases, eye disorders and asthma. Overall, REACH has improved environmental protection, bolstered consumer confidence and enhanced the reputation of the chemicals industry.
Despite the high level of optimism surrounding the initial launch of REACH, some of its key objectives have yet to be realised, however. It was expected that the number of chemicals exposed to humans and released to the environment might be reduced and some of the more dangerous substances replaced by innovative, less harmful alternatives. Evidence that some of the more hazardous chemicals are being phased out is, to date, patchy.
At a conference organised by the German chemicals company BASF in September 2012, Bjorn Hansen from the commission’s environment directorate, declared that it was too early to say that REACH is achieving its objectives. He went on to comment: “We’re seeing at least anecdotal evidence that [REACH is] starting to look like it’s working.” Hansen added that this was itself an achievement, given that it had been in operation for only five years.
Elephant in the room
Yet, despite the plethora of information and guidance on REACH (see below), there is mounting concern that many UK firms are still unaware of their wide-ranging legal responsibilities under REACH.
There is a common misconception that REACH applies only to the chemicals industry, which is not the case. Under the regulation, manufacturers, importers and all downstream users are responsible for identifying, assessing and managing the risks posed by chemicals and for providing appropriate safety information to their users. Failure to comply can result in substantial costs and heavy fines.
A recent survey by the manufacturers’ organisation, EEF, revealed a lack of awareness of the implications for manufacturers, especially among smaller companies. EEF declared that the scale of the ignorance of REACH “remains worryingly high”, and reinforced fears that companies are failing to recognise the full scope and significance of the regulation.
“REACH continues to be the ‘elephant in the room’ for many companies, which are either unaware of the implications or still believe it is a chemicals-only issue,” comments Gareth Stace, head of climate and environmental policy at EEF. “REACH has serious requirements for all manufacturers who are facing either restricted use or banning altogether of some substances.”
The EEF survey shows that 20% of UK manufacturers believe REACH is not applicable to them, while a further 30% say it is not important to their business. According to EEF, a more worrying aspect of the poll findings is that even where smaller companies were aware of REACH, half were not monitoring developments. Stace warns that this could have serious consequences for businesses.
“For many companies there is the very real risk of lost business if they are unable to advise their suppliers whether their products contain certain materials and, where they do, how their use is being monitored,” he says. “Furthermore, if companies don’t plan for substance bans, it could prevent production entirely.”
Lowering the limit
REACH sets a series of time limits for the registration of chemicals based broadly on volume of production or imports per year and level of risk. The registration deadline for annual volumes of more than 1,000 tonnes was November 2010 – chemicals classed as “highly toxic” and produced at more than one tonne per year also had to be registered by the same date.
For chemicals produced or imported in annual quantities of between 100 and 1,000 tonnes, the registration deadline is set for 31 May 2013, while for those produced in batches of between one and 100 tonnes each year, the registration deadline is May 2018. Around 30,000 substances are expected to be registered by 2018.
So far, the registration process has cost an estimated €2.1 billion. The ECHA expects the lowering of the quantity threshold in May to add at least another 2,300 chemicals to those governed by REACH, on top of the 7,884 registered since the regulation came into force.
The May 2013 deadline will bring tighter controls on manufacturers, importers and users of hazardous chemicals and will affect greater numbers of small and medium-sized enterprises (SMEs) – those identified by EEF as lacking knowledge about the implications of REACH for their business.
The ECHA has launched the “REACH 2013 – act now” campaign and produced a register of substances identified by industry, which includes those substances that were not already registered by the 30 November 2010 deadline. This will help manufacturers, importers and downstream users that want to check whether a substance must be registered by the end of May deadline.
But EEF and others claim more companies are likely to be affected this time around and are calling on the UK government and EU regulators to do more to raise awareness about the registration process and the downstream legal obligations implicit in the regulation.
The commission’s REACH review acknowledges that more needs to be done to reduce the impact of the regulation on SMEs. Among the recommendations to alleviate the perceived “burden” on small firms are for the ECHA and industry to develop more user-focused guidance, with special attention to SMEs, and for the Helsinki-based regulator and national REACH helpdesks to develop activities and guidance on integrating REACH processes early into research and development, and companies’ other innovation processes. In addition, the ongoing review of REACH fees aims to lower the costs for SMEs.
Another issue that requires urgent attention is the impact of REACH on the EU’s own campaign to promote resource efficiency and recycling. Recycled products that contain REACH-related substances would have to comply with the regulation.
Recycled plastic products pose particular problems, as they may contain chemical substances that are both difficult to identify and no longer authorised under REACH. This creates problems for manufacturers that rely on waste as a secondary raw material and the added cost of REACH registration could undermine the economic viability of plastics recycling in the future.
Ironically, REACH could seriously undermine the commission’s plans to transform Europe’s economy into a sustainable one by 2050. In its Roadmap to a resource efficient Europe, published in 2011, the commission outlined its plans to increase resource productivity and decouple economic growth from resource use and its environmental impact. According to Hansen at the environment directorate, the commission is working to “ensure that the interface [between REACH and recycling] works in the future.”
Beyond 2013, the May 2018 deadline for substances manufactured or imported in quantities of 1–100 tonnes looks set to capture an even larger portion of organisations under the REACH regulation. But perhaps the biggest challenge is what to do about those chemicals that currently slip under the radar of REACH.
Nanomaterials are by definition very small and are measured in grams and kilograms rather than tonnes. The commission has published a legal definition of nanomaterials and a regulatory framework, which is based more on the size of nanoparticles. But, unlike other potentially hazardous substances, it has yet to address the pressing issues of health and safety.
WWF says the commission must ensure the underlying principles of protecting human health and the environment are not undermined.“REACH is a major step forward. However, it needs to keep up to date and respond to new threats identified by scientific evidence to ensure a high protection level for human health and the environment. This includes, among other things, the issue of nanoparticles,” says Long.
The EU remains divided on what to do about nanomaterials. France already maintains a nanomaterials inventory and Germany wants to extend REACH to nanomaterials.
The commission’s preference is to amend the annexes of the regulation for those substances already covered by REACH and to undertake an open impact assessment on the possibility of a community-wide nanomaterials register. The REACH review says a draft implementing act could be published by the end of the year, including necessary amendments to the REACH annexes, should the commission consider that further regulation of nanomaterials is necessary.
Meanwhile, NanoReg, a Dutch-led project launched in January, aims to address priority questions on aspects of manufactured nanomaterials such as characterisation, dosimetry, exposure issues, in-vivo and in-vitro testing, life cycle and safe-by-design.
The REACH review was due to be published in June 2012, but was delayed several times because of the complexity of the subject matter and the range of data and information that had to be processed. And, with nanoscience and nanotechnologies developing rapidly – 2012 data reveals that more than 1,300 nanotechnology-enabled products have entered the market over the past few years – the regulation of chemicals is likely to get more complex still.
According to the commission, it will be 30 years before the health and environmental benefits of REACH fully emerge. For now, the immediate concern is to ensure companies whose substances will now be covered by REACH comply.
REACHing common standards
One of the key benefits of REACH is that it establishes common standards across the internal market so that the same rules apply to all businesses. This reduces compliance and regulatory burdens and harmonises assessment criteria for the safe management of chemical substances used or imported into the EU.
The Health and Safety Executive (HSE) is the competent authority for REACH in the UK, working in partnership with the Environment Agency and other government departments. The HSE has responsibility for enforcing compliance, evaluating selected prioritised substances and proposing restrictions.
This is particularly important for substances of very high concern (SVHC), which are those with serious consequences for human health or the environment. SVHC are defined as having carcinogenic or mutagenic characteristics, as toxic for reproduction or as bioaccumulative.
Substances classified as of very high concern – there were 138 listed by the ECHA at the end of 2012 – must be authorised before they can be placed on the market and those that fail the authorisation process may be banned.
Currently, 27 chemicals have been placed on the REACH authorisation list, which means they can only be used with permission after a certain date.
In the UK, REACH safety data sheets are issued by the HSE, along with guidance on how to determine whether compliance with the regulations is required for particular substances. These explain the obligations and registration procedures for those substances covered by the regulation.
The HSE also provides guidance on the Classification, Labelling and Packaging Regulation (1272/2008) (CLP) – a generic classification and labelling regime for hazardous chemicals. CLP came into legal force in all EU member states in January 2009 in response to an international agreement for the introduction of a harmonised system across the world. The transitional period for implementing CLP will be completed in 2015. This is to give suppliers and users of chemicals time to adapt.
Since its adoption in 2007, the chemicals industry has responded well to REACH by ensuring that manufacturers and others are fully aware of the regulation and what is required to ensure compliance.
The Chemicals Industry Association established REACHReady in 2006, ahead of the regulation, to provide advice and support to its members in the implementation of the Regulation.
REACHReady provides a confidential and comprehensive service to help organisations fulfil their specific registration and authorisation needs. This service includes training and consultancy services, as well as regular updates on the latest REACH developments and additional advice on the CLP.