The world needs a global standard for chemical safety and management, according to Hannu Vornamo, secretary general of the Helsinki Chemicals Forum (HCF). ‘Chemicals have been a global industry for some time and it has become obvious that REACH couldn’t just be a European issue,’ he said before the 2013 Forum. ‘Similar legislation has been discussed in Russia and South Korea as well as the US.’
But before looking at REACH itself, Bjorn Hansen, head of unit, DG Environment, European Commission, described the overall environment that has led to the adoption of this approach, highlighting the theme of the 7th EU Environment Action Programme (EAP): ‘Living well, within the limits of our planet’. He noted that Objective 3 within the programme is to safeguard EU citizens from environment-related pressures and risks to health and well-being, since the top environmental concerns of the public in the EU are water, air pollution and chemicals. But he emphasised: ‘There is virtually nothing that we purchase that doesn’t involve chemicals, but every human activity produces pollution’. He therefore posed the question: ‘What level of pollution is acceptable?’
And Nina Cromnier, director general of the Swedish Chemicals Agency, added a second question: ‘What degree of regulatory control is needed? Answering her own question, she said that for substances like pesticides, for example, the need for control is high, but lower as one moves through substances and mixtures, ending up with much lower levels of control for finished products and articles.
Hansen believes that the REACH and Classification & Labelling of Products regulations provide a baseline of protection, and that REACH and other chemicals legislation will be the EU’s contribution to meeting the 2020 goals of the UN Environmental Programme. UNEP’s goal is that chemicals are used and produced in ways that lead to the minimisations of significant adverse effects on human health and the environment, as laid out in the Johannesburg Plan of Implementation. Hansen also noted, however, that the Strategic Approach to International Chemicals Management (SAICM), adopted by the International Conference on Chemicals Management (ICCM) in February 2006 in Dubai as a policy framework to foster the sound management of chemicals, needs to be strengthened to assist in building chemical management systems in other countries and regions. He recognised that the OECD also has an important role is supplying relevant tools and ways of working together.
Commenting on REACH, Hansen said: ‘There are perfect elements in REACH, and there are some that could be even more perfect’, adding that he believes ‘REACH registration is routine – there were no upheavals’. However, he did also note that the recent REACH review by the European Commission did identify some issues, including quality issues that can lead to non-compliance, as well as issues regarding small- and medium-sized companies (SMEs) and the SIEFs - the Substance Information Exchange Fora through which companies that intend to register the same substance can share data on the intrinsic properties of the substance and to avoid the duplication of studies - and particularly the costs of REACH, which he said have been higher than originally expected. ‘But the Commission never did complete a full cost evaluation’, he added.
Supporters of REACH have always said that it would promote innovation in the chemical sector, however, Hansen said that what had actually occurred has been a shift of emphasis into compliance, although he believes downstream users of chemicals have increased innovation to give better products. He emphasised that in order to meet the goals of the 7th EAP, including working towards a non-toxic environment and product cycle, ‘we need innovation to meet these goals and remain competitive’.
He noted, however, that there is hardly any debate about where we want to go but the issue appears to be what to do in the short term. ‘Innovation needs information and the more that is available, then the more innovation we get,’ he said, adding that competition then becomes an issue of information, ‘which means building the chemical knowledge base’.
Commenting on the 2020 goals, Kai Madsen, senior programme officer, chemicals branch in the division for technology, industry and economics of the UN Environment programme (UNEP), highlighted that is important to differentiate between countries and what they can achieve: ‘ we can’t apply some standards to different countries’, he said. He hopes ‘that developed countries will have implemented all the aims, while helping developing countries on basic aims like removing lead from paint’. But he also added that ‘goals are moving targets, we always have to look at minimising the effects of chemicals beyond 2020’.
Baskut Tuncak, staff attorney at the Center for International Environmental Law (CIEL), believes that with chemicals use in developing countries growing by more than 20%, without sound chemicals management, there are five key challenges to meeting the 2020 goals: implementation of national and regional legislation; provision of sufficient financial resources; filling the information gaps; overcoming the narrow scope of existing systems; and finding a satisfactory route through the thicket of existing treaties, which are generally narrowly defined and of limited scope. He believes a stronger global regime is needed, both through utilising existing global agreements and the development of new agreements.
Madsen said the most important aspect is the availability of financial resources, but Martin Kayser, head of the ICCA’s global product strategy, BASF, added that chemicals management also has to be high on a country’s agenda to gain external funding, for example, from the World Bank.
Although Kayser agrees with Tuncak regarding his list of challenges, he added that he believes the biggest challenge is capacity building. ‘We have to find a way to combine industrial expertise and the experience of regulatory agencies,’ he added, adding: ‘We need to build trust.’
To demonstrate how capacity building can be achieved, Kayser described Project Africa, a two-year project at two port areas in Kenya and Ghana, which serve as import hubs for chemicals designed to promote the sound management of chemicals in terms of transport and warehousing . ‘We are not talking about sophisticated management,’ he said, ‘we are starting with the basics.’
Hansen agreed that capacity building is important but also supported Madsen’s comments about the need to motivate countries to put chemicals management high on their agendas. Madsen added that such motivation doesn’t necessarily go as far as the political leaderships, which have other issues including more basic issues such as sanitation and polluted water. ‘We need to explain the potential benefits that sound chemicals management can bring,’ he added.
Regarding Madsen’s comments on the need for progress on treaties, Tuncak said that the narrow treaties that exist today had very specific aims but we are now faced with much wider ranging issues and challenges like nanomaterials (See "Big talk on small matters" below): ‘ We need to understand their potential impacts and need to think about how they can be managed,’ he added.
Overall, Madsen believes there is still much work to be done. ‘We are not yet on track to achieve the 2020 goals,’ he concluded, But as Hansen added: A mandatory management scheme would achieve these goals but in reality this appears to be unachievable. Information exchange is one thing, but national resistance to specific measures and information exchange makes it unachievable.’
Christina Ruden, a professor in regulatory toxicology and ecotoxicity at Stockholm University, emphasised that since our main exposure to chemicals is through consumer products, a life cycle approach to the control of chemicals is necessary.
As soon as chemicals are incorporated into products, their management takes on a wholly different character where communication becomes the key issue, according to Erwin Annys, director, REACH/chemicals policy at CEFIC, who added that communication ‘needs more than just safety data sheets’. A more understandable way of communicating with downstream chemical users is needed, he said, to indicate, for example, the presence/percentage present of substances of concern, but this cannot just apply within the EU as a large number of substances and finished articles are produced elsewhere.
Once again, HCF 2013 provided much food for thought on chemicals management, and secured its key role in promoting international discussion on legislative development – so much so that attendance at the annual event is now part of the training programme for the European Chemical Agency (ECHA), including board members, according to Geert Dancet, ECHA’s exceutive director.
Big talk on small matters
Nano materials are increasingly being highlighted as a potential threat to health and well-being but there is very little agreement on how, and indeed if, they need specific regulatory control to ensure their safe use. Nanomaterials represent ‘one of the most challenging global aspects of chemical safety’, according to Hanno Vornamo, who believes that environmentalists tend to work on the principle that ‘things that sound strange must be bad’.
However, nanomaterials are not as strange as they are made out. Otto Linher, deputy unit head, DG enterprise and industry, European Commission, emphasised that ‘nanomaterials are much more common, and “normal”, than public discussions seem to reflect, and the EU definition, at least potentially, brings in many “conventional” materials as well’. He said that there is no objective reason to treat them differently than intentionally modified substances. ‘They are just like conventional materials, in that some may be toxic, some not,’ he added. He believes REACH sets out the best framework for the risk management of nanomaterials, although some detailed requirements are missing.
A lack of information was also highlighted by David Azoulay, managing attorney, CIEL, who said it is impossible to rationally discuss adequate risk assessment and management since ‘no-one knows in any detail the nanomaterials being produced, in what quantities, where they are used and how much or where they are released’. He believes the EU framework is better than most existing frameworks but it is still very far from the minimum requirement. He called for greater cooperation to make the introduction of nanomaterials a success, ‘but currently the signs are not good’.
As Rudolf Weinand, vp, product safety inorganic materials at German chemical major Evonik, pointed out: ‘ Nanotech is an integral part of modern life….nanotech is evolution and definitely not revolution.’ He agrees that REACH principally also covers nanomaterials but notes that different sectors apply different definitions. ‘Industry supports increased transparency by using existing sectoral registers but does not support generic EU registration and specific labelling.’
Mixtures & cocktails
While regulating single substances presents many problems, as soon as substances are combined, then those problems multiply exponentially. As Jukka Malm, ECHA director of regulatory affairs, pointed out: ‘For mixtures, as for nanomaterials, there are no “one size fits all” solutions’, adding that we shouldn’t wait for the perfect solution.
The size of the potential problem was emphasised by Thomas Backhaus, a professor of environmental sciences at the University of Gothenburg, Sweden: ‘As The Sun newspaper highlighted in 2009, 515 chemicals are applied to women’s faces everyday on average, while in any Swedish river there are at least ten pesticides found in the water – up to 33 in total.’
This, as Derek Knight, ECHA’s senior scientific advisor, pointed out, presents a number of challenges involving exposure to mixtures released from a formulated product; the same substances released from different sources at different times; and different sources released from different sources at different times.
The adverse effects resulting from such exposures are also potentially complicated, said Knight. They may be due to the individual substances in a mixture or the mixture as a whole, and the properties of the constituents could be affected by the others. ‘We need to understand how the release of different substances from different sources combine at the target,’ he emphasised, noting that the added complication for the environment is the fate of the sources and their distribution.
To this list, Jean-Lou Dorne, a toxicologist at the European Food Safety Authority (EFSA), added the fact that such mixtures can be intentional, but also coincidental.
For Rikke Donchil Holmberg, senior advisor, Danish ministry of environment, there is a danger of ‘paralysis by analysis’. She noted that the default methodology for the concept of dose addition requires detailed information covering the hazard and exposure for each chemicals, adding, however, that as discussed at the Forum, the quality of such information being submitted in the REACh dossiers is not of a high standard. ‘With 146 compliance checks in 2012 showed that less than 10% were without deficiencies, therefore there is still a long way to go in terms of single substances let alone mixtures’.
Holmberg added that there are no EU instruments to address mixtures and combination effects, despite numerous international activities. She did note, however, that the Classification & Labelling regulations do cover some mixtures.
Backhaus believes that we must move from looking at priority compounds to priority mixtures, recognising that ‘there are some compounds that have a major impact while others do not in mixtures’. He also emphasised that we need to improve our understanding of how and when synergistic effects occur. Then we need to look at how the different regulatory agencies that cover different substances can work together to cover mixtures.
In terms of whether there is enough scientific knowledge to act, he said: ‘We know almost nothing abouit almost everything as regards exposure.’ But the main challenge he identified is the number of new substances that are registered by the American Chemical Society with a new CAS number – 70 every hour (C&I, 2013, 7, 5).
Neil Eisberg is editor of C&I