Chemical INDUSTRY JOURNAL WINTER 2016
C 02 I
Meeting the challenges of
Supporting UK Chemical sector Attracting young talent Working together
Regulations with a long REACH Welcome to the latest edition of the Chemistry Industry Journal, much of which is dedicated to the way that the REACH (Registration, Evaluation and Authorisation of Chemicals) regulations have affected the industry over recent years. Few, if any, industries are subject to more stringent regulation than the chemical industry, which is inevitable given the hazardous nature of many of the substances with which it works on a daily basis. REACH was a response to concerns about the level of knowledge about some of the materials being handled and its stipulations called for a uniform level of earlier identification of the exact nature of substances.
Editor in chief
Although its implementation has been a challenge for the industry, often requiring new ways of thinking and operating, there has also been a general acknowledgement that the rules were necessary and that they have proved a force for good. In this edition of the magazine, we trace the evolution of REACH and examine some of the work being done to ensure that companies continue to implement the regulations in the best possible way. What has become clear is that REACH has proved itself a catalyst for some high quality work by the experts that advise companies on the substances that they handle and now all eyes are turning on how the next evolution of the regulations will take shape and what new challenges the industry will face. This edition of the magazine also looks at the way that the chemical industry is being supported in ways that extend beyond help with REACH. Chemical companies rely on a whole host of supporting companies, everything from logistics experts to health and safety specialists and legal firms, all of whom play their part in making the industry such a success, and in this edition we celebrate their work.
Another key focus of this edition is the work that is under way to tackle one of the biggest problems facing the sector, if not the biggest problem, namely the recruitment of new talent. For many years, the low number of young people in the UK studying maths, science and engineering at GCSE, A Level and at university has proved a concern for industry leaders. They have seen their experienced people retiring at a rate not being matched by the emergence of young people at the beginning of their scientific careers and it does not take a genuis to work out the long-term ramifications for industry of such a situation. At a time when the Asian countries are placing so much emphasis on nurturing young talent, there is a real danger that the UK becomes less competitive as the skills gap widens. Such a situation would be disastrous. However, that gap is slowly narrowing in the UK with the numbers of students taking STEM subjects at higher levels on the rise after years of decline and campaigns under way to attract more young people in science and, in particular, to persuade girls that science would make a good career. Such initiatives are absolutely vital because we can talk about REACH and health and safety and logistics as long as we want but if we have not got the people to take the industry forward it will have limited effects. The message for all of us is clear â€“ in everything we do we must enthuse our young people to realise that science, and chemistry, can be an exciting career. Our news sections regularly feature exciting work being done in the lab and inspiring young people about the potential for their own breakthroughs is vital if we are to ensure the bright future for the industry that we all desire.
20-37 REACH 38-40 Supporting UK Chemical Sector
41-59 REACH 60-61 Attracting Young Talent 62-65 Risks and Regulations 66-67 Working Together
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Fusion reactors ‘economically viable’ say experts Fusion reactors could become an economically viable means of generating electricity within a few decades, and policy-makers should start planning to build them as a replacement for conventional nuclear power stations, according to research. Researchers at Durham University and the Culham Centre for Fusion Energy in Oxfordshire re-examined the economics of fusion, taking account of recent advances in superconductor technology for the first time. Their analysis of building, running and decommissioning a fusion power station shows the financial feasibility of fusion energy in comparison to traditional fission nuclear power. The research builds on earlier findings that a fusion power plant could generate electricity at a similar price to a fission plant and identifies the advantages in using the new superconductor technology. Professor Damian Hampshire, of the Centre for Material Physics at Durham University, who led the study, said: “Obviously, we have had to make assumptions but what we can say is that our predictions suggest that fusion won’t be vastly more expensive than fission.” The researchers say that such findings support the possibility that, within a generation or two, fusion reactors could offer an almost unlimited supply of energy without contributing to global warming or producing hazardous products on a significant scale. Fusion reactors generate electricity by heating plasma to 100 million degrees centigrade so that hydrogen atoms fuse together, releasing energy. This differs from fission reactors which work by splitting atoms at much lower temperatures. The advantage of fusion reactors over current fission reactors is that they create almost no radioactive waste and there is no high level radioactive material to potentially leak into the environment which means disasters like Chernobyl or Fukushima are impossible because plasma fizzles out if it escapes. Fusion energy is also seen as politically safer
z An Illustration of a tokamak with plasma. Image from: ITER Organization because a reactor would not produce weaponsgrade products that proliferate nuclear arms. It is fuelled by deuterium, or heavy water, which is extracted from seawater, and tritium, which is created within the reactor, so there is no problem with security of supply.
available data, that fusion power stations could soon be economically viable. We hope this kick-starts investment to overcome the remaining technological challenges and speeds up the planning process for the possibility of a fusion-powered world.”
A test fusion reactor, the International Thermonuclear Experimental Reactor, is about ten years away from operation in the South of France. Its aim is to prove the scientific and technological feasibility of fusion energy.
The report, which was commissioned by Research Council UK’s Energy Programme focuses on recent advances in high temperature superconductors. These materials could be used to construct the powerful magnets that keep the hot plasma in position inside the containing vessel, known as a tokamak, at the heart of a fusion reactor.
Professor Hampshire said that he hoped that the analysis would help persuade policymakers and the private sector to invest more heavily in fusion energy. He said: “Fission, fusion or fossil fuels are the only practical options for reliable large-scale base-load energy sources. Calculating the cost of a fusion reactor is complex, given the variations in the cost of raw materials and exchange rates. However, this work is a big step in the right direction. “We have known about the possibility of fusion reactors for many years but many people did not believe that they would ever be built because of the technological challenges that have had to be overcome and the uncertain costs. “While there are still some technological challenges to overcome we have produced a strong argument, supported by the best
This advancing technology means that the superconducting magnets could be built in sections rather than in one piece. This would mean that maintenance, which is expensive in a radioactive environment, would be much cheaper because individual sections of the magnet could be withdrawn for repair or replacement, rather than the whole device. While the analysis considers the cost of building, running and decommissioning a fusion power plant, it does not take into account the costs of disposing of radioactive waste that is associated with a fission plant. For a fusion plant, the only radioactive waste would be the tokamak, when decommissioned, which would have become mildly radioactive during its lifetime.
Team observes super-fast process
Esso UK hands Hoyer a bigger contract
Hoyer Petrolog has won a new threeyear contract from Esso to handle its UK delivery business for Tesco Express (Alliance). The contract, which runs to June 2019, also covers Esso’s industrial and wholesale delivery network in the UK. Under the new contract Hoyer Petrolog will also undertake all supply chain management activities, including order taking, stock management, planning and delivery confirmation for Esso.
Station upgrade A team of researchers combining chemistry and bioscience have observed how a light-activated compound alters the structure of DNA, which could lead to new cancer treatments. Photo-dynamic therapy, a form of treatment for conditions including several cancers and psoriasis, uses light to activate a drug in a specific area of the body and can reduce the side effects observed in conventional anticancer treatments. Now, scientists working in Reading and Dublin have identified a new way of finding out how such compounds work. It is difficult to observe such fast processes in living cells but the much simpler environment of a DNA crystal has enabled the team to watch the process in great detail. The crystals contain a ruthenium compound which is bound to a short piece of DNA. This class of compound is used in DNA-sensing and is of interest to the pharmaceutical industry for cancer treatment. The researchers found that by using infrared radiation, they could get a snapshot of the process – which occurs in half a billionth of a
second – that takes place when light is shone on the crystals. This activates the compound, making it cause damage to DNA. This research was carried out using two UK central research facilities: the laser facilities in the Central Laser laboratory of the Science and Technology Facilities Council (STFC) and Diamond Light Source, the UK national synchrotron facility. Dr Susan Quinn, from the School of Chemistry at University College Dublin, the lead author of the study, said: “These results are very exciting as they demonstrate the ability to follow the flow of electrons from DNA to a molecule whose exact position is known and this is an enormous advantage in the study of the early events that lead to DNA damage.” Professor Christine Cardin, from the University of Reading, a nucleic acid crystallographer, led the UK team, which has received major funding from the Biotechnology and Biological Sciences Research Council to support the work, which included co-author Dr James Hal Prof Cardin said: “Among other things, the insights from this study will feed into the development of new drugs that target cancerous tissue, without damaging healthy tissue around it.” A key element of the funding for the collaboration has been provided by the Royal Irish Academy-Royal Society exchange programme, running since 2008 between Trinity College Dublin and the University of Reading.
Air Products has been awarded funding from the Hydrogen Refuelling Stations Infrastructure Grants Scheme, run by the Office for Low Emission Vehicles, to upgrade two of its refuelling stations in the London area. Working in consultation with car manufacturers such as Hyundai and Toyota, the company will use the funding to improve its SmartFuel stations at Heathrow and Hendon, aimed at encouraging commercial and public adoption of hydrogen transport
Research by chemists at the University of York has revealed new information about bacterial gels. The research in the Department of Chemistry demonstrated that alginate gels, which can be produced as biofilms by bacteria, are more dynamic than previously thought. Understanding the dynamics may ultimately suggest new ways of helping prevent or better control such bacterial infections, which can be particularly critical in the lungs of cystic fibrosis patients. Dr Victor Chechik and Professor David Smith worked with visiting Romanian scientist Dr Gabriela Ionita on the research.
Carbon capture comes under scrutiny A UK university team is helping to investigate ways to improve monitoring of carbon capture and storage (CCS) sites, work that has implications for the chemical industry as it increasingly embraces the technology. The University of Bristol seismologists are part of a new international collaborative research initiative funded by the UK Carbon Capture and Storage Research Centre, which recently got under way at the CMC Research Institute field research station in Alberta, Canada. The collaboration aims to improve monitoring for CCS sites where carbon dioxide (CO2) is captured as it is produced – for example at a power station, chemical plant or oil well – then injected deep below the surface to be stored permanently in geological formations. The aim of CCS is to prevent CO2 being released to the atmosphere, thereby mitigating climate change and many chemical companies are considering its potential application as a way of improving their environmental performance. Storage reservoirs are usually more than 1.5km deep so sophisticated monitoring methods, such as geophysical and geochemical surveys,
are required to ensure the CO2 remains at this depth. Dr Anna Stork, Dr Anna Horleston and Professor Michael Kendall from the Bristol University Microseismicity Projects group in the School of Earth Sciences have been installing specialist equipment at the site, located 20km southwest of Brooks, Alberta, Canada, in affiliation with the University of Calgary. Dr Stork’s project will see a total of seven broadband seismometers installed at distances ranging from 200m to three kilometres from the site’s two injection wells. She said: “The extremely sensitive seismometers will detect local microseismic events, some so small their energy is the equivalent of a pad of paper falling off a desk. They are also capable of recording large earthquakes occurring on the other side of the world. “
Barring any power or equipment failures, the seismometers will run continuously for the next year with data used to map the underground structures in the area. Dr Stork said: “We haven’t previously had the opportunity to study any CO2 injection this shallow and working out what happens if CO2 gets to these depths and how you can detect it is very important. We need to determine what methods are most suitable for monitoring at shallow depths.” Don Lawton, Director of CMC’s Containment and Monitoring Institute and a professor of geophysics at the University of Calgary, said that the work will help advance research to ensure CO2 can be stored securely in large-scale CCS operations. He said: “By sharing data and results researchers will be able to offer industry and government regulators best codes of practice for the long-term monitoring of stored CO2.”
Major opportunity to recover materials from waste within the UK bioeconomy Best practice has simply demonstrated risk mitigation of environmental impact of landfill and incineration. But these controls are not necessarily practiced around the world. Instead of burying the problem or turning it to carbon dioxide in a very expensive way, why not make use of our waste and turn it back into consumer products such as personal care products, food and drink and transport. Bio refineries are today’s solution for bringing waste back into the production stream. Europe is facing the challenge of accumulating waste, where 80% of the population is expected to live in Cities by 2020. Every year, 242 million tonnes of municipal solid waste is generated, 55% of this is disposed to landfill or incinerated. Urban organic waste has low value applications such as energy production and animal feed; otherwise it is disposed to landfill. This releases harmful green house gases. But what if waste was redefined as a resource; one that could potentially drive the production of biofuels for transportation and
domestic heating, and provide alternative routes to petrochemicals for the production of commodity chemicals. Industrial Biotechnology has potential to move the treatment of urban organic waste up the waste hierarchy, transforming a disposal problem into a valuable raw material and a secure source of sustainable chemical feedstocks. Biological technologies such as enzymes and micro-organisms can convert heterogeneous biowastes to homogenous intermediate chemicals such as sugar and methane gas. These can be fermented or
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Researchers develop catalyst to increase the yield of biodiesel
Researchers from the Cardiff Cataylsis Institute have devised a way of increasing the yield of biodiesel by using waste left over from its production process. Using catalysis, the Cardiff University researchers have been able to recycle an unwanted by-product created when biodiesel is formed from vegetable oil and convert it into an ingredient to produce even more biodiesel. It is believed the new process will have significant environmental benefits by improving the yield of biodiesel in a sustainable way that doesn’t require the use of additional fossil fuels, and could potentially reduce the costs of the biodiesel production process. The work could have international ramifications because, by 2020, the EU alone aims to have ten per cent of the transport fuel of every EU country come from renewable sources such as biofuels. Fuel suppliers are also required to reduce the greenhouse gas intensity of the EU fuel mix by six per cent by 2020 in comparison to 2010. At present, biodiesel is produced by combining fats and oils with methanol, which is usually derived from fossil fuels. A waste product from this process is crude glycerol, which is formed
on a large scale and contains many impurities that make it costly to purify and re-use in other areas.
a growing part of the EU fuel pool, with statutory amounts being required to be added to diesel that is derived from fossil fuels.
In their study, the researchers developed a way of turning the crude glycerol back into methanol, which could then be used as a starting reactant to create more biodiesel.
“We’ve provided unprecedented chemistry that highlights the potential to manufacture biodiesel in a much more environmentally friendly, and potentially cheaper, way, by converting an undesired by-product into a valuable chemical that can be reused in the process.”
To achieve this, they reacted glycerol with water, to provide the element hydrogen, and a magnesium oxide (MgO) catalyst. The reaction involved a simple one-step process and could be performed using mild conditions. Using the recycled methanol, the researchers estimate up to a ten per cent increase in biodiesel production, which they claim would be very helpful to industry. The work is currently in its early stages and in future studies the researchers will look to optimise the design of the catalyst and significantly increase its activity and selectivity. Lead author of the study Professor Graham Hutchings, Director of the Cardiff Catalysis Institute, said: “Biodiesel manufacture is
Co-author of the study Professor Stuart Taylor, Deputy Director of the Cardiff Catalysis Institute, said: “We set out to establish ways in which the waste product glycerol could be used to form other useful compounds but we were surprised when we found that feeding glycerol and water over such a simple catalyst gave such valuable products and interesting chemistry. “This research has the potential to transform the way in which waste is dealt with, and seriously improve the quality of life by reducing carbon emissions from fossil fuels and encourage efficient use of resources.”
The Sussex Drug Discovery Centre - part of the School of Life Sciences at the University of Sussex - has been awarded £1.8 million by the Medical Research Council to use biology and chemistry to combat the side effects of anxiety drugs like Valium. Led by Professors John Atack, Simon Ward and Martin Gosling, the team at the centre will use biological and medicinal chemistry methods to develop next-generation drugs. Their aim is to identify a non-sedating anxiolytic – in other words, Valium without the side effects.
Saving rare elements z BASF Littlehampton
Expanded plant opens BASF has opened an expanded Littlehampton production site to meet the growing global demand for biological solutions for agriculture and horticulture. The move means that BASF can increase its production volumes of beneficial nematodes and inoculants, moving ahead with its strategy to develop beyond conventional crop protection. Philipp Rosendorfer, Vice President R&D Functional Crop Care, said: “We are making significant investments in innovating and delivering the best in biological and chemical solutions.” The expansion will allow BASF to double production capacities for beneficial nematodes,
which are microscopic organisms that can control a diverse range of insect and slug pests. Graeme Gowling, Global Biologicals Marketing, Functional Crop Care, said: “The demand for our beneficial nematodes has increased significantly over the past five years. Our customers see an increasingly important role in using beneficial nematodes in Integrated Pest Management programmes as they are easy to apply, have a longer window of activity and can effectively control yield-robbing pests.” Additionally, the newly expanded site in Littlehampton will increase the supply of inoculants from BASF worldwide and especially to Europe and Africa. Inoculants are rhizobia bacteria that, in a symbiotic relationship with their host legume plants, produce root nodules to conduct nitrogen fixation. BASF produces biological inoculants as an ingredient for seed treatments.
A research team including the University of Liverpool, University College London and Binghamton University has demonstrated a new semiconductor material made from abundant elements instead of rare ones. Semiconductors, used in everything from smart phones to solar panels, rely on rare elements such as tellurium, gallium and indium. Researchers focused on zinc tin nitride, which has been recently synthesized by research groups around the world using zinc and tin, readily available through recycling facilities. The research was funded by the UK Engineering and Physical Science Research Council and US National Science Foundation.
The Royal Society of Chemistry is offering scholarships of £25,000 to chemistry graduates who want to become teachers. The Department for Education (DfE) has announced the scholarships in partnership with the RSC, to attract high calibre graduates into teaching chemistry. More information is available at www.rsc.org/news-events/rsc-news/ articles/2015/oct/nurturing-thescientists-of-tomorrow/
z WORLD NEWS
Pioneering cells work leads to Nobel Prize The Nobel Prize in Chemistry for 2015 has been awarded to three scientists whose work is adding immensely to the understanding of human cells. Members of the judging panel awarded the prize jointly to Tomas Lindahl, Paul Modrich and Aziz Sancar for having mapped, at a molecular level, how cells repair damaged DNA and safeguard genetic information. Their work has provided fundamental knowledge of how a living cell functions and is already being used for the development of new cancer treatments. Tomas Lindahl works at the Francis Crick Institute and Clare Hall Laboratory, Hertfordshire, UK, Paul Modrich at the Howard Hughes Medical Institute and Duke University School of Medicine, Durham, NC, USA, and Aziz Sancar, at the University of North Carolina, Chapel Hill, NC, USA. All three have carried out work which examined the nature of changes in human cells and their relationships to diseases such as cancer. Each day our DNA is damaged by UV radiation, free radicals and other carcinogenic substances, but even without such external attacks, a DNA molecule is inherently unstable. Thousands of spontaneous changes to a cellâ€™s genome occur on a daily basis and defects can also arise when DNA is copied during cell division, a process that occurs several million times every day in the human body. The reason our genetic material does not disintegrate into complete chemical chaos is that a host of molecular systems continuously monitor and repair DNA. The Nobel Prize in Chemistry 2015 awards three pioneering scientists who have mapped how several of these repair systems function at a detailed molecular level. Tomas Lindahl demonstrated that DNA decays at a rate that ought to have made the development of life on Earth impossible. This insight led him to discover a molecular machinery, base excision repair, which constantly counteracts the collapse of our DNA.
Aziz Sancar has mapped nucleotide excision repair, the mechanism that cells use to repair UV damage to DNA. People born with defects in this repair system will develop skin cancer if they are exposed to sunlight. The cell also utilises nucleotide excision repair to correct defects caused by mutagenic substances, among other things Paul Modrich has demonstrated how the cell corrects errors that occur when DNA is replicated during cell division. This mechanism, mismatch repair, reduces the error frequency during DNA replication by about a thousandfold. Congenital defects in mismatch repair are known, for example, to cause a hereditary variant of colon cancer. According to the judging panel from Royal Swedish Academy of Sciences, the Nobel
Laureates in Chemistry 2015 have provided fundamental insights into how cells function, knowledge that can be used, for instance, in the development of new cancer treatments. Tomas Lindahl was born 1938 in Stockholm, Sweden and was Professor of Medical and Physiological Chemistry at University of Gothenburg between 1978â€“82 before becoming Emeritus group leader at Francis Crick Institute and Emeritus director of Cancer Research UK. American Paul Modrich is an Investigator at Howard Hughes Medical Institute and James B. Duke Professor of Biochemistry at Duke University School of Medicine, Durham, NC, USA. Aziz Sancar, a US and Turkish citizen, is Sarah Graham Kenan Professor of Biochemistry and Biophysics, University of North Carolina School of Medicine, Chapel Hill, NC, USA.
European chemical ‘needs help to remain competitive’
WORLD NEWS z
Malvern Instruments has set up a new biopharmaceutical applications laboratory in the heart of San Diego’s biotechnology cluster. The laboratory has been developed in partnership with Sevion Therapeutics, a San Diego-based biopharmaceutical company that develops next-generation biologics. Sevion Therapeutics will host the laboratory for which Malvern will provide analytical instrumentation, training and continuing support.
German chemical group BASF has opened a new production plant for concrete admixtures in Lagos, Nigeria, BASF’s first production plant in western Africa looking into the production of stronger and more durable concrete admixtures. For more than 20 years, BASF has been selling construction chemicals in the western African market.
European chemical industry leaders have backed plans to transform the European Union into a competitive low carbon economy. The recent annual General Assembly of the European Chemical Industry Council, the Brussels-based organisation representing the European chemical industry, voiced its full support for tackling climate change. However, it also urged EU policymakers to ensure that the European industry is able to stay competitive and not hamper its efforts to compete with the rest of the world. Cefic made the comments on the back of predicted modest growth prospects within the EU of +1.5% for 2016.
Moreover, says Cefic, through to 2030, the European chemical industry’s global market share is likely to continue the decline which started in the early 2000s. This contrasts sharply with expectations that demand for chemical products will double, with the United States and Asia as the main beneficiaries in a fiercely competitive environment. Jean-Pierre Clamadieu, President of Cefic and CEO of Solvay, said: ”We have safeguarded our competitiveness partly by reducing energy intensity year after year, halving it since 1990, and we will pursue our efforts. “As a provider of solutions and innovations for almost all manufacturing sectors, the chemical industry enables the EU to achieve its goals for climate change mitigation and energy transition but we also need the EU to help us regain competitiveness by adopting clear, realistic, long-term policies that bring investments and growth back into the region.”
We’ll drink to that
Researchers at the University of Bologna in Italy have developed a biorefinery model that would produce polyphenols, fatty acids, biopolymers, and biomethane from the skins and seeds left over from wine production. The country produces about five million metric tons of the feedstock annually that currently has little value and the new model combines supercritical carbon dioxide with anaerobic digestion, microbial treatment, and anaerobic fermentation to produce the chemical products.
z WORLD NEWS
Casting light on air pollution
Researchers in Canada have unlocked some of the chemistry behind urban air pollution. The team have determined for the first time that natural sunlight triggers the release of smog-forming nitrogen oxide compounds from the grime that coats buildings, statues and other outdoor surfaces in towns and cities. University of Toronto team member James Donaldson, Ph.D said: “The current understanding of urban air pollution does not include the recycling of nitrogen oxides and potentially other compounds from building surfaces. ”But based on our field studies in a real-world environment, this is happening. We don’t know yet to what extent this is occurring, but it may be quite a significant, and unaccounted for, contributor to air pollution in cities.” Urban grime, according to Prof Donaldson, is a mixture of thousands of chemical compounds spewed into the air by automobiles, factories and a host of other sources. Among these compounds are nitrogen oxides. When in the air, these compounds may combine with other air pollutants — known as volatile organic compounds — to produce ozone, which is the main component of smog. Scientists had long suspected that nitrogen oxides become inactive when they are trapped
in grime and settle on a surface. However, Prof Donaldson and his colleagues at the University of Toronto have collected data that challenges the theory.
Some of the collection devices were left in the sun; others were put in the shade, but had adequate air flow so that grime could collect on their surfaces.
In previous work, they discovered that nitrate anions disappeared from grime at faster rates than could be explained by wash-off due to rainfall. In a subsequent laboratory comparison, they found that nitrate disappeared from grime 10,000 times faster than from a water-based solution when both were exposed to artificial sunlight.
In Leipzig, the researchers found that grime in shaded areas contained ten per cent more nitrates than grime exposed to natural sunlight, which was consistent with the team’s laboratory findings.
In another study, they exposed grime to either artificial sunlight or kept it in the dark. The grime exposed to a “solar simulator” shed more nitrates than the grime left in the dark, suggesting that light can chemically convert nitrogen compounds back into active forms that can return to the atmosphere. Prof Donaldson set out to test this concept in the real world. Working with colleagues in Germany, he set up a six-week field study in Leipzig and a similar year-long study in Toronto. The researchers placed grime collectors containing glass beads throughout both cities. The beads create more surface area for grime to gather on than a flat surface, such as a window.
Prof Donaldson said: “If our suspicions are correct, it means that the current understanding of urban air pollution is missing a big chunk of information. In our work, we are showing that there is the potential for significant recycling of nitrogen oxides into the atmosphere from grime, which could give rise to greater ozone creation.” To test this idea, his team hopes to conduct field experiments in a place that is “really grubby” and someplace that is “really clean.” They also plan to examine the effects of humidity, grime levels and various amounts of illumination on the recycling of nitrates back into the atmosphere. The work was supported by the American Chemical Society.
WORLD NEWS z
Sparking solution to a dental problem Diamonds could turn out to be a dentistâ€™s best friend, according to research carried out in the United States. Gold, silver and porcelain are among the many materials dentists can use to fix damaged teeth but the research suggests that microscopic diamonds could have a role to play as well, according to the American Chemical Society. The scientists have developed a new material with nanodiamonds that has the potential to improve current root canal therapies and help prevent future infection. Millions of people undergo root canal procedures every year to clear out damaged or infected pulp, the soft part in the middle of a tooth. Dentists tend to use a rubber compound called gutta-percha to fill the gaps. In some cases, however, a patientâ€™s tooth can get re-infected, which calls for another
treatment. To prevent this from happening, researchers have been exploring other fillers, including nanodiamonds.
The scientists say future studies will check whether the composite works in clinical practice.
Researcher Dean Ho and his colleagues combined nanodiamonds, gutta-percha and amoxicillin, a broad-spectrum antibiotic, into a new material.
Funding for the research came from the National Science Foundation, the Center for Scalable and Integrated NanoManufacturing, the V Foundation for Cancer Research, the Wallace H. Coulter Foundation, the National Cancer Institute, the Society for the Laboratory Automation and Screening and Beckman Coulter Life Sciences.
Laboratory testing showed it was stronger than gutta-percha by itself and was effective at killing Staphylococcus aureus, which is one of the bacteria responsible for root canal reinfections.
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Test devised for second-hand marijuana exposure A team of analysts has developed a urine screening method that is sensitive enough to detect even small amounts of the chemicals that result from exposure to cannabis. The team in the United States says that its work should be viewed against a background of increased legalisation of marijuana for medicinal and recreational purposes in the US and growing concern about the potential health effects of its second-hand smoke. Writing in the American Chemical Society’s journal Analytical Chemistry, the team say that current drug tests can detect large amounts of the psychoactive marijuana component tetrahydrocannabinol (THC) and its metabolites in urine. That, they say, is sufficient when testing whether or not a potential employee or professional athlete has used the drug but in the case of second-hand marijuana smoke, the levels of the substances in the urine are too low to be recorded, making it difficult to assess if this type of exposure could cause harmful health effects. As a first step toward investigating the effect of second-hand marijuana smoke exposure, Binnian Wei and colleagues at the U.S. Centers for Disease Control and Prevention sought
to develop a more sensitive urine test for cannabinoids. The researchers combined ultrahigh performance liquid chromatography and tandem mass spectrometry with positive electrospray ionization to develop a reliable, fast and accurate method to test for THC and its metabolites. The approach is 10 to 100 times more sensitive than current methods. In laboratory tests, the method detected the substances at levels approximating those that would be in the urine of someone exposed to second-hand marijuana smoke. The team were supported by funding from the Centers for Disease Control and Prevention and the work comes as reports suggest that marijuana use in the US has more than doubled since 2001, with women, middle aged and older people, Hispanic and black people showing notable increases. Researchers, who say the number of adults that had used marijuana in the past year
rose from 4.1% in 2001 to 9.5% in 2013, based their findings on data from the National Epidemiologic Survey on Alcohol and Related Conditions. The researchers, writing in the journal JAMA Psychiatry, looked at rates of marijuana use and marijuana use disorders. They found that prevalence of marijuana use had increased among people aged between 45 and 64, black and Hispanic people, women, those living in the South, and those with the lowest incomes. The study comes as 23 states have legalised medical marijuana, with four of these allowing the drug for recreational purposes. Authors said that along with the increase in use, they also saw a rise in marijuana use disorders – which they say should serve as a caution regarding the relaxation of laws surrounding the drug. They reported that rates of marijuana use disorder, which includes abuse or dependence, rose from 1.5% in 2001/2002 to 2.9% in 2012/13, accounting for 6.8 million people in the US, or three in every ten marijuana users.
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z WORLD NEWS
N-ice work from research team
US specialty materials company Celanese has completed construction of its Clear Lake, Texas, methanol unit, and is now operating at full capacity. The new plant is a joint-venture between w and Japanese company Mitsui, and was built with an investment of around $800m. The Clear Lake facility has an annual production capacity of 1.3 million tonnes.
India’s first solar-powered renewable fuelling station has been inaugurated, having been constructed by Air Products. Part of a national public transport bus programme, the SmartFuel® station generates 100 percent renewable hydrogen from solar energy via an electrolyzer and is located at the Solar Energy Center near Delhi, part of a project managed by the National Institute of Solar Energy.
Scientists have unlocked some of ice’s mysteries and provided a better understanding of how water freezes, which could have significant implications for safer air travel. Supported by the American Chemical Society, the team set out to discover what makes water freeze at high altitude, a major concern for airlines. Tiny particles such as dust, soot, pollen and bacteria give water a seed to crystalize around. Without them, water can remain liquid even at temperatures below its freezing point. Researcher Angelos Michaelides and colleagues set out to find a way of preventing the formation of ice.
Using computer models of simple crystalline particle surfaces, the researchers pinpointed how their structures and interactions with water on a molecular level impact support ice crystallization. A commonly held assumption was that, if a particle’s surface structure is similar to that of ice, it acts as a template for water molecules and encourages ice to form. However, the team found that a surface that acts as a template for one ice face will not necessarily act as a template for another and two identical surfaces can result in ice crystals in three different orientations. In addition to proving useful in the fields of climate science and cryopreservation, the researchers say that their results could help guide the future design of materials to prevent ice formation, for example, on airplane wings. Funding support for the work came from the European Research Council and the Royal Society of Chemistry, in the UK.
Production is expanded
German chemical group BASF is expanding production capacity of emollients and waxes at its Jinshan site, located in Shanghai, China. A new facility scheduled to be operational from 2017 is expected to increase current production of wax esters, emulsifiers and primary surfactants at the Jinshan site, and serve the growing personal care market in the Asia Pacific region.
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z REACH FEATURE
challenges of REACH Few regulations can have proved as challenging for the chemical industry over recent years than REACH, which has required companies to rethink the way they do safety. The roots of REACH (Registration, Evaluation and Authorisation of Chemicals) can be traced back to 13th February, 2001, when the European Commission adopted a White Paper setting out the strategy for a future Community Policy for Chemicals. The European Commission’s original legislative proposal on REACH was adopted on 29 October 2003 and two years later the European Parliament approved a final version. Having come into force in 2007, REACH aims to improve the protection of human health and the environment through the better and earlier identification of the intrinsic properties of chemical substances. This is done by the four processes of REACH, namely the registration, evaluation, authorisation and restriction of chemicals. REACH also aims to enhance innovation and
competitiveness of the EU chemicals industry. The REACH Regulation places responsibility on industry to manage the risks from chemicals and to provide safety information on the substances. Manufacturers and importers are required to gather information on the properties of their chemical substances, which will allow their safe handling, and to register the information in a central database in the European Chemicals Agency (ECHA) in Helsinki. The Agency is the central point in the REACH system: it manages the databases necessary to operate the system, co-ordinates the in-depth evaluation of suspicious chemicals and is building up a public database in which consumers and professionals can find hazard information.
The Regulation also calls for the progressive substitution of the most dangerous chemicals, referred to as ‘substances of very high concern’, when suitable alternatives have been identified. One of the main reasons for developing and adopting the REACH Regulation was that a large number of substances had been manufactured and placed on the market in Europe for many years, sometimes in very high amounts, and yet there was insufficient information on the hazards that they pose to human health and the environment. Having entered into force in 2007, REACH provisions are being phased-in over eleven years with thinking now turning to the next phase of their adoption.
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REACH is working
but we must look to the future Trade body the European Chemical Industry Council (Cefic) admits that REACH is challenging for businesses but also believes that it is working.
from the experience in implementing REACH. The Commission has launched a number of studies to this effect. Cefic will actively contribute to the upcoming discussions.”
However, it is keen for greater clarity about what happens after the current time frame of 2018 for implementation runs out.
• how to make REACH work better for SMEs and downstream users
Cefic released a statement from its Brussels headquarters in October saying: “REACH is the cornerstone of EU chemicals legislation. REACH entered into force in June 2007 with three different registration phases for chemicals, starting with high tonnage chemicals. The current third registration phase for chemicals – between one and 100 tonnes - is ongoing until 2018. “Eight years down the road, REACH is working and the European Chemicals Agency has created a powerful database on chemicals, a veritable EU ‘chemicals Wikipedia’. “Cefic has been very active in making REACH work, explaining this very complex legislation to its direct and indirect membership. “In view of the REACH review in 2017, now is the moment to start to draw the lessons
In particular, Cefic says it will look closely at: • whether REACH has delivered on its objectives in bringing increased competitiveness and innovation for the European chemicals industry
• the prioritisation and coordination of enforcement as key elements in the successful and efficient implementation of REACH
• specific areas of safety concerns, such as endocrine disruption, nano materials, combination effects and substances in articles • ways to progress sustainable chemistry and to advance regulatory science so as to stimulate innovation • international regulatory and chemical management cooperation as a means to raise the level of safe chemicals management globally • making sure that REACH assumes the role of reference-legislation in an integrated and consistent framework of EU chemicals law.
Eight years down the road, REACH is working and the European Chemicals Agency has created a powerful database on chemicals, a veritable EU ‘chemicals Wikipedia’.
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2016 – a crucial year for REACH By Sue Bullock and Mike Padgham Ramboll Environ
Once the preserve of chemical manufacturers, product stewardship should now be a priority on the agenda in every boardroom. From product registration to restriction, and from raw material to finished product and end-oflife, many companies are already adapting their organisations and processes to address these concerns, protect product integrity and optimise their business and markets. Businesses need more support than ever to effectively and efficiently manage their product portfolios, supply chains and communications with different stakeholders as they respond to these demands. At the centre of product regulatory compliance within industry for over 30 years, Ramboll Environ’s role is to bring the right strategic and technical support and regulatory expertise to our clients to improve their market position and, equally, ensure continued availability of key products to keep markets functioning. Amongst numerous short-term challenges, the REACH registration deadline of 2018 threatens to bear down quickly and dramatically, with companies in very different states of preparation. With continued efforts to clarify whether the business case for registration justifies the costs, many firms are waiting for others to take a leading role and initiate activity. However, a wait-and-see strategy may create problems down the line: there is a
real risk that companies will face higher costs, less qualified advice or unacceptable delays as expert resources become more and more squeezed into 2016 and 2017. Laboratories already warn of limited availability for new studies and an inability to guarantee delivery in time for the submission deadline. By June 2018, a significant number of substances will no longer be available on the EU market: a timely and well-planned approach is needed to avoid non-compliance and supply chain failure. REACH registration dossiers need to be technically robust, even for very low volume substances. However, insight into the regulation and associated science can help companies achieve this goal cost-effectively and with reduced use of animals. For example, Annex III offers a potential derogation from the standard set of testing requirements, where this can be adequately justified. In addition, while REACH clearly foresees use of alternative methods to avoid unnecessary testing on animals, in practice, regulators have typically rejected such methods during dossier evaluation. With no sense of irony, regulators are using these same tools to justify further requests for often complex and expensive animal testing. A thorough understanding of these methods – and experience applying them – is ever more critical to delivering robust arguments and successfully navigating the evaluation process. While registration is causing headaches for chemical producers and importers, the phasing-out of substances via the REACH authorisation process is having the same effect for many of their customers further down the supply chain, but here the stakes can be
much higher. Substances of Very High Concern that are identified for authorisation often support critical functions and performance that cannot be replaced in the short-term. In these cases, industry must prepare robust arguments demonstrating that the conditions for authorisation are met in order to continue to use these substances. Failing to do so could have devastating consequences for individual businesses, industry sectors and even society. Having prepared one of the very first successful authorisation submissions in 2013, Ramboll Environ has been playing a key role in this process ever since, with direct involvement in half of all the applications for authorisation submitted to date. We have assisted companies using different substances in a variety of niche and not so niche applications. In each case we have worked closely with the business and other key parties to find the optimal solution, including informing policy-makers where appropriate. As well as complying with technically complex laws and standards, businesses need to keep informed about an array of legal decisions and emerging regulations to ensure their products are ‘future-proof’. Customer pressure for safer products also requires companies to anticipate the implications of emerging public concern, science and policy. Product stewardship and REACH provide challenges, but also opportunities. As REACH-like legislation is introduced in different countries across the world, those companies that have taken stock and planned to take advantage of these opportunities are those that will thrive. www.ramboll-environ.com
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Safe chemicals through effective communication of REACH data One of the main goals of REACH is to ensure the safe use of substances. This goal will only be achieved if the wealth of information on hazard and risks gathered into the registration dossiers is communicated effectively to those who use the substances. Especially formulators face this communication challenge. In this article we will highlight some of the issues these companies encounter and provide insights that can help companies to communicate the critical health and safety information more effectively. By Leo van der Biessen, Jean-Marc Abbing, Randy Cleijsen, Christiaan van Daalen THE CHALLENGE OF REACH
To increase the level of protection during the handling of chemicals and sharply decrease the high number of 100,000 European casualties per year due to exposure at the workplace. This will only happen when the correct health and safety information is passed down the supply chain in such a manner that it helps the users to improve their game. This is especially challenging for formulators as they must select the relevant data in the extended Safety Data Sheets (eSDSs) of the substances and prepare readable and meaningful information which will allow their users to handle mixtures safely.
THE STATUS QUO
REACH has been tremendously successful in the generation of data on the hazards and risks of substances. Unfortunately industry struggles with communication of this data in the supply chains. This has a number of causes, of which we deem the following the most important: • The amount of data in the eSDSs is overwhelming. It is hard for users to extract the essential information they need. • The variability of the data in the eSDS appendices. This variability not only relates to the format and structure of the eSDS. Also operational conditions and risk management needed for safe use can be quite different for the exact same substance. • The operational conditions and risk management measures listed do not always reflect reality or what is feasible. • Formulators are lacking tools to aggregate the eSDS information. As a result they do not communicate, or communicate unreadable and therefore useless data (e.g. all eSDSs available for the substances in the mixture). This makes it virtually impossible for secondary formulators or downstream users to assess safe use of their mixtures. A complicating factor is that formulators do
not want to share the exact composition of their mixtures. • Poor data management resulting in companies not using the latest relevant information. Our experience shows that questions from downstream users about the content of a supplier eSDS – or even the reporting of missing uses - hardly ever results in any answer from the supplier. The legally obliged timeframe for this is 1 month. ECHA, Competent Authorities and industry have recognized the problem and created the Exchange Network on Exposure Scenarios (ENES), that aims to improve the quality of eSDS information and create tools for effective communication. This is including but not limited to: an EScom standard with standardized phrases and a system of electronic data exchange through XMLfiles, better descriptions of the operational conditions and risk management measures
for sectors of industry and tools to help formulators select the relevant information.
OUR SOLUTION FOR FORMULATORS Royal HaskoningDHV developed basically a three step program: Step 1: Make sure the right data is available Step 2: Select the substance(s) which determine the risk of the mixture Step 3: Generate meaningful information In Step 1 the latest eSDSs are collected. The quality of the eSDS is checked and the best ones are selected. The necessary phys-chem and hazard data for Step 2 is extracted and appended when missing. If needed the procedures on data management are improved in this step. During the quality check we look at the completeness of the document, the implementation of the hierarchy of control and uses covered.
In Step 2 the substance(s) that determine(s) the hazard and risk of the mixture is/are determined. Based on good industrial hygiene practices and the tools generated in the ENES programme, Royal HaskoningDHV has created a protocol and a set of rules to assess the combined hazard in risk of substances within a mixture. Based on the physicochemical properties of the substances, the relevant limit value and the activities performed, the relative contribution of a substance to the risk of an activity is calculated using the reciprocal procedure as suggested by the ACGIH. This is done for all relevant exposure routes. The substances that contribute most to the hazard and risk of the mixture are lead substances. The information of the eSDSs of those substances is used in the initial preparation of safe use information for the mixture. If substances are classified as CMR or sensitizing, they are individually assessed. In order for the downstream user to be able to assess the risk of this mixture, a mixture specific limit value and mixture specific concentration is calculated for the lead substance(s). These values take into account the toxicity of other components in the mixture, assuming simple addition. This is in most cases a conservative approach unless clear toxicological evidence points to the contrary. This approach also allows for adaptation of the lead substance to
be used, either for CBI purposes or to reduce the amount of mixture eSDS appendices to be communicated. During Step 3 relevant health and safety information is extracted from the lead substance(s) eSDS. This information is cross-checked with the data from the eSDS of the other substances in order to ensure compliance with REACH. Then the information is transferred to an eSDS appendix. For mixtures marketed to end-users the newly developed Safe Use of Mixture Information (SUMI) sheet is in our opinion the most effective method to present the information. A SUMI is a single page sheet listing how a product can be used safely and which risk management measures the user should take to protect himself and the environment. SUMIs are based on practices within a certain sector and therefore sector specific. For numerous sectors we are able to determine good practices from our wide experience, for others we delve into good practices listed by industry. In the coming years more and more sectors will produce such sector specific descriptions and safe use conditions, in our view leading to a great improvement of worker safety. www.royalhaskoningdhv.com
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For one of our clients we have assessed over 30 of their products. These products are contained in different compositions over 90 hazardous substances with an eSDS. By selecting the appropriate lead substances we were able to cover these products with no more than 8 eSDS appendices. The information we provided not only reduced the amount of information but the mixture specific concentration and DNEL also allowed for the communication on the hazard of a mixture without revealing the exact composition. For another client we generated sets of SUMIs, reducing the size of the appendix from over 150 pages to no more than 5 per sector of use.
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Easier access to information and registration of chemicals With the beginning of the new calendar year, the REACH deadline in 2018 is approaching even faster. The European Chemicals Agency (ECHA) has repeatedly urged industry to prepare for the registration deadline. A number of new initiatives from ECHA and the European Commission will facilitate the way forward for registrants, report Jens Tørsløv and Anne Rathmann Pedersen. Both are Senior Consultants with DHI, Environment and Toxicology, where they specialize in impacts of chemical substances. MORE USER-FRIENDLY DATABASE OF CHEMICALS
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ECHA has the most exhaustive information database of chemical substances based on publicly available information on chemical substances registered since the start of REACH. “It is already possible to access this information but this year, ECHA will make the access even more user-friendly,” Jens Tørsløv says. Through the new web page, it will be possible for consumers or companies to obtain short substance specifications (Info Card) but also more detailed specifications will be available through a brief substance profile (Brief Profile). In addition, the web page will offer a complete and detailed overview of available substance data as well as the legal requirements on the individual substances.
“The improved access is part of ECHA’s ongoing activities to update their portals and its tools”, Jens Tørsløv says. It will also be possible to register substances online and without local installation of the IUCLID database. This may be relevant for registrants who are part of a joint substance registration and only need to submit company specific data.
STRENGTHENING THE PRINCIPLE OF ONE SUBSTANCE ONE REGISTRATION
The upcoming Implementing Regulation on data sharing from the European Commission empowers ECHA to enforce the OSOR principle (One Substance One Registration). “The aim is to ensure effective application of REACH with regard to the data sharing process,” Anne Rathmann Pedersen explains. The draft Implementing Regulation holds provisions on transparency in data sharing and in data sharing agreements along with provisions on fairness and non-discrimination for cost sharing. “The regulation will limit the number of individual submissions”, Anne Rathmann Pedersen adds. It will help registrants of the
same substance to agree on data sharing and will ensure a proportionate way forward for registrants who are blocked due to disputes in the SIEF process (Substance Information Exchange Forum). However, a full or a partly opt-out from the joint submission is still possible. In case of disputes, ECHA has the mandate to resolve.
FACTS ABOUT DHI
EASIER TO CLARIFY SAME SUBSTANCE IDENTITY
• consulting engineers and contractors
ECHA will introduce sector-specific substance identification guidance to make it easier to clarify same substance identity and to identify and confirm co-registrants of same substance in the pre-SIEF process. The guidance will not replace the official guidance on substances identity, but will work as support for registrants within specific sectors.
Provides consultancy services within water, environment and health to: • public and governmental authorities
• industry sectors such as chemicals industries, ports, water utilities, energy, infrastructure and transportation • Operates globally and has offices in more than 30 countries For more information www.tox.dhigroup.com
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Risk assessment of chemicals Strategies for REACH registrations and SVHC substances Chemical compliance and regulatory toxicology Environmental laboratory services Hazard classifications and Safety Data Sheets for your global market Software tools incl. our new ChemClass for classification of chemicals mixtures according to national or regional implementation of GHS
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Contact: firstname.lastname@example.org For more information, visit www.tox.dhigroup.com
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z REACH FEATURE
REACH authorisation: avoiding the pitfalls, arriving successfully Start with determining the strengths and weaknesses of your case
HOW CRITICAL IS YOUR SUBSTANCE? PUTTING IT ALL INTO PRACTICE The REACH authorisation process is complex and critical to your business. To give a practical example, in 2013 Vlisco (textile industry) requested our support for the authorisation of trichloroethylene. In a first step, we developed the dossier strategy. This was done together with the company’s management by means of in-house workshops. These workshops led to the determination of the major strengths and weaknesses of their potential application. Not an easy exercise and already at the early beginning of the process key questions had to be resolved…
• How safe is your use really? How low is your exposure? How easily can you demonstrate this? • Is there evidence of a research program for the replacement of trichloroethylene? Or even better, do you already have an alternative in the pipeline? If yes, by when can you get it installed? • What will you do if authorisation is not granted (non-use scenario)? • Can we already make some judgement on whether the benefits of a granted authorisation will outweigh the risks?
Once the dossier strategy was set and Vlisco decided to proceed, an application for authorisation was generated for this non-threshold substance. The dossier building started with the preparation of a company specific exposure scenario. Personal monitoring information was used and we demonstrated minimization of emissions. Bio-monitoring data, generated during the course of the project, further supported the outcome of the assessment. In a final stage, the “weakest” exposure point was identified and additional measures were proposed for further improvement. In the analysis of alternatives, a long list of potential alternatives was identified and assessed. From this long-list a short-list was generated. For each alternative on the short list it was then demonstrated that the potential alternatives could not be considered technically feasible, nor economically feasible, nor would they result in a risk reduction. Next to the alternatives, also several non-use scenarios (in simple terms… what will we do if authorisation is not granted) were intensively discussed leading to the identification of the most plausible non-use scenario. This non-use scenario formed the input for the socioeconomic analysis.
HOW STRONG IS YOUR CASE?
In the end, all arguments present on the table lead to the identification of the most appropriate review period. In this case, the applicant (Vlisco) requested a review period of 12 years. Both the Risk Assessment Committee (RAC) and the Socio-Economic Committee (SEAC) confirmed that 12 years was considered an appropriate review period based on the arguments and the research plan provided by the applicant.
• Get your strategy straight from the beginning. • Generating an application for authorisation is not a one-man job. If you want this to work out ensure you have the right team involved. • Time is of the essence. Start in time as timely data collection has proven to be a challenge. • Be to the point, clear, transparent • Ensure the story is credible! www.apeiron-team.eu
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A basic guide to REACH Substance Identity and Analytics for first time registrants in Phase 3 Feedback from ECHA on phases 1 and 2 was particularly critical of identity quality; “correct and unambiguous substance identification is a frequent shortcoming in registration dossiers”. A simple review of the requirements is therefore of value. According to the REACH legislation, substances fall into three broad categories: • Single constituent (main component typically >80%, with the remainder being impurities) • Multi-constituent substances (no single component at >80% but two or more between >10% and <80%, with impurities also possible) • Undefined, Variable, Complex or Biological (UVCB, defined by the starting material and the process, no impurities possible, all contained materials are constituents) For single and multi-constituent substances, all impurities >1% must be identified and named. This limit drops to >0.1% if it is believed that the impurity may be hazardous. The total composition of the substance in both cases must add up to 100%. Note that multi-constituent substances are not just formulations. Instead, they are cases where it is physically impossible to create the two substances individually while maintaining the same properties. For UVCBs, all components present at >10% must be identified. However, naming those under 10% is also an advantage, even if only by a structure proposal. Unknowns should be grouped as far as possible and categorised according to general structure type or key similarities. The standard recommended analytic techniques are UV-Visible and IR spectroscopy for basic identity, NMR spectroscopy and/or mass spectrometry for precise identity and GC or HPLC for purity. It is important that these techniques are employed to the maximum extent to avoid the demand for repeat analysis. For example, consider also acid and alkaline environments in the UV-Visible spectrum and ensure the NMR spectrum is run fully and not just to the point of the expected peaks. These techniques should not be considered as exhaustive. Further tests, as appropriate to the substance nature, should be added in order to justify the identity. Examples of additional techniques are: XRD, atomic absorption, carbon
v metal balance, GPC, database comparisons, CHN combustion analysis, Karl-Fischer or silver nitrate titration, BET surface area and electron microscopy Traceability is essential for high quality reporting and GLP should be employed if further toxicity tests are envisaged. A good starting point on each report would be; substance name, CAS number, batch number, manufacturing data, batch expiry date, purity pre-estimate, substance nature and appearance, laboratory name, laboratory address, analysis date, operator name and signature plus laboratory manager name and signature. A detailed interpretation of the results should be provided explaining clearly how this indicates the declared composition. The raw data, spectra and full method description should also be given. It is important that the declared composition covers all sources of the substance as handled by the legal entity. This is particularly relevant for importers whose materials may come from diverse non-EU sources. As a result, multiple spectra may be required.
The lead registrant will usually release a basic Substance Identity Profile which is usually limited to just the substance identifiers (such as CAS and EC number) and maximum level of any common impurities. Prescriptive analytical instructions are not normally given. The co-registrant therefore remains fully responsible for their private analytics, identity and composition with the lead having no responsibility for certifying these or confirming any applicability to the joint registration. Full liability for the substance identity in a submitted registration (lead or co-registration) lies with the individual registrant. ECHA and the national authorities are unable to accept any aspect of liability so unsupported statements, based on identity belief or assumptions, will generally be met with a request to provide further proof. Finally, it is vital that analytics are carried out as early as possible. Experience has shown that surprises often emerge such as the identification of previous false identity assumptions. Addressing such issues closer to the registration deadline may not be possible and could prevent a successful registration.
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Science solutions for a changing world The REACH (Registration, Evaluation, Authorisation and restriction of Chemicals) timeline continues relentlessly harmonising chemical information requirements and placing the burden of proof (and cost) on the manufacturers and importers. While the data gathering exercise for those substances manufactured and/or imported in the highest amounts and those considered the most hazardous have been dealt with during the 2010 and 2013 registration deadlines, the focus has shifted to the May 2018 deadline for those substances in the 1-100 tonnes per year category. This will have significantly more registrations than previously experienced, and interestingly, European Chemicals Agency (ECHA) have stated that it will include many more inexperienced registrants from nonchemical industry sectors. Some consortia could consist of just one organisation. This will not only place a financial burden on the organisations involved but may stretch them technically, the extent of which will be dependent on the substance information already available, whether any data requires generating and any individual complexities of the substance. While Substance Information Exchange Forums (SIEF) and consortia work towards the 2018 registration deadline, substances that have been identified as ‘potential concern’ are undergoing substance evaluation as part of the Community Rolling Action Plan (CoRAP). Substance evaluation may be triggered by a number of concerns including: potential for human and/or environmental exposure, persistence, bioaccumulation and toxicity (PBT), very persistent and very bioaccumulation (vPvB), endocrine disruption and/or carcinogenicity, mutagenicity and/ or reproductive toxicity. During this process substances suspected to pose a risk to human and/or environmental health are evaluated by Member State competent authorities which may lead to requests for further information before a decision is finalised. The requests from CoRAP pose some of the most interesting challenges for the chemical safety community due to the diverse nature of these compounds.
Over the past five or six decades, since the publication of Silent Spring, environmental chemical risk assessment has been dominated by the requirements of the agrochemical industry, with the development of a comprehensive and technical program of experimental testing and risk assessment science. Sectors without this environmental risk history, have subsequently adopted the established methodologies, guidelines and principles. While chemical groups such as pharmaceuticals can be different to agrochemicals there is some overlap of the chemical space. Deploying ‘standard’ methodologies to generate the data required will be challenging for the chemically diverse range of substances included in CoRAP, some of which are very different from the substances for which standard methodologies were first developed. This will make satisfying the usual validity criteria of standard studies, technically very challenging and in some cases impossible. Substances with very low water solubility may be problematic. Where significant exposure of environmental surface waters is expected then investigations of the rate and route of degradation in water/sediment systems may be required (e.g. OECD 308). The protocol for this type of study usually requires substances to be applied at concentrations below the solubility limit and also requires detection limits of one percent of the applied concentration, which is often unachievable for substances applied at low levels due to water solubility restrictions. This leaves two choices: either operate the study at application
levels above the water solubility or increase the acceptable minimum lower quantification limit. Neither of these options is ideal but pragmatic solutions and acceptance of those solutions will be required. Funding organisations and laboratories have risen to the challenge of developing experimental methodologies for substances with challenging characteristics, but some of these projects are on-going and/or yet to be accepted by regulators. In the meantime we will need to work collaboratively and supportively, and accept pragmatic solutions to these challenges.
By Chris Sinclair
Senior Environmental Chemist
Pioneering Protection • Reducing risk and ensuring safety • Helping your business save time and money • Protect your business’ investment
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Nanomaterials under REACH: progress and opinion The purely exploratory period for nanomaterial (NM) technologies is now over and they are becoming commonplace in industry due to their revolutionary potential. For a company to widely and sustainably release NM innovations into the market it is crucial to ensure the correct registration processes are followed to achieve REACH compliance. However, there are currently no established guidelines under REACH due to testing difficulties at the nano-scale, where novel properties and behaviours occur compared to dissolved or bulk forms of the substance. Based on current NM registrations, and knowledge, ECHA has released some recommendations for registering NMs via the â€œGroup Assessing Already Registered Nanomaterialsâ€? (GAARN). Concerning substance identity registrants should be able to demonstrate they are/are not working with a NM basing their conclusion on the current commission definition for NMs (2011/696/EU). Following this an appropriate strategy based on substance identity should be derived. The GAARN documents highlight specific NM physicochemical characteristics that should be assessed but at which product life-stage remained uncertain. Current international consensus is that due to the impact NM characteristics may have at each life-stage on the behaviour and fate of the NM, that the best practice will be characterization asmade/prepared, as-bought, as-dispersed and as-exposed. The same is also true for hazard assessment. The adoption of such a regime will allow the appropriate implementation of a testing strategy to assess human and environmental hazard and fate based on NM characteristics and changes throughout the whole life-cycle, and highlight characteristics that drive toxicity. The derivation of NM physicochemical characteristics should be from a multi-method approach (i.e. dynamic light scattering and transmission electron microscopy for size distributions) as technological limitations mean no single method can appropriately assess the necessary parameters. It is pertinent to note that any capping-agent on the NM will
be classed as an integral part of the NM and as such the NM+coating combination will be considered a single entity. Opinion toward existing OECD guidelines for the testing of chemicals is that they remain acceptable for NMs. However, in some instances based on the NMs novel physicochemical characteristics, and behaviour in the test system, adaptation may be necessary. Within the test system dosimetry needs to account for not only mass balance but also particle number, and the concentration of the soluble fraction (if dissolution occurs i.e. transition metals). These should be assessed to elucidate the major drivers and best fitting relationships with toxicity, i.e. to produce an appropriate dose-response relationship. Such details are now part of R.7 ECHA document, but are subject to change as further knowledge is gained. For risk characterisation a major issue, and concern, is the inability for current models (e.g. EUSES) to appropriately predict the eventual exposure level of NMs due to their novel behaviours. Validation of such models is also problematic when trying to separate nano-forms from the naturally occurring form when an abundance exists naturally in environmental samples. Or, when release levels lead to concentrations that are undetectable using current analytical
methods. Probabilistic exposure models do exist, and more are in development. These probabilistic models currently represent the best option for determining exposure, unless monitoring data are available. The regulatory landscape for NMs still holds many uncertainties and, is rapidly changing. Advancements in knowledge will inevitably feed into regulation and consensus opinion is slowly being reached. A whitepaper regarding regulation under REACH should be available by 2020, via EU funded projects e.g. NANoREG. However, for companies wanting to register nanoforms of a substance and remain compliant with the REACH 2018 deadline this is not soon enough. The registration should therefore follow the few guidelines presently available and testing strategies should be developed specific to each NM based on physicochemical characteristics. The test strategies adopted beyond that of the guidance that will ensure longevity of the dossier in light of new developments will be the responsibility of the registrant and, expert opinion should be sought. Blue Frog Scientific Limited is a UK based independent regulatory consultancy that uses good science, innovative thinking and clarity to achieve regulatory compliance.
Dr. Kai B. Paul
Scientific & Regulatory Affairs Consulting REACH 2018: A Deadline not to Underestimate firstname.lastname@example.org www.bluefrogscientific.com
Chemicals I Human Pharmaceuticals I Veterinary Medicines I Agrochemicals I Feed Additives
z REACH FEATURE
Requirements for a Global Emergency Telephone Service By Ulrich Mann
GBK GmbH Global Regulatory Compliance, Ingelheim, Germany If you are responsible even for the transport of adhesives in small tubes you need an emergency phone number, not only for airfreight shipping documents but also for the safety data sheet. Having an emergency telephone number is a legal requirement for:
• US-Transport: DOT § 49 CFR 172.604 (Docket HM-126 C)
• Air freight: IATA-Dangerous goods regulations - Deviations of the Governments and Airlines • Sea freight: IMDG-Code
• Safety data sheets: REACH Annex II Requirements for SDS - EU-Regulation 1907/2006 (Registration, Evaluation, Authorization and Restriction of Chemicals)
If you do not comply with these requirements there can be several consequences, such as the refusal of transport by airlines and shipping companies. It can also lead to a breakdown of transportation flow due to official bans including the risk of fines of up to $10,000. The end result can also lead to product liability risks. In order to avoid these risks, there is a simple solution. GBK GmbH Global Regulatory Compliance can take care of these responsibilities on your behalf. You supply us with the necessary data and we can take care of everything else. We will provide you with the following support services: • Access to our emergency call center (24 hours / 7 days)
• Emergency call service in 170 languages • Fulfillment of your legal obligations
• Transposition of the airline and shipping company requirements • Medical advice in case of poisoning
• Additional in the USA: Disposal service
US-DOT DEFINITION OF “EMERGENCY RESPONSE INFORMATION”
The US-DOT definition of “emergency response information’’ means information that can be used in the mitigation of an incident involving hazardous materials and, as a minimum, must contain the following information:
• The basic description and technical name of the hazardous material as required by Sec. Sec. 172.202 and 172.203(k), the ICAO Technical Instructions, the IMDG Code, or the TDG Regulations, as appropriate (see Sec. 171.7 of this subchapter);
• Immediate information regarding hazards to health; • Risks of fire or explosion;
• Immediate precautions to be taken in the event of an accident or incident; • Immediate procedures for handling fires;
• Initial procedures for handling spills or leaks in the absence of fire; and • Preliminary first aid measures
• Further requirements regarding Emergency response (DOT): a) A person who offers a hazardous material for transportation must provide an emergency response telephone number, including the area code or international access code, for use in the event of an emergency involving the hazardous material.
The telephone number must be monitored at all times that the hazardous material is in transportation, including storage incidental to transportation. b) The telephone number of a person who is either knowledgeable of the hazardous material being shipped and has comprehensive emergency response and incident mitigation information for that material, or has immediate access to a person who possesses such knowledge and information.
and c) entered on a shipping paper in a clearly visible location. This provision may be used only if the telephone number applies to each hazardous material entered on the shipping paper, and if it is indicated that the telephone number is for emergency response information (for example: ``EMERGENCY CONTACT: * * *).
The telephone number required by paragraph (a) of this section must be the number of the person offering the hazardous material for transportation or the number of a competent agency or organization accepting responsibility for transportation and capable of providing detailed information concerning the hazardous material.
REQUIREMENT FOR AN EMERGENCY TELEPHONE NUMBER ON SAFETY DATA SHEETS Annex II of the REACh Regulation stated that under Chapter 1.4 of every Safety Data Sheet references to emergency information services shall be provided. If an official advisory body exists in the Member State where the substance or mixture is placed on the market (this may be the body responsible for receiving information relating to health referred to in Article 45 of Regulation (EC) No 1272/2008 and Article 17 of Directive 1999/45/
EC), its telephone number shall be given and can suffice. If availability of such services is limited for any reasons, such as hours of operation, or if there are limits on specific types of information provided, this shall be clearly stated. In addition to the above mentioned specifications, an Emergency Telephone Number of the company and/or an appropriate public information service as well as a commercial private support service provider of an emergency center can be given.
DON’T FORGET PRODUCT SAFETY ASPECTS
For compliance in other areas like detergents, the integration of the emergency response system into the companies is needed. It is also necessary that a toxicologist can be called in on demand. Last but not least, there are special national requirements for countries like China and Australia. In these countries, a national emergency response telephone number is required. The regulatory basis for the emergency telephone number on Chinese product labels, is “GB15258-2009 General rules for preparation of precautionary label for chemicals” and in “GBT 17519 2013 Guidance on the compilation of safety data sheet for chemical products.”
GBK – EMTEL® HOW IT WORKS IN DIFFERENT MODULES
Module 1 – Providing the emergency telephone number for the transport documents (worldwide) Module 2 – Providing the emergency telephone number for all MSDS (according EC-Guideline)
Module 3 – Providing the emergency telephone number for product labels (consumer product; just in combination with module SDS/MSDS) Module 4 – Providing the emergency telephone number for China on the product label and in the MSDS Module 5 – Providing the emergency telephone number for detergents
In order to be fully compliant, you have to fulfil the regulatory requirements regarding emergency response. The benefits of using the services of a professional provider include • Capable solution for additional services concerning hazardous materials/goods • Legal compliance
• Limitation of liability
• Reduction of internal costs and effort www.gbk-ingelheim.de
Supporting enterprises in the field of Environment, Health & Safety
Our services: > GBK – EMTEL® 24/7 Emergency Response
> Management Systems
> Regulatory Compliance
> Product registration
> Contract Support
> Training Partner
> Chemicals Law and Hazardous Substances Ordinance
> Dangerous Goods Safety Advisor
> Dangerous Goods regulations
> IT-Consulting services
> Workplace Safety > Company responsible officer
GBK GmbH Global Regulatory Compliance Königsberger Str. 29 55218 Ingelheim/Germany Managing Director: Bjoern Noll
> USA-Service > Logistics Consulting
Tel: +49 61 32 / 9 82 90 - 0 Fax: +49 61 32 / 8 46 85 email@example.com www.gbk-ingelheim.de
The performance of the UK chemical industry, including pharmaceuticals, has made it one of the world’s top chemical-producing nations. Indeed, it is the second largest industry in the UK, in terms of both turnover and value added and the latest Government figures show the sector turned over £57.5 billion and added £18.8 billion in value. However, driving its success is not just the chemical companies themselves but businesses and organisations offering support services, everything from energy, raw materials logistics to financial back-up, advice on regulation and design expertise. Indeed, when the national UK Chemistry Growth Strategy Group (CGSG) delivered its vision of the future of the industry a couple of years ago, it identified support services as crucially important. The CGSG, which was formed by industry leaders to identify recommendations that
will accelerate national economic growth in the sector, included in its suggestions the securing of competitive energy and feedstock sources, support for a more robust supply chain, backing for innovation when it comes to new products and bringing industry and the financial community together to strengthen their understanding of each other’s business requirements. One of the key areas in which the UK chemical industry receives support is in breaking into foreign markets. Indeed, the GCSG has estimated that by 2030, the UK chemical industry will have further reinforced its position as the country’s leading manufacturing exporter and enabled the chemistry-using industries to increase their Gross Value Added contribution to the
UK economy by 50%, from £195 billion to £300 billion. Much of the support comes from UK Trade and Investment (UKTI), which helps the UK chemicals sector do more business internationally. UKTI works with industry representative organisations as well as with individual businesses to help them engage with export opportunities overseas in close co-operation with the network of embassies and consulates around the globe. In addition, UKTI works closely with other Whitehall departments including Business Innovation and Skills to ensure that policies and initiatives are well co-ordinated with business.
CONTINUED ON PAGE 40
CONTINUED FROM PAGE 39
UKTI helps UK companies to: • increase their presence in overseas markets • overcome difficulties getting in to markets • develop supply chain opportunities • partner internationally in technology innovation UKKI does this this by: • promoting opportunities arising from prime contractors supply chains, ideally at pre-bidding stage • promoting the industry overseas through the Prime Minister’s Trade Envoys, and our Embassies and High Commissions • developing relationships with international chemicals companies, equipment manufacturers and Tier 1 suppliers • aligning with UK-based Tier One contractors to position UK supply chain companies effectively for future business opportunities One of the most useful UKTI services is the alert system which makes companies aware of opportunities for new contracts and partnerships, which can be found at www.businessopportunities.ukti.gov.uk/ export/sectors/chemicals.html Security is another important area in which the sector benefits from strong support, including from the Chemical Business Association (CBA), which won the chemical security category in the Cefic European Responsible Care Awards for 2015. CBA’s award submission outlined its recent work to preserve the security of hazardous substances in transit and its longer-term development of industry Codes and Guidelines to protect the chemical supply chain from terrorist threat.
Peter Newport, CBA’s Chief Executive, said: “The award is an acknowledgement of the innovative work CBA has undertaken on behalf of the UK supply chain and the model it has provided across Europe and globally.” As early as 2002, CBA developed a Security Code for its Responsible Care Programme that was subsequently adopted by its sister European organisations. A Code of Conduct and Security Guidelines followed a few years later to promote best practice throughout the supply chain. These measures built on CBA’s existing Joint Code of Conduct relating to drugs and precursors for chemical weapons. The Code was revised to include explosives precursors within two weeks of the London bombings in July 2005. After further development of the Code by CBA, it evolved into the European Voluntary Agreement on Trade Controls of Fecc in 2013 and that of the International Council of Chemical Trade Associations distributor’s organisation in 2014. CBA continues to deliver its security expertise to a wide range of international organisations and has been invited to share its expertise at international conferences in Tbilisi, Istanbul, Warsaw, Thailand, The Hague, Brussels, and India. Safety is another important area of support for the industry and the most recent report from the Chemical Business Association showed that accidents to employees working in the UK chemical supply chain are at an all time low. CBA’s annual Indices of Performance Report – containing the aggregate safety, health, and environmental performance of its member companies - records the lowest Lost Time Accident Rate it has ever reported. During 2014. CBA members made more than one million journeys to deliver more than
three and a half million tonnes of chemicals to virtually every sector of the UK economy. CBA’s Indices of Performance report, now in its twenty-second year, is based on returns from 93 distributor member companies employing 5,453 people. Andrew Beck, Chairman of CBA’s Responsible Care Committee, said, “In at least two respects – reportable accidents and transport incidents – CBA’s data goes beyond the statutory minimum reporting requirements. Despite these self-imposed higher standards, member companies continue to demonstrate continuous improvements in their performance.” Distributor companies reported 16 accidents in 2014, a 20% reduction on the previous year. Four accidents resulted in serious injury, down from eight in 2013, and six resulted in incapacities of more than seven days. Accidents resulting from a manual handling process or a slip, trip or fall represented 44% of total accidents, down from 55% on 2013. Just two accidents resulted from an exposure to harmful substances, the same as 2013. The Lost Time Accident (LTA) rate for those reportable under RIDDOR, plus the additional recordable accidents resulting in incapacities of more than three days decreased to 0.16, the lowest rate ever reported by CBA. The LTA rate is the ratio of reportable accidents to 100,000 man-hours – the assumed number of hours worked by one person during a lifetime. In 2014, CBA member companies made more than one million separate journeys to distribute over three and a half million tonnes of chemicals. Seven transport incidents were reported, the same as 2013. This equates to 1.9 transport incidents for every million tonnes of product distributed by CBA members in 2014 - a slight increase on the previous year.
REACH FEATURE z
Embattled chemicals: how does this affect my business?
What are embattled chemicals? Substances can become embattled in a number of ways. Many find their way into this arena because of known chemical/hazard properties. However, the embattled substance arena is not just driven by regulations, but often by green NGO activity, or by a particular substance getting into the public eye due to media scares making a particular chemical the issue of the day. TIGHT FIT – REGULATORS’ RESPONSE TO SEMICARBAZIDES SHOWS HOW REMOVING ONE PROBLEM CAN NEARLY CREATE ANOTHER. For example, semicarbazide, a possible mutagen, was found in samples of baby food in 2003. In the subsequent drama, the source was traced to products used as blowing agents for the PVC seals for the jars. Authorities moved quickly to ban the source chemical’s use in PVC seals for food packaging. It reads well, except that the ban was introduced so quickly that the industry was left frantically searching for an alternative way to keep food sealed. This potentially replaced one relatively low risk with a higher risk of microbiological contamination.
COMPANIES NEED A PLAN
The embattled substances arena is a messy one. However, companies can do much to create order and avoid being caught out. We have a three stage process to manage this with our clients. 1. Involve an expert team. If you are close to the REACH process, then your core REACH team is a good place to start. As well as this, operations, regulatory affairs and marketing teams are essential partners in your planning phase. Involving outside experts can also help fast-track the process.
their use in cosmetics is sensibly being phased down. ‘Paraben-free’ has become a common promotion, except this phrase draws in both the branch-chain parabens and also linear parabens – which are widely used in cosmetics. Replacing these products with an alternative is a challenge as the range of preservatives available becomes narrower. This can result in increased costs and reduced efficacy “If I can’t pronounce it, it ain’t going into my body” proclaimed the announcer for the Jack Lalanne Juicer in a long-running TV advert for this product. The substance he couldn’t pronounce was α-tocopherol (vitamin E).
Laws made fast, and in a kneejerk way are often weak. Yet the story of semicarbazide is not uncommon. These products, ‘embattled chemicals’ as they’re known in the industry can be driven by regulations, such as REACH, but also by media, retailers, NGO activity or even social media. And because most consumers aren’t chemists the science gets simplified. Here are two examples.
THE COSMETIC INDUSTRY TODAY FACES REAL CHALLENGES ON PRESERVATIVES.
Branch chain parabens have been associated with endocrine disruption properties and
These challenges are likely to grow. The cosmetic industry today faces real challenges on preservatives used to keep water-based products like shampoos, hand creams and liquid skin cleansers free of bugs. Like the PVC packaging in the baby food, kneejerk responses could replace one perceived problem with another. There are many substances that are embattled in some way; the list is only likely to grow as each new cause célèbre surfaces. Each one gives a substance a bad name and once a substance has a bad name, it often keeps it. This can be based on solid science, but often it is not. A browse around a supermarket shelf will reveal that significant marketing energy goes into selling products that are “free of…” The consumer’s base assumption is: if a product is being offered that is “free of X”, whatever “X” is must be bad.
2. Draw up a systematic list of potentially problematic substances and where they’re used in your business. Think wider than the science, scan NGO literature, use your expert team to keep this process broad. 3. Have a clear plan to track and address each problematic substance. This again goes wider than pure science. Engagement with regulators and other stakeholders is a key action. Working with marketing and communications teams to keep the agenda plain English is also important. Regrettable substitutions need to be avoided. Companies see a substance under threat and dive for the best-looking alternative. But is it better? This can be a bigger challenge when replacement timelines are long, such as in the aeromotive industry.
By Alan Ritchie
firstname.lastname@example.org +44 20 3116 6072
WSP | Parsons Brinckerhoff Alan has 25 years of chemical regulatory, REACH and related regulatory issues. He is happy to provide advice on strategies for managing embattled substances.
z REACH FEATURE
Pre-emptive risk management option analysis (PRMOA) under REACH As part of the European Commission’s SVHC Roadmap to 2020, the risk management option analysis (RMOA) has been introduced as a step in the decision-making process for the authorities, although there is no legal obligation for it. Associated with it, the Public Activities Coordination Tool (PACT) was published by ECHA, listing the substances for which a RMOA or an informal hazard assessment for PBT/vPvB (persistent, bioaccumulative and toxic/very persistent and very bioaccumulative) properties or ED (endocrine disruptor) properties is either under development or has been completed since the implementation of the SVHC Roadmap commenced in February 2013.
considerable investment for improving current operation conditions, significant obsolescence management and/or replacement cost, potential supply chain disruption, as well as dramatic market reactions. Therefore a strategy-level analysis and action plan is recommended to determine the potential risk management options that the authorities may apply and how to act accordingly. This exercise can be described in roughly four steps:
An RMOA is a case-by-case analysis conducted by authority to conclude for an identified substance of concern, whether and which additional regulatory instrument(s) should be proposed to manage the risks from its use to human health or the environment. The main conclusions that will be drawn are one or multiple choices of the following:
• Identification as SVHC (entering the Candidate List before prioritised for REACH authorisation) • REACH restriction • REACH substance evaluation • CLP harmonized classification and labelling • Other EU-wide measures • No need for follow up regulatory action at EU level From companies’ point of view, there is an imminent need to actively manage the regulatory risks, because any of the regulatory actions being decided can mean
1. Monitoring 2. Analysing
the decision criteria and the related timelines. The goal of the analysing step is to make a realistic prediction of the RMOA outcome and the associated timetable, which will be the input for the intervention and the strategic planning steps.
The idea of intervention is to provide the right information to the right party at the right time. There are a few things that companies can do: 1. Keep the registration dossier up to date and reflecting the reality
4. Strategic planning
The PACT list is the main list to be followed, which gives the first signal of which substances the authorities are working on, and whether there may be impact on the business. Knowing which authority is working on what subject is also important for potential intervention activities.
Companies can try to put themselves into the authorities’ shoes and make the RMOA themselves. It should be important to understand, that RMOAs for potential SVHC are normally looking at the full range of uses for a given substance. For individual companies or sector trade associations, it may be difficult to know this big picture. However, it should be understood that the main data source for the authorities, namely the registration information, is mostly available to the general public through ECHA’s dissemination tool as well. In addition, it is important for the companies to understand
Updating the registration dossier to reflect the most current understanding is particularly important for information that is used as selection criteria, such as information on hazardous properties that may change the classification or qualification as PBT, vPvB and/or ED, as well as information on the uses and volumes. It is also important to coordinate this work with the Substance Information Exchange Forum under REACH, because every registrant needs to update in order for the change to be taken into consideration. 2. Participate in the public consultations with the most useful information The public consultation is the only official route to provide the decision makers with information that is not available in the registration dossier. The information concerning the use conditions, volumes, alternatives, as well as the socio-economic effects are all issues that may help authorities to make the most proportionate regulatory decisions.
REACH FEATURE z
RESTRICTION? Did you know that your voice matters before such regulatory decisions are made?
In addition to individual companies’ activities, the trade associations often play important roles in lobbying for a more appropriate regulatory option. For example, a use already regulated by specific EU laws aiming at the protection of human health or the environment may have the grounds for claiming inclusion of an exemption in Annex XIV based on REACH Article 58(2).
In addition to the intervention activities, companies should develop a regulatory roadmap as part of their strategic planning. Such roadmap may address key issues such as
• processes to be designed or optimised on the substance and use information collection,
Our Advocacy Support Services help you to achieve the best possible outcome for your business! We help you to provide the right information, at the right time, to the right counter-parties and with the right strategy. By taking a pro-active approach your company can make a diﬀerence!
• mitigation of regulatory risks along the supply chain, • timely obsolescence management, • cost-effective replacement plan, • portfolio optimisation,
• effective public communication. As a conclusion, industry has now more possibilities than earlier to interact with the authorities during the RMOA and the subsequent regulatory decision making processes. Companies are advised to take a proactive approach to safeguard their future business in the best possible way. The pre-emptive risk management option analysis and strategic planning offers a structured concept to implement this approach.
PUBLIC CONSULTATIONS EXEMPTION STUDIES PRE-EMPTIVE RMOAS STRATEGIC PLANNING LEGAL CONSULTING
FINLAND / BELGIUM / TURKEY / INDIA REACHLaw Ltd. HQ: Vänrikinkuja 3 JK 21, FI-02600 Espoo, Finland +358 (0) 9 412 3055, sales@reachlaw.ﬁ
Dr. Ying Zhu
Partner-COO REACHLaw Ltd
z REACH FEATURE
EU REACH is now extending to Turkey
Chemicals management is taking its place on top of the priority list for manufacturers and exporters since there is a changing regulatory environment and new chemical legislations are being introduced all over the world; the most complicated one being the EU’s REACH regulation. As a benchmark, the REACH Regulation triggered Asia Pacific countries like China, Japan, South Korea, but also Turkey as a EU candidate country, to implement REACH. Turkish Ministry of Environment and Urbanisation (MoEU) published two major By-Laws on Chemicals and a new regulation on Safety Data Sheets since 2008. Several EU Implementation Projects are on-going in Turkey and one of them completed in December 2013 resulting with the new Turkish REACH Regulation known as KKDIK that stands for Chemicals Registration, Evaluation, Authorisation and Restriction in Turkish. Many companies completed their notifications for chemicals put into the Turkish market before March 2011 which was the deadline for By-Law on Inventory and Control of Chemicals commonly known as CICR. Importers and manufacturers of chemical substances, mixtures/formulations have the obligation to notify and update their notifications every 3 years according to the CICR unless they are exempt. The By-Law also allows companies exporting to Turkey to appoint a “Representative” to comply with the obligations rather than leaving the duty to the importers who do not have the information necessary to comply either because of confidentiality reasons or lack of technical background. This has led manufacturers out of Turkey to appoint local representatives who can fulfil manufacturers responsibilities
and execute the job in Turkish language as requested. Consequently, a Turkish national inventory has been established since 2011. Opposite to the EU approach, SEA is launced before Turkish REACH in Turkey. Turkish By-Law on Classification, Packaging and Labelling of dangerous substances and mixtures abbreviated as SEA was published in December 2013 with a notification deadline of June 2015 for the substances imported into the Turkish market before June 2015. However, the MoEU registration portal used for the SEA notification is open for companies who missed the deadline or have new substances to notify. Although CLP and SEA have a lot in common, there are also some differences. Foreign companies can submit notifications through their appointed representatives located in Turkey and assume that this is an exercise before the Turkish REACH (KKDIK) regulation as they will need to appoint an Only Representative to submit pre(registration)s through the same registration portal soon. Finally, after several drafts and a delay as a result of the general elections on last November, KKDIK is to be published in the first quarter of 2016 by the MoEU. Therefore, all manufacturers have to be ready with a comprehensive inventory of substances,
mixtures and articles they put into the Turkish market. It is mandatory for companies to go through a pre-registration process which already has been experienced as the first step before doing a SEA notification. This also leads companies to join a Substance Information Exchange Forum (SIEF) called ÖN MBDF (in Turkish) which will enable companies to communicate or co-operate on availability of required data and data sharing similar to EU REACH Regulation through SIEFs. REACH Global Services S.A. (RGS) does not cooperate with a local partner, but instead is giving Turkish Compliance Services through their own Turkish Branch Office directly employing Turkish speaking qualified technical team having years of both EU REACH experience and Turkish Chemical Regulations. Please contact RGS if you are NOT Compliant with Turkish Chemicals Laws or need more details on our services.
Dr. Yaprak Yüzak KÜÇÜKVAR Reach Global Services S.A. Turkey Office Manager www.reach-gs.eu
DO YOU EXPORT CHEMICALS TO TURKEY? DO YOU COMPLY WITH THE CURRENT TURKISH BY-LAW ON CHEMICALS? DO YOU KNOW ABOUT THE NEW TURKISH REACH REGULATION (KKDIK)?
Have you appointed a representative to comply with the Turkish: • By-Law on Inventory and Control of Chemicals (CICR)? • By-Law on Classification, Packaging and Labelling of Dangerous Substances and Mixtures (SEA)? • Has your representative done your substance notification with the local authorities? • Do you follow the updates to the notifications?
THE NEW TURKISH REACH REGULATION AS OF 2016 • Did you assign your local Only Representative? • Do you know which substances to (pre)register? • Are you aware of the deadlines?
If your answer is NO, RGS will assist you to: • Assess the chemicals you put into the Turkish market
• Determine your company’s regulatory obligations • • • • •
vis-a-vis Turkish Chemicals Regulations Act as your Turkish representative for CICR and SEA Complete Submission of notifications in Turkish with the required data set Be your Only Representative in Turkey, for Turkish REACH Pre(register) your substances in compliance with the Turkish REACH (KKDIK) obligations Liaise with the Turkish Authorities when required
Your regulatory compliance partner
RGS - Belgium Head Office + 32 (2) 234 77 78
RGS - Turkey Office + 90 (212) 454 09 93
z REACH FEATURE
Getting ready for REACH 2018 James Hagan, Global Director of Product Stewardship and Compliance at Elementis Specialties, explains the challenges of REACH 2018 and how EUPHOR, a Registration Management System tailored to compliance regulations, is helping Elementis prepare for the 2018 deadline. THE CHALLENGE: MEETING REACH 2018 FULL COMPLIANCE WITH LIMITED RESOURCES
The 2018 REACH Campaign applies to substances manufactured or imported in the EU of more than 1 metric ton per year. This new phase of REACH will require numerous companies to register many more substances than they registered in REACH 2010 or 2013. Elementis, a global Specialty Chemical company, is going to register 4 times the number of substances than were registered in 2013. Historically, Elementis would have considered significantly increasing the number of resources devoted to generating the data and assembling the dossiers drawn from a breadth and depth of technologies and geographies. The increased number of data points, tasks and people working on the project substantially raises the probability for an error or missed event. When reviewing the registration requirements and the project plan, Elementis recognized that its previous registration approach and the current landscape of available project management tools would be inadequate for the scope of REACH 2018. Registration of so many substances is an extraordinary challenge to both internal and external registration teams. Efficiently tracking the progress of each registration, managing all the data for each substance, tracking every activity, staying on schedule and managing the registration budget presented a significant project management challenge.
Elementis’ previous reliance on Excel, email and standard project management tools to manage all the activities was not going to deliver the necessary return on investment. Elementis demanded a robust and simple tool to manage the complexity of REACH registrations, allow greater team collaboration and provide an automated way to drive errorfree based performance while keeping the registrations on-time and on-budget.
THE SOLUTION: INDUSTRY & COMPLIANCE KNOWLEDGE COMBINED WITH TECHNOLOGY SOLUTIONS EXPERTISE
To succeed against these inherent challenges presented by the REACH 2018 deadline, Elementis Compliance and IT teams have collaborated with business solution firm xTensegrity, combining their industry compliance knowledge and software technical expertise, to create EUPHOR, a web-based Registration Management System (RMS) tailored to compliance regulations. EUPHOR is designed to enhance the capability of project and process management in one easy-to-use package (constructed for cloud or on premise) synchronizing industrial domain knowledge with the automation of state of the art technology. EUPHOR allows the internal and external REACH registration teams to confidently manage, collaborate and track the registration workflow from start to finish. It is a primary workbench to ensure that REACH activities are managed, error-free and that the registration program is accurately completed on-time and on-budget.
THE CONCLUSION: A ROBUST REGISTRATION MANAGEMENT SYSTEM MAKING YOU EUPHORIC WITH REACH 2018
“We, at Elementis, see EUPHOR as an essential solution to ensure 100% accurate and on-
time REACH dossiers for the 2018 deadline. Cross functional team coordination and transparency brings a level of accountability to ensure everyone’s contribution is making the project a complete success. EUPHOR’s pre-built dashboards enable my managers and I to track key metrics such as budget and time fences for each substance and empower ad hoc or formalized reporting in line with the Business Units’ expectations. Thereby EUPHOR is generating proactive management of a large number of REACH registrations with the confidence to know nothing gets missed and that all dossiers will be completed on time and on budget. In short, we have transformed the REACH 2018 Challenge into an opportunity for productivity, building company-wide confidence in my team’s capability to deliver and driving up our value add to the business. We can be proud of our investment in brand equity through EUPHOR.” James V Hagan Global Director Product Stewardship & Compliance Elementis Specialties
www.euphoreach.com email@example.com +1 (732) 322 7970
REACH 2018: WE’RE READY, ARE YOU?
Be EUPHORIC with REACH 2018 and let EUPHOR be your key to smooth registration.
KEY FEATURES Robust Web-Based Application
Web-based, self-service oriented, customizable and available on the cloud and on premise.
Manage, Collaborate & Track
Collaboration within cross functional teams and automated alert system for upcoming and missed events.
EUPHOR CAN HELP YOUR ORGANIZATION… Manage and document your registration process in
one centralized place from start to finish and collaborate within cross-functional registration teams.
Assign specific roles to each registration’ stakeholder
and keep them engaged through an automated alert system notifying of upcoming and missed actions within your registration process.
Managers can instantly check project status and spot activities falling behind schedule.
Identify at-risk projects thanks to dashboards that
Time savings and transparency
Record all activities involved within your REACH
Reduce the amount of time and resources needed to manage and track REACH activities.
track your registration progress and accurately report on budget, time and other resources.
program to ensure smooth sailing with auditors.
EUPHOR is a web-based Registration Management System (RMS) tailored to compliance regulations. EUPHOR synchronizes industrial domain knowledge with state of the art technology to enhance the capability of project and process management in one easy-to-use package (constructed for cloud or on-premise).
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REACH 2018 – first time registrants
The 31st May 2018 may seem a distant date right now but for those stakeholders who bear a REACH registration obligation for this date it is just around the corner. The first registration deadline realised 3400 phase-in substances having been registered representing greater than 20000 dossiers. The second registration deadline brought about approximately a further 3000 substance registrations represented by approximately 9000 dossiers. However, for the 2018 deadline it is expected that 25000 substances will need to be registered, covered by an estimated 70000 dossiers. This represents an extraordinary challenge for both industry and the European Chemicals Agency alike. The biggest concern is that many parties involved will be first time registrants and may well be unaware of the urgency to act now. Experience to date has highlighted a number of difficulties for registrants. Notable examples are substance identity and substance sameness, data and cost sharing, dossier preparation, use patterns and extended safety data sheets to name but a few. With the greatly enhanced number of registrations expected for 2018 these difficulties and others are likely to be repeated many times over. This is indeed a daunting prospect for first time registrants, especially small and medium enterprises (SMEs), who perhaps, to date, have not engaged with the REACH registration process. In addition, given the current timeline, there exists a serious concern that there may be insufficient testing laboratory capacity to conduct any necessary studies in time for 2018 given the high number of substances involved. It is imperative that those first time registrants recognise that they have obligations and to act now. Although there is lots of guidance, help desks and consultants available to assist first time registrants these companies somehow need to find sufficient internal resource to address their obligations and not suspect that those obligations will somehow “take care of themselves” or be met by other parties. This
is in addition to budgeting for the undoubted costs that will be incurred. Once this is understood, the pressing need is to evaluate the substance inventory of the organisation. Whilst this may be straightforward for simple mono constituent substances supplied in neat form, the supply of multi constituent or UVCB substances brings enhanced complexities, which may be compounded should those substances be imported as finished products in the form of complex mixtures. Thereafter, the organisation needs to preregister these phase-in substances as soon as possible in order to begin engagement with the Substance Information Exchange Forums (SIEFs). Although companies should have pre-registered the majority of substances in their product portfolio by the end of 2008, pragmatic strategies are still available to facilitate continued supply up until the registration process is complete. Once engagement with the SIEFs has been established and the substance sameness has been determined, the discussions can begin about data availability, data gaps and costs. From this point there are a number of scenarios that the newcomer may face: • For a substance that has already been registered in either 2010 or 2013, the process may not be so onerous. In this eventuality the pertinent data should already be available and the majority of the regulatory work completed. In addition, if there are a large number of SIEF members the overall costs of the letters of access may be considerably reduced since the overall cost of generating the original data package will be divided by a large number of registrants. This scenario is probably the best that the first time registrant can expect but even then complications can occur should the substance fall under additional REACH
Dr John Weetman Exponent International Ltd +44 (0)1332 868004 firstname.lastname@example.org Dr John Weetman has worked in the field of regulatory affairs for over 20 years and has supported the notification and registration of chemicals in markets across the globe. John has extensive experience as a consultant, offering strategic advice and registration services to the chemicals industry. compliance issues such as substance or dossier evaluation or even authorisation. • If the substance has yet to be registered then a lead registrant needs to be appointed. The presence of an experienced company may help, and realistically, the newcomer is unlikely to wish to take this role. However, if other SIEF members are also newcomers, or unwilling to accept the mantle of lead registrant there is a dilemma to resolve and completing the registration process will likely require external assistance. Thereafter, data availability and data gaps need to be quickly determined and a strategy agreed and implemented to fill those gaps, which may mean placing studies. As the data package is developed the dossier needs to be prepared in IUCLID and if applicable a Chemical Safety Report prepared. Other scenarios can of course arise, e.g. the substance is unique to the new registrant although the two described above are the most likely scenarios the first time registrant is likely to face. However, in essence, first time registrants need to engage with the REACH process now in order to determine quickly what scenario awaits them in their respective SIEFs and to ensure they meet their obligations by the 2018 deadline. Failure to act now may result in companies facing non-compliance issues and ultimately having to withdraw substances from the EU market so it is vital to implement a REACH plan without delay.
Not Sure About REACH? REACH requires companies that supply substances in quantities of one tonne or more per year to register them with the European Chemicals Agency. Although nearly 7,000 existing chemicals have already been successfully registered, the Agency has estimated that a further 25,000 substances will require registration by June 1, 2018 and will need to be supported by a comprehensive dossier, and in many cases a chemical safety report. This presents an enormous challenge to industry and with time running out, it is important to act now before it is too late.
Let Exponent Help You Exponent is one of the largest scientific and regulatory consulting firms in the world and a leading provider of services to companies in the chemical industry, both large and small. Exponent’s REACH team includes regulatory affairs professionals, project managers, risk assessors, socio economic analysts and technical specialists with extensive experience in solving complex regulatory problems and the expertise to assist you in the run up to the 2018 REACH deadline.
Examples of Our Services • Regulatory strategy and advice
• Dossier preparation and submission
• Programme and project management
• Chemical safety assessments/reports
• SIEF and consortia management
• Evaluation and authorisation services
• Data evaluation and gap analysis
• Extended Safety Data Sheets
• Use of Intelligent Testing Strategies (ITS)
• Only Representative and Third Party Representative services
• Study placement and monitoring
Explore Exponent Julian Reddy Head of REACH and Chemical Notification Services email@example.com • Office: +44 (0) 1332 868000
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Would you be ready for a REACH/Biocides Audit?
Compliance with REACH and Biocides legislation continues to present challenges for businesses whether you are based in the EEA and manufacturing or importing, or based outside the EEA and supplying into the EEA. REACH/biocides audits are an increasing part of the regulatory landscape in the EEA. Whether it is you or one of your customers that is being audited your compliance will be under the spot light. A REACH audit protocol is essential to ensure that key information is assembled quickly and efficiently. REACH REGISTRATION
If you have a registration obligation, your starting point is to ensure your registrations/ pre-registrations are held by the correct group company i.e. the company which is the manufacturer or “importer” for REACH purposes. This is not always as straightforward as it sounds. Just because an entity is an importer for tax purposes doesn’t automatically make it an importer under REACH. If your registrations are not in the correct name you are not REACH compliant. It may be possible for you to re-organise your internal supply chain to make one entity the importer into the EEA. Product could then be transferred from the “importer” to other entities in the same group. Alternatively it may be possible to transfer your REACH registrations/pre-registrations through a ‘legal entity change’. This requires careful consideration, to assess whether your situation can qualify as a “legal entity change”, and if so how this should be documented. Another common problem is incorrectly appointed Only Representatives (“OR”). Many non EEA companies, sourcing products from the Far East, have appointed ORs when they had no right to do so. Only a person established outside the EEA who manufactures a substance on its own or in a mixture, formulates a mixture or produces an article which is then imported into the EEA can appoint an OR.
REACH requires each manufacturer, importer, downstream user and distributor to retain all relevant information to carry out its REACH duties for at least 10 years from the last date of manufacture, import, supply or use of the substance or product. This information has to be made available without delay on request of any EEA regulator in any Member State in which it is established or to ECHA (European Chemicals Agency). Key considerations include: • Do you have systems in place to provide this information quickly? • How competent are your local staff to respond to initial queries from the regulator? • Who will attend any audit?
product containing that active substance is placed on the market. Requirements vary depending where the product is sourced. Your local entity may need its own approval or registration under that national law. From September 2015, a biocidal product cannot be supplied for distribution or use in the EEA unless the active substance supplier or biocidal product supplier is on the approved list in the Product Type applicable to your use. The key is demonstrating someone in your supply chain is listed. Don’t forget that only the active substance in the product is exempt from REACH. Any other ingredients should be checked for REACH compliance.
Whilst the focus has been on REACH compliance, there have been wide ranging changes to the way biocides are regulated in the EEA.
Non-compliance raises concerns about enforcement by regulators, potential breaches of customer contracts and commercial considerations regarding your ability to supply product in the EEA. As regulators focus more on auditing compliance, and with 2018 looming, whether you are newly affected or a larger group with registrations already in place, now is the right time to revisit your REACH and biocides compliance.
Transitional arrangements apply whilst ECHA and the European Commission consider an active substance (and Product Type) in the Review Programme. During this period the challenge for business is to comply with national law in the Member State where the
For more information please contact: Elizabeth Shepherd Head of Environment Tel: 0845 497 8215 Intl: +44 161 831 8215 firstname.lastname@example.org
• Will your safety data sheets stand up to scrutiny?
It’s in our DNA Helping you comply with REACH regulations REACH requires each manufacturer, importer, downstream user and distributor to hold records on, and be able to provide immediate information of, usage of a substance or product, for at least 10 years from the last date of manufacture, import, supply or use. – Do you have systems in place to provide this information quickly? – How competent are your local staff to respond to initial queries from the regulator? – Who will attend any audit? – Will your safety data sheets stand up to scrutiny? Eversheds is a leading advisor to the chemicals industry. We have strong relationships with EU and member state regulators responsible for the REACH regulation. We work with consultants, in-house technical experts
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and lobbyists to achieve our clients goals and we have successfully disputed ECHA decisions.
For further information about how we can help you REACH compliance please contact: Elizabeth Shepherd Partner Tel: +44 161 831 8215 email@example.com
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REACH 2018 – Are you prepared for registration? By Caroline Raine
their registrations rejected for late payment. Considering payment terms and accruing costs during planning is therefore a critical part of preparation.
National Chemical Emergency Centre (NCEC) Principal Consultant
FORMATTING FOR SUBMISSIONS
The deadline for REACH 2018 is looming. By the 31st May 2018, all companies manufacturing or importing chemical substances in the European Union in quantities over one tonne per annum must register these substances with the European Chemicals Agency (ECHA). More than 70,000 registrations are anticipated in the 2018 round of REACH, over three times those submitted in 2013, many of which will be done by first time registrants. Registration remains a complex and costly process, particularly for small to medium enterprises (SMEs) which are predicted to make up much of the 2018 intake. As the cost of failing to register is exclusion from trading in the EU, developing a clear path to submission that takes into account all supply chain risks and identifies the financial and technical support required is essential to ensuring business continuity. Here Caroline Raine, global regulations and compliance expert for the UK National Chemical Emergency Centre (NCEC), shares the practical tips and the lessons learned from supporting companies to prepare for REACH and secure regulatory compliance.
PROVING SUBSTANCE SAMENESS
One of the greatest challenges in REACH preparation is the generation and sharing of chemical information. ECHA’s REACH 2018 Roadmap foresees only one registration per substance and companies are expected to share data and submit registrations jointly, which is particularly complicated when exchanging knowledge with competitors. The first step to this process requires companies to prove “substance sameness”. Ensuring that all materials are correctly identified is critical, as incorrect identification will add time and cost to the process. Sameness can be demonstrated using spectral data, however an approved laboratory is not required for testing. Instead, documentation detailing the analytical methodology must be submitted so that it can be repeated to get the same results. Impurities above 1% must also be accounted for, along with any impurities that are relevant to the classification, ensuring that all constituents add up to 100%. Appointing an external partner can help streamline document collection, while also bridging the gap between collaborative submissions and ensuring competitive information remains private.
An external partner can bridge the gap when sharing data for joint REACH 2018 submissions, ensuring competitive information remains private
IDENTIFYING SUPPLY CHAIN RISKS
Registrants are also expected to collect information on the supply chain for their substance. As the REACH deadline draws closer it is becoming increasingly clear that many suppliers plan to withdraw from the market place. During preparation, companies must consider a range of market variables, such as whether their supplier is likely to withdraw, and, if so, what alternative sources for formulations and substances are available. It is also important to determine whether substances will have restrictions at the time of submission and what plans are in place to compensate for this. Without supply chain insight, many companies risk being caught out with little time to react.
REACH registration financing is often difficult to predict and budget for as data costs depend on the number of registrants as well as the level of hazards. Companies must determine whether the cost of building the internal capacity to ensure REACH registration is viable, or whether partnering with a regulatory consultancy is a more cost-effective approach to securing compliance. Companies must also set aside funds to ensure that ECHA charges are promptly paid, as ECHA enforces strict payment terms. During the previous REACH stages some companies with otherwise exemplary submissions have found
REACH 2018 registrations are submitted via dossier creation in IUCLID and completed via the REACH-IT website. The current version of IUCLID is 5.6 but a new version (IUCLID 6) is expected in 2016. Creating the dossier in the correct version of IUCLID, and ensuring that the legal entity (LEOX file) matches the one in your REACH-IT account, is key to successful submission. Again, registrants must identify whether they have sufficient in-house resource to submit effectively, or whether external support is required. Clearly the more submissions you need to make the more resources you may require. It is also worth noting that the REACH-IT account is only accessible during the week, Monday 10:00 to Friday 21:00. Reach registration is a complex process, however with careful planning an organisation can overcome many costly and time consuming challenges. For more information on EU compliance, visit the NCEC website’s REACH service page at http://the-ncec.com/reach-services/ or contact Caroline Raine at caroline.raine@ ricardo.com for helpful advice.
NCEC provides industry leading expertise on the legislation relating to the manufacture, distribution, use, treatment, and disposal of chemicals to support manufacturers to secure compliance across the global supply chain. NCEC is able to support all aspects of REACH registrations, including: Joint Registration, Lead Registration, Only Representative, Third Party Representation, Authorisation, Production and Process Orientated Research and Development (PPORD) exemption. Famous for our regulatory expertise as well as over 40 years as the world’s leading emergency response centre, NCEC staff are customer focussed and provide bespoke support which delivers real value for our clients.
Experts in chemical emergency telephone response, with the ability to provide bespoke advice and a fully compliant global solution. That’s why we are used by 50% of the world’s top 100 chemical companies and over 400 others. Our customers value our ability to protect people, property, the environment and their reputation when the worst happens.
Our products and services include: • Bespoke advice, provided by chemists trained in emergency response. • Multilingual, 24/7 emergency telephone response. • Provision of a fully compliant global emergency response solution, including for China through our partnership with the National Registration Centre for Chemicals (NRCC). • Crisis notification service built on our emergency response infrastructure and expertise. • Hazardous chemical information software – used by all UK fire and rescue services.
• Training and exercising. • Dangerous goods safety adviser support. • Safety data sheet (SDS) and other safety documentation authoring. • Regulatory, risk and crisisbased consultancy. • Full liability cover of five times a contract’s value. • Annual conferences specialising in emergency response for the public and private sectors. These include the Global Chemical Conference (20 and 21 April 2016, Windsor UK) and Hazmat (18 and 19 May, Stratford-upon-Avon, UK).
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Registration strategy REACH is a complex chemical regulation that aims to protect human health and the environment from substances that are hazardous, by using information about the substance to determine the risk and hence safe use. So this can be achieved there are many parts of the regulation that a manufacturer or importer of substances must comply with. In 2018, manufacturers or importers of substances into the EU who do so at 1-100 tonnes per year must complete REACH registration. The requirements of registration vary according to; 1) the amount manufactured or imported; 2) the substance itself; 3) the use of the substance. Understanding the data requirements can be a minefield.
that of agreement on the classification and labelling of the substance (and, if they agree to do so, jointly submit the guidance on safe use and the Chemical Safety Report, if above 10 tonnes). The main part of a REACH registration is a REACH Technical dossier, which comprises:
A useful place to start is with a registration strategy, which will look at what is needed for registration for a particular substance. This can be tailored to the company and may include business costs and risks if the substance isn’t registered and therefore cannot be manufactured or imported, thus ensuring business continuity.
• General registrant information (Annex VI);
The strategy can include information about the substance properties; its uses can be utilised to determine if registration is required or if it can be exempt, and the parts of the regulation that are required. This will inform on the information needed as part of a REACH registration, which is dependent on tonnage and substance type.
• Information on exposure for substances registered in quantities between 1 and 10 tonnes per year per manufacturer or import (Annex VI);
It may be possible to register the substance jointly as part of a Substance Information Exchange Forum (SIEF), which allows for data sharing with other registrants of the same substance, instead of generating data by an individual company which may be costly if this involves significant data generation, and
Particular data on potential human health and environmental hazards are required for study summaries and robust study summaries and registrants have to collect all available information. Existing data can be located via a literature search for public data, may include company data, and/or data that can be used in
• Identification of the substance (Annex VI); • Information on manufacture and use(s) of the substance(s) (Annex VI); • Classification and labelling (Annex VI); • Guidance on safe use (Annex VI);
• Study summaries (Annexes VII and VIII); • Robust study summaries (Annexes VII and VIII).
a read across/weight of evidence approach. Considering the existing data and the information needs, any gaps in the data package can then be assessed. These may be addressed in a number of ways, for example, in vitro data, in vivo data, data from valid (Q)SARs and data from structurally related substances (read-across approach) or data waiving. Any additional information required to fill data gaps may take some time to generate, therefore starting early is recommended. When completing the dossier, information will also be required on classification and labelling and safe use of the substance, with those manufacturing or importing >10 tonnes per annum required to provide exposure scenarios and to ensure communication along the supply chain. As the 2018 deadline captures those that manufacture or import lower quantities of substances, it is envisaged that more of these registrants will be SMEs. The European Chemicals Agency governs REACH and a large amount of information is available via its website (www.ECHA.europa.eu) which is specifically targeted at these groups. Expert help can also be used to assist with complying with this large piece of legislation and a registration strategy will help clarify what is required to ensure compliance.
REACH Registration, Evaluation, Authorisation and Restriction of Chemicals REACH provides a single regulatory regime for the management of chemicals in the EU. For the first time, manufacturers and downstream users must work together to provide data and carry out risk assessments in order to continue using chemicals of importance to their business. How can we help? The National Centre for Environmental Toxicology (NCET), a specialised team within WRc, can offer a wide range of REACH services, tailored to meet your needs. NCET includes experienced mammalian and environmental toxicologists, risk assessment analysts, chemists and REACH legislation experts, and has extensive experience of dealing with National and European regulators. WRc is proud to be a REACHReady Approved Supplier (the UK Chemical Industry Associationâ€™s approval scheme for companies conducting work in this area). As you are aware, the deadlines for REACH affect manufacturers, importers and users of chemicals in different ways. 2018 Deadline The final REACH deadline is May 2018 for manufacturers or importers of chemicals from 1-100 tonnes/year. There is much to be done collating and assessing data, and with little time to spare, are you ready for REACH?
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Ready for REACH 2018? Tempus Fugit! Time Flies! Very traditional on a grandfather clock but not good for companies dealing with the 2018 REACH registration deadline. We are more than halfway through the 5 year “wait” between the 2013 and 2018 registrations and the ECHA REACH 2018 webpage (http://echa.europa.eu/reach-2018), added in January 2016, has a countdown to keep it visible.
While ECHA is counting days, companies need to be counting kilos. Kilos by component, that is. Counting currency has always been a part of business and counting the kilos that account for that currency is standard; REACH is requiring companies to count kilos by chemical component, which can be problematic for more complex mixtures. The challenge escalates when some components of the mixtures are both imported and domestically sourced. REACH is “straightforward” if the business only sources domestic inputs already covered by the manufacturer. Doing so is rare for most companies. Who is tracking the importer of record at the component level? What if chemical reactions are involved? Is the reaction another substance or is it a polymer where monomer tracking is required? These points must be taken into consideration when implementing a REACH solution. Larger companies with higher volumes who participated in earlier registrations may have this covered, but the upcoming 2018 registration is only 1000 kgs per annum. This will add a large number of small-to-mediumsize businesses who may not be as prepared. In the chemical industry, 1000 kilos per annum isn’t much and volumes can ramp quickly. A counting system needs to be in place no later than 1 Jan 2017 to have figures (and registrations) by May 2018 and counting as of 1Jan2016 would have been preferable to show year over year trend. (Please note: If tracking
finds a chemical wasn’t pre-registered, companies may be able to take advantage of the late pre-registration option until 31 May 2017.) Tracking component-level data via Excel spreadsheets or Access database has proven to be time consuming and highly subject to error. Now is the time for the ERP system to “talk” to the chemical composition system in order to help the business decide what needs to be notified. For example, at UL The Wercs, our systems connection technology (called DTE) marries sales data from ERP systems, like SAP or Oracle, with component-level data within The Wercs software. Companies having taken similar compositional reporting to an automated process have stated reductions of labor days per report reduced down to minutes per report; leaving more time for other steps in the process. ECHA’s REACH 2018 Infographic shows 7 steps from “Know Your Portfolio” to “Keep Your Registration Up-to-Date”. Once the chemicals that need to be registered are determine, one still needs to find co-registrants, get organized, assess hazard and risk, prepare the dossier and then submit the registration. The steps leading up to dossier preparation may take longer than expected. Finding co-registrants shouldn’t be an issue in theory because there are other companies that have stated their intent to register the chemical component available through ECHA. Unfortunately, some are experiencing response to initial pre-SIEF
inquiries to potential co-registrants running as low as 20%. Dossier preparation may not be a concern if your business plans to join an existing dossier submission but don’t under-estimate the amount of time, and cross-functional involvement, in contacting an existing SIEF and getting documentation in place to be part of that submission to ECHA. Cost of Letters of Access and making sure all downstream uses are covered is time consuming and expensive. Several companies who have shared their registration experiences have talked about the administrative costs as much as the actual registration fees. Planning should start with ECHA’s REACH 2018 website, (http://echa.europa.eu/reach-2018). If further assistance is required with chemical component counting, please contact us at firstname.lastname@example.org.
By Joan McGuffey
Senior Regulatory Specialist UL Information & Insights | The Wercs The Wercs provides leading software automation tools and services for GHS SDS Authoring and Distribution, REACh, and Supply Chain Insights that help advance environmental health and safety around the globe. www.thewercs.com
Attracting girls into scientific careers
One ongoing concern for government ministers and industry leaders alike has been the lack of girls taking STEM GCSEs and the shortage of those going onto A Level and university courses as well. To counter the problem, recent research highlighted the benefits of science, technology, engineering and maths qualifications to girls’ future earnings. The analysis, led by consultancy firm London Economics, showed that studying science or maths at A level sends girls’ earnings soaring by a third. The research shows that achieving two or more A levels in science, technology, engineering or maths subjects adds 7.8% to a man’s earnings, when compared to just gaining GCSE-level qualifications, but the returns for women are much higher, with earnings being boosted by 33.1%. Since 2010 the government’s plan for education has included a focus on encouraging more young people, especially girls, to study
STEM subjects. This has resulted in 10,000 more STEM A level entries for girls, with chemistry seeing a 19% rise. Using data tracking more than 13,000 people since 1970, researchers analysed the earnings associated with different levels of qualifications by the time these people reached the middle of their careers. The analysis also showed that performance in maths tests at primary school is a significant indicator of future earnings. It shows that girls who perform in the top 25% of maths tests at age ten earn almost a quarter more than those scoring in the bottom 25% by the time they reached the middle of their careers.
Education Secretary Nicky Morgan said: “More girls are studying maths and sciences than ever before and the report shows that this can benefit their earnings by as much as a third. “Encouraging more young people - especially girls - to study STEM subjects is a vital part of our plan for education and it has been vindicated by this in-depth research. “STEM A level entries are up by as much as a fifth since 2010 - but we won’t stop here. We are investing millions to get more children studying these subjects by training an additional 17,500 teachers over the next 5 years and setting up expert maths hubs to replicate the success of top-performing Asian countries.
Encouraging more young people – especially girls – to study STEM subjects is a vital part of our plan for education and it has been vindicated by this in-depth research. Nicky Morgan Education Secretary
In search of new teachers Part of the UK’s drive to recruit more teachers is the Government’s teacher recruitment campaign, Your Future: Their Future, which is seen as crucial to find the 35,000 trainee teachers needed every year.
STEM subjects campaign starts to bear fruit
When the UK’s GCSE results were announced last summer, many of the headlines surrounded the sharp rise in the number of 17-year-olds leaving education with good GCSEs in English and maths. But look deeper into the figures and you would find further statistics that bodes well for the future of the sciences, including companies in the chemical industry who are concerned at the dearth of new talent coming through. The figures showed that the number of young people taking STEM subjects, including maths but also science and engineering, had jumped by more than 78,000 in just a year. The figures, released by the Joint Council for Qualifications, showed, compared to 2014: • maths - up 24,827 (3.4%) • computer science - up 18,641 (111.1%) • science - up 20,523 (5.5%) • engineering - up 1,882 (37.4%)
Overall entries for girls in STEM subjects were also up by more than 30,000, including more than 14,000 in maths. The figures underlined the progress being made by government ministers and industry leaders in their efforts to increase the flow of young people into scientific careers. Among UK education reforms that have been introduced by the Government was a stipulation that all young people who do not achieve at least a C at GCSE in English or maths at 16 should continue studying until they reach that standard. The 2015 figures showed the impact of these reforms. For 17-year-olds and over, GCSE entries in maths were up 30%. As a result there were more than 7,500 more maths passes than the previous year.
America looks for the next generation of scientists There has been a similar push in other countries, including the United States where President Barack Obama recently announced more than $240 million in new private-sector commitments to help more girls and boys – especially those from underrepresented groups – to excel in the STEM fields. The announcement meant that the President’s “Educate to Innovate” campaign has resulted in more than $1 billion in financial and in-kind support for STEM programmes.
Nicky Morgan said: “Great teachers are at the heart of our drive to extend opportunity to every single child. That is why we are focused on attracting more talented people into the profession, to inspire young people, open doors to their future and help prepare them for life in modern Britain.” Among those supporting the campaign is Mat Galvin, Head of Science and Assistant Head Teacher at the Firth Park Academy in Sheffield. Mat, who always wanted to be a teacher and has a 2:1 degree in chemistry, said: “I love my job and it’s great to be able to share that passion with others. Teaching offers a real challenge but it’s also so rewarding working with young people. Sharing my subject knowledge and watching students develop and reach their potential is really fulfilling.” To attract new talent, the Government is offering a new range of generous bursaries and scholarships for the academic year 2016 to 2017 - worth up to £30,000 tax-free - in key academic subjects to top graduates who train to teach. These include increased bursaries of up to £25,000 in subjects including maths, biology, chemistry, computing, languages and geography and 700 tax-free scholarships worth up to £30,000 for physics, and £25,000 for maths, chemistry and computing trainees, delivered in partnership with the professional bodies for these subjects.
Integration of Management Systems The 2015 Control of Major Accident Hazards (COMAH) Regulations require that hazardous sites demonstrate within the COMAH Safety Report that risk management is integrated into all their activities, and the focus of the regulator on the right balance between human management systems and physical control barriers is more concentrated than ever before. How this can be achieved might seem unclear considering how the key themes required of the Safety Report, for example safety management systems, risk assessment and the demonstration of safe design, seem to lend themselves exclusively to either a human or physical approach to management. So how can it be ensured that the COMAH Safety Report is integrated? The key themes might seem autonomous, but by considering the how and why behind the human and physical risk management systems on a site, the links can be established. An example of this in the Safety Report is in the demonstration of safe design. The demonstration sets out all of the key risk control measures in place on site to prevent, control or mitigate a major accident hazard. By nature, these controls are all safety critical. However, it is easy to forget that behind every safety critical measure is a safety critical task, whether operational or related to maintenance. These are tasks that have direct contact with a major accident hazard, to be carried out by the operator or technician in order to ensure the ongoing effectiveness of the control barrier. Take an alarm system. This is a physical barrier to a major accident, yet this measure would be ineffective without the controlled human input into risk assessment, design, maintenance, testing and the response action by trained and competent personnel. Control of these tasks is through a network of subsystems held within the safety management system, such as procedures, standards and competence management. The control of safety critical activities is imperative to the success of the onsite arrangements for major accident hazard management, and the programme of maintenance of these systems should therefore be regarded as equal to those in place for the physical systems that they enable. The physical control barriers cannot be sustained without the human influence of the safety management system, and the safety management system cannot manage risk alone where there are no physical control barriers in place. The same goes for emergency response â€“ both the strategy and resource are interdependent and should be organised
and maintained in tandem. Response is also reliant on those measures in the ALARP demonstration and the cycle goes on.
the COMAH Regulations are established and the requirements for a holistic and integrated Safety Report met.
In recent times, this kind of thinking has been facilitated by the increasing focus of the regulator on human factors. By considering the influencing factors that the environment, organisation, and operator/technician behaviour and characteristics might have on a task, and incorporating these considerations into the management system, additional layers of protection are created.
By Carolyn Nicholls and Jenny Hill
With more joined up thinking and systematic consideration of the how and the why, the links between the separate themes within
RAS RISK & HAZARD MANAGEMENT
Understanding and facilitating the effective management of risk is our core business. Only when the risk facing an organisation is well understood can it be effectively managed. Key to the successful identification, assessment and management of risk is engagement with the right people, using the right processes at the right time. We believe we are different to many of our competitors and our approach is distinctive, we don’t always walk the well-trodden path but look at each client’s particular risk context and develop a tailored solution, working in partnership with our client.
Safety Risk Our safety risk assessment and management expertise covers risk identification techniques such as HAZIDs and HAZOP, predictive modelling advice and the facilitation of risk management techniques, particularly in the demonstration of ‘ALARP’. The area of Control of Major Accident Hazards (COMAH) is a particular specialism within the company.
Business Risk It could be argued that all risk – whatever its label – can be defined as ‘Business Risk’. Ultimately, whatever risk is being considered, whether safety, environmental, commercial, financial, if it’s not understood and managed effectively, it becomes a risk that affects the whole organisation.
Environmental Risk Our services in the Environmental Risk area range from the assessment of the risks related to the environment in relation to Major Hazards, based on our Source, Pathway, Receptor risk assessment model, through to the preparation of Environmental Permits (PPC in Scotland) – full applications or variations of existing permits – particularly in relation to planning for new developments.
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Training for addressing human factors issues in Process Safety and COMAH reviews Human Reliability for the Oil, Gas and
Human Factors is recognized as a key topic for addressing safety in the oil, gas, onshore chemical plants, pharmaceutical manufacturing and power generation sectors. This course covers all the topics necessary to produce the Human factors Factors is recognized as a key topic for addressing human analyses to satisfy COMAH safety report safety in the oil, gas, onshore chemical plants, pharmaceutical submissions, together with guidance on producing the manufacturing and power associated procedures andgeneration. competency management documentation based on these analyses. Human Reliability Associates offer a comprehensive training programme in Human Factors in Process Safety. Human Reliability Associates offer a This includes hands-on workshops and case studies based comprehensive training programme in Human in on our extensive practical experience over theFactors past 34 ProcessThe Safety. Thiscan includes hands-on workshops years. course be taken as individual days,and two day case studies based on our extensive practical experience modules or as a complete, integrated four day course. over the past 34 years. The course can be taken as individual days, two day modules or as a complete, Trainers integrated The coursesfour willday be course. given by Dr David Embrey (Managing Director), Jamie Henderson and Neil Hunter with more Trainers than 50 years of collective experience. The courses will be given by Dr David Embrey (Managing Director), Jamie Henderson and Neil Hunter with more than 50 years of collective experience.
Course dates 2016
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Complete Course (Two Modules-4 days): (Payment must be made via a single invoice) Module 1: Introduction to human factors (HF), predicting and preventing Slips, 9th-10th 29th-30th Mistakes and Violations, HF in process plant design, addressing HF in in Major February March Course dates 2016 Accident scenarios for COMAH safety reviews, task and error analysis tools and 2016 2016 techniques Module 1: Human Factors in Plant design, safety cases, 17th8th 9th-10th May September procedures and competency Module 2: Human failure identification, identifying and improving factors affecting error probability, using task and error analysis to develop ‘Risk Aware’ Procedures 8th-9th 12-13th and Competency management, Shift handovers, staffing levels and safety March April Module 2: HF incident analysis, safety critical communication, 14th-15th 7th-8th 2016 critical communication, incident investigation methods, quantifying human error 2016 June October workload and human reliability assessment probabilities for QRA
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The importance of emerging from the silo One of the biggest challenges for science has long been the process by which researchers embrace different disciplines for the common good. For some chemists, broadening their horizons means disputing the old adage ‘once a chemist always a chemist’ and recent times have seen clear signs that the new thinking is working, particularly in the marriage of chemistry and bioscience, leading to advances in the field of medicine as ‘silo thinking’ breaks down. A good example of this enlightened approach to chemistry has been occurring at the University of Southampton where there is a philosophy of combining different sciences to great effect. One example is the way they have developed a molecule that could potentially help treat type 2 diabetes and obesity, combining chemistry and bioscience. The new molecule, called ‘compound 14’, inhibits the function of a cellular enzyme
Ali Tavassoli, Professor of Chemical Biology at the University of Southampton whose research team discovered and developed compound 14, started out his career as a synthetic chemist but a spell working in America broadened his horizons. He said: “I was a synthetic chemist and that was how I viewed myself but by working as a postdoc in a multidisciplinary lab, I was exposed to the work of biologists and realised that the work I was doing had applications in bioscience as well. z Professor Ali Tavassoli
z Professor Phil Bartlett
called ATIC, which is involved in metabolism, leading to the build-up of a molecule called ZMP in cells. This increase in ZMP makes cells think that they have run out of energy by activating the cell’s central energy sensor, known as AMPK, thereby causing cells to try and increase their energy levels by increasing glucose uptake and metabolism. The researchers found that activating AMPK with compound 14 led to a reduction in blood glucose levels, improved glucose tolerance and, at the same time, promoted weight loss in obese mice.
“It is important that chemists take that view. The space occupied by traditional chemistry has become filled over the past 100 years or so, and increasingly you have to look to the interfaces and broaden your approach. There is a lot of potential in using chemistry for applications in biology, physics, mathematics and computer sciences. “The way we have set up the lab at Southampton is to do just that. The multidisciplinary approach does take our scientists out of their comfort zone, which in my opinion has the potential to make them better scientists. “But it is important to note that there are two philosophies out there, one of which tends to be driven by funding which says that you
will need a separate chemist and a separate bioscientist for an interdisciplinary project to work. The obvious solution is to put them together, but that can sometimes feel like a forced collaboration. “Much better, I would argue, is the second way, which is to take a holistic view and integrate multidisciplinary skillsets into a single lab to give students knowledge of other disciplines.” His team’s work on AMPK proved the point because it married chemistry and bioscience. Driving the work was the evidence from previous studies that if you could selectively activate AMPK with a small molecule, it could have potential benefits in the treatment of several diseases, including type 2 diabetes.
Combining chemistry and archaeology gives scientists a real buzz
Prof Tavassoli said: “Working in this way can be challenging for students and it does require a lot of adapting but it will widen the way they work and prove better for their career prospects and, by bringing together different disciplines, we are coming up with some exciting results. But ultimately the limits of a single lab’s interdisciplinary expertise will be reached and so good collaborations are essential.” The same view is held by Chemistry Department colleague Professor Phil Bartlett, an electro chemist. He has worked on a variety of projects that cross disciplines and said: “Electro-chemistry is a discipline that already allows you to work in different fields, everything from corrosion to fuel cells and biosensors and I think that is important because it keeps you fresh. You are learning new things all the time. “Sometimes if you work in the same field all the time, you can get to a stage where you do not think there is much more you can do. “Finding out about other disciplines not only widens your own knowledge but it presents opportunities. You may be working on something which someone else can use. For instance, I was working on project dealing with colour on metal film which ended up feeding into work on DNA sensors. “I have always liked collaborative working and it can be a surprise what collaborations can throw up. Sometimes, they just drop into your lap. “I think it helps that the university does not erect barriers between the disciplines. They do not want people sitting in their own labs without contact with anyone else. “Remove those barriers, as we do at Southampton, and it makes it easier for people to work together and learn about each other’s disciplines. “It can be more difficult working collaboratively than on your own – you have to take into account what each other needs but certainly for me, it keeps me interested.”
That ability to use chemistry to help other sciences is being illustrated across many disciplines. Take the way scientists have combined chemistry with archaeology as part of new research from the University of Bristol. The team took as its starting point evidence from prehistoric rock art that was interpreted as showing honey hunters, and images from Pharaonic Egyptian murals that show early scenes of beekeeping. However, the close association between early farmers and the honey bee remained uncertain so to find out more archaeologists turned to chemistry. The study gathered together evidence for the presence of beeswax in the pottery vessels of the first farmers of Europe by investigating chemical components trapped in the clay fabric of more than 6,000 potsherds (pottery fragments) from more than 150 Old World archaeological sites. The distinctive chemical ‘fingerprint’ of beeswax was detected at multiple Neolithic sites across Europe indicating just how widespread the association between humans and honeybees was in prehistoric times. For example, beeswax was detected in cooking pots from an archaeological site in Turkey, dating to the seventh millennium BC – the oldest evidence yet for the use of bee products by Neolithic farmers.
The paper was based on more than 20 years of research carried out at Bristol’s Organic Geochemistry Unit (School of Chemistry) led by Professor Richard Evershed. Coauthors of the paper include archaeologists involved in the large scale investigation of sites across Europe, the Near East and Northern Africa. Professor Evershed said: “The lack of a fossil record of the honey bee means it’s ecologically invisible for most of the past 10,000 years. Although evidence from ancient Egyptian murals and prehistoric rock art suggests mankind’s association with the honey bee dates back over thousands of years, when and where this association emerged has been unknown – until now. “Our study is the first to provide unequivocal evidence, based solely on a chemical ‘fingerprint’, for the palaeoecological distribution of an economically and culturally important animal. It shows widespread exploitation of the honeybee by early farmers and pushes back the chronology of human-honeybee association to substantially earlier dates.”
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