Global Business Briefing / May 2014chemicalwatch.com 1

Written by a former member of ECHA’s Management Board, the book Power, plastics, poison and our children has been selling well in Sweden, where it was published recently. Described by the publisher as an account of “the power game within the triangle of chemistry, economics and politics”, it gives a number of examples of how these forces clashed, as well as providing a short checklist of actions to minimise your exposure to certain substances in plastics, and a crash course on hazardous chemicals.

The author, Ethel Forsberg, ran the Swedish Chemicals Agency (Kemi) for nine years and was one of the names tipped to be shortlisted for the post of ECHA executive director, when the agency was being established (CW 27 September 2007). Since leaving Kemi, she has remained an influential figure in chemicals policy, speaking at conferences and leading the team of experts that produced a recent report on nanomaterials for the Swedish environment ministry (CW 15 October 2013).

The idea for the book came, says Ms Forsberg, as new information emerged during her time at Kemi about the risks posed by toxic substances in chemicals, and about sensitive population groups, and this meant that the scenarios “were getting turned worse and worse”. But she found it hard to explain the issues. “When I was faced with a questioning attitude from my political leaders in the government, I realised I really had a problem. I felt there were too many important influential people that I and my staff weren’t successful enough in convincing about this message.”

Why chemicals in plastics?After she left Kemi, Ms Forsberg became a partner in a consultancy working on sustainable business development and one of her tasks was to look at electronic products used in the home. She used public databases to compile a list of 75 hazardous substances found in such products, and then realised that almost all of these were present in the products’ plastic parts. ”So then I started to think about how much plastic material we have in our homes. I knew about the discussion concerning plastics in toys

and plastic baby toys, but plastics are widely used in our homes.”

Some might say that many of these substances are safe because they are locked into the plastic, especially if it is a hard, rigid material, such as polycarbonate, and the problem, if there is one, is limited to softer plastics like PVC. But Ms Forsberg disagrees. “Some substances are strongly held in the plastic, but the material gets worn out. For example, after a couple of years, a Teflon pan has scrape marks; it looks different. The plastic is worn out, and the material is starting to degrade. Substances like the softeners used in other plastics can leave the material quickly. Also, how is the waste plastic handled? Where do the different substances go? It’s a question of when, not if, they come out.”

Another issue, she says, it that “very few people have been able to tell me in a credible way which substances are present in a plastic. The plastics industry says they will not emigrate and people will not be exposed, but I don’t know which substances

Memoirs of a chemicals regulatorEthel Forsberg, a key figure in European chemicals policy, has written a book highlighting what she sees as the continued use of dangerous substances in plastics

May 2014• ISSUE 67

The continued use of some substances comes under fire in the book by Ethel Forsberg (inset) Makt Plast Gift & Vara Barn

Global Business Briefing / May 2014chemicalwatch.com 2

they are talking about as I often hear them say they don’t know what’s in it. I also believe they know too little about how these substances react in all these different environments during use. So yes, it is a matter of precaution.”

The book contains a number of examples which explain, says Ms Forsberg, why she “doesn’t trust the chemical industry’s judgement at all times”. One is Kemi’s well-documented disagreement in 2001-2002 with the plasticiser industry about the agency’s risk assessment of the phthalate DEHP - a substance which, under the REACH authorisation process, today faces a phase-out in Europe with a very small number of exemptions. The book includes a copy of a letter she received from the European Council for Plasticisers and Intermediates (ECPI), which said that by holding a seminar looking at future risk management measures for DEHP before the assessment was finished, Kemi seemed determined to pre-empt the outcome, and to “try and destroy the

market for DEHP purely to suit Sweden’s domestic agenda”. It added that if the seminar went ahead, the agency ran the risk of legal action should there be damage to the market as a result of “any incorrect, misleading or factually incomplete claims”. In the event, the seminar went ahead and no legal action was taken.

Has the chemical industry ever agreed with the concerns that she or Kemi have had about a particular substance or use of a substance? “My experience is that the chemical and plastics industry trade groups are often more conservative, but I have lots of examples of how it can be easier to get an understanding with some product manufacturers downstream of these industries. “

Things are changing, of course, since Ms Forsberg first joined Kemi, especially with the arrival of REACH. The Regulation, she says, “is a great thing, and a necessary step forward, but we always knew it would not bring us all the way. Registration is going well, but authorisation has turned out to go much slower than had been expected. I even hear people in Kemi say that the rate of progress is even slower than before REACH.”

Ms Forsberg has also continued to join in the debate about risk assessment and the precautionary principle. A couple of years ago a legal journal published her response to an article by professor Ragnar Lofstedt - a critic of the way the European Commission uses the precautionary principle (GBB April 2014) – entitled Risk versus hazard assessment: how to regulate in the 21st century. In her opinion, she said, there is no such choice between a hazard-based and a risk-based approach, and that the regulatory processes she had been involved in, “were all based on risk assessments, where

the hazard was the trigger, or the starting point of the process. It is not a choice between two methods, but a balance between political ambition and scientific facts within one method.”

In Europe, law making, such as regulations on chemicals, is in the hands of politicians, she stresses in her article. “We elect them. And as we like to keep and defend our democratic society, I believe we have to accept that our politicians… like to have an influence on the decision making on regulation. So the fact that decisions based on a risk assessment is allowing political influence seems to be quite in order.” She also defends the lobbying process. “Lobbying would not have been invented if there was no political influence on decision making. To present possible or probable consequences to politicians, pre-decision, is, according to my experience, a most valuable activity. A lot of mistakes have been avoided due to lobbying. Politicians are more informed when the time comes to vote in the chamber.”

Her article also took up the argument that it is easy for Sweden to take strong anti-chemical positions because it has a relatively small chemical industry, and referred to a 2010 Kemi report on the chemical industry from an economic perspective, which described how the turnover and profitability of the Swedish chemical industry had developed rapidly in recent years, and how the number of substances produced or imported into the country had increased, as well as the total volume. “Chemicals are vital to our loved lifestyle. My iPod, my laptop and my car are very dear to me. I could not enjoy any of that if it was not for the chemical industry. There is a lot of consumer ground to create loyalty. But that process is hindered by a common feeling that industry is covering up. Open up instead!”

Whether you think Sweden is “anti-chemicals” or not, most people agree that environmental issues are higher up its agenda than those of other countries. “People in Sweden don’t go to church much, but we do go to the forest,” says Ms Forsberg.” We need to pick berries, listen to the wind and see the birds, otherwise we feel miserable. We have a much stronger relationship with nature than urbanised countries.”

Ms Forsberg’s book is currently only available in Swedish.

To comment on this article, click here: Chemical Watch Forum

News

Biography

» 1981-1988 employments environmental manager, Federation of Swedish Farmers (LRF) » 1989-1994 senior administrative officer, Swedish Ministry of

the Environment » 1995-1999 environmental manager, Coop Sweden » 1999-2001 director, Administration of Health, Food and

Environment, City of Stockholm » 2001-2010 director general, National Chemicals

Inspectorate/Swedish Chemicals Agency (Kemi) » 2007-2010 member of ECHA Management Board » 2010-2011 partner at U&We sustainability consultants » 2012- director of city development, Region of Gotland » 2013 heads expert committee that produces report on

nanomaterials for Swedish environment ministry

‘My experience is that the chemical and plastics industry trade groups are often more conservative, but I have lots of examples of how it can be easier to get an understanding with some product manufacturers downstream of these industries’

Global Business Briefing / May 2014chemicalwatch.com 3

A golden opportunity

Comment

India’s new leader, Narendra Modi, has a reputation as someone who gets things done. As Gujarat state’s first minister, he oversaw economic development that was the envy of the rest of the country. Expectations are high that, having secured an absolute majority in the recent national election, his party, the BJP, will be able to deliver strong government.

Welcoming the election result, the Confederation of Indian Industries said it would greatly help to revive investor sentiments: “With a decisive mandate,” it said, “the new government can take the tough decisions that are urgently needed to revive economic growth.”

Business organisations in and outside the country hope New Delhi will witness an efficiency revolution that will kick-start the country’s industry, including the chemicals sector. Up to now, many multinational chemical companies have chosen to take a pass on India. Currently, the country is ranked 134 out of 189 countries on the World Bank’s ease of doing business index.

The last, Congress party-led government recognised the need for a suite of actions to do this. What would have been the country’s first national chemical policy listed the challenges it faces – inadequate infrastructure, lack of investment, poor R&D base – and said a new National Chemical Centre would make recommendations for rationalising statutory regulations

and creating a new “chemical management framework” (GBB February 2014). But the policy failed to get adopted before the election began.

India has a modest chemical infrastructure on which global companies can build. But with such a huge market, the growth opportunities are there, especially for speciality chemicals such as personal care ingredients and additives, paints and coatings, and construction and water chemicals.

Regardless of whether the new government rubber stamps, revises or tears up the proposed national chemical policy, the document’s goals and ideas will chime with those of the new leadership. Mr Modi’s powerbase, Gujarat, is home to 50% of the country’s chemical industry. There is a golden opportunity for foreign and domestic chemical companies in India to help the bureaucrats create a regulatory framework that will improve the sector’s safety and environmental record, attract skilled workers, increase productivity and output, and make doing business easier. The chemical industry should do everything it can to ensure it is not wasted.

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ContentsOpinions in print .............1Ethel Forsberg’s new book targets chemicals in plastics

In the news .........................4CW top stories since the last GBB

Canada’s progress ..........5Moving forward on chemicals assessment

Taiwan’s inventory ........7Another chance beckons to nominate substances

Nanobiocides ....................8Which nanomaterials are used in biocides?

Pre-emption’s effect....10The tussle for supremacy between US state and federal law

SCP Regulation ...............12Alternatives assessment in California

Events ................................. 15

Jobs .......................................16

Supply chain insights 17Best practice in authoring multilingual SDSs and labels

REACH & CLP Hub .........19Valuable lessons from the SEA route

NGO Platform .................20Redraft the EU’s conflict minerals proposals

Guest column..................22Lena Perenius, executive director, international chemicals management, Cefic

Global Business Briefing / May 2014chemicalwatch.com 4

The World Health Organisation (WHO) called for a co-ordinated internal response to increasing exposure to endocrine disrupting chemicals (EDCs). It said increases in the incidence of disease mean that genetic factors cannot be the sole explanation – environmental and other non-genetic factors, such as nutrition, viral diseases and exposure to chemicals, also contribute, but are difficult to identify (7 April). Two weeks later, an earlier WHO report on the scientific evidence for the existence of EDCs was castigated by a chemical industry funded review (24 April). Meanwhile, the US chemical industry’s opposition to DG Environment’s proposals for an EDCs categorisation system similar to that for CMRs was emerged in a US government report on trade barriers (16 April).

Legal proposals on how Siefs should share data and costs under REACH and reduce the registration burden on SMEs are being prepared by the European Commission and a draft may surface before the summer recess (10 April). The issue has risen up the agenda because many SMEs will have to register substances for the first time in order to meet their obligations under the final registration deadline in 2018.

China’s existing chemicals registration programme began with publication of a list of 84 substances for which users or producers must submit risk assessments and emissions data (10 April). NGOs complained that the list included few CMRs or PBTs, but the environment ministry said more substances will be added.

In their last voting session before this month’s election, MEPs approved an amendment to the EU packaging Directive that would ban all CMRs and EDCs from all packaging materials (16 April). The potentially far-reaching amendment has alarmed the chemical and packaging industries, but the packaging Directive

proposals have a long way to go before final adoption.

The 100nm upper limit used by the European Commission to define what constitutes a “nanoparticle” could be “completely meaningless” in terms of biology, scientists warned (17 April). The definition is due to be reviewed this year.

The Eurasian Economic Commission, comprising Russia, Kazakhstan and Belarus, adopted a chemicals technical regulation. Due to come into force in July 2017, it covers industry’s obligation to register their substances, classify them and provide precautionary labels in accordance with the UN Globally Harmonized System (GHS), and says a chemicals inventory will be established (1 May).

A team of German and Danish scientists said that for the first time, research showed a direct link between exposure to a number of endocrine disrupting chemicals found in consumer products and human male infertility (13 May). The researchers said a third of the 96 substances tested

Scientists developed artificial human skin which they said could be used to test the safety of cosmetics ingredients and as a model for the study of skin conditions (1 May). Animal welfare groups welcomed it as a step towards reducing animal testing.

The TTIP trade talks between the US and EU should explore the mutual recognition of cosmetics ingredients and the creation

of a common list of concentration limits for chemicals in textiles, said the European Commission (15 May). Prioritisation of substances for assessment, convergence of classifications, data sharing and CBI protection, and responses to emerging issues such as nanomaterials, endocrine dusruptors and mixtures toxicity were also listed as possible areas of greater co-operation.

The EU Joint Research Commission launched a database which can be used to find out which regulatory inventories a chemical appears in, and whether it has been tested in a major research project – for example, to discover, which REACH registered chemicals have been tested under the US ToxCast programme. It can also help identify which set of chemicals used in the EU Seurat or US Tox21 alternative testing programmes have a particular structural motif (15 May).

The European General Court confirmed the European Commission’s decision to deny Germany’s request for it to keep its national limit values for arsenic, antimony and mercury in toys, rather than adopted those in the EU toy safety Directive on the grounds that Germany failed to prove that its limit values – which are expressed in terms of bioavailability – do not offer greater health protection than the EU limits, which are expressed as migration limits (15 May).

The US Court of Appeals for the District of Columbia upheld the majority of the Securities and Exchange Commission’s (SEC) regulation on conflict minerals (see pages 20-21) and said it still expects companies to submit their reports to the SEC by the 2 June deadline. But it found the regulation’s requirement that issuers describe their products as ‘DRC conflict’ or ‘DRC conflict-free’, to be a violation of the First Amendment’s right to free speech and therefore no company is required to describe in such a manner (30 April).

In the news

Top CW stories since the last Global Business Briefing

Global Business Briefing / May 2014chemicalwatch.com 5

Canada’s model Chemicals Management Plan (CMP) faces its toughest test in the months ahead as it tackles the second half of its second phase (CMP2). At issue at the halfway point in CMP2, is whether regulators and stakeholders can develop the data and methodologies to assess risk for groups of chemicals with significant information gaps and manage those health and environmental risks. CMP2 advances the accomplishments of CMP1, such as developing an inventory of existing chemicals, and anticipates the third and final phase of the 15-year plan to regulate chemicals in the second largest country in the world. The management plan is also addressing questions about the risk assessment and management of polymers, which make up about 14% of the 4,300 chemicals in commercial use in the country.

A good startThe CMP was launched in 2006, following the revision in 1999 of the Canadian Environmental Protection Act (Cepa). Under the programmer, Canada’s regulators whittled down an inventory of 23,000 chemicals in commerce to a list of 4,300 priority substances. Using screening processes and information gathered from multiple sources, 200 chemicals in CMP1 were deemed harmful to human health or the environment (GBB September 2011). The programme is overseen jointly by Canada’s environment and health ministries, Environment Canada and Health Canada. It is divided into three five-year plans, with the ultimate goal of restricting exposure to existing and new harmful chemicals, says Jake Sanderson, Environment Canada’s manager of horizontal policy and planning. CMP2 was launched in October 2011 (GBB April 2012), and the third phase is scheduled to begin in 2016. Its strategy is to involve a wide spectrum of stakeholders and multiple sources of data in the design and implementation of a national risk assessment and risk management programme.

So far, it has developed assessments on 1,100 of the 4,300 substances in CMP1. Of these assessed substances, 43 were deemed harmful to health or environment, and risk management restrictions have been developed for 32 of them, including bisphenol A (BPA). This was banned in baby bottles, but was considered safe in other food packaging, including that for baby food products because of low exposure levels. Harmful chemicals used in cosmetics have been added to Health Canada’s Cosmetic Ingredient Hotlist (CIH), and are restricted or prohibited.

Risk assessments for about 400 new substances, focusing on nanomaterials and biotechnology products, were conducted

during CMP1 and regulatory actions were adopted for 20 of these in 2013 as part of CMP2. Significant New Use Activity (Snac) notices, requiring submission of more detailed data and further analysis, were issued for 14 of the substances and restrictive Ministerial Conditions (MC) were placed on the remaining six.

CMP2 at the crossroadsRatcheting up the degree of difficulty in CMP2 is the challenge of addressing 1,500 chemicals by the end of 2016, including groups of substances for which there are significant data gaps, says Ardeep Khosla, executive director of business umbrella group, the Industry Coordinating Group (ICG) for the Canada Environmental Protection Act.

Where the data compiled during last year’s update to the Domestic Substances List (DSL) (GBB July/August 2013) contains gaps, the substances have been grouped together for risk assessment and, ultimately, risk management. Data can also be drawn from other sources, including industry and other regulatory databases, although gaps will probably remain, says Mr Khosla. In effect, regulators will assess similar chemicals as if they pose the same, or similar risks.

Under this substance groupings initiative, the government is assessing the potential risks associated with nine groups of substances, including phthalates (CW 10 October 2011). So far, a draft assessment has been released for the 174 substances in the aromatic azo and benzidine-based substances group. It has proposed that all azo disperse dyes, solvent yellow 77 and pigment red 4, do meet at least one of the criteria to be considered toxic under Cepa, and thus should be restricted.Assessments for four more groups – substituted diphenylamines; cobalt-containing substances; MDI/MDAs; and internationally classified substances – are in the works and scheduled for publication later this year.

Methodologies employed during assessments of groupings, including how data from multiple sources is used during “read-across” procedures and computational analysis, will test the Canadian system, several chemical industry representatives tell Chemical Watch. The stakeholder group much in the spotlight now is the CMP’s science committee, which will determine methodologies to be used in assessing risk for the groupings.

In addition to taking into account data received during last year’s update of the DSL, officials will examine data gathered from other regulators, such as ECHA, and from Canada’s chemical industry.In other regulatory geographies, mention of assessing groups of substances has drawn opposition from industry representatives, who argue that substances should be assessed and regulated individually. Put another way, looking across incomplete data for individual substances in order to assesss the group opens the

Moving forward on chemicals assessment

Canada

In the first of two articles on Canada’s Chemicals Management Plan (CMP), we look at its progress to date

Global Business Briefing / May 2014chemicalwatch.com 6

Canada

door to the precautionary principle, says the ICG’s Mr Khosla.But overall, industry is satisfied with how CMP2 is unfolding, says Gordon Lloyd, vice president of technical affairs for the Chemistry Industry Association of Canada. Execution of the second phase to date is “not as crisp” as CMP1, he adds, but, in the months ahead, he looks for substance groupings to progress through the assessment and risk management processes. But industry has some concerns, he adds. For instance, with the azo substance groups, he questions why some of them were not considered as a significant new activity, instead of being placed on the restrictive Cosmetic Ingredient Hotlist. “There’s a bit of concern about clarity. Trying to sort this issue out is a bit of a challenge. If you’re going to develop a hodge-podge approach to chemical management, it’s going to be difficult.”

The polymer approachPolymers account for about 600 of the 4,300 chemicals being assessed under the CMP. Canada is adopting a two-tiered approach for assessing polymers that closely mirrors the process used for groupings. Information gathering and analysis over the past two years are expected to yield polymer-specific surveys, this year and next. Information was gathered primarily from the DSL, but also from international and domestic sources.

A manufacturing or importing threshold of 1,000kg/calendar year is used to define the two tiers, for both existing and new substances. Substances falling below the threshold volume will be considered “not in commerce” and “the likelihood of exposure to these polymers resulting from commercial activity is low”, says Environment Canada. However, if low-volume polymers demonstrate “highly hazardous

properties”, Snac provisions, including further analysis, would apply before deciding on the appropriate risk management response.

For polymers exceeding the 1,000kg threshold, substance-specific information would be required by regulators, including hazard data that would allow regulators to classify either a specific polymer, or a group, in a risk management category. Computational and look-across techniques may be used.

While much of the attention on the CMP relates to its innovative regulatory strategies, proof of its success ultimately will be determined by whether biomonitoring shows that exposure to harmful chemicals is reduced, says Fe de Leon, researcher for the Canadian Environmental Law Association (Cela) and a member of the CMP stakeholder advisory council (SAC). So far, the government has completed two cycles of an annual human biomonitoring survey for 91 chemicals in populations ranging in age from six to 79, while an environmental survey has been completed for eight groupings of substances in surface water, sediment, fish, birds, air and wastewater. But, says Ms de Leon, much more biomonitoring needs to be done. She adds that Canada’s National Pollutant Release Inventory, which comprises data on the emissions of 300 substances from some 7,700 industrial facilities, is showing signs of neglect because of resources funnelled into CMP. Tracking the presence of chemicals from the CMP’s first phase in the environment and human body remains difficult, she says, and it’s not clear which chemicals will be monitored in future.

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Global Business Briefing / May 2014chemicalwatch.com 7

As Taiwanese authorities prepare to manage the implementation of changes to their two key laws for chemical product risk management covering worker safety and environmental protection, they used the occasion of the recent ChemCon Europe conference in Istanbul to thank non-EU companies for their feedback and let them know about the resources and tools they are developing.

“The answer is yes”, Jowitt Li of Taiwan’s Safety and Health Technology Center (Sahtech) told the audience of over 350 companies drawn primarily from Europe and the US. There will be a third opportunity for companies to nominate chemicals to Taiwan’s national chemicals inventory this summer (CW+ AsiaHub 8 May 2014). The further nomination window, which will run from 1 June for two months, was organised by the authorities in response to a high level of demand. It allows companies another opportunity to nominate for inclusion on the inventory any substances that were manufactured, handled, used or sold domestically between 1 January 1993 and 31 December 2011. In addition, Dr Li revealed that discussions are underway to grant companies that introduced substances to the Taiwanese market after the 31 December 2011 inventory eligibility deadline but before 1 January 2015, a grace period in order to register these substances.

Thousands more chemicals are expected to be nominated in the third round this summer, adding to the 79,000 substances already nominated to the inventory. It is important that companies can provide proof of transactions involving the substances within the eligibility period, Dr Li emphasised. This could comprise invoices, customs clearance documents, safety data sheet shipments, data protection claims among other documents. An initial screening by authorities of the substances already on the inventory indicates, he said, that around 20,000 of these will require classification.

Following the third nomination round, the entire inventory will be searchable on the Chemical Substance Nomination and Notification site, hosted by the labour ministry’s Occupational Health and Safety Administration (Osha).

The eligibility period was devised in order to set some limit on the size of the inventory to make it manageable. If substances are not on the inventory, companies will need to seek prior approval at least 90 days in advance of introducing them onto the Taiwanese market, following an extensive overhaul of the country’s Occupational Safety and Health Act in the summer of 2013 and its Toxic Chemical Substances Control Act (TCSCA) in December

2013. These prior registration requirements will apply from as early as 11 December. For future new chemical substances, companies will need to make sure they know their registration obligations under both of these laws. However, thanks to an inter-agency cooperation process, it seems that Osha and the Environmental Protection Administration “are leaning to adopt the same chemical substance inventory” to avoid companies having to register separately for each agency, Dr Li says.

To enable online registration, the government is designing a portal called the CHEMical Information System and Tool (CHEMIST). A beta version of the site is due to be trialled shortly. Only Taiwanese local entities will be permitted to submit dossiers to the site, but access to it is open to other companies. CHEMIST does not support the import of data in Iuclid XML format as this is considered too extensive for Taiwanese needs, at present. While data formats will look very similar, Dr Li says, companies will need to fill them in separately. “However, we reserve the possibility to upgrade CHEMIST to be compatible with Iuclid” at a future date, he says.

Many details are still being worked out under both laws, with a suite of secondary legislation expected by the end of the year. Following a series of public consultation periods, amended clauses are likely to enter into force as early as 3 July, the labour ministry said in May.

Taiwan is aiming to fully implement classification rules that bring it into line with the second revision of the Globally Harmonized System on the Classification and Labelling of Chemicals – as specified in the so-called UN Purple Book - by 1 January 2016. However, at the same time, Taiwan’s GHS National Standard CNS 15030 is being updated to adopt the fourth revision of the UN Purple Book. Dr Li advised firms to submit data and classifications compliant with the more recent fourth revision if they have it – “the newer, the better”, he said. He also pointed firms to a tool offered by the Asia Pacific Economic Cooperation (APEC) organisation, called the GHS Reference Exchange and Tool (GREAT). This provides standard GHS phrases ready translated into the region’s different languages to enable companies to save time and money.

Further updates on the progress of Taiwan and other countries in modernising their chemicals regulations will be given at ChemCon The Americas, from 27-31 October in Chicago. Chemical Watch will once more be publishing the daily conference newsletter, together with the ChemCon team. The Istanbul newsletters can be viewed here.

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Another bite at the cherry

Taiwan

Firms have another chance to nominate substances to Taiwan’s chemicals inventory

Global Business Briefing / May 2014chemicalwatch.com 8

Expert focus: biocides/nanomaterials

A key feature of the EU biocidal products Regulation (BPR) is the provisions regarding nanomaterials. Article 4 of the BPR states that an approval for an active substance does not cover the nanomaterial form as well, except in cases where it is explicitly mentioned. Furthermore, in order to get an authorisation for a biocidal product containing nanomaterials, a specific risk assessment must be performed separately for the nanomaterial in question, and it is not possible to apply for a simplified authorisation, if the biocidal product contains nanomaterials (Articles 19 and 25).

With these requirements tailored to address concern about nanomaterials, the BPR provides the most ambitious piece of nanospecific legislation yet to be implemented by European legislators. Meeting the goals of the BPR involves a number of key challenges that legislators and registrants of biocides have to face.

Use of nanomaterials in biocidal products and treated articlesA registrant that wishes to use a given nanomaterial in a biocidal product has to be granted authorisation, and the granted approval for the active substance must apply to the nanoforms of that active substance, except where explicitly stated otherwise. Hence, the current list of approved substances, and those substances being examined under the Review Programme, gives a good indication as to which kinds of nanomaterials might be used in biocidal products in the EU and therefore might be subject to nano-specific BPR requirements. This list currently contains almost 90 substances, of which, basic copper carbonate, boric oxide, copper (II) oxide and copper hydroxide are

commercially available in nanoform (see, for instance, Nanowerk’s database). For most of these materials, it is unknown whether the nanoform is being sold as a biocidal ingredient in Europe, although some are clearly being marketed as such, such as the “biocidal copper carbonate nanoparticles” sold by the German company nanoSaar.

The Competent Authority Reports (CARs) for copper carbonate, copper oxide and copper hydroxide (available from CIRCABC) specifically mention that the nanoforms of these substances are not

included in the reports. For instance, for basic copper carbonate, the CAR states that “the applicant is not currently placing nanoforms of basic copper carbonate on the market. Therefore, the submitted dossier and the finalised assessment report don’t cover potential nanoforms of this copper compound, should such forms exist.”

For synthetic amorphous silicon dioxide, the situation is different. The CAR says “this approval covers synthetic amorphous silicon dioxide as a nanomaterial in the form of stable aggregated particles of particle size >1μm, with primary particles of nanosize.” There is no doubt that the substance under evaluation in this specific CAR is a nanomaterial, according to the BPR based on a primary particle size (<25 nm) and specific surface area by volume, but the hazard and risk of the nanoparticles were not evaluated in the CAR (ie individual particles not aggregated). The reason is that “exposure to nanoscale primary particles was not expected during the specific intended

The biocides market for nano actives

Information is emerging on which nanomaterials might be used in biocides, but new test methods are needed

0

20

40

60

80

100

Air filtration Clothing Cosmetics Personal care Sporting goods

5

18

10

81

7

Copper SilverN

um

ber

of

mat

eria

ls

Number of products claimed to contain nanosilver and nanocopper versus consumer product categories according to The Nanodatabase, available at www.nanodb.dk

A registrant wishing to use a given nanomaterial in a biocidal product has to be granted authorisation of that active substance

Global Business Briefing / May 2014chemicalwatch.com 9

Expert focus: biocides/nanomaterials

biocidal use”, as the data provided by the notifier showed that “primary particles are aggregated in particles of 1-6μm”. The argument is that an “aggregate means a particle comprising of strongly bound or fused particles” and that aggregates are the smallest stable particles under conditions of normal handling and use. This seems to somewhat contradict the intention of the BPR.

A number of substances currently included in the review programme, such as silver, could be nanomaterials, but it is unclear whether the specific substances under review fulfil the BPR definition.

Besides active substances and biocidal products, the BPR also contains provisions that apply to articles, which incorporate a biocidal product or have been treated with one. Articles can only be treated with active substances, which have been approved in the EU for that specific purpose. It is not clear which articles commercially available in the EU have been treated with nanomaterials or which incorporate a biocidal form. It is, however, well known that, for instance, nanosilver and nanocopper are used in consumer products because of their antibacterial properties. Since 2012, we have maintained a European nanoproducts inventory, the Nanodatabase, in collaboration with the Danish Ecological Council and the Danish Consumer Council. Out of the 1,275 products containing nanomaterials which are estimated to be on the European market, around 200 contain nanosilver and four contain copper. Most of the products that use nanosilver fall into the health and fitness category (for example, personal care products and clothing), home and garden (cleaning products) or food and beverages (food supplements and cooking). In about 10% of the products that use silver, the producers make antibacterial claims.

It is interesting that none of the products in this database have a label to say they contain nanomaterials, the specific related risks and including the word “nano” in brackets, following each reference to the given nanomaterial. This is the case despite the fact that labelling is a key provision (Article 68) in the BPR for products marketed after 1 September 2013.

Risk assessment challengesThe BPR requires nano-specific tests (or

arguments for the appropriateness of existing tests), and specific risk assessment of nanomaterials in order to get active substances or biocidal products authorised. However, how registrants should meet these requirements is still subject to interpretation. According to Annex II (5), the tests submitted to support the approval of an active substance must be conducted according to the methods laid out in the 2008 EU test methods Regulation. These are mostly based on the corresponding OECD guidelines for the specific test. However, many were

developed for soluble chemicals, and it is well established that most nanoparticles are (partly) insoluble. Often, a nanoparticle test suspension will contain a mixture of individual primary particles, aggregates and agglomerates of these. Although the OECD has initiated much work to help member countries address the challenges of testing nanomaterials, there are currently no actual OECD standard test guidelines for health and hazard testing of nanomaterials. In 2009, a preliminary OECD review of the current test guidelines for their applicability to nanomaterials was published. In relation to ecotoxicity testing, 24 guidelines were reviewed to evaluate their adequacy in addressing nanomaterials and to identify the need for development of new test guidelines or a revision of existing ones. The key finding of the review was that guidance on: » material characterisation; » exposure preparation and delivery of

substance to test systems; » monitoring of stability and consistency

of nanomaterials during the tests; and » measurement and use of dose metrics,

was insufficient for testing of

nanomaterials, and these findings were common for all test guidance documents. It was found, however, that the basic toxicological principles and test endpoints were adequate. The recommendation was, therefore, not extensive modification of all OECD guidelines, but instead to address specific issues related to testing of nanomaterials in a separate document. It was also noted that the terminology used in many cases was not applicable to nanomaterials, and these terms also need to be revised.

As the preliminary review revealed, a primary failing of the current test guidelines was guidance on sample preparation. As a result, in 2010 the OECD published a guidance document on sample preparation and dosimetry, and this was reviewed and amended two years later. However, this still does not offer an actual test guideline with specific steps and requirements, but rather an outline of important considerations that researchers should bear in mind in order to obtain meaningful and reproducible test results. The lack of clear and specific guidance on how to complete nano-specific testing creates a significant challenge for registrants. How can they demonstrate that they have completed nano-specific testing and risk assessment of the nanomaterial in the biocidal product that they wish to register? Similarly, how can the competent authorities assess the appropriateness of the submitted data and whether the risk assessment of the bulk form of a given active substance covers the nanoform as well?

The challenges are by no means small and easily solved, but they must be addressed in the near future to allow the BPR to reach its full potential in addressing the health and environmental concerns associated with the use of nanomaterials as active substances, in biocidal products and treated articles.

The authors wish to acknowledge the valuable contribution of Nanna Isabella Bloch Hartmann in producing this article.

The views expressed in contributed articles are those of the expert authors and are not necessarily shared by Chemical Watch.

To comment on this article, click here: Chemical Watch Forum

Although the OECD has initiated much work to help member countries address the challenges of testing nanomaterials, there are currently no actual OECD standard test guidelines for health and hazard testing of nanomaterials

Global Business Briefing / May 2014chemicalwatch.com 10

Expert focus: TSCA

Chemical control in the US is facing uncertain times. Much of the Toxic Substances Control Act (TSCA) has been criticised as ineffectual by industry and consumer advocates alike (CW 5 August 2009). State governments, and even “big box” retailers (like Walmart and Target), are stepping in to fill perceived gaps in federal regulation by imposing bans and restrictions on various chemicals, as well as forcing wholesale changes in the design, manufacture and sale of consumer products (GBB April 2014). As a result, companies up and down the supply chain have to contend with an ever-changing patchwork of chemical control laws across the country.

Recognising the need for reform at the federal level, Congress is considering legislation that would fundamentally change how chemicals are regulated in the US. At the heart of this debate is the extent to which federal law should pre-empt state regulation. In exchange for more robust chemical control at the federal level, industry is clamouring for broad pre-emption, so that some level of consistency and predictability is achieved. Consumer advocates, on the other hand, counter that states should retain the authority to impose more stringent chemical restrictions, including bans. Much is at stake. Pre-emption will dictate who decides which chemicals get regulatory priority, which scientific approaches will be used to assess risks, and, ultimately, what balance is struck between fostering technological development and promoting commerce, and providing adequate protections against chemical risks. As drafted now, the proposed legislation would likely go a long way to reaching industry’s goals. But it would not result in

complete pre-emption. States would still be able to regulate chemicals, and in some cases, to a significant extent.

Gap-filling: states and big box retailersUnder TSCA’s current pre-emption provision (Title 15 US Code Section 2617), states have wide-ranging authority to regulate chemicals within their borders. States are generally free to impose restrictions on any substance, unless the US EPA has explicitly regulated that chemical. Moreover, even where the EPA has taken action, states may adopt a requirement that

is identical to federal law or impose an outright ban. Finally, under a waiver provision, states may regulate a chemical, provided that the restrictions result in a significantly higher degree of protection than the federal standard and the state meets several other requirements (for example, it does not unduly burden interstate commerce). It should be no surprise that there are no court decisions, outside of TSCA’s specific regulations governing polychlorinated biphenyls (PCBs), finding a state law pre-empted under TSCA. As a result, states have adopted an increasing number of chemical restrictions. These range from state-wide bans and other requirements imposed on specific substances, like brominated flame retardants, phthalates and bisphenol A, to

more comprehensive green chemistry programmes, such as California’s recently adopted Safer Consumer Products Regulations. And this trend has continued in 2014. According to the database of the National Conference of State Legislatures, over 400 bills are now pending before state legislative bodies dealing with chemicals, with at least 150 directly aimed at some type of chemical control. Several big box retailers, moreover, in response to expanding state regulation and growing customer demand for safer goods, are putting pressure on their suppliers to reduce or eliminate certain chemicals in their product lines, such as those in the cosmetics, cleaning and baby care markets. Walmart, for example, will require suppliers to not only publicly disclose their use of “priority” chemicals – substances that have been designated by authoritative bodies as posing health or environmental concerns – but also consider employing green chemistry principles to limit or phase out the use of such substances. Similarly, the Target retail chain has adopted a programme in which it will be evaluating and scoring products based, in part, on the public disclosure of ingredients and the absence of any chemicals with significant health concerns. Products with favourable scores will then be rewarded with various incentives.

When taken together, state regulations and retailer programmes are, in many instances, doing for chemical control what the federal government has been unable to accomplish under TSCA. They are addressing all levels of the supply chain and creating what are essentially de facto industry and regulatory standards. All of this begs the question, what would the proposed pre-emption provisions do to change the status quo? Pre-emption: legislative proposalsReform legislation in the Senate (S 1009, the Chemical Safety Improvement Act or

Pre-emption: the relationship between federal and state lawWhat could be the impact on US state regulation of federal law reform?

Recognising the need for reform at the federal level, Congress is considering legislation that would fundamentally change how chemicals are regulated in the US

Global Business Briefing / May 2014chemicalwatch.com 11

Expert focus: TSCA

CSIA) (CW 22 May 2013) and House of Representatives (Discussion Draft dated 22 April 2014, the Chemicals in Commerce Act or CICA) (CW 23 April 2014) provide for broader pre-emption than TSCA. The CSIA and CICA contain similar provisions, including the following: » pre-emption where the EPA has placed

prohibitions or restrictions on a “high priority” chemical that is also regulated by a state; » pre-emption where the agency has

determined that a chemical is a “low priority” or otherwise does not present a risk to health or the environment; » pre-emption of a state test rule, or other

requirement for the development of information on a chemical, where the agency has already acted in this regard; » pre-emption of a state law or regulation

requiring notice of a new use, where the agency has already required such notification; and » limited exceptions to pre-emption,

including where the state law or regulation were adopted pursuant to another federal law. The key differences to TSCA, highlighting a more expansive approach, are: » even where the EPA has regulated a

particular chemical, TSCA allows states to ban that chemical or, under certain conditions, adopt restrictions that are more stringent than the federal regulation. Neither the CSIA nor the CICA, however, permit bans under those circumstances and, moreover, they significantly limit exceptions to pre-emption. For example, the CICA does not permit stricter state regulations and contains only one exception to pre-emption – where the state has acted in order to comply with another federal law; » TSCA generally permits a state to

regulate a particular chemical where the EPA has not imposed any restrictions designed to protect health or the environment, or has not otherwise affirmatively taken action (such as imposing testing requirements). Under the proposed legislation, however, even where the agency has designated a chemical as “low priority” and, therefore, decided not to place any restrictions on the chemical, a state might still be prohibited from adopting any regulation under certain circumstances; and » under TSCA, a state is typically allowed

to regulate a chemical until the point that the agency imposes restrictions on that substance. However, pre-emption may be triggered earlier in the regulatory process

under the CSIA. For instance, pre-emption kicks-in, at least with regard to state laws or regulations adopted after the CSIA’s effective date, when the EPA schedules a “high priority” chemical for further evaluation, long before any restrictions could be imposed at the federal level.

Examples of pre-emption under proposed legislationGiven the different approaches taken by states to regulate chemicals, there are many scenarios under which the proposed pre-emption provisions could come into play. By way of example, state labelling/warning laws and green chemistry programmes could be implicated. This type of pre-emption has not been seen under TSCA to date.

For instance, California’s Proposition 65 requires businesses to provide warnings for products containing chemicals that are known to cause cancer or reproductive harm. Moreover, under California’s Green Chemistry Regulations, manufacturers can be required to label products with warnings and use instructions. Some have expressed concern that these requirements could be pre-empted under the proposed legislation. This includes where the EPA has designated a given chemical as “low priority” in certain circumstances; where the agency has completed a risk or safety evaluation for a “high priority” chemical, even where it does not to impose any manufacturing or use restrictions; or where the EPA has imposed labelling or warning requirements that directly conflict with state law.

In the same vein, critics of the proposed legislation argue that other aspects of California’s Green Chemistry Regulations might also be pre-empted. For example, California requires manufacturers of designated product/chemical combinations to conduct an extensive alternative analysis (AA), in which the manufacturer compares potential risks of the product to safer alternatives. In particular, the analysis must consider factors like health and environmental

risks, chemical and exposure hazards, and disposal issues. If the EPA and the courts broadly interpret the CSIA and CICA, it is possible that this obligation will be viewed as requiring the development or submission of information regarding the targeted chemical, and thus be pre-empted, where the EPA has already required similar types of information to aid in any EPA safety or risk assessment.

Continued state regulationAlthough the proposed legislation provides for more extensive pre-emption than TSCA, there would still be room for state chemical regulation, including, in some instances, significant restrictions or even bans. For example: » there would be no wholesale pre-emption

of state chemical controls. Pre-emption would only occur on a chemical-by-chemical basis. Where the EPA has not addressed a chemical, states would be free to act; » for many chemicals, it will be years –

perhaps a decade or more, considering the EPA’s limited resources, inevitable extensions and delays, and potential legal challenges – before the agency will take any final action; » for chemicals deemed to be “low

priority” by the EPA, state regulations existing at the time the CSIA becomes effective, or before such designation is made under the CICA, would not be pre-empted; » as a practical matter, the agency may

significantly delay taking any action with regard to chemicals that are already adequately regulated by states; and » the CSIA and CICA retain a provision in

TSCA which has been interpreted as preserving tort suits (actions brought to protect an individual’s private rights) under state law. The CICA also contains language specifically preserving tort suits, and it has been reported that the CSIA may be amended to do the same.

It remains to be seen whether Congress will move ahead with TSCA reform and, if so, what form pre-emption will take. But under the proposed legislation, industry would, over time, secure some limited, but not total, relief from burgeoning state regulation.

The views expressed in contributed articles are those of the expert authors and are not necessarily shared by Chemical Watch.

To comment on this article, click here: Chemical Watch Forum

The proposed legislation provides for more extensive pre-emption than TSCA, but there would still be room for state chemical regulation

Global Business Briefing / May 2014chemicalwatch.com 12

Expert focus: SCP Regulation

In March this year, California’s Department of Toxic Substances Control (DTSC) revealed the identity of the first three of its priority products under its Safer Consumer Products (SCP) Regulation (CW 17 March 2014). The DTSC’s announcement was the culmination of a laborious process which had begun seven years earlier as the flagship of the state’s green chemistry programme. The Regulation, which passed into law last October, is designed to highlight the use of hazardous substances in consumer products and, by doing so, to encourage – indeed, to require – the assessment of alternatives that would offer less hazard while fulfilling the same function.

The general thrust to “de-toxicify” consumer products is at the heart of the green chemistry movement, and there is no question that the Regulation seeks to achieve this through the selection of consumer-facing cases where the hazards are clear and palpable. Indeed, only the most hardened sceptic would challenge the assertion that the most effective way of controlling risk is to reduce hazard at source. However, the question is: can it and will it work? This article seeks to address some of the challenges the Regulation faces, and draws from other alternative assessment experiences to identify the areas where approaches differ.

Nothing new Early experiences of industrial chemical use in the consumer realm are littered with cases where uncontrolled hazards resulted in unacceptable risks. Inevitably, this resulted in the hunt for alternatives. The use of ammonia as a refrigerant, for example, was prevalent in the early part of the twentieth century when Thomas

Midgley, a DuPont researcher at the time, became responsible for the introduction of a most remarkable substitute which had thermodynamic properties absolutely suited to the application, and yet was so inert that it posed no obvious threat to human health. The substitute was chlorofluorocarbons, or CFCs as they became widely known, and the rest, as they say, is history. We shall return to this example later to draw further lessons.

For those uses of industrial chemicals that appeared benign (ie there was no evidence of acute human health effects), the belief was that there were no hazards and no resulting risks. The use was said to be “grandfathered” by the fact that the history of previous generations indicated no effect that could be linked to the

chemical. However, this assumed that researchers were looking in the right place for such effects. As research began to shift from the acute to the chronic, more linkages emerged, especially in the areas of carcinogenicity and reprotoxicity. This has since led to the emergence of a series of toxicological endpoints requiring systematic evaluation. However, for a long while, the burden of proof lay with society – as represented through its regulators.

Shift in burden of proofThe EU REACH Regulation was among the first to formally shift the burden of proof to those placing a chemical on the market. Its goal is that all suppliers to the market must develop a common set of data to address a set of prescribed toxicological endpoints. Most importantly, this applies to all existing substances, irrespective of their perceived level of hazard. Therefore, previously grandfathered chemicals have not been exempt from registration under REACH.

The ongoing development of such a comprehensive hazard dataset has naturally attracted the attention of

The emerging challenge of alternatives assessmentHow do California’s new rules on assessing alternatives to certain chemical/consumer product combinations differ from other regulatory regimes?

California may have bitten off more it can chew with its alternatives assessment programme

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Global Business Briefing / May 2014chemicalwatch.com 13

regulators in other jurisdictions and this, in turn, has spawned a number of REACH-like regulations around the world to help capture the same datasets. The regulators also wanted to acknowledge those chemical companies which had been proactive in their development of such data, and so they created a framework within which access to data would need to be purchased (typically via a letter of access). Whilst this is an important principle to establish, it has made the use of the same data in multiple jurisdictions harder, especially if data-holders do not have interests in those jurisdictions. How California selected its chemicals of concern In preparing its list of chemicals of concern, the DTSC drew on the work of a number of other agencies around the world. This work has included some of that carried out by the US EPA under the Toxic Substances Control Act (TSCA). REACH has also been a prime source of priority substances, since those which have been identified as having real issues have already found themselves on the candidate list (151 substances in total at this time). However, the regulatory process is always some years behind the curve when it comes to the science. If the science is unambiguous, then this is not so much of a problem because there may already be consensus about the need to act. However, in many cases the science is contested, and this can lead to dilemmas about how and when to act. In some cases, the market takes matters into its own hands. The issue becomes one of philosophy, with the more precautionary approach being to act sooner rather than later. However, if we were to apply that principle to everything in our lives, we wouldn’t drive or fly, because the precautionary approach would be to avoid the hazard. Instead, we take the risk because the benefits of travel are seen to outweigh the risk. Similarly, when a hazardous substance is used, we need to have the ability to assess the risk alongside the benefit.

The judgement of hazard and risk becomes even more important when the hazard data is second-hand. Again, REACH requires a disclosure of all uses and the inclusion of an exposure scenario for each of them, in order to produce a risk assessment – the chemical safety report – for that substance. Therefore, if a particular chemical is chosen for substance evaluation under the community rolling

action plan, there is primary data available within the dossiers for each substance registered. Evaluation is the purview of the regulator… It is unsurprising that regulators around the world have decided that evaluating the data is their prerogative. While they rely on co-operation with the industries producing and using a chemical for much of the information, they understandably wish to keep the ultimate evaluation step in-house. This is fine when the evaluation is limited to hazard, but when it extends to risk, as the selection of priority products does, the extent to which the precautionary principle influences the assessment will have a substantial bearing on the outcome, especially where reliable exposure data is

limited. In this context, it is noteworthy that the DTSC has selected as one of its first priority products the use of methylene diphenyl diisocyanate (MDI) in sprayed polyurethane foam (SPF) - something for which exposure and monitoring data is already being collected by the US EPA because MDI is one of substances it chose as a work plan chemical. This is particularly frustrating for industry, because a more measured approach would have been for the DTSC to wait for the work plan to be completed, before drawing its conclusions on whether SPF should qualify as a priority product. Indeed, this is one of the challenges being highlighted by industry as we move into the public consultation period.

There is an additional issue about the linkage of specific chemicals with specific uses. It appears that some of the data in the priority product profile for SPF, issued in March 2014, relates to chemicals that are not used in the products in question.

However, without access to something equivalent to a REACH chemical safety report, there is no reason why the DTSC would have known this in advance. …but what about the alternatives? As has already become clear, it is only possible to evaluate an alternative at the “use” level. This explains why the SCP Regulation focuses on products and why authorisations under REACH (exemptions from what would otherwise be a ban) are only granted for well-defined, and often narrow, uses.

There are inherent challenges in evaluating alternatives. Firstly, the evaluation of alternatives from a hazard and risk perspective may be less well advanced than for the chemical of concern because it hasn’t received the same regulatory priority. Secondly, it may be that the hazards are in different areas, which may be less well understood or defined. This is particularly the case for endocrine disruptors, for which, as yet, there are no agreed criteria for regulatory classification. It is little surprise that the conclusion of an alternative assessment depends on its scope. It is no criticism of Thomas Midgley that he did not consider ozone depletion in his initial assessment, but he would be interested to note that, 80 years on, CFCs are being replaced by ammonia because the hazard can be better defined and managed.

Who should do the alternative assessment?Bearing in mind the interest of the regulators in being in control of the evaluation step, it is fascinating to realise that, both in REACH and the SCP Regulation, the responsibility for alternative assessment has been handed back to industry. This is possibly because the respective regulators believe that industry will understand the technical and economic factors more clearly. While this is the case, the view will vary, depending where in the supply chain the alternatives are being assessed. Picking up the prospect of an alternative assessment for SPF, a building owner might look at alternative insulation materials and make trade-offs in thermal performance. However, this will be of greater concern to the climate scientist, who would see poorer energy efficiency as an outcome. The alternative supplier might argue for greater thicknesses to compensate, but this would be less resource efficient.

Expert focus: SCP Regulation

‘While evaluators around the world they rely on co-operation with the industries producing and using a chemical for much of the information, they understandably wish to keep the ultimate evaluation step in-house’

Global Business Briefing / May 2014chemicalwatch.com 14

Expert focus – SCP Regulation

Therefore, alternative assessment is inevitably an outcome of balancing a number of potentially conflicting factors. The DTSC has made it clear that there will be 13 factors considered in the case of the SCP Regulation (the so-called A-M List) – but it has not said how they should be weighted. It is very difficult to see how industry can be left to prioritise 13 different criteria in a meaningful and self-consistent way. Early pilots have suggested that the field needs to be narrowed down quickly to make the process manageable. One way of doing so is to make hazard a subset of risk, but this may not be acceptable to green chemistry purists. Equally, if different jurisdictions apply different criteria and priorities, the outcomes will be many and varied and lead to greater disaggregation in markets.

Is there an alternative way?The replacement of CFCs, and of HCFCs and other ozone-depleting substances, has been brought about by a willingness to assess the situation at a global level and seek appropriate alternative solutions that meet technical, economic, hazard and risk criteria. The UN Montreal Protocol on ozone-depleting substances has not always

been successful, and substitutes such as n-propyl bromide serve as a painful reminder of what can happen when the dataset is either incomplete or contested – resulting in this instance in a failure to identify significant neurotoxic effects on workers. Nevertheless, carrying out the evaluation once within an expert body (in

this case, the Montreal Protocol’s technology and economic assessment panel), including access to various stakeholders, provides the best chance of reaching a successful outcome on both the desirability of a substitution and the selection of an appropriate alternative.

The DTSC appear to have bitten off a massive amount to chew and, in the absence of access to primary data, and with a myriad of criteria to prioritise

(including a very narrow definition of economic factors), it seems unlikely that an industry-led, localised alternative assessment process will reach a satisfactory outcome, even if the priority products survive the consultation process.

There is, perhaps, a case for stepping back and focusing our efforts on “doing it once and doing it right”, either as a global assessment or as parallel assessments using a standardised approach. Either of these would not only need the co-operation of industry, but also between jurisdictions. They would also need careful co-ordination of stakeholder interests. Ironically, the lack of consistency in methodologies could prove to be the biggest barrier to the successful de-toxicification of the supply chain that so many crave.

The views expressed in contributed articles are those of the expert authors and are not necessarily shared by Chemical Watch.

To comment on this article, click here: Chemical Watch Forum

‘There is, perhaps, a case for stepping back and focusing our efforts on “doing it once and doing it right”’

Global Business Briefing / May 2014chemicalwatch.com 15

27-29 May 2014 » Global cosmetic compliance summit » IQPC, Amsterdam » Website: Summit details

4 June 2014 » REACH evaluation workshop: Is the ECHA Board of Appeal

helping or hindering REACH registrants? » Keller And Heckman LLP, Brussels » Website: Workshop details

10-11 June 2014 » Cosmetics Europe conference 2014: “Cosmetics at the

crossroads of science and regulation” » Cosmetics Europe, Brussels » Website: Conference details

11 June 2014 » Managing REACH for suppliers of articles: How compliant are

you? » REACHReady, Derby » Website: Workshop details

11 June 2014 » Chemical control law and GHS: China, South Korea and Taiwan » Chemical Hazards Communication Society and CIRS, London » Website: Seminar details

17-19 June 2014 » The 18th annual green chemistry and engineering conference

(GC&E) » ACS Green Chemistry Institute, Washington DC » Website: Conference details

24 June 2014 » Cefic REACH information and experience exchange forum

(RIEF) » Cefic, Brussels » Website: Forum details

24 June 2014 » Food contact materials: are you in compliance? Lunch and learn

sessions » Intertek, Rotterdam » Website: Event details

24 June 2014 » Module 17 – EU CLP (GHS) classification for supply –

substances » Chemical Hazards Communication Society, Manchester » Website: Course details

24-25 June 2014 » REACH: legal implications and supply chain strategies

conference 2014 » IBC Legal Conferences, Brussels » Website: Conference details

25 June 2014 » Module 18 – EU CLP (GHS) classification for supply – mixtures » Chemical Hazards Communication Society, Manchester » Website: Course details

26 June 2014 » Module 19 – EU CLP (GHS) labelling for supply » Chemical Hazards Communication Society, Manchester » Website: Course details

26 June 2014 » Substitution of hazardous chemicals – regulation-driven

innovation » The REACH & CLP Helpdesk Luxembourg and CRP Henri

Tudor, Kirchberg, Luxembourg » Website: Event details

2 July 2014 » Module 7 – basic CHIP classification for supply » Chemical Hazards Communication Society, London » Website: Course details

22-23 July 2014 » Crops and chemicals USA 2014 » Informa, North Carolina » Website: Event details

10-11 September 2014 » 14th International Fresenius conference – the biocidal products

Regulation » Die Akademie Fresenius GmbH, Mainz » Website: Conference details

27 September-1 October 2014 » Society for Chemical Hazard Communication fall 2014 meeting » Society for Chemical Hazard Communication (SCHC),

Washington DC » Website: Meeting details

7-9 October 2014 » CEPA update conference » CEPA ICG, Toronto » Website: Conference details

11-13 November 2014 » Ecochem – the sustainable chemistry and engineering event

2014 » Vego Ltd, Basel » Website: Event details

26-27 November 2014 » SpeChem China 2014 » CCPIT Sub-Council of Chemical Industry, Shanghai » Website: Event details

7-12 December 2014 » RACI congress 2014 » ICMS Pty Ltd, Adelaide » Website: Congress details

To view all upcoming events, visit our Events page

To have your events listed here, contact Jessica Breakwell atjessica@chemicalwatch.com

Events

Global Business Briefing / May 2014chemicalwatch.com 16

Jobs

Job title Location Summary Organisation

Regulatory specialist Manchester The Acta Group is seeking a regulatory affairs professional. The ideal candidate will be educated, preferably in the biological sciences, chemistry, and/or toxicology fields, and have a strong knowledge of, and experience in, international chemical regulatory affairs, namely industrial, pesticides/biocides and fertilisers.Closing date: 22-May-2014

Expert product safety and regulatory affairs

Siegen, Germany SAP delivers enriched component data, product-specific safety data sheets (SDSs), label text and supporting data for product safety and hazardous materials management. The Content as a Service Team is looking for regulatory affairs experts to further develop our SAP EHS Regulatory Documentation OnDemand services group.Closing date: 24-May-2014

Product safety specialist

Siegen, Germany SAP delivers enriched component data, product-specific safety data sheets (SDSs), label text and supporting data for product safety and hazardous materials management. The Content as a Service Team is looking for product safety specialist professionals to support our SAP EHS Regulatory Documentation OnDemand services groupClosing date: 24-May-2014

Country regulatory manager – DACh region

Germany This role is ideal for someone who already has sound experience in agrochemicals and is looking to take the next step in their career. Being part of an expanding company with offices across Europe, this is the perfect opportunity to widen your skills and assume a more senior position. Closing date: 1-June-2014

Senior regulatory specialist – REACH

Midlands, UK As a REACH specialist you will be working within a established team for a leading speciality chemicals company. You will be working on REACH and biocides (98/8).Closing date: 1-June-2014

Regulatory toxicologist/ toxicologist

Oxford Nonstop Recruitment is looking for a toxicologist to join an organisation with a strong brand value. Working within a highly lucrative market, our client is a company that invests significantly in developing a competitive product range. Offering some of the most advanced product technologies, this opportunity will allow you to develop your career and channel your toxicological expertise to a diverse product range.Closing date: 1-June-2014

European EHS specialist

Brussels ChemADVISOR, a leading vendor of international environmental health, safety and transportation (EHS&T) regulatory products, is seeking applicants for the position of European EHS specialist for its Brussels’s office. The successful candidate will have responsibility for sourcing and analysis of EHS&T regulations, specifically for Germany and REACH. Additional duties will including training, assistance in REACH compliance efforts and support of product registration and notification requirements.Closing date: 7-June-2014

To advertise your vacancy here, and on our website, please contact lotte@chemicalwatch

Global Business Briefing / May 2014chemicalwatch.com 17

Supply chain insights

Manufacturers and distributors of all sizes increasingly face challenges related to globalisation in the marketplace and changing international regulatory initiatives. Often, these challenges directly affect a company’s ability to efficiently and effectively produce and maintain the currency of safety data sheets (SDSs), labels and other hazard communication documents for their products. Effective, compliant and up-to-date documents – especially SDSs – are both a global requirement and a critical centrepiece for effective product stewardship practices throughout the product lifecycle.

In today’s environment, merely producing an SDS is not enough. Quality, accuracy and currency are critical components to fulfilling the requirements of this documentation in the first place. Many companies now view providing detailed hazard communication documentation as an essential element within their corporate social responsibility (CSR) policies or strategies. Providing comprehensive and accurate SDSs, therefore, has become a strategic imperative for the responsible corporation.

Exploring the regulatory landscapeThe increased focus on the SDS is partly due to developments in the global regulatory landscape. While this is incredibly dynamic and ever-evolving, many regulations do have a common theme or emphasis on the safety of those handling – or exposed to – chemicals.

Consider the fact that regulatory verbiage typically includes statements like “the purpose of this Act is to protect public health and the environment (as seen in South Korea’s K-REACH Act) or “adopted to improve the protection of human health and the environment from the risks that

can be posed by chemicals” (as seen in the EU REACH Regulation).

Accurate hazard communication documentation promotes workplace safety and helps protect workers around the world. The days of the SDS going unread are gone as we move towards efforts to increase worker/public safety and awareness of the health and environment.

This is made clear in regulations such as the US Hazard Communication Standard 2012 (GBB June 2012), most notably in Appendixes A-F. EU requirements for SDSs are set out in REACH and its annexes. For example, Annex I details what must be included in the chemical safety report after the chemical safety assessment has been conducted, while Annex II outlines what should be included in each of the 16 SDS sections. Labelling obligations are covered by the Regulation on classification, labelling and packaging (CLP) of chemicals. Individual nations are also implementing regulations which adopt the framework of the UN model GHS system. For example, the Malaysian Department of Occupational

Safety and Health (DOSH) has issued the Industry Code of Practice on Chemicals Classification and Hazard Communication (CW+ AsiaHub 24 April 2014). This explains what companies must do to comply with Malaysia’s regulations for the adoption of the GHS, and includes SDS format and confidential business information (CBI) requirements.

The GHS has had a tremendous impact on the development of SDSs, as it sets the stage for updating them for multiple countries simultaneously, using the latest information available. As a result, classifications are consistent across all regions, although remnants of past regulatory systems are often brought forth and included in the country’s implementation of GHS. This is probably through a desire to maintain the same level of protection to the health and environment of the region’s people as previously offered by the old system.

An example of such a customised adaptation is the implementation of HSC 2012, which includes flammable liquids category 4 to address materials with a flashpoint of >60C

Best practices in authoring multilingual SDSs and labelsMany countries have their own safety data sheet templates and labelling rules, so what’s the best way for firms to have a global perspective?

Trading places: keeping up with changes around the world is a growing challenge

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Global Business Briefing / May 2014chemicalwatch.com 18

Supply chain insights

and <=93C, a move which correlates to the US Department of Transportation’s NA1993 combustible liquids.

Remnants of South Korea’s Toxic Chemical Control Act are also evident in K-REACH, which will focus on the registration and evaluation of chemicals and comes into force on 1 January 2015 (GBB May 2013). Similarly, Canada is working to align its Workplace Hazardous Products Act (WHMIS) laws by June 2015 in preparation for their adoption of GHS. As each country adopts its version of the GHS, chemical companies in the global market must prepare for the new requirements set forth, as with each new implementation, additional compliance challenges are presented.

Industry challengesDeveloping and maintaining a compliant hazard communication system is not without challenges. Companies are advised to start preparing as early as possible for the various country regulations that are coming into play by staying up to date with regulatory feeds/pushes and looking at training and webinars for the individuals whom the company relies upon to maintain compliance.

Global companies, in particular, must have a comprehensive plan in place. They must be on top of all changing country requirements and meet them head-on in order to maintain compliance while doing business on an international scale.

While the GHS offers a template system for all countries globally, the latter are increasingly customising their adaptations. Additionally, many countries have set specific SDS template requirements, meaning that the format of documents takes careful research and planning to ensure that all requirements are followed.

For example, in comparing US, EU and South Korean document requirements, there are many differences. It would stand to reason that companies which do business on a global scale need to maintain a knowledgeable staff, who are aware of the various regulatory bodies that play key roles in compliance in the various countries.

Companies should consider the possible influx of work demands on their team and determine if they are prepared to handle it. Looking to an outside solution provider can help facilitate conformance with

deadlines and prevent lost revenue by helping in-house teams prepare to manage the new regulations through training and/or by updating existing authoring platforms and SDS templates. Many companies take one of three approaches: » authoring-in house: this allows a

company to continue to use its own staff where the employee level of knowledge and areas of expertise are well-known and understood; » co-sourced authoring: this minimises

costs and reduces training efforts by removing the need for in-house expertise in all regulatory areas. It can also reduce the need for extra staff during busy periods. While many aspects of authoring are completed by an outside service provider, it allows the company to

maintain control of many of the facets of their authoring operations. Co-sourced authoring allows the best of both worlds; the ability to maintain an active role in the authoring and decision-making process, without the staffing demands; or » outsourced authoring: outsourcing the

authoring function completely allows the company to focus on what it does best- bringing its products and services to the market place.

Authoring in the real worldOften companies deploy a combination of these approaches before finding the right solution. Consider the case of one small North American chemical company, which was searching for a way to fill the gap left by a departing (retiring) employee.

The company originally planned to leverage its current authoring system and supplement its efforts with a co-source authoring service. However, after an audit of its existing system, it became clear that it had not been maintained, both in regards to data as well as templates for various regions.

Because this company sold its products globally, it was important that all documents were in compliance with the region to which they were shipped. After concluding that the cost of updating the system would be high

and, therefore, prohibitive, it decided to fully outsource its SDS and label authoring. This allowed it to have all documents for all regions authored on the most up to date SDS templates, as required by the various regulations, while also providing them with all of the data from regulatory feeds, without weeks to months of work to update their existing system.

This is just one example of how a company overcame the challenges of authoring on a global scale by deploying a customised solution to meet its needs. While developing a comprehensive and successful authoring strategy for your business is not an easy task, if you engage all stakeholders and clearly identify authoring needs and expectations, you will most definitely be able to deploy an effective strategy that meets your specific business needs.

The views expressed in contributed articles are those of the expert authors and are not necessarily shared by Chemical Watch.

To comment on this article, click here: Chemical Watch Forum

Tips for developing a comprehensive and successful authoring strategy

» Maintain a knowledgeable staff: keep them up to date on regulation changes and refresh and seek new training regularly. » Maintain an updated authoring

system complete with regular regulatory data feeds. » Stay ahead of the curve: ensure

that new country requirements are implemented prior to the deadline, leaving ample time to make the change, and ensure accuracy. It is important to recognise that countries can change their requirements, and that many do so with very little notice. » Seek outside counsel: determine

early if the work needed to maintain compliance demands additional and expert service providers.

‘Co-sourced authoring allows the best of both worlds’

Global Business Briefing / May 2014chemicalwatch.com 19

REACH & CLP hub

21 November 2013 was not only the latest application date for diarsenic trioxide (EC 215-481-4, CAS 1327-53-3), but also when authorisation applications were filed for the first time under the socio-economic analysis (SEA) route. Under the REACH authorisation framework, companies seeking to keep a “non-threshold” substance (those for which an acceptable exposure threshold has not been set) on the market for a particular use, or uses, must apply for authorisation under the SEA route. This means that, in addition to proving that there are no feasible alternatives available, the applicant needs to demonstrate that the socio-economic benefits of continued use of the substance outweigh the health and environmental risks. REACHLaw prepared and submitted two applications for its clients for the use of diarsenic trioxide in the production of zinc, and this article summarises the main lessons learned during the process.

It is true that the application for authorisation through the SEA route comprises three main documents: the chemical safety report (CSR); the analysis of alternatives (AoA) and the SEA. It is also the case that in order to prepare the three documents, very different competences are required: toxicology, ecotoxicology, exposure scenario and risk assessment competences for the CSR; industry-specific know-how in the AoA; and socio-economic competence in the SEA.

However, the three parts should not be developed independently, because they are deeply interlinked and dependant on each other. The CSR has data for both the risk reduction assessment in the AoA and the analysis of human health and environmental impacts in the SEA. The AoA requires SEA expertise for the economic feasibility analysis. At the same time, the AoA often determines the SEA’s non-use scenario by establishing

which alternative the applicant would most likely switch to if the authorisation was not granted. As such, the experts preparing the three reports should be working closely together throughout the process, continuously exchanging input.

Early supply chain consultation Consultation with the supply chain is often necessary, both to collect data and to define the scope of the analysis. Downstream users possess valuable information on substance usage, exposure, alternatives and potential socio-economic impacts if the authorisation is not granted. However, the identification of, and engagement with, supply chain actors is often difficult and time-consuming. The companies’ relationships have rarely been mapped out in detail before and previous communication between them has often been limited. They may not have a good understanding of the authorisation process, or how it affects them. Therefore, the exercise should be undertaken early on in the process, and the effort required should not be underestimated.

It is a common myth that an application for authorisation requires extensive amount of confidential business information (CBI), especially with regard to the AoA and SEA. But our experience tells a different story.

Concerning the AoA, it should be understood that it doesn’t equal the replacement programme a company conducts internally. The AoA is an examination of the suitability of the publically-known potential alternatives. If a company has a top secret replacement programme, it is likely that the rest of the world doesn’t know about it. But there is no need to reveal it, because you will probably not be challenged during the public consultation.

The aim of the SEA is to demonstrate that the socio-economic benefits of continued use of the substance outweigh the human health and environmental risks. The idea is not to conduct a comprehensive analysis of the

business and social environment surrounding a company. If the arguments are clear, and the case is strong with publically available information, then just stop there.

After the submission, the applicant will be asked further questions concerning its application by ECHA’s Risk Assessment and Socio-economic Analysis Committees. In our case, more than three pages of very detailed questions were asked, requiring over 40 pages of written answers and supporting documents. The time given to come up with such a document was less than two weeks. The committees were asking for more supporting evidence and wanted to know the detailed methodology/considerations behind the conclusions made. The questions were relevant, but they required a significant effort in terms of communication and organisation of data. Therefore, you need to do your homework well. Don’t leave any stones unturned, because the committees are likely to ask about them, and you will have very limited time to do the work properly.

It is not an exact scienceApplicants should also remember that this is not an exact science. On the contrary, it is more like an educated guess, because the SEA is an analysis of possible future scenarios and therefore inherently involves a degree of uncertainty. Values should be estimated conservatively on both sides - underestimating socio-economic impacts and overestimating potential health and environmental impacts. As they are speculative, it may be best to describe them qualitatively rather than quantitatively. An analysis that shows that the benefits outweigh the costs even with conservative estimates is likely to be a convincing case.

The views expressed in contributed articles are those of the expert authors and are not necessarily shared by Chemical Watch.

To comment on this article, click here: Chemical Watch Forum

Drawing valuable lessons from the SEA routeWhat did REACHLaw learn from its first authorisation applications?

Global Business Briefing / May 2014chemicalwatch.com 20

NGO platform

The reach and sophistication of modern supply chains mean that natural resources that have financed conflict in places like Colombia, Afghanistan, Central Africa and Congo, are bought by European companies. Rebel groups and abusive military forces earn millions from the trade in precious stones and metals, and use this money to fund their operations. In many instances, these groups commit grave human rights violations against local civilians, and their activity undermines development. In the absence of a law compelling European companies to source the metals they use responsibly, consumers in the EU have no guarantee that the products they buy are not fuelling violence.

In March this year, the European Commission published a proposal designed to close this regulatory gap by setting out clear responsible sourcing standards for European companies. This was an important opportunity for Europe to bring its companies in line with international standards and restore its consumers’ right to information. It was also a chance to build on momentum generated by new legislation in the US and Africa, which requires companies sourcing tin, tantalum, tungsten and gold to check their supply chains and ensure their purchases do not fund fighting.

Yet, in its current form, the proposal put forward by the Commission – a voluntary scheme for around 400 importers of tin, tantalum, tungsten, gold and their ores – would fail to prevent the EU acting as a hub for the trade in conflict resources (CW 13 March 2014). It also risks undermining existing international corporate responsibility standards at a time when progressive companies are working together to clean up the minerals trade.

The EU needs a law that compels companies

to address the risk of conflict financing in their supply chains. Voluntary schemes typically do little to change companies’ sourcing behaviour, as only the most progressive businesses choose to heed them. Indeed, non-binding OECD Guidance, endorsed by the EU, already provides a practical due diligence framework for companies sourcing from conflict areas, so the proposal adds minimal value to existing international efforts.

The range of companies directly affected by the Commission’s proposal is also too small for the scheme to have a notable impact on the quantity of conflict minerals

entering Europe. It needs to be broadened to include end-user companies that import finished products containing these natural resources. By only targeting a limited number of primary importers of metals and raw ores, the EU proposal currently captures a paltry 0.05% of Europe-based companies using and trading those metals.

It is also disappointing that the proposal focuses only on four minerals, ignoring the role that the trade in other natural resources, such as precious stones, plays in funding rebel groups and abusive military and security forces. Two examples are jade financing Myanmar’s military old guard, and the exploitation of chromite, marble and precious stones by insurgency networks in Afghanistan.

It would be perfectly possible for the EU to

enact effective, affordable and viable legislation that changed the incentives for companies, and thereby helped to cut off a vital source of funds for fighting. Indeed, landmark legislation passed in the US (Section 1502 of the Dodd Frank Act, known as the “conflict minerals provision”) has shown that requiring consumer-facing companies to do due diligence can be a powerful way of cleaning up mineral supply chains globally.

Section 1502, passed in 2010, compels US-listed companies to carry out and report on due diligence for products containing tin, tantalum, tungsten and gold, sourced from the Democratic Republic of Congo (DRC) or its nine adjoining countries. The law has triggered changes in sourcing practices all along supply chains, as end-user companies demand more transparency from their suppliers around the world.

Motivated by Section 1502, companies have started to work together to identify and mitigate the risk of conflict financing. For example, the world’s largest processor company, Intel, announced in January that their microprocessors are conflict-free, showing that is possible to work with suppliers to ensure responsible sourcing. Similarly, Apple recently released a list of smelters in their supply chain.

In the African Great Lakes region, companies have begun to engage in closed-pipe supply chain projects, whereby minerals are tracked from mine to final product, to guarantee conflict-free supply. And Section 1502 has also catalysed domestic reforms in the Congo and Rwanda, where governments have issued laws incorporating the OECD Guidance.

This issue isn’t going to go away. Taken together, the American and African laws, Chinese government steps to put in place responsible sourcing guidelines, and the

A voluntary measure is a half measure

Europe’s new batch of MEPs should redraft the Commission’s conflict minerals proposals

In the African Great Lakes region, companies have begun to engage in closed-pipe supply chain projects, whereby minerals are tracked from mine to final product

Global Business Briefing / May 2014chemicalwatch.com 21

NGO platform

actions of progressive companies, are a strong indication of the direction of travel.

In addition, the recent ruling by the US Court of Appeals – to uphold the majority of the final rule implementing Section 1502 in the face of industry appeals – suggests that companies trying to resist or delay progressive law making are most likely swimming against the tide. Despite the decision by US industry associations on 5 May to file an emergency motion to stop implementation (CW 7 May 2014), the Securities and Exchange Commission has committed to move forward with the filing deadline for its conflict minerals provision.

Indeed, the US experience has shown that OECD due diligence does not need to be costly or difficult. And there are tangible business benefits of greater supply chain transparency, including the ability to better identify and manage risks, as well as reputational advantages gained by meeting consumer and investor expectations.

Julie Schindall of the Electronic Industry Citizenship Coalition recently claimed that Section 1502 is giving companies more knowledge of their supply chains than

ever before. Companies are now being ethically and legally compelled to find out what is in their supply chains, “literally from the phone in your hand to the mine itself, [which] is very powerful.”

In this context, with its current timid proposal, Europe risks relinquishing its role as a leader on development and human

rights, undermining global progress, and appearing to incentivise a race to the bottom.

Global Witness and our coalition partners are therefore calling on Europe’s incoming parliamentarians to redraft the proposal so that a robust piece of legislation gets passed, which prevents Europe from acting as a trading hub for conflict minerals.

In the meantime, enlightened European

companies can show leadership by unilaterally addressing conflict financing in their supply chains. They can do this by building the OECD’s process-based framework into their existing risk management systems, and demanding that their suppliers do the same. This would give them a competitive advantage, given the way in which natural resource governance is evolving.

With innocent civilians in resource-rich parts of Africa and Latin America suffering at the hands of abusive armed groups, Europe’s failure to legislate effectively would be unconscionable. The opportunity exists to redraft the legislation to ensure all EU companies that import natural resources at risk of armed group predation are compelled to source responsibly, and consumers enjoy the right to know what is in their purchases. It must be taken.

The views expressed in contributed articles are those of the expert authors and are not necessarily shared by Chemical Watch.

To comment on this article, click here: Chemical Watch Forum

The US experience has shown that OECD due diligence does not need to be costly or difficult

Global Business Briefing / May 2014chemicalwatch.com 22

Guest column – Lena Perenius

Chemicals were brought clearly into the frame when the European Commission released on 14 May its much-anticipated negotiating positions (CW 15 May 2014) for the fifth round of talks on the Transatlantic Trade and Investment Partnership (TTIP) on 19-23 May in the US.

The Commission’s TTIP position on chemicals regulatory co-operation acknowledges that current regulations differ significantly on both sides of the Atlantic, and proposes that harmonisation and mutual recognition should be off the table. They rightly see scope, however, to co-operate in four areas that could bring efficiencies and costs saving to both regulators and industry.The chemicals sectors in the EU and US strongly support TTIP: we should. Total EU-US chemicals trade was €49bn in 2013, of which more than a third involves intra-company trade. We also see the TTIP as a way to save costs and reduce complexities, both in traditional trade issues and in enhanced regulatory co-operation. These benefits would help companies compete better in an increasingly globalised and competitive chemicals market.

Even if both the EU REACH Regulation and the US Toxic Substances Control Act (TSCA) aim at better protection of health and the environment, there remain big differences in approach. But despite this, common elements do surface that form the basis for closer regulatory co-operation. Together with the American Chemistry Council, the European Chemical Industry Council (Cefic) has set out proposals for how EU and US authorities could work better together, while keeping high levels of health and environmental protection.

Some politicians and consumer and environmental NGOs fear that regulation

and the level of environmental and health protection will be watered down because of the TTIP (GBB Dec 2013/Jan 2014). Our proposal respects that regulatory standards must be upheld. Enhanced regulatory co-operation between the EU and US is the best route. That co-operation can help both sides seek efficiencies in the regulatory process and possibilities to share the burden between authorities Critics also point out that by establishing scientific committees, the TTIP will cool down implementation of regulation – something termed regulatory “chill”. It won’t: regulations will remain in place, and deadlines will be respected. More consultations on scientific issues would have to be completed within the set timelines of current legislation.

There are clear benefits for reaching a common scientific basis for decision making. If regulators start with the same understanding of the effects of chemicals, even if we have different systems, we up the chances – in the long run – of narrowing the differences in regulatory decisions. Early co-operation, including early consultation on emerging scientific issues, would present opportunities to align views before regulatory decisions and prevent divergence of regulations.

To do this, our specific proposal is to establish a procedure to bring scientists together from both sides, either in a formal joint scientific committee with scientists from the EU and US, or on an ad-hoc basis for particular issues. Regulators should agree cases when they should seek advice, and this would be in the form of a recommendation. The committee would have to be absolutely transparent, and we encourage broad stakeholder participation. Burden sharing will also improve implementation of chemicals regulation. Both US and EU chemicals legislation contains procedures for the prioritisation of assessment work and to ensure work starts on the substances of highest priority. Here we ask for common prioritisation principles and

burden sharing for assessment of high-priority chemicals. By doing this, costs drop and resources can be used more efficiently by authorities and industry alike. And perhaps most importantly, we could avoid duplicative testing, and thus save lots of animal lives.

The US EPA and ECHA could co-operate in identifying chemicals for further assessment, see where they have overlaps, and then identify ways to share the burden. If this ma-terialises, however, there will also be a need to develop mechanisms for sharing data and information, including adequate safeguards for confidential business information.

A third element to consider is classification and labelling. In both the US and EU, the Globally Harmonized System (GHS) is applied. This takes a building block approach, to make it easier for countries to implement it, but it has also led to differences between the EU and US approaches that creates unnecessary administrative burdens. We propose to put in place a mechanism that further aligns classification and labelling across the Atlantic, while promoting the GHS, by seeking alignment on the use of the same building blocks. This would help facilitate trade and also provide a level playing field for companies. And if the two major economic areas can reach such an agreement, it would set a global standard for common implementation of the GHS.

The TTIP is a remarkable opportunity for the old continent and the not-so-new continent that could give an economic boost to both, while respecting high regulatory standards for chemicals. The negotiations remain challenging, but there must be continued progress.

The views expressed in contributed articles are those of the expert authors and are not necessarily shared by Chemical Watch.

To comment on this article, click here: Chemical Watch Forum

The TTIP: a historic opportunity

If the EU and US agree on common classification and prioritisation principles, the burden could be cut for both companies and regulators