« Evidence for EDCs More Definitive Than Ever »

« Endocrine Society calls for regulation to ensure pre-market testing for such effects. Evidence that some chemicals disrupt hormones, in a way that causes a range of serious health problems, has become more compelling, says international scientific organisation the Endocrine Society.

The organisation published a review of the evidence from the last five years. This concludes that exposure to chemicals, such as bisphenol A (BPA), phthalates, flame retardants and pesticides such as atrazine and DDT, is associated with an increased risk of diabetes and obesity, infertility, hormone-related cancers, prostate conditions, thyroid disorders and neurodevelopmental issues.

“The evidence is more definitive than ever before – endocrine disrupting chemicals disrupt hormones in a manner that harms human health,” said Andrea Gore, professor and Vacek chair of pharmacology at the University of Texas, and chair of the task force that produced the statement.

“Hundreds of studies are pointing to the same conclusion, whether they are long-term epidemiological studies in humans, basic research in animals and cells, or research into groups of people with known occupational exposure to specific chemicals.

“It is clear we need to take action to minimise further exposure,” said professor Gore. “With more chemicals being introduced into the marketplace all the time, better safety testing is needed to identify new EDCs and ensure they are kept out if household goods.”

In the statement, the society calls for:

  • regulation to ensure that chemicals are tested for endocrine activity, including at low doses, prior to being permitted for use;
  • additional research to infer more directly cause-and-effect relationships between EDC exposure and health conditions;
  • advice for the public and policymakers on “how to keep EDCs out of food, water and the air, as well as ways to protect unborn children from exposure”; and
  • chemists to create products that test for and eliminate potential EDCs.

“The science is clear and it’s time for policymakers to take this wealth of evidence into account as they develop legislation,” said society member Jean-Pierre Bourguignon, professor of paediatrics at the University of Liège.

A global issue

The statement executive summary says, although some countries and US states have banned some EDCs, “the fact that EDCs are ubiquitous makes it a global issue that requires international partnerships among developed and developing nations.”

It also backs the “evidence integration” philosophy of the US National Toxicology Program in deciding whether a chemical may have a health impact.

“When high-quality endocrinological studies demonstrate that a chemical interferes with hormone action in vivo and in vitro at environmentally (human) relevant concentrations, and when we have a high degree of evidence that these hormone systems are essential for normal development, it is reasonable to infer that these chemicals will produce adverse effects in humans,” says the summary.

To back up its call for the provision of “substantial information” before a chemical can be used in household products, it says BPS, which has been used to replace BPA, “is now shown to have endocrine-disrupting activity on a par with BPA”.

NGOs welcomed the statement. The Health and Environment Alliance (HEAL) urged countries at the UN conference to back a proposed Resolution on EDCs put forward by developing countries. Healthcare Without Harm (HCWH) irged EU policy makers to identify EDCs in medical devices and to replace them with safer alternatives. »


Article (29 September 2015) : https://chemicalwatch.com/37422/evidence-for-edcs-more-definitive-than-ever
Endocrine Society press release : http://www.endocrine.org/news-room/current-press-releases/chemical-exposure-linked-to-rising-diabetes-obesity-risk
Statement executive summary : http://press.endocrine.org/doi/pdf/10.1210/er.2015-1093
HEAL press release : http://www.env-health.org/resources/press-releases/article/heal-reaction-to-endocrine-society
HCWH statement : https://noharm-europe.org/articles/news/europe/hcwh-europe-welcomes-endocrine-societys-scientific-statement-endocrine


« ECHA Must Take a Stand On Compliance’

« Following the REACH “no data, no market” principle, a chemical is only allowed on the market, once manufacturers and importers register the substance and prove it is safe by submitting specific information.

Competent authorities will only be able to regulate chemicals effectively, when they have a clear picture of what’s on the market – and this can only be established through information provided by companies. This information would also better inform citizens about the chemicals they are exposed to.

Registration dossiers are, therefore, the pillar of REACH and this is why it is so crucial that the information provided is accurate, adequate, reliable, relevant and trustworthy.

However, the quality of registration dossiers is embarrassingly poor. According to Echa, 69 % are not even in compliance. The main problems are with the identification of the substance and the waivers or justifications given for not submitting studies or parts of the safety report. This is fundamental information to ensure substance safety.

In order to help companies to improve the quality of the registration dossiers, Echa, since 2009, has launched a very varied bunch of soft measures, such as quality observation letters, informal contact with companies, targeted letter campaigns, lists of substances that are likely to face compliance checks, REACH guidance updates, more streamlined and concise advice and statements of non-compliance (Soncs).

Nevertheless, despite the agency’s efforts, compliance has not improved at all. The percentage of non-compliant dossiers has remained well over 50 % for the last five years as demonstrated in the following figures:

in 2009 – 50 %;

in 2010 – 64 %;

in 2011 – 92 %;

in 2012 – 67 %; and

in 2014 and 2015 – 69 %.

Moreover, the German Federal Institute for Risk Assessment (BfR) released a study, this year on data availability in REACH registrations that showed only one dossier, out of 1,814, was compliant with standard information for all endpoints.

It is evident that the soft measures applied by Echa are highly ineffective. Not only is there a lack of incentives to ensure compliance, there are too many encouraging the opposite, such as the lack of regulatory action and the low chance that a dossier will be evaluated – under REACH, Echa has been required to examine 5% of registration dossiers for the first two deadlines.

It’s time to move on from soft measures, guidance and advice to getting serious about enforcing compliance.

We propose that Echa:

*does not grant registration numbers, in the first place, for empty dossiers or dossiers with inadequate information, such as insufficient description of a substance identity. More manually examined dossiers and fewer automated completeness checks, that don’t evaluate how adequate the information, are needed;

*completeness checks, performed for the whole registration dossier, including chemical safety reports;

*exclude from the market, by cancellation of registration numbers, those substances where safety has not been proven (for example, if the compliance check shows very bad quality dossiers or the dossier is not complete) in order to ensure a level playing field that favours companies taking REACH seriously. Although Echa agreed it may invalidate registration numbers in well-justified cases a few years ago, revocation has only been considered in cases where registration numbers were assigned to non-existent registrants, and where they failed to pay the correct registration fee. However, there are some “good cases”, such as the ongoing Board of Appeal case where an almost empty dossier was accepted by Echa;

*apply a “naming and shaming” mechanism, such as disseminating the names of non-compliant companies, or a traffic light system for the dossiers that pass an evaluation in the dissemination portal. These mechanisms would be a very good incentive to compliance as both market access and reputation are very important for companies. Moreover, it would ensure informed decisions by citizens, increase market pressure and protect human health and environment; and

*increase the compliance checks rate beyond 5 % of registration dossiers.

After eight years, the compliance problem is no different; two thirds of the information provided by companies under REACH is not reliable or compliant, putting the credibility of the process at stake and blocking any protective action by competent authorities.

The compliance checks process is the most important measure to improve the quality of dossiers but Echa is seen as very weak by most registrant companies, which are doing nothing to improve their dossiers.

A more ambitious approach by the agency, that gives fewer carrots and more sticks to non-compliant companies in order to ensure full compliance with the legal text, should be by hook or by crook the minimum. »

Article of Tatiana Santos, senior chemicals and nanotechnology policy officer, EEB

Cet article n’engage que son auteur/ This article is the sole responsibility of the author

New Phase for ECHA Board of Appeal

« It is thought that the BoA’s caseload is likely to increase in volume and complexity over the coming years as more companies come within the remit of Echa’s decision making, both for REACH and the EU biocidal products Regulation.

But the BoA has had its internal challenges, which have at times made it seem vulnerable. Fundamental changes to its organisation, to be ushered in by a Commission Regulation, could help to address these.

EU legislators foresaw the need for an appeals mechanism, when they negotiated the EU REACH Regulation. The law cites that a three-member Board comprising a chairman and two other members, supported by alternates where needed, “should be set up within the agency to guarantee the processing of appeals for any natural or legal persons affected by decisions taken by the agency”. It gives the BoA the right “to exercise any power which lies within the competence of the agency or remit the case to the competent body of the agency for further action.”

In an interview during his candidacy for the executive director post of Echa in 2007, Geert Dancet foresaw the work of the BoA as a key test of the agency’s credibility, alongside its ability to deliver robust REACH guidance and IT infrastructure and to manage the pre-registration period and the first registration deadline in 2010.

Chairman of the BoA, Mercedes Ortuño, once described the institution as a “safety net” – not only for those affected by REACH but also for the agency – able to check, rectify or endorse decisions .

Check and balance role

Has this ‘check and balance’ role been borne out in practice? Chemical Watch asked a range of stakeholders for their views, receiving generally very positive responses concerning the impartiality; quality and usefulness of the BoA’s decisions.

The European Commission’s DG Grow comments that: “Thanks to the quality of its decisions, the Echa Board of Appeal has established a good reputation and is now perceived as a competent and independent party. Despite the expected increase in workload, the board should continue to be an easily accessible referee in appeal cases.”

Mr Dancet’s view is that in the context of implementing an evolving complex regulation, the board has “been helpful in determining the boundaries of our decision making and our administrative practices”. Its decisions for and against the agency in each appeal have satisfied him that “the processes we have set up have been set up in a solid and legally correct way but here and there we have had to give legal and scientific interpretations which were not in the legislation itself.” Decisions made by the European Court similarly help to mould the legislation and validate Echa’s approaches, he notes.

And Nina Cromnier, Chair of Echa’s Management Board, to which the BoA is directly accountable, comments that it “has given very high quality decisions that have fostered good trust in the whole system. It definitely has played an important role and the quality of the decisions is respected by all stakeholders … It really is a learning body, ensuring that issues that are not clear in the legislation are made clear”.

Indeed, from its start the BoA has had to delve into some of the darkest grey areas of REACH. On the controversial issue of animal testing to meet the data demands of the Regulation, the BoA has now adopted some key rulings, for example, in a case brought by Honeywell, it concluded that Echa had acted disproportionately in requesting the company to carry out an additional animal test.

In another example, it found that Echa had been too inflexible in a case brought by CINIC Chemicals Europe over its procedures for admission of information that could have prevented unnecessary animal testing. It shed clarity on Echa’s role in adjudicating data-sharing disputes, when it waded through the arguments in a case brought by the Vanadium Consortium, to conclude that the agency had fairly assessed whether each party in the dispute had made every effort to ensure that costs were determined in a fair, transparent and non-discriminatory way. It also ruled that Echa needed to change its procedures, regarding the verification of SME status of registrants and corresponding fees payable.

Over this last summer, the BoA has issued two further rulings on contentious compliance issues, which Echa and other stakeholders are still evaluating the implications of. One was its decision on the legal standing of the agency’s “statements of non-compliance”, or Soncs, in a case brought by Solutia Europe and the other, in September, was its first decision involving the substance evaluation process of REACH in a case brought by nine companies asked to provide more safety data on medium-chain chlorinated paraffins.

Neither the number nor the complexity of cases that the BoA deals with is expected to diminish, especially now that Echa has also been made responsible for the EU biocidal products Regulation, which, therefore, makes it an area of law on which appeals can be brought to its BoA.

Of the 43 cases brought to conclusion so far, nine have gone in Echa’s favour, seven have been upheld and 18 were withdrawn by appellants. In a further nine cases, the agency exercised the power afforded by REACH to rectify its decisions rather than going ahead with the case, after an initial examination of the grounds for appeal and a consultation with the BoA chairman on the admissibility of the case.

With each of its rulings, the BoA has taken pains to explain the legal background, the circumstances and provide wider context and lessons for its decisions. It has always urged stakeholders to read its rulings carefully to ensure they grasp their context and broader messages. This, it says, means that it is offering far greater value to stakeholders and it has resulted in widespread acceptance of its judgements, evidenced, for instance, by the lack of any cases of companies further seeking to challenge BoA decisions at the European Court of Justice. However, Ms Ortuno says even if BoA decisions were challenged further, she would welcome this as an opportunity to validate its judgements.

The breadth of its rulings can pose considerable challenges to the agency, Mr Dancet says. He notes the BoA’s decisions on data-sharing cases, which brought “important clarifications which are useful”. He also points to the recent “famous Sonc case”. “We want to understand what it means because it was not a standard case.”

The case concerned a substance notified as a new substance for the EU market, under the previous EU ‘NONS’ legislation, and which was automatically transferred to the REACH system rather than being registered afresh. “It is not entirely clear whether [the BoA judgement] is limited to that kind of case or has further impact.” The agency always re-examines its procedures in light of the BoA’s rulings whether or not they are in its favour, he says, “but the wider the conclusions are written in those decisions we are not winning, the more analysis in terms of consequences we have to consider”. He also points out that with substance evaluation cases now being brought to appeal, another lesson being learned is that Echa is a more complex decision-making body than first appears. For instance, discussions in the Member State Committee cannot just be overturned by the agency.

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Given that Echa is a party to every appeal, interpretation of REACH recital 106 and Article 76, mandating that the BoA should be a part of the agency, is a key issue.

Until now, this has meant that Echa supplies HR services to the BoA and provides its ‘registry’, scientific and legal support, using Echa staff who are dually accountable to the agency and the BoA. While members of the BoA are not permitted to also work for the agency, the registry staff can, and they do.

In the absence of any other direct instructions in the REACH Regulation itself, the agency and BoA agreed between them in June 2009 “administrative arrangements for safeguarding the independence of the Board of Appeal”. This document explains how Echa runs the BoA registry as an “independent administrative unit” within its walls. Mr Dancet says the arrangement has worked “extremely well in my perception” and has allowed the flexibility to deploy resources to the BoA when needed but to otherwise use them in the agency.

The executive director also sets the budget for the BoA and controls decisions on how much secretarial support it can have. He is accountable on this to the Management Board, which also has the role to ensure that the BoA has adequate resources to work independently and effectively.

However, the REACH Regulation stipulates that while the Management Board should directly appoint the chairman of the BoA and other members and alternates, it may appoint additional members, based on a recommendation by the executive director on the capacity needed to ensure that appeals can be processed at a satisfactory rate.

Given this intricate arrangement, it is perhaps not surprising that there have been issues in the relationship between Echa and the BoA, something the Management Board examined at its last meeting.

Last year, the Management Board’s BoA working group assessed whether more could be done to ensure the independence of the registry. It sought legal advice from the European Commission and, this summer, a letter summarising this advice was published as an annex to a working group report on its recommendation that the BoA should, for the second time, be confirmed as a permanent institution rather than an ad-hoc body convened only when necessary. The report was published as part of the Management Board meeting proceedings.

The letter, dated 16 December 2014 from Antti Peltomäki, deputy director general of DG Grow, concludes that “despite the fact that Echa’s executive director is doing its utmost to ensure the independence of the Board of Appeal, the Commission considers that additional measures must be taken in order to avoid the perception that the independence of the Board of Appeal could be at risk.” It adds: “Following an in-depth legal assessment, the Commission considers that currently these issues deserve special attention in order to guarantee the independence and impartiality of the members of the Board of Appeal of Echa.”

It says that “there is no need to re-open REACH to address the issue” as it falls into “the discretion of the Commission implementing powers”. And it concludes: “Consequently, the Commission intends to amend the Commission Regulation (EC) No. 771/2008 on the rules of procedure of the Board of Appeal and its organisation … in the sense that the Registrar of the Board of Appeal and its staff are appointed by the chairman of the Board of Appeal directly”.

The precise scope of the Commission’s intended amendment of the Rules of Procedure Regulation is not yet known. The Commission told Chemical Watch in September that it “intends to make a formal proposal to amend the existing rules of procedures before year end. The planned changes include measures to further reinforce the independence of the Board of Appeal, that was not initially foreseen to be a permanent structure. The practical details and technicalities are still being discussed.”

Another point made in Mr Peltomäki’s letter is that an additional action that the executive director could take directly would be to delegate powers to the chairman of the BoA on the yearly performance evaluation of its registrar and registry staff. This is a “matter for the executive director to decide and would require only a modification of the current administrative arrangements”.

Commenting on these pending changes, Ms Cromnier says “there is no doubt about the general direction … it is now very likely that the registry will be part of the Board of Appeal [or] Echa” but she cautioned that until the Commission presents its amended regulation, the details of the changes will not be clear. On the nature of the relationship between the Echa secretariat and the BoA, she only alludes to these, saying: “They are different roles and, of course, the dynamic between these roles is quite expected. As in all working life relationships, it is always important for good smooth cooperation to put yourself in the shoes of the other and use a professional and respectful attitude. That’s what I believe in and what I expect of the relationship in this case.” Asked if the Commission’s decision might make the relationship easier, she says: “I can’t really tell. It would clarify who is responsible for what and if things are clear then, in that respect, I would hope that it would but I would have to see it in practice to give an opinion.”

Similarly, Mr Dancet comments: “We have to still wait and see how the decision is phrased and how it is practically implemented to see what consequences it may have.” He notes that greater autonomy will bring significant additional administrative tasks that the BoA will also have to manage.

Ms Ortuño feels the difference in responsibility for the registry to the BoA, will not be so much about the impact it makes to its daily life – she praises the registry for its “vital” hard work in the past six years and its dedication to supporting appellants to ensure that the appeals process runs smoothly. But it will make a big difference in terms of the principle she says: “Our supportive body will be dependent on the Board of Appeal and not on the agency’s executive director. That, to me, was a really serious factor influencing the independence of the Board of Appeal. When your support depends on one of the parties to an appeal … that is a huge problem to me.”


Will the BoA have the resources it needs, in future, to tackle an unpredictable but likely increasing caseload? In common with other parts of Echa, the board has suffered cuts to its legal and scientific support. This, together with “other factors outside the board’s control” that have not been publicly stated but are thought to be staffing-related, has led to a backlog of cases, which the BoA now needs to plough through.

In her annual statement to the Management Board in June, Ms Ortuño made a strong plea for no further cuts in legal and scientific support or other interventions and for a period of stability to enable the BoA to get on with its work. “Trust us and leave us in peace with what we have to do” is its message. Speaking at the same meeting, Mr Dancet gave an assurance that he did not plan any further cuts to the BoA budget and staff, over the coming years. He told Chemical Watch he stands by this but he adds: “Of course, given the volume of work increasing, they will have to become more efficient. I cannot turn the clock back and say you can now have double the resources if the rest of the house is making cuts. While the workload is increasing … one can only follow the Commission mantra that we all have to find ways to do more with less.”

Ms Ortuño’s view is that the BoA is already operating very efficiently for such a small body and is ready to do more where possible. She notes measures, such as allowing appellants to join like cases into one appeal to cut down on time and costs; taking steps to pare down appeal cases to the key legal decisions so as not to be distracted by other issues; publishing clear and detailed decisions that enable others to learn from them and may prevent further unnecessary appeals; and publishing clear procedures, as well as offering support from the time an enquiry is made, to help potential appellants. One testament to the clarity of the process, she says, is that companies do not always feel that they need to use lawyers in order to bring appeals.

On the down side, greater clarity of the rules can lead to fewer potential appellants resulting in less fees income for the BoA – for example, the number of appeals regarding SME status has dropped considerably. She also observes that the BoA has many of the same responsibilities and procedures as a legal court – it examines all pleas made by appellants, it listens to arguments from other interested parties and allows rights of response. This is different to boards of appeal under other jurisdictions, she says, where the process is more like mediation. And in comparison, while court cases take four years on average, the BoA’s average turnaround time is one and a half years. The backlog in cases has not gone unnoticed among the stakeholders Chemical Watch interviewed. But Ms Ortuño says that in the feedback the BoA has received, there have not been any complaints about the length of the appeals process.

Commenting on the Management Board’s role in safeguarding the BoA’s finances, Ms Cromnier, while observing that financial constraints affect all parts of Echa’s work, concludes that: “It is an important issue and things do change and the workload of the Board of Appeal is not something that is totally predictable. We will have to work off the best estimates but that changes with time and we have to follow that very closely.

“I definitely wish to see a continued strong Board of Appeal that makes strong decisions in an effective time and the board has proved very good at these things and I wish them to do so also in the future.”

OctGBB Echagood3

OctGBB Echagood4

Article of Mamta Patel

Cet article n’engage que son auteur/ This article is the sole responsibility of the author

Alternatives Assessment: Embracing the Concept

« The recent publication of the California Department of Toxic Substances Control’s (DTSC) draft Stage 1 Alternatives Assessment Guide marks an important milestone in the growing practice of alternatives assessment (AA), as there are now about twenty AA frameworks that promote informed substitution.


Although the concept of “alternatives assessment” is enshrined in the Environmental Impact Assessment requirements of the US National Environmental Policy Act, the practice of AA, or Chemical Alternatives Assessment (CAA), is just now being embraced on a worldwide scale by businesses and governments as a vehicle for moving away from chemicals of concern in products to safer alternatives.

Historically, risk assessment methods were used to ensure safety by providing businesses with a means to assess the likelihood of harm following exposure to chemicals in products. But risk assessment did little to compel continual improvement of products or materials, containing hazardous substances, toward greener and inherently safer chemicals.

Alternatives assessment

CAA can be defined as a form of alternatives assessment that focuses on finding alternative chemicals, materials or product designs to replace hazardous substances in products. Figure 1 illustrates some of the leading AA paradigms in use around the world, most of which can be accessed through the OECD Substitution and Alternatives Assessment Toolbox.

AAs all use standardised procedures to assess whether alternatives have improved health and environmental hazard profiles compared to a chemical of concern. In addition, most AAs assess them for levels and types of exposure (defined as contact with a chemical or physical agent and a target), cost, performance and commercial availability.

Some AA frameworks, such as the Interstate Chemicals Clearinghouse (IC2) AA Guide, also provide guidance for additional assessment modules such as life cycle thinking, stakeholder engagement and materials management. Exposure is considered in an AA, but is treated differently than in risk assessment. An AA treats exposure as one of several variables, in addition to inherent hazards to consider in a decision framework, while promoting the use of inherently safer alternatives.

In risk assessment, levels of exposure are used to define acceptable limits for the use of hazardous chemicals. Although existing in name and concept 30 years ago, AA was not ready for prime time in its application to chemicals until recently because many tools that support its practical application were not yet in existence, such as the principles of Green Chemistry (published in 1998), the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) (adopted by the United Nations in 2002), and software and databases to support hazard classification (such as Qsar Toolbox and Echa’s toxicity database for REACH registered substances).

Risk assessment

This is defined as the practice of estimating the severity and likelihood of harm to human health or the environment occurring from exposure to a chemical substance, biological organism, radioactive material, or other potentially hazardous substance or activity.

Risk assessment came into its prime in the 1980s with the publication of the NRC publication Risk Assessment in the Federal Government: Managing the Process (“the Redbook”) and the Royal Society’s report titled Risk Assessment: A Study Group Report. When applied correctly, risk assessment methods can estimate how likely exposure to a substance will harm a target population such as a child, adult, and/or organism in the environment.

For example, risk assessment methods can estimate the likelihood that a worker will develop cancer, following exposure to a chemical such as benzene under certain occupational exposure scenarios, estimate a predicted no-effect concentration (Pnec) for an aquatically toxic chemical such as a benzidine-based dye, or whether a body lotion with high levels of the UV absorber benzophenone poses an unreasonable cancer risk to consumers.

The plethora of lists of chemicals of concern, such as California DTSC’s candidate chemicals list (totalling approximately 2,300 chemicals) and Echa’s Community Rolling Action Plan (Corap) list (currently totaling 267 chemicals) reflect a reconsideration of the use of these highly hazardous chemicals in products.

OctGBB frameworks

While risk assessment has been effective in many ways as a working framework, it has failed to drive movement away from the use of highly hazardous chemicals and to ensure safety across the lifecycle of a product.

Reasons for the failure of risk-based methods to reach the intended goal are debatable and include flaws in the approach with respect to a focus on single chemicals rather than mixtures and related effects, variability in how it is applied by different practitioners, data gaps and perhaps even the evolution of higher expectations to consider risks across a product lifecycle and throughout the supply chain, rather than to focus primarily on the safety of the product user.


Risk assessments are designed to answer the question: “Is this chemical or product safe enough for the intended use?” It can be used to set regulatory limits and to help prioritise chemicals for reduction or phase-out. In contrast, alternatives assessments are intended to answer the question: “Which chemical or product is inherently safer?” AAs can also help to prioritise chemicals for reduction or phase-out.

However, unlike risk assessment, AA also supports decisions in the product design and development phase that result in the selection of increasingly benign chemicals or technologies, eliminating the concept of acceptable risk from the design process altogether (see figure 2). The use of AA in product design and development can help to minimise risk. And risk assessment can be used subsequently to ensure safe use, even of inherently low hazard chemicals.

A growing community practicing AA has fostered its continued evolution in different industry sectors including textiles, aerospace and electronics, particularly in the US and EU. Organisations such as the OECD, the Lowell Center for Sustainable Production and Massachusetts Toxics Use Reduction Institute at UMASS Lowell, IC2, Northwest Green Chemistry and BizNGO provide resources for governments and businesses of all sizes interested in undertaking AA and adopting safer chemicals.

A commitment to accelerating the use of AA, while a new form of an old approach, provides a useful new tool in the toolbox for safety and sustainability and to help overcome some of the limitations of risk assessment. Its not too late, as the adage goes, “While the best time to plant a tree was 20 years ago. But the second best time is today.”


Article of Margaret Whittaker

Cet article n’engage que son auteur/ This article is the sole responsibility of the author

Guest Column – Dr Sue Marty on Endocrine Disruptors

« Recent reports have raised questions about the possible effects of some chemicals on the human endocrine system.
Some natural and man-made chemicals can and do interact with the endocrine system, or are “endocrine-active.” In some cases, this interaction is harmless – the substances lack sufficient potency, or exposures are so low that no effects occur at all; in other cases, the body naturally adjusts, and the exposure causes no health effect.


However, some substances under certain exposure scenarios go beyond a simple interaction and can result in adverse health effects – these substances are referred to as “endocrine disruptors”.

Through governmental, academic and industry efforts, considerable progress has been made to develop methods, tests and data to help answer questions about whether and how certain chemicals may affect the endocrine system. However, some recent studies have failed to incorporate critical information including exposure and weight-of-evidence analysis or have used unreliable methods, reducing their relevance to sound decision making.

More research is needed to better understand whether, how and to what effect specific chemicals interact with the endocrine system.

By improving screening and testing, regulatory agencies can make decisions based on scientific evidence as they develop and implement programmes intended to reduce risks associated with endocrine disrupting chemicals (EDCs).

The American Chemistry Council (ACC) recently released 11 “Principles for Identifying Endocrine-Active and Endocrine Disrupting Chemicals”, a set of recommendations to promote reliability, consistency and scientific integrity in the screening and testing of chemicals for endocrine activity and endocrine disruption.

These principles are industry’s latest contribution to advancing scientific understanding of endocrine-active and endocrine disrupting chemicals. Industry’s Long Range Research Initiative also has developed cutting-edge screens and tests to support these efforts and has made substantial contributions to development of high-throughput tools that can help prioritise and screen chemicals at a much faster pace than traditional methods.

Chemical manufacturers also have participated in the US EPA’s Endocrine Disruptor Screening Programme and have submitted data and analysis on test-method development and chemicals, for use by regulators to determine whether they activate the endocrine system and, if so, whether they cause adverse health effects due to that interaction.

Chemistry is fundamental to human life; everything is made of chemicals, including the human body and all of nature. Chemical manufacturers take seriously their responsibility to produce chemistries that enable important product performance benefits and that can be used safely, and they undertake extensive scientific analyses to evaluate potential risk of their chemicals, from development through use and safe disposal.

Box: Summary of the 11 principles

1. Apply precise and accurate characterisations to chemicals: Chemicals should not be labelled as endocrine disruptors unless there is scientific consensus that they cause adverse health effects through an endocrine mediated pathway. This will prevent confusion and potential unnecessary market disruption.

2. Adhere to credible testing methods and data: Programmes should incorporate objective measures of data quality and follow Organization for Economic Cooperation and Development (OECD) guidelines for good laboratory practices.

3. Conduct thorough investigation: Screens and tests should examine hormone-related effects, characterise systemic toxicity and consider biological factors such as absorption, distribution, metabolism and excretion.

4. Mutual acceptance of data: Data from tests, conducted according to OECD guidelines, should be acceptable for use by multiple organisations so duplicative testing can be minimised.

5. Engage in transparent decision making: Testing programmes should engage in clear, public and consistent decision-making processes.

6. Be effective and efficient: Testing programmes should be designed to maximise efficiency and minimise delays.

7. Apply advanced technology: Programmes should utilise validated, new technologies to increase progress and reduce the need for animal testing.

8. Consider real world exposures: Testing programmes must incorporate relevant exposure information so conclusions are based on actual risk, not solely on hazard.

9. Incorporate weight-of-evidence analysis: All credible evidence should be incorporated to ensure that the most reliable and relevant studies carry the greatest influence on conclusions and outliers do not skew findings.

10. Embrace a proactive approach: Screens and tests should be highly sensitive and as accurate as possible. Screens should err on the side of over-identification, and in cases where results are ambiguous, further testing should be pursued.

11. Accept safe levels of exposure: Thorough examination can identify safe exposure levels. The hypothesis that low levels of exposure can cause harmful effects that are not adequately captured by traditional toxicological studies is often discussed, but rigorous reviews by scientists at regulatory agencies have been unable to validate the hypothesis, so changes to current testing and safety assessment approaches are not warranted. »

Article of Dr Sue Marty, PhD, ICCA representative on Unep Advisory Group on Endocrine Disrupting Chemicals; Dr Marty is also toxicology and environmental research and consulting science leader at The Dow Chemical Company.

Cet article n’engage que son auteur/ This article is the sole responsibility of the author

Green Chemistry and the Circular Economy

« This discussion on the circular economy focuses on recycling, reuse and use of renewable sources. However, another important aspect is to ensure that the cycle gives us material that is safe enough to reuse.


To achieve a circular economy, the market needs safe recycled materials of known and high quality, so that it can become an attractive alternative to virgin materials. Substances of concern ending up in recycled materials are an obstacle to this, which is why green chemistry and the innovation of new and safer substances is a key issue for non-toxic material cycles and the circular economy.

There is a great need for regulatory frameworks to address substances of high concern, through the whole material cycle. When products in use today become waste, we need to treat that waste so that hazardous substances are not re-circulated into new products.

Materials that contain substances of very high concern (SVHCs) are not at all suitable for recycling. If we allow material containing them in the recycling processes, we will both continue to expose ourselves and the environment to these substances and undermine the reputation of recycled material as something good for the environment.

Parts of the chemicals industry are preparing for the necessary shift – in the resource base for chemical production – from fossil feed stocks to renewable raw materials.

Such a transition provides opportunities to change the entire concept of synthesising and producing true green chemistry that promotes the development of non-toxic, resource lean and climate neutral solutions. When aiming to reduce the climate impacts of a material, the hazardous properties need to be fully considered by the industry and regulators as hazardous substances can also be made from bio-based sources.

Improved information on the contents of hazardous chemicals in products is essential for a greener economy.

Due to global trade, this is certainly an international issue and the Unep-led programme on Chemicals in Products (CiP) is a good starting point. This global programme focuses on increasing the availability and access to the information needed – throughout the life-cycle of products – so that informed decisions can be made on design, the way products are produced and handled and also the material in them.

At the fourth International Conference on Chemicals Management in late September and early October, it was agreed that all stakeholders of the Strategic Approach to International Chemicals Management (Saicm) should implement a CiP programme proposal. In the implementation of this programme, both industry and the authorities will need to take into account the link between the circular economy, green chemistry and sustainable development.

Efforts aimed at developing chemicals with less hazardous properties, such as low toxicity, good degradability, combined with good functionality, are regarded as a key aspect of “green chemistry”. From a regulatory point of view, safer chemicals and safe use is primarily a responsibility for the industry, with a framework of legal requirements aiming to ensure that this responsibility is met.

Regulation’s role in promoting green chemistry

A regulatory framework for chemicals management, where roles and responsibilities are defined, is an asset for doing business in a country. Companies that meet product and food safety standards, develop an improved potential for business expansion and international trade.

Regulatory frameworks thereby provide support and incentives for the chain of research, innovation and market introduction of safer chemicals. Well-functioning legislation that encourages substitution is, therefore, a central tool to support the development and use of substances with safer properties.

The European chemicals regulation REACH, the CLP Regulation, regulations for plant protection and biocides and other chemicals legislation all promote substitution of hazardous substances with less hazardous or methods without chemicals involved.

One purpose of REACH is to phase out SVHCs by progressively substituting them with safer chemicals or technologies. In 2012, the European Commission published a study that examined the impact of the REACH Regulation on the capacity to innovate in the European chemical industry. One finding was that the registration process has had an impact on innovation and that the candidate list of SVHCs is driving most activity.

To further promote less hazardous substances on the market, it is necessary to develop additional supportive policies and measures as a stable framework for the development of green chemistry. »

Article of Jess Clayton

Cet article n’engage que son auteur/ This article is the sole responsibility of the author

Presentations from Acute Toxicity Workshop Now Available

« Presentations from the Sept. 24–25 workshop on « Alternative Approaches for Identifying Acute Systemic Toxicity: Moving from Research to Regulatory Testing » are now available below and on the NICEATM website.

At this workshop, representatives from regulatory agencies, academia, and industries developed strategies for advancing alternative methods for product safety testing that meet the needs of regulatory agencies. The workshop was co-organized by NICEATM, Physicians Committee for Responsible Medicine, and PETA International Science Consortium Ltd., and was held at the National Institutes of Health in Bethesda, Maryland.

Materials from the workshop are available below and on the NICEATM website. The workshop proceedings will be submitted for publication early next year.

Acute systemic toxicity tests are the most commonly performed type of safety test worldwide. At this workshop, over 60 representatives from regulatory agencies, academia and industry discussed the state of the science of alternatives to animal use for acute systemic toxicity testing and explored ways to facilitate their implementation.

Workshop attendees identified several resources as necessary for meaningful progress in identifying and implementing alternatives: high quality reference data, training on use and interpretation of computational approaches, and global harmonization of testing requirements. Attendees particularly noted the need to characterize variability in reference data being used to evaluate new approaches. NTP and NICEATM scientists plan to take a lead role in coordinating data collection from a number of sources identified during the workshop.

Workshop breakout groups explored different approaches to reducing or replacing animal use for acute toxicity testing, with each group crafting a roadmap and strategy for accomplishing this within a three-year timeframe. NICEATM will coordinate the creation of and provide support for a working group comprised of workshop participants that will be charged with implementing the strategies.

Proceedings from the workshop will be submitted for publication in early 2016. Presentations from the workshop are available below.

This workshop was cosponsored by NICEATM, the PETA International Science Consortium Ltd., and the Physicians Committee for Responsible Medicine. »

Workshop Program

Session 1: The Regulatory Landscape: When Is Acute Toxicity Data Required and How Is It Used?

U.S. Consumer Product Safety Commission
Joanna Matheson, Ph.D., Directorate for Health Sciences, U.S. Consumer Product Safety Commission

Acute Toxicity Testing: Office of Pesticide Programs
Elissa Reaves, Ph.D., Office of Pesticide Programs, U.S. Environmental Protection Agency (EPA)

Requirements and Evaluation of Toxicity Testing in the TSCA New Chemicals Program
Louis Scarano, Ph.D., Office of Pollution Prevention and Toxics, EPA

Session 2: State of the Science for Acute Toxicity Testing Methods

Alternative Methods for Acute Systemic Toxicity Testing
Rabea Graepel, Ph.D., Systems Toxicity Unit, European Union Reference Laboratory for Alternatives to Animal Testing

From QSAR to Big Data: Developing Mechanism-Driven Predictive Models for Animal Toxicity
Hao Zhu, Ph.D., Department of Chemistry, Rutgers University–Camden

Biokinetic Considerations in the Use of In Vitro Systems for Estimating Acute (Systemic) Toxicity
Bas Blaauboer, Institute for Risk Assessment Sciences, Utrecht University

NRC Report: Application of Modern Toxicology Approaches for Predicting Acute Toxicity for Chemical Defense
David Dorman, D.V.M., Ph.D., Department of Molecular Biosciences, North Carolina State University

Session 3: Case Studies

Vision for Animal-free Pesticide Formulation Assessments
Sean Gehen, Ph.D., Dow AgroSciences LLC

Predicting Acute Toxicity Hazard in the Absence of Experimental Data: Case Studies from the Alternatives Assessment Paradigm
Jay Tunkel, Ph.D., SRC, Inc.

Zebrafish Models for Human Organophosphorus Poisoning
Natàlia Garcia-Reyero, Ph.D., U.S. Army Engineer R&D Center, U.S. Army Corps of Engineers

Session 4: Looking Ahead: Mechanisms and Adverse Outcome Pathways

Mechanisms of Acute Toxicity
Dan Wilson, Ph.D., The Dow Chemical Compnay

Computationally Predicted AOPs
Shannon Bell, Ph.D., Integrated Laboratory Systems, Inc.

High-throughput In Vitro Assays at NCATS
Menghang Xia, Ph.D., Division of Preclinical Innovation, National Center for Advancing Translational Sciences

Agenda : http://ntp.niehs.nih.gov/iccvam/meetings/at-wksp-2015/at-workshop-final-draft-agenda.pdf
Federal Register notice announcing workshop : http://ntp.niehs.nih.gov/ntp/pressctr/frn/2015/80frn152atm20150807_htm.pdf

Cet article n’engage que son auteur/ This article is the sole responsibility of the author