Chemicals Health Monitor

Major medical and scientific societies recognize the harmful effects of endocrine-disrupting chemicals and work towards precautionary policy

Monica Guarinoni — 2009-11-24T12:31:18Z

A major medical and scientific society, the Endocrine Society, has released a Scientific Statement on Endocrine-Disrupting Chemicals. The Society, a renowned body devoted to research on hormones and the clinical practice of endocrinology, states that chemicals can have endocrine-disrupting effects, and that effects vary based on age when exposed, exposure to mixtures, latency of chemicals, and other factors. In particular, they note that the research regarding adverse reproductive effects is “strong,” and that there is growing evidence for assorted other endocrine system effects as well. The Endocrine Society recommends using the precautionary principle to inform how exposure to endocrine disruptors and potential endocrine disruptors is regulated.

The American Medical Association (AMA), in response to the Endocrine Society's Statement, has passed a resolution in support of the AMA working with the US government to develop policies that decrease exposure to endocrine-disrupting chemicals. They are particularly committed to regulation that centralises oversight of endocrine-disrupting chemicals, that considers low-level exposures, and that involves scientists from multiple relevant specialties in the policy-crafting process.

These two initiatives broaden the base of institutional support for precautionary policies regulating the use of endocrine-disrupting chemicals, and are a significant call for action on endocrine disruptors.

HEAL supports policies that are both precautionary in nature and consider the cumulative risk of endocrine-disrupting chemicals to protect public health.

REACH question time at the European Parliament: October 2009

Monica Guarinoni — 2009-11-24T12:28:41Z

On 6 October 2009, Commission staff from DG Enterprise (Zourek) and DG Environment (Borchardt) answered questions raised by members of the Committee on Environment, Public Health, and Food Safety about the implementation of REACH.

Commission staff described some of the challenges associated with REACH, including setting up ECHA within a short time period, pre-registration of an enormous number of chemicals, and offering technical guidance to companies as they register their substances.

The number of chemicals that companies pre-registered greatly exceeded estimates, but it is expected that companies will only go on to formally register: approximately 75,000 chemicals. For those chemicals being registered before the deadlines, the average time that has been needed to complete a dossier is one year, but depends on tonnage and includes test time. However, the quality of dossiers submitted for registration so far has been sub-par: only 120 registrations have been completed out of 600 dossiers submitted.

The Commission also discussed that it reviewed the criteria for persistent, bioaccumulative, and toxic (PBT) and very persistent and very bioaccumulative (vPvB) substances, and has decided that they need to be amended. MEP Schluyter advocated on behalf of the majority of member states, and the European Chemicals Agency, for a position shared also by a number of health and environment stakeholders, that the Commission adopt a particular option in its revision. This option involves consistency with UNEP Stockholm Convention on Persistent Organic Pollutants (so that chemicals identified here are also identified as PBT / vPvB chemicals under REACH), recognition of new science (differing modes of bioaccumulation between air breathing and water organisms – some chemicals bind to proteins instead of lipids), as well as the use of expert judgment that could take a weight of evidence approach.

Commission staff also addressed questions about the amount of animal testing required to comply with REACH, and maintained that the number of animals required for tests will be the same as originally estimated, refuting a recent study that estimated the number of animals required to be substantially higher.

Read also:
Invisible burden - Good reasons to get rid of PBT chemicals

EU Laws regulating harmful chemicals in electric products being revised: first discussion in EU Parliament

Monica Guarinoni — 2009-11-24T12:25:41Z

The WEEE (Waste Electrical and Electronic Equipment) and RoHS (Restriction of Hazardous Substances in Electrical and Electronic Equipment) directives are being revised in an attempt to improve upon the text passed originally, now that initial lessons from implementation can be learned. At a first discussion on the topic in the European Parliament, Members of the European Parliament (MEPs) considered how these two directives should be considered in relation to REACH, and also in relation to each other. In particular, expanding the scope of each directive was discussed as a potential revision.

With regards to the waste Directive, MEPs were particularly troubled by the finding that only 33-40% of eligible electric and electronic equipment was processed under WEEE regulations (despite 85% being collected). Additionally, MEPs advocated for harmonized enforcement across member states, as opposed to the wide variations observed currently.

With regards to RoHS, a major change proposed would be to shift the burden of proof to the manufacturer for obtaining an exemption which would allow them to use a banned substance in a particular application, rather than, as it currently stands, on the Commission. And although a binding list of chemicals to be regulated has been proposed, what this list would look like in reality was debated and discussed. However, MEPs agreed that having such a list would allow for more effective harmonization across member states and across different chemical regulations.

RoHS was also discussed in the European Parliament on November 18th, at a conference on greening consumer electronics that was organised by the International Chemical Secretariat (ChemSec).

Chemicals Agency Director Discusses REACH at European Parliament

Monica Guarinoni — 2009-11-09T10:07:51Z

On November 3, the executive director of the European Chemicals Agency (ECHA), Geert Dancet, attended the European Parliament Committee on Environment, Health, and Food Safety to discuss REACH. Dancet identified three major challenges the Agency will be facing in 2010, which will be one of the most important years for REACH's implementation, with the first deadline for companies to submit health and safety information about and thereby register their chemicals. The primary challenge for the Agency will be managing the registrations submitted, given uncertainties in the volume of registrations and when they will be submitted prior and up to the deadline.

This first batch of registrations, which must be submitted by 1 December 2010, is an important stage in REACH. It will be instructive to see how well this stage goes, particularly as this first deadline applies to some very harmful chemicals:
those which are recognized carcinogens, mutagens and toxic to reproduction (CMRs); and
to chemicals produced and used in very high volumes (1000 tonnes per year), and
to chemicals which are very toxic to aquatic organisms and produced at over 100 tonnes per year).

The purpose of registration is to reverse the situation under prior legislation which had not produced sufficient, publically available information about the health and environmental effects of the majority of chemicals on the EU market. The identification and assessment of risks – both of a chemical's intrinsic hazard, and from actual exposure to humans and the environment – had been very slow, as had the subsequent application of measures to control, reduce or eliminate the risks. Now, any company manufacturing or importing a chemical must submit a registration for each substance manufactured or imported in quantities of 1 tonne or above per year. Failure to register means that the substance is not allowed to be manufactured or imported. Through registration, not only will a certain amount of information about chemicals on the market become centrally held and publically accessible (see related CHM article), but also the phase is intended to ensure that all agents from the chemical manufacturers all the way through the downstream users chain, to the final retailer, have information about and are responsible for understanding the properties of the chemicals they are using, and manage the potential risks.

In the Parliamentary Committee, many MEPs questioned whether, since there were twenty times more pre-registrations than expected, the expected number of registrations would remain as estimated. Dancet said that the Agency expects the same number of registrations as estimated earlier, for several reasons: the same chemicals were pre-registered multiple times, companies pre-registered all chemicals they had ever produced (including some that they're no longer manufacturing), and that the fee structure associated with registration of chemicals will discourage unnecessary registrations of chemicals. Nevertheless, ECHA has developed alternate scenarios to determine how they will respond if the number of registrations exceeds original estimations.

MEPs also asked questions about small- and medium-sized enterprises (SMEs) and how they are managing with their obligations under REACH. Dancet reported that ECHA is offering support to SMEs in the registration process, including through national help desks to ensure that assistance is provided in all EU languages, but that SMEs will generally not be affected by this first deadline because they are producing substances at smaller volumes, so they will have more time to prepare within the deadlines specified by REACH.

Jo Leinen, chair of the Environment Committee, closed the discussion by emphasizing that REACH and ECHA form an important cornerstone of environmental work in the European Union.

US EPA releases principles for precautionary reform of US chemical regulation

Monica Guarinoni — 2009-11-09T09:59:40Z

Lisa Jackson, the new chief of the US Environmental Protection Agency appointed by President Obama, announced on 29 September the Obama administration's goals for reform of the US's 1976 Toxic Substances Control Act (TSCA). This is the single central piece of legislation at federal level that governs the management of industrial chemicals. The proposed reforms are precautionary in nature, including protecting susceptible subpopulations, encouraging green chemistry, and increasing access to information. Moreover, the reforms are similar to REACH in that they require manufacturers to prove a chemical's safety. The Obama administration and the EPA plan on working with Congress in the upcoming months to develop legislation to strengthen TSCA.

For more information, visit:

• EPA principles for chemicals policy

• more information from EPA

• Environmental Defense Blog posting

A Problematic Approach to Assessing Chemical Safety? The EU Scientific Committees on the Threshold of Toxicological Concern and HEAL submissions

Monica Guarinoni — 2009-11-09T09:55:33Z

The news:

The Threshold of Toxicological Concern (TTC) concept posits that for chemicals whose toxicity is well understood, safe levels of exposure can be developed for those chemicals and related chemicals, that is, for ‘classes' of chemicals.

The European Union's three Scientific Committees are jointly working on a report on how TTC could be used in the European Union, as per the request of the European Commission last year. In particular, the committees were tasked with determining if TTC was appropriate for assessing the human health risk of chemicals for consumer products (including cosmetics) and food materials. A working group comprised of members from the Scientific Committees on Consumer Products; on Health and Environment; and on Emerging and Newly Identified Health Risks prepared a draft report last December and held a public consultation on its contents. At that time, the Health and Environment Alliance, and two environmental groups, the European Environmental Bureau, and WWF, put in submissions regarding weaknesses in the draft report. Subsequently the draft report was revised, and a scientific hearing was held on September 24th 2009.

HEAL input to the Scientific Hearing on TTC:

Professor Dr. Nik van Larebeke, of Ghent University's Study Centre for Carcinogenesis and Primary Prevention of Cancer, presented public comment on behalf of HEAL that critiqued the TTC method for three primary reasons:

Does not account for mixed exposures and potentially synergistic interactions between chemicals

Does not account for higher sensitivity of vulnerable subpopulations, including developing fetuses and children

Does not sufficiently protect against mutagenic substances that may be more toxic at lower levels (this phenomenon is known as having a supralinear dose-response curve)

HEAL's representative Dr. van Larebeke and the European Environment Bureau's representative Tony Tweedale also discussed the nature of the threshold of toxicological concern as being scientifically invalid for any chemical that disrupts hormones (commonly known as endocrine disruptors), and as most chemicals have endocrine disrupting properties, the TTC approach may be only rarely useful. They also explained that the TTC approach should not apply to REACH.

For more details, please see HEAL and EEB's written submission and comments provided by Professor Dr. N. van Larebeke of Ghent University on behalf of HEAL (see uploaded documents).

Next steps:

The EU Scientific Committees working group on TTC will review the comments given at the Scientific Hearing and prepare another revision of the report, which will be subsequently be published on the Scientific Committees website, if adopted by a vote of the joint Scientific Committees.