EuroMix presented at the National Toxicology Programme (NTP) workshop at US EPA, Washington DC, April 29-30, 2019.
Johanna Zilliacus from Karolinska Institutet, Sweden was invited to present the EuroMix AOP based approach for mixture testing and risk assessment and discuss in a break out group how the EuroMix approach can contribute to development of mixture risk assessment of carcinogens based on in silico and in vitro data. More information on the workshop can be found here.
The EUROMIX consortium organised the fourth of a series of workshops to discuss international harmonisation of approaches to the risk assessment of combined exposure to chemicals on 15 April 2019. The workshop was held at WHO HQ, Avenue Appia 20, 1202 Geneva, CH. The 18 participants at the workshop were drawn from a range of geographical and regulatory areas, with risk assessors from several regions (Europe, North America, South America and Asia) and organisations (EFSA, JRC, OECD, WHO, FAO, RIVM, BfR, ANSES, FSNAZ, CFSA) present.
The main aims of this workshop were to evaluate the EuroMix
Handbook, section by section. On this basis, a number of risk assessment bodies
were asked to provide (i) their perspectives on the potential utility of the
Handbook in the risk assessment of combined exposure to multiple chemicals by
their own organisations and (ii) their feedback on how the Handbook could be
improved. Participants were also asked to consider which sections of the
Handbook would be most relevant for discussion at the WHO Expert Consultation,
16-18 April 2019, and to identify any potential limitations.
The Handbook was generally well received. Participants felt
that it was clearly laid out and that, together with the Toolbox, it should
make a significant contribution towards international harmonisation of
approaches and methods used in the risk assessment of combined exposure to
Participants made a number of suggestions on how the Handbook might be clarified or extended. The Handbook should be “neutral” in the approach and methods used, to provide maximum flexibility for the range of problem formulations that arise in different chemical sectors and regions. The difference among the Handbook, the Toolbox and the User Manual for the Toolbox, and their respective roles should be clarified. The balance of the text, which is extensive in some areas but relatively short in other, equally important, areas should be improved. Guidance should be provided on options where AOPs are not available for the chemicals being assessed, including assessing confidence in AOPs developed de novo for an assessment and options where AOPs cannot be developed. Options should be discussed also for exposure-based grouping rather than only toxicologically-based grouping of chemicals. The section on exposure should be expanded to consider approaches in addition to the full probabilistic assessment described. It should be ensured that templates are suitable for data exchange, for example are harmonised with the OECD templates for data collection. Some guidance should be provided on reporting standards, including suitable summaries for risk assessors and for risk managers.
The participants concluded that there were several sections of the Handbook and modules in the Toolbox that could potentially contribute to risk assessment of combined exposure to multiple chemicals by JECFA/JMPR and that would merit discussion at the Expert WHO Consultation, to be held 16-19 April 2019. However, potential limitations were also identified, including availability of suitable data on exposure, formats for consumption data, transparency of the models used in the Toolbox, and the need for verification of methods, algorithms and software.
A report of the workshop has been prepared and is available here.
On April 16-18, 2019, WHO was responsible, within the EuroMix project,
for organising an expert consultation in WHO/HQ Geneva. The consultation
involved experts from EU and non-EU countries on the development of guidance
for the risk assessment of combined exposure to multiple chemicals.
An overview of the JECFA (Joint FAO/WHO Expert Committee on Food Additives) and JMPR (Joint Meeting on Pesticide Residues) processes and a summary of the EuroMix Handbook and Toolbox were presented.
A practical approach to the risk assessment of combined exposures to multiple chemicals was developed to be piloted by JMPR and JECFA in 2019.
The proposed approach is summarised in a report that can be accessed here.
The final report will be published soon and include the summary of presentations.
Imperial College London, London W12 0NN, UK
25 October 2018
The EuroMix consortium organised the third of a series of workshops to discuss international harmonisation of approaches to the risk assessment of combined exposure to chemicals on 25 October 2018. The workshop was held at the Hammersmith Campus, Imperial College London, London W12 0NN, UK. The 15 participants at the workshop were drawn from a range of geographical and regulatory areas, with risk assessors from several regions (Europe, USA, Canada and Brazil) and authorities (EFSA, JRC, OECD, WHO, US EPA, RIVM, BfR) present.
The main aims of this workshop were to explore ways in which
the EuroMix toolbox can contribute to harmonised scientific approaches to the
risk assessment of combined exposures to chemicals in the diet, in relevant
legislation. In support of this objective, illustrative case studies from the
USA and from Europe were presented and discussed, and used to inform guidance
for consideration at the final workshop.
The programme and presentations can be accessed here.
In general, there is appreciable alignment of the principles
for assessment of combined exposure to multiple chemicals by OECD, EFSA, EPA
and other organisations. These all emphasise the importance of problem
formulation, including specification of the objectives and acceptable degree of
uncertainty for assessment, the basis for grouping chemicals and the choice of
assessment approach. There is also general agreement on the need for tiered
approaches for both hazard and exposure assessment, to avoid being overly
conservative. The use of mode of action information in refining assessment
groups has also been broadly incorporated, as has been transparent delineation
of uncertainties at each tier. In a number of chemical sectors, there is common
application of these principles. However, in the area of pesticides, there are
significant differences between the proposed approach in Europe and that which
is in use in the USA.
The EuroMix toolbox has potential application, regardless of
the approach used, in different sectors or geographical regions, for both data
rich and data poor chemicals. Whilst harmonisation of the specific risk
assessment methodology might not be possible, at least in the short term, the
EuroMix toolbox can contribute to harmonisation of the principles used, in
addressing the above issues, the standard of reporting and data templates.
EuroMix is developing a Handbook to provide best practice for the range of
problem formulations that might concern risk managers and will encourage
further harmonisation, to the extent possible.
The conclusions of the workshop have been written
up in the report of the meeting and will be explored further at the 4th
workshop in the series, to be held in Geneva, 15th April 2019.
On 26 March
2019 two Horizon2020-funded projects, EDC-MixRisk
and EuroMix, held a joint stakeholder
workshop, entitled The Chemical Cocktail Challenge, at Thon Hotel EU,
Brussels. This workshop was organised to gather key scientists,
researchers, policy makers, and stakeholders from authorities, industry and
civil society. The aim of the workshop was to highlight
the main results and conclusions from the two projects, and their implications
for future needs for chemical mixture risk assessment. Both projects
presented key results and demonstrated new tools and approaches for risk
assessment of combined exposure to multiple chemicals (mixtures) and how these
could benefit future European food and chemical safety policy.
Abstracts from the joint morning session can be found here.
In total, 116
participants attended the joint stakeholder workshop with representation from
the European Member States and the associated countries, as well as the USA,
Canada and Japan.
Abstracts from the EuroMix afternoon session can be found here.