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Total Human Exposure Assessment Study including toxicogenomic approach (THEXAS-chem)

Objective

Specific Objectives:

The overall objective of the action will be to examine the potential risks for consumer health related to the presence of chemicals in consumer products and to identify the most relevant issues in that respect. Moreover, to establish and evaluate the link between products and processes as they affect human health in indoor and occupational environments:
1. To assess, validate, and harmonise methodologies to measure exposure of chemicals released from consumer products/articles (e.g. cleaning products, textiles, toys, building materials, food packaging, paints, wallpaper);
2. To develop, validate and harmonise methodologies and tools for integrated exposure assessment. This includes inhalation, dermal and oral exposure to chemicals;
3. To investigate the issue of exposure to chemicals (including exposure measurements to environmental tobacco smoke) and the associated health effects in indoor and occupational environments in order to define important and critical routes of exposure;
4. To develop, validate and harmonise methods and models to assess the relationships between chronic low and high dose (occupational) exposures to chemical substances from different routes (inhalation, dermal, oral);
5. To optimise mitigation measures to reduce exposure to chemicals according to cost/benefit considerations for society and sustainable development;
6. To evaluate science and policy issues related to total human exposure (including the interactions between chemical, biological and physical agents).

Anticipated milestones and schedule:
1. Establishment of a Pan-European R&D platform and Information/Reference System on "risks from chemicals in products and on the development /harmonisation of testing methods (EIS-CHEMRISKS);
2. Critical appraisal for establishing Indoor exposure limits for selected chemical substances in the EU;
3. Establishment of the Community Reference Laboratory for Food Contact Materials;
4. Validation and harmonisation of consumer exposure models;
5. Toxicological Assessment of Human Exposure to Chemicals;L%6. Preparation of the second update of the Cosmetic Ingredients Inventory.
Planned Deliverables:
EIS-CHEMRISKS: Formation of an Advisory Board and of a Steering Committee (January 2003) Kick-off meeting (April 2003) Feasibility Study and User Requirement Study on the design, development and operation of EIS-CHEMRISKS (May 2003) Organisation of sectoral workshops on "risks from chemicals in products" tattoo/piercing colors and materials (April 2003) clothing/textiles (June 2003) toys (October 2003), Progress report on the "Development of European Exposure Factors for Consumer Products/Articles" (December 2003) Progress report "Methodology review and development of standards for the determination of emissions of chemicals from products/articles and for the assessment of human exposure" (December 2003) Progress Report "Experimental studies in the INDOORTRON Laboratory on the determination of emissions of chemicals from products/articles e.g. Computer Products" (December 2003)) Progress Report on Tobacco Additives (December 2003) Progress Report on Risks from Tattoo and Piercing practices in the EU (December 2003) Progress report on the integration of harmonised modelling concepts of exposure to chemicals released from products into EIS-CHEMRISKS (December 2003) Progress report on the prospects for utilisation of biomarker data within EIS-CHEMRISKS (December 2003) Development and demonstration of a prototype web-tool for information exchange and dissemination within EIS-CHEMRISK (December 2003) Publication of the Annual Status Report of EIS-CHEMRISK (December 2003) Critical appraisal for establishing indoor exposure limits for selected chemical substances in the EU: Progress report on indoor exposure limits for selected chemical substances (December 2003) ECA report on "the harmonisation of indoor material labelling systems in the EU", (September 2003) ECA Report on "Ventilation, good Indoor Air Quality and national use of energy" Final, (April 2003) ECA Report on "Identification of risk groups in non-industrial indoor environments", (April 2003) ECA Report STRATEX "Strategies to evaluate the impact (contribution) of indoor air pollution on human exposure"), (October 2003).

Establishment of the Community Reference Laboratory for Food Contact Materials: AREA 1 METHOD DEVELOPMENT, HARMONISATION AND MONITORING:
1. Contaminants from can coatings 1.1. Finalisation of method description (part of CEN TC 194 SC1 WG8) May 03 1.3. Chairing of working group 8 of CEN May 03, Oct. 03 1.4. Preliminary phase of trial May/Nov03 Note: phase of trial is contigent to CEN mandate finalisation by the DGs;
2. Contaminants from adhesives from multilayer materials 2.1. Contribution to method development for the quantitative confirmation of primary aromatic amines (on-going) 2.2. Chairing of task group 9 of CEN TC 194 SC1 May/Oct03;
3. Contaminants from baby food jars sealant 3.1. Publication of EU survey on Epoxidised soybean oil (ESBO) Jan. 03 3.2. Presentation of results to the Scientific Committee for Food (SCF) Jan 03 3.3. Joint Industry study for the determination of migration parameters 3.3.1. presentation of EU survey to joint industry group Jan 03 3.3.2. examination /factorial analysis of results March 03 3.3.3. Selection of model system/food and parameters for systematic study May 03 3.3.4. finalisation of sample types and manufacture June 03 3.3.5. Sample analysis July-December 03 3.4. Presence of chlorohydrin adducts from ESBO in baby foods 3.4.1. presentation of analytical strategies to the SCF Jan 03 3.4.2. Finalisation of quantitative method for food March 03 3.4.3. Isolation of chlorohydrin for toxicity testing March 03 3.4.4. Toxicity testing of chlorohydrins MayÂ-Sept 03 3.4.5. Interpretation of results and report to Commission Sept-Dec 03 4. Contaminants of dry foods 4.1. Comparison of dry simulant and fatty foods June 03 4.2 kinetics of migration on paper and board, May 03 4.3. preliminary data on multilayers comparing liquid and solid simulant. Sept 03 4.4. comparison of various simulants for dry foods Oct. 03 AREA 2 - PREPARATION OF FUTURE WORK AND SUPPORT TO POLICIES 1. Groundwork for validation of methodologies 1.1. Transfer of petition methods to electronic format (n>250) April 03 1.2. Checking of method description and refinement into CEN model June 03 1.3. Initiate merging of similar methods for multianalyte testing approach March-Dec03 1.4. Initiate in-house testing Nov. 03;
2. Support to CEN 2.1.Chairing the working group CEN TC 194 WG8 (analysis of coatings) May/Oct.03 2.2.Charing of CEN TC 194 WG2 TG9 (analysis of aromatic amines) May/Oct.03;
3. Performance Testing Participation in proficiency testing for rounds of 11th, 12th and 14th series consisting of overall migration, specific migration and oils and fats analysis, respectively (2 tests per year for each series);
4. Community Reference Laboratory 4.1. Accreditation scheme on-going 4.2.1. quality manual May 03 4.2.2. validation of method Dec 03 4.2. Strategy planning June03 4.3. formation of board of advisors Sept. 03 AREA 3 DISSEMINATION OF INFORMATION AND PUBLIC SERVICES 1. Reference collections of monomer and additives 1.1. stability testing of substances (n>300) by FT-IR May 03 1.2. stability testing of substances (n>300) by GC-MS June 03 1.3. stability testing of substances (n>300) by NMR June 03 1.4. new substances characterisation and insertion all 2003;
2. Databanks 2.1. Creation of entirely electronic databank for the legislative, toxicological, physico-chemical and spectral information of the reference collection June 03 2.2. Update of databank of spectra (FT-IR, GC-MS, NMR) June 03 2.3. Development of an interfacing of the databank to a web base Dec. 03;
3. Dissemination of information (http://cpf.jrc.it/webpack/). 3.1. update with a focus on ERA and the 6th framework programme June 03 3.2. Update of legislative documents June 03 4. Service to IRMM Stability testing of the BCR 537, 538, and 539 for overall migration in olive oil Feb. 03 Validation and harmonisation of consumer exposure models: Progress Report (December 2003) Toxicological Assessment of Human Exposure to Chemicals: Toxicogenomic analysis for the "in vivo" experiments on arsenic in drinking water (June 2003) Workshop on gender Differences in Risk Assessment (October 2003) Report on assessment of toxicogenomic approaches in chemical toxicology (December 2003) Scientific papers on toxicogenomic evaluation in mice exposed to arsenic in drinking water (October 2003). Preparation of the second update of the Cosmetic Ingredients Inventory: Progress Report (December 2003).
Summary of the Action:

The EU Environment Council has put forward a request to the European Commission to undertake action for eliminating existing deficiencies in data on human exposure to chemicals. This gives the JRC a clear mandate to accurately evaluate the risk for European citizens deriving from the overall exposure to chemicals through different routes (food intake, air inhalation, skin contact, etc.) occurring in indoor and occupational environments. In the frame of this action human exposure is seen a holistic approach, which includes estimates and assessment of exposures to chemicals released from products and articles (e.g. VOC, phthalates, biocides, dyes etc.) as the basis for the development, testing and implementation of: - consumer exposure models - common measurement methods and protocols - exposure guidelines.

The work will be carried out in dedicated laboratories specialised on the different types of exposure pathways to chemical substances. These are being developed to act in their respective areas as Reference Laboratories at EU level to improve the currently achievable quality, representativeness and comparability of measured data related to consumer and occupational exposure. Rationale For the development and efficient implementation of European policies in the field of chemical substances in order to protect human health and the environment, the Commission needs sound scientific knowledge on occurrence, source strengths, distribution and fate and on reliable exposure data.

In the current stage of the development of the EU strategy on chemicals, there is abundant evidence among experts and policy makers, that human exposure data represent a major bottleneck to any level of risk assessment. The EU Council of Environmental Ministers has put forward a request to the European Commission to undertake action for eliminating existing deficiencies in exposure data. This gives the JRC a clear mandate to accurately evaluate the risk for European citizens deriving from the overall exposure to chemicals through different routes (food intake, air inhalation, skin contact, etc.) occurring in indoor and occupational environments.

Funding Scheme

JRC - Joint Research Centre research

Coordinator

Institute for Health and Consumer Protection
Address
Via E. Fermi 1
21020 Ispra
Italy