Risk assessments linked to chemical substances resulting from long exposure at low doses, which must be carried out in particular within the scope of polluted soil studies or within the scope of ICPE (Classified Installations for Environment Protection) impact studies are built up, in part, from physical, chemical, toxicological, ecotoxicological, analytical and regulatory reference data that characterises the chemical substances in question.
The Pollution and Risk Prevention Division of the French Ministry for Ecology, Sustainable Development and Spatial Planning has therefore asked INERIS to make available to risk assessors and, more generally, to all parties interested in the assessment of these risks, a set of "toxicological and environmental data sheets" intended to constitute an operational tool summarising the technical data and information available, thus facilitating the task of risk assessment.
INERIS draws up these toxicological and environmental data sheets for chemical substances by using, as a priority, published and recognised information of a scientific or regulatory nature.
For "existing substances", as defined by European legislation, the monographs published by internationally recognised organisations are examined.
Recent data produced by known and widely recognised independent authors is also used. In certain cases, this data can still be open to some debate. If so, this is mentioned in the data sheet.
In this way, INERIS formulates proposals for certain assessment and exposure parameters and for concentrations without foreseeable effects on the environment - fauna/flora - (its PNEC or Predicted No-Effect Concentration value). These proposals are drawn up in accordance with methodological guidelines put in place by the European Union. Some of these already reflect a scientific consensus at the European Union level whereas others still need to be discussed at a European level.
Status of toxicological and environmental data sheets
The data sheets have informative value. INERIS points out that it is not qualified to set limit values of a health or environmental nature.
It is therefore up to risk assessors themselves to justify the use that they make of the information and data taken from the data sheets.
The use of all or part of the data detailed in the toxicological and environmental data sheets for chemical substances is the sole responsibility of risk assessors.
Similarly, the scientific accuracy of the data detailed in the data sheets, which has been gleaned from internationally recognised publications, is the sole responsibility of the authors of these publications, which are always cited in the data sheets.
These data sheets are the property of INERIS and are available for downloading free of charge. They can be downloaded, used and copied freely unless otherwise specified in the data sheet concerned.
However, if thesedata sheets are posted on an intranet network or disseminated from another website, even if there is a link to the INERIS website, prior authorisation must be obtained from INERIS.
How the data sheets are developed
The development of these data sheets is carried out in compliance with the deontology rules in force within INERIS and in accordance with a methodology aiming to ensure the quality, the consistency, the exhaustiveness within the limit of recognised scientific knowledge and the appropriate nature (particularly with regard to existing regulations) of the information proposed to be detailed in the toxicological and environmental data sheets.
The toxicological and environmental data sheets comprise the following headings:
General remarks, date last updated
Evolution in the environment
Exposure assessment parameters
Toxicological data for human health
Official health and environmental data and statistics
Methods of detection and quantification in the environment
Group of experts
INERIS has set up a multidisciplinary group of experts with expertise in the various aspects detailed in the toxicological and environmental data sheets for chemical substances. This group is responsible for developing data sheet projects within the scope of the work programme defined in agreement with the Ministry.
Process for validating data sheets
The toxicological and environmental data sheets are firstly examined with a view to establishing a consensus within the working group. INERIS’ Chronic Risks Department then transfers them for validation to the Institute’s Scientific Department, which submits them to the review of one or several external experts.
After finalisation, the toxicological and environmental data sheets are then sent to the DPPR (Risk and Pollution Prevention Division) of the French Ministry for Ecology, Sustainable Development and Spatial Planning , then published on INERIS’ and the Ministry’s websites.
Indicative list of websites
As an example, herewith a few websites of French and international organisations that it may be useful to consult within the scope of risk assessment studies.