Under the terms of the National Endocrine Disruptor Strategy (SNPE), ANSES has published the results of its assessment of five chemical substances suspected of being endocrine disruptors. The Agency has also published its latest work concerning the assessment of the health risks associated with exposure to Category 2 reprotoxic substances and/or endocrine disruptors present in consumer products. These three reports reflect the current state of knowledge on the uses, the sources of exposure and the toxicity of several substances of the class of polybrominated compounds. The Agency is currently continuing its work by assessing the five substances listed in its 2017 work programme in the framework of the SNPE.
There are several chemical substances that can affect the normal functioning of the hormonal system and certain substances are suspected of having adverse effects on human health and the environment by this mode of action. ANSES has been working on this issue for several years and is continuing its expert appraisals on this theme.
Five substances assessed in 2016 in the framework of the SNPE
The third National Environmental Health Action Plan 2015-2019 (PNSE3) has set itself the challenge of contributing to the implementation of the SNPE and has entrusted ANSES with the task of "assessing more accurately and more specifically the hazards and the exposure of populations and the environment to endocrine disrupting substances so that their management can be improved". In this context, ANSES was given the mission of assessing at least five substances per year. ANSES has published its Opinion on the assessment of the five substances listed in its work programme for 2016: TMBPF (4,4'-methylenedi-2,6-xylenol), triclocarban, RDP (tetraphenyl m-phenylene bis(phosphate)), dicyclopentadiene and tin sulphate.
TMBPF, triclocarban and RDP were subjected to a Risk Management Option Analysis, following the procedure used by the European Chemicals Agency (ECHA) and the Member States of the European Union in the framework of the REACh Regulation.
Dicyclopentadiene and tin sulphate were assessed under the REACh Regulationon the grounds, respectively, of a suspected reprotoxic effect and suspected carcinogenic-mutagenic-reprotoxic (CMR) properties plus a sensitising effect.
In the framework of the SNPE, five other substances are currently undergoing expert appraisal as part of the Agency's work programme for 2017: homosalate, triflusulfuron methyl, triphenyl phosphate, bisphenol B and BDE-47.
The uses, sources of exposure and toxicity of substances of the class of polybrominated compounds
In 2009, ANSES was asked by the Directorate General for Health to identify and characterise exposure situations potentially posing a risk to health, especially the health of the most vulnerable populations, associated with the use of common consumer products and items containing certain chemicals.
Three reports have been published reflecting the current state of knowledge on the uses, the sources of exposure and the toxicity of several substances of the class of polybrominated compounds, commonly used as flame retardants in the manufacture of furniture and electronic equipment. The objective was to characterise the main toxic effects in connection with exposure to these compounds and to determine the major sources of human exposure.
On completion of this analysis, some brominated compounds such as BDE 28, 47, 99, 100, 153, 154, 183 and 209, tetrabromobisphenol A (TBBPA), and hexabromocyclododecane (HBCDD) were considered as justifying an assessment in the framework of the REACh Regulation. BDE-47 was chosen specifically for an assessment of its potential as an endocrine disruptor in humans and the environment, under the Agency's 2017 work programme, in the framework of the SNPE. The expert appraisal of this substance is currently under way.
These three reports mark the completion of the expert appraisals carried out and published by the Agency following the request by the Ministry of Health in 2009, on around 30 chemical substances identified as Category 2 reprotoxic and/or endocrine disruptors and found in consumer goods. These publications included studies of bisphenol A and other bisphenols, phthalates, and perfluorinated compounds.
Bisphenol A recognised by ECHA as having endocrine disrupting properties
It should be remembered that in February 2017, ANSES submitted a proposal to ECHA for bisphenol A to be classified as a Substance of Very High Concern (SVHC) in the framework of the European REACh Regulation, on the grounds of its properties as an endocrine disruptor for human health. This proposal was adopted by ECHA's Member State Committee in June 2017. The inclusion of bisphenol A on the list of Substances of Very High Concern opens up the possibility of limiting its uses, by making them conditional on the granting of a temporary, renewable authorisation.
A Risk Management Option Analysis (RMOA) is a guidance tool for the management of one or more risks related to the use of a substance: it helps determine whether or not a risk management measure (or a combination of measures) is justified. The RMOA was originally intended to be an informal step, prior to the formal proposal of a risk management measure (for example through the preparation of an Annex XV restriction dossier or the identification of a substance as being of very high concern, i.e. an SVHC). The REACh Regulation does not stipulate that such an analysis is necessary; it remains a voluntary action by the Member States or ECHA. It is also the format chosen by ANSES to analyse substances listed in the SNPE and suspected of being hazardous.
The REACh Regulation (EC) No 1907/2006 concerns the registration, evaluation and authorisation of chemical substances. It is based on the obligation on the producers and importers of chemical substances to provide data according to the tonnage of the substance, which effectively transfers the burden of proof from the public authorities to industry. In other words, the producer or importer is obliged to prove that its substance can be used without risk to human health or to the environment.
REACh provides for a thorough assessment of the substances for which there is any doubt or concern, in order to remove or confirm this doubt, by authorising the authority concerned to ask the company making the declaration for additional information, if necessary. The assessments are carried out on a voluntary basis by the Member States and, depending on the conclusions, can lead to requests for additional information and/or studies. If the Member State carrying out the assessment considers that the risk management measures proposed in the chemical safety report are insufficient to ensure the protection of people and the environment, it may propose risk management measures in addition to those proposed by the company submitting the declaration.