Substances Reprotoxiques

ANSES publishes its recommendations to reduce exposure to five substances which are reproductive toxicants and/or endocrine disruptors

ANSES was asked in 2009 by the Ministry of Health to identify and characterise exposure situations potentially posing a risk to health and associated with common consumer products and/or items containing certain chemicals classified as Category 2 reproductive toxicants (according to the European CLP regulation) or considered to be endocrine disruptors. Today, ANSES publishes several expert assessment reports and an opinion on five of these substances. The conclusions of the expert assessment reveal evidence of exposure situations that potentially pose a risk for embryonic or foetal development in association with exposure by pregnant women to toluene, n-hexane and cis-CTAC found in certain items or products. ANSES issues recommendations which aim to reduce the exposure of pregnant women to all five of the substances under study, in general and in the workplace in particular. It also is issuing recommendations specific to each of these substances.

ANSES was asked in 2009 by the Ministry of Health to identify and characterise potential exposure situations posing a risk to health and associated with common consumer products and/or items containing certain chemicals. This request involved approximately 30 chemicals classified as Category 2 reproductive toxicants (according to the European CLP regulation) or identified as being potential endocrine disruptors by the European Commission. Today ANSES publishes its reports and opinion based on the health risk assessment of: 

  • three substances classified as Category 2 reproductive toxicants:
    • n-hexane, used as a solvent in consumer goods;
    • toluene, used as a solvent or as an intermediate in chemical synthesis;
    • cis-CTAC, used as a preservative in numerous products, and in certain repellents in particular.
  • two substances identified as potential endocrine disruptors by the European Commission:
    • o-phenylphenol (OPP), used for its biocidal properties as a disinfectant and preservative;
    • methyl tert-butyl ether (MTBE), used as an additive in petrol.

ANSES's expert assessment work

ANSES entrusted the multidisciplinary working group on endocrine disruptors, created in 2010, with this expert appraisal. The experts assessed the available scientific literature on these five substances, targeting the effects on reproduction in particular and identifying data on the mechanism of action of endocrine disruptors.

The experts assessed the risk for populations which might be exposed to these substances through the use of products or articles containing the various substances in question, including in an occupational setting. In fact, the exposure levels due to the use of these products in a work context are often higher than exposure by the general public. 

Identification of the products containing these substances, which are marketed in France, was made possible thanks to a literature review and a survey of manufacturers, which pinpointed certain products, items and uses. However, these data did not enable an exhaustive inventory to be made of all of the products containing these substances, especially those used as preservatives in a large number of mixtures.

ANSES's conclusions

ANSES emphasises how difficult it is to gather information on consumer goods and associated formulation data representative of the French market. Nevertheless, this data is essential in order to characterise population exposure and the possible risks to health. The experts have therefore had to issue hypotheses all throughout the expert assessment process, as well as to identify the sources of uncertainty, to qualify them and to take them into account in the conclusions included in the reports and opinion issued by the Agency. 

In view of the experts' conclusions, ANSES considers that exposure situations posing a potential risk for embryonic or foetal development may exist, due to occupational or non-occupational exposure of pregnant women to certain products containing toluene, d-hexane or cis-CTAC. 

Situations posing a risk for reproduction (MTBE) and the nervous system (toluene and n-hexane) have also been brought to light, although the Agency emphasises that strong uncertainties exist with regard to the risk situation identified for MTBE.

In addition, the five substances being examined in this expert assessment are also currently undergoing risk assessment in the framework of the REACh regulation  (for n-hexane, toluene and MBTE) and of the Biocides regulation  (for cis-CTAC and OPP). ANSES participates in the EU’s examination of these substances, both in its assessment capacity (MTBE in 2014), and by examining and commenting on the work of the other Member States and participating actively in discussions within the European institutions. These evaluations take into account all of the publicly available information as well as information from dossiers provided by the manufacturers. Once these evaluations have been made, the additional information they provide on the uses and hazards of these substances and on exposure to them, will make it possible to fine-tune the findings of ANSES’s risk assessment work on the topic.  

ANSES recommendations

In view of the potential health risks linked to exposure to these five substances, ANSES recommends the following measures:

  • pregnant women should avoid using the DIY products, cleaning products and repellents identified in the risk assessment work conducted by the Agency which contain toluene, n-hexane or cis-CTAC;
  • inform the general public and worker populations, especially pregnant women, of the potential risks for the foetus linked to use of products containing these substances;
  • inform the general public about hygiene measures and good practices that make it possible to limit the exposure of pregnant women: ventilate and aerate indoor areas when using these types of products, avoid using them in combination, comply with the recommendations for use and reduce the time that pregnant women are present during the application and the drying phases, especially in occupational environments;
  • educate health professionals (general practitioners, gynaecologist-obstetricians, midwives, etc.) about the potential risks linked to use of products containing these substances during pregnancy;
  • add to and update the inventory of consumer products available on the French market which contain the substances in question, and in doing so enable access to their formulation data;
  • improve the availability of data on the contamination of air in lodgings, outdoor air, and settled dust in indoor environments;
  • reinforce modelling work by providing exposure measurements representative of the actual conditions of use of consumer products by users;
  • revise the reference values currently in force for three of these substances (occupational exposure limits (OELs), toxicity reference values (TRVs));
  • identify biomarkers of internal exposure or of effects;
  • identify substitutes for the various substances studied for which risk situations have been identified, and evaluate their toxicity.

The Agency also issues in its opinion specific recommendations for each substance, in order to grow knowledge on the hazards of these substances and their modes of action, on the possibilities for substitution, as well as on the different routes of population exposure.

ANSES is pursuing the risk assessment, scientific monitoring and research work on substances identified as Category 2 reproductive toxicants and/or potential endocrine disruptors that it began in 2009 at the request of the Ministry of Health. 

In 2014, as part of the National strategy on endocrine disruptors, the Ministry of Ecology also asked ANSES to assess five suspected endocrine disruptors within the framework of the REACh regulation.