What are the main contentious issues of this declaration?
Proven impact on human health
With this new definition of endocrine disruptors, the European Commission suggests that specific attention should be paid to evidence, since the question is to prove �the relevant effects to human health�. This reference to the effects on human, and not mammal health limits the quantity of evidence currently available.
Indeed, according to the civil society, several warning signals usually come from experiments on animals and not on humans. To illustrate their words, various spokespersons remind that barely a hundred substances are considered as certain carcinogenic for human (according to OMS classification). Effects on humans can take years to appear, hence the importance of in vitro tests or tests on animals. According to the HEAL association, the ensuing risk would be the occurrence of health damages before the withdrawal of the incriminated substances from the market.
As for industrial business associations, many support this point of the new definition. Indeed, the previous definition was often considered by industrials as �over-cautious� and unrealistic with regard to available evidence. Thus, it would allow companies to reintroduce substances on the market that had been considered dangerous but whose impact on human health had never been proved.
Classification by category
The approach chosen by the Commission consists in a binary classification and not a classification by category as it is the case for carcinogenic substances. If the substance is classified as endocrine disruptor, it will be banned. Otherwise, it will be accepted.
Scientists and civil society members criticize this measure, stating that the precautionary principle is totally put aside. The classification by category, which is supported by these actors, leaves room for doubt: the harmfulness of a substance is certain, suspected or uncertain.
The industry is also disappointed by this classification. ECPA�s executive director Jean-Charles Bocquet declared that the Commission proposal �may lead to banning plant protections products, which have the same endocrine disrupting properties as everyday products like coffee�.
Hazard-based approach
As a reminder, the European Commission considers that �a hazard-based approach regulates substances on the basis of their intrinsic properties, without taking account of the exposure to the substance. A risk-based approach factors in the exposure�.
In its definition proposal, the European Commission declares that �Under this legislation, as a general rule, endocrine disruptors are banned on the basis of hazard, without undergoing a specific risk assessment on the basis of considerations of exposure (although in some cases derogations � either hazard, risk or considering socio-economic issues � may apply on a case by case basis, as stipulated by the legislation).�
NGOs and some politicians agree on the fact that it is essential that substances should be judged on their inherent proprieties, and not on the exposure quantity of an individual. For them, the possibility of derogations is a huge risk.
On the contrary, industrials think that risk-based approach should not be a simple derogation but the general European rule.
This is why industrials support the integration of the notion of potency to the definition (the potency of a chemical substance describes its ability to produce an effect at a particular dose level) which reflects the risk-based approach.
New possible grounds for derogations
Until now, the EU legislation for biocidal products and plant protection products provides that �active substances which are endocrine disruptors shall not be approved, unless � in the case of plant protection products � there is negligible exposure or � in the case of biocides � a negligible risk.�
In the proposal, the European Commission decided that �the grounds for possible derogations for plant protection products should be updated so as to refer � in line with the biocides legislation � to "negligible risk"�.
Specialists are worried by the change of the term �exposure� by �risks�. R�my Slama, French epidemiologist and PNRPE�s President (Programme National de Recherche sur les Perturbateurs Endocriniens, National Research Program on Endocrine Disrupters) fears that a complete evaluation of the risks (which means knowing about both exposure and hazards) will have to be conducted before regulating any substance. This would lead to a reversal: a risk-based approach would predominate over a hazard-based approach, even though the latter is essentially defended by the Commission.
What are the main contentious issues of this declaration?
Proven impact on human health
With this new definition of endocrine disruptors, the European Commission suggests that specific attention should be paid to evidence, since the question is to prove �the relevant effects to human health�. This reference to the effects on human, and not mammal health limits the quantity of evidence currently available.
Indeed, according to the civil society, several warning signals usually come from experiments on animals and not on humans. To illustrate their words, various spokespersons remind that barely a hundred substances are considered as certain carcinogenic for human (according to OMS classification). Effects on humans can take years to appear, hence the importance of in vitro tests or tests on animals. According to the HEAL association, the ensuing risk would be the occurrence of health damages before the withdrawal of the incriminated substances from the market.
As for industrial business associations, many support this point of the new definition. Indeed, the previous definition was often considered by industrials as �over-cautious� and unrealistic with regard to available evidence. Thus, it would allow companies to reintroduce substances on the market that had been considered dangerous but whose impact on human health had never been proved.
Classification by category
The approach chosen by the Commission consists in a binary classification and not a classification by category as it is the case for carcinogenic substances. If the substance is classified as endocrine disruptor, it will be banned. Otherwise, it will be accepted.
Scientists and civil society members criticize this measure, stating that the precautionary principle is totally put aside. The classification by category, which is supported by these actors, leaves room for doubt: the harmfulness of a substance is certain, suspected or uncertain.
The industry is also disappointed by this classification. ECPA�s executive director Jean-Charles Bocquet declared that the Commission proposal �may lead to banning plant protections products, which have the same endocrine disrupting properties as everyday products like coffee�.
Hazard-based approach
As a reminder, the European Commission considers that �a hazard-based approach regulates substances on the basis of their intrinsic properties, without taking account of the exposure to the substance. A risk-based approach factors in the exposure�.
In its definition proposal, the European Commission declares that �Under this legislation, as a general rule, endocrine disruptors are banned on the basis of hazard, without undergoing a specific risk assessment on the basis of considerations of exposure (although in some cases derogations � either hazard, risk or considering socio-economic issues � may apply on a case by case basis, as stipulated by the legislation).�
NGOs and some politicians agree on the fact that it is essential that substances should be judged on their inherent proprieties, and not on the exposure quantity of an individual. For them, the possibility of derogations is a huge risk.
On the contrary, industrials think that risk-based approach should not be a simple derogation but the general European rule.
This is why industrials support the integration of the notion of potency to the definition (the potency of a chemical substance describes its ability to produce an effect at a particular dose level) which reflects the risk-based approach.
New possible grounds for derogations
Until now, the EU legislation for biocidal products and plant protection products provides that �active substances which are endocrine disruptors shall not be approved, unless � in the case of plant protection products � there is negligible exposure or � in the case of biocides � a negligible risk.�
In the proposal, the European Commission decided that �the grounds for possible derogations for plant protection products should be updated so as to refer � in line with the biocides legislation � to "negligible risk"�.
Specialists are worried by the change of the term �exposure� by �risks�. R�my Slama, French epidemiologist and PNRPE�s President (Programme National de Recherche sur les Perturbateurs Endocriniens, National Research Program on Endocrine Disrupters) fears that a complete evaluation of the risks (which means knowing about both exposure and hazards) will have to be conducted before regulating any substance. This would lead to a reversal: a risk-based approach would predominate over a hazard-based approach, even though the latter is essentially defended by the Commission.
