Such chemicals can be found in pesticides and herbicides used to help grow feed for livestock.
Cefic was responding to the Commission’s proposals, presented in June, when it chose ‘option 2’ of four earlier policy options. This means the definition will be based on the World Health Organisation (WHO) definition that these chemicals should be defined as an “exogenous substance or mixture that alters function(s) of the endocrine system and consequently causes adverse health effects in an intact organism, or its progeny, or (sub)populations”.
Which is all well and good, said Cefic, but leaves some significant holes that prevent robust criteria being set: “The [endocrine disruptors] criteria in the proposed option 2 are not fit for purpose. They do not meet the aim of identifying harmful from harmless substances for regulatory decision-making. This will have unintended consequences for public health, food supply and the EU economy,” said the association in its analysis.
It added that, in order to clearly distinguish between safe substances and those that could be harmful to people or the environment, hazard characterisation such as potency, lead toxicity, severity and irreversibility, should be included in the criteria. Potency, in particular, is “a key omission”, said Cefic. “Potency is a fundamental principle of toxicology and of hazard characterisation specifically.
“Without potency built-in, substances present in everyday food and drinks which are safe for consumption such as caffeine or soy bean proteins could be identified as [endocrine disruptors],” it said.
Cefic added it does not agree with critics of integrating the potency concept into the law, who argue that it introduces risk assessments into what should be a clearer cut hazard-based regulation. It pointed to examples of potency being used in other hazard-based EU legislations such as for acute toxicity, sensitisation and specific target organ toxicity.
WHO standpoint backed
“While the Berlin scientific consensus statement refers to potency not being required to identify [endocrine disruptors], it clearly refers to the use of potency and risk assessment for the regulation of [endocrine disruptor] substances. Cefic urges the Commission to use all aspects of this statement,” said the analysis.
That said, the association stressed it would support the use of the WHO definition of endocrine disruptors as a starting point for developing the Commission’s final guidance, as long as its concerns about the hazard characterisation, such as potency, are addressed. Cefic also supports the review of all relevant scientific evidence as well as making a weight of evidence assessment before coming to conclusions about a substance.
The guidance is to be used to help implement the EU’s biocidal products regulation and plant protection products regulation. A Commission note said that member states will now vote on the criteria regarding plant protection controls, while a group of member states experts will discuss their application for biocidal products ahead of the Commission’s final adoption of this guidance.