There is mounting concern about the possible negative effects of so-called endocrine disruptors on human health and the environment. Cefic is committed to ensuring that people and the environment are properly protected from harmful exposure to chemicals. We want to see endocrine-affecting substances – if found to be harmful - properly regulated.
The European Commission is currently delivering on its obligation to propose appropriate science-based criteria for identifying endocrine disruptors that require regulatory action. Back in June 2014, the Commission published a roadmap, proposing four options defining possible criteria. A public consultation was held concluding in January 2015 with some 27, 000 contributions. Its report was published at the end of July 2015.
The European chemical industry provided its input to the consultation via Cefic and other trade associations. While fully supporting the European Commission in its initiative, Cefic is concerned to ensure that the Commission comes up with a workable definition of an endocrine disruptor, acknowledging potency thresholds and the severity of effects. We have long been asking for regulation to be based on science, to avoid restrictions on chemical substances that would lead to the loss of useful products with no gain in chemical safety for people or the environment.
Read more about the public consultation
Read more about the industry position
The Commission’s Impact Assessment work programme for ED criteria development includes two studies. The first one examines, across a selection of substances, how well the four policy options can distinguish substances of potential regulatory concern from those of low relevance.The second study assesses the consequential impact on health, economy and society. Following further evaluations and discussions, the Commission should come forward with a proposal for criteria. Although the initial timeline expected the first study to be published in April 2016 and the second by the end of the year, Commissioner Andriukaitis confirmed at the press conference closing the Council meeting of March 4th, that the Commission was actively working towards completing the impact assessment and would present both studies in parallel as well as proposals for criteria before the summer.
In December 2015 the substances that have been selected for screening as part of the process.
Read more about the nature of these substances which are under no circumstances a list of recognised EDs.
Despite claims to the contrary in some quarters, endocrine disruptors are already addressed by the current strict EU regulatory framework, in a number of legal instruments such as REACH, (Regulation on the Registration, Evaluation and Assessment of Chemicals) Regulation, the Water Framework Directive, the Cosmetic Products Regulation, the Biocidal Products Regulation and the Crop Protection Products Regulation. This legislation, applying to all chemical substances, ensures that chemical products placed on the market are safe.. It’s a matter of determining together – public authorities, the scientific community, industry, competent independent agencies and civil society – the most appropriate criteria for defining what is and what is not an endocrine disruptor.
Why the criteria?
We support the Commission in its undertaking to define scientific criteria for identifying endocrine disruptors. These criteria will enable to clearly distinguish those substances of potential regulatory concern from those of low relevance. Incorporated in the various regulatory texts, they will make it easier for authorities and industry to take suitable regulatory measures. They will, moreover, bring clarity and predictability for operators and will avoid unjustifiably restricting many harmless substances which bring major value to society and the European economyThe sooner they are in place the better.
Chemical substances are used on a daily basis for the benefits they provide. Moreover, some directly protect humans and the environment. For instance, crop protection products allow farmers to grow healthy crops and biocides allow our hospitals and households to remain clean and free of germs
Our preferred option
Industry favours option four of the Commission’s roadmap for defining criteria, but with additional elements of hazard characterisation to be incorporated into the ED criteria, namely severity of effect, (ir)reversibility of effect, potency and lead toxicity. The purpose of the definition is to enable the regulator to identify those substances that need to be regulated. If every substance falls within the definition, then the regulator would have to regulate them all, regardless of need.
We consider potency, a fundamental and well-established principle of toxicology, as a key element for the identification of endocrine disruptive substances of regulatory concern. Ignoring potency could lead to the prohibition of many synthetic substances that are no more harmful than everyday plant-based foods such as grains, vegetable and fruits. A threshold – the level at which exposure to a substance is considered safe for human health and/or the environment – should be determined for endocrine-disruptive substances (on a case-by-case basis) and should be used in the regulatory context. A regulatory threshold is several times lower, thereby building in additional margins of safety, which means that exposure to endocrine disruptive substances can be considered safe for human health and/or the environment.
Over the last twenty years, the chemical industry has made significant contributions to the basic and applied research on endocrine mechanisms and testing methodologies, in the first instance through its LRI (Long-range Research) programme.
Endocrine disruptors are also addressed at the international level, where the International Council of Chemical Associations (ICCA) plays an active role. The OECD is developing test methods and guidance for the assessment of endocrine disruptors. In the context of the United Nations Environment Programme (UNEP), the Strategic Approach to International Chemicals Management (SAICM) in ICCM3 identified endocrine-disrupting substances as emerging policy issues, agreeing to implement cooperative actions to increase awareness and understanding amongst policymakers and other stakeholders. This was reaffirmed at ICCM4 - that took place in October 2015. Cefic will continue to contribute its expertise to the work of the European Commission, OECD and EU member states, in developing a framework for systematically identifying substances with endocrine-disruptive properties.
For more information:
Our press release "Society needs a compass’
The joint statement from ACC, Cefic, CLA, CLC, CLI and ECPA on review of WHO-UNEP 2012 report on Endocrine Disruptors
Our response to the public consultation about criteria to identify endocrine disruptors