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. Having held a public consultation with stakeholders, concluded on January 16 2015, the Commission has now analysed the input received – some 27, 000 contributions. Its report was published at the end of July 2015. Back in June 2014, the Commission published a roadmap, proposing four options defining possible criteria.
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 is also carrying out two studies. The first one assesses substances individually to determine which substances are characterised as endocrine disruptors by each of the four sets of criteria. The second study assesses the consequential socio-economic impact. We expect these studies to be published respectively towards the end of 2015 and 2016. Following further evaluations and discussions, the Commission should come forward with a proposal for criteria end 2016.
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), the Water Framework Directive, the Biocides Directive and the Pesticides Regulation. This legislation, applying to all chemical substances, ensures that chemical products placed on the market are safe. There is, then, no legal vacuum where endocrine disruptors are concerned. It’s a matter of determining together – public authorities, the scientific world, 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 endocrine disruptors to be clearly distinguished from other endocrine active substances. 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. The sooner they are in place the better.
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.
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. 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 oint 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