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-active substances – if found to be harmful – properly regulated.
On June 15th the European Commission finally announced its proposals for scientific criteria for the definition of endocrine disruptors, under the Biocidal Products and Plant Protection Products Regulations. Along with other stakeholders, our industry has been awaiting these proposals. For clarity and legal certainty, the EU chemical industry requires European-level scientific criteria to pinpoint these substances and enable harmless substances to continue adding value to society and the European economy. In response to the proposals, Cefic, together with PlasticsEurope and the European Crop Protection Association (ECPA) issued a joint statement
Of the four options defining possible criteria, proposed in its roadmap back in 2014, the Commission has chosen option two. The criteria under this option centre on the WHO (World Health Organisation) definition, excluding both potency and categories. Our concern with this option is that, by focusing on the WHO definition, the Commission fails to distinguish between substances that can affect the endocrine system and those which will – under realistic worst case scenarios. For those regulations which do not foresee a full risk-based assessment in the regulatory decision-making process (Biocidal Products Regulation and Plant Protection Products Regulation) this could lead to substances being withdrawn from the market to no avail in terms of improving human health or the environment.
Our industry supports inclusion of potency as part of these criteria. We believe potency - the capacity of a substance to induce adverse effects depending on its concentration - is an important consideration in identifying which substances should be regulated as endocrine disruptors. Despite the fact that this is not included in the criteria, we note that the Commission has made provision for elements of risk assessment to be considered in the regulatory decision-making.
The package unveiled by the Commission on June 15th also included a communication providing an overview of the scientific and regulatory context, plus an impact assessment report representing the state of science regarding different criteria to identify endocrine disruptors, and providing information on possible consequences.
The two draft legal acts presented will now need to be adopted according to their relevant procedures, which in both cases involve Parliament and Council.
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. Commissioner Andriukaitis confirmed at the press conference on June 15th that the Impact Assessment is now online.
In December 2015 the Commission announced 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. Proper 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 should avoid unjustifiably restricting many harmless substances which bring major value to society and the European economy.
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.
Read the Cefic brochure on setting the right criteria to identify endocrine disruptors
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