no2hormonedisruptingchemicals.org
EN - ES - DE - FR - SV - NL - DA

THEIR QUESTIONS, OUR ANSWERS

Options for determining hormone disrupting properties

The roadmap on hormone disrupting chemicals, also known as endocrine disrupting chemicals (EDCs) defines four different options for the criteria to identify which chemicals have endocrine disrupting properties. Below is a response to each option.

OPTION 1: The interim criteria remain in place.

Info This corresponds to Questions 2.1.1, 2.1.2 and 2.1.3 in the EU public consultation

There are three technical questions for option 1, to which we advise the answer ‘no’.  If you exceptionally want to answer yes, please use the European Commission website to directly submit your answers to the consultation.

  • No, I have not conducted nor am I aware of an assessment of substances which would be identified as hormone disrupting chemicals according to option 1.​
  • No, I am not aware of any assessment(s) of substitutability of the identified substances.
  • No, I am not aware of any assessment(s) of the socio-economic impact if the identified substances were regulated without further risk assessment.

This option will mean some hormone disrupting chemicals will be overlooked

I do not agree with option 1.

In option 1, the interim criteria set in the plant protection product (PPPR) and biocidal products regulation (BPR) continue to apply. These are the only laws in the EU that say if a substance is a hormone disrupting chemical (or endocrine disrupting chemical or EDC for short) it will not get permission to be used in the EU.

But all EDCs need to be identified, no matter if they are used as pesticides, biocides, in cosmetics or food packaging, children’s toys or elsewhere.

Therefore, criteria for a scientific identification of EDCs are needed for other EU laws, and any other uses as well; which option 1 will not deliver.

Moreover, option 1 will not protect people because the current interim criteria can overlook EDCs which do not cause cancer or harm reproduction, but affect the brain or metabolism, and thus can contribute to mental disorders, diabetes or obesity.

This corresponds to Question 2.1.4 in the EU public consultation

OPTION 2: Using the World Health Organization International Programme on Chemical Safety (WHO/IPCS) definition to identify hormone disrupting chemicals (hazard identification)

Info This corresponds to Questions 2.2.1, 2.2.2 and 2.2.3 in the EU public consultation

There are three technical questions for option 2, to which we advise the answer ‘no’. If you exceptionally want to answer yes, please use the European Commission website to directly submit your answers to the consultation.

  • No, I have not conducted nor am I aware of an assessment of substances which would be identified as hormone disrupting chemicals according to option 2.
  • No, I am not aware of any assessment(s) of substitutability of the identified substances.
  • No, I am not aware of any assessment(s) of the socio-economic impact if the identified substances were regulated without further risk assessment.

This option will leave out “potential hormone disrupting chemicals (EDCs)”

I do not agree with option 2.

In option 2, the World Health Organization International Programme on Chemical Safety (WHO/IPCS) definition to identify confirmed EDCs will apply. But option 2 leaves out the twin WHO definition for “potential EDCs”. Using only the definition for confirmed EDCs is a ‘black or white’ only approach which blocks full and effective consideration of the state of the science.  This truncated definition would also exclude all chemicals that need to be further investigated to determine whether they are EDCs or not.

The EU pesticide and biocide laws aim to ban both confirmed and suspected EDCs as the legal texts say ‘may cause adverse effects’.  So we need a definition that is not only for “confirmed EDCs”.

The world’s leading scientific report on the “State of the science of EDCs 2012” from the WHO and United Nations Environment Programme (UNEP) highlights that endocrine disrupting chemicals are a global threat to human health and ecosystems. Therefore, we must be able to distinguish between definite and potential disruptors and track potential ones until more evidence can confirm or eliminate their ‘potential’ status.

This corresponds to Question 2.2.4 in the EU public consultation

OPTION 3: Using WHO/IPCS definition to identify hormone disrupting chemicals and categories based on strength of evidence

Info This corresponds to Questions 2.3.1, 2.3.2 and 2.3.3 in the EU public consultation

There are 3 technical questions for option 3, to which we advise the answer ‘no’. If you exceptionally want to answer yes, please use the Commission website to directly submit your answers to the consultation.

  • No, I have not conducted nor am I aware of an assessment of substances which, in addition to those identified according to option 2, would be identified as suspected endocrine disruptors or endocrine active substances according to option 3.
  • No, I am not aware of any assessment(s) of substitutability of the identified substances.
  • No, I am not aware of any assessment(s) of the socio-economic impact if the identified substances were regulated without further risk assessment.

Best option to protect public health.

Option 3 would provide a good way forward.

In option 3, the WHO/IPCS definition to identify EDCs will apply, with the addition of three categories (confirmed; suspected; potential EDC). This set of categories is very transparent and portrays the different levels of scientific evidence available. This option can be used to properly rank a given chemical according to the data situation.   It allows for an effective and efficient use of resources by focusing regulatory action in the right places – in differentiated ways according to the categories. It must be pointed out, however, that the WHO definition is a scientific working definition and not a regulatory definition. The legal text such as Regulation 1107/2009 talks of pesticides with endocrine disrupting properties that ‘may cause adverse effects’.

This option is coherent with current approaches to rank other chemicals, e.g. how cancer causing chemicals are classified. It also facilitates regulating these chemicals according to the different laws governing their various uses (food contact materials, pesticides, cosmetics, etc.).

The first two categories (confirmed; suspected) should be used for regulation.  The third category (potential) is important to steer industry to gather more information on the potentially harmful properties. This additional information will help to either remove chemicals from this category or upgrade them. 

When placing chemicals in the different categories, it will be crucial not to raise the bar of proof too high. Waiting for complete knowledge means risking taking action too late to prevent illness and save lives (as happened with asbestos). EU law has recognised that we can’t afford to delay for absolute proof of harm, because it seeks to ban pesticides and biocides that “may cause adverse effects”, instead of only banning definite hormone disruptors.

This process of categorising chemicals can only be successful if the criteria for assessing endocrine effects are applied in a strictly scientific way. There are too many cases in current regulatory assessments where a concern relating to a substance is downplayed because of doubts about “human relevance” without a valid scientific justification.

Humanity faces rising levels of hormone related illnesses, so what the European Commission must do is to establish a system that leads to reducing our exposures to hormone disruptors, to help prevent these illnesses.  Using categories is a sophisticated but powerful and necessary part of such a system.

This corresponds to Question 2.3.4 in the EU public consultation

OPTION 4: Using WHO/IPCS definition to identify endocrine disruptors and include potency.

Info This corresponds to Questions 2.4.1, 2.4.2 and 2.4.3 in the EU public consultation

There are 3 technical questions for option 4, to which we advise the answer ‘no’.  If you exceptionally want to answer yes, please use the Commission website to directly submit your answers to the consultation.

  • No, I have not conducted nor am I aware of an assessment of substances which would be identified as endocrine disruptors according to option 4.
  • No, I am not aware of any assessment(s) of substitutability of the identified substances.
  • No, I am not aware of any assessment(s) of the socio-economic impact if the identified substances were regulated without further risk assessment.

No way. Worst option.

I do not agree with option 4.

In option 4, the WHO/IPCS definition to identify EDCs will apply, with the addition of potency as a cut-off. This proposal is scientifically flawed and is contrary to the policy advice the European Commission received in reports by the Joint Research Centre (JRC) and the European Food Safety Agency (EFSA). This option is preferred by pesticides and chemical companies who want to effectively minimise the number of chemicals barred from the market. However, the identification of EDCs needs to identify all hormone disrupting chemicals which harm our health, not just some, which is what the potency factor would result in.

Potency is not used to identify chemicals which cause cancer or are toxic for the reproduction, and it makes no scientific sense for identifying whether a chemical is a hormone disruptor or not.

EDCs vary in how strongly they affect different parts of the body and different hormone systems, so relying on selective tests for potency may wrongly leave some chemicals unidentified. For example, an EDC may be weak in disrupting female hormonal signalling but strong in disrupting some aspect of brain development.  Furthermore, many animals in our ecosystems are also exposed, but potency may vary dramatically between different species – so using potency cannot reliably protect people and wildlife.

Furthermore, industry protocol studies often dose test animals with very high, unrealistic amounts of the chemical under examination and do not include many low doses. However, the effects occurring at the high doses will be qualified as irrelevant using the potency criterion. In addition, because effects are not adequately examined over a range of low doses and the effects looked for may not represent the most sensitive ones, even quite potent chemicals are likely to be missed.  Therefore, a potency cut-off should not be applied to the criteria.

In addition, during the most vulnerable periods, such as development in the womb, even extremely small amounts of ‘weak’ EDCs may contribute to ill health, particularly later in life.

Moreover, people and wildlife are exposed to many EDCs from different sources at the same time and over time, and science has shown that EDCs can act together, leading to harmful cocktail effects.  Not identifying ‘low potency’ EDCs would hamper any attempts to address health risks arising from cumulative exposure to these EDCs.

Therefore, option 4 is absolutely inadequate as identification criteria because it would lead to EDCs which can severely affect human health not being identified or restricted.

This corresponds to Question 2.4.4 in the EU public consultation

Options for approaches to regulatory decision making

Should we change democratically agreed laws?

The EDC roadmap defines three different options for approaches to regulatory decision making. Option A (no changes of the existing provisions in BPR and PPPR), Option B (introduction of further elements of risk assessment) where necessary and desirable to reduce potential socio-economic impacts, and Option C (introduction of further socio-economic considerations) where necessary and desirable to prevent adverse socio-economic impacts.

Info This corresponds to Questions 3.1 and 3.2 in the EU public consultation


There are 2 technical questions for this Section, to which we advise the answer ‘no’.  If you exceptionally want to answer yes, please use the Commission website to directly submit your answers to the consultation.

  • No, I have not conducted nor am I aware of an assessment applying any of the 3 different options for regulatory approaches to decision making (option A-C) to substances identified as endocrine disruptors by any of the options for defining criteria (option 1-4)
  • No, I have not conducted nor am I aware of an assessment of the socio-economic impact of the 3 different options for regulatory approaches to decision making (option A-C) for substances identified as endocrine disruptors by any of the options for defining criteria (option 1-4)

If the consultation format would have allowed it, I would have shown my support for Option A, no regulatory changes.

What else needs to be done?

The solution in a nutshell

The only practical solution is committed regulatory action, by putting EU laws into practice, and improving and making new laws, to reduce all our exposures. Criteria which clearly identify all EDCs without a potency filter will enable the European Union (EU) to effectively address the threats of long-term health and environmental damage posed by EDCs.

EDCs are a threat to our society’s current and future public health and prosperity. Europe should take a leading role in regulating EDCs, as this will stimulate innovation so that all industries in the various sectors develop and use better and safer alternatives. In this way, European industry can ensure its share of the growing world market for safer products and move to more sustainable production and sustainable agriculture.

 

I believe that this public consultation is not really for the public

The consultation is aimed at the concerns of certain industry sectors, and ignores important questions for citizens, society and companies interested in replacing EDCs with safer alternatives. For example, what will be the benefits of stricter controls for EDCs? How much will we save in terms of reduced health care costs? What are the business opportunities for innovative solutions?
 

I believe the micro and macro-economic, social, political and environmental benefits of reducing our exposure to EDCs should be included in impact assessments

The following reports and studies made an attempt to cost the benefits of stricter controls for EDCs and reduced human exposure. These should be integrated in the Commission’s impact assessment:

 

I believe regulatory option A, no change in the law, is the best way forward

I am opposed to the European Commission’s proposed regulatory options B and C to make changes to established EU laws. These are unacceptable because they would undermine the democratically agreed rules in the EU pesticides law adopted by the elected European parliamentarians and national governments in 2009.

The EU pesticides and biocidal laws already contain provisions for exemptions so that no changes are necessary or useful.
 

I believe policy makers should act on the existing scientific evidence

Scientists have repeatedly voiced concerns about EDCs because it is likely that they are contributing  to the dramatic increases of serious diseases and health disorders, such as reproductive and fertility problems, breast, prostate and testicular cancers, effects on brain development and nervous system problems, and obesity and diabetes. 

Recent biomonitoring studies from across Europe have shown that people in the general population are typically contaminated with several chemicals. Special care should be taken to reduce exposures before and during pregnancy, in early childhood, and during puberty. 

Many people come into contact with EDCs on a daily basis including from consumer products, indoor air, water, food or from the workplace.  Wildlife is also suffering from exposure to hormone disrupters and impaired reproduction and development linked to EDCs has been reported in many species, including fish, birds, otters and even polar bears.

The following studies highlight the levels of certain chemicals in urine and hair, found several EDCs in children and their mothers.

This corresponds to Question 4.1 – Provide any other data or information that could help the Commission to conduct its impact assessment.in the EU public consultation

More information

 

EDC-Free Europe campaign


Useful resources


Other ways to take action!