The Commission proposes to the Council and the European Parliament to adopt a strong science-based approach to the identification of endocrine disruptors and to endorse the WHO definition.
Endocrine disruptors are substances, both natural and chemical, that can alter the functions of the hormonal system and consequently cause adverse effects on people or animals. Today, the European Commission presents two draft legal acts with scientific criteria that will allow for a more accurate identification of chemical substances which are endocrine disruptors, in the plant protection products and biocides areas.
Today's package includes:
- A Communication providing an overview of the scientific and regulatory context;
- an Impact Assessment Report which presents the state of science regarding different criteria to identify endocrine disruptors, and provides information on possible consequences;
- and two draft legal acts – one under the Biocidal Products legislation, the other under the Plant Protection Products legislation – which set the criteria to identify endocrine disruptors.
The President of the European Commission Jean-Claude Juncker said: "Endocrine disruptors can have serious health and environmental impacts and even if many substances containing them are already banned as a result of existing legislation on pesticides and biocides, we have to remain vigilant. The Commission is committed to ensuring the highest level of protection of both human health and the environment, which is why we are today putting forward strict criteria for endocrine disrupters – based on science – making the EU regulatory system the first worldwide to define such scientific criteria in legislation."
The Vice-President for Jobs, Growth, Investment and Competitiveness Jyrki Katainen declared: "The scientific criteria for endocrine disruptors presented today will contribute to the objectives of minimising exposure to endocrine disruptors and to bringing legal certainty. Today’s Communication outlines the issues we have considered in this process, it defines the scope of what is relevant to determining the scientific criteria, and sets out the implications of setting these criteria – for the two pieces of legislation directly concerned and for other parts of the EU regulatory framework and actions.”
Commissioner for Health and Food Safety, Vytenis Andriukaitis, said: "The scientific criteria that the Commission is presenting today guarantee that the high level of protection of human health and of the environment set in our legislation on plant protection and biocidal products is maintained. The plant protection products and biocides' legislation are among the strictest in the world because of their prior approval system, their extensive data requirements, and their hazard approach for decision making. The Commission reinforces today its commitment to protect health of people in European Union."
The scientific criteria endorsed by the Commission today are based on the World Health Organisation's (WHO) definition of an endocrine disruptor, for which there is a wide consensus.
The WHO defines a substance as an endocrine disruptor if:
- it has an adverse effect on human health;
- it has an endocrine mode of action;
- and if there is a causal link between the adverse effect and the mode of action.
The criteria endorsed today also specify how the identification of an endocrine disruptor should be carried out:
- by making use of all relevant scientific evidence;
- using a weight of an evidence-based approach;
- and applying a robust systematic review.
The Commission Communication which accompanies the two acts providesan overview of the complex scientific and regulatory context around endocrine disruptors and describes how a scientific consensus on the definition has grown over the last years, all of which has been taken into account by the Commission in arriving at its decision. Looking beyond the criteria, the Communication sets out a number of actions where the Commission will increase its efforts to minimise exposure to endocrine disruptors, in the short-term (research and international cooperation), mid-term (test methods) and long-term (regulatory).
To ensure that swift action is taken, today the Commission is also asking the European Food Safety Authority and the European Chemicals Agency to begin looking at whether approved individual substances that show indications of being endocrine disruptors can be identified as endocrine disruptors according to the criteria in the draft texts presented today. This will also help to ensure that the two regulatory Agencies are ready to apply the criteria as presented today by the Commission, and in accordance with the applicable regulatory procedures, once the criteria enter into force.
The two draft legal acts containing the criteria now need to be adopted by the Commission under the relevant procedures. In the context of the Plant Protection Products Regulation, the draft legal text specifying the criteria will be voted by Member States. In the context of the Biocidal Products Regulation, the draft measure will be discussed in a group of experts of Member States prior to adoption by the Commission.
Both measures involve the European Parliament and the Council. In order to ensure coherence between the two acts, the Commission will present both texts simultaneously to the European Parliament and the Council for them to exercise their functions.
The Commission is also proposing to adjust the ground for possible derogations under the plant protection products legislation in order to take into account the latest scientific knowledge. The 'hazard-based' approach of the Pesticides Regulation will be maintained, meaning that substances are banned on the basis of hazard without taking account of the exposure. However, the grounds for possible derogations have been adjusted so they are based on scientific knowledge and make the best use of available scientific evidence including information related to exposure and risk.
Background
Endocrine-disrupting chemical substances are substances that alter the functions of the hormonal system and consequently cause adverse effects to human health. As scientific awareness of endocrine disruptors grew, the Commission responded with a "Strategy for endocrine disruptors" in 1999.
Under EU legislation on chemicals endocrine disruption is often considered specifically (Plant Protection Products, Biocidal Products, REACH, water quality legislation), or addressed through general risk assessment methodology, thus insuring a high level of protection for consumers and the environment.
Many chemicals used in plant protection products or biocidal products have already been banned because of their adverse effects. This testifies to the EU's commitment to protect citizens from risks resulting from unsafe chemical substances.
Frequently Asked Questions: Endocrine disruptors
Brussels, 15 June 2016
What are endocrine disruptors (EDS)?
Endocrine disruptors are chemicals which impact on the hormone system of animals and humans. They have three cumulative characteristics: a hormonal function, an adverse effect, and a causality between the two.
The main characteristic compared to other chemicals is that we do not only look at the effect, but also at a mode of action. In fact, endocrine disruption is a relatively recent way of looking at the toxicity of chemicals, which helps to understand how certain adverse effects happen. The usual approach to defining the toxicity of chemical substances is "end points" – whether there is an adverse effect. The new, additional, element is the concept of "mode of action", the way in which a chemical substance has an impact.
The World Health Organisation (WHO) defined in 2002 an Endocrine Disruptor as a 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.
What is the issue at stake?
As awareness of endocrine disruptors grew, so did public and political interest.The Commission responded with a "Strategy for endocrine disruptors" in 1999.[1] This set out a number of actions at EU level, with the short-term (research and international cooperation), mid-term (test methods) and long-term (regulatory) steps to take. The key objective was to adopt legally-binding scientific criteria to determine what an endocrine disruptor is. The Commission worked closely with Member States, got input from EU regulatory agencies, independent scientific committees advising the Commission, the Commission's in-house scientific body (the Joint Research Centre[2]), and from multilateral and bilateral scientific and regulatory cooperation with third countries, as well as extensive contacts with stakeholders over the past 15 years.[3] The discussions have shown the complexity of the topic: so too does the fact that no other country has so far adopted legally-binding scientific criteria to determine what an endocrine disruptor is. Against this background, the Commission conducted a thorough preparation of the measures by reconfirming its unequivocal commitment to the EU co-legislators to finalise its ongoing work and present the criteria before the summer 2016.
Are endocrine disruptors (EDS) already taken into account in EU legislation?
Yes. EU regulatory agencies, independent scientific committees, the Commission and Member States already look at endocrine disruptors. This work is regulated through sectorial legislation in areas including the human health (including for consumers and workers), animal health, and the environment. Examples are the EU legislation on occupational safety and health (where the legislation on chemical agents at work[4] includes all chemical agents, including endocrine disruptors), food and feed safety (where toxicological risks, including those stemming from endocrine disruptors, are subject to comprehensive risk assessment), and consumer products (including for example cosmetics and toys, REACH), as well as environmental legislation. Moreover, in the specific areas of Biocides[5] and Plant Protection Products[6] the legislation already determines the regulatory consequences for endocrine disruptors and interim criteria are in place so far (please see next question).
How does EU legislation regulate endocrine disruptors (EDS) in Plant Protection Products and Biocidal Products?
The EU has one of the strictest systems in the world for the assessment of Plant Protection Products ("pesticides", e.g. herbicides) and Biocidal Products (e.g. hand disinfectants). Hundreds of substances have gone through, or are going through, a stringent scientific assessment process. The EU approval of a substance is only granted for a limited period of time (up to 15 years) and must be renewed regularly.
In practice, EU legislation requires that allchemicals used in Plant Protection Products (PPP) and Biocidal Products (BP) are approved at EU level before being placed on the market. This is called "prior approval". It means that all chemicals are allowed on the market - and for use – only once their safe use is proved according to a thorough scientific assessment. In addition, particularly hazardous substances which do not fall under specific derogations, like substances which may cause cancer, effects on reproduction, or endocrine disruptors are not even going through this risk-assessment but are per se not approved. Finally, in case of relevant new scientific and technical knowledge, approvals can be reconsidered at any time and their status can change into non-approval or a more restrictive condition of use. Because of this "prior approval" system, the extensive data requirements, and the hazard approach for decision making, the European legislation for Plant Protection Products and Biocidal Products is considered to be one of the most solid worldwide.
"Hazard-based" and "risk-based" decision making on chemicals: what is the regulatory context?
The regulation of chemical substances can be approached in two different ways: based on hazard or based on risk. A hazard-based approach regulates substances on the basis of their intrinsic properties, without taking account of the exposure to the substance. A risk-based approach factors in the exposure. In the area of chemical safety, there are several pieces of EU legislation that apply a hazard-based approach to toxicological safety, while others follow a risk-based approach.[7][8] A common analogy used is from the animal kingdom: a lion is intrinsically a hazard, but a lion safely constrained in a zoo is not a risk, since there is no exposure.
However, the issue faced by the Commission in this exercise is to establish criteria to determine what is or is not an endocrine disruptor for the purposes of plant protection products and biocidal products – not to decide how to regulate these substances.
The EU regulation of pesticides and biocides is based, for some substances (for example, carcinogens) on hazard, not on risk, subject to very limited exceptions, where a risk assessment is conducted.
What will the criteria mean for the regulatory areas of Plant Protection Products and Biocidal Products?
The EU legislation for Plant Protection Products and Biocidal Products provides that active substances which are endocrine disruptors shall not be approved, unless – in the case of Plant Protection Products – there is negligible exposure or – in the case of Biocides – a negligible risk. In principle, the question whether an active substance is an endocrine disruptor would be assessed each time the substance is subject to an approval procedure or a renewal procedure at EU level. As mentioned, all active substances used in plant protection products and biocidal products are only approved for a limited period of time, and their approvals are routinely reviewed.
It is important to stress that some of the adverse effects caused by endocrine disruptors (for instance effects on reproduction) have been the matter of assessment for many years. This, in practice, means that many substances where evidence as endocrine disruptors is available have been already banned in the EU. The new criteria will however allow for a more accurate and up to date assessment.
Will the new criteria be applied immediately?
As a general rule, and in order to ensure quick action and that recent scientific developments will be taken into account, the more accurate scientific criteria will be applied immediately. In addition, in order to allow the further scientific assessment work to start, the Commission will ask today the European Food Safety Authority (ESFA) and the European Chemicals Agency (ECHA) to start already looking at individual substances - for which indications exist that they could be endocrine disruptors - to accelerate the process once the criteria are in force.
This ensures that these two regulatory Agencies are ready to apply those criteria, once these are adopted in accordance with the regulatory procedures.
What is the Commission presenting?
Two separate draft measures were endorsed by the College on the 15th of June, 2016: They specify the criteria to identify endocrine disruptors and more precisely how the identification of endocrine disruptors should be carried out:
- one delegated act containing criteria applicable to the chemical substances falling under the Biocidal Products Regulation; and
- a Commission Regulation containing criteria applicable to the chemical substances falling under the Plant Protection Products Regulation, and which will need to be adopted in accordance with the Regulatory procedure with scrutiny.
The draft measures are accompanied by a Communication on endocrine disruptors and the impact assessment report. The presentation of the criteria to identify endocrine-disrupting substances will fulfil the legal obligations under the plant protection products and. Once adopted, under the biocides legislation. Once adopted, the EU regulatory system will be the first regulatory system worldwide to define scientific criteria for endocrine disruptors in legislation confirming the Commission's commitment to ensuring the highest level of protection of both; human health and the environment
What are the next steps in terms of procedure?
Following the presentation of today's package, the Commission calls upon Member States and EU institutions involved in the further adoption process to work closely and constructively in order to swiftly adopt these texts.
In the context of the Plant Protection Products regulation, the draft legal text specifying the criteria should now be voted by Member States.
In the context of the Biocidal Products regulation, the draft measure will be discussed with experts from Member States prior to adoption by the Commission.
Both measures involve the European Parliament and the Council. In order to ensure coherence between the two acts, the Commission will present both texts simultaneously to the European Parliament and the Council for them to exercise their scrutiny functions.
The two drafts will also be notified to the World Trade Organisation, to allow third countries to comment on them because the criteria will also apply to products imported into the EU.
For more information
Press Release on Endocrine disruptors
Impact Assessment
Roadmap on endocrine disruptors
[1] COM(1999)706 final, 17.12.1999.
[2] JRC Scientific and Policy Reports (2013), Key scientific issues relevant to the identification and characterisation of endocrine disrupting substances. Report of the Endocrine Disrupters Expert Advisory Group. Report EUR 25919 EN, http://publications.jrc.ec.europa.eu/repository/bitstream/JRC79981/lbna25919enn.pdf; JRC Scientific and Policy Reports (2013), Thresholds for Endocrine Disruptors and Related Uncertainties. Report of the Endocrine Disrupters Expert Advisory Group. Report EUR 26068 EN, http://publications.jrc.ec.europa.eu/repository/bitstream/JRC83204/lb-na-26-068-en-n.pdf .
[3] More information on the multitude of EU activities is available on the dedicated Commission web portal: http://ec.europa.eu/health/endocrine_disruptors/policy/index_en.htm.
[4] Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical agents at work (OJ L 131, 5.5.1998, p.11).
[5] Regulation (EU) No 528/2012 of the European Parliament and of the Council concerning the making available on the market and use of biocidal products (OJ L 167, 27.6.2012, p. 1).
[6] Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market (OJ L 309, 24.11.2009, p. 1).
[7] Generally, a risk-based approach allows more consideration of proportionality when taking regulatory (i.e. risk-management) decisions.
[8] The Commission is currently conducting a "fitness check", under the REFIT programme, to assess these aspects more in-depth (see http://ec.europa.eu/smart-regulation/roadmaps/docs/2015_grow_050_refit_chemicals_outside_reach_en.pdf ).
