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.
The European Commission has presented 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.
The 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 said: "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."
But Nick von Westenholz, chief executive officer of the Crop Protection Association (CPA) said: "What’s usually missing in this debate is an understanding of the difference between risk and harm; whilst we welcome this publication, it is disappointing that the opportunity to make this distinction has been lost.
"The reality is that everyday life is full of things that could harm, but we manage appropriately because they are very useful. If you call for a ban of pesticides in this instance, you might as well as call for a ban on walking to eliminate the risk of tripping over.
"These criteria are likely to result in farmers losing a safe and essential tool that helps them to produce the food we all take for granted."
And the European Crop Protection Association expressed disappointment with the European Commission’s long awaited proposal setting out criteria for endocrine disruptors. The criteria fails to distinguish between those substances which cause actual harm and others which pose no threat to human safety.
Jean-Charles Bocquet, director general of ECPA, said: "This criteria fail to distinguish between those substances which may cause actual harm and others which pose no threat to safety. In our view, this could lead to bans of crop protection products with the same endocrine disrupting properties found in every day products like coffee. We certainly recognise the significant public interest in this topic but believe we need a proposal that targets only those substances which cause actual harm otherwise we risk taking away tools from farmers which they need to sustainably produce our safe, healthy, affordable food".
The scientific criteria endorsed by the Commission on 15 June are based on the World Health Organisation's (WHO) definition of an endocrine disruptor.
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 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 on 15 June.
This will also help to ensure that the two regulatory agencies are ready to apply the criteria as presented 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.