Text adopted by Parliament, single reading  
2019/2683(RSP) - 18/04/2019  

The European Parliament adopted by 447 votes to 14 with 41 abstentions, a resolution on a comprehensive European Union framework on endocrine disruptors, in response to the Commission communication on the subject.

The resolution was tabled by the EPP, S&D, ECR, ALDE, GUE/NGL, Greens/EFA, and EFDD groups.

Parliament recalled that the UNEP/WHO report of 2012 called endocrine disruptors (‘EDCs’) ‘a global threat’, and noted emerging evidence of adverse reproductive outcomes (infertility, cancers, malformations) from exposure to EDCs, together with mounting evidence of the effects of these chemicals on thyroid function, brain function, obesity and metabolism, and insulin and glucose homeostasis. It considered that the Union framework for EDCs as suggested by the Commission in the Communication is not adequate to address the threat to human health and the environment due to exposure to EDCs, and that it does not deliver what is required pursuant to the 7th Environmental Action Programme (7th EAP).

Accordingly, Members called on the Commission to make legislative proposals no later than June 2020 to insert specific provisions on EDCs into the Cosmetics Regulation, similar to those on substances that are carcinogenic, mutagenic or toxic for reproduction (CMR substances). They noted that the Commission’s Communication lacks both a concrete action plan to minimise exposure to EDCs and a timeline for the next steps to move forward.

Horizontal definition

Parliament considered that EDCs are a class of chemicals that is of equivalent concern to CMR substances, and should therefore be treated identically in Union legislation. The Commission was asked to develop, no later than June 2020, a horizontal definition based on the WHO definition for suspected EDCs as well as for known and presumed EDCs in line with the classification of CMRs in the Regulation on classification, labelling and packaging of substances and mixtures (CLP Regulation). That horizontal definition must be accompanied by proper guidance documents.

Members went on to note that the scientific criteria developed for the determination of EDCs in pesticides and biocides lack a category of ‘suspected EDCs’ and are therefore not fit for horizontal application. This is not consistent with the classification of CMR substances under the CLP Regulation and the 7th EAP. The resolution highlighted that the ability to identify suspected EDCs is extremely important, all the more so because both the Cosmetics Regulation and the Toy Safety Directive not only restrict known and presumed CMRs (categories 1A and 1B), but also suspected CMRs (category 2). Parliament called on the Commission to:

- draw up legislative proposals no later than June 2020 to insert specific provisions on EDCs into the Toy Safety Directive, similar to those on CMR substances but without any reference to thresholds of classification, as such thresholds are not applicable for EDCs;

- revise Regulation (EC) No 1935/2004 on materials and articles intended to come into contact with food no later than June 2020 in order to effectively reduce the content of hazardous substances therein, with specific provisions to substitute the use of EDCs;

REACH

Parliament pointed to the failures in the implementation of the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Regulation, stressing the high percentage of non-compliant registration dossiers, slow evaluations due to missing data and failure to take regulatory action on substances found following evaluation to pose a serious risk to human health or the environment. Stating that such failures also lead to a failure to minimise exposure to known or suspected endocrine disruptors, it called on the European Chemicals Agency, the Commission and the Member States to take all necessary measures to ensure the compliance of registration dossiers with the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Regulation by the end of 2019, to accelerate substance evaluation and to implement effectively the final conclusions of substance evaluations under REACH as an important means of minimising exposure to endocrine disruptors.

Research and monitoring

Parliament pointed to the fact that the UNEP/WHO report states that close to 800 chemicals are known or suspected to be capable of interfering with hormone receptors, hormone synthesis or hormone conversion. However, only a small fraction of these chemicals have been investigated in tests capable of identifying overt endocrine effects in intact organisms, and there is a lack of adequate tests and data requirements to identify EDCs in the relevant Union legislation. Members felt that there is an urgent need to accelerate test development and validation in order to properly identify EDCs, including new approach methodologies. Furthermore, data requirements should be continuously updated in all the relevant legislation in order to take account of the latest technical and scientific progress, so that EDCs can be properly identified.

Members called on the Commission to:

-promote research into EDCs, in particular with regard to their epigenetic and transgenerational effects, their effects on the microbiome, novel EDC modalities and characterisation of dose-response functions, as well as safer alternatives;

-ensure adequate bio-monitoring of EDCs in human and animal populations, as well as the monitoring of EDCs in the environment, including in drinking water.

Lastly, noting that to date the Commission has not adopted a Union strategy for a non-toxic environment, nor did it take horizontal measures by 2015 to ensure the minimisation of exposure to EDCs as required under the 7th EAP, Parliament stressed the need to ensure that the Union framework on EDCs becomes an effective contribution to the Union strategy for a non-toxic environment, to be adopted as soon as possible.