EU Endocrine Disrupting criteria will have various implications for industry.

by Jimena Murillo Chávarro 22 Aug. 2017

In this article we examine the legal and political moves to regulate endocrine disruptors over the past 20 years and the most recent developments in this regard…

By Jimena Murillo Chávarro

There is growing concern in the EU and worldwide about the negative human health and environmental impacts possibly caused by endocrine disruptors. So, what are endocrine disruptors (ED)? They are chemicals that may interfere with the endocrine (hormonal) system and thereby produce harmful effects in both humans and wildlife. Hormones regulate the body's development, growth, reproduction, metabolism, immunity and behavior. Endocrine disruptors interfere with natural hormone systems, and the health effects can be felt long after the exposure has stopped. Exposure to endocrine disruptors in the womb can have life-long effects and can even have consequences for the next generation.


ED may be found in many everyday products including, among others, cosmetics (such as shampoos, body creams, make-up, wet wipes), toys, plastic bottles, metal food cans, pesticides (plant protection products and biocides), detergents, and flame retardants (present among others in cleaning products). Therefore, regulating ED is very important for both consumers and the industry, particularly for those working on the chemical sector and products production.


At the EU level, research on ED goes back to 1998, after the European Parliament called upon the Commission to take action on this issue, particularly to reinforce research efforts, make information available to the public, and improve the legislative framework.


The Commission then adopted the “Community Strategy for Endocrine Disruptors - a range of substances suspected of interfering with the hormone systems of humans and wildlife” COM(1999) 706. Therein, the Commission described the short, mid, and long term actions to take including, among others: 1) the establishment of a priority list of substances for further evaluation of their role as ED, and 2) to adapt or amend EU legislative instruments which cover chemical as well as consumer, health and environmental protection to take account of endocrine disrupting effects. Concerning this second action, the Community Strategy explicitly mentions that two pieces of legislation must be reviewed: one concerning plant protection products (PPPs) and other biocidal products.


By 2006, the Commission already had a preliminary priority list of substances for further evaluation and continued gathering data on endocrine disrupting effects. In terms of prioritization, it was found that, out of 575 substances, 320 substances showed evidence or potential evidence for endocrine disrupting effects, while in total, 109 substances were not retained in the priority list, either due to insufficient data on endocrine disrupting effects or insufficient scientific evidence. 147 substances have been excluded from the evaluation during the process as they were identified as double entries, mixtures or of doubtful relevance. An assessment of the legal status of the substances with evidence or potential evidence of endocrine disrupting effects showed, that most of them are already subject to a ban or restriction or are addressed under existing Community legislation, although for reasons not necessarily related to endocrine disruption.


In the last years, ED have been addressed, either directly or indirectly in different pieces of EU legislation, such as the Water Framework Directive, the Regulation on the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), which considers ED chemicals as substances of very high concern, and the Biocidal Products Regulation. The latter explicitly requests the Commission to adopt no later than 13 December 2013 specific criteria for the determination of endocrine disrupting properties.


In December 2015, the General Court of Justice found the Commission to be in breach of EU law by failing to act on ED, since it had not complied with the obligation to specify the scientific criteria for the identification of chemicals that have endocrine disrupting properties. The Commission has taken longer than expected to comply with its obligations since it considered it necessary to first carry out an impact assessment on the issue. But the Court in its decision stated that such an assessment was not required. 


The Commission has continued moving forward to comply with its obligation. In mid-June 2016 it presented two draft legal acts setting the criteria to identify ED in the Plan Protection Products Regulation and the Biocidal Products Regulation. These drafts must be adopted according to their respective procedure, subject to scrutiny in both cases by the European Parliament and the Council.


Stakeholders on all sides of the debate are critical of the proposals, and members of the European Parliament are divided on the issue.


The procedures to adopt these drafts are going ahead. The Commission has already had various discussions with experts and Member States. On 4 July 2017 Member States representative voted in favor of the Commission’s proposal on scientific criteria to identify endocrine disruptor in the field of Plant Protection Products. The text will be sent to the Council and the European Parliament. They will have 3 months to examine it. If they do not oppose the Commission will adopt the proposal.


Concerning the Biocidal Products Regulation, the Commission had a meeting on 12 July 2017 with experts from Member States Competent Authorities. After taken into account the discussions and views of the experts, stakeholders and comments received during consultations, the Commission will adopt the Delegated Regulation and will submit it to the Council and the European Parliament for their examination (after the summer recess period). If they do not object, the Delegated Regulation will be adopted by the Commission.


Moreover, the European Chemical Agency (ECHA) and the European Food Safety Authority (EFSA) are working on a guidance document for identifying ED. At this moment, a draft guidance on how to identify pesticides and biocides with endocrine disrupting properties have been developed and is currently subject to expert consultation. The deadline for commenting is 31 August 2017. Then, a revised draft version will be subject to public consultation, but only after the European Parliament and the Council have adopted the ED criteria proposed by the Commission. The outline of the Guidance is publicly available.


The proposed ED criteria is moving ahead. Its adoption, expected to happen in the next months, will have various implications.


Once the proposed ED criteria for Plant Protection Products and Biocides is adopted, it will be possible to identify which substances fall under each category. Therefore, the use of such substances will be banned unless exposure to humans is negligible or the risk from exposure of the non-target organisms is negligible. Potentially, the ED criteria could also affect articles and materials treated with biocidal products (such as textiles, furniture, toys, paints, and antimicrobial soaps and other cosmetics), or food that comes in contact with materials where biocidal has been used.


Another consequence worth mentioning is that the ED criteria could be applied in other areas such as in the cosmetic industry. In fact, the Regulation on cosmetic products contains a provision stating that when community or internationally agreed criteria for identifying substances with endocrine disrupting properties are available, the Commission must review this Regulation concerning substances having endocrine disrupting properties. This provision is part of an article dealing with the prohibition to use some substances classified as carcinogenic, mutagenic or toxic for reproduction (CMR substances).


Additionally, the REACH Regulation (Article 138(7)) provides the Commission with the possibility to assess whether to include substances having endocrine disrupting properties as part of the prohibited substances, for which an authorization can only be obtained in specific circumstances. The aim will be to reduce the use of substances having endocrine disrupting properties and ultimately replace them for other substances that are safer.


Ultimately, the proposed ED criteria could be understood as an EU community criteria applicable to all other areas that are affected directly or indirectly by substances having ED properties.