ECHA

To get a biocidal active substance approved, your application must contain an assessment of possible endocrine disrupting (ED) properties. This requirement was specified by the European Commission in the endocrine disruptor criteria for biocides, which took effect in June 2018. If you are preparing an active substance application, read our tips on how to assess if your substance is an endocrine disruptor.

The requirement for ED assessment is based on a growing scientific concern that endocrine-disrupting chemicals may be responsible for increases in endocrine-related diseases and disorders in humans. Changes have also been observed in wildlife species.

In principle, substances that have endocrine-disrupting effects on humans are excluded from use in biocidal products. The criteria for identifying endocrine disruptors for biocides and pesticides from 2018 aim to protect human health and the environment and are based on the World Health Organisation’s widely accepted definition for endocrine disruptors:
 

“An endocrine disruptor is an exogenous 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.”

The current standard data requirements under the Biocidal Products Regulation (BPR) and the related test methods do not specifically address the issue of endocrine disruptors. However, to assess the ED criteria, applicants should do a literature review and carry out an in-depth examination to check if the available data shows any indication that a substance may be acting as an endocrine disruptor. This duty applies to any new applications, but also for substances that already have an assessment ongoing.

What about completed applications?

Since the requirement only entered into force in June 2018, existing applications do not generally contain all the information needed to conclude whether the substance is an endocrine disruptor or not.

For some older applications, it is too late for evaluating competent authorities to return to applicants and ask for more data. This is the case for active substances where Member States concluded their assessment before 1 September 2013. For these, applicants may be granted a shorter approval period – for five years, instead of the usual 10 years. In practice, this means that those applicants would need to start generating the missing data soon to assess the endocrine-disrupting potential of their substance so that they can include it in their renewal application.

Top tips for applicants

It takes time to carry out an ED assessment, and this is only one part of your application on top of everything else. So make sure you start in time and seek expert help where necessary.

It is possible that the existing dataset that you have for your substance is insufficient to conclude that your substance does not meet the ED criteria. If this is the case, additional testing may be needed and some tests may not be part of the standard data requirements. If you are not sure if further testing is needed, contact your evaluating competent authority – they can help you confirm if additional tests for your product composition are needed.

Remember to carry out a systematic literature review and check all available sources to find relevant information that will help you assess the endocrine-disrupting potential of your substance. The ECHA-EFSA guidance for the identification of endocrine disruptors in biocides and pesticides should be your main source of information. In addition to detailed instructions, it includes a table with useful databases that can be used as resources for identifying endocrine disruptors and a spreadsheet template to be used for summarising data for your ED assessment. The objective is for you to have enough data to support a conclusion on whether your substance is an endocrine disruptor.

Who does what?

Once you have carried out the initial ED assessment and included it in your biocidal active substance application, it is time for the evaluating competent authority to examine the application and the ED assessment contained within it.

The assessment will also go through a peer review with other competent authorities and, if necessary, the substance can be discussed in ECHA’s Endocrine Disruptor Expert Group, too. This expert group gives informal scientific advice related to identifying endocrine-disrupting properties but does not take part in decision making. Opinions on biocidal active substance approval are formed by ECHA's Biocidal Products Committee. Their opinion is sent to the Commission for the final decision.

In principle, the Commission will not approve the use of any active substances, which have been identified as endocrine disruptors for humans. However, if there is evidence that the active substance with ED properties is essential to prevent or control a serious danger to human or animal health or to the environment, its use can be exceptionally approved. The same applies if the risk from exposure is shown to be negligible. In these cases, the approval may be granted, but for a maximum of five years.

Further developments in 2019

The Commission is currently discussing the standard information requirements in the BPR with a view to revising them by the end of 2019. The change would include an obligation for applicants to include the data needed for a proper ED assessment in their applications following the existing guidance.

The update could also mean that active substance applicants would, in the future, need to carry out some new studies that would give more information on ED relevant endpoints.

In summer 2019, ECHA plans to publish an additional short guide that will provide applicants with an overview of the process related to ED assessment. It also explains how this differs from information requested earlier and why applicants need to include a literature review in their applications.

Did you know? A formal ED assessment is required for all biocidal active substances and all biocidal products, including all non-active substances they contain. It is the duty of the active substance manufacturer or importer to put together an active substance application dossier and carry out the ED assessment. If you are applying for product authorisation, you do not need to assess the active substance again yourself, but you need to assess all non-active substances included in your product. There is no lower limit to the concentration in which an endocrine-disrupting substance exists in your product. Even if only one compound used in a very low percentage in your product is identified as an endocrine disruptor, your product will be identified as an endocrine disruptor.

Further information:

Guidance for the identification of endocrine disruptors in biocides and pesticides

Endocrine disruptors: major step towards protecting citizens and environment, European Commission, Press release 4 July 2017 

Endocrine disruptors – Hot topics

Endocrine Disruptor Expert Group

Text by Päivi Jokiniemi

Published on: 16 May 2019

Top image: © Pixabay/Free Photos
 

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