ECHA

The EU has decided on criteria for identifying whether a substance used in a biocidal product has an impact on our endocrine system. The criteria will apply from 7 June 2018. We take a deeper look at what endocrine disruptors are, why they should be regulated and what the new criteria mean for companies.
 

What are endocrine disruptors?

Our bodies have a network of glands and organs that produce, store and secrete hormones called the endocrine system. Many organs can produce and release hormones, but the standard endocrine organs include the brain, ovaries, testes, thyroid, pancreas and adrenal glands. The hormones travel around the body in blood and other bodily fluids, signalling any organ that has a receptor for that particular hormone.

When certain substances enter the body, they can trigger abnormal processes in the endocrine system, with potentially severe health consequences. Substances that act in this way are called endocrine-disrupting chemicals (EDCs).

Some EDCs mimic the structure of a hormone and bind to the receptor instead, causing a similar effect or blocking the action of the natural hormone. Others may bind to transport proteins in the blood altering the amount of natural hormones, or may interfere with metabolic processes in the body affecting the synthesis or breakdown rates of natural hormones.

EDCs have been linked to health issues related to growth and development, immunity, metabolism, reproduction and behaviour and more, because hormones regulate nearly every process in the body.

 

Where are they found?

A wide range of mainly man-made substances may cause endocrine disruption. EDCs can be difficult to identify because they may produce effects that vary depending on the substance, the species affected and its life stage. Sometimes, their effects may also only be seen long after exposure.

Exposure to EDCs may happen through different routes and come from contaminants in food, drinking water or in our environment and the different household and industrial products we are exposed to.

In wildlife, effects that are suggested as being related to endocrine disruption have been seen in molluscs, crustaceans, fish, reptiles, birds and mammals in various parts of the world. In some species, growth is altered, reproduction has been impaired and development has been delayed causing a decrease in populations.

 

Defining the EDC criteria

In June 2016, the European Commission presented draft criteria to identify endocrine disruptors in the fields of plant protection products and biocidal products. The criteria endorse the World Health Organisation’s (WHO) definition of an endocrine disruptor as "an exogenous substance or mixture that alters functions of the endocrine system and consequently causes adverse health effects in an intact organism, or its progeny, or (sub)populations".

After scrutiny by the European Council and the European Parliament, the final criteria were officially published in the Official Journal in November 2017 and will apply from 7 June 2018. According to the criteria, a substance is considered to have endocrine-disrupting properties if:

• it shows an adverse effect in an intact organism or its offspring, which changes the morphology, physiology, growth, development, reproduction or life span of the organism and impairs its functional capacity, its ability to compensate for stress or increases its susceptibility to other influences;
• it has the potential to alter the functions of the endocrine system; and
• there is a biologically plausible link between the adverse effect and the endocrine activity.

Conclusions on whether the criteria are met have to be drawn separately for humans and for non-target organisms.

 

Why regulate them?

The growing concern in the EU about endocrine disruptors possibly causing negative human health and environmental impacts led authorities to introduce specific legislative obligations to try to control the risks stemming from EDCs. For substances under approval as biocides or registered under REACH, the potential for endocrine disruption is a property considered in the assessment process.

Under biocides legislation, the ED criteria are either exclusion criteria (for effects on human health) or substitution criteria (for effects on the environment). Derogations exist, for example, if there are public health concerns, negligible exposure or disproportionate negative impacts on society.

Member State authorities are starting to evaluate biocidal active substances against the new criteria for EDCs. All substances that are currently under evaluation in the review programme will be looked at. For substances that have already been approved, the Commission and national authorities are in talks on whether and when these should also be assessed for endocrine disruption according to the new criteria.

It is expected that including this assessment for active substance approval will significantly increase the volume of work for authorities and ECHA’s endocrine disruptor expert group (EDEG) and will delay the assessment of active substances this year and probably in the coming years. EDEG provides informal, scientific advice on questions related to identifying endocrine disrupting properties of chemicals, including biocides.

EDCs can also be considered on a case-by-case basis under REACH as an equivalent regulatory concern to substances of very high concern (SVHCs). This means that they can be identified alongside substances known to cause cancer, mutations and toxicity to reproduction as well as those that are persistent, bioaccumulative and toxic and very persistent, very bioaccumulative. The aim is to reduce their use and ultimately replace them with safer alternatives.

Under CLP, endocrine disruption is not a specific hazard class, but EDCs have a mode of action that may lead to classification for reproductive toxicity, carcinogenicity, or specific target organ toxicity. Adverse effects related to the environment and caused by an endocrine disruptive mode of action may also lead to classification.

 

Guidance soon available

The Commission requested ECHA and the European Food Safety Authority (EFSA), with support from the Joint Research Centre (JRC), to develop a common guidance for the identification of endocrine disruptors in the context of the Biocidal Products and the Plant Protection Products regulations.

The draft guidance was subject to a public consultation from December 2017 to January 2018. More than 2 000 comments were received. Since then, the document has undergone a further consultation with ECHA and EFSA’s scientific bodies.

Currently, a final consultation is ongoing with the representatives of the Member State competent authorities for biocides and plant protection products. The final guidance document will be published in June – by the time the endocrine disruptor criteria for biocides become applicable.

 

How companies placing biocides on the market can prepare   Review the active substances in your products and portfolio in light of the new criteria. Be prepared to provide more information on the possible endocrine-disrupting properties of your active substance in your application. Consult the national authority responsible for the evaluation of your active substance before starting to test it to support the identification and assessment of possible endocrine disrupting properties. If your substance has already been approved at EU-level, note that the European Commission and national authorities are in talks on whether and on what level already approved substances should undergo assessment for endocrine-disrupting properties. Note that the criteria will also apply to co-formulants, not only active substances. Stay up-to-date - talk to your national industry association and follow ECHA’s news

 

Further information:

Hot topics: endocrine disruptors

European Commission’s web pages on endocrine disruptors

Commission's press release presenting criteria to identify EDCs in the pesticides and biocides areas – 15 June 2016

EFSA: What are endocrine disruptors?

Biocidal Products Regulation

Plant Protection Products Regulation

ECHA’s endocrine disruptor expert group

OECD work on endocrine disrupting chemicals

 

 

Text by Nedyu Yasenov and Veera Saari

Top image: © IStock.com/newannyart

 

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