On December 16 2015 the EU General Court(1) stated that the European Commission had failed in its obligation to adopt a delegated act specifying scientific criteria for the determination of endocrine-disrupting properties pursuant to the EU Biocides Regulation.(2)


Endocrine disruptors are chemicals that could have harmful effects on the body's endocrine (hormone) system. Biocidal products may contain such chemicals and pose risks to humans, animals and the environment because of their intrinsic properties. The possible negative effects of endocrine disruptors on human health and the environment are a growing concern. The European Union has introduced specific legislative obligations aimed at phasing out endocrine disruptors in water, industrial chemicals, plant protection products and biocides, in order to improve the free movement of biocidal products within the European Union, while simultaneously ensuring a high level of protection. In Sweden, the occurrence of endocrine disruptors in products, cosmetics and food packaging, among other things, has been under debate in recent years and the Swedish Chemicals Agency has expressed its intention to identify and phase out the use of endocrine disruptors.


The case was initiated by an action brought by the Swedish state against the European Commission on July 4 2014. Sweden claimed that the commission had failed to comply with Article 5(3) of the Biocides Regulation, stating that the commission should have adopted delegated acts to specify the scientific criteria for identifying endocrine-disrupting properties by December 13 2013 at the latest. Thus, Sweden held that the commission infringed the regulation and sought a declaration from the court that, according to Article 265 of the Treaty on the Functioning of the European Union, the commission had unlawfully refrained from laying down rules. Such actions are rarely brought before the European courts.

The General Court found that it was explicit in the regulation that the commission had a clear, precise and unconditional obligation to adopt delegated acts regarding the specification of the criteria by December 13 2013. The court considered the regulation's wording to be clear and unambiguous, and there was therefore no reason to interpret the obligation in light of its context or purpose.

In its defence, the commission argued that the scientific criteria that it had proposed had been subject of severe criticism on the grounds that they would have a negative effect on the internal market and had no basis in science. According to the court, the criticism was irrelevant considering the fact that the commission was obliged to adopt the scientific criteria before December 13 2013.

The tribunal stated that the regulation reflects the legislature's desired balance between the aim of improving the functioning of the internal market with regard to biocidal products on the one hand and the aim of protecting human and animal health and the environment on the other. The commission cannot question that balance when exercising the powers delegated to it by the legislature. The commission cannot rely on the fact that the regulation's objective is to improve the functioning of the internal market and therefore call into question the commission's clear, precise and unconditional obligation to adopt delegated acts on scientific criteria, or allow the commission to withdraw from this obligation. The court did not consider the commission's argument that interim criteria would guarantee a sufficiently high level of protection.

Thus, the court concluded that the commission had failed to fulfil its obligation under the Biocides Regulation to adopt delegated acts as regards the scientific criteria for the determination of endocrine disruptive properties.


The judgment concerns only the Biocides Regulation, but it may have an effect in other areas – for example, the use of endocrine disruptors in plant protection products and cosmetics.

For further information on this topic please contact Madeleine Edqvist at Advokatfirman Lindahl KB by telephone (+46 40 664 66 50) or email (madeleine.edqvist@lindahl.se). The Advokatfirman Lindahl KB website can be accessed at www.lindahl.se.


(1) Case T-521/14.

(2) EU Regulation 528/2012 concerning the making available on the market and use of biocidal products.

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