The Court of Justice of the EU (CJEU) has provided guidance on claims permitted to be made in the labelling and advertising for biocidal products under the Biocidal Products Regulation (Regulation (EU) No 528/2012 (BPR).
The BPR aims to improve the free movement of biocidal products (substances intended to destroy, deter, render harmless, prevent the action of or otherwise control harmful organisms) while ensuring a high level of protection for human and animal health and the environment.
In its judgment in Case C-296/23 Zentrale zur Bekämpfung unlauteren Wettbewerbs eV (ZBUW) v dm-drogerie markt GmbH & Co. KG on 20 June 2024, the CJEU ruled on a question referred from the Bundesgerichtshof (Federal Court of Justice) in Germany. The case concerned labels on a disinfectant named BioLYTHE, sold by dm-drogerie markt GmbH & Co. KG.
The CJEU ruling clarified that the BPR prohibits advertisements that are misleading regarding risks to human or animal health or the environment or efficacy. That prohibition included the indication "skin friendly" in the case referred.
Advertising of biocidal products
Under the BPR, the term 'natural' and/or other similar expressions such as 'low-risk biocidal product', 'non-toxic', 'harmless', 'environmentally friendly', and 'animal friendly' are not permitted to appear on the label (BPR Article 69(2)) or in an advertisement (BPR Article 72(3)) for a biocidal product made available on the market. This applies also in cases where the word 'natural' and/or other similar terms are part of a registered trademark and regardless of the natural origin of an active substance contained in the product. BPR Article 72(3) states:
"Advertisements for biocidal products shall not refer to the product in a manner which is misleading in respect of the risks from the product to human health, animal health or the environment or its efficacy. In any case, the advertising of a biocidal product shall not mention "low-risk biocidal product", "non-toxic", "harmless", "natural", "environmentally friendly", "animal friendly" or any similar indication."
The label of the BioLYTHE disinfectant contained the statements 'Ecological Universal Broad-Spectrum Disinfectant', 'Skin, hand and surface disinfection', 'Effective against SARS-Corona' and 'Skin friendly " Organic " Alcohol-free'. The labelling was challenged by the Zentrale zur Bekämpfung unlauteren Wettbewerbs eV (ZBUW), a German anti-unfair competition association.
ZBUW was successful at first instance. On appeal, however, the higher regional court in Karlsruhe found that the indication "skin friendly" was not a "similar indication" within the meaning of BPR Article 72(3). It found that this indication did not qualify the level of risk from the product at issue, its effects or their potential to cause harm and merely described in general terms the effect produced on human skin.
When ZBUW appealed that finding, the Bundesgerichtshof referred the case to the CJEU, asking whether the term "similar indication" in BPR Article 72(3) means "only such an indication contained in an advertisement which, in the same manner as the terms expressly listed in that provision, downplays properties of the biocide as regards the risks from the product to human health, animal health or the environment or its efficacy by means of a blanket statement" or whether it includes "all terms which, in respect of the risks from the product to human health, animal health or the environment or its efficacy, downplay the risks in a manner comparable to the terms expressly listed but are not necessarily also general in nature like those terms."
In response, the CJEU said that the term "any similar indication" includes "any indication in the advertising for biocidal products which, like the indications referred to in that provision, refers to those products in a manner which is misleading in respect of the risks from the product to human health, animal health or the environment or their efficacy, by downplaying those risks or even denying their existence, without necessarily being general in nature".
CJEU reasoning
The CJEU said that the commonality of the indications listed in BPR Article 72(3) "lies in the fact that they downplay the risks from biocidal products to human health, animal health or the environment or their efficacy, or even deny the existence of those risks, without necessarily being general in nature".
It stated that the BPR covers the effective communication of information on risks resulting from biocidal products, labelling to provide consumers with information about those products and misleading indications. In this context, BPR Article 72(3) establishes general rules on advertising based on consumers' reactions, which apply irrespective of the actual risks and properties of those products.
The indications in the second sentence of BPR Article 72(3) and the term "any similar indication" are examples of indications that are "manifestly misleading". The CJEU added that "both general and specific indications" may manifestly mislead the user.
It ruled that the second sentence of BPR Article 72(3) "intended to regulate, in a detailed and comprehensive manner, the wording of statements on the risks of using of biocidal products which may appear in advertisements for those products". It noted, apparently in relation to BPR Article 72(1), that the BPR specifies a mandatory statement to be included in advertisements ('Use biocides safely. Always read the label and product information before use'). Overall, the CJEU found that BPR Article 72(3) expressly prohibits certain statements and that it seeks, more generally, to prohibit any advertising statement "which is misleading in respect of the risks from the product to human health, animal health or the environment or its efficacy."
BPR Article 72(3) does not therefore in principle prohibit the use of statements that are not among those specifically listed and which do not downplay or deny the risks from biocidal products in the advertising of those products. However, according the CJEU statements "which refer to the absence of risk, to a low risk or to certain beneficial effects of those products with a view to downplaying or even denying those risks" are not permitted, as they may encourage excessive, negligent or incorrect use.
The CJEU addressed the use of the indication "skin friendly" in the case in which the referral arose. It said:
"such an indication which has, prima facie, a positive connotation that avoids suggesting any risk, may qualify the harmful side effects of that product or even ... imply that that product could be beneficial for skin."
That indication was therefore misleading within the meaning of BPR Article 72(3).
Conclusion: a strict approach
The judgment appears to interpret these aspects of the BPR fairly strictly. Manufacturers and retailers of biocidal products are already familiar with the need to describe their products in a way that is compliant with the terms of its authorised use, but should also exercise caution with the language that they use when describing their products in labels or advertising. Any description, even if not specifically listed in BPR Article 72(3), that tends to mislead, to deny or play down the risks of biocidal products, or wrongly imply benefits, is likely to be prohibited. Regulatory intervention requiring corrective action and possible sanctions may follow, and the non-compliant product may also breach specifications in supply agreements with customers.
It is important therefore to be clear about the potential risks of the specific product and ensure that any labelling or advertising language used accurately reflects these risks and is not misleading.
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