HEALTH AND FOOD SAFETY DIRECTORATE GENERAL
Safety of the food chain
Pesticides and Biocides
Note for discussion with Competent Authorities for Biocidal Products
This document is an attempt to provide guidance in the interest of consistency, and has been drafted by the Commission services responsible for biocidal products with the aim of finding an agreement with Member States' Competent Authorities for biocidal products. Please note,however, that Member States are not legally obliged to follow the approach set out in this document, since only the Court of Justice of the European Union can give authoritative interpretations on the contents of Union law.
Subject:Article 55(1) of the BPR – requests from the Netherlands and Sweden
1.- Background and purpose of the document
(1)Recently, the Commission has received requests in accordance with Article 55(1) of the BPR from two competent authorities, the Netherlands and Sweden. Both requests are uploaded on CIRCABC (CA-Nov16-Doc.4.11.a and CA-Nov16-Doc.4.11.b) and concern the use of biocidal products for the control of insects. The purpose of these requests is to seek a decision from the Commission allowing extension of the national measures taken by these two Member States that allow the use of those biocidal products.
(2)This note aims atstarting a discussion with Member States on some aspects of these requests, which are linked to the implementation of this particular provision of the BPR, before the drafting of the respective Commission decisions.
2.- Problem statement
(3)According to Article 55(1), a competent authority maypermit by way of derogation from Articles 17 and 19, the making available on the market or use of a biocidal product which does not fulfil the conditions for authorisation laid down in the BPR. This can only be done under the prerequisite that:
(a) such a measure is necessary because of a danger to public health, animal health or the environment,
(b)and it cannot be contained by other means.
(4)Recital (48) in the BPR states that the provisions in Article 55(1) can be applied in "the event of an unforeseen danger threatening public health or the environment…". This recital points out that the legislator appears to consider that this Article is intended to address unforeseen situations rather than standard cases that could be addressed under the normal authorisation procedures. In other words, it appears to indicate the legislators' intention to restrict the use of the article to situations with an exceptional character.
(5)Moreover, it is important to note that the recital uses, like Article 55(1), the concept of "public health" and not human health as it is being included in many other provisions of the BPR. Therefore the legislator appears to have deliberately made a distinction between the use of "public health" and "human health" in the BPR and in particular in Article 55(1).
(6)The dictionary definition of public health is "the health of the population as a whole, especially as monitored, regulated, and promoted by the state.
(7)According to WHO, "Public health" is a social and political concept aimed at the improving health, prolonging life and improving the quality of life among whole populations through health promotion, disease prevention and other forms of healthintervention[1].
(8)Against this background, it follows that a danger for public health at national level would be seen as something:
(a)affecting or having the potential to affect relatively large population groups rather than a limited number of individuals,
(b)requiring a priority action to solve an identified problem with a view to ensure that (large) human (or animal) populations stay healthy.
3.-Questions relevant for the request by Sweden
(9)Sweden has temporarily authorised the use of an insecticide for the control of midges in order to protect workers in sewage treatment plants. Although these midges are not considered to be responsible for bites or the transmission of vector borne-diseases, according to the information provided by Sweden, long-lasting occupational exposure to large amounts of adult midges and its potential sensitisation can cause the development of asthma and allergic reactions, which can for example, induce anaphylaxis in more severe cases (see document CA-Nov16-Doc.4.11.a).
(10)In the Swedish case, this leads to the following questions:
(a)Notion of "unforeseen danger":
Can a situation like the suitability to control non-biting insects (like midges or flies) in areas such as sewage treatment plants, manure treatment plants or even farms, be considered as an "unforeseen danger threatening public health or the environment"?
(b)Condition of "necessary because of a danger to public health, animal health or the environment":
Althoughit is considered that exposure to midges may trigger the development and occurrence of allergies and asthma to individual persons, would there be in this case sufficient elements justifying the presence of those midges as "a danger for public health"?
Should a danger to public health be seen as affecting or having the potential to affect relatively large population groups with potential severe health effects rather than a limited number of individuals?
Should any other elements be considered?
4.- Questions relevant for the request by the Netherlands
(11)Article 55(1) requires thatderogation can only be provided if the danger to public health, animal health or the environment cannot be contained by other means. It is therefore important to agree on the application of this conditionin Article 55(1) of the BPR.
(12)The Netherlandshave temporarily authorised the making available on the market and the use of an insecticide for the control by certified operators of larvae from invasive exotic mosquitoes. According to the Netherlands, the concerned product has a different mode of application than other biocidal products already available on the market by virtue of Article 55(1) of the BPR. The concerned product is applied asgranulates, which complement the use of the other biocidal products in those spots where the applicationby spraying is not or less effective (see document CA-Nov16-Doc.4.11.b).
(13)Therefore, it seems that the proposed derogation concerns a product which complements other products and being the only effective product in a specific situation.
(14)Notwithstanding it is acknowledged that there is an obvious need to protect public health from vector borne diseases in the request of the Netherlands, it is important to agree on whether the use of an alternative product not posing some practical disadvantages(e.g. application method or frequency) compared to other products already available on the market could be considered as a valid justification to consider the condition in Article 55(1) that the organism "cannot be controlled by other means" as met.
(a)Is it necessary to demonstrate by a Member State in an Article 55(1) request that no other products can control the organism?
(b)Or is it sufficient to demonstrate for a Member State that the product is the mostsuitable or effective compared to other products available on the market?
5.-Action requested
(15)Bearing in mind the above,the Commission services invite the CA meeting to provide their views on the application of Article 55(1). These views are essential to achieve a common understanding by all the CAs, in order to follow a harmonised approach when assessing anyrequests received and to consider whether the basic requirements in the BPR are fulfilled.
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