Modification of the interpretation practice relating to permethrin-containing topical insecticides
The assessment authorities (FOPH, FOEN, SECO and FSVO) have adopted the following decision:
A product that contains the active substance permethrin and which is advertised or used directly on the skin or on the pelt of animals to control insects shall not be considered as a biocidal product within the meaning of the Ordinance on Biocidal Products (SR 813.12, OBP) therefore cannot be authorised as such.
In collaboration with Swissmedic it has been decided that in Switzerland, analogously to the interpretation adapted in several EU countries, these products in future will fall under the Therapeutic Products legislation and accordingly are a veterinary medicinal product subject to authorisation. This includes all delivery forms, i.e. permethrin-containing collars, ear tags and similar products that remain for long periods on the animal.
The distinction between veterinary medicinal product and biocide was previously often made by means of a case-by-case decision based on differentially weighted arguments. It was generally considered that products claimed to control insects and arachnids, and which remained for longer periods on the animal, were classified as veterinary medicinal products. In contrast, products that contained notified active substances of product type 18 and which claimed to control insects that remained for only short periods on the animal, were previously classified as biocidal products.
The present decision on the modification of the interpretation practice was taken by considering the reasons set out in points 1 and 2. The distinction and classification of permethrin-containing products as veterinary medicinal products, independently of the claimed target organism, is thus clearly comprehensible and consistent.
1. Permethrin is a pharmacologically active substance with an insecticidal and acaricidal action. The use of permethrin-containing products on the skin or pelt of animals results in an action against insects and arachnids; because it is associated with specific diseases it is classified as a veterinary treatment against ectoparasites. This also applies to treatments against insects, such as e.g. flies that temporarily remain on or in contact with animals, because these insects may also transmit and cause diseases to animals. Consequently, the product falls under the definition of Article 4 of the Therapeutic Products Act (TPA) and is regarded as a veterinary medicinal product subject to authorisation.
2. The topical application of biocidal products of the product type 18 (insecticides, acaricides and products to control other arthropods) is not explicitly provided for in the European Biocidal Products Regulation (BPR) or the Swiss Ordinance on Biocidal Products (OBP). This is in contrast to the product types 1, 3 and 19 (human hygiene; veterinary hygiene; repellents and attractants), for which the possibility of such an application is explicitly mentioned. For all other product types there are no biocidal products that have been authorised for topical application – except for PT18 up to now in the veterinary field. Topical insecticides for use on humans have already to be authorised as a medicinal product today.
For insecticidal and acaricidal biocidal products for topical use and which contain active substances other than permethrin, the previous interpretation is maintained until the active substance is assessed in the EU (review programme) and a decision for approval is taken (admission of the active substance into the Union list or not). The same applies to products that contain permethrin and other additionally notified active substances that are still being assessed.
The concerned authorisation holders will be informed in writing in due time whether the product can be authorised as a biocidal product or will be regarded as a veterinary medicinal product subject to authorisation. The abovementioned authorities will closely follow the decision-making process for the interpretation in the EU. However, it is likely that products that contain notified active substances of product type 18 and are foreseen for topical application on an animal will in future be regarded as veterinary medicinal products.
Please note that such products (containing active substances other than permethrin, or additional active substances combined with permethrin) can already be authorised as veterinary medicinal products if they meet the required conditions.
Sales deadlines in accordance with Article 26a OBP will be granted for those products already present on the market and which are impacted by this modification of the interpretation. The Notification Authority for Chemicals will adopt such an action and deliver it to the authorisation holders concerned.
Last modification 14.05.2019