Standards and guidelines
Current legal situation within the European Community
Active substances and substance formulations that are used to repel or kill mosquitoes and other blood-sucking arthropodes are subjected to the European Biocide Directive 9878/EG, and need to be authorized in accordance with the provisions. Repellents and attractants belong to product type 19, and insecticides are classified as product type 18 within the Directive. Biogents is working according to official standard methods and test guidelines.
At the moment, a collaborative program between the EU member states reviews the capability of active substances that have been placed on the market before May 14, 2000, to be used in biocidal products. A substance that passes the review process will be included in Annex I of the Directive. During this transition period, while the decision process on inclusion and non-inclusion continues, EU member states are allowed to dispense their currently available rules – as soon as a substance is included into Annex I, biocidal products that contain this substance have to be authorized according to the EU regulations.
Registration of a biocidal product
The registration of a biocidal product includes comprehensive efficiency tests. Mandatory standards or guidelines to test product type 19 (repellents) have not been designated, therefore the European Commission suggests the use of international, European, or national guidelines (Technical Notes for Guidance by the European Commission). Skin repellents or repellent impregnated textiles should be tested in Arm-in-Cage tests against Culex ssp. and Aedes ssp. The efficacy of a formulation should be based on the protection time, that is, the time between repellent application and the time of two (or more) bites on the treated arm, or the first confirmed bite (= a bite followed by another bite within 30 min).
Our test methods are based on international standard procedures and guidelines, like specifications from the World Health Organization (WHO), the American Environmental Protection Agency (EPA), or the American Society for Testing and Material (ASTM).
Our team of experts has a long-term experience in modifying or establishing experimental set-ups to evaluate new product ideas that are still not covered by the international standard methods and test guidelines. Today, we are able to adopt more than ten standard testing procedures for a specific efficiency evaluation of different anti-mosquito products.
Important standard methods and test guidelines for the efficacy testing of repellents and insecticides (treated surfaces)
- ASTM International. E 951-94. Standard Test Method for Laboratory Testing of Non-Commercial Mosquito Repellent Formulations on the Skin (reconfirmed in 2000)
- ASTM International. E 939-94. Standard Test Method for Field Testing Topical Applications of Compounds as Repellents for Medically Important Pest Arthropods (including Insects, Ticks and Mites): I Mosquitoes (reconfirmed in 2000)
- Guidelines for Efficacy Testing of Mosquito Repellents for Human Skin (2009)
- Guidelines for Efficacy Testing of Spatial Repellents (2013)
- Product Performance Test Guidelines. OPPTS 810.3700: Insect Repellents to be Applied to Human Skin (2010)
- Transitional Guidance on the Biocidal Products Regulation. Efficacy Assessment for Product Type 18, Insecticides, Acaricides & other Biocidal Products against Arthropods and Product Type 19, Repellents & Attractants (2016)
- Guidelines for Laboratory and Field Testing of Long-Lasting Insecticidal Mosquito Nets (2005)
- Test Procedures for Insecticide Resistance Monitoring in Malaria Vectors, Bio-Efficacy and Persistence of Insecticides on Treated Surfaces (1998)
- German Army TL 8305-0331. Vektorenschutzausrüstung für textile Flächengebilde (Juli 2016)