INSECT REPELLENTS REGULATORY
Figure 1 Repellents containing IR3535 have a longstanding effect against ticks and mosquitoes
Ixodes (above) is one of the tick species that IR3535 has been proven to be effective against
days,” says Sztuka. “IR3535 is ideal if customers worry about sustainability. In many cases they’ll do anything to get rid of insects, but that doesn’t mean they’re willing to compromise when it comes to water pollution, harming the countryside and human health, and even hurting the actual insects. That’s why repelling insects rather than killing them is becoming so popular: look after yourself, don’t harm the environment – and support biodiversity.”
1
Scott P. Carroll, Carroll-Loye Biological Research, 2006, Davis, California, USA.
strong; they should adhere to the claim made on the label. They should also be long lasting and at the same time safe for use by all family members.” Market research also confirms that consumers seek emotional benefits in their products. “Modern customers expect sprays, lotions and creams to feel good on the skin, to smell right, to be suitable for frequent use – at all times of the year – and perhaps most importantly, not cause irritation, redness, rashes or swelling. IR3535 ticks all the right boxes in that regard,” explains Dr Thomas Broschard, Head of Chemical Toxicology from the Chemical and Preclinical Department at Merck. “We know from our own customers that more and more companies want an alternative to DEET, quite simply because they need something that is tested, safe, reliable and suitable for all target groups – families, young children, the elderly. Formulations that contain IR3535 are even suitable to use on sensitive skin.” And the environment? “That’s crucial these
Figure 2 IR3535: Dependence of the effect on the concentration1
PRODUCTS ON THE EU MARKET Generally, repellents can only be marketed in the EU in compliance with the Biocidal Products Regulation (BPR, Regulation (EU) No. 528/2012). Therefore, repellents are considered biocidal products and to gain authorisation, the properties of biocidal products containing any of the active ingredients IR3535, DEET, or Icaridin, which are all EU-approved, must be evaluated by the competent authority according to equal standards. Evaluations cover, among others, efficacy, toxicology and ecotoxicology, and the process has been harmonised to allow authorities to define stringent biocidal product declarations. To date, three active ingredients have been officially approved in the EU under the BPR for use as an insect repellent on human skin (PT19). These include the active ingredient marketed by Merck KGaA, Darmstadt, Germany: Ethyl butylacetylaminopropionate – Insect Repellent 3535 (IR3535).
Apart from its active ingredient IR3535, Merck applied for authorisation of four market-ready formulations. These have been authorised for use on human skin, offering highly effective protection against stings and bites from mosquitoes and ticks. The efficacy of IR3535, which Merck not only developed but has also gained full approvals for, has been researched and verified in more than 40 validated internal efficacy studies involving mosquito and tick species such as Aedes, Culex, Anopheles and Ixodes. These studies have also confirmed that Merck’s proprietary IR3535 formulations provide comparable or even longer lasting protection than products containing DEET or Icaridin.
WHY LOOK OUT FOR IR3535 REPELLENTS? The benefits of IR3535 as an active substance are similar to those of DEET in a number of areas, with some important exceptions. IR3535, is tough on insects. In studies it performs the same in terms of staying power. And of course, it is effective against
1A. Liebisch, Institut fur Parasitologie der Tierarztlichen Hochshule Hannover – ‘Efficacy Data of IR3535’, 1981.
IR3535 mode of action Repellents are substances that are applied (as a cream or spray) onto the skin (or clothing) to protect you from insects. They ward off pests – so the aim is not to actually kill them. How? Once evaporated, repellents leave behind a scented veil that disorientates insects and ticks.
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