IR3535® Safety and Registration
Safety and tolerance of Merck's insect repellent IR 3535®
Extensive toxicological studies have been performed to show the particular safety and tolerance of IR3535®.
The safety and tolerance of IR3535® have been confirmed by noted national authorities and international organizations which have registered and approved IR3535®, e.g. the U.S. Environmental Protection Agency EPA which states, "there is reliable data to support the conclusion that IR3535® is practically non-toxic to mammals, including infants and children."
IR3535® has been evaluated by the World Health Organisation Pest Evaluation Scheme WHOPES. It is recommended as a safe and effective insect repellent for human use. IR3535® can be used for products applied to the general population including children.
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Registration
In most countries of the world, insect repellents are regarded as pesticides or biocides by definition. Due to this classification they have to be approved by the national authorities. The following synopsis is intended to give a general overview of the registration status. If you have specific questions with regard to the registration in your country, please contact us.
| Country/Region | Registration | Comments |
|---|---|---|
| Asia/Pacific | Different types of registration | Registered and marketed in a number of countries, some registrations are ongoing |
| Australia | NRA registration | Approved 2000 |
| European Union | Biocidal Products Directive | Notification submitted and accepted |
| South American countries | Different types of registration | Registered and marketed in most countries |
| USA | EPA registration | Approved 1999 |
| WHO | WHOPES evaluation and recommendation | Approved 2001 |
Some remarks on the situation in the European Union. The Biocidal Products Directive BPD (Directive 98/8/EG) came into force May 2000. For details see: http://ecb.jrc.it/biocides.
Merck has notified IR3535®. It is listed in Annex II of the Commission Regulation (EC) No 2032/2003. The full dossier was submitted to the Rapporteur Member State in April 2006 according to the call for submission. For particular advice on how to act in the transition period, please contact us.
You will find all relevant documents and certificates concerning your chosen product under the heading 'Related Documents'. Brochures are available on request.
