Regulatory Information
Regulatory Support
Saltigo is at hand to provide regulatory information to manufacturers planning a product based on Saltidin®.
Saltidin® (Picaridin/Icaridin) is a repellent that efficiently deters ticks and other insects without harming or killing them. Due to this active ingredient’s range of excellent properties, many countries are seeing a fast growth in demand.
Depending on the location the regulatory requirements for the manufacture and marketing of insect repellents can vary significantly. At global level, our active ingredient Saltidin® (Picaridin) may fall under a range of denominations governing cosmetics, medicines, pesticides or biocides and be regulated accordingly.
Registration is a common requirement for market access
In most countries insect repellents must go through regulatory approval before they may be launched on the market. In some countries the active ingredient must also pass a separate pre-registration process. The good news is that Saltigo has already registered Saltidin® (Icaridin/Picaridin) as an active ingredient in more than 40 countries – including all of the EU, the UK, the USA, Canada, Australia, China and Thailand. For instance, Saltigo has registered reference products containing Saltidin® (Picaridin) in countries such as the USA, China and Canada. We are happy to discuss granting access to our license – just get in touch with us.
How to access support for the registration of your insect repellent product
Saltigo is continuously driving forward the registration of the Saltidin® (Icaridin/Picaridin) active ingredient across additional countries. We support our customers building on our many years of expertise gained in successful insect repellent registration.
Saltigo has developed guide formulations for a variety of applications, from aerosols to gels and creams. Some of our guide formulations are also already registered in several countries. For selected compositions we can make comprehensive data packets available to the relevant authorities to support your registration process.
For the USA and Canada, Saltigo also offers the option of a Master Copy Registration for selected products.
Taking the first steps towards your Saltidin® (Picaridin) project
Our product managers are the perfect go-to partners for manufacturers wishing to develop a new Saltidin® (Picaridin) product. Typical questions we will ask you when starting our collaboration include:
- Which countries are you planning to market your product to?
- Will the product be for human or animal use?
- Which type of formulation are you planning on?
- Who is the target group for your product?
- What quantity of product are you planning on?
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To get in touch with our product managers simply fill out our contact form
Checking the regulatory requirements in your target market
Launching a new Saltidin® (Picaridin) product onto the market requires precise information on the regulatory requirements. On request we can put you in touch with specialized consultancy firms that you can mandate to deal with the approval process for your insect repellent containing Saltidin®.
Saltigo can support you in your dealings with regulatory authorities by providing a Letter of Access (LoA) – granting you use of Saltigo’s proprietary active ingredient data. If you avail of our technical or regulatory support, we will first require the signing of a non-disclosure agreement and subsequently of an access contract (Contract on Access, CoA). The Letter of Access informs the relevant authorities that you have been authorized to use our data. This data packet includes for example:
- efficacy studies,
- dermatological data,
- toxicology reports on the active ingredient.
Selling products containing Saltidin® (Picaridin/Icaridin) in the EU
The EU has standardized the approval process for active biocidal substances – including repellents – under the Biocidal Products Regulation (BPR, EU Regulation No. 528/2012). As of February 2022, Saltigo has approval to use the active ingredient Saltidin® (Picaridin/Icaridin) in insect repellents in the PT19 product category governed by the BPR. Until February 2022, Saltidin® (Icaridin) remains governed by the national licensing regulations of the respective EU countries. For companies wishing to sell their Saltidin® (Picaridin) products in accordance with our reference product family in the EU, Saltigo offers the option of using Saltigo's proprietary registration of the reference product family.
©marqs - stock.adobe.comWhat to look out for in order to comply with the REACH regulation
Active ingredients produced in the EU for sole usage in biocidal products are considered registered if one of the named requirements in Article 15(2) of REACH is fulfilled. This is the case for Saltidin® (Picaridin), which is approved for use under REACH with the registration number 01-0000016971-65-0000.
The ingredient Saltidin® (Picaridin/Icaridin) has been approved according to the BPR regulation (EU) as an existing substance for use in biocides pertaining to the product type 19.
BillionPhotos.com - stock.adobe.comCertified Quality: advantages beyond registration
Saltidin® (Picaridin) is halal certified (reference standards: JAKIM MS 1500:2019, MUI HAS 23000, OIC/SMIIC1:2019, GSO 2055-1). This is considered a seal of quality even amongst non-Muslim target customers. Get in touch with us if you require such confirmation for marketing your product.
Saltidin® (Picaridin) is manufactured to controlled quality standards. Saltigo is certified according to ISO9001/2015 (quality management) and ISO 14001/2015 (environmental management) norms. In addition, the test laboratory is certified according to ISO 17025. Saltigo receives regular auditsfrom a globally recognized certification organization.
Saltidin®(Picaridin/Icaridin) - internationally accredited and recommended
- KBR3023 (old name for Icaridin/Saltidin®) is one of the substances recommended by the World Health Organization (WHO) to prevent infection with the Zika virus or Chikungunya fever.
- The U.S. Centers for Disease Control and Prevention (CDC) recommend using insect repellents containing EPA-approved active ingredients such as Picaridin/Icaridin to protect against mosquito bites and associated transmittable diseases.
- Products containing Icaridin are amongst those recommended by the German Society for Tropical Medicine, Travel Medicine and Global Health (DTG) in the prevention of malaria.
- TheRobert Koch Institute (RKI) too recommends Icaridin for protection including against tick bites and associated transmittable diseases.
- Regulatory requirements in the United States differ from the EU. Please visit www.picaridin.saltidin.com to get in touch with our US team -
