Authorisation conditions for PT 19 repellents

Background 

Recent evaluations indicate that PT 19 products based on Icaridine, DEET, and IR3535 frequently do not meet the approval criteria under Article 19(1) of the BPR, due to identified unacceptable risks to human health and, in certain cases, also to the environment. At the same time, these products are essential for the protection of public health,  particularly against vector-borne diseases. A clear societal need exists. Non-chemical alternatives, such as screens, bed nets and protective clothing, do not provide full protection. In addition, travellers without adequate protection may return from abroad infected with tropical diseases and subsequently transmit disease to others in the Netherlands. Furthermore, the risk of diseases transmitted by invasive mosquito species in the Netherlands is expected to increase in the coming years. 

Against this background, products that do not comply with Article 19(1) requirements will nevertheless be authorised under Article 19(5) of the BPR. Such authorisations are subject to additional risk mitigation measures and stricter conditions of use, also aimed at aligning and harmonising instructions for use. These measures are intended to ensure better control of exposure for humans and the environment, while maintaining the availability of sufficiently effective products. 

The Ctgb emphasises that the application of Article 19(5) is based on the current availability of products on the Dutch market and the existing societal need. If sufficient PT 19 products become available in the future that comply with Article 19(1) of the BPR and adequately protect public‑health, the Board may reconsider this approach and revise the authorisation conditions accordingly. Authorisations based on art 19(5) may then be withdrawn. 

Specific considerations for use in tropical regions 

Different risk considerations apply to the use of repellents in tropical regions compared to the'Netherlands. In such circumstances, protection of travellers may require more flexible usage patterns. For this reason, the Summary of Product Characteristics (SPC) will include a standard reference to the National Coordination Centre for Traveller Health Advice (LCR), which provides tailored advice on product choice, frequency of application and additional protective measures for travel to regions where vector-borne diseases are prevalent. 

These tailored considerations are not part of the standard Dutch authorisation and apply exclusively to use in tropical regions.

Revision to authorisation conditions 

1. Enforcement and addition of risk mitigating measures (RMMs) 

Existing harmonised European RMMs remain in force and are supplemented with the following measures (both under art 19(5) as art 19(1)): 

• Extra attention to non‑chemical alternatives, such as physical barriers (clothing, screens, bed nets). 

• An additional environmental measure: do not apply immediately before showering or swimming. 

• Reference to the LCR for situations involving travel to countries where tropical diseases are prevalent. 

2. Maximum concentration of active substance 

For authorisation granted under Article 19(5): 

• The maximum permitted concentration is 30% active substance. 

Products exceeding this concentration will not be authorised under art. 19(5), to prevent unnecessarily high exposure and environmental burden. At present, this restriction concerns only products containing DEET > 30%. 

3. Co‑formulants with Endocrine Disrupting Properties 

Product contains a co‑formulant identified as having endocrine disrupting (ED) properties, the product will not be authorised under article 19(5). 

4. Daily use limits 

To minimise total exposure and ensure consistency across products, the following fixed use limits are established: 

• Adults and children ≥ 2 years: maximum 2 applications per day 

• Children < 2 years: maximum of 1 application per day, due to increased likelihood of oral exposure 

For products for which only an authorization pursuant to Article 19(1) applies, a daily use limit is likewise imposed, as is the case for an authorization under Article 19(5), in accordance with Article 37(2). This is to ensure harmonization of the SPC and to maintain a level playing field in the market. 

For products intended for both skin application and clothing treatment, the same conditions apply as for products intended solely for skin use. For products intended exclusively for the impregnation of clothing, the Ctgb will assess on a case‑by‑case basis whether additional or alternative conditions are required. 

Text to be included in SPCs 

The following RMMs will be included (both under art 19(5) as art 19(1)): 

• Give preference to mechanical protection such as mosquito nets, window screens, and protective clothing. 

• Apply only to uncovered skin of the arms, hands, legs, and face. 

• Do not apply to the hands of children under 2 years of age. 

• Avoid contact with food and food preparation surfaces. 

• Wash hands before handling food. 

• Avoid contact with eyes, mucous membranes, nose, lips, and damaged skin. 

• For children under 12 years: use only when applied by an adult. 

• Do not use in the presence of animals/pets. 

• Wash the product off as soon as protection is no longer needed. 

• Avoid inhalation of vapours or spray mist; use outdoors or in well-ventilated areas. 

• Do not apply shortly before showering or swimming. 

• If you are traveling to countries where diseases such as malaria or dengue occur, different usage recommendations may apply. It is important to follow the advice of the National Coordination Centre for Travel Health Advice (http://www.lcr.nl/landen). 

In Dutch these RMM's will read: 

• Geef voorkeur aan mechanische bescherming zoals klamboes, horren en bedekkende kleding. 

• Alleen aanbrengen op onbedekte huid van armen, handen, benen en gezicht. 

• Niet aanbrengen op handen van kinderen < 2 jaar. 

• Vermijd contact met voedsel en voedseloppervlakken. 

• Was handen voor contact met voedsel. 

• Vermijd contact met ogen, slijmvliezen, neus, lippen en beschadigde huid. 

• Voor kinderen < 12 jaar: uitsluitend toepassen door een volwassene. 

• Niet gebruiken in aanwezigheid van (huis)dieren. 

• Was het middel af zodra bescherming niet meer nodig is. 

• Vermijd inademing van dampen/spuitnevel; gebruik buiten of in goed geventileerde ruimtes. 

• Niet aanbrengen vlak voor douchen of zwemmen. 

• Als u reist naar landen waar ziekten zoals malaria of dengue voorkomen kunnen andere gebruiksadviezen gelden. Het is belangrijk om dan de adviezen van het Landelijk Coördinatiecentrum Reizigersadvisering (http://www.lcr.nl/landen) te volgen.