Immediate notification potentially harmful or unacceptable effects
The authorisation holder has a legal obligation to report Ctgb immediately about adverse effects of the active substance or biocidal product, development of resistance, inadequate efficacy or other new data.
According to Article 47 of Regulation 528/2012, the authorisation holder of a biocidal product has a legal obligation to report to the Ctgb any new information that may affect the authorisation. Adverse effects of the active substance or biocidal product, development of resistance, inadequate efficacy or other new data must be reported immediately to the Ctgb by the authorisation holder of a biocidal product. It does not matter whether the product is authorised in the Netherlands under transitional law or under the European Biocidal Products Regulation.
In particular, the authorisation holder is obligated to report immediately:
- new data or information on adverse effects of the active substance or biocidal product on humans, especially vulnerable groups, as well as on animals or the environment
- all data indicating the development of resistance to the active substance
- new data or information that the biocidal product is not sufficiently effective
Use the form ‘Immediate Notification’ and mail this by e-mail to Ctgb. Notification by regular mail is possible via the following postal address: Ctgb, PO Box 8030, 6710 AA Ede, The Netherlands.
The Ctgb assesses the notification based on applicable criteria and prepares a conclusion. This conclusion is communicated to the authorisation holder by e-mail or regular mail. If a request for amendment is included, the report and submitted data will be assessed and, if necessary, the authorisation will be amended.
The fees for an immediate notification are shown in the Ctgb Tariffs Decree under Obligatory Notification (IKV-B). Depending on the outcome of the assessment, it will be determined whether measures are necessary and whether the authorisation needs to be amended.
If the authorisation holder has a proposal for amending the authorisation, they simultaneously submit a request for amendment.
Examples of situations that an authorisation holder must report immediately
- Incidents with humans
All negative, unexpected and unforeseen events that occur with people, which may be associated with the use of a biocidal product. The Ctgb must be notified as soon as these incidents are known to the authorisation holder. Based on the available data, the Ctgb assesses whether the reported effects can be attributed to the specific biocidal product.
- Incidents with animals
Immediate notification is required even if the effects are not widespread.
- Impact on the environment
Potentially harmful or unacceptable effects on soil, water or air quality, aquatic ecosystems, non-target organisms (e.g. beneficial insects, vertebrates) or other environmental compartments or systems that are possibly caused by the use of an authorised biocidal product where it is plausible that the conditions of authorisation are no longer complied with.
- New data
Unsubmitted data on the active substance or plant protection product from technical studies, or from studies required by law, demonstrating that the product no longer complies with the authorisation criteria of the active substance (Article 4) or biocidal product (Article 19 and Article 25).
- Official decisions or assessments by international organisations or government bodies
Which may be relevant for the decision of the Ctgb on the authorisation of the biocidal product and which have been brought to the attention of the authorisation holder. Such decisions may originate from non-EU legislators or international organisations involved in the evaluation of biocidal products, such as the FAO and the WHO.
- Development of resistance
Situations where there is a suspicion or demonstration that the target organism is developing resistance, published in annual reports of international resistance management organisations: IRAC (www.irac-online.org), FRAC (www.frac.info) and HRAC (www.hracglobal.com)], industry resistance monitoring programmes or any other source that has brought this to the attention of the authorisation holder.