Procedure
An application for simplified authorisation in Switzerland must be submitted to the Notification Authority for Chemicals via the European Register for Biocidal Products (R4BP). The data for an application for simplified authorisation must be submitted as a IUCLID file.
Companies that are interested should contact the Notification Authority for Chemicals beforehand and fill in the completeness checklist for a simplified authorization (XLSX, 15 kB, 05.06.2018).
In general, a complete dossier will be assessed and ruled upon within 90 days, subject to the receipt of payment of the deposit for the authorisation fee. Should the Notification Authority consider the submitted application incomplete, it will grant an appropriate grace period for submission of the missing information.
Period of validity
The OBP does not explicitly define the period of validity of the simplified authorisation. The active substances in Annex 1 also are no longer limited in regard to their inclusion as they were in the past. According to the general principles of EU Biocidal Products Regulation No. 528/2012 (art. 17, para. 4 BPR), a simplified authorisation is therefore granted for a maximum period of 10 years.
Dossier for a simplified authorisation
Biocidal products that can be authorised through the simplified procedure are, by definition, products that contain only active substances with a low risk potential and only substances that are not of concern. Toxicological and ecotoxicological data for the product are, therefore, not required. However, a summary of the biocidal product characteristics (SPC) and information on its efficacy and shelf life are needed (art. 20, para. 1, lit. b BPR). The application dossier is to be submitted as a IUCLID file and must include the following elements:
- a summary of the biocidal product characteristics (SPC) according to art. 20, para. 1, lit. a, no. ii BPR;
- information on its efficacy;
- any other relevant information that would allow the conclusion that the biocidal product fulfils the requirements laid out in article 25 BPR.
If the biocidal product for which authorisation is being requested using the harmonised European procedure is already on the market in Switzerland under a transitional authorisation:
- its authorisation number (CHAN or CHAC) and proprietary name (IMPORTANT: additional costs will be charged if queries arise)
In terms of the efficacy data, the requirements detailed in section 6 of Appendix III BPR are relevant. For active substances listed in Category 6 of the list in Appendix 1 OBP, proof of technical equivalence must be submitted along with the application. Since the IUCLID dossier must include written confirmation from the competent authority indicating that authority's consent to an assessment of the application, the Notification Authority should be contacted prior to submission.
Additional details regarding the procedure and the dossier to be submitted can be found in the corresponding guidelines of the European Chemicals Agency (ECHA) (see links).
Market access in Switzerland without authorisation
Biocidal products that are already authorised in the EU through the simplified procedure do not require an application for authorisation in Switzerland according to the procedure described above; they may be placed on the market after prior notification. The authorisation holder must submit such notification to the Notification Authority 30 days prior to the first placement on the market. Notification must include the product's trade name and authorisation number (art. 13c OBP) and is to be submitted via the European Register for Biocidal Products (R4BP). An electronic version of the draft label is to be added. Article 38 OBP applies to the labelling. In this way Switzerland guarantees the same market access conditions as EU Member States. Based on the Mutual Recognition Agreement (MRA), the same procedure applies vice versa for products that have been authorised in Switzerland through the simplified procedure. After notification of the competent authorities in the respective EU countries, such products may be placed on the market in those countries.
Note
The processes and procedures for the authorisation of biocidal products can change at short notice. We therefore advise interested parties to regularly consult the website of the Notification Authority for Chemicals and to subscribe to the FOPH's Consumer Protection newsletter. 1] If the active substance is already included in the list of Annex I of the EU Biocidal Products Regulation No. 528/2012 (BPR, see list of links) but implementation in Switzerland (through inclusion of the active substance in the list of Annex 1 OBP) has not yet happened, an application for simplified authorisation in Switzerland may nevertheless be submitted.
