This type of authorisation is applicable only in cases, in which all active substances contained in the product have been included in the Lists of Annex 1 and/or 2 of the OBP (previously list IA and/or I). At least one active substance must be in the list of Annex 2, the others can be included in the list of Annex 1. If the product contains a substance of concern or a nanomaterial, or personal protective equipment is required for use, then an authorisation AL must be requested, even when the product contains only active substances from the list of Annex 1. If the product contains one or more notified active substances that have not yet been included in these lists, then no authorisation AL may yet be requested for the product. An application for authorisation AN is to be submitted to the Notification Authority.
When the active substances of a biocidal product are included in the list of Annex 1 or 2, more stringent requirements apply for an authorisation of the product. In the case where the product is also placed on the market in the EU, an authorisation may be requested there and the recognition of the EU authorisation can be subsequently requested in Switzerland. For a separate authorisation in Switzerland (AL) the same requirements apply as in the EU.
The application submitted for an authorisation AL must be accompanied by a dossier with the data according to Annex 5 OBP. Applications are to be submitted exclusively through the Register for Biocidal Products R4BP 3 at the Notification Authority for Chemicals. Companies that are interested should contact the Notification Authority for Chemicals beforehand and fill in the completeness checklist for an authorization AL (XLSX, 24 kB, 05.06.2018).
The submitted dossier will be validated within 30 days, subject to the receipt of payment of the deposit. This takes the form of a test for completeness of the submitted documents. A complete and validated dossier is generally assessed and ruled on within 365 days.
Period of Validity
The period of validity of the authorisation AL is limited to a maximum of 10 years. Depending on the active substance, the time limit may also be shorter, e.g. if it concerns an active substance to be replaced according to Article 10 of the Regulation (EU) no. 528/2012. An application for renewal has to be submitted 550 days prior to the expiration of the authorisation in order to be able to continue to market the product without interruption.
Dossier for an authorisation AL
The data requirements are listed in Annex 5 of the OBP, where reference is made to the Annexes II (for the active substance) and III (for the product) of the Regulation (EU) no. 528/2012 on biocidal products. The dossier for an authorisation AL shall be established according to the guidelines of the EU Regulation. Annex III of the EU Regulation lists the required data for the biocidal product and contains the following sections:
- Identity of the biocidal product
- Physical, chemical and technical properties
- Physical hazards and respective characteristics
- Methods of detection and identification
- Effectiveness against target organisms
- Intended uses and exposure
- Toxicological profile for humans and animals
- Ecotoxicological studies
- Environmental fate and behaviour
- Measures to be adopted to protect humans, animals and the environment
- Classification, labelling and packaging
- Evaluation and summary
Extensive data are required for each section, and are entered into the product dossier that is being established. Thus, the effectiveness and suitability inter alia of the product (section 6) must be determined (by laboratory or field studies, depending on the field of application), the exposure of the user or indirectly affected person (section 7) summarised, fate and behaviour of the substance in the environment (section 10) described by measured data or adequate numerical modelling, and a risk assessment carried out for humans, animals and the environment (section 11).
The EU presents detailed instructions "Guidance on information requirements" on the ECHA website: