Application for Authorisation AL

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.

Procedure

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 (XLS, 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:

  1. Applicant
  2. Identity of the biocidal product
  3. Physical, chemical and technical properties
  4. Physical hazards and respective characteristics
  5. Methods of detection and identification
  6. Effectiveness against target organisms
  7. Intended uses and exposure
  8. Toxicological profile for humans and animals
  9. Ecotoxicological studies
  10. Environmental fate and behaviour
  11. Measures to be adopted to protect humans, animals and the environment
  12. Classification, labelling and packaging
  13. 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:

The guidance corresponds to the current state of scientific knowledge and the Swiss authorities are likewise guided by it. In many cases it refers to the "Technical Notes for Guidance" for the RL 98/8/EG (TNsG, found under "Biocidal Products Directive" in the listed link to ECHA), which continue to retain their validity, in so far as no revised documents become available.

The IUCLID software (International Uniform Chemical Information Database) is used for collecting, organising and saving data on the active substances and the biocidal product. The structured data then allows the dossier to be drawn up and submitted in the manner required by the OBP. All information required for drawing up a IUCLID dossier is found in the "Biocides Submission Manual 1: Using IUCLID for biocide applications":

The program itself as well as all associated documents and supplementary databases can be downloaded free of charge from the following site:

Access to the active substance dossier 

In order to include an active substance in Annex I of Directive 98/8/EC or for its approval pursuant to the EU Directive, the applicant has already had to submit a dossier on the active substance and on a product. For the product dossier of an authorisation AL, one may refer to or use this reference dossier or part of it. A prerequisite for this is the Letter of Access to the Reference Dossier. Whether the Reference Dossier or part of it may simply be cited or also submitted, must be clarified in each case with the authorities (Notification Authority).

When preparing the dossier, the special provisions on the active substance in the List in Annex 2 of the OBP and in the Assessment Report on the active substance from the EU have to be taken into account found under:

The contents and conclusions of this report form the basis for the assessment of the product.

If the biocidal product contains active substances in the form of nanomaterials, then the assessment of the active substance must have explicitly taken into account the nanoform. Otherwise the authorisation AL applies only to the biocidal product with active substances that are not present in nanoform.

Fees

According to the chemical fees ordinance (SR 813.153.1, ChemGebV; not available in English) the fee for an authorisation AL ranges from CHF 15 000 to 60 000. The criteria for the calculation of the fee within this range are the following: 

Basic fee

The basic fee for a simple dossier amounts to CHF 30'000.-

A simple dossier for a biocidal product consists of:

  • One active substance
  • For one application method
  • For one product type
  • For one user category

Extra charge

An increase of the basic charges of 8% is claimed for:

  • Each additional active substance
  • Each substance of concern
  • Each candidate for substitution
  • Each additional product type
  • Each additional application method
  • Each additional application
  • Outdoor application
  • Studies on potential residuals in food and animal feed 

The basic fee is increase of 5% per claim because of missing or incomplete documents.

The fee for biocidal product families is made up of the basic fee for the relevant authorisation (e.g. Authorisation AN, CHF 1000). In the case of biocidal product families with one sub-family, the basic fee is increased by 50%. An increase of a further 25% is made for each additional sub-family. 10 biocidal products may be included in each sub-family. For each additional biocidal product in a sub-family, the fee increases by one per cent. No additional charge is made for biocidal products in a biocidal product family or sub-family that do not differ (i.e. whether in their use, method of use etc.) other than by their concentration of pigments, colorants or fragrances.

Deductions

The following deductions are granted:

- up to 50%, if:

  • The biocidal product is comparable with the biocidal product which was representative in the competent authority report (CAR) for the active substance.
  • The biocidal product is comparable with the biocidal product for which the company already has a authorisation AL in Switzerland. 

- up to 8%, if:

  • The company is allowed, not to submit certain data (waiving; except for physical-chemical properties).
  • The company obtained a letter of access to data of comparable biocidal products which are already authorised (except for physical-chemical properties).

Remark: The applicant has to submit an application for the deductions justifying them.

Example how to calculate the fee

The following excel file allows calculating the prospective fee for a practical example:

Advance payment

An advance payment in respect of costs is a prerequisite for the treatment of an application.

Remark

The processes and procedures for the authorisation of biocidal products can change at short notice as a result of technical and administrative guidelines of the EU Commission and/or of the European Chemicals Agency ECHA as well as due to the updating of the mutual recognition agreement relating to biocidal products (MRA) between Switzerland and the EU. Consequently, we advise interested parties to regularly consult the website of the Notification Authority Chemicals and to subscribe to the Consumer Protection newsletter from the FOPH.

Last modification 05.06.2018

Top of page