Published on 22 May 2025

Declaration of Biocidal Products placed on the market at a later date

Procedure for the declaration of biocidal products placed on the market at a later stage, belonging to an already authorised biocidal product family AN.

Requirements:

  • An authorization AN for a biocidal product family has already been granted
  • The biocidal product in question has not yet been included in the previous evaluation and authorization
  • The biocidal product can be assigned to an existing subfamily based on product type, use, risk potential, formulation, and composition
  • The composition falls within the defined variation of the already authorized biocidal product family and subfamily
  • You require a user account to enter products concerning the third informationlevel information in the Product register for chemicals:

Hilfsmittel:

Procedure:

Basic principles:

  • Applications should be submitted online via www.rpc.admin.ch;
  • A user account is necessary for online registration User accounts;
  • The declaration must be made at least 30 days before the planned market launch;
  • The declaration is only considered submitted once the competent authority has been notified by email after the electronic submission of the dataset;
  • Fees will be charged after the procedure is concluded or expires.

Entering the data set:

  • Duplicate the dataset of an existing product belonging to the relevant subfamily;
  • Adjust the relevant elements of the duplicate (e.g., trade name);
  • Under the «Intended use» section, no elements may be added; otherwise, the product will no longer be considered identical. However, elements may be removed, allowing the product to be placed on the market with fewer intended uses;
  • Make necessary adjustments in the «Composition» section. Substances may only be removed if a lower concentration limit of 0% was previously declared. Substances may only be added if they were previously declared for the corresponding subfamily.

Required documents for each declared product (to be uploaded under the «Documents» section of the respective dataset):

  • a. Swiss label draft, including efficacy claims and instructions for use in at least one official language. The requested product types must already be listed on it or must be evident from the claims or instructions for use;
  • Technical data sheet or user manual;
  • c.  Swiss Safety Data Sheet or EU Safety Data Sheet with CH cover sheet (if necessary under Art. 19 ChemO) Safety Data Sheet (SDS);
  • d. The Updated form «Information Biocidal Product Family»;
  • e. Form «Retrospective declaration BPF».

Authorization Number:

The declared biocidal product receives its own authorization number. The declarant determines this, subject to approval, according to the following scheme:

The authorization numbers for the biocidal product family and its subfamilies remain unchanged. The authorization numbers of subfamilies are assigned sequentially. Example: The authorization number for the product family is CHZN1000. The authorization number for subfamily 1 is CHZN1000.01, for subfamily 2 it is CHZN1000.02, and so on. If two biocidal products of subfamily 1 are already authorized, they will be numbered CHZN1000.01.01 and CHZN1000.01.02.

If the authorization holder intends to place a third biocidal product of subfamily 1 on the market through a declaration, this product will receive the authorization number CHZN1000.01.03. The last two digits, «03,» represent the final authorization number, which must be determined by the authorization holder.

Submitting application:

Once all data has been entered and the necessary documents uploaded, submit all datasets in the RPC system. Then, please notify us by email:

  • To: cheminfo@bag.admin.ch
  • Subject: Name of the family, Declaration for Biocidal Product Family AN
  • Accompanying text:
    • Declaration for Biocidal Product Family AN
    • Name and authorization number (prefix) of the already authorized biocidal product family
    • CPID of the declared products
    • Contact details

Fees:

  • CHF 150.-
  • Per additional request: CHF 50.-
  • In individual cases (e.g. investigations involving other authorities or in-depth document or literature searches), fees may be charged according to the actual cost.

Invoicing is usually done after the procedure is completed and is carried out exclusively through the designated authorisation holder.