Published on 22 May 2025

Type 1: In situ systems with at least one precursor WITHOUT a device

No generation device is required for this in situ system. At least one precursor is placed on the market as a biocidal product.

Requirements:

  • The relevant in situ system of the biocidal product is still notified for one of the product types concerned at the time of the application;
  • No device is required for the production of the in-situ active substance;
  • The other active substances contained or generated in situ may already be on one of the lists in accordance with Annex 1 or 2 OBP;
  • The authorisation owner is domiciled or has its registered office or branch in Switzerland. PO box addresses without a street name or similar are not permitted;
  • You require a user account to enter products 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;
  • It generally takes up to 60 days to process a complete application;
  • For each precursor, as well as for the in-situ generated active substance, a data set is required. For example, for the in-situ system Chlorine dioxide generated from sodium chlorite by acidification, three (3) data sets are needed:
    • For the precursor sodium chlorite;
    • For the precursor «acid» - the acid must be clearly identified;
    • For the in-situ generated active substance in the generated concentration
  • If the precursors are firmly or loosely connected, e.g., peracetic acid produced from Sodium percarbonate and TAED, then only one data set is necessary for both precursors;
  • For disinfectants and wood preservatives, proof of efficacy must be provided. Authorisation procedure AN for disinfectants   Wood preservatives. Some exceptions apply for certain alcohol-based disinfectants;
  • Product types, and methods and fields of use that were selected in the data set for the electronic notification but are not featured on the label or in the instructions, will not be processed and will be rejected;
  • Product types, and methods and fields of use that were not selected in the data set for the electronic notification are considered not approved, even if they are listed on the submitted label or instructions;
  • The application is only deemed submitted once the Notification Authority has been additionally notified by email after the data set has been submitted electronically;
  • Fees will be charged after the procedure is concluded or expires.

Entering data for the In situ generated active substance:

  • Carefully enter all the data requested;
  • Provide the composition that corresponds to the best possible scenario under stoichiometrically ideal conditions. All components (solvents, active substances, residual precursors, metabolites, impurities) must total 100.0%;
  • If you cannot find a component in the database, stop the entry process and notify us in writing. We will endeavor to resolve the issue, update the database, or suggest an alternative.

For the In situ generated active substance, the following documents must be provided and uploaded under the ‹Documents› tab:

  • a. Technical data sheet or instructions for use;
  • b.  Swiss Safety Data Sheet or EU Safety Data Sheet with CH cover sheet (if necessary under Art. 19 ChemO), unless the active substance generated in situ is generated and used in a closed system Safety Data Sheet (SDS) ;
  • c. Proof of efficacy for disinfectants and wood preservatives (complete test reports);
  • d. Additional document Additional information (RTF, 68 kB, 30.08.2023);
  • e. Proof of the source of the active substance in accordance with Art. 95 EU-BPR , either with the following form or by enclosing a letter of conformity from the supplier. Form Declaration Art. 95 BPR (PDF, 73 kB, 16.11.2022). See also : article 95 (of the EU biocidal product regulation, BPR);
  • f. Power of attorney1, either with the template or with a personalized letter;
  • g. Letter of Access, if you are referring to data from another authorisation AN or another authorisation holder that you cannot provide (e.g. efficacy tests)  Letter of Access_de_fr_it Template (PDF, 187 kB, 27.10.2022)
  • 1 A power of attorney (PoA) is required if the designated authorisation holder is represented by another person, e.g. a consultant. The power of attorney allows the Notification Authority to contact the representative if they have any questions or queries. If you do not have a representative, no PoA is necessary.

Recording Precursor Data Sets:

  • Enter all data requested by the system conscientiously. It is recommended to duplicate the already created data set of the in-situ generated active substance and then adjust this duplicate;
  • Record the complete composition accurately. Ensure that the sum of all components equals 100.0%;
  • If you cannot find a component in the database, stop the entry process and notify us in writing. We will endeavor to resolve the issue, update the database, or suggest an alternative;
  • The In situ generated active substance should also be recorded in these data sets, but with a concentration of 0% w/w;
  • Regardless of whether the precursor substances are classified as hazardous according to CLP, assign the attribute «hazardous substance» to them.

For each precursor, the following documents must be provided and uploaded under the ‹Documents› tab:

  • a. Swiss label design, including efficacy claim and instructions for use in at least one of Switzerland’s official languages. The product types applied for must already be listed, or result from the claim or instructions for use;
  • b. Technical data sheet or instructions for use;
  • c. Swiss Safety Data Sheet or EU Safety Data Sheet with CH cover sheet (if necessary under Art. 19 ChemO), unless the active substance generated in situ is generated and used in a closed system Safety Data Sheet (SDS)

Submitting application:

Once you have entered all data in the Product Register and uploaded the necessary documents, you can submit all the data sets. Please then notify us by email (cheminfo@bag.admin.ch), including the following information

  • Subject: CPID | Trade name of the In situ generated active substance, application for AN authorisation
  • Accompanying text:
    • Application for AN authorisation
    • CPID's | Trade names of all data sets
    • Contact details

Fees:

  • Summary procedure for biocidal products of type 1, 2, 3, 4, 5, 8 and 19): CHF 900,-
  • Summary procedure for biocidal products belonging to all other product types: CHF 525,-
  • For the in-depth review and renewed authorisation (for example products checked in the course of market inspections necessitating a correction and thus a new authorisation): CHF: 1500,-
  • For each additional query owing to missing documents: 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.

Validity period:

An AN Authorisation once issued is valid for 6 months after the last active substance of the biocidal product is included in the lists of Annex 1 or 2 OBP. Thereafter the product may still be placed on the market for up to 360 days and supplied to end consumers for additional 360 days (720 days in total). Professional or commercial use is not limited insofar there is not an unacceptable effect on humans, animals and the environment.

Should the product remain on the market, please take note of the Transitional regulations

If a decision is taken by the EU Commission to deny the inclusion of the active substance in Annex 1 BPR or in the Union lists of approved active substances, then the authorisation of biocidal products containing this active substance will be revoked by the Notification Authority. After the decision of the Commission, the product can be placed on the market for up to 360 days and supplied to end consumers for an additional 360 days (720 days in total). Professional or commercial use is not limited insofar there is not an unacceptable effect on humans, animals and the environment.