Modifications of existing Authorisations AN / AC
Make changes to biocidal products already authorised under the transitional authorisation procedure AN.
Requirements:
- The authorisation is still valid (Art. 8, para. 1, let. c OBP);
- You require a user account to enter products in the Product register for chemicals.
Hilfsmittel:
Procedure:
Basic principles:
- The authorisation number remains unchanged even after the modification;
- 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 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 displayed 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.
Exceptions: Notifications that are not recorded in the product register:
- Transfer of authorisation to another person: Confirmation via letter from both parties is required;
- Definitive market withdrawal: Email cheminfo@bag.admin.ch with a list in Excel format of the products to be withdrawn from the market (CPID, authorisation number, trade name).
Entering the data set:
- Enter the modification and correct any error messages;
- Accurately enter the composition in full. Make sure that the sum of all components adds up to 100.0%;
- If you cannot find one of the components in the database, stop entering the composition and notify us in writing. We will do our best to clarify the matter, amend the database, or propose an alternative.
For every application, 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) Safety Data Sheet (SDS) ;
- d. Proof of efficacy for disinfectants and wood preservatives if the composition and/or product types are changed (full test reports). Also required if efficacy needs to be updated based on new test reports;
- e. Additional document Additional information (RTF, 68 kB, 30.08.2023);
- f. 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);
- g. Power of attorney1, either with the template or with a personalized letter;
- h. 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.
Submitting application:
After entering all data into the product register and uploading the required documents, you can submit the dataset. Then, please notify us via email at cheminfo@bag.admin.ch with the following details.
- Subject: CPID | Trade name, Application for amendment of a AN Authorisation
- Accompanying text:
- Application for amendment of a ZN Authorisation
- CPID | Trade name
- Detailed description of the modification made
- Contact details
Fees:
- Standard fee: CHF 300.-
- 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 1,000,-
- For each additional query owing to incorrect or 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.