Application for the approval of a (new) active substance
The Swiss authorities can also take on the role of evaluating authority for a new biocidal active substance.
Conditions
Switzerland participates in the EU review programme for the assessment of existing substances (notified substances). Switzerland adopts the corresponding decisions ("approval" or "non-approval") taken by the EU Commission and regularly updates its active substance lists in Annexes 1 and 2 of the OBP. Products with notified active substances require a transitional authorisation AN in Switzerland before they can be placed on the market.
Active substances can also be assessed and approved outside of the review programme. These are «new» active substances in legal terms. Products with a new active ingredient cannot benefit from the transitional period and, in such cases, no transitional authorisation AN can be granted for the period until a decision is taken regarding their approval. Products with new active substances can only be assessed and authorised if the active substance meets the criteria and has been approved for the corresponding product type.
Resources
Details of the procedure to be followed when applying for the approval of an active substance and of the documents that need to be submitted may be found in ECHA’s “Practical guide on the approval of biocidal active substances". The applicant must find an authority that agrees to assess the new active substance. The application must then be submitted to the ECHA together with the assessing authority’s declaration of consent.
Procedure
Switzerland as the assessing authority for new active substances (or for renewing the approval of an active substance):
Companies wishing to submit an application for a new active ingredient with Switzerland as the assessing authority should contact the Notification Authority for Chemicals as early as possible. Our authority only takes decisions twice a year (at the end of April and October) on whether we can accept such assessments. To this end, the applicant must send us a pre-CoC list (checklist) at least one month before the decision is taken. Applications for the renewal of approvals must be submitted to the Notification Authority for Chemicals at least 550 days prior to the date on which the validity of the active substance expires. Here too, please refer to ECHA’s «Practical guide on the renewal of approval of biocidal active substances». A pre-Coc list must also be filled out for renewal applications. On the basis of this list, we can estimate the outlay and resources required to conduct the assessment. After the meeting in April or October, we inform applicants as to whether we are able to assess the active ingredient and, if so, when the resources will be available.
Applications must be submitted via the European Register for Biocidal Products R4BP. The data must be submitted in IUCLID format.
Fees
The fees payable to ECHA for an application for approval of an active substance are based on EU Fees Regulation No. 564/2013. Added to this come the fees for the assessment of the active substance by the national authority that has been selected.
In Switzerland, the fee framework for the assessment of an active substance (with Switzerland as the assessing authority) is set out in the Chemicals Fees Ordinance (813.153.1 ChemGebV/OEChim) Annex II, Number 9.
Period of validity
The approval of an active substance will generally be valid for ten years and can subsequently be renewed (Articles 8 and 9 OBP). Approved active substances are entered in the Union list and Annex 2 OBP and can be viewed by the public.