Overview of the legal foundations and administrative procedures for the authorisation of biocidal products following the entry into force of the revised MRA.
This document provides an overview of the legal foundations and the most important procedural points relating to the authorisation of biocidal products, applicable since the entry into force of the revised version of Annex 1, Chapter 18 of the Mutual Recognition Agreement (MRA, SR 0.946.526.81) between Switzerland and the European Union (EU). For more detailed information, please consult the following sources (see Links):
- Annex 1, Chapter 18 of the Swiss-EU MRA
- Explanatory document on the revised MRA, jointly prepared by the State Secretariat for Economic Affairs (SECO) and the Federal Office of Public Health (FOPH);
- Notification Authority for Chemicals guidance on individual authorisation procedures (see "Biocidal products à Authorisations" on this website).
Authorisations according the European harmonized system
Why was the biocides chapter of the MRA revised?
The revision of the MRA chapter on biocidal products (Annex I, Chapter 18, MRA), which had been in force since 18 October 2010, became necessary as a result of changes in the legal foundations both in the EU - the applicability of Regulation (EU) No 528/2012 (BPR) from 1 September 2013 - and in Switzerland - the entry into force of the revised Ordinance on Biocidal Products (OBP) on 15 July 2014. Like the earlier version of the MRA, it is based on the mutual recognition of biocidal product authorisations in view of the equivalence of the two parties' biocidal products legislation. The revised MRA concerning biocidal products came into force on 14 April 2015.
What is unchanged?
There is no change in the MRA's goal of avoiding duplication of efforts in authorisation procedures for biocidal products and in assessment procedures for active substances. As before, biocidal products of product types 15, 17 and 20 and products containing genetically modified organisms cannot be authorised in Switzerland. However, biocidal products containing pathogenic microorganisms are now eligible for authorisation.
Unchanged is the principle that biocidal products which are authorised in the EEA under the BPR can be recognised in Switzerland and vice versa. Recognition of this kind involves a procedure which is more rapid and less costly than for first authorisation. There have, however, been changes in the details for submissions and the possible types of procedure (recognition in sequence or in parallel, and recognition of Union authorisations). An authorisation holder may, under the revised MRA (contrary to the requirements specified in Art. 5 para. 3 OBP), be domiciled or have a registered office in Switzerland or in the EU.
As before, the MRA only applies to authorisation procedures for biocidal products whose active substances are approved and included in the Union list or in Annex I to the BPR (see Annex 1 or 2, OBP), apart from certain exceptions (see Chapter 18 MRA). The transitional authorisations AN/AC are therefore not covered by the MRA. They continue to be governed solely by the relevant provisions of the OBP.
Switzerland continues to participate in the EU review programme for the assessment of existing active substances. Switzerland accepts any decisions ("approval" or "non-approval") adopted by the European Commission and, accordingly, regularly updates the lists of active substances in Annexes 1 and 2 to the OBP. Swiss applicants wishing to apply for the approval of an active substance can have it assessed by the Swiss authority or by an EU member state authority.
What is new?
With the applicability of the BPR in the EU, various new authorisation procedures have been created which are also used in Switzerland, facilitating coordinated placing on the market:
- Authorisation of eligible products under the simplified procedure
- Placing on the market in Switzerland of a product authorised under the simplified procedure on the basis of a declaration to the Notification Authority
- Authorisation for parallel trade
- Identical biocidal products
- Union authorisation, which will generally be recognised by the Swiss authority
- Provisions concerning renewal, amendment, etc.
Under the revised MRA, the Swiss authorities have the same rights as the national authorities of EU member states with regard to objections and derogations in the recognition of products. Switzerland will endeavour to maintain equivalence with currently applicable EU legislation and to ensure harmonised enforcement practice in accordance with Art. 50a OBP.
A Union authorisation is not directly applicable in Switzerland, but recognition is simplified in accordance with Art. 14a para. 2 OBP. Under the MRA, it is also possible for a company with a registered office in Switzerland to submit an application for Union authorisation to the European Chemicals Agency (ECHA).
All applications for authorisation or recognition, or for the amendment or renewal of existing authorisations, are to be submitted using the IT tools (currently R4BP 3 and IUCLID 5) specified by the ECHA. More detailed information on access to these tools and the conditions for their use is available online (see the links below). This does not concern applications for authorisation AN (including identical products and product families, where reference is made to an AN authorisation), or for the amendment of existing authorisations AN and AC. The European Register for Biocidal Products (R4BP) now also serves as a medium for communication between parties. Decisions are thus to be communicated directly by electronic means.
Swiss applicants wishing to submit applications concerning technical equivalence of active substances (Art. 54 BPR) should contact the ECHA directly. The ECHA is also the contact point for Swiss persons for requests concerning data sharing (Art. 62-63 BPR). If the decision of a court is required concerning compensation of a data owner, the matter may be submitted to a Swiss court.
In the event of unexpected effects, Art. 47 BPR is applicable: under these provisions, authorisation holders are required to report such effects not only to the competent Swiss authority (i.e. the Notification Authority for Chemicals) but also to the ECHA (in the case of a Union authorisation, the European Commission and the ECHA).
Labelling is harmonised: labelling requirements are the same for the Swiss and the European market, subject to an official review and the provisions (Art. 34b ChemO) concerning labelling languages.
In accordance with the MRA, persons domiciled or with a registered office in Switzerland may have themselves included directly in the ECHA list specified in Art. 95 BPR. This supersedes the procedure set out in Art. 62d para. 1 lett. b-d OBP.
Switzerland will participate in all procedures in line with the EU.
Explanatory document on the revised MRA (PDF, 160 kB, 28.11.2016)available only in German, French and Italian
Last modification 17.01.2017