Application for an Union authorisation
With the new procedure for the Union authorisation the European Biocidal Products Regulation (BPR)1 makes it possible for a biocidal product to be authorised for the entire EEA Market (plus Switzerland)2, thereby obviating the need for an application in the individual states for national authorisations or recognition.
Prerequisites / basics
As with all other types of authorisations according to the European harmonized system, the prerequisite for this is that the active substance(s) contained in the biocidal product have been assessed and approved, i.e. these have been included in the lists according to annex 1 and/or 2 OBP.
Based on the MRA a Swiss Company can likewise obtain access to the entire EEA Market for the biocidal product in question by means of a Union authorisation3.
An important condition for granting a Union authorisation is that the product has similar conditions of use in all Member States of the EEA (cf. the Guideline «Note for Guidance on similar conditions of use», see list of links). An application for the Union authorisation can also be submitted for a biocidal product family.
A Union authorisation is not possible for the following products:
- Products containing active substances that meet the exclusion criteria (Art. 5 BPR)
- Products of the product types 14, 15, 17, 20 and 21
Please note the document on the ban on misleading trade names.
Procedure
The procedure is based on an evaluation of the product by a national authority. The applicant is entitled to choose the evaluating authority. However, in each case the national authority must clearly state its readiness to carry out the evaluation.
The application must be submitted to the European Chemicals Agency (ECHA), via the European register for biocidal products (R4BP). Once ECHA has accepted the application, after the fees have been paid, the evaluating authority validates the application dossier within 30 days. The evaluating authority's fees must be paid before validation. The subsequent evaluation lasts 365 days. Once the evaluation is complete, the ECHA's Biocidal Products Committee (in which Switzerland participates) prepares the ECHA's opinion on the product within 180 days. Based on this opinion and possible requests for derogation from the EU Member states (Art. 44 para. 5, 2 section BPR), the European Commission decides upon the approval requirements and grants the Union authorisation.
Pursuant to the MRA, Switzerland is obliged to strictly apply the Union authorisations granted by the EU Commission for the area of the EEA Member States. The Union authorisation is not directly valid in Switzerland but is confirmed by the Notification Authority in a highly simplified procedure (cf. Art. 14a para. 2 OBP). Pursuant to the MRA, Switzerland can provide for derogations before the Union authorisation is adopted, pursuant to Article 44 para. 5, 2nd section OBP. Following the Swiss decision on the Union authorisation the Notification Authority delivers the authorisation to the authorisation holder for the Swiss Market.
Application
ECHA advises those companies that intend to submit an application for Union authorisation, to submit a «pre-submission» consultation at the latest 6 months beforehand. This is used to confirm whether the product may actually be considered for a Union authorisation and that the requirements for the similar conditions for use in the entire EEA are met.
For details on how to proceed with an application for Union authorisation, and which documents are to be submitted, please refer to the ECHA guideline «Practical guide on biocidal products regulation - Union authorisation» (cf. list of links). If the biocidal product for which authorisation is being requested using the harmonised European procedure is already on the market in Switzerland under a transitional authorisation, the applicant has to provide the authorisation number (CHZN or CHZB) and the trade name to the notification authority for chemicals.
Biocidal products that are placed on the market in Switzerland with a transitional authorisation AN or AC and for which an application for Union authorisation had been submitted to ECHA at the latest up to the date of the inclusion of the last active substance, may remain on the market for a further 3 years, insofar as the authorisation holder has provided evidence to the Notification Authority that the application for the Union authorisation for the corresponding product was submitted before the deadline (Art. 22 OBP). As proof, the Swiss authorisation holder must inform the Notification Authority of the «Case Number» assigned in the R4BP 3.
The AN or AC authorisation holder does not have to be identical to the applicant for the Union authorisation. After the Union authorisation is granted, the biocidal product can be supplied with the old label to the end user for a further 12 months and may be used professionally or commercially.
Switzerland as the evaluating authority
Companies that are interested have to contact the Notification Authority for Chemicals beforehand and fill in the completeness checklist for a Union authorization. The applicant requires written confirmation from the Swiss authority that it will take over the assessment of your biocidal product.
Period of Validity
The period of validity of the Union authorization is limited to a maximum of 10 years. An application for renewal has to be submitted 550 days prior to the expiration of the authorisation in order to be able to continue to market the product without interruption.
Fees
The fees payable to ECHA for an application for Union authorisation are in accordance with the EU Regulation on fees no. 564/20134. Additional fees are payable for the assessment of the product by the chosen national authority. These fee rates are defined at the national level and are available from the national authority in question.
In Switzerland the fee for assessing a Union authorisation (Switzerland as the assessing authority) is based on that for a first authorisation AL (Annex number II 1.1 ChemFO).
The decision of the Notification Authority for the Union authorisation (i.e. recognition of the Union authorisation) is free of charge.
Remark
The processes and procedures for the authorisation of biocidal products can change at short notice as a result of technical and administrative guidelines of the EU Commission and/or of the European Chemicals Agency ECHA as well as due to the updating of the mutual recognition agreement relating to biocidal products (MRA) between Switzerland and the EU. Consequently, we advise interested parties to regularly consult the website of the Notification Authority Chemicals and to subscribe to the Consumer Protection newsletter from the FOPH.
1] Regulation (EU) 528/2012 of the European Parliament and of the Council of 22 May 2012 on the placing on the market and use of biocidal products (Regulation [EU] 528/201, OJ. L 167 of 27. 6. 2012, p. 1., last amended by Regulation (EU) 334/2014, OJ. L 103 of 5. 4. 2014 p. 22.
2] EU (http://europa.eu/about-eu/countries/index_fr.htm) as well as Norway, Iceland, Liechtenstein
3] Applications for authorisation are to be submitted by the potential authorisation holder or in their name.
4] Implementing Regulation (EU) 564/2013 of the Commission of 18 June 2013 on the fees and submissions to the European Chemicals Agency pursuant to the Regulation (EU) 528/2012 of the European Parliament and of the Council on the placing on the market and use of biocidal products. OJ. L 167, p. 17.