Union authorisation

The Union authorisation is an administrative act used by the European Commission to permit accessibility to the market and the use of the biocidal product or family of biocidal products on the Union territory or part of its territory.

The Union authorisation grants each Member State the same rights and obligations as a national authorisation. Instead of lodging an application for national authorisation and mutual recognition of authorisations, the applicant should submit an application for Union authorisation.

The application should be submitted through the R4BP 3 system of the European Chemicals Agency (ECHA). The applicant notifies the Agency on the name of the competent authority of the Member State that is proposed for application assessment. The application must comprise the confirmation that the biocidal product will be used under similar conditions across the entire Union.

The authorisation is issued if the biocidal product fulfils all conditions with regard to the accessibility of the biocidal product, it must have suitable features, be appropriately labelled and have a safety sheet.

The authorisation is not issued for biocidal products that refer to the products used for pest control (rodenticides, avicides, piscicides, control of other vertebrates) and products in connection with anti-vegetation means.

The fee for the authorisation issue must be paid to the European Commission for Chemicals in accordance with Table 1 of Annex II of the Commission Implementing Regulation (EU) No. 564/2013.

Legal protection

  • Judicial remedy: Appeal
  • Competent authority: European Chemicals Agency (ECHA)

Other activities

For the authorisation renewal, the application for renewal must be submitted to the European Chemicals Agency (ECHA) 550 days prior to its expiry.

Last updated: 10 years

Responsible: Ministry of Health | Last updated: 10. 02. 2016