Delays in the authorisation of biocidal products

The Biocidal Products Regulation EU 528/2012 (BPR) describes the authorisation procedure for biocidal products. The objective is “authorisation” as prerequisite for the making available and use of biocides. However, there are increasing delays in the authorisation of biocidal products. This has major consequences, especially for small and medium-sized enterprises, and causes much uncertainty.

• Market Freeze
  An already granted authorisation is the prerequisite for the marketing of same products and for mutual recognition in sequence. Without authorisation, no new trade names can be marketed, and no existing products can be newly placed on the market in other Member States.
• Market distortion
  Authorised and non-authorised biocidal products of the same product-types are sometimes legally available on the market in parallel for more than 10 years. This market distortion is a particular burden on companies which produce "niche products" for special requirements. In certain circumstances, the consequences for such companies can be as severe as going out of business.
• Obstacle to innovation
  Improved formulations as well as innovative products cannot be made available on the market.
• Legal uncertainty
  The legal basis is unclear for products for which no authorisation is granted three years after approval of the active substance.

In this position paper, FCIO and VCI explain the consequences of the delays in authorisation procedures for industry and society.PDF | 308 kB | Version as of: 17 February 2021 Proposals are made on how policy-makers and authorities can counteract this development and keep the described problem from intensifying.