• Pharmaceutical Consulting | Consulenza Farmaceutica | Di Renzo Regulatory Affairs
  • Pharmaceutical Consulting | Consulenza Farmaceutica | Di Renzo Regulatory Affairs
  • Pharmaceutical Consulting | Consulenza Farmaceutica | Di Renzo Regulatory Affairs
  • Pharmaceutical Consulting | Consulenza Farmaceutica | Di Renzo Regulatory Affairs
  • Pharmaceutical Consulting | Consulenza Farmaceutica | Di Renzo Regulatory Affairs
  • Pharmaceutical Consulting | Consulenza Farmaceutica | Di Renzo Regulatory Affairs
  • Pharmaceutical Consulting | Consulenza Farmaceutica | Di Renzo Regulatory Affairs
Home PMC and Biocides Biocides Future prospects

Future prospects

Further modifications to the legislations regulating the marketing authorisation of biocidal products have been reported in the Regulation Proposal COM (2009) 267 of the 12th June 2009. This proposal aims to enhance the existing regulations, by introducing a new regulation for the beginning of 2013.

This proposal was made after a careful analysis of issues related to the existing regulations, in particular:

  • Exclusion from the area of application of materials and items treated with biocidal products
  • Poor results in the use of simplified procedure for “low risks biocidal products” and “new substances” (the Annexes IA and IB contain very few active substances listed)
  • Low application of the European procedure MRP

In order to resolve the issues observed, the new regulation involves the introduction of numerous innovations and modifications such as:

  • Introduction of a centralised procedure
  • Elimination of Annex IB (“basic substances”)
  • Extension of the area of application (introduction of biocidal products in contact with food etc.)
  • Introduction of items treated with biocidal products
  • Possible revision of some PTs (in particular PT5 and PT20)
  • Enhanced use of data sharing in order to avoid the useless repetition of studies on vertebrates
  • More responsibilities given to the European Chemical Agency (ECHA)
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