Where there are significant indications that a biocidal active substance no longer satisfies the approval conditions, the European Commission may early review the approval of this active substance. The Commission may also early review the approval if there are indications that the use of the active substance in biocidal products or treated articles raises significant concerns.
When starting such a review, the Commission must make public the information that it is carrying out a review publicly available and must provide an opportunity for the applicant(s) to comment. The Commission may request an opinion of the European Chemicals Agency on any question related to the review of approval. Where the significant indications are confirmed that a substance no longer satisfies the approval conditions, the Commission will adopt an act amending the conditions of approval of an active substance or cancelling its approval.
An early review has been initiated on the following active substances:
A request for opinion has been transmitted to ECHA, pursuant to Article 75(1)(g) of Regulation (EU) No 528/2012 related to the review of approval of the active substances iodine, polyvinylpyrrolidone iodine and zineb (annex to the mandate).
Applicants have provided the following information following the initiation of the early review.
- PVP iodine: