The penultimate session of the AFI Symposium is dedicated to biocides, specifically “PMCs vs Biocides: from National Legislation to European Regulation.”
In this interview, Dr. Antonio Conto, for ten years coordinator of the AFI Biocides Study Group and expert in regulatory affairs, explains in detail where we are in the transition from national legislation to harmonized regulation for all European states.
First of all, let’s remember that this is not a recently passed measure, in fact the regulation in question is No. 528 of May 12, 2012, which replaced the old Parent Directive on Biocidal Products EC No. 98 of 2008. It is an extremely complex regulation, however, and even more so is the transition by European states to a single regulation.
Transition from national legislation to European regulation
Conto explained that the transition from one regulation to the other is very complex, and so are the timelines; in fact, from the time the active substances in a given biocide are approved, 18 to 24 months pass before they are placed on the market. The workability of this transition is proving to be more arduous and longer than expected, mainly because, despite the harmonization of the legislation, the approval of active substances still takes place at the national level, which is not helpful especially to companies interfacing with other countries. For example, when a product is approved in Italy, one would expect, thanks to the new European regulation, that approval in other states would happen quickly; instead, this does not happen because each country can still apply its own regulations regarding active substances. The situation in our country is further complicated by the fact that many small companies do not have an in-house regulatory affairs office, so the timelines are further lengthened. The economic issue also weighs heavily: submission to the European regulation has onerous costs.
The most significant innovation introduced by the European regulation compared to the national regulation was the introduction of risk assessment, both with regard to human health and the assessment of a potential ecological risk, all of which is certainly complicated to assimilate but is aimed at the common goal of protecting human and animal health and our planet. In addition, legislation provides for the withdrawal of certain products from the market, not so much because they may be dangerous but because they have lost their efficacy in comparison with newer, more recently approved active substances.
During this session of the symposium, relevant authorities will be asked to explain the state of the art of this transition, as well as give valuable technical guidance.