The objective of the new Regulation is to improve the functioning of the internal market in biocidal products whilst ensuring a high level of environmental and human health protection. The new Regulation will also remedy a number of weaknesses that were identified during the 11 years of implementation of the current Directive 98/8/EC.
The new text simplifies and streamlines the requirements for approving active substances and authorizing products. The new provisions will also reduce animal testing by making data sharing compulsory and encouraging a more flexible and intelligent approach to testing. A dedicated IT platform (the Register for Biocidal Products) will be used for submitting applications as well as recording decisions and disseminating information to the public. The new Regulation is also the first piece of legislation to build in the new Commission definition on nanomaterials.
The text is also a major breakthrough for the internal market with the creation of a Union authorisation of biocidal products, which will allow industry to directly place their products on the entire Union market.
The European Chemicals Agency (ECHA) will provide a strong scientific and technical back-up to the Commission and the Member States under this new Regulation. 100 persons will eventually work on biocides related activities for a total annual budget of 25 Mion EUR.
ECHA will in particular be responsible for the assessment of applications for the Union authorisation of biocidal products.
The total number of opinions to be delivered by ECHA is expected to grow from 80 in 2014 to 300 in 2020.
The total cost savings for the industry – to be achieved through the measures concerning product authorisation, data sharing and data requirements – are significant and estimated to ca. €2.7 billion over a period of 10 years.