Biocidal Products Regulation

Introduction


Biocidal Products and the Active Substances contained in them have been subject to varying degrees of control for a number of years in Europe. This was harmonised over a decade ago by the bringing into force of the Biocidal Products Directive (Directive 98/8/EC). Recently,  the Biocidal Products Directive has been repealed in favour of the Biocidal Products Regulation (Regulation (EU) 528/2012). The aim of the Biocidal Products Regulation is to further improve the functioning of the biocidal products market in the EU, whilst ensuring a continued high level of protection to both humans and the environment.


The proposal for the new regulation was agreed in 2009 and the text adopted in May 2012. The Regulation applies from the 1st September 2013.


What does this change mean?


Firstly it is important to understand that much of the content of the former Directive remains, albeit not always defined in exactly the same way. However, the change to a Regulation brings with it some major revisions in the form of significant additions and some minor but important alterations.


The most significant changes are the addition of articles covering the regulation of materials from alternative suppliers, the bringing into scope of Treated Articles for the first time and the inclusion of nanomaterials. Also significant is the increased role that the European Chemicals Agency (ECHA) will play in the process of authorising biocidal products and in overseeing a new concept of Union Authorisation. Submissions will be made to ECHA using a dedicated IT platform.


There are several changes that are less prominent than the more obvious difference found above. Some changes are very subtle, but give their subject more prominence. One of these types of changes is the move from Frame Formulations to Product Families. Product Families may offer an opportunity for reducing the burden of cost.


How does this impact the formulator?


The major, short term impacts will be two fold, both on those formulators whose products were considered as Treated Articles under the BPD but are now in scope under BPR either as Treated Articles with labelling requirements or as full blown Biocidal Products and on those who currently take their active substances from a supplier who is currently outside of the notification process. There are short deadlines for compliance with these two changes. All formulators must be taking their active substances from a supplier recognised on a list maintained by ECHA by the 1st September 2015 and all Treated Articles (with labelling requirements) must be notified by 2016.


The Review process has been extended to 2025 and there is a temptation to think that Formulators may have an extended time period in which to prepare their products for Authorisation. However, it is very important to remember that in many European Countries interim measures exist and these are becoming more demanding of supporting data – especially efficacy data. It is also important to note that once the active substance has had an inclusion decision taken for it then the formulator has only two years to prepare their product dossier for submission to the relevant Authorities. This period passes very quickly and it is prudent to start building the data package as early as possible to spread the cost and to ensure that the product performs in the best possible manner under testing. BluTest offers the opportunity to set in place programmes to become BPR ready, by combining consultation on compliance with optimised testing packages to support product dossiers.

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