Regulatory Requirements
A biocidal product is a substance or mixture with the intention of controlling harmful organisms, by any means other than mere physical or mechanical action, and that is not intended to be used on plants or plant products.
The placing of biocidal products on the European market is regulated by the Biocidal Products Regulation (EU) No. 528/2012. The aim of this regulation is to ensure a high level of protection for human and animal health and the environment while facilitating the free movement of biocidal products within the EU.
A central principle of the BPR is its two-tiered approval system:
- Active Substance Approval: Before a biocidal product can be marketed, its active substance must be evaluated and approved at EU level. This scientific assessment takes into account both the efficacy of the active substance and its potential impacts on health and the environment.
- Product Authorisation: Once the active substance has been approved, the biocidal product itself must undergo a separate authorisation procedure. This can take place in various ways: via a national authorisation, mutual recognition in one or more Member States, a centralised Union authorisation or a simplified authorisation procedure. Each route involves a detailed examination of the composition, intended use, labelling, risk assessments and user safety of the product.
The regulation also sets out specific compliance obligations, including:
- Data Sharing Requirements
- Technical Equivalence Demonstrations
- Inclusion of Suppliers in the Article 95 List, a prerequisite for legal market access
In addition to Regulation No. 528/2012, there are other regulations and national legislations that govern the authorization and placing on the market of active substances and biocidal products, including:
Commission Delegated Regulation (EU) No 1062/2014, or the Review Programme Regulation, sets the work/ review programme detailled rules for the examination of existing biocidal active substances referenced in the BPR transitional provisions.
Commission Implementing Regulation (EU) No 354/2013 sets rules on changes to authorised biocidal products/ product families.
The procedure for authorisation of biocidal products that are identical to another biocidal product or family which has been authorised or registered or for which an application has been submitted is laid out in Regulation (EU) No 414/2013.
REACH Regulation (EC) No 1907/2006 may apply on certain biocidal substances.
Classification, labelling and packaging of hazardous substances/ mixtures (including biocidal mixtures) are regulated under CLP Regulation (EC) No 1272/2008.
Certain national legislations have to be considered in the member states (e.g. ChemBiozidDV in Germany, Real Decreto 1054/2002 in Spain).
The European Chemicals Agency (ECHA) is the central EU agency responsible for the regulation of biocides.
The regulatory landscape is complex and of evolving nature. Proactive planning and expert support ensure successful market access.