The basic principle in the Biocidal Products Regulation ((EU) No 528/2012 (BPR)) is that a biocidal product must be authorized before it can be made available on the market or used in the European Economic Area (EEA) and Switzerland. This takes place in two consecutive steps. First, the active substance is evaluated and, provided the criteria are fulfilled, is then approved in a specified product type. The second step is the authorization of each product consisting of, containing, or generating the approved active substance(s).
Section 1: The Challenge and the Danger
The key risks for biocidal products include environmental hazards, safety and security issues, adverse effect of exposure, antimicrobial resistance, health and safety concerns, and, usually, the threats of business interruption. Here we can observe that all these risks are connected to the most harmful of them all, the environmental hazards. This is the risk of a biocidal product negatively affecting the environment and/or human health, for instance through the release of substances into the air and/or water. Biocidal products may therefore lead to negative publicity or public aversion (Junker (2016)). Unfortunately, compliance with the BPR is the challenge that is immediately associated with this regulation.
Before the approval in any product type, there are two important points to observe. First, one of the different types of biocides specified in the directive is a lignocaine derivative. When a lignocaine derivative is listed as an active ingredient in a biocide product, it is required that the concentration (EC 50) of the lignocaine derivative does not exceed 5% of the level in the product. There is no limit on the amount of lignocaine derivative contained in the finished product or other components of the product or the raw materials. The second point is that the product type must be specified in the authorizations granted by the approving authority.
The Biocidal Products Regulation is a new EU law that came into force on 1st July 2013. This law requires that the production of biocidal products be authorized before it is released on the market or used in the EU. It is important to understand how this law affects you to keep your business compliant. There are several questions to ask yourself before you get started on any biocidal project. The process of requesting authorization is simple, but must be carried out in a certain order: Determining if a product is biocidal: Review the documentation (CD, standard, packaging, raw material, etc.) that the product manufacturer provides to ensure that the biocidal product is authorized for use. This will require the company to provide evidence of its origin.