EU 528/2012 Biocide Regulation - Regulation (EU) No. 528/2012 on the Market Availability and Use of Biocidal Products

Biocides are chemicals intended to destroy, repel or render harmless organisms considered to be harmful, such as fungi, bacteria, viruses, rodents, insects, and the like. There are 4 types of biocidal products determined for today, divided into 22 groups. The groups of biocides are:

• Disinfectants (human or animal hygiene, disinfection of surfaces, drinking water and similar)
• Protection products (preservatives, wood protection products, building materials alike)
• Pest control products (such as rodenticides, insecticides, repellents)
• Other biocidal products (embalming fluids, antifouling products)

Biocidal products and the active substances they contain are subject to the regulation (in short, the biocidal regulation) on the keeping and use of biocidal products on the market, numbered 528/2012, published for the keeping and use of biocidal products. This legal regulation aims to harmonize the placing on the market and use of these products in the European Union countries. The main purpose of these regulations is to put on the market only biocidal products that are effective and do not pose unacceptable risks, and provide a high level of protection for humans, animals and the environment.

According to the EU 528/2012 biocidal regulation, the evaluation of biocidal products is carried out in two stages:

• Biocidal active substances must obtain approval at European Union level for one or more specific product types among the 22 products defined in biocidal regulations.
• A marketing authorization application must be filed as soon as the self-containing active substances are approved for the relevant product type. This marketing authorization can be issued on a country basis or at European Union level. PWithin the scope of recrimination permit applications, the effectiveness of biocidal products and the risks on humans and the environment arising from their use are evaluated.

Companies that want to apply for a marketing authorization for a biocidal product within the scope of the said regulation should apply at the level of the member country or union where they want to market their products. The marketing authorization application dossier must contain all information enabling the assessment of the risks to humans and the environment for its use, as well as the efficacy of the product for the claimed uses.

Our organization, among the numerous test, measurement, analysis and evaluation studies it provides for businesses in various sectors, with its trained and expert staff and advanced technological equipment, testing services within the framework of the regulation on the availability and use of biocidal products no. 528/2012 (in short, the biocide regulation). also gives.