Before placing biocidal products on the market authorization must be obtained. Active substances contained in the biocidal products must be previously approved. A dossier for Biocides testing is submitted for approval to the competent authorities of each Member State after we have compiled the product dossier containing the necessary information.
The authorization of a biocidal product is specific to the company responsible for placing the product on the market.
The following documentation is necessary to register your products:
- Product’s data – technical leaflet, marketing authorization holder, producers of active ingredients.
- Identity of product – formula.
- Physical and chemical properties – product specifications, MSDS, specification for all raw materials and AS.
- Analytical methods for detection and identification – analytical methods for the determination of active substance.
- Efficacy studies – screening, laboratory and field tests.
- Toxicological and metabolic studies – acute toxicity, oral-dermal-inhalation, skin and eye irritation, skin sensitization, summary of mammalian toxicology and conclusions, including no observed adverse effect level (NOAEL), no observed effect level (NOEL), overall evaluation with regard to all toxicological data and any other information concerning the active substances.
- Ecotoxicological studies
- Measures necessary to protect humans, animals and the environment, such as Poison Centre Information and any other relevant information such as recommended methods and precautions concerning handling, use, storage or transportation, possibility of reuse or recycling, possibility of neutralization of effects, etc.
- Classification and Labelling – hazard symbol(s), indications of danger, risk & safety phrases, etc.