Regulatory Information

Also in Disinfectants – Antiseptics

Regulatory Information for Sanitizers

Before you can place your biocidal products on the market, you must obtain authorisation. In addition, the active substances contained in the biocidal products must have been previously approved. We compile the product dossier containing the necessary information. The dossier is submitted for approval to the competent authorities of each Member State.

What documents are necessary

The authorisation 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 as recommended methods and precautions concerning handling, use, storage or transportation, possibility of reuse or recycling, possibility of neutralisation of effects, etc.
  • Classification and Labelling – hazard symbol(s), indications of danger, risk & safety phrases, etc.

How much does the registration process cost?

Fill in our contact form to request our price list and find out how our QACS Laboratory team can help you.