Biocides
For the registration of biocides, Renolab performs analytical studies and efficacy tests in accordance with GLP principles and under the certification awarded by the Italian Ministry of Health.
Biocidal products encompass a broad range of substances and formulations designed to control harmful organisms, including bacteria, fungi and viruses.
Their regulatory assessment requires the generation of robust analytical data in accordance with the European framework governing biocidal products.
These products cover multiple application areas, such as preservatives, pest control products, disinfectants and antimicrobial formulations, including skin disinfectants, surface antimicrobials and environmental disinfectants.
Analytical Studies for Biocidal Products
Renolab performs analytical studies on both active substances and formulated products in order to generate the data required for regulatory evaluation.
The laboratory carries out:
- determination of physical and chemical properties of active substances and formulated products;
- 5-batch analysis of the active substance, including determination of active ingredient purity and impurity profile;
- stability studies, including hot, cold and long-term stability tests.
These studies support the characterisation of the active substance and formulation as required for regulatory submissions.
Efficacy Testing
Renolab performs efficacy testing on microorganisms to evaluate the performance of biocidal products.
In accordance with relevant UNI-EN ISO standards, including UNI-EN ISO 14885, Tests are carried out on: fungi, bacteria and viruses.
The laboratory also performs:
- rinsing tests on treated surfaces;
- wiping tests on test materials such as stainless steel, plastic (HDPE) and glass.
These studies contribute to the evaluation of the antimicrobial performance of disinfectants and other biocidal formulations.
Regulatory framework
- Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products.
- UNI-EN ISO standards tests for efficacy.
- Guidance on the Biocidal Products Regulation Volume I: Identity of the active substance/physico-chemical properties/analytical methodology – Information Requirements, Evaluation and Assessment - Parts A+B+C.
- ARTFood Draft Proposal DRAFT Guidance on Estimating Transfer of Biocidal Active Substances into Foods – Professional Uses.
FAQ
What are biocidal products?
Biocidal products are substances or formulations used to control harmful organisms such as bacteria, fungi and viruses. They include products such as disinfectants, antimicrobial formulations, preservatives and pest control products.
Which studies are required for biocide registration?
The registration of biocidal products typically requires physicochemical characterisation of active substances and formulations, stability testing and efficacy studies demonstrating antimicrobial activity.
Does Renolab perform GLP studies for biocides?
Yes. Renolab performs analytical studies and tests in accordance with GLP (Good Laboratory Practices) and under the certification awarded by the Italian Ministry of Health.
What is 5-batch analysis for biocides?
5-batch analysis is a study performed on the active substance to determine the purity of the active ingredient and the impurity profile across different production batches.
What microorganisms are tested in biocide efficacy studies?
Efficacy tests evaluate the activity of biocidal products against microorganisms such as fungi, bacteria and viruses according to relevant UNI-EN ISO standards.
Which surfaces can be used for disinfectant efficacy testing?
Rinsing and wiping tests can be performed on different test materials, including stainless steel, plastic (HDPE) and glass.