Biocidal products regulation

Biocidal products are agents which can control the growth of harmful microorganisms on inanimate surfaces. These products are effectively used in several applications from healthcare settings to domestic purposes to prevent microbial contamination. These products pose several impacts on both human health and the environment, therefore, efficacy and safety of these products are among the important criteria to be considered while testing.

The EN 14347 standard, specifies a method for determining the basic sporicidal activity of disinfectants and antiseptics. This European Standard is part of a series of standards that focus on the antimicrobial efficacy of chemical disinfectants which are intended for use in the medical, veterinary, food, industrial, domestic, and institutional areas.

EN 14347 standard

EN 14347 is a phase 1 suspension test, which means it is a preliminary test generally used to demonstrate the basic efficacy of a product in controlled conditions. The results obtained from these tests are used for guiding further testing and product development. This standard is important for products which claim to possess sporicidal activity. It ensures that the tested products meet minimum requirements for effectiveness before being released to the market or used in real-world conditions. This article discusses how testing under EN 14347 contributes to demonstrating the sporicidal efficacy of disinfectants for biocidal products regulation, detailing the critical steps, challenges, and best practices necessary to meet this standard as part of the broader regulatory compliance and successful market entry.

Preparing for EN 14347 Compliance

Meeting the requirements of EN 14347 for biocidal products regulation involves conducting specific laboratory testing to demonstrate the sporicidal efficacy of disinfectants, along with proper documentation of test results.  This section briefs about the preparatory steps necessary to gain EN 14347 certification.

Laboratory Testing

• EN 14347 testing for disinfectants follows a standard protocol to evaluate the sporicidal activity of the product. This test method involves selecting the bacterial spore strains, preparing test samples, and performing the test method as mentioned in the standard. The testing laboratories are therefore supposed to be accredited and proficient in the use of EN 14347 to ensure valid and reliable results.

Product formulation and development

• In the product formulation and development phase, manufacturers design the product to potentially meet sporicidal efficacy standards, but it’s the EN 14347 standard that primarily assesses the efficacy of the formulation. The results from these initial tests can guide manufacturers in refining or choosing the most effective formulations. 

Documentation and analysis of the data

• The testing process, results, and analyzed data must be documented properly. This is important for product approval. It includes maintaining detailed records of the laboratory procedures and also a thorough analysis of the data to demonstrate compliance. This documentation serves as the base for regulatory submission and review.

Navigating regulatory submission and review

Regulatory submission and review is the first phase in biocidal products regulation. This step requires thorough preparation and understanding of the regulatory requirements to ensure that the approval process goes on smoothly.

Regulatory document preparation

Regulatory document preparation is one of the important parts wherein the relevant information needs to be collected for the preparation of regulatory documents. These are likely to include product formulation, laboratory test reports, safety assessments, and a full analysis demonstrating efficacy of the product as per EN 14347. Ensure that the document is complete, well-organized, and clear in justifying the product’s efficacy.

Submission to competent authorities

The submission process starts by interfacing with the responsible regulatory authorities for the authorization of the biocidal product. This includes identification of the specific requirements for submission and submission of the document in the required format. Manufacturers should involve themselves in pre-submission meetings with the regulatory authorities to clarify ambiguities and receive further guidance.

Addressing queries 

The regulatory review will raise queries and probably request additional data from the authorities. Be prepared to respond promptly and efficiently to keep the approval process on track. It might include performing additional testing, further analysis of data, or clarification of the existing documentation, if required by the authorities. Open communication and collaboration with the authorities can be useful in such situations.

How can Antimicrobial Testing Laboratories help?

MIS provides specialized testing services necessary to evaluate the sporicidal efficacy of chemical disinfectants and antiseptics. By conducting standardized tests as outlined in EN 14347, we can generate the empirical data required to demonstrate the product’s effectiveness against resilient bacterial spores. Our expertise not only ensures the accurate and reliable assessment of a product’s antimicrobial properties but also assists manufacturers in understanding the complexities of the regulatory bodies.

Looking for EN 14347 testing services, get in touch with our team of experts today.