In the world of disinfectants, the European standard EN 14347 assumes a very important role, especially when it comes to sporicidal agents. This article unveils the importance of EN 14347 and its relation to regulatory compliance. The standard is essential in guiding manufacturers, particularly those in the health and sanitation sectors, on how to develop their products and services effectively while ensuring compliance with regulations.
Understanding EN 14347
EN 14347 is a European Standard specifying the test methods for the determination of sporicidal activity of chemical disinfectants. The need for such a standard arises because of the highly resistant character of the spores towards nearly all physical and chemical agents. This guideline specifies the temperature, contact time, and types of microbial spores for which tests should be conducted. These provide an excellent framework for thorough assessment of the product thus enabling the manufacturer to show the product’s efficacy against spores.
EN 14347’s role in regulatory compliance
Regulatory compliance within the disinfectants domain involves a complex outline that guarantees safety, effectiveness, and the absence of any risk, both to users and the environment, from the products. Here is how EN 14347 interplays with regulatory compliance:
- Product development: The standards of EN 14347 will influence the research and development of the product. It may involve massive testing and development in the refinement of the sporicidal property of the product, and the manufacturer may need to change the formulation so that the stringent requirement of the standard is met.
- Safety and Efficacy: Regulatory compliance with EN 14347 is often a prerequisite for marketing the product as a disinfectant within the European Union. It reassures regulators and consumers that the disinfectant product gives an excellent standard of sporicidal efficacy for areas where microbial control is very important and can be used successfully in institutions like hospitals, laboratories, and food processing plants.
- Harmonization across the EU: EN 14347 supports harmonization of criteria for sporicidal efficacy in such a way as to facilitate free movement of disinfectant products in the market. This standardization is key for manufacturers who aim to distribute their products in different countries throughout the EU ensuring that their product is in compliance with an accepted European benchmark.
- Supporting legislation: In spite of EN 14347 being a voluntary legislation, regulatory compliance of the same lends support to the adherence of the broader EU legislation related to biocides products and chemical safety (Biocidal Products Regulation (BPR, Regulation (EU) No 528/2012)). This regulation demands a complete evaluation of the safety and efficacy of all biocides, including disinfectants, before being placed in the market.
The Impact of Compliance
Adhering to EN 14347 is beneficial both for the manufacturer and the consumer. It allows the manufacturer to enter the market and position their product in the competitive environment with the assurance that their products meet high safety and efficiency standards. This provides consumers and professional users of disinfectant products with assurance that these products are active against bacterial spores, thereby reducing the risk of infections.
Role of MIS
As a specialized microbiology testing company, MIS provides essential services for evaluating the sporicidal efficacy of disinfectants against stringent benchmarks set by EN 14347. By conducting rigorous testing, we aid manufacturers in navigating the complex landscape of regulatory compliance, ensuring their products meet the high standards required for market approval. Our expertise not only supports product development and certification processes but also reinforces public health by contributing to the availability of effective and reliable disinfectant products.
Want to know more about our testing services, reach out to our experts today!
