Meet Alexandre Laygnez from Salveco, an expert in biocides regulation who sheds light on the benefits and processes of obtaining marketing authorizations for disinfectant products in Europe.
Find out how Salveco, at the forefront of disinfection with a favorable profile for health and the environment, has become a regulatory expert, to offer you safe and effective advice and solutions, thanks to their unique patented lactic acid technology.
This interview delves into the heart of simplified SMA, revealing Salveco’s criteria, competitive advantages and commitment to responsible solutions that meet today’s challenges.
Hello Alexandre, thank you for this interview on biocides regulations and the benefits they offer customers. Can you tell us a little more about your expertise in this field?
Hello, I’m delighted to share my expertise with you. As a member of the Salveco team, I’m proud to work for a company that is a pioneer in the field of low-harm disinfection. Our commitment to safety and the environment is paramount, and we have accumulated expertise in building dossiers to obtain marketing authorizations (MA) for biocidal products.
At Salveco, we firmly believe in the importance of providing disinfection solutions that are both effective and respectful of health and the environment. That’s why we constantly strive to develop innovative products that meet the most stringent regulatory standards.
Our experience in obtaining MA testifies to our commitment and ability to ensure that our products are safe and comply with legal requirements.
Regulatory benefits
1. Obtaining Marketing Authorization (MA)
Could you explain what Marketing Authorizations (MA) are in the context of biocidal products?
With the aim of harmonizing the biocides market and guaranteeing a high level of safety in the European Union, the BPR Regulation has required since 2013 that all biocidal products must have an authorization in order to be placed on the market (MA).
To be granted a marketing authorization, active substances must be approved by ECHA. However, this evaluation work is still ongoing until 2030, with substances being assessed (efficacy, toxicological and ecotoxicological profiles) as and when they are approved.
Lactic acid was one of the first to be authorized as a biocidal active substance.
What are the different types of marketing authorization provided for under the BPR and what are their particularities?
Marketing authorizations (MA) are used to evaluate biocidal products in order to guarantee their efficacy and safety on application.
There are several types of MA. Firstly, there is the Union MA, which is approved by the European Chemicals Agency (ECHA) and is valid throughout the European Union and the European Economic Area.
Then there’s the national MA, valid in a single EU country but possibly recognized in others via mutual recognition.
Finally, the Simplified Marketing Authorization (SMA), which offers an accelerated approval process for biocidal products with characteristics favorable to health and the environment
3. Advantages of Simplified Marketing Authorization (SMA)
What are the requirements for simplified MA?
BPR (Biocidal products regulation) provides for the possibility of obtaining a SMA (Simplified Marketing Authorization) for products containing a biocidal active substance deemed low-risk by ECHA.
In addition, the formula must meet all the following criteria:
- All active substances contained in the product must be included in the restricted list of low-risk substances defined by ECHA, in Annex I of the BPR, and comply with the specified restrictions,
- The product does not contain any substances of concern or nanomaterials,
- The product is sufficiently effective according to current standards.
- The use and handling of the product does not require personal protective equipment.
What makes a product with an SMA a competitive advantage?
In a competitive, fast-changing market, and in an increasingly stringent regulatory context, committing to a product with an SMA is a long-term, secure guarantee for the marketing of our customers’ products. The main advantage of this approach is that we can speed up the marketing of the least hazardous products, with a dossier assessment lasting around 6 months, compared with 3 to 4 years for a conventional MA. The other advantage is that the SMA is a European authorization, accessible to all countries of the European Union and the European Economic Area, in the same way as EU MAs, unlike national MAs, which grant authorization in only 1 country
3. Case study at salveco
At Salveco, you are the first AMMS holder in Europe for your products. Can you explain how your unique lactic acid disinfection technology has contributed to this?
At Salveco, we’re proud to be pioneers and leaders in disinfection with a more favorable profile for health and the environment. Our commitment to safety, health and the environment led us to develop a unique lactic acid-based disinfection technology, effective at low doses. Our unique patented technology is a real turning point in the disinfection market, as it is not only effective, but also more favorable to health and the environment.
Thanks to this innovation, we were the first laboratory in Europe to obtain Simplified Marketing Authorization (SMA) for our ready-to-use biocidal formulations back in 2014. This achievement demonstrates our commitment to the excellence and efficacy of our formulas, in addition to our ability to meet the most stringent regulatory standards.
Since then, we have continued to innovate and obtain SMAs for over 130 of our disinfectant products. What’s more, we are also proud to hold an EU Marketing Authorization for our specific concentrated technology, still based on lactic acid. This additional recognition attests to the quality and reliability of our products, reinforcing the confidence of our customers and partners.
What are the specific benefits for your customers of these marketing approvals?
Thanks to our marketing authorizations, our customers benefit from patented biocide technology that is less harmful, complies with regulations and has been approved by the ECHA. They facilitate access to the European disinfection market. Supported by our experts, brands, distributors and manufacturers of cleaners and disinfectants can rapidly launch their range of “ecofriendly” products, based on plant chemistry, in a sustainable and simplified way.
Furthermore, in view of forthcoming changes to European biocides regulations, certain products and active substances will no longer be allowed on the market. Today, our solutions represent a secure, long-term solution for companies looking for innovative, effective and environmentally-friendly alternatives.