Letter of Access to BPR dossierACT.Global holds nine Biocidal Products Regulation (BPR) active substance dossiers for the use of free radicals generated in situ as active substances in biocides. We are offering Letters of Access (LoA) to these dossiers on a commercial basis in order to recover and share our development costs. This website provides basic information on the content and history of those dossiers and offers the opportunity to purchase a LoA.
Under BPR, biocidal products are classified into 22 biocidal Product Types. ACT.Global holds an active substance dossier in the following nine product types:
PT2 Disinfectants and algaecides not intended for direct application to humans or animals
PT3 Veterinary hygiene
PT4 Food and feed area
PT5 Drinking water
PT7 Film preservatives
PT11 Preservatives for liquid-cooling and processing systems
PT13 Working or cutting fluid preservatives
PT21 Antifouling products
Read more about the Product types and what they cover here
Free Radicals in Disinfectants and Algaecides
Safe, environmentally friendly and effective against microbes over long periods of time, free radicals generated in situ are an exciting area of development for producers of disinfecting and purifying products.
Fields in which free radicals could be applied include:
- air purification production
- photocatalytic coatings
- TiO₂ pigment supply
- chemical biocide production
- UV & ozone disinfection equipment production
See the section on “Use Cases” for industry-specific applications of free radicals generated in situ.
Based in Copenhagen, Denmark, ACT.Global has built substantial expertise in the use of free radicals in situ in disinfectants and currently have nine dossiers registered with the European Chemicals Agency (ECHA).
In addition to offering Letters of Access (LoA) to these dossiers, we also produce sustainable disinfectant solutions for industries where a low-microbial environment is mission-critical.
The Biocidal Product Regulation (BPR, Regulation (EU) 528/2012) covers the availability and use of biocidal products in the EU. Biocide’s that protect humans, animals, materials or articles against harmful organisms, such as microbes or viruses, through the action of active substances contained they contain.
BPR came into effect on September 1, 2013. From this date, a dossier containing data requirements and risk assessments has been required for active substances used in biocidal products.
Since September 1, 2015, a biocidal product cannot be made available on the European Union market unless either the substance supplier or the product supplier is included in the list for the Product Type (PT) to which the product belongs, known as the Article 95 list.
Since September 1, 2017, any organization seeking to market a biocidal substance or product type that involves active substances must register its dossier with the European Chemicals Agency (ECHA).
Applicant organizations must refer to an approved dossier owned by a third party to support their submission under the BPR. This authorization takes the form of a Letter of Access (LoA) in which certain rights of referral are provided to the applicant.
The ECHA is responsible for the publication of the Article 95 list of relevant substances and the respective substance and product suppliers. The purpose of this list is to ensure that all organizations placing active substances on the market receive equal treatment.
Purpose of Letter of Access
A Letter of Access (LoA) is a valuable instrument for any organization that plans to sell a new biocidal product in the European Union. To comply with the European Union’s Biocidal Products Regulation a producer of biocides must have its product registered in accordance with Article 95 or Article 93.
The holder of a LoA can use another organization’s existing data and risk assessments—known as a “dossier”—to meet EU requirements for biocides that involve active substances. Using a LoA in this way enables a company that wants to market biocidal products, with the same active substance, to avoid duplication of effort and to bypass a series of expensive and time-consuming regulatory hurdles.
Through a LoA, you buy rights to refer to data from a company such as ACT.Global that has already submitted a active substance dossier related to the active substance for your Product Type.
A LoA lets you join the Article 95 list by referring to the research and documentation in one of the accepted active substance dossiers. In this way, a producer or supplier can gain access to the EU market through one of the registered companies on the Article 95 list.
Please note that the scope of each LoA that ACT.Global offers are subject to the following limits:
- A specific named product
- A specific Product Type
- A specific territory of authorization
- A specific legal entity
A Biocidal Products Regulation (BPR) dossier for the use of free radicals generated in situ has a range of potential uses across a variety of industries.
The following section looks at typical use cases for a Letter of Access (LoA) to ACT.Global’s Product Type 2 dossier, covering “Disinfectants and algaecides not intended for direct application to humans or animals”.
Air Purification Products
ACT.Global’s LoA provides an ideal starting point for manufacturers of air purifiers looking to add “beyond HEPA” antimicrobial protection to their products.
By coating highly efficient particle filters with e.g. a titanium dioxide coating they become anti-microbial, given them a truly unique selling proposition. Now the filters will not only provide clean air, but they will also provide microbial free air as well. A tremendous advantage considering the high percentage of microbial contaminants that are airborne.
This will open up a whole new product in a market that is becoming more and more aware of the risk of airborne cross-contamination. All spaces where people gather like hospitals, offices, schools, kindergartens, or public transportation would benefit from reducing contaminants in the air.
Access to use environmentally friendly in situ generated free radical’s makes it possible to obtain a competitive edge. With a LoA biocidal products authorization can be obtained at a fraction of the cost and time otherwise required.
Our LoA provides suppliers of photocatalytic coatings with a fast track to serving the industry’s most rapidly growing market for biocidal antimicrobial coatings. For producers of photocatalytic coatings having or missing a dossier or LoA means a world of difference.
Without, it is not possible to commercialize or highlight the anti-microbial effect of the coating – even though it is one of the most sustainable ways to create low-microbial environments. Every wall, every surface is transformed into a self-disinfecting agent that decomposes bacteria, viruses, airborne mold spores and chemical compounds like VOCs. Providing clean air and microbial clean rooms to the end-user.
With a LoA, the products can harvest all the benefits of a biocide to the numerous industries such as health care, hotels and restaurants, food processing, or beverage production where a low-microbial environment is mission critical.
Access to ACT.Global’s dossier allows a company to quickly and easily take advantage of e.g. nano-titanium dioxide (nano- TiO₂), an approved, eco-friendly substance that is increasingly in demand in this sector.
Ozone & UV Purification
ACT.Global’s LoA is an invaluable tool for a maker of ozone or ultraviolet (UV) purification looking to provide products with greater antimicrobial protection.
The biocidal effect of ozone and UV purification is in situ generated free radicals. Without a dossier or LoA all products that claim a biocidal effect are illegal on the European market.
With a LoA however, the documented biocidal effect of ozone can protect people, animals and products in a market that is increasingly looking for sustainable disinfection alternatives. Most countries in the EU are actively looking for purification alternatives to chlorine and other toxic chemicals. In this process ozone and UV-purifiers can play an important role.
Access to our in situ generated free radical’s dossier would allow a company in one of these sectors a simpler and more economical path to the registration ozone and UV-based products and features, saving time and money.
Pigments & Chemical Biocides
ACT.Global’s LoA greatly simplifies the introduction of new products with eco-friendly properties for companies in the pigments & chemical biocides sector. Titanium dioxide is one of the most common pigments on the market. Exposed to light it has a documented biocidal effect.
In other words, all white paintings have the potential to make surfaces self-disinfecting, providing the end user with cleaner air and a low-microbial environment.
Imagine the possibilities this would have in a B2C market. Not only are you decorating your home, but you are also protecting your family from harmful microbes and air pollutants like volatile organic compounds at the same time. What better and more relevant way to stand out in the market?
Access to ACT.Global’s active substance dossier is the simple and cost-efficient route to approval of advanced nano-TiO₂-based antimicrobial pigments that customers are increasingly demanding.
Letter of Access
If you want to obtain a Letter of Access (LoA) for Product Type 2, you can do so by using the contact form at the bottom of this page.
Before contacting us, please read the term sheet. The term sheet is a nonbinding agreement that sets out the standard terms and conditions for purchasing a LoA from ACT.Global.
Rather than a physical letter, the LoA is delivered in the form of an electronic token. This token then notifies the European Chemicals Agency (ECHA) that your organization is authorized to access our Product Type 2 active substance dossier for the biocidal product that you specify in the Term Sheet.
Please note that LoAs are available only on a “per legal entity” basis. If you are an only representative or third-party representative, you must purchase an LoA for each company and substance that you represent.