BPR Dossier

Letter of Access to BPR dossier

ACT.Global holds nine Biocidal Products Regulation EU 528/2012 (“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 cost-recovery basis to help defray our expenses related to dossier preparation, prosecution, and approvals.

This website provides basic information on the history and content of our dossiers, what you can expect if you purchase an LoA, and how to make a purchase.

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

PT12     Slimicides

PT13     Working or cutting fluid preservatives

PT21     Antifouling products

You can read more about these product types on the European Chemicals Agency (ECHA) website.

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 may apply include:

  • air purification production
  • photocatalytic coatings
  • TiO₂ pigment supply
  • chemical biocide production
  • UV & ozone disinfection equipment production

Please refer to the “Use cases” section for industry-specific examples of how free radicals generated in situ may be used.

Letter of Access

If you want to obtain a LoA any of our approved dossiers, you can do so by using the contact form at the bottom of this page.

Before contacting us, we suggest reviewing our LoA term sheet. The Term Sheet is a nonbinding doscument that sets out the standard terms and conditions for purchasing an LoA from ACT.Global.

Rather than a physical letter, the LoA will be delivered to both you and ECHA electronically and will list one or more unique tokens. The tokens notify the European Chemicals Agency (ECHA) that your organization is authorized to access our 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.

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

About the dossier holder

ACT.Global was established in 2013 with headquarter in Copenhagen, Denmark, and is a leader in the development and incorporation of free radicals generated in situ for important and mission-critical low-microbial environments such as health care, hotels and restaurants, food processing and beverage production. ACT.Global’s solution is eco-friendly, sustainable and reduce the consumption of plastic and harmful chemicals.

ACT.Global offers, in addition to BPR approved LoAs, a unique solution and services where disinfection and long-term cleanliness and high air quality are essential.

Dossier history

Biocides are substances that protect humans, animals, materials or articles against harmful organisms, such as bacteria or viruses, through the action of the active ingredients they contain. The Biocidal Product Regulation (EU) 528/2012 (“BPR”) is the governing legislation that controls the availability and authorized use of biocidal products across the European Union.

The BPR came into effect on September 1, 2013. From this date forward, a BPR-approved dossier containing test data, risk assessment and at least one product instantiation is required for any biocidal product that is placed on the EU market.  Dossier approvals are specific to a single Product Type (“PT”) even though the underlying data may be applicable across a range of PTs.  An additional level of qualification came into effect on September 1, 2015, where biocidal products could only be approved if the active substance or the entire product came from an approved supplier as listed on ECHA’s Article 95 list. The purpose of this list is to ensure that all organizations placing active substances on the market receive equal treatment.

In 2013, ACT.Global started its research and development activities on the use of free radicals generated in situ and worked closely with ECHA in determining how the BPR would apply to its use in biocidal products.  Over the course of six years, ACT.Global spent more than €6M on tests, laboratory reports, product development, and agency updates, all of which were needed in support of its dossier application.

Any organization seeking to place a biocidal product on the EU market must associate its product with an existing approved BPR dossier via a registration process with ECHA.  Failure to do so exposes the organization to potential penalties or compulsory product recalls and consumer liability.

As of December 2018, applicant organizations must refer to a pre-existing, approved dossier to support their submission under the BPR. This authorization takes the form of a Letter of Access (“LoA”) in which certain rights of referral to an approved dossier are provided.

Purpose of Letter of Access

A Letter of Access 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, supplier, or importer of biocides must have its product registered in accordance with Article 95.

In order to avoid the duplication of expensive laboratory tests, dossier preparation, burdensome regulatory filings and increase speed to market, the holder of an LoA is entitled to use another organization’s existing data and risk assessments—known as a “dossier”—to meet EU requirements for biocides that involve active substances.  In order that latecomers to biocidal products do not obtain an unfair cost advantage from avoiding the cost of dossier production,  dossier holders are entitled to cost recovery of their dossier expenses attributable to dossier approval.

An LoA enables an organization to join the Article 95 list by referring to the research and documentation contained in one of the accepted active substance dossiers. In this way, a new or prospective producer or supplier can gain access to the EU market through a previously registered Article 95 company.

Contact us for a Letter of Access

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Use cases

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, giving them a unique selling proposition versus conventional HEPA filters. Free radicals generated in situ coated HEPA filters will not only provide clean air, but they will also provide microbial free air as well. This conveys a distinct performance 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.

Authorization to use sustainable and environmentally friendly free radicals generated in situ makes it possible to obtain a competitive edge. Through ACT.Global’s LoA, biocidal product authorization can be obtained at a fraction of the cost and time otherwise required.

Photocatalytic coatings

ACT.Global’s LoA provides suppliers of photocatalytic coatings with a fast track to serving the industry’s most rapidly growing market for biocidal antimicrobial coatings. For companies that could not afford the cost of their own dossiers, ACT.Global’s LoA opens a new market for photocatalytic coatings that was previously deemed inaccessible.

Without an approved dossier or LoA, it is not possible to commercialize or highlight the antimicrobial 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 surfaces to the end-user.

With ACT.Global’s LoA, new products can be brought to market that harvests all the benefits of a biocide with application to 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 stems from the use of free radicals generated in situ. Without an approved dossier or LoA that authorizes the use of this active substance, products that claim a biocidal effect are not permitted to be placed on the European market.

With an 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 ACT.Global’s free radicals generated in situ dossier allows a company in one of these sectors, a simpler and more economical path to approved use of ozone and UV-based products and features, saving time and risk.

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 globally recognized biocidal effect.

In other words, the use of titanium dioxide in paints has the potential to make painted surfaces self-disinfecting, providing the end-user with cleaner air and a low-microbial environment.

Access to ACT.Global’s active substance dossier is the simple and cost-efficient route to the approval of advanced nano-TiO₂-based antimicrobial pigments.