Registration of Biocidal Products at the Office – Requirements

The current epidemiological situation has contributed to an increase in the number of available biocides. However, before the Office allows a given preparation to be sold, we must obtain a permit to trade in biocidal products. Before biocidal products are registered on the official list of preparations with an authorization number, they undergo mandatory biocidal effectiveness tests. In what sectors of the economy are products of this type used?  What is the process of registering products intended for disinfection? Why is it worth entrusting it to specialists?

Biocidal products – general characteristics

The SARS-CoV-2 epidemic has led to an increase in the population’s awareness of disinfectants. Today, biocidal products are available in many forms. These include hand fluids and gels as well as liquids and fogging agents. Wipes for disinfecting surfaces and devices are also common. These preparations are used wherever there is a particular risk of transmitting bacteria and microorganisms. They are also present where access to running water is difficult or the use of biocides is required by law, e.g. in the medical field.

How do biocides work?

The most popular ingredient of preparations intended for disinfection is ethyl or isopropyl alcohol.  Typically, the alcohol concentration in the finished product is 60-85%. These products have a killing effect on bacteria, yeasts and fungi, spores, tuberculosis bacilli and viruses. However, it is necessary to confirm the effectiveness of the killing effect in each of these ranges. Biocidal products, in addition to their main function of destroying unwanted pathogens, also act as a preservative for a given surface. This way they limit secondary contamination.

Areas of application of biocides

Products for disinfection in private, industrial and institutional areas

This sector covers both everyday life and public and industrial activities. Biocidal preparations have become a permanent fixture in homes, institutions, educational institutions, beauty salons, fitness clubs, workplaces and food processing or production facilities. The legal provisions in force in Poland oblige entrepreneurs to introduce the HCCP system, one of the elements of which is the so-called Good Manufacturing Practice (GMP) regulating systems for maintaining appropriate storage conditions for food and products ensuring safety.

Disinfection products in the medical area

In the medical industry, preparations intended for disinfection are of particular importance. Biocides are used at every step of the operation of hospitals, clinics and private medical offices. Using the above-mentioned preparations are an indispensable element of disinfection, including the hands of medical staff before various types of procedures, or a mandatory factor in maintaining cleanliness in hospital rooms, up to the disinfection of surgical instruments.

Disinfection products in the veterinary area

In veterinary medicine and related fields, biocidal products are used, among others: in the field of disinfection of breeding rooms, livestock buildings, disinfection of veterinary offices, breeding plants and stables. This sector uses particularly strong disinfectants.

What conditions must a product meet to be considered biocidal?

If you wish to register biocidal products for the market, the manufacturer is absolutely obliged to conduct biocidal effectiveness tests depending on the type of preparation and area of ​​use. For a product to be registered by the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, it must meet specific criteria. According to the information available on the Office’s website, a product may be subject to registration as a biocidal product if:

• Biocidal product means a substance or mixture consisting of one or more active substances, the purpose of which is to destroy, neutralize and repel harmful organisms, combat them and prevent their action in a way other than physical or mechanical action.
• The intended use of the product should fall within the categories and product groups included in Annex V to Regulation No. 528/2012.
• The active substances used to produce the biocide are included in Annex II of the EU Commission Delegated Regulation No. 1062/2014 of 4 August 2014.
• If substances other than those listed in Annex II are used to produce a product, they should be included in a different list. The list is available in Art. 9(2) in Regulation 528/2012.
• Other substances that are included in Annex I in Regulation No. 528/2012 are also permitted for the production of the product. Of course, they must not infringe any other restrictions listed in this regulation.

Registration of biocidal products

In order to register biocidal products on the market, it is necessary to test them to assess their biocidal effectiveness, which can be carried out in professional laboratory facilities providing such services. During the tests, the killing effectiveness of the above-mentioned substances is confirmed. bactericidal, fungicidal and e.g. virucidal preparations.

“Testing of agents in laboratories of this type is performed using applicable legal standards. Thanks to the help of specialists, it is possible to assist in completing documents, submitting an application and going through the individual stages of entering the product on the list of biocides and disinfectants at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products. – confirms the specialist in biocidal, fungicidal and disinfectant products.