Authorisation of the active substances in the European Union

K. Doleželová, R. Švejstil

The National Institute of Public Health, Unit for Chemical Safety, Šrobárova 49/48, 100 00, Praha 10

katsiaryna.dolezelova@szu.cz

Protein databank currently includes 205 795 protein structures. Numerous of them are solved with the ligands, which could play different roles, for example: an inhibitor of metabolic reactions [1],  ion- channel modulations (ion- channels are the primary target sites for several classes of natural and synthetic insecticidal compounds) [2], oxidizing agents, electrophilic agents (include inorganic ions such as silver, copper and mercury), and enzyme inhibitors and others [3]. With the recent technical breakthroughs in structural biology, many new high-resolution structures in complex with the active substances, have been solved, shedding light on their molecular mechanisms of action, however, some are still not revealed.

What all these substances have in common? All of them share the varieties of mechanisms mode of action, but could be used against target harmful organisms and authorised under the Biocidal Products Regulation (EU) No 528/2012 (BPR), consequently sold under a brand name in the European Union (EU)/European Economic Area (EEA) as a biocide.

The active substance is evaluated from the perspective of efficacy, human health, risk mitigation measures, environmental risk in respect to the guidance and norms, which are in appliance. The competent authority of the Czech Republic participates actively in the mentioned process above, and it is represented in the international working groups and specialised committees. The authorisation takes place in two consecutive steps. As the first step, the active substance is evaluated and, provided criteria are fulfilled, is then approved in a specified product-type (PT).  Article 6 of the BPR [4] lists the requirements for the application for active substance approval. ECHA provides more advice on information requirements as given by Annexes II and III to the BPR and the assessment of the information in the Guidance on information requirements for Biocides. Quite similar principles exist for medicinal products, for human and veterinary use, medical devices, food and feed and cosmetics. Namely, the authorisation of medicines is built on three key criteria: quality, safety and efficacy, to ensure that products administered to patients are of suitable quality and provide a positive benefit-risk balance.

[1] Amaraneni, Sreenivasa Rao, Sudhir Kumar, and Samudrala Gourinath. "Biophysical aspects of lysozyme adduct with monocrotophos." Analytical and bioanalytical chemistry 406 (2014): 5477-5485.

[2] Bloomquist, Jeffrey R. "Ion channels as targets for insecticides." Annual review of entomology 41.1 (1996): 163-190.

[3] Fraise, Adam P., Jean-Yves Maillard, and Syed Sattar, eds. Russell, Hugo and Ayliffe's principles and practice of disinfection, preservation and sterilization. John Wiley & Sons, 2012.

[4] https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02012R0528-20220415

[5] https://echa.europa.eu/

[6] https://www.rcsb.org/

Supported by MZ ČR – RVO (The National Institute of Public Health, NIPH – SZÚ, IČ 75010330).