|
Kontrola efikasnosti dezinficijenasa i antiseptika - značaj i izazovi u regulativi i zaštiti javnog zdravlja
Efficacy control of disinfectants and antiseptics: Challenges in regulation and public health protection
Sažetak
Efikasnost biocidnih proizvoda ključna je za njihovu bezbednu i uspešnu primenu. U skladu sa regulativom Evropske Unije (BPR, Regulation (EU) No 528/2012), neophodno je sprovesti rigorozna ispitivanja pre stavljanja biocidnih proizvoda na tržište. Vodič Guidance on the Biocidal Products Regulation Volume II: Efficacy Parts B+C, Version 6.0 (August 2023) pruža okvir za procenu efikasnosti dezinficijenasa i antiseptika i drugih biocidnih proizvoda, definišući metode testiranja, kriterijume prihvatljivosti i postupke evaluacije rezultata. Održavanje visoko pouzdanih metoda ispitivanja ključno je za preciznu procenu efikasnosti biocida, dok usklađivanje sa regulatornim zahtevima osigurava dostupnost delotvornih i bezbednih proizvoda na tržištu. Ključni aspekti metoda ispitivanja efikasnosti uključuju: laboratorijska ispitivanja koja se sprovode u kontrolisanim uslovima kako bi se procenila osnovna efikasnost biocidnog proizvoda protiv ciljnih organizama, simulaciona ispitivanja koja nastoje da reprodukuju realne uslove upotrebe proizvoda u kontrolisanom okruženju i terenska ispitivanja koja se sprovode u stvarnim uslovima kako bi se procenila efikasnost proizvoda u okruženju za koje je namenjen. Implementacija strožih kriterijuma efikasnosti omogućava da biocidni proizvodi ostvare očekivanu delotvornost u realnim uslovima čime doprinose zaštiti javnog zdravlja, povećanju bezbednosti potrošača i očuvanju ekološke ravnoteže. Efikasnost dezinficijenasa i antiseptika direktno utiče na smanjenje rizika od infekcija, posebno u bolničkom okruženju, prehrambenoj industriji i sistemima za vodosnabdevanje. Nedovoljno efikasni proizvodi mogu dovesti do perzistencije patogena, razvoja antimikrobne rezistencije, hidričnih i drugih epidemija, zagađenja životne sredine i negativnih efekata na zdravlje ljudi i životinja. Stoga je kontinuirana kontrola efikasnosti biocida neophodna kako bi se osigurala njihova delotvornost i bezbednost, ali i optimizovala njihova upotreba. Pravilnim nadzorom i usklađivanjem sa savremenim smernicama moguće je smanjiti nepotrebnu upotrebu hemikalija i njihov štetan uticaj na zdravlje i životnu sredinu, čime se postiže dugoročno održiv pristup u zaštiti od bioloških pretnji.
Abstract
The efficacy of biocidal products is essential for their safe and successful application. In accordance with European Union regulations (BPR, Regulation (EU) No 528/2012), rigorous testing is required before placing biocidal products on the market. The Guidance on the Biocidal Products Regulation Volume II: Efficacy Parts B+C, Version 6.0 (August 2023) provides a framework for assessing the efficacy of disinfectants and antiseptics and other biocides, defining testing methods, acceptability criteria, and evaluation procedures. Maintaining highly reliable testing methods is crucial for the accurate assessment of biocide efficacy, while compliance with regulatory requirements ensures the availability of effective and safe products on the market. Key aspects of efficacy testing methods include: laboratory tests conducted under controlled conditions to assess the basic efficacy of a biocidal product against target organisms, simulation tests that aim to replicate real-world usage conditions in a controlled environment, and field tests conducted in actual conditions to evaluate the product's effectiveness in the intended environment. The implementation of stricter efficacy criteria ensures that biocidal products achieve the expected effectiveness under real-world conditions, thereby contributing to public health protection, increased consumer safety, and the preservation of ecological balance. The efficacy of these products directly influences the reduction of infection risks, particularly in hospital settings, the food industry, and water supply systems. Insufficiently effective biocides may lead to pathogen persistence, the development of antimicrobial resistance, waterborne and other epidemics, environmental pollution, and adverse effects on human and animal health. Therefore, continuous efficacy monitoring of biocidal products is essential to ensure their effectiveness and safety, as well as to optimize their use. Proper oversight and alignment with modern guidelines can reduce unnecessary chemical use and their harmful impact on health and the environment, achieving a long-term sustainable approach to biological threat protection.
|