Analysis of legislative regulation of the use of silver nanoparticles in the leather industry

Abstract

Purpose of the study is to compare the regulatory approaches of the European Union, the United States of America, and Ukraine to the use of silver nanoparticles in the leather industry and to formulate practical recommendations for harmonizing the Ukrainian regulatory framework with international
standards. Methodology include an analytical review of the literature on the properties of leather materials as substrates for the sorption and growth of microorganisms, the potential use of silver nanoparticles as biocidal agents for the treatment of leather and leather products, and an analysis of regulatory instruments conducted through a comparative legal assessment of the applicable documents of the European Union, the United States of America, and Ukraine. Results demonstrate that natural leather as a footwear material creates favorable conditions for the growth of bacteria and fungi, thereby increasing the risk of infections, particularly among individuals with diabetes, peripheral circulatory disorders, and immunodeficiencies. Antimicrobial agents (biocides) reduce microbial load. Silver nanoparticles (AgNPs) exhibit high biocidal activity; however, their use is associated with uncertainties regarding long-term safety, potential toxicity, and environmental risks. It was found that in the EU the application of AgNPs requires a separate assessment of the nanoform, registration, labeling, and post-market surveillance; in the USA regulation is distributed among the EPA, FDA, CPSC, and OSHA depending on the intended use of the consumer product; in Ukraine, legislative provisions governing the use of nanomaterials are currently absent. Scientific novelty lies in a comprehensive comparative legal assessment of the regulatory models of the EU, the USA, and Ukraine concerning the use of AgNPs as biocidal agents in the leather industry. The substantiation of specific risks associated with the use of AgNPs in leather manufacturing has been further developed. Gaps in Ukrainian legislation have been identified and systematized, in particular the absence of requirements for the registration, labeling, and toxicity assessment of nanomaterials, in contrast to the EU REACH Regulation and the approaches applied by the EPA and FDA in the USA. The results of the study are relevant for the development of national technical regulations and safety standards for leather materials with antimicrobial properties. Practical recommendations have been elaborated for harmonizing the Ukrainian regulatory framework with EU requirements, which will contribute to enhancing the competitiveness of Ukrainian products on the international market and ensuring environmental safety. The proposed approaches may be used by certification and supervisory authorities to introduce mandatory labeling of products containing nanomaterials, as well as by leather manufacturers to develop safe protocols for antimicrobial treatment.