The regulatory environment for manufacturing wet tissues varies by region and nation. Depending on their stated purpose, the Food and Drug Administration (FDA) classifies wet wipes as either over-the-counter drugs or cosmetics in the United States. This means wet wipes must satisfy the same regulatory requirements as over-the-counter medications and cosmetics. The FDA demands wet wipes manufacturers guarantee the safety, efficacy, and quality of their products by carrying out different testing as well as labelling requirements.
In the European Union (EU), wet wipes are governed by the Biocidal Products Regulation (BPR). The BPR seeks to ensure the proper application of biocidal products, such as those utilised in wet wipes, by governing the active ingredients and their suppliers. Manufacturers of wet wipes must adhere to the BPR by making sure their products contain only authorised active ingredients and by adhering to labelling requirements.
In Asia, manufacturing regulations for wet tissues differ by country. The State Administration for Market Regulation regulates wet wipes in China, and manufacturers must adhere to the Hygienic Standard for Disposable Sanitary Products. Besides, the Ministry of Health, Labour, and Welfare regulates wet wipes in Japan, and manufacturers must adhere to the Standards for Cosmetics. In South Korea, the Ministry of Food and Drug Safety regulates wet wipes as quasi-drugs and wet wipes manufacturers must adhere to the Pharmaceutical Affairs Act. In India, wet wipes are regulated by the Central Drugs Standard Control Organisation as cosmetics. The Drugs and Cosmetics Act and Rules, which establish labelling specifications, standards for manufacturing, and quality control standards, must be followed by wet wipes manufacturers. In Singapore, the Health Sciences Authority regulates wet wipes. Following these regulations ensures that customers may utilise wet wipes safely and effectively.
Guidelines for Wet Wipes Manufacturing
In addition to regulatory requirements, there are numerous guidelines and best practices for manufacturing wet tissues. These guidelines address diverse details related to wet wipe production, including materials, manufacturing procedures, and quality control.
One of the guidelines is the Code of Practice for the Manufacture of Wet Wipes, issued by the European Disposables and Nonwovens Association (EDANA). This code specifies the best practices for manufacturing wet tissues, including specifications for raw materials, production processes, and packaging. The code additionally contains testing and quality control recommendations to assure product effectiveness and safety.
Good Manufacturing Practices (GMPs) issued by the International Organization for Standardization (ISO) are another set of guidelines. The ISO 22716 standard addresses the manufacturing, quality management, storage, and transportation of cosmetic products, including wet wipes. By adhering to GMPs, wet wipes manufacturers adhere to a standardized approach to production that ensures the safety and quality of their products.