Regulatory Requirements of Fragrances and Perfumes in Household Chemicals

As substances with pleasant scents and aromas that can be smelt or tasted by human beings, perfumes are raw materials used for preparation of fragrances, which can be divided into natural perfumes and synthetic perfumes. Prepared with perfumes and other ingredients, fragrances are substances that give products certain pleasant scents. Fragrances can be divided into three main categories of flavoring essences, daily used essences and essences for other uses. Household chemicals mainly use daily used essences and essences for other uses.

Disinfection products, detergents and household pesticides are household chemicals commonly used in people’s lives, which often add fragrances to cover unpleasant smells of product media or meet consumers’ demands on scents of products. Although the management is not as rigorous as that on flavoring essences, fragrances and perfumes in household chemicals cannot be added freely, which must comply with corresponding national standards and policies. Addition of fragrances and perfumes in certain products will even have impacts on products’ registration and filing. Chemical Inspection & Regulation Service (CIRS) will specify the requirements on addition of fragrances and perfumes in disinfection products, detergents and household pesticides from the perspective of regulatory compliance.

1. Compliance requirements on fragrances and perfumes in disinfection products

As health products closely associated with our daily lives, disinfection products can kill and eliminate pathogenic microorganisms on transmission media, and play the role of prevention and control of infectious and communicable diseases. Disinfection products include disinfectants, disinfection devices and hygienic products. Disinfection products can be divided into the following three categories by risk level of objects of products: the first category is disinfection products with relatively high risk that requires rigorous management to ensure safety and efficacy, such as high-level disinfectants and disinfection devices used for medical devices. The second category is disinfection products with moderate risk that requires strengthened management to ensure safety and efficacy, which mainly include disinfectants and disinfection devices other than the first category of products as well as antibacterial (bacteriostatic) agents. The third category is hygienic products other than antibacterial (bacteriostatic) agents with comparatively low risk level, which only requires regular management to ensure safety and efficacy. Hygienic products under the third category are the most common ones in our daily lives, which mainly include disposable hygienic products such as wet wipes, hygiene wet wipes, sanitary napkins commonly used for period, sanitary pads, nappies, diapers (pad and paper) and urine mats.

Normally among the first and second category of disinfection products, very few ones use fragrances and perfumes other than antibacterial (bacteriostatic) hand sanitizer, antibacterial (bacteriostatic) gynecological lotions and antibacterial (bacteriostatic) mouthwash due to relatively rigorous regulation on those products, which require hygiene and safety evaluation report before market as well as registration with local health authorities. Addition of fragrances and perfumes may make product formulas more complicated, which may increase the difficulty in product composition test, affect the chemical stability and bactericidal capability of their bases, and even have side effects on objects. More importantly, the authorities may require separate registrations for products of different scents. For instance, disinfection products of the same type but with different scents need to be registered separately. However, that is not always the case, the Guangzhou Health Commission believes products of the same type but with different scents can be treated as one product, and only one registration is required. Enterprises shall consult local health commission during product registration, and submit compliant registration materials based on thorough understanding of local policies and regulations as well as related requirements. In addition, antibacterial (bacteriostatic) agents under the second category of disinfection products shall also meet fragrance limit requirements of products under the 5^th, 6^th, 8^th and other related categories prescribed in GB/T 22731-2017 Daily Used Fragrances.

Hygienic products under the third category are the products use the most fragrances and perfumes among disinfection products at the moment, which require no hygiene and safety evaluation report and registration but regular management pursuant to regulatory requirements. Manufacturers often add some fragrances and perfumes based on market demands and consumers’ preferences. For instance, wipes and tissues would often add some fragrances with floral scents of jasmine, rose and other flowers or fruity scents of lemon, grapefruit and other fruits, which give products different scents. Addition of fragrances to this type of products shall be conducted in accordance with GB/T 22731-2017 Daily Used Fragrances, which categorized household products and prescribed limits of fragrances allowed to be used in different categories of products. Among which, face wipes, sanitary napkins, napkins, tissues and toilet papers are under the 9^th category, while baby diapers are under the 10^th category. The maximum limits for alcohol-based and aldehyde-based fragrances allowed to be used in products under the 9^th and 10^th categories are 5.0% and 2.5% respectively. Limits for the use of certain ester-based fragrances are comparatively low, and the maximum limits for fragrances used in products in contact with skin are relatively rigorous. Besides, it’s strictly prohibited to add a variety of musk, benzene and its compounds and rosin to aforesaid products.