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.

2. Compliance requirements on fragrances and perfumes in detergents

Detergents present a category of products that contain soap or/and surfactants for washing and cleaning, which can be presented in any of the following forms: liquid, powder, paste, slice, bar and block.

As non-functional additives commonly used in production of detergents, perfumes and fragrances play very important and active role in improving sensory effects and wining the favor of consumers. For example, fragrances with scents of jasmine, lily, cherry blossom and lemon are often added to commonly seen wash-care products. Detergents normally can be divided into three categories by objects:

Category A: detergents used for food, food related tools and equipments, which include dishwashing detergents and fruit and vegetable detergents;
Category B: detergents used for personal care, which include soap, bath lotion and hand wash;
Category C: detergents used for other items, which include washing powder, liquid laundry detergent, laundry soap, powder laundry soap, laundry paste, sanitary cleanser, kitchen cleaner, glass cleaner, floor cleaner, furniture cleaner, laundry detergent, softener and liquid stain remover as well as animal cleaner.

Fragrances used in category A detergents shall meet requirements prescribed in QB/T 1505 Flavoring Essences before 2017, which’s abolished by No. 23 announcement made by Ministry of Industry and Information Technology on June 7, 2017. After that, fragrances used in category A products are temporarily subject to related provisions of GB 30616-2014 National Food Safety Standards - Flavoring Essences and GB 2760 National Food Safety Standards – Standards for the Use of Food Addictives at the moment. Fragrances used in category B and C products shall comply with GB/T 22731 Household Fragrances’ requirements on the use of fragrances in products under related categories. Among which, hand-wash detergents are products under the 5th category, which allows the use of a great variety of fragrances that vary a lot in maximum limits. Hand-wash laundry detergents, machine-wash laundry detergents (liquid, powder and bar) along with hand-wash dishwashing detergents are products under the 10th category, and the most common maximum limit for alcohol-based and aldehyde-based fragrances allowed to be added is 2.5%. Machine dishwashing detergents and deodorizers as well as machine dishwashing detergents are products under the 11th category, which have relatively loose fragrance limits and basically no maximum limit.

Compared with disinfection products under the first and second categories that need registration, China’s supervision over fragrances in detergents is not very rigorous. As trace amount addictives used for production, fragrances and perfumes can be properly added within the allowable limits of regulations.

3. Compliance requirements on fragrances and perfumes in household pesticides

As relatively special pesticide products, household pesticides refer to pesticide products that can be directly used by users indoor without dilution and other treatments for prevention and control of mosquito, fly, cockroach, ant and other pests in living environment of human beings as well as farmed animals in agriculture and forestry. Common products include aerosol, mosquito coil, vaporizing mosquito repellent mat, vaporizing mosquito repellent liquid, mosquito repellent spray, mosquito repellent milk, mosquito repellent floral water and mothproofing agents.

Fragrances added to household pesticides can cover unpleasant odors of raw materials in solvents of products, give pleasant scents to products to a certain extent, and thus guide consumption. However, household pesticides are mainly used indoor, and fragrances and perfumes essentially belong to limited addictives in pesticide products rather than perfumes or air fresheners, which shall be added properly. Accompanied with development of household pesticide related regulations, management on scents of household pesticides has changed a lot. Before December 1, 2017, the same household pesticide is not allowed to have more than three scents, and the scents of the household pesticide shall be registered, which’s also known as ‘one certificate for three scents’. Such regulation was abolished on December 1, 2017, there’s no more limit on the number of scents of the same household pesticide product, content of fragrances in household pesticides shall not exceed 1%, and it’s not necessary to apply for registration of changes in case of changes in the types of fragrances. In other words, it’s not necessary to submit composition of fragrances if changes in scents of household pesticides will not lead to significant changes in their compositions (change ≤1%), and it’s not necessary to apply for alteration registration if changes in fragrances used in household pesticides will not result in significant changes in their compositions. See details in Table 1.

Table 1 Changes in provisions concerning the use of fragrances in household pesticides in Ministry of Agriculture’s announcements

Announcement	Old: No. 1132 announcement made by Ministry of Agriculture – Announcement on Standardized Management of Scents Used in Household Pesticide Products (December 25, 2008)	New: No. 8 [2017] Order of Ministry of Agriculture – Ministry of Agriculture’s Decisions on Amendment and Repeal of Certain Rules, Regulations and Normative Documents (December 1, 2017)
Detailed contents	1. Pesticide manufacturers can apply for the use of different scents during application for registration of household pesticide products, and the same household pesticide product can apply for up to 3 scents. 2. Scents used in household pesticide products are subject to registration system. 3. Ministry of Agriculture shall file pesticide manufacturers’ application for scents of household pesticide products, and mark the scent information in the pesticide registration certificate (or certificate for temporary registration of pesticides) after approval and consent. 4. Fragrances (perfumes) added to household pesticide products shall comply with China’s related regulations and standards on management of household fragrances (perfumes), which shall not affect composition, quality, safety and effect of products. 5. In case of changes in scents of household pesticide products that lead to significant changes in composition of addictives (change ≥1%), their manufacturers shall reapply for registration formalities.	The decisions abolished management on the scents used in pesticide products prescribed in No. 1132 announcement made by Ministry of Agriculture on December 25, 2008, which means the country has cancelled ‘one certificate for three scents’ from December 1, 2017. In other words, the same household pesticide product is no longer subject to limit on number of scents. At the present stage, number of scents used in the same household pesticide product is no longer subject to limit. When the content of fragrances in household pesticides is no more than 1%, it’s not necessary to apply for registration of changes in types of fragrances.

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