28-29 June 2016, the 2nd Summit Meeting on Cosmetic Regulations in Asia pacific, jointly hosted by China Association for Consumer Product Quality and Safety Promotion (CACPQSP) and Chemical Inspection & Regulation Service (CIRS), was successfully convened. The officials Mr. Liu Xiaogang from China Food and Drug Administration, Mr. Hao Yue from General Administration of Quality Supervision, Inspection and Quarantine, Ms. Sun Jiawen from Shanghai Entry-Exit Inspection and Quarantine Bureau-Food Safety Department gave presentations on the trend of administration and surveillance of cosmetics and cosmetic ingredients. The experts Mr. Xu Liang from Beijing Daily-Use Chemicals Institute and Ms. Zhang Hongwei from China Center for Disease Control & Prevention presented the current important Chinese cosmetics regulations including the Regulations Concerning the Supervision and Administration of Cosmetics, Guidelines on Safety Risk Assessment of Cosmetic Products and Technical Safety Standard for Cosmetics. Mr. Hou Zhenghong from Taiwan Biotechnology Industry Alliance (TABCIA), Mr. Sang-won You from Global Registered Certification (GRC), Mr. James Wakefield from Delphic HSE Solutions Limited, Mr. Brian Priestly from Australian Centre for Human H, Monash University, Mr. Steve Bidinger from MK Life Inc, Mr Manorath Khullar from MAC Aesthetic Hair And Skin Clinic made presentations for cosmetics regulations in Taiwan, Korea, EU, Australia, Japan and India. Mr. Jiang Yifan from Colgate and Mr. Zhang Quanshun from Institute for In Vitro Sciences are invited to speak at the summit on the management of oral care product in China and other countries as well as alternative methods in cosmetics.
During 2015 and 2016, many of the cosmetic regulations in China were updated and completed. Some important cosmetic regulations, such as the Regulations Concerning the Supervision and Administration of Cosmetics(revised draft for examination),Technical Safety Standard for Cosmetics(ver. 2015) as well as the combination of two certificates (National Industrial Production Permit and Sanitary Certificate of Cosmetics Manufacturers), was also updated, which will deeply affect the current situation and the development of cosmetic industry in China. Once the Regulations Concerning the Supervision and Administration of Cosmetics formally comes into effect, the approval of new cosmetic ingredients will be managed depending on the level of safety risk, and cosmetic products will be classified in terms of safety risk and efficacy claiming. As two certificates on cosmetics production have been combined, enterprises manufacturing toothpaste should also apply for cosmetics production certificate. Given theTechnical Safety Standard for Cosmeticswill come into force soon, cosmetic enterprises may have to adjust their products formula and quality control requirements. For instance, the preservatives “chloroacetamide, urotropin, methyldibromo glutaronitrile, poly quaternary ammonium salt-15, sodium iodate and isobutylparaben” are prohibited to use in cosmetics. Enterprises shall also apply for alteration if the approved cosmetics contain the above-mentioned ingredients. As introduced by experts, China Food and Drug Administration is drafting an implementation guideline for Technical Safety Standard for Cosmetics so that cosmetic enterprises can better understand and execute the new standard.
The competent authority for the management of cosmetics in Taiwan is Food and Drug Administration. The regulations for the management of cosmetics are Cosmetics Hygiene Control Act and Implementation Guideline for Cosmetics Hygiene Control Act. According to the two cosmetic regulations, cosmetic products can be classified as general cosmetics and medicated cosmetics (cosmetics for the purpose of sun-screening, whitening, hair dye, decoloration, hidroschesis and deodorization, horniness softening, etc.). Registration is not required for general cosmetics but mandatory for medicated cosmetics. Cosmetic ingredients shall be managed in accordance with negative lists including List of Prohibited Ingredients Used in Cosmetics,Regulation on the Limit of Heavy Metal as Impurities in Cosmetics and positive lists including Medicated Cosmetics Criterion,List of Allowed Colorants and List of Use Standard for Preservatives.
Cosmetics in South Korea are classified as general cosmetics and functional cosmetics (cosmetics for the purpose of whitening, anti-wrinkle, sunblock and sun tanning). According to the latest amendments of cosmetic regulations, products for hair dye shall be managed as cosmetics. The revised regulation also ruled that cosmetics and cosmetic ingredients conducted in animal tests are not allowed to put in the market. Additionally, the registration of manufacturer sales business is not required for secondary packing or labeling only not related to the quality and safety of cosmetics. Labelling contents including products name, name of manufacturer and retailer, price, expiration as well as batch code shall be indicated on the external packages of cosmetics less than 10ml or 10g, cosmetics not for sale and imported cosmetics.
Cosmetics in Japan are divided into cosmetics and quasi-drug. The management systems for the two different types of cosmetics are totally different. Quasi-drugs include cosmetics for the purpose of whitening, hair growth, hair dye, deodorization, acne treatment, etc. Relevant cosmetic regulations are Pharmaceutical Affairs Law,Enforcement Regulations for Pharmaceutical Affairs Law, Cosmetic Ingredients and Cosmetics Standard Released by Ministry of Health and Welfare. According to the requirements of Pharmaceutical Affairs Law,the product name, production code, name and address of the manufacturer and importer, ingredients of products, expiration of products and other matters required by regulations issued by Ministry of Health and Welfare have to be labelled on the packaging container and external package.
Cosmetics in Australia are also managed according to classifications. Therapeutic cosmetics (such as sunblock) should have pre-market approval by Therapeutic Goods Administration. Nevertheless, registration is not required for general cosmetics except complying with the industrial standards. If a cosmetic ingredient is not listed in AICS list, a notification is needed with NICNAS. Recently, the evaluation of imported new chemical substance is in the process of amending. According to the amendments, chemical substances will be divided into three categories including very low-risk chemicals, low-risk chemicals and medium to high-risk chemicals. It is estimated that, under the new evaluation framework, it will be easier to get approval of new cosmetic ingredient notification
According to Drug & Cosmetic Law, the cosmetics can be imported to India after obtaining the license from Drug Controller General of India (DCGI). Overseas enterprises can accredit companies registered in India as legal representatives to apply for license of imported cosmetic. Application dossier includes power of attorney for legal representatives, labelling, Certificate of Free Sale (CFS), product quality control requirement and test methods etc. the validity period of registration certificate is 3 years. After obtaining the license, in case the product is expected to changing quality control requirements or product ingredients, applicant shall provide alteration application to authority 30 days before product importation. In addition, in case the imported cosmetics are used for stability research, package testing and other scientific research and product development, or imported semi-finished products are used for sub-packaging and exportation, registration is not required.
Cosmetic Safety and Risk Assessment
Cosmetic safety risk assessment is one of the most reliable methods to evaluate product safety and reflect the potential risk of cosmetic. Currently, US, EU, Japan and other developed countries or regions have used risk assessment method widely to conduct cosmetic safety evaluation. The Guidelines on Safety Risk Assessment of Cosmetic Products will be an important normative document to regulate and guide cosmetic safety risk assessment in China. The GUIDELINES are compiled based on the Guidance for Safety Evaluation of Cosmetic Products (version 11) in Europe and China national situation. As expert introduced, the GUIDELINES are expected to come into force this year, but only the toxicological tests for domestic non-special cosmetics can be waived in the condition that the risk assessment result is sufficient to verify the safety of products. In addition to this, the risk assessment can be waived for the ingredients on the positive list of Technical Safety Standard for Cosmetics, including preservatives, sun-screening agents, colorants and hair dyes, etc.
Management of Oral Care Products in Asia-Pacific Area
Up to now, toothpaste is only regulated as cosmetics on manufacturing license in China. Given there are no standards issued for the management of mouthwash in China, so manufacturing license is not required for mouthwash. Pre-market approval is not needed for toothpastes yet. Imported toothpaste shall pass the label review by CIQ based on GB8372. It is not allowed to have the claiming of medical treatment such as gingivitis and periodontitis. The functions like anti-caries, preventing dental plaque, anti-dentin hypersensitivity, relieving gingival inflammation, whitening, dental calculus prevention and reducing bad breath should be verified in terms of QB/T 2966 as reference. Efficacy verification can be waived on the condition that the additive amount is higher than the amount of verified product having same claiming and functional ingredient.