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Monthly Recap: Global Cosmetic Regulatory Updates | August 2022

China

Guangzhou Government to Cancel the Notification of over 300,000 Batches of Non-compliant General Cosmetics

On July 26, 2022, Guangzhou Administration for Market Regulation (AMR) announced to cancel the notification of over 300,000 batches of general cosmetics. These non-compliant general cosmetics include unconfirmed cosmetics on the new Cosmetics Registration and Notification Platform, and cosmetics lacking the required annual report. Cosmetics subject to cancellation shall not be sold or imported from the date of cancellation.

China NMPA Officials Clarify Matters Related to Ingredient Safety Information Submission

On July 28, 2022, the Department of Cosmetics Regulation of National Medical Products Administration (NMPA) convened provincial medical products administrations (MPAs), National Institutes for Food and Drug Control (NIFDC), NMPA Information Center, and China Association of Fragrance Flavour and Cosmetic Industries (CAFFCI), holding a video symposium with industry associations. At the symposium, NMPA systematically analyzed the situation of ingredient safety information submission, and clarified some recent concerns of the industry.

China Consults on Technical Guidelines for Special Cosmetics with Freckle-removing and Whitening Efficacy

On August 1, 2022, NIFDC released the draft Technical Guidelines for Special Cosmetics with Freckle-removing and Whitening Efficacy (Guidelines) for public consultation. This draft Guidelines integrates the regulatory requirements for "freckle-removing and whitening cosmetics" in Cosmetic Supervision and Administration Regulation (CSAR) and its subsidiary regulations, as well as provides the basis for registrants to prepare registration documents and for the technical review department to review registration documents.

NIFDC Introduces Requirements for the Consulting Experts on Cosmetics Technical Review

On August 1, 2022, NIFDC released the Measures for the Administration of Cosmetics Technical Review Consulting Experts (Measures), which came into force upon its release. Consisting of nine chapters, the Measures specifies the management requirements for consulting experts from six main aspects, including qualification and responsibility, right and obligation, selection and appointment, daily administration, training and assessment, as well as supervision and management.

Shanghai Municipal Administration for Market Regulation Penalizes Cosmetics Claiming Anti-aging

On August 8, 2022, Shanghai Minhang AMR released an administrative penalty, punishing a cosmetic company that claimed its essence had anti-aging efficacy in its Tmall flagship store. According to the explanation for the penalty given by the regulatory authority, it is not recommended for cosmetics to claim anti-aging, for the scope of this claim is too large. If the stakeholder wants to claim anti-aging for a product, it is required to conduct tests for all the efficacy evaluation items of cosmetics, and provide the evidence issued by the hospital to support the claim.

NMPA to Raise the Qualification Threshold for Cosmetics Testing Institutions

On August 11, 2022, China NMPA commenced a three-week public consultation on Accreditation Conditions on Cosmetics Testing Institutions (Accreditation Conditions). The implementation of CSAR boosts the demands for efficacy claim evaluation and cosmetics testing. According to NMPA, currently there are 339 cosmetics testing institutions, achieving an increase of nearly 80 institutions since the beginning of 2021. However, along with this expansion, cases of false and unqualified testing are reported continuously. Responding to it, NMPA released the Accreditation Conditions, which sets strict requirements that testing institutions shall fulfill, including organizational structure, management system, testing capabilities, personnel, instruments and equipment.

CSAR Subsidiary Regulations: China Drafts the First Regulation on the Supervision for Cosmetics' Online Operation

On August 17, 2022, China NMPA launched the public consultation on the first regulation specifically for the online operation of cosmetics, Supervision and Administration Measures on Online Operation of Cosmetics (Draft for Comments). The draft comprehensively and systematically stipulates the management requirements on cosmetics e-commerce platforms, cosmetics operators on the platforms, and supervision and administration departments. Any suggestions for this draft can be sent to NMPA no later than September 6, 2022.

China to Implement the Electronic Registration Certificate System for Cosmetics from October 1, 2022

On August 19, 2022, China NMPA issued an announcement stating that the electronic registration certificate system for cosmetics would be officially implemented from October 1, 2022. From then on, electronic registration certificates will be issued for special cosmetics and new cosmetic ingredients approved for registration, as well as special cosmetics approved for registration certificate change and renewal.

China General Administration of Customs (GACC): 10 Batches of Cosmetics Rejected in July

On August 20, 2022, GACC updated the list of rejected food and cosmetics in July. 10 batches of cosmetics respectively imported from Australia, South Korea and the United States failed customs inspection. The reasons for rejection were expired products, inconsistency between products and certificates, excessive bacterial counts, and lack of required qualified documentation.

China Provincial MPA Clarifies the Compliance Requirement for Cosmetics Applicable to Pregnant Women

On August 29, 2022, Tianjin MPA released one administrative penalty, in which one cosmetic company was fined for producing unregistered special cosmetics. The company claimed two batches of their products suitable for the pregnant women. However, these cosmetics were found to be unregistered. Tianjin MPA reiterated that cosmetics claiming suitable for pregnant women were classified as special cosmetics with "new efficacy", which shall be subject to registration before entering the market.

China NMPA Approves Six New Cosmetic Ingredients

In August, China NMPA updated the notification information of six new cosmetic ingredients (NCIs). The basic information of these new NCIs are as follows:

1) TMP Lauryl Dimethicone (CAS: 1961223-88-0), notified on August 2, 2022

2) Cyclohexylglycerin, notified on August 18, 2022

3) Polyurethane-34, notified on August 19, 2022

4) Polyurethane-48, notified on August 19, 2022

5) Acetylneuraminic Acid (CAS: 131-48-6), notified on August 19, 2022

6) Bakuchiol (CAS: 10309-37-2), notified on August 26, 2022

China Issues Six Cosmetics-related Standards in August

China issued six cosmetics-related standards in August, including one national standard, one industry standard, and four group standards. The basic information is as follows:

Release DateInitiatorStandard NameSource
August 15, 2022Flavors Fragrances and CosmeticsDetermination of Functional Component Astaxanthin in Cosmetics by High Performance Liquid ChromatographyNational Standard
Technical Guidelines for Skin TonicIndustry Standard
August 19, 2022Cosmetic Ingredients: Salicylic Acid
August 12, 2022Fujian Daily Chemicals AssociationMethod for Assessment of Cosmetic's Soothing Properties by in vitro Test Method for NO Content with Lipopolysaccharide-Induced Macrophage RAW 264.7Group Standard
August 24, 2022China Association of Fragrance Flavour and Cosmetic IndustriesTest Method for Efficacy Measurement of Nourishing Cosmetic Products
August 27, 2022Chronic Skin Disease Management and Health Promoting Branch of China Anti-aging Promoting AssociationSkin Aging Evaluation Standard

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Taiwan, China

Taiwan Introduces Supplements to Product Information File (PIF) Guidelines

On July 28, 2022, Taiwan Food and Drug Administration (TFDA) released the updated Guidelines on the Establishment of PIF (updated Guidelines). Compared to the previous version, the updated Guidelines newly includes six test methods for the preservative efficacy of cosmetics, six animal testing alternatives, and four PIF templates.

Taiwan Tightens the Labeling Requirements for Children Cosmetics

On August 17, 2022, TFDA implemented the revised Guidelines for Safety of Children Cosmetics (revised Guidelines). Compared to its predecessor, the revised Guidelines amends the labeling requirements and microbiological specification for children cosmetics.

South Korea

MFDS Data Shows the R&D of Sun Blocks and Hair Health Products Rose in H1

On August 2, 2022, the Ministry of Food and Drug Safety (MFDS) released a batch of statistical data on the cases of evaluated/reported functional cosmetics. In the first half of 2022, 9,447 cases of functional cosmetics were evaluated by or reported to MFDS, among which 8,783 cases were domestic cosmetics and 836 cases were imported ones. The new applications for sunblocks and hair health products increased by 17.6% and 10.8%, respectively, showing a sign of the market demand for sunblocks and hair health products.

South Korea Issues New Regulation on Risk Assessment of Human Applied Products

On August 29, 2022, MFDS released new Regulations on Risk Assessment of Human Applied Products, replacing the old version which included the cosmetics assessment methods. The new regulation is only applicable to the risk assessment of food, food additives, container, and packaging in Food Sanitation Act, livestock products in Enforcement Decree of The Livestock Products Sanitary Control Act, and agricultural and fishery products in Regulation on GM Agricultural and Fishery Products Labeling and Agricultural and Fishery Products Safety Assessment.

Interim measures are brought out as the new regulation excludes the risk assessments for cosmetics. For the cosmetic risk assessment, enterprises can refer to the old version of Regulations on Risk Assessment, etc. of Human Applied Products published on January 22, 2020, until new regulation for cosmetic risk assessment is established. 

Indonesia

Indonesia Implements the Amended Cosmetic Ingredient Use Requirements

On July 28, 2022, Indonesia released and implemented the finalized amendment to Technical Requirements for Cosmetics Ingredients. Business actors who already have a cosmetics notification number prior to July 28, 2022, must comply with the revised requirements before July 28, 2024.

Saudi Arabia

Saudi Arabia Drafts a Guideline for Reporting Cosmetic Undesirable Effects, Recalls and Manufacturing Errors

On August 2, 2022, the Saudi Food and Drug Authority opened a month-long public consultation on the draft of the Guideline for Reporting Cosmetic Undesirable Effects, Recalls and Manufacturing Errors. The draft sets out procedures for importers and manufacturers in Saudi Arabia to recall, report, etc. cosmetic products with undesirable effects or manufacturing errors.

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The European Union

EU RAPEX Receives 72 Alerts for Non-compliant Cosmetics in 2022 H1

From January to June 2022, the EU Rapid Exchange of Information System (RAPEX) received 72 alerts on measures taken against non-compliant cosmetics. These cosmetics were notified by 14 countries, among which Sweden, Ireland, Lithuania, Germany and France ranked the Top 5. For the notified cosmetics, the detection of prohibited ingredient (45%) is the primary non-compliance reason, followed by other reasons such as failing to meet the use condition (26%) and risk of being contaminated (20%).

The United States

California Tightens the VOC Limits in Cosmetics

On August 1, 2022, the California Air Resources Board approved the proposed amendments to the state's consumer products regulations, including the Regulation for Reducing Volatile Organic Compound (VOC) Emissions from Antiperspirants and Deodorants. This revision introduces tighter VOC limits for seven consumer product categories, namely, four categories of hair care products, as well as personal fragrance products, manual aerosol air fresheners, and aerosol bug insecticides.

Canada

Canada Amends Cosmetic Ingredient Use Requirements

On August 26, 2022, Canada released and implemented the updated Cosmetic Ingredient Hotlist, which newly included 2 restricted ingredients, as well as revised the name of 1 prohibited ingredient and the use requirements of 3 restricted ingredients.

Webinar Recommendation

Presented by Health Canada | Overview of the Canadian Regulatory Framework for Cosmetics

All cosmetics sold in Canada must be safe to use and must not pose any health risk. According to the Food and Drugs Act and the Cosmetic Regulations, cosmetic manufacturer and importer must provide a list of the product's ingredients, and notify Health Canada that they are selling the product. Failure to notify may result in the denied entry into Canada or removed from sale.

ChemLinked will team up with Health Canada to host a webinar on September 15 to explain the cosmetic regulatory framework, compliance requirements, ingredient use requirements, future regulatory plan, etc., and provide references and guidance for the industry. Welcome to register here and get the opportunity to engage with Health Canada.

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