Monthly Recap: Global Cosmetic Regulatory Updates | July 2022

Three Regulations Have Been Implemented in July 2022

China NMPA Clarifies the Claims of Toothpaste

In view of the recent market chaos about the claims of toothpaste products, China National Medical Products Administration (NMPA) released a popular science article on July 5, 2022, pointing out that toothpaste is not a medicine, cannot treat diseases, and does not have the efficacy of "promoting teething of young children", "repairing teeth cavities", "closing the gap between teeth", "stabilizing loose teeth", "regenerating teeth", etc.

Shanghai Penalizes a Company for Using the Restricted Cosmetic Substance Beyond the Specified Use Scope

On July 5, 2022, Shanghai Municipal Administration for Market Regulation (AMR) imposed a penalty of “confiscation of illegal products and illegal gains of ¥1,146,600” on a cosmetics company for importing and selling two skin care products containing ingredient " tetrasodium etidronate". This is because the ingredient is a restricted substance in the Safety and Technical Standards for Cosmetics 2015 (STSC), which is allowed to be used in hair products and soaps only. The use of this substance in skin care products is a violation to STSC.

These two products were notified four years ago and have been sold so far. In this regard, industry experts reminded companies that the completion of notification does not necessarily mean product compliance. The regulatory departments may conduct technical review on notification dossiers after notification. Companies found to be non-compliant will face penalties. Enterprises should raise the bar on themselves and conduct notification in strict accordance with regulatory requirements.

China Provincial MPA Fines Two Notifiers for Failing to Upload Cosmetic Efficacy Evaluation Summary

On July 6, 2022, China Tianjin Medical Products Administration (MPA) released two administrative penalties. Two general cosmetic enterprises were warned and fined 10,000 yuan respectively for failing to upload the cosmetic efficacy evaluation summary to the general cosmetic notification information management system. This is the first batch of penalty cases for failing to upload evaluation summary after NMPA required enterprises to evaluate the cosmetic efficacy, which is quite a warning to the industry.

China NIFDC Consults on Three Testing Methods for 72 Cosmetic Ingredients, Including Fragrance Components and Prohibited Colorants

On July 8, 2022, China National Institutes for Food and Drug Control (NIFDC) launched a 24-day public consultation on three draft testing methods for 72 cosmetic ingredients, including 40 fragrance components, 24 prohibited colorants, and 8 hair perming agents. The draft testing methods are:

• Determination of Ethyl Acrylate and Other 39 Kinds of Components in Cosmetics

• Determination of CI 59040 and Other 23 Kinds of Components in Cosmetics

• Determination of Thioglycollic Acid and Other 7 Kinds of Components in Cosmetics

China's First Clean Beauty Standard Released

On July 10, 2022, the Guangdong Cosmetics Association released a new group standard, T/GDCA 011-2022 Cosmetics—General Principle of Clean Beauty, which will be implemented on August 8, 2022. This is the first standard specifically for clean beauty in China's cosmetics industry. It specifies clean beauty’s terms and definitions, basic principles, design, production, packaging, storage, use, recycling, and other requirements.

Shanghai Releases New Rules for Online Livestreaming Marketing Activities

On July 13, 2022, the Shanghai Municipal AMR issued the Compliance Guidelines for Online Livestreaming Marketing Activities in Shanghai, which is China's first provincial-level^* guideline to regulate online livestreaming. It elaborates on the responsibilities and obligations of livestreaming marketing platforms, operators of the platforms, operators of the livestreaming room, streamers, streamer service agencies and other market operators in online livestreaming marketing activities. The industry-related contents include:

• When advertising food, cosmetics and other goods or services, the advertisement shall not involve disease treatment functions, and shall not use medical terms or terms that may easily confuse the products or services with drugs, medical devices or medical services.

• Livestreaming marketing activities shall not arbitrarily claim "infants and young children only" and "children only" for differentiated publicity and high-priced sales.

^*Shanghai, as a municipality directly under the central government, is managed as a provincial-level administrative region

Provincial MPAs Cancel Hundreds of Thousands of Cosmetic Notifications

On July 13, Fujian MPA announced to cancel the notification of 898 products from 149 cosmetics companies whose business licenses have been cancelled. On July 26, 2022, Guangzhou AMR issued two notices to cancel the notification of about 300,000 domestic general cosmetics in the city that have not submitted their annual reports within the stipulated time or have been unconfirmed on the new notification platform. The cancelled product categories include creams, essences, masks, shampoos, etc.

According to the Cosmetic Supervision and Administration Regulation, if cosmetics are still on the market after being cancelled by the regulatory authorities, depending on the severity of the violations, the relevant responsible persons will be subject to fines, administrative penalties or even criminal penalties.

China NMPA Further Clarifies the Requirements for Cosmetic Labeling

On July 20, 2022, China NMPA issued an announcement, answering four FAQs about cosmetic labeling. The announcement clarifies that the responsible subjects of cosmetics are the registrant and the notifier. Contents that may lead consumers to misunderstand the cosmetic manufacturer and the responsible subject shall not be marked on the product label, such as "supervised by", "produced by", "brand licensor", etc., as well as other trademarks, except for the brand name in the product name.

Shanghai Pudong Finalizes Provisions to Encourage Cosmetics Innovative Development

On July 21, 2022, Shanghai Municipal People's Congress approved the finalized version of Several Provisions on the Innovative Development of Cosmetics Industry in Shanghai Pudong New Area (the Provisions), which is set to take effect on August 1, 2022. The Provisions encourages enterprises to accurately develop general cosmetics that meet the individual needs of consumers, allows notifiers in Shanghai to set up business premises to provide consumers with personalized services, optimizes the customs clearance for imported cosmetics, and provides ingredient supply and quality management services for enterprises in Pudong New Area, etc.

Shanghai to Implement Grading Management for Cosmetics Manufacturers

On July 22, 2022, Shanghai Municipal MPA issued the Measures for the Quality and Safety Risk Grading Management of Cosmetics Manufacturers in Shanghai (Trial), planning to try out a dynamic classified management system, which grades cosmetic manufacturers with four grades (A, B, C, and D), within its jurisdiction from September 1, 2022, to August 31, 2024. The quality and safety risk grading of cosmetic manufacturers will be assessed annually. Based on the grading results, Shanghai Municipal MPA will determine the key varieties, measures, random inspection ratio, frequency, etc., of supervision and inspection for cosmetic manufacturers.

China NMPA Issues a New Cosmetic Supplementary Testing Method

On July 28, 2022, China NMPA released a new cosmetics supplementary testing method, Determination of Five Components Including Mupirocin in Cosmetics, which specifies the determination method of mupirocin, fusidic acid, timolol, terbinafine and erythromycin in cosmetics. The method is applicable to the qualitative and quantitative determination of these five components in cream, lotion, and liquid (water) cosmetics.

China NMPA Approves Eight New Cosmetic Ingredients

In July 2022, China NMPA updated the notification information of eight new cosmetic ingredients (NCIs). The basic information of these new NCIs are as follows:

1. Amidinobenzyl Benzylsulfonyl D-Seryl Homophenylalaninamide Acetate (CAS No: 1393815-16-1), notified on July 5, 2022

2. Lard (CAS No: 61789-99-9), notified on July 6, 2022

3. Hydrolyzed Calcium Hyaluronate, notified on July 12, 2022

4. Chlorotrifluoropropene (CAS No: 102687-65-0), notified on July 18, 2022

5. Silicone Ouaternium-20 (CAS No: 280569-78-0), notified on July 20, 2022

6. Dimethicone/Bis-Isobutyl PPG-20 Crosspolymer (CAS No: 1043538-34-6), notified on July 28, 2022

7. Hydroxyethyl Imidazolidinone (CAS No: 3699-54-5), notified on July 28, 2022

8. Piperidinepropionic Acid (CAS No: 26371-07-3), notified on July 28, 2022

Multiple Regulatory Authorities Publish FAQs Regarding Cosmetic Regulations

In July 2022, multiple regulatory authorities including China NIFDC, Shandong Center for Food and Drug Evaluation & Inspection, and Guangzhou AMR issued four batches of FAQs, which pertain to notification dossiers, cosmetics labeling and packaging, entrust production, staffing requirements, etc.

Taiwan Food and Drug Administration Implements a New List of Prohibited Ingredients in Cosmetics

On July 1, 2022, the finalized version of the List of Prohibited Ingredients in Cosmetics officially took effect. Compared to the previous list, the updated list deletes two ingredients due to duplication and newly adds four ingredients. Cosmetics manufactured after the date should comply with the new requirements.

JCIA Releases a Voluntary Labeling Standard for Aerosol Products

On July 21, 2022, Japan Cosmetic Industry Association (JCIA) formulated a Voluntary Labeling Standard for Aerosol Products based on the Labeling Precautions for the Use of Cosmetics. The voluntary standard includes the definition, scope, product standards, and labeling requirements.

PMDA: 43 Batches of Cosmetics Recalled in July

In June 2022, Japan Pharmaceuticals and Medical Devices Agency (PMDA) announced that 43 batches of non-compliant cosmetics were recalled. Among them, 26 batches of cosmetics failed due to the lack of required licenses for cosmetics manufacturing and sales. 9 batches were recalled due to incomplete ingredient labeling. The remaining substandard cosmetics were rejected because of labeling and production errors.

South Korea Cracks Down on Illegal Online Cosmetic Advertisements

On July 6, 2022, the Ministry of Food and Drug Safety (MFDS) unveiled 108 cases of illegal online cosmetic advertisements. The improper advertisements include “cell regeneration”, “anti-inflammatory effects”, and other drug-like expressions.

ASEAN Introduces Amendments to the Ingredient Lists of ACD: 3 New Ingredients Included and 13 Ingredients Revised

The 35^th ASEAN Cosmetic Scientific Body (ACSB) meeting was held in May 2022. In the meeting, ASEAN adopted new changes to cosmetic ingredients in the Annexes of the ASEAN Cosmetic Directive (ACD):

1. Annex II: List of prohibited ingredients – 1 added and 1 revised

2. Annex III: List of restricted ingredients – 1 added and 10 revised

3. Annex VI: List of permitted preservatives – 1 added and 2 revised

Philippines FDA Consults on the Revised Accreditation Guidelines for Testing Laboratories of Health Products

On July 19, 2022, Philippines Food and Drug Administration (FDA) launched a one-month consultation on the draft Revised Rules of Procedures and Requirements for the Food and Drug Administration (FDA) Accreditation of Testing Laboratories Repealing FDA Order No. 2012-001 (the Revised Rules). Compared to the guideline currently in force, the Revised Rules:

• Further details the application procedures for applicable testing laboratories, and offers remote assessment as an available option when on-site assessment is not possible;

• Provides instances where the application for a Certificate of Accreditation (COA) may be denied, suspended or canceled;

• Defines the responsibilities of the accredited testing laboratory.

Any suggestions for this draft can be mailed to Philippines FDA (labaccreditation@fda.gov.ph) no later than August 18, 2022.

Philippines Drafts New Requirements on the PIF Audit for Cosmetic Products

On July 21, 2022, Philippines FDA commenced a public consultation on a preliminary draft entitled Updated Guidelines on Product Information File (PIF) for Cosmetic Products Repealing FDA Circular No. 2018-001 “Reiterating the Mandatory Implementation of Article 8 of the ASEAN Cosmetic Directive, Product Information” (the Updated Guidelines). Compared to the Circular No. 2018-001 currently in force, the Updated Guidelines adopts proper classification to present the previously included guidelines in a more clear and logical manner, providing important supplements to PIF Audit. All concerned stakeholders can submit comments to cchuhsrr-policy@fda.gov.ph no later than August 11, 2022.

Thailand Publishes a List of Claims Allowed in the Labels and Advertisements of Cannabis Cosmetics 

On May 20, 2022, the Thai Food and Drug Administration (Thai FDA) issued a guideline for claims on the labels and advertisements of cosmetics containing cannabis and hemp, aiming to encourage the innovation of the products added with these ingredients and facilitate business stakeholders. The guideline mainly applies to six cosmetics categories, such as facial/body care products, hair products and masks. For example, facial/body care products containing hemp seed oil or hemp seed extract can claim skin conditioning, emollient, moisturizing, etc.

Thailand Allows Renewal of Cosmetics Notification Receipts via E-Submission System

On June 22, 2022, the Thai FDA published a notification on the application for renewal of cosmetic notification receipts, providing notifying parties who wish to renew the notification receipt with three options to submit applications. They can, within 180 days before the expiry date, apply directly to the Thai FDA or the Provincial Health Office, or via the e-submission system. 

Thailand Updates the Cannabis and Hemp Regulations for Cosmetics

On June 9, 2022, the Thai FDA released the revised criteria and requirements for the registration of cannabis and hemp-based cosmetics as well as a checklist of required registration documents. On June 22, 2022, it issued the cannabis cosmetic certificate templates and a Q&A collection. According to these regulations, only four types of Thai domestic cannabis and hemp ingredients are allowed for use in cosmetics in Thailand. The four ingredients are:

• Hemp seed oil or hemp seed extract with a THC content no more than 0.2% w/w;

• The bark, stem, fiber, branch, root, and leaf (without flowers and inflorescence) of cannabis and hemp, as well as the hemp seed;

• Cannabidiol (CBD) extracts with a THC content no more than 0.2% w/w;

• Terpenes derived from cannabis or hemp.

Malaysia NPRA Adopts Six Changes to Cosmetic Ingredient Use Requirements

On July 6, 2022, Malaysia National Pharmaceutical Regulatory Agency (NPRA) released Circular No. 1/2022 Information on the Updated Status of Ingredients in Annex of the Guidelines for Control of Cosmetic Products in Malaysia. According to the Circular, six changes are made to cosmetic ingredient use requirements, including:

1. Adding one prohibited ingredient, one restricted ingredient, and one permitted preservative;

2. Amending the use requirements of two restricted ingredients and one permitted preservative.

Malaysia Amends Guidelines for Control of Cosmetic Products

On July 19, 2022, Malaysia NPRA released the updated Guidelines for Control of Cosmetic Products in Malaysia (the Guidelines). The Guidelines will replace the previous 2017 version and take effect on August 1, 2022. After the date, Cosmetic Notification Holder (CNH) shall comply with all provisions in the Guidelines. The main amendments are:

1. Adding product examples classified as cosmetics and not classified as cosmetics, requirements for product complaints, as well as three guidance for hand sanitizers, antibacterial hygiene products, and product reporting and recall;

2. Revising and clarifying requirements for cosmetic notification, GMP inspection, GMP certificate, as well as cosmetic naming, labeling, claiming, and advertising.

Vietnam Updates Cosmetic Ingredient Use Requirements

On July 26, 2022, Vietnam released Official Letter No. 7048/QLD-MP on Amending Cosmetic Ingredient Use Requirements. The amendments are based on the results of the 35th ASEAN Cosmetic Council Meeting (ACC) and the 35th ASEAN Cosmetic Scientific Body (ACSB). The main amendments are:

• Adding one prohibited ingredient, one restricted ingredient, and one permitted preservative;

• Amending the use requirements of two restricted ingredients and one permitted preservative.

Vietnam Strengthens Supervision on Cosmetics

On July 28, 2022, Vietnam issued Official Letter No. 7261/QLD-MP on Strengthening Cosmetics Management. Recently, the Drug Administration of Vietnam (DAV) found some portable cosmetics of unknown origin and without the receipt number issued by DAV were being sold on e-commerce websites and social platforms, and some manufacturers and operators had non-compliant activities. Therefore, DAV recommends provincial health departments:

• Strengthen the inspection of cosmetics manufacturers and operators, focusing on inspecting product recalls and the address of production & operation sites; and investigating and punishing counterfeit cosmetics, cosmetics without receipt number, cosmetics with illegal claims, etc.;

• Ensure that the traits and use purposes of the cosmetics issued with the receipt number do not exceed the cosmetic scope;

• Impose severe penalties on companies and individuals who violate cosmetic manufacture and operation regulations.

India Proposes the New Drugs, Medical Devices, and Cosmetics Bill 2022

On July 8, 2022, the Ministry of Health and Family Welfare (MoHFW) opened a 45-day public consultation on a draft of the new Drugs, Medical Devices, and Cosmetics Bill 2022, aiming to supersede the existing Drugs and Cosmetics Act of 1940 to keep pace with changing time, needs, and technology. The 2022 Bill updates the definition of “cosmetics”, adds the definition of “new cosmetics”, and amends the provisions pertaining to the prohibition of import of drugs and cosmetics in public interest, etc.

Australia Adds One Chemical into Australian Inventory of Industrial Chemicals

On July 28, 2022, the Australia Government published a notice to add the chemical Oils, Schinus Terebinthifolius (CAS No. 949495-68-5) to the Australian Inventory of Industrial Chemicals (AIIC). The chemical has been assessed:

1. as an essential oil of Schinus Terebinthifolius (Anacardiaceae) obtained from red berries by supercritical carbon dioxide extraction; and

2. as imported in fragrance formulations at less than or equal to 1 tone/annum in volume and at less than or equal to 1% in concentration, with reformulation and/or repackaging occurring in Australia; and

3. for an end use as a fragrance ingredient in:

● fine fragrances and air care products at concentrations of 1% or less,

● deodorants at concentrations of 0.3% or less,

● other consumer household and cosmetic products at concentrations of 0.2% or less.

Australia Reminds Introducers to Submit Annual Declarations

On July 28, 2022, the Australia Government issued a notice stating that importer or manufacturer who introduced the chemicals or products containing industrial chemicals during the 2021-22 registration year shall submit an annual declaration from August 1, 2022. The annual declaration shall cover the period September 1, 2021 to August 31, 2022. The due date to submit it is November 30, 2022. 

Australia’s Transitional Period for NICNAS Exemptions Expires on August 31, 2022

On July 28, 2022, the Australia Government announced that introducers of chemicals categorized as exempted during the 2021-22 registration year shall submit separate post-introduction declarations by November 30, 2022. This means that the transitional period for exemptions granted under the National Industrial Chemicals Notification and Assessment Scheme (NICNAS) will expire on August 31, 2022. After that date, enterprises cannot manufacture or import industrial chemicals under NICNAS exemptions.

EU Amends the Use Requirements for 2 UV Filters in Cosmetics Regulation

On July 7, 2022, in a published official journal, the EU updated the use requirements for two UV filters in Regulation (EC) No 1223/2009 (Cosmetics Regulation), Benzophenone-3 (CAS No. 131-57-7) and Octocrylene (CAS No. 6197-30-4). These two UV filters are currently allowed for use in cosmetic products, while it has been recently verified by the Scientific Committee for Consumer Safety (SCCS) that there is potential risk to human health arising from their use at the concentrations currently allowed. Therefore, the use requirements for Benzophenone-3 and Octocrylene are amended. The new amendments entered into force on July 28, 2022.

EU Lowers the Labelling Threshold for Formaldehyde Releasers in Cosmetics Regulation

On July 11, 2022, the EU announced to amend the labelling requirement for formaldehyde releasers in the preservatives list to the Cosmetics Regulation. The new amendment is made in accordance with the SCCS’s scientific advice on the present threshold, which entered into force on July 31, 2022. Subject to this amendment, the present labelling threshold of 0.05% (500 ppm) is reduced to 0.001% (10 ppm).