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Monthly Recap: Global Cosmetic Regulatory Updates | June 2022

Chinese Mainland

China NMPA Approves One New Cosmetic Ingredient

In June 2022, China National Medical Products Administration (NMPA) updated the notification information of one new cosmetic ingredient (NCI). The basic information of the new NCI is as follows:

INCI Name (Chinese Name)

Oligopeptide-215 (寡肽-215)

CAS Number

/

Character

White to pale yellow powder, with a slight characteristic odor

pH Value

4.0-6.5

Purpose of Use

Skin protectant

Applicable Scope

All kinds of cosmetics applicable for any skin

The Maximum Concentration

≤3.0%

Matters Needing Attention

Avoid using in combination with compounds containing aldehyde or ketone groups, strong acids, strong alkalis, or active enzymes.

Oligopeptide-215 is the 12th notified NCI in 2022 and the first notified new peptide compound in China. The industry believes that the development of Oligopeptide-215 is expected to replace the banned EGF as the new star ingredient in the field of skin repairing and firming due to its proven ability to tighten and repair the skin as well as promote collagen production.

12 National Standards Have Been Implemented since June 1

No.

National Standards

1

GB/T 40891-2021 Determination of lyral in cosmetics—Gas chromatography-mass spectrometry


2

GB/T 40950-2021 Determination of alkyl (C12~C22) trimethyl ammonium salt in cosmetics—High performance liquid chromatography tandem mass spectrometry

3

GB/T 40955-2021 Determination of octamethylcyclotetrasiloxane(D4) and decamethylcyclopentasiloxane(D5) in cosmetics—Gas chromatography


4

GB/T 40970-2021 Determination of ammonia in cosmetics—Titration method


5

GB/T 40895-2021 Determination of prohibited tetracaine and its salts in cosmetics—Ion chromatography


6

GB/T 40894-2021 Determination of prohibited substances thiamazole in cosmetics—High performance liquid chromatography


7

GB/T 40898-2021 Determination of prohibited bemegride and its salts in cosmetics—High performance liquid chromatography


8

GB/T 40897-2021 Determination of alkali sulfides and alkaline earth sulfides in cosmetics—Methylene blue spectrophotometric method


9

GB/T 40896-2021 Determination of diethylene glycol monoethyl ether in cosmetics—Gas chromatography mass spectrometry


10

GB/T 40900-2021 Determination of fluorescent brightener 367 and fluorescent brightener 393 in cosmetics—Liquid chromatography-tandem mass spectrometry


11

GB/T 40901-2021 Determination of eleven kinds of prohibited azoles antifungal agents in cosmetics—Liquid chromatography-tandem mass spectrometry


12

GB/T 40899-2021 Determination of prohibited bromisoval, carbromal and carisoprodol in cosmetics—High performance liquid chromatography


Shanghai Clarifies the Reviewing Tips for Children Cosmetics’ Advertisements

To help cosmetics manufacturers, operators, and advertising agencies, better grasp the compliance requirements for children cosmetics' advertising, Shanghai Municipal Administration for Market Regulation issued several tips for reviewing the advertisements for children cosmetics on June 1, 2022. The key points are:

  • The advertisements for children cosmetics shall not contain terms such as "gene technology", "nanotechnology", "freckle-removing and whitening", "anti-acne", "anti-dandruff", "anti-hair loss", "hair dyeing", "food grade", "edible", etc.;

  • Children cosmetics shall be labeled with the NMPA-designated children cosmetics logo on the display panel of the sales package. Please be noted that the logo only serves as an identification mark for children cosmetics rather than a quality certification mark.

China NIFDC Introduces Temporary Measures to Alleviate COVID-19’s Impact on Cosmetics Registration and Notification

To help cosmetic enterprises withstand the impact of COVID-19, China National Institutes for Food and Drug Control (NIFDC) introduced a series of temporary measures for cosmetics registration and notification on June 2, 2022.

  • Under the regulatory department’s incompleteness-tolerant policy, cosmetics registrant and notifier are allowed to submit the electronic copies or photocopies first when applying for registration and notification;

  • Extra eight months have been granted for the registrant and notifier who are unable to complete the documents supplementation and formula change to registered and notified cosmetics;

  • Digital Certificate Authority is applicable to be used as the seal on the electronic registration and notification dossiers.

China NIFDC Clarifies the Management Measures for the Previously Approved Imported Non-Special Use Cosmetics

On June 6, 2022, China NIFDC issued a notice, clarifying the registration and notification management of the previously imported non-special use cosmetics that had obtained administrative licenses through the original registration and filing platform. For the previously imported non-special cosmetics that have obtained administrative licenses, companies can either supplement required paper documents to NMPA or apply for re-notification on the new platform to continue supplying products.

Beijing Municipal MPA Answers Questions About Cosmetic Classification Code

On June 9, 2022, the Cosmetics Evaluation and Inspection Center under Beijing Municipal Medical Products Administration (MPA) released several FAQs pertaining to the cosmetics classification code in the Notification Application Form to help companies figure out some confusing concepts and thereby avoid notification failures.

Guangdong MPA Recommends Toothpaste be Labeled with Reference to Cosmetic Labeling Regulation

On June 11, 2022, Guangdong MPA stated in its response to public inquiries that the notification of toothpaste must comply with Administrative Measures on Toothpaste, which would be finalized later. Before the finalized Measures are implemented, toothpaste shall comply with the current regulations. But regarding labeling, toothpaste is recommended to be labeled with reference to Administrative Measures on Cosmetics Labeling.

Beijing MPA Issues a Notice on the Renewal of Special Cosmetic Registration Certificate during the COVID-19

On June 16, 2022, Beijing MPA issued a notice on the renewal of special cosmetic registration certificate during the COVID-19 rebound. If the registrant fails to submit the registration renewal application documents within the prescribed time limit due to the impact of COVID-19, the registrant or domestic responsible person shall submit “Force Majeure Statement for Registrant/Domestic Responsible Person Applying for Renewal” and supporting documents within ten working days after the impact of COVID-19 is eliminated in Beijing. After receiving the written opinion issued by Beijing MPA, the registration renewal application shall be submitted to NMPA. Before the renewal of the registration certificate is completed, the product shall not be produced or imported.

China GACC Modifies Declaration Requirements for Imported Cosmetics

On June 20, 2022, General Administration of Customs, P.R. China (GACC) released an announcement modifying the declaration requirements for some imported cosmetics. When the consignee of the imported cosmetics and their agents declare cosmetics whose HS code starts with 3303 and 3304, they should fill the product quantity in the customs declaration form according to the updated requirements. Cosmetics import tax rates are still effective in accordance with the previous requirements and have not been revised.

China GACC: One Batch of Cosmetics Rejected in May

On June 21, 2022, GACC updated the list of rejected food and cosmetics in May. One batch of cosmetics imported from France failed customs inspection. The reason for rejection was failing to pass sensory inspection.

Shanghai Pudong Drafts Provisions to Encourage Cosmetics Innovative Development

On June 22, 2022, the draft of Several Provisions on the Innovative Development of Cosmetics Industry in Shanghai Pudong New Area (Provisions) was deliberated on the 41st Session of the Standing Committee of the 15th Shanghai Municipal People's Congress. The Provisions has been made public and is soliciting public comments. Any suggestions can be sent to lqi256@163.com before July 8, 2022.

The Provisions proposes to encourage enterprises to accurately develop general cosmetics that meet the individual needs of consumers, allow notifiers in Shanghai to set up business premises to provide consumers with personalized services, optimize the customs clearance for imported cosmetics, and provide ingredient supply and quality management services for enterprises in Pudong New Area, etc.

China to Issue New Regulations for Cosmetic Sampling Testing

On June 24, 2022, the second draft of Measures for the Management of Cosmetic Sampling Testing (Measures) was released for public consultation. Any suggestions can be sent to hzpjgc@nmpa.gov.cn before July 14. The Measures spells out the requirements and procedures for sampling testing, and the corresponding obligations of all stakeholders. It highlights that the focus of sampling testing is children’s cosmetics, special cosmetics, and cosmetics containing new ingredients.

China to Implement the Finalized Good Manufacturing Practices for Cosmetics in July 2022

On July 1, 2022, China implemented the finalized Good Manufacturing Practices for Cosmetics. The Practices stipulates the qualification requirements and duties of the person in charge of quality and safety, ensures the products traceability from production to market, refines the requirements for sample retention, further clarifies the requirements for entrusted production, etc.

Starting from July 1, 2022, cosmetics registrants, notifiers, and entrusted production enterprises (including cosmetic enterprises that only engage in the preparation of semi-finished products, and toothpaste enterprises) shall organize the cosmetic production in accordance with the Practices.

化妆品合规BANNER 810 150  gif.gifChina Issues 17 Group Standards in June

China issued 17 group standards in June. Fifteen have come into effect, while two are still drafts.

Release Date

Release Department

Group Standard

Source

June 6, 2022

China Association for Small & Medium Commercial Enterprises

T/CASME **-2022 Cosmetic Ingredient β-Nicotinamide Mononucleotide (Draft)

Reference Link

June 13, 2022

Shanghai Association for Food & Cosmetics Quality Safety Management

T/SAFC 001-2022 Rotary eyebrow pencil

Reference Link

June 14, 2022

Beijing Daily Chemical Association

Guideline of Efficacy Evaluation for Chinese Botany Resource Cosmetics (Draft)

Reference Link

June 17, 2022

Suzhou Standardization Association

T/SZBX 077—2022 Hair shampoo

Reference Link

June 24, 2022

China Association of Fragrance Flavor and Cosmetic Industries

T/CAFFCI61-2022 Cosmetic ingredients-Isopentyldiol

Reference Link

T/CAFFCI62—2022 Cosmetic ingredients - Aminoethylphosphinic Acid

T/CAFFCI63—2022 Cosmetic ingredients - Raspberryketone Glucoside

T/CAFFCI64—2022 Cosmetic ingredients - Capryloyl Glycine

T/CAFFCI65—2022 Cosmetic ingredients - Capryloyl

June 28, 2022

T/CAFFCI 52-2022 Liquidambar formosana oil

Reference Link

T/CAFFCI 53-2022 Schisandra oil

T/CAFFCI 54-2022 Linalool compound spice

T/CAFFCI 55-2022 Tetrahydrogeraniol compound spice

T/CAFFCI 56-2022 Ionone compound spice

T/CAFFCI 57-2022 Citral compound spice

T/CAFFCI 58-2022 Methyldihydrojasmonate compound spice

T/CAFFCI 59-2022 Citronella compound spice

Hong Kong S.A.R.

Hong Kong Proposes to Ban CBD-containing Products

According to an industry media, Hong Kong Security Bureau submitted a document to the Hong Kong Legislative Council in June, proposing to classify CBD (cannabidiol) as a dangerous drug to prevent CBD-containing products from circulating in Hong Kong. If the document is passed, Hong Kong will ban the manufacture, import, export, supply, sale, possession and transshipment of CBD-containing products. The document also clarifies that the use of CBD will be exempted from the ban if permitted by other regulations, or with a license issued by the Department of Health. ChemLinked will publish a detailed article soon.

Taiwan, China

Taiwan Finalizes the Amendment to Safety Assessment Report Signer’s Qualification

On November 11, 2021, Taiwan Food and Drug Administration (TFDA) launched a public consultation on the amendment to the qualification of the safety assessment report’s signer. After a commenting period of 60 days, TFDA introduced the finalized amendment on June 16, 2022. It basically remains the same as the draft version, and only adopts minor changes in terms of wording and the order of the content. Subject to this finalized amendment, the qualification scope of the signer is expanded to two types of persons.

South Korea

South Korea Cosmetic Category Amendments Enter into Effect on June 19

The cosmetics category list is moved from the Attached Table 3 of the Enforcement Rule of Cosmetics Act to the Regulation of Labelling Cosmetics Precautions for Use and Fragrance Allergens. As the revised Regulation of Labelling Cosmetics Precautions for Use and Fragrance Allergens came into effect on June 19, 2022, the new cosmetics category became effective on the same day. ChemLinked suggests enterprises paying attention to the amendments to cosmetic precautions and product code for entry notice.

Japan

PMDA: 76 Batches of Cosmetics and Quasi-drugs Recalled in June

In June 2022, Japan Pharmaceuticals and Medical Devices Agency (PMDA) announced that 76 batches of non-compliant cosmetics and quasi-drugs were recalled. The recalls were primarily associated with non-compliant labeling, including inconsistent ingredient names, product names, or manufacturer information, or were not labeled in Japanese.

Indonesia

WTO Circulates Indonesian Decree on Materials Excluded From Halal Certification Obligation

On June 14, 2022, WTO circulated Indonesian Decree on Materials Excluded From Halal Certification Obligation. Materials included in the Decree do not require halal certification, which are:

  • Materials derived from nature, such as plants and mining materials, without any further processing step;

  • Without risk of containing haram substances;

  • Non-dangerous materials and without contacting with haram substances.

Philippines

The Philippines to Modify the Requirements for Licensing and Inspection of Health Products, Cosmetics Included

On May 27, 2022, the Philippines Food and Drug Administration released a draft of Updated Guidelines on the Unified Licensing Requirements and Procedures of the Food and Drug Administration Repealing Administrative Order No. 2020-0017 (the Updated Guidelines). Compared to its predecessor, AO No. 2020-0017, the Updated Guidelines further clarifies the qualification for the qualified person, supplements requirements for LTO application, and devises a more comprehensive plan to regulate inspection. The Updated Guidelines shall take effect 15 days after its publication in at least two nationwide circulated papers, and upon filing at the Office of the National Administrative Register (ONAR) at the UP Law Center, Diliman Quezon City.

Singapore

Singapore Updates Subsidiary Legislation under Health Products Act 2007

On June 1, 2022, Health Sciences Authority released the Health Products (Cosmetic Products — ASEAN Cosmetic Directive) (Amendment) Regulations 2022 and Health Products (Good Manufacturing Practice Certificate — Cosmetic Products) (Amendment) Regulations 2022, revising fees-related provisions in these two pieces of subsidiary legislation under the Health Products Act 2007. The amendment took effect on July 1, 2022.

Australia

Australia Releases the Poisons Standard June 2022

On June 1, 2022, the Therapeutic Goods Administration (TGA) issued the Poisons Standard June 2022 to supersede the Poisons Standard February 2022, principally incorporating a number of changes to existing entries, and a number of specified substances to the Poisons Standard for the first time. The Poisons Standard June 2022 commenced on June 1, 2022.

The United States

Colorado Bans PFAS in Cosmetics

On June 3, 2022, the Governor of Colorado signed HB 22-1345 into law, banning the intentional addition of perfluoroalkyl and polyfluoroalkyl substances (PFAS) in consumer products, such as cosmetics, food packaging, and upholstered furniture. The bill will take effect on January 1, 2024. A year of grace period is given to cosmetics to comply with the bill. After January 1, 2025, cosmetic products containing intentionally added PFAS chemicals shall not be sold, distributed, or used in Colorado.

Tanzania

Tanzania Publishes Draft Standard for Shea Butter for Cosmetic Use

On June 6, 2022, the Tanzania Bureau of Standards (TBS) released the draft standard DEAS967-1:2022 Butter for cosmetic use – Specification Part 1: Shea butter. The main contents include the scope of application, normative references, terms and definitions, usage requirements for raw and auxiliary materials, quality requirements, safety and hygiene standards, packaging and labeling regulations, sampling and testing methods, etc. The comment period for the draft standard is until July 6, 2022.

Webinar Recommendation

1. How to Comply with the Cosmetic Regulations in the Middle East

The Middle East has long been a relative patchwork of chemical substance regulations, from some countries implementing significant restrictions and requirements on the management of such items to others that appear to employ little-to-no regulation. The landscape for cosmetic products is similarly fragmented, although several countries in the region have taken significant steps to implement regulatory controls on these types of products within their borders. To help stakeholders to have a much stronger understanding of how cosmetic products are regulated in the Middle Eastern market, ChemLinked will team up with m4 Global Consulting LLC to host a webinar on July 14 to detail all these knowledge. Welcome to register here.

640-4261x-55.png2. Thailand Cosmetic Market: Beyond Regulatory – A Practical Guide to Sell Cosmetics in Thailand

Thailand is traditionally one of the main cosmetic markets in Asia, and its growth is estimated by 5.5% per annum until 2025. The faster-growing product segments are skincare (42%), hair products (15%), soaps and hygiene (14%), oral and dental care (12%), and makeup (12%). Direct to Consumer channel is booming with double-digit percentages, and the trend is expected to continue due to the convenience of direct-to-consumer delivery, that in Thailand is extremely efficient and well-organized.

Beyond all the forecast, this scenario opens a great opportunity for foreign manufacturers, that can access the consumer market bypassing the traditional distributorship and getting a higher margin by using the innovative License-holding system.

ChemLinked will team up with Siam Trade development to host a webinar on July 27 to give you market information with an updated analysis, a summary regulatory landscape, and a lot of practical hints on how to access the market directly, with no local footprints. Welcome to register here.

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