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Monthly Recap: Asia-Pacific Cosmetic Regulatory Updates | June 2021

Chinese Mainland

1) Cosmetics Supervision

China Punishes a Cosmetic Quality and Safety Director

In May 2021, Guangdong Medical Products Administration (MPA) disclosed a punishment on a cosmetic quality and safety director as he deliberately provided false sales prices and false recall documents to MPA. Different from the past, the punishment fell on an individual apart from the company. This is the first time that China has publicly imposed penalties on the quality and safety director of cosmetics company after the implementation of China's new overarching regulation-Cosmetic Supervision and Administration Regulation (CSAR). (ChemLinked News)

China Finalizes Requirements for Cosmetic Labeling

On June 3, 2021, China National Medical Products Administration (NMPA) released the finalized Administrative Measures on Cosmetics Labeling. The Measures spells out the requirements for the labeling and prohibited claims of cosmetics (including cosmetics provided to consumers in the form of trial, gift, and exchange) under China's new cosmetic regulations. The Measures is scheduled to come into force on May 1, 2022. Starting from the implementation date, all cosmetics to be registered or notified shall comply with the Measures. For cosmetics that have been registered or notified before June 3, 2021, but not complied with the Measures, the registrants or notifiers shall update the labels by May 1, 2023. (ChemLinked News)

Four Batches of Cosmetics were Rejected in May 2021

On June 17, 2021, the China General Administration of Customs announced the new rejected food and cosmetics in May. Four batches of perfumes imported from Turkey failed customs inspection in May forunqualified notification certificates. (Reference Link)

China NMPA Passes the Notification of Imported General Cosmetics Exemption from Animal Testing

On June 18, 2021, China NMPA disclosed the notification information of the first imported general cosmetics exemption from animal testing, which means this product is allowed to goes on sale. It is also the first imported general cosmetics that the notification information has been disclosed since the launch of the new registration and notification system. The basic information of this product is as follows:

Product Name

Notification   Number

Notifier

Notification   Date

Kate Somerville Eradikate Sulfur Acne Treatment

国妆网备进字(沪)2021500076

Kate Somerville Skincare, LLC.

June 18, 2021

(Reference Link)

China Consults on Supervision and Administration Provisions on Children Cosmetics

On June 18, 2021, China NMPA released the draft of Supervision and Administration Provisions on Children Cosmetics for public consultation. Any suggestions can be mailed to huazhuangpinchu@163.com before July 31, 2021. The new Provisions covers all aspects of children cosmetics supervision, including the definition, formula design principles, safety assessment, labeling, production and operation, registration and notification, as well as sampling inspection. Compared with the current guidance for children cosmetics, the new Provisions is stricter and more systematic. (ChemLinked News)

China NMPA Reaffirms Matters Related to the Notification Management of General Cosmetics

On June 25, 2021, China NMPA issued an announcement, reiterating matters related to the general cosmetics notification management, mainly the following three points:

  • The notification of general cosmetics is deemed to be completed after the submission of required documents, which means the product can be sold on the market straight away;

  • All provincial MPAs should strictly follow CSAR and must disclose relevant notification information to the public within five working days;

  • During the post-notification surveillance, if the notifiers are found to submit false notification documents or documents that fail to  meet the requirements, or the notified cosmetics have violations of laws and regulations, they shall be severely punished in accordance with CSAR and other relevant regulations. (Reference Link)

China NMPA Announced the Second Batch of Key Research Projects

On June 28, 2021, China NMPA announced The Second Batch of Key Projects of China's Pharmaceutical Regulatory Scientific Action Plan, which involved two cosmetic projects, namely:

  • Research on new cosmetic ingredient (NCI) technical guidelines and research on cosmetic safety monitoring and analysis early warning methods, including: NCI quality standard system development plans and quality standards, technical guidelines and review guidelines for NCI-used  innovative technologies, online screening platforms for cosmetic risk substances, and cosmetic adverse reactions judgment standards;

  • Research on the safety and effectiveness evaluation of new biomaterials: a skin model based on Chinese human-derived cells and a whitening efficacy evaluation standard based on a melanin-containing skin model will be established. (Reference Link)

China NMPA Approves Two New Cosmetic Ingredients

On June 29, 2021, China NMPA approved two domestic NCIs. These are the first two NCIs for which the notification has been completed after the CSAR implementation. The basic information of the two NCIs is as follows:

Chinese Name

N-乙酰神经氨酸

月桂酰丙氨酸

INCI Name

Acetylneuraminic Acid

Lauroyl Alanine

CAS Number

131-48-6

52558-74-4

Use Purpose

Humectant

Cleansing agent

Applicable Scope

Body skincare

All kinds of cosmetics

Usage

2%

≤20%

Notifier

Wuhan Zhongke Optics Valley Green   Biotechnology Co.,Ltd.

Suzhou Weimei Biotechnology Co., Ltd.

Please refer to ChemLinked webinar for detailed interpretation of NCI notification requirements: Get Ready for China's New Cosmetic Ingredient Registration and Notification.

(Reference Link)

China NMPA Answers FAQs about Cosmetics Registration and Notification

On June 29, 2021, China NMPA issued an announcement, answering frequently asked questions about the cosmetics registration and notification, mainly related to the access to the new system account, the precautions for using the new system, and the precautions for the enterprise information management function and general cosmetics notification management function. (Reference Link)

2) National and Industry Standards

China Releases a National Standard Regarding the Determination of Plastic Microbeads in Cosmetics

On May 21, 2021, the Standardization Administration of China released GB/T 40146-2021 Determination of Plastic Microbead in Cosmetics, which will take effect on September 1, 2021. The standard stipulates the principles, reagents and materials, instruments and equipment, sample processing, spectrum testing, spectrum analysis and result report for the determination of plastic microbeads in cosmetics by fourier transform infrared spectroscopy and fourier transform microinfrared spectroscopy. The standard is applicable to the determination of plastic microbeads in cosmetics (except for makeup products). Other daily chemical products such as toothpaste, soap and laundry detergent can also refer to it. (ChemLinked News)

China Approves 11 National and Industry Standards Related to Cosmetics and Oral Care Products

On May 21, May 27, and May 31, 2021, China State Administration for Market Regulation, Standardization Administration, and Ministry of Industry and Information Technology issued three announcements, which approved 11 national standards and industry standards related to cosmetics and oral care products. And six cosmetic industry standards are scheduled to be formulated, as follows.

No.

Standard Number

Standard Name

The   Previous Standard Number

Implementation Date

1

GB/T 40146-2021

Determination of Plastic Microbead in Cosmetics

/

Sep. 1, 2021

2

GB/T 40145-2021

Determination of 11 glucocorticoids including desonide in cosmetics—Liquid chromatography-tandem mass   spectrometry

/

Dec. 1, 2021

3

GB/T 22114-2021

Humectants for toothpastes—Glycerin and polyethylene glycol

GB 22114-2008

Dec. 1, 2021

4

GB/T 40185-2021

Determination of 5 kinds of ammonium chloride antibacterial agents in toothpaste—High performance liquid chromatography method

/

Dec. 1, 2021

5

GB/T 40189-2021

Determination of metronidazole and norfloxacin in toothpaste—High performance liquid chromatography method

/

Dec. 1, 2021

6

GB/T 40190-2021

Determination of forbidden bleach in toothpaste—High performance liquid chromatography method

/

Dec. 1, 2021

7

QB/T 40191-2021

Determination of restricted preservatives in toothpaste—High performance liquid chromatography method

/

Dec. 1, 2021

8

QB/T 5594-2021

Determination of Tranexamic Acid in Cosmetics—High performance liquid chromatography method

/

Oct. 1, 2021

9

QB/T 5600-2021

Oral cleaning and nursing products—Determination of steviol glycosides in toothpaste—High performance liquid chromatography method

/

Oct. 1, 2021

10

QB/T 5601-2021

Oral cleaning and nursing products—Determination of antibacterial activity of lysozyme in toothpaste and oral cleaning and nursing solutions

/

Oct. 1, 2021

11

QB/T 5602-2021

Oral cleaning and nursing products—Determination of epigallocatechin gallate in toothpaste—High performance liquid chromatography method

/

Oct. 1, 2021

12

QBCPZT0949-2021

Cosmetics ingredient—dipotassium glycyrrhizinate

/

To be determined

13

QBCPZT0950-2021

Cosmetics ingredient—Methylparaben, ethylparaben, propyl hydroxybenzoate, ButylparabenButyl Hydroxybenzoate

/

To be determined

14

QBCPZT0951-2021

Cosmetics ingredient—Tetrahydromethylpyrimidine   carboxylic acid

/

To be determined

15

QBCPZT0952-2021

Cosmetics ingredient—Sclerotium gum

/

To be determined

16

QBCPZT0953-2021

Cosmetics ingredient—sodium lauroyl sarcosinate

/

To be determined

17

QBCPZT0954-2021

Oil-based foundation

/

To be determined

(Reference Link: SAMR & SA Notice; MIIT Notice I; MIIT Notice II)

China CAFFCI Approves Two Group Standards for Cosmetic Ingredients

On June 25, 2021, China Association of Fragrance, Flavour and Cosmetic Industries (CAFFCI) approved two group standards, which are T/CAFFCI 47-2021 Cosmetic Ingredients - Paeonia albiflora root extract and T/CAFFCI 48—2021 Cosmetic ingredients - Ginkgo biloba leaf extract. (Reference Link)

3) CBEC

Sichuan Regulates the Offline Display of Cross-border E-commerce (CBEC) Imported Goods

On June 8, 2021, the Sichuan Provincial Department of Commerce issued an announcement regulating offline display places for CBEC imported goods. The offline exhibition hall of CBEC imported goods needs to:

  • Set up a special experience area and prompt signs. CBEC imported goods shall not be sold on-site or mixed with goods imported through general trade;

  • Provide consumers with risk notifications in a prominent position in the experience area;

  • CBEC imported goods are allowed to be displayed without Chinese labels. (Reference Link)

China to Expand CBEC Comprehensive Pilot Zone

On June 22, 2021, the State Council executive meeting clarified that:

1) The support policies for CBEC development should be improved by expanding CBEC comprehensive pilot zones, optimizing the CBEC positive list, facilitating CBEC import and export returns and exchanges, etc.

2) Actively promote the development of overseas warehouses. Encourage traditional foreign trade companies, CBEC platforms, and logistics companies to participate in the construction of overseas warehouses. (Reference Link)

Taiwan, China

Taiwan Releases a New List of Prohibited Ingredients in Cosmetics

On June 17, 2020, Taiwan Food and Drug Administration (TFDA) released a new list of prohibited ingredients in cosmetics, which revised 41 ingredients and added 254 ingredients. The list has come into effect from July 1, 2021. It is prohibited to manufacture, import, sell, supply, or display cosmetics containing the ingredients in the list from that date. (ChemLinked News)

South Korea

South Korea Revises the Functional Cosmetics Evaluation Regulation

On June 3, 2021, the Ministry of Food and Drug Safety (MFDS) issued the draft of Functional Cosmetics Evaluation Regulation to solicit public opinion. Soon after, on June 30, the authority issued the revised version of the regulation. It adds ISO testing method as the permitted SPF testing method, specifies the requirements of raw materials’ origin and development process dossiers, and clarifies the label standards. The authority updated this regulation in an effort to guide the enterprises to develop more SPF products. (Reference Link)

South Korea Publishes New Guideline for Functional Cosmetic

On June 17, 2021, South Korea released the Guideline for Human Testing on Itchy Skin Cosmetics. This guideline is to help enterprises better understand the human testing of cosmetics with the function of helping restore the skin barrier to relieve the skin itching.

The document also specifies the efficacy valuation index, the scope of test subjects, test design, and test methods, etc. (Reference Link)

Japan

Japan Revises the List of Permitted Additives in Quasi-drugs

On June 28, 2021, the Ministry of Health, Labour and Welfare (MHLW) unveiled an amendment to the list of permitted additives in quasi-drugs. According to the amendment, MHLW corrected the problem that the ingredient name in the Japanese Standards of Quasi-drug Ingredients 2021 for “NO.1002” is not marked. (Reference link)

Japan Updates the FAQs about the Approval of Quasi-drugs

On June 28, 2021, Japan MHLW released the FAQs about the Approval for Quasi-drugs, which involved marketing/manufacturing approval of quasi-drugs, testing, cosmetic standards, etc. There are 75 questions in the FAQs, among which Q47, Q48, Q53, Q54, Q74, and Q75 were newly added questions. (Reference link)

Japan Expands the Approval Authority for Quasi-drug by Prefectural Governor

On June 28, 2021, the MHLW announced that liquid toothpaste (used for brushing teeth after spitting it out), as quasi-drug, could be submitted to the prefectural governor for approval. Besides, the announcement also indicated the active ingredients, concentration, and efficacy of the liquid toothpaste. (Reference link)

Japan Approves the Amendment to the Standards for Marketing Approval of Some Quasi-drugs

On June 28, 2021, Japan MHLW officially approved the amendments for three kinds of quasi-drugs: medicated oral-care products, hair coloring agents, and permanent wave agents. The changes came into effect on July 1st, 2021. (ChemLinked news)

Thailand

Thailand Updates the List of Restricted Cosmetic Ingredients and the List of Permitted Cosmetic Colorants

On June 21, 2021, Thailand Food and Drug Administration issued three notices to amend the cosmetic ingredient standards in Cosmetic Act B.E. 2015, which came into force on June 22, 2021. The key amendments include: 1) revising the use restrictions of two restricted Tagetes ingredients; 2) adding a new Tagetes ingredient and its labeling requirements; 3) releasing a new list of permitted colorants in cosmetics. (Reference Link)

Australia

Australia Releases the 2021-22 AICIS Registration and Application Fees

On June 30, 2021, Australia AICIS released a schedule of registration fees and charges for 2021-22. Compared with the previous 2020-21 schedule, there is a slight increase in the registration fee, but no increase in the registration charges for 2021-22. The new fees and charges have taken effect from 1 July 2021. (Reference Link)

*In Australia, the registration cost consists of a low flat fee that all industrial chemical importers and manufacturers pay, plus a charge that varies according to the value of industrial chemicals introduced in the previous financial year.

Australia Extends the Public Comment Period on the Evaluations of 17 Chemicals

In May 2021, Australia AICIS opened a public consultation on the evaluations of 17 chemicals until 25 June 2021. Among them, eight chemicals are personal care products. On June 23, 2021, AICIS extended the consultation period to 20 August 2021. (Reference Link)


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