Monthly Recap: Global Cosmetic Regulatory Updates | April 2022

China NMPA Answers the Key Questions on Cosmetic Annual Report Submission and Dossiers Supplementation

On April 8, 2022, China National Medical Products Administration (NMPA) released a collection of FAQs, giving further interpretation on the submission of the annual report and supplementary documents of notified cosmetics to help cosmetic stakeholders better comply with the new regulatory requirements. The key points include:

China Drafts the Technical Guidelines for Children Cosmetics

On Apr. 11, 2022, China National Institutes for Food and Drug Control (NIFDC) released the draft of Technical Guidelines for Children Cosmetics ("the draft Guidelines") for public consultation. The draft Guidelines clarifies the specific requirements for safety assessment, products designed for the Chinese market, and children sunscreens. It also puts forward more stringent requirements for ingredient use, labeling, claims, etc.

Once implemented, the Guidelines will provide technical guidance for the registrant, notifier, and Chinese domestic responsible person when applying for registration and notification of children cosmetics. The Guidelines will also serve as the basis for the competent authorities' technical review of special children cosmetics and post-notification review of general children cosmetics.

Sichuan, Beijing Municipal, and Gansu MPAs Issues Notices on Matters Related to General Cosmetics’ Annual Report

Under China’s new cosmetic regulatory framework, notifiers shall submit the annual report of general cosmetics notified over one year through the new platform. The annual report's submission period lasts from January 1 to March 31 of each year.

On April 12 and 21, 2022, Sichuan, Beijing Municipal, and Gansu Medical Products Administration (MPA) respectively issued notices to extend the deadline for submitting the annual report. General cosmetics failed to submit the annual report before March 31, 2022 shall submit the annual report before June 30, 2022 according to the rectification opinion issued by the local municipal MPA. If the rectification is not completed as required within the time limit, the notification of the product will be automatically canceled.

The Provincial and Municipal MPAs Issued Notices on Matters Related to Notification Dossiers Supplementation and Product Label Update

In April 2022, multiple provincial and municipal MPAs issued notices on matters related to notification dossiers supplementation and product label update, as listed below:

China NIFDC Releases FAQs Regarding Cosmetic Review

On April 19, 2022, China National Institutes for Food and Drug Control (NIFDC) released 24 FAQs on cosmetic review, involving the acceptance process and technical review. In response to the corrective measures for cosmetic label’s defects that are concerned by the cosmetic industry, NIFDC gave the following suggestions: “If there are defects in cosmetic labels that do not affect quality and safety and will not mislead consumers, enterprises can reprint the label or correct the defects by pasting a new one and covering the old one.”

China General Administration of Customs (GACC): A Batch of Cosmetics Rejected in April

On April 21, 2022, GACC gave an update on rejected food and cosmetics in March. A batch of cosmetics imported from South Korea failed customs inspection. The reason for rejection was the detection of boric acid and borate components.

China SAMR Unveils the 2022 Legislation Scheme

On April 27, 2022, China State Administration for Market Regulation unveiled its 2022 legislation scheme. The scheme includes 69 regulations, among which one regulation is related to cosmetics, namely the Administrative Measures on Toothpaste.

NMPA Relaxes the Qualification Requirements for the Person in Charge of Cosmetic Quality and Safety

According to CSAR, cosmetics registrants, notifiers and entrusted production enterprises shall be equipped with a person in charge of quality and safety, who shall have professional knowledge related to the quality and safety of cosmetics and more than five years of work experience in cosmetic production or quality and safety management. 

On April 27, 2022, China NMPA relaxed the qualification requirements for the person in charge of cosmetic quality and safety in its reply letter to Jilin and Chongqing Municipal MPA’s request for relevant issues of the person. NMPA stated that since the principles of production as well as quality and safety management of health-related products such as drugs, medical devices, and special foods are basically the same as those of cosmetics production as well as quality and safety management, the person's experience in the production and quality management of drugs, medical devices, and special food can be regarded as the experience in the production and quality and safety management of cosmetics, under the premise of having professional knowledge related to cosmetics' quality and safety.

Shanghai Municipal and Guangdong MPAs Issues Temporary Measures for Local Cosmetics Registration and Notification Management During the COVID-19 Outbreak

On April 27, 2022, China NMPA issued a notice approving Shanghai Municipal MPA’s request for implementing the temporary measures for cosmetics registration and notification management during the COVID-19 outbreak. Specifically,

• For cosmetic registration and notification documents that cannot be affixed with seals by registrants or notifiers, and other originals of supporting documents that cannot be provided temporarily, the relevant photocopies or electronic documents can be accepted first, and the originals of relevant documents can be supplemented as required after this wave of COVID comeback ends.

• The time limit for supplementing cosmetic registration and notification documents and uploading the abstract of efficacy claim basis in Shanghai will be extended from May 1, 2022 to December 31, 2022.

On April 29, 2022, Guangdong MPA introduced a similar notice, allowing notifiers and domestic responsible persons affected by the pandemic to submit a written statement to their local medical products regulatory authorities to apply for a delay in submitting the abstract of efficacy claim basis and supplementing notification dossiers. Notably, the corresponding work shall be completed within three months after this wave of COVID comeback ends and no more than December 31, 2022 in principle.

NMPA Lays down the Special Rectification Work Plan on Cosmetics Safety

On April 28, 2022, China NMPA held a webinar on the supervision of cosmetics' online operation, reporting the progress of the special rectification work on cosmetics safety in the first quarter. The webinar also clarifies the focus of cosmetics safety special rectification work in the next stage, which includes the following three points:

1. Severely crack down on serious illegal activities such as the production of cosmetics without licenses, falsification of registration and notification dossiers, illegal addition of prohibited ingredients and substances that may endanger human health, etc.; strengthen the monitoring of cosmetic online operations; and improve the risk prevention, control, and coping ability of cosmetics.

2. Investigate and punish the entire chain of registrants, notifiers, entrusted production enterprises, and operators involved in illegal cosmetics business per the law.

3. Combine the special rectification campaign with daily supervision work.

China NMPA Approves Two New Cosmetic Ingredients

In late March and April, China NMPA updated the notification information of two new cosmetic ingredients (NCIs). The basic information about the new NCIs is as follows: 

China Issues Six Group Standards in April

China issued six group standards in April. The basic information is as follows:

CAFFCI, Beijing Municipal, and Guangzhou MPA Publish FAQs Regarding Cosmetics Notification and Registration Management

In April, CAFFCI, Beijing Municipal, and Guangzhou MPA issued five batches of frequently asked questions, which pertain to the cosmetics registration and notification management, ingredient requirements, sales, etc., under China's new cosmetic regulations.

Kuaishou Revises Three Platform Rules Concerning Efficacy Claims

On April 15, 2022, Kuaishou, China's second-largest short video sharing app, issued three notices revising the platform rules Personal Care and Cleaning Industry Promotion Specifications, Beauty Industry Promotion Specifications, and Specifications for the Release of Products in the Beauty/Personal Care and Cleaning Category to strengthen the content supervision of the beauty and personal care industry.

The three new rules mainly increase the regulatory requirements for medical claims, false advertising, claims beyond the allowed description scope, absolute terms, etc. It can be seen that the revision direction of Kuaishou’s new platform rules is basically consistent with the requirements of national policies such as the CSAR and the Administration Measures on Cosmetic Labeling. All three rules have come into effect on April 23, 2022.

Taiwan Revises the List of Prohibited Ingredients in Cosmetics

On April 27, 2022, the Taiwan Food and Drug Administration (TFDA) released the finalized List of Prohibited Ingredients in Cosmetics, which adds four ingredients and deletes two. The finalized list will take effect on July 1, 2022. Cosmetics manufactured after the date should comply with the new requirements.

Taiwan Releases Two Test Methods for Cosmetics

On April 21, 2022, TFDA released two test methods for cosmetics. The basic information is as follows:

PMDA: 72 Batches of Cosmetics were Recalled in April

In April 2022, Japan Pharmaceuticals and Medical Devices Agency (PMDA) announced the recall of two batches of non-compliant cosmetics. Among them, one batch was recalled due to the detection of "formaldehyde," an ingredient that is not allowed to be used in cosmetics. The rest batch of quasi-drugs and cosmetics were recalled due to labeling issues. 

South Korea Implements the Cosmetic Safety Standards: Specifying New Prohibited and Restricted Ingredients

On April 1, 2022, the Ministry of Food and Drug Safety (MFDS) unveiled the updated Regulation on Safety Standards, etc., for Cosmetics. Seven kinds of Perfluorinated Compounds and persistent pollutants are newly specified as prohibited ingredients. New restricted colorants in hair dye products and their use limits are added. The regulation also clarifies the exemption situations of using radioactive substances, THC and CBD, as well as a fluorescent whitening agent in cosmetic products.

South Korea Publishes Examples of Inappropriate Online Advertisements of Cosmetics, Food, Health Functional Food, and Quasi-drugs

On April 5, 2022, MFDS unveiled a collection of Examples of Inappropriate Online Advertisements of Cosmetics, Food, Health Functional Food, and Quasi-drugs for enterprises' reference. This collection concludes the improper advertisements on cosmetics and other goods sold online. The non-compliance reasons are outlined as well.

South Korea Updates the Guideline of Alternative Animal Testing Methods: Vitrigel-Eye Irritancy Test Method

On April 18, 2022, MFDS updated the Guideline of Alternative Animal Testing Methods for Cosmetics: Vitrigel-Eye Irritancy Test Method. The new version newly adds the test methods applicable for solid substances.

South Korea Modifies the Guideline of Alternative Animal Testing Methods: In Chemico Skin Sensitisation: Direct Peptide Reactivity Assay (DPRA)

On April 18, 2022, MFDS modified the Guideline of Alternative Animal Testing Methods of Skin Sensitizing for Cosmetics (In Chemico Direct Peptide Reactivity Assay, DPRA). A summary is newly inserted to the guideline.

South Korea Revises Cosmetics Precautions Regulation

On April 27, 2022, MFDS modifies the Regulation of Labelling Cosmetics Precautions for Use and Fragrance Allergens. The regulation newly adds the external genital cleaning product and its precautions for use. The Attached Table "Precautions for Use" is re-organized. The regulation will be effective on June 19, 2022. However, the amendments related to the external genital cleansing product will come into effect on December 19, 2022.

Indonesia Bans Palm Oil Exports

On April 22, 2022, Indonesia, the world's biggest palm oil producer, announced that it would stop exporting palm oil. On April 27, the ban was expanded to crude palm oil, RBD palm oil, and used cooking oil. The ban took effect on April 28 and will last until Indonesia's domestic cooking oil prices ease. As an important basic ingredient for cosmetics, palm oil derivatives include glycerin, medium and short-chain triglycerides, fatty alcohols, fatty acids, etc., which are widely used in cosmetics.

Australia Updates Guide on the Categorization of Chemicals at the Nanoscale

The Categorization Guide, first released in 2020 by the Australian Government, is a step-by-step instruction for introducers to categorize their chemical introduction as listed, exempted, reported, or assessed. On March 31, 2022, the Australian Government released Version 1.4 of the Categorization Guide, making changes to some steps to give more guidance for importers and manufacturers on the categorization of certain chemicals at the nanoscale.

Australia Updates the Guidance for Foreign Companies and Chemical Data Providers

A chemical data provider, also known as a chemical identity holder, is a person or business that submits information as part of another person's AICIS (Australian Industrial Chemicals Introduction Scheme) application or submission. For example, the chemical data provider can provide chemical identity details directly to the Australian Government but not to the applicant because the information is considered confidential or commercially sensitive.

On April 8, 2022, the Australian Government updated its guidance for foreign companies and chemical data providers. This update is to help foreign companies interested in selling their chemicals and products in Australia, and to assist businesses that supply information in AICIS applications or declarations but do not wish to disclose their trade secrets. The changes include information about applying for an assessment certificate as a foreign company, detailed instructions on how a foreign business can create an AICIS business ID and register their business on AICIS business services, etc.

Australia Consults on 27 Draft Evaluation Statements Covering 157 Industrial Chemicals

On April 22, 2022, the Australian Government published a notice to seek public comments on 27 draft evaluation statements, covering 157 industrial chemicals that are identified as having the potential to pose a risk to human health and/or the environment, and are unlikely to require further regulation in Australia to manage human health risks. The consultation will end on June 17, 2022.

Australia Introduces New Guidance on the Acceptance of INCI Names in Pre-Introduction Reports

On April 29, 2022, the Australian Government introduced a new INCI guidance for the introduction that is in the reported category and needs to submit a pre-introduction report (PIR). The INCI guidance allows enterprises to provide an INCI name instead of a CAS or IUPAC name as their chemical’s proper name in the PIR, provided all the following four criteria are met:

1. The chemical does not have a CAS or IUPAC name.
   

2. The chemical is a plant extract.

3. The name for the plant extract is an INCI name based on a proper botanical name.

4. The plant extract cannot be chemically modified.

TGA Issues FAQs on the Therapeutic Goods Advertising Code

The Therapeutic Goods Advertising Code is the cornerstone of the therapeutic goods advertising regulatory framework, setting minimum requirements for advertising therapeutic goods to the public. The new 2021 Advertising Code has taken effect on January 1, 2022, and will be subject to a 6-month transition period until June 30, 2022. During the transition period, both the 2018 and 2021 Advertising Codes will apply.

In response to a number of questions about the Code interpretation, the Therapeutic Goods Administration (TGA) created an FAQs page on April 27, 2022, to complement the Guidance on Applying the Advertising Code Rules. The FAQs cover testimonials and endorsements, mandatory statements, health warnings, short-form advertisements, restrictive representations, social media advertising, etc.

TGA: Multiple Sunscreens Were Recalled due to Detection of Benzene

On April 28, 2022, the TGA announced that several sunscreen products, which are regulated as medicines in Australia, are being recalled due to the presence of benzene. Benzene is not an ingredient in sunscreens but can be a contaminant in raw materials used in the manufacturing process. It can cause cancer in humans, depending on the level and length of exposure. Benzene levels in sunscreens sold in Australia shall be below two parts per million (ppm).

EU to Revise the Ingredient Lists in Cosmetics Regulation: 2 Newly Restricted Ingredients and 2 Newly Permitted UV Filters

On April 12, 2022, the EU introduced new amendments to cosmetic ingredients in Regulation (EC) No 1223/2009 in a draft Commission Regulation notified to the WTO. The draft regulation is made based on the latest scientific opinions from the Scientific Committee on Consumer Safety, and is open for comment until June 11, 2022. The amendments include:

1. Adding 2 restricted ingredients;

2. Adding 2 permitted UV filters;

3. Revising the use requirements for 1 UV filter.

UK to Revise the Ingredient Lists in Cosmetic Regulations

On April 13, 2022, the United Kingdom notified a draft regulation to the WTO, intending to amend the Annexes of the retained EU legislation Regulation (EC) No 1223/2009 to prohibit and restrict the use of some cosmetic ingredients. The amendments include:

• Banning the use of the skin whitening agent deoxyarbutin and over 30 CMRs;

• Deleting 2 restricted ingredients and amending 2 restricted ingredients;

• Deleting 1 permitted preservative and amending 1 permitted preservative.