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Monthly Recap: Global Cosmetic Regulatory Updates | November 2022

China

China NIFDC: Advertising "Ingredient Submission Code Obtained" Suspected of False or Exaggerated Publicity

On October 27, 2022, China National Institutes for Food and Drug Control (NIFDC) released an announcement answering a question related to the generation of cosmetic ingredient submission code. It emphasizes that using terms such as "ingredient submission code obtained" to falsely claim that the ingredients have been approved or recognized by regulatory authorities is suspected of false or exaggerated publicity, and will be investigated and punished.

GACC Relaxes the Requirements for Exporting Cosmetics Containing Triethanolamine (TEA) to China

On October 28, 2022, the Department of General Operation of China General Administration of Customs (GACC) released an announcement to further clarify the requirements for exporting cosmetics containing Triethanolamine (TEA) to China. In accordance with the announcement, if TEA is added as a pH adjuster in cosmetics, and the product's testing report shows that TEA monomers are not detected, the enterprise is not required to provide the Import License for Dual-use Items and Technologies.

Beijing Municipal MPA Consults on Guidelines for Dealing with Minor Illegal Act

On November 2, 2022, Beijing Municipal Medical Products Administration (MPA) released the draft of Guidelines for Investigation and Punishment for Minor Illegal Act in Cosmetic Operation Supervision in Beijing (Trial) (the draft Guidelines) for public consultation. Applicable to small-sized enterprises, the draft Guidelines specifies eight types of minor illegal acts, and corresponding conditions for them to be exempted from punishment. The specified illegal acts of cosmetic operator include:

For cosmetics operators
  • Marketing deteriorated and/or expired cosmetics;

  • Marketing cosmetics whose labels do not conform to Cosmetic Supervision and Administration Regulation (CSAR);

  • Failing to store and transport cosmetics in accordance with CSAR;

  • Failing to establish and implement the purchase inspection and record   system in accordance with CSAR;

  • Marketing cosmetics whose labels have deficiencies, but these   deficiencies do not affect product's safety and quality, and do not mislead consumers;

  • Marketing cosmetics that do not meet mandatory national standards, technical specification, and/or the technical requirements stated in cosmetic   registration and notification dossiers;

  • Marketing unregistered special cosmetics or unnotified general cosmetics when operators are not sure about the cosmetic's registration and notification status through the purchase inspection.

For operators of cosmetics e-commerce platforms
  • Failing to fulfil the management obligations such as real-name registration, cessation and report of illegal acts, and cessation of providing e-commerce platform services, etc., in accordance with CSAR

China NMPA Pilots Cosmetics Personalized Services in Five Provinces and Cities

On November 10, NMPA issued an announcement deciding to carry out a one-year pilot project of cosmetic personalized service in Beijing, Shanghai, Zhejiang, Shandong and Guangdong. The pilot project aims to explore feasible models and effective regulatory measures for cosmetics personalized services, and to form replicable experiences and practices. NMPA will evaluate the effect, and determine whether to extend the pilot time, expand the pilot scope, and increase the variety of pilot products.

China Clarifies the Supervision of Cosmetics Containing Sodium Hyaluronate

On November 14, 2022, NMPA announced the Administrative Classifications of Medical Sodium Hyaluronate Products. As a common moisturizer, Sodium Hyaluronate is widely used in cosmetics. In accordance with the new classification rules, cosmetics containing Sodium Hyaluronate should not be administered as drugs or medical devices. Besides, such cosmetics shall not claim medical effects.

China NMPA Issues a New Cosmetics Supplementary Testing Method for 16alpha-hydroxyprednisolone

On November 23, 2022, NMPA released a new cosmetics supplementary testing method, BJH 202203 Determination of 16alpha-hydroxyprednisolone in Cosmetics, which specifies the qualitative and quantitative determination method of the prohibited ingredient 16alpha-hydroxyprednisolone. It is applicable for the determination of 16alpha-hydroxyprednisolone in cream, lotion, and liquid (water) cosmetics.

China to Establish 33 More CBEC Comprehensive Pilot Zone

On November 24, 2022, the State Council issued an official reply which approved the establishment of 33 new cross-border e-commerce (CBEC) comprehensive pilot zones. The provincial governments are responsible for rolling out the detailed plans. This is the 7th expansion since the establishment of the first pilot zone in Hangzhou in 2015. With this expansion, there will be a total of 165 CBEC comprehensive pilot zones in China.

GACC: Five Batches of Cosmetics Rejected in October

On November 24, 2022, GACC updated the list of rejected food and cosmetics in October. Five batches of cosmetics respectively imported from Japan, Germany and France failed customs inspection. The reasons for rejection were inconsistency between products and certificates, and lack of required qualified documentation.

China Consults on Guidelines for Collecting and Reporting Cosmetic Adverse Reaction

On November 25, 2022, China National Center for ADR Monitoring commenced a public consultation on the draft of Guidelines for Cosmetic Registrants and Notifiers to Collect and Report Cosmetic Adverse Reaction (Trial). All concerned stakeholders can submit comments to lilan@cdr-adr.org.cn before December 9, 2022.  

To standardize the collection and reporting of cosmetic adverse reaction, the draft sets detailed requirements for registrants and notifiers in each link of the monitoring, including information collection, recording, verification, submission, analysis, etc. In addition, the draft proposes that the person in charge of quality and safety shall assist the legal representative or the main responsible person in performing the management duties of cosmetic adverse reaction monitoring.

Provincial and Municipal MPAs Cancel the Notification of Non-compliant General Cosmetics

In this April, multiple provincial and municipal MPAs issued notices to extend the deadline for notifiers to submit the annual report to June 30, 2022. As this deadline has expired, in November, provincial MPAs of Jiangsu, Sichuan, Shandong, Liaoning, Fujian and Heilongjiang, as well as Municipal MPA of Chongqing announced to cancel the notification of general cosmetics lacking the required annual report. These cosmetics shall not be sold or imported from the date of cancellation.

China NMPA Approves Two New Cosmetic Ingredients

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

1) Cordyceps Cicadae Mycelium Extract, notified on November 4, 2022

2) Euphausia Superba Oil, notified on November 4, 2022

Multiple Regulatory Authorities Publish FAQs Regarding Cosmetic Regulations  

In November 2022, multiple regulatory authorities, such as Guangzhou Administration for Market Regulation (AMR) and Beijing Municipal MPA, issued four batches of FAQs concerning the requirements for notification dossiers, cosmetic labeling, sample retention, entrust production, etc.

Release DateRegulatory AuthorityBatch
November 1, 2022Shandong Center for Food and Drug Evaluation & InspectionThe 7th Batch
November 21, 2022Guangzhou AMRThe 27th Batch
November 21, 2022Guangzhou AMRThe 28th Batch
November 22, 2022Beijing Municipal MPAThe 14th Batch

China Issues Nine Cosmetics-related Standards in November

In November, China issued nine cosmetics-related standards. The basic information is as follows:

Release   DateInitiatorStandard Name Effective Date
November 4, 2022Jiangsu Health Food And Cosmetic Safety AssociationEvaluation Method for Nourishing Efficacy of CosmeticsDecember 4, 2022
November 4, 2022Evaluation Method for Firming Efficacy of CosmeticsDecember 4, 2022
November 9, 2022Guangdong Chamber of Daily Used ChemicalsFirming Lifting Efficacy Test of Cosmetics - In Vitro Test Method of Elastin Content with Fibroblast (Draft)/
November 9, 2022Soothing Efficacy Test of Cosmetics-In Vitro Test Method for the Inhibition of Nitric Oxide (NO) Released from Lipopolysaccharide-induced Macrophage (Draft)/
November 11, 2022Cosmetic Ingredients: Aillum Sativum Extract (Draft)/
November 8, 2022Zhejiang Health Products & Cosmetics Industry AssociationTest Method for Anti-dandruff Efficacy of CosmeticsDecember 31, 2022
November 24, 2022Test Method for Repairing Efficacy of Cosmetics - In Vitro Test Method for Human Fibroblast Migration AbilityFebruary 1, 2023
November 24, 2022Test Method for Firming Efficacy of Cosmetics - In Vitro Test Method for Human Fibroblast ActivityFebruary 1, 2023
November 24, 2022China Association for Small & Medium Commercial EnterprisesCosmetic Ingredients: β-Nicotinamide Mononucleotide (NMN)December 1, 2022

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Japan

PMDA: 62 Batches of Cosmetics and Quasi-drugs Recalled in November

In November 2022, Japan Pharmaceuticals and Medical Devices Agency (PMDA) announced that 62 batches of non-compliant cosmetics and quasi-drugs were recalled. The recalls were primarily related to labeling, including sale name, trademark, etc. In addition, 21 batches of cosmetics were rejected for using the ingredient that cannot be used in cosmetics applied to mucosa.

South Korea

South Korea Cracks Down on False Advertising Claiming Anti Hair Loss

On November 7, 2022, the Ministry of Food and Drug Safety (MFDS) disclosed 172 cases of shampoo advertisements violating the advertisement requirements. In the non-compliance cases, medicine-like advertising practices account for the most, with a proportion of 93.0%. The advertisements claiming general cosmetics as functional cosmetics and advertisements deceiving consumers took up 2.9% and 4.1%, respectively. The webpages where the advertisements published would be blocked, and business entities violating the regulations would face administrative penalties.

South Korea to Issue the Guideline on Reporting Functional Cosmetic

On November 21, 2022,Korean Cosmetic Association (KCA) unveiled a notice to solicit public opinion on the new Guideline on Submission of Reporting Functional Cosmetic. The Guideline drafts the report submission procedures and the instructions for filling in the report for different situations.

KCA Publishes the Guideline on Cosmetic Good Manufacturing Practice

On November 25, 2022, Korean Cosmetic Association (KCA) published the Guideline on Cosmetic Good Manufacturing Practice (CGMP). This Guideline is to help enterprises better understand the Regulations on Cosmetic Good Manufacturing and Quality Control Practices (Regulations). It explains the requirements for general provisions, human resources, manufacturing requirements, quality control, and inspection in the Regulations.

The Regulations, an example of CGMP standard, FAQs, and application method are included in the appendix of the Guideline.

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Indonesia

Indonesia Releases the Amended Regulation for Supervision on the Entry of Drugs and Food into the Territory of Indonesia and Regulation for Supervision on the Entry of Drugs and Food Ingredients into the Territory of Indonesia

On November 14, 2022, Indonesia BPOM released the amended Regulation for Supervision on the Entry of Drugs and Food into the Territory of Indonesia and Regulation for Supervision on the Entry of Drugs and Food Ingredients into the Territory of Indonesia. Imported cosmetic products and ingredients are required to obtain SKI Post Border prior to entering Indonesia. The two regulations stipulate the procedures and required documents for applying for SKI Post Border for drugs (including cosmetics), food and their ingredients.

Thailand

Thailand Revises the List of Permitted Sunscreens Used in Cosmetics

On November 11, 2022, Thailand's Ministry of Public Health announced the revision of the list of permitted sunscreens used in cosmetics, adding the permitted sunscreen agent Methoxypropylamino Cyclohexenylidene Ethoxyethylcyanoacetate and its labeling requirements. The revisions took effect on November 12, 2022.

Australia

Australia Adopts Rules for Chemical Introductions at Low Volumes

On November 25, 2022, Australia AICIS adopted and implemented the Industrial Chemicals (General) Amendment (Introductions of 10 kg or Less) Rules 2022, following the public consultation on the proposed changes for introductions of 10 kg or less in October 2022. To help stakeholders ensure their compliance, the authority also updated the corresponding guide for the categorization of chemical introduction (importation and manufacture).

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The European Union

EU SCCS Finalizes the Scientific Advice on Triclocarban and Triclosan

On November 4, 2002, EU SCCS released the final scientific advice on Triclocarban and Triclosan in cosmetics. Compared to the preliminary version released in this March, the final advice further clarifies the applicable consumers in different use conditions of these two ingredients, as well as additional concerns regarding their use in cosmetics.

EU to Adopt Six Changes to the Use Requirements for Cosmetic Ingredients

On November 11, 2022, EU released the Commission Regulation (EU) 2022/2195, introducing new amendments to the use requirements for cosmetic ingredients in Regulation (EC) No 1223/2009 (Cosmetics Regulation). All amendments aim at the lists of restricted ingredients and permitted UV filters, including:

  1. Adding two restricted ingredients and two permitted UV filters;

  2. Amending the use requirements for one restricted ingredient and one permitted UV filter.

EU to Ban 30 More CMR Substances in Cosmetics from December 2023

On November 17, 2022, EU notified WTO of a draft Commission Regulation which proposed to newly include 30 more CMR substances (those classified as carcinogenic, mutagenic or toxic for reproduction) into the prohibited ingredients list in Cosmetics Regulation. The draft is currently open for comments until January 16, 2023, and will officially take effect from December 1, 2023.

The United States

US Proposes to Increase the Fees for Color Additive Certification Services

On November 2, 2022, the US FDA opened a public consultation on the fee increase for color additives certification services, which will last until January 3, 2023. Once finalized, the fees for straight colors including lakes would be $0.45 per pound ($0.10 per pound increase) with a minimum fee of $288. There would be similar fee increase for repacks of certified color additives and color additive mixtures.

Canada

Canada Proposes to Require Cosmetics to Label Certain Toxic Substances

On October 29, 2022, Canada published the Canada Gazette, Part II, Volume 156, Number 44, including a Notice of Intent on the Labeling of Toxic Substances in Products. According to the notice of intent, Canada plans to require certain products (including cosmetics) to be labelled with the information on substances listed in the List of Toxic Substances (Schedule 1) of the Canadian Environmental Protection Act (CEPA). Stakeholders can mail any suggestions to Substances@ec.gc.ca before Jan. 12, 2023.

Canada Proposes to Amend Cosmetic Ingredient Use Requirements

On November 18, 2022, Health Canada released a notice concerning the review of the Cosmetic Ingredient Hotlist, considering to make several amendments to the Hotlist. Companies are welcome to contact Health Canada (cosmetics@hc-sc.gc.ca) to provide safety information or other considerations about the proposed ingredients, which may further inform Health Canada's decisions.

Canada Proposes to Amend the Manufacture and Import Requirements of Cosmetics Containing Glycine, N,N-bis(carboxymethyl)-, Trisodium Salt

On November 26, 2022, Canada published the Canada Gazette, Part I, Volume 156, Number 48, including a Notice of Intent to Amend the Domestic Substances List Under Subsection 87(3) of CEPA. According to the notice of intent, Canada plans to amend the manufacture and import requirements of cosmetics containing glycine, N,N-bis(carboxymethyl)-, trisodium salt (CAS No. 5064-31-3). An article will be published later explaining the main amendments.

Webinar Recommendation

1. Overview of Cosmetic Labeling and Claims Regulations in the EU, UK, US and Canada

Just as attractive labeling is one of the product's most important features when it comes to sales, so is correct labeling essential for the compliance of the cosmetic product with the cosmetics regulations around the world.

ChemLinked invited Mr Tadej and Ms Tjaša from CE.way to interpret the labeling regulations in the EU, UK, US and Canada, which must be followed if enterprises want to sell cosmetic products in these four regions. Welcome to register here.

1201.jpg2. Practical Experience of Customs Clearance for Food and Cosmetic Products to China

China is at the forefront of the world's food and cosmetics imports. However, products are subject to stringent supervision in China and must undergo a series of inspections for customs clearance.

ChemLinked will host a webinar on December 7 to introduce the regulatory requirements of food and cosmetic products, as well as customs clearance, including the steps, commonplace mistakes and tips to mitigate the potential risks.

1207-1.jpg3. Comparison between EU and China Cosmetic Regulatory Framework

China's brand-new regulatory system has similarities and differences with the EU's. For European companies or companies already marketing cosmetics in Europe, what differences should be considered before placing cosmetics on the Chinese market? 

ChemLinked will host a webinar on December 12 to detail the similarities and differences in basic regulatory information, pre-market requirements, post-market surveillance, company responsibility, etc. Welcome to register here.

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4. Panel Discussion: Deep Dive into the Global Cosmetic Sustainability Policies and Regulations

With the increasing global concerns over climate, environment, and energy issues, cosmetic sustainability has gained significant momentum throughout the world recently, leading to a boosting market volume. In response to the emerging and promising market, global governments have successively introduced regulations for cosmetic sustainability, such as microbeads ban, eco-label, packaging recycling, etc. 

ChemLinked invited experts from the Independent Beauty Association (IBA)Cosmed and REACH24H Korea to expound the latest regulatory requirements of sustainable cosmetics in the world's important beauty markets, as well as the sustainability-related practices and initiatives of some beauty giants, so as to provide references and suggestions for enterprises to enter the race.

1215.jpg5. Overview and Comparison of EU and US Cosmetic Regulations

When it comes to cosmetic product regulation, EU and the United States of America have very different standards. Yet, these two markets are very attractive and represent nearly 50% of the value of the global cosmetics industry.

To help companies interested in going to Europe or looking to expand to the US understand EU and US cosmetic regulatory framework, ChemLinked has teamed up with EcoMundo to host a webinar on December 19. The experts from EcoMundo will describe the regulations in place in these two different regulatory areas and will identify the similarities and differences between the two. They will also provide precious information and tips to help companies reach regulatory compliance in the targeted destinations.

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Further Reading

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