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.
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.
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|
|For operators of cosmetics e-commerce platforms|
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.
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.
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.
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.
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.
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 firstname.lastname@example.org 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.
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 Date||Regulatory Authority||Batch|
|November 1, 2022||Shandong Center for Food and Drug Evaluation & Inspection||The 7th Batch|
|November 21, 2022||Guangzhou AMR||The 27th Batch|
|November 21, 2022||Guangzhou AMR||The 28th Batch|
|November 22, 2022||Beijing Municipal MPA||The 14th Batch|
China Issues Nine Cosmetics-related Standards in November
In November, China issued nine cosmetics-related standards. The basic information is as follows:
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.
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.
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.
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 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.
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.
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).
The European Union
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.
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:
Adding two restricted ingredients and two permitted UV filters;
Amending the use requirements for one restricted ingredient and one permitted UV filter.
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.
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The United States
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.
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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.
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 (email@example.com) to provide safety information or other considerations about the proposed ingredients, which may further inform Health Canada's decisions.
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.
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.
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.
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.
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.
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.