To reinforce cosmetic safety surveillance, China’s National Institutes for Food and Drug Control (NIFDC) announced on September 2, 2022, to solicit public comments on the formulation and revision suggestions of the Safety and Technical Standards for Cosmetics until September 15, 2022.
On September 6, 2022, the Endangered Species Import and Export Management Office of China and the General Administration of Customs of China jointly issued a new version of the Commodity Catalog of Import and Export Wild Fauna and Flora to supersede the 2018 Commodity Catalog of Import and Export Wild Fauna and Flora.
The new Catalog, which was implemented on September 15, 2022, further clarified the regulatory scope of the international trade of endangered species and removed the regulatory requirements for many species previously exempted from CITES Appendices and some species included in the List of National Key Protected Wild Animals or the List of National Key Protected Wild Plants.
On September 7, 2022, Guangdong Provincial Medical Products Administration (MPA) published a popular science article, clarifying that "exosome cosmetics" were suspected of false and exaggerated claims.
The scientific community has not widely recognized the application effect of exosomes in the medical field. Related application trials are still in the clinical research stage. In addition, exosome-related ingredients neither are included in NMPA’s the Inventory of Existing Cosmetic Ingredients in China 2021 (IECIC 2021), nor have passed the registration or notification of new cosmetic ingredients.
Products claiming “exosome cosmetics” are suspected of misleading and deceiving consumers, falsely exaggerating claims, as well as expressing or implying medical effects. The regulatory authorities will investigate such products and punish the stakeholders soon.
On September 8, 2022, China's State Council released a notice announcing further to strengthen the governance of excessive packages for commodities. The Notice puts forward the objectives to generally build a whole-chain governance system for restricting excessive packaging of commodities, advance legislation system, improve governance capacity, and curb the excessive packaging for key targeted commodities like cosmetics, tea and mooncake. The objectives will last until the end of 2025. To achieve them, the Notice proposes 11 measures in three aspects and designates responsible authorities for each measure.
On September 13, 2022, China NMPA released a new cosmetics supplementary testing method, BJH 202202 Determination of Eight Components Including Elubiol in Cosmetics, which specifies the determination method of eight prohibited ingredients.
On September 19, 2022, Shanghai Advertising Association issued a notice clarifying the review tips for toothpaste product advertisements. The main contents include that 1) toothpaste advertisements should be true and legal, and should not claim to have medical effects; 2) toothpaste advertisements claiming special efficacy should be supported by efficacy evaluation reports; 3) non-toothpaste products may not be misleadingly advertised as toothpaste.
On September 20, 2022, GACC updated the list of rejected food and cosmetics in August. Six batches of cosmetics imported from Japan, Thailand and Germany failed customs inspection. The reasons for rejection were inconsistency between products and certificates, excessive bacterial counts, and not being approved for inspection and quarantine.
The finalized Measures for the Management of Cosmetic Adverse Reaction Monitoring took effect on October 1, 2022. It provides systematic requirements for cosmetic adverse reaction monitoring in China.
On October 1, 2022, China NMPA launched the upgraded new version of the National Cosmetic Adverse Reaction Monitoring System as well. Where cosmetic registrants, notifiers, entrusted production enterprises, operators, or medical institutions find or learn any cosmetic adverse reaction, they shall submit a report through the system.
On August 19, 2022, China NMPA announced that the electronic registration certificate system for cosmetics would be officially implemented from October 1, 2022. Starting from the date, electronic registration certificates are issued for special cosmetics and new cosmetic ingredients approved for registration, as well as special cosmetics approved for registration certificate change and renewal.
In September 2022, China NMPA updated the notification information of six new cosmetic ingredients (NCIs). The basic information about these new NCIs is as follows:
1) Polylactic Acid (CAS No: 9051-89-2), notified on September 5, 2022
2) Saccharomyces / Pearl Ferment Lysate Filtrate, notified on September 13, 2022
3) Acetobacter / Lactobacillus / Saccharomyces / Camellia Sinensis Leaf Extract / Sucrose Fermet Filtrate, notified on September 13, 2022
4) Silicone Quaternium-26 (CAS No: 1551351-87-1), notified on September 15, 2022
5) Palmitoyl Dipeptide-18 (CAS No.: 1206591-87-8), notified on September 15, 2022
6) Bis-diisopropanolamine-PG-Propyl Dimethicone/Bis-Isobutyl PEG-14 Copolymer (CAS No.: 1253692-80-6), notified on September 20, 2022
China National Institutes for Food and Drug Control, Hainan Medical Products Administration (MPA) and Beijing MPA Publish Frequently Asked Questions Regarding Cosmetics Registration and Notification
In September, China National Institutes for Food and Drug Control (NIFDC), Hainan Provincial MPA and Beijing Municipal MPA issued three batches of frequently asked questions, which pertain to the general cosmetics notification, cosmetic labeling, and ingredient submission code.
September 26, 2022
September 28, 2022
September 29, 2022
China Issues Seventeen Group Standards in September
China issued seventeen group standards in September. The basic information is as follows:
Implementation Date / Deadline for Comments
September 15, 2022
Beijing Daily Chemical Association
September 30, 2022
September 16, 2022
Guangdong Cosmetics Association
October 1, 2022
To be effective
September 28, 2022
Shanghai Society of Toxicology
October 15, 2022
T/SHSOT004.2-2022 Guidelines for the Optimization of Standard Methods for In Vitro Toxicity Testing - Part 2 Test Methods for In Vitro Reconstructed Human Epidermis Model for Skin Irritation Testing Optimization
September 7, 2022
China Association of Fragrance Flavour and Cosmetic Industries
October 10, 2022
September 14, 2022
Shanghai Society of Toxicology
October 15, 2022
September 15, 2022
Guangdong Daily Chemical Chamber of Commerce
October 14, 2022
On September 5, 2022, the Ministry of Food and Drug Safety (MFDS) published a notice to solicit public opinions on the modifications of Regulation on Safety Standards, etc., for Cosmetics. Five hair dye ingredients are to be designated as prohibited as they are possibly genotoxic according to the authority's regular inspection results. Stakeholders can send suggestions to the authority prior to September 26, 2022.
In Japan, the determination of the UVA-prevention efficacy of cosmetics can be referred to as "ISO 24442: 2011 Cosmetics - Sun protection test methods - In vivo determination of sunscreen UVA protection", which was first published by the International Organization for Standardization (ISO) and adopted by the Japan Cosmetic Industry Association (JCIA) as a voluntary standard for sunscreen cosmetics.
As ISO released an updated version in June 2022, JCIA made corresponding updates to its voluntary standard on September 1, 2022. Compared with the 2011 version, the major revisions of ISO 24442: 2022 include the definition of minimal persistent pigment darkening dose (MPPDD), sampling, and judgment criteria.
In September 2022, Japan Pharmaceuticals and Medical Devices Agency (PMDA) announced that 55 batches of non-compliant cosmetics and quasi-drugs were recalled in September. 20 batches were recalled for swelled container. The remaining 35 batches were rejected because of the wrong labels of the ingredient or product name.
From September 5 to 20, 2022, the Thai Food and Drug Administration conducted a public consultation on the following five draft notifications:
2. Notification of the Ministry of Public Health Re: Preservatives that May be Used as Ingredients in Cosmetics
3. Notification of the Cosmetics Committee Re: Warnings on the Labels of Cosmetics Containing Preservatives
5. Notification of Ministry of Public Health to Determine Criteria and Guideline for Cosmetics Refilling at Refill Station.
It is worth noting that the latter two were also notified to the WTO on September 19, 2022, and members' comments will be accepted for 60 days after the notification date.
On September 2, 2022, Indonesia BPOM released the draft Regulation Concerning the Control of Perfume Refill for public consultation. This regulation stipulates the requirements for perfume refill, including factory design, manufacturing facility, ingredients, packaging materials, environmental sanitation, storage conditions, document, labeling, supervision and inspection, as well as non-compliance penalties.
On August 23 and 24, 2022, the Malaysia Good Manufacturing Practice (GMP) Section, Centre of Compliance and Quality Control (PKKK), National Pharmaceutical Regulatory Agency (NPRA) organized the Cosmetic GMP Training 2022 for local cosmetic manufacturers. During the training, participants asked 170 questions. On September 15, Malaysia NPRA released a compilation and summary of the answers to the 170 questions.
On September 19, 2022, AICIS issued a notice, adding more details to its “specific information requirement” webpage. The added information includes but is not limited to:
an example of a “specific information requirement” introducers may see on an inventory listing;
various scenarios to help introducers understand how specific information requirements work and how introducers meet their obligations, if required;
On September 26, 2022, AICIS opened a public consultation on proposed rules changes for chemical introductions of 10 kg or less until October 11, 2022. The proposal aims to provide more risk proportionate requirements for certain lower risk chemicals introductions at volumes of 10 kg or less in a registration year.
The European Union
On September 5, 2022, the EU released a draft regulation which amended Annex XVII to Regulation (EC) No 1907/2006 Concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). This draft aims at imposing tighter restrictions upon products containing intentionally-added microplastics. For cosmetics subject to this draft, transitional periods ranging from 4-12 years are proposed.
Early this year, the EU launched a public consultation on the draft Commission Regulation concerning the use of CMR substances (substances classified as carcinogenic, mutagenic or toxic for reproduction) in cosmetics. On September 16, 2022, the EU introduced the finalized version of this Regulation. According to it, the adopted amendments will apply to all Member States from December 17, 2022.
On September 15, 2022, the EU introduced 56 newly identified fragrance allergens in cosmetics in a draft Commission Regulation notified to the WTO. Subject to the individual labelling requirement, these newly identified fragrance allergens shall be indicated in the list of ingredients when their concentration exceeds 0.001% in leave-on products or 0.01% in rinse-off products. The draft is open for comment until November 14, 2022.
On September 27, 2022, EU Scientific Committee on Consumer Safety (SCCS) released the final opinion on Genistein and Daidzein. According to the safety assessment based on available relevant data, and in consideration of the potential endocrine disrupting properties of phytoestrogens, the SCCS is of the opinion that:
a. the maximum use of Genistein in cosmetic products of 0.007% is safe;
b. the maximum use of Daidzein in cosmetic products of 0.02% is safe.
The United Kingdom
The official consolidated version of the UK Cosmetics Regulation (UKCR) has been published on legislation.gov.uk. The consolidated version takes into account the changes needed for the application of the EU Cosmetic Products Regulation to the Great Britain market.
On September 5, 2022, the Office for Product Safety and Standards (OPSS), the UK competent authority for cosmetic products, sent registered users a function update notice of Submit Cosmetic Products Notifications (SCPN) portal.
The function to upload a PDF file containing ingredients will be replaced with an “input ingredient information page”. This will allow users to enter ingredients individually in exact or range concentrations using a new functionality which draws from the EU Glossary of Cosmetic Ingredients. The update was implemented on October 3, 2022.
Following the departure of the UK from the EU Single Market in December 2020, the UK Cosmetics Regulation entered into force with a two-year transitional provision allowing companies to implement necessary changes, namely, labelling compliance for cosmetics. The two-year grace period was due to expire on December 31, 2022.
OPSS has reviewed the labeling requirement with the UK RP and has decided to extend this transitional provision for five years, until December 31, 2025. Until this date, the name and address of the responsible person and the country of origin requirements are satisfied where there is compliance with the requirements of Article 19(1)(a) of the EU Cosmetic Products Regulation (EU CPR).
On September 19, 2022, Brazil issued Resolution 752, which stipulates the definition, classification, technical requirements for labeling and packaging, parameters for microbiological control, as well as technical requirements and procedures for the regularization of personal hygiene products, cosmetics and perfumes. The Resolution came into force on October 3, 2022.
Turkey is the bridge between Asia and Europe where there is a high demand for cosmetics. Despite COVID-19, Turkey's cosmetic market grows 10% each year. Turkey has a special cosmetic supervision system, that is, a declaration system for cosmetic products based on manufacturer's statements. The definition of "manufacturer" in Turkey is different from people’s general understanding, whose scope also includes "importer". However, still, the Turkish cosmetic industry has particular procedures for certification requirements.
ChemLinked invited Ms. Burcu Seven, an attorney from CETİNKAYA, to host a webinar on October 20 to explain Turkey's cosmetic regulations. She will give an overview of cosmetic requirements in Turkey. Welcome to register here.