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Monthly Recap: Global Cosmetic Regulatory Updates | September 2022

China

China Conducts Another Round of Public Consultation on Safety and Technical Standards for Cosmetics

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.

China Releases the 2022 Commodity Catalog of Import and Export Wild Fauna and Flora

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.

Guangdong Provincial Medical Products Administration Clarifies that “Exosome Cosmetics” Are False and Exaggerated Claims

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.

China to Further Strengthen the Governance of Excessive Packaging for Commodities

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.

China NMPA Issues a New Cosmetics Supplementary Testing Method, Eight Prohibited Antifungal Agents Involved

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.

Shanghai Advertising Association Clarifies the Reviewing Tips for Toothpaste Products Advertisements

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.

China General Administration of Customs (GACC): Six Batches of Cosmetics Rejected in August

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.

China NMPA Implements Adverse Reaction Monitoring Regulation and Launches Monitoring System on October 1

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.

China Implements the Electronic Registration Certificate System for Cosmetics from October 1, 2022

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.

China NMPA Approves Six New Cosmetic Ingredients

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.

Release Date

Regulatory Authority

Batch

September 26, 2022

Hainan MPA

The 1st Batch

September 28, 2022

NIFDC

The 3rd Batch

September 29, 2022

Beijing MPA

The 12th Batch

China Issues Seventeen Group Standards in September

China issued seventeen group standards in September. The basic information is as follows:

Type

Release   Date

Initiator

Group Standard

Implementation   Date / Deadline for Comments

Effective

September 15, 2022

Beijing Daily Chemical Association

Guidelines for Efficacy Evaluation of Cosmetics Containing Plant Resources with Chinese   Characteristics

September 30, 2022

September 16, 2022

Guangdong Cosmetics Association

T/GDCA 012-2022 Evaluation Method of Fragrance Retention for Hair Products

October 1, 2022

To be effective

September 28, 2022

Shanghai Society of Toxicology

T/SHSOT003-2022 Cosmetic Sensory Analysis - General Guidance

October 15, 2022

T/SHSOT004.1-2022 Guidelines for the Optimization of Standard Methods for In Vitro Toxicity Testing - Part 1 General Principle

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

T/SHSOT005-2022 Integrated Approaches for Testing and Assessment for Eye Irritation Based on BCOP and CAMVA Method

T/SHSOT006-2022   Integrated Approaches for Testing and Assessment for Skin Corrosion and Irritation Based on Reconstructed Skin Model

Draft

September 7, 2022

China Association of Fragrance Flavour and Cosmetic Industries

Cosmetic Ingredients - Acetylneuraminic Acid

October 10, 2022

Cosmetic Ingredients - Diethylamino Hydroxybenzoyl Hexyl Benzoate

Cosmetic Ingredients - Benzophenone-4

Cosmetic Ingredients - Octocrylene

September 14, 2022

Shanghai Society of Toxicology

Testing Approach for Assessing Mildness (No Irritation) of Rinse-off Products Based on Skin

Lipid Barrier

October 15, 2022

September 15, 2022

Guangdong Daily Chemical Chamber of   Commerce

Assessment Requirements for Quality Grading and Forerunner - Mask

October 14, 2022

Assessment Requirements for Quality Grading and Forerunner - Skin Care Cream

Assessment Requirements for Quality Grading and Forerunner - Skin Care Lotion

Assessment Requirements for Quality Grading and Forerunner - Facial Washing Milk, Facial   Washing Cream

Assessment Requirements for Quality Grading and Forerunner - Oral Rinses

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South Korea

South Korea to Revise the Cosmetics Safety Standard

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.

Japan

Japan Revises the Sun Protection Test Methods

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.

PMDA: 55 Batches of Cosmetics and Quasi-drugs Recalled in September

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.

Thailand

Thailand Consults on Five Draft Notifications on Prohibited Ingredients, Permitted Preservatives and Refilled Cosmetics

From September 5 to 20, 2022, the Thai Food and Drug Administration conducted a public consultation on the following five draft notifications:

1. Notification of the Ministry of Public Health Re: Substances Names of Prohibited Ingredients in Cosmetics

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

4. Notification of Cosmetics Committee Entitled of Refilled Cosmetics label;

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.

Indonesia

Indonesia Consults on the Draft Regulation for Perfume Refill

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.

Malaysia

Malay NPRA Publishes FAQs on Good Manufacturing Practice for Cosmetics

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.

Australia

Australia Updates the “Specific Information Requirement”

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;

Australia Proposes to Change the Rules for Chemical Introductions of 10 Kg or Less

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

EU to Impose Strict Restrictions on Synthetic Microplastics in Cosmetics

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.

EU Adopts Amendments Concerning CMR Substances to the Cosmetics Regulation

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.

EU to Extend the Individual Labelling Requirement for 56 Newly Identified Fragrance Allergens in Cosmetics

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.

EU SCCS Releases the Final Opinion on Genistein and Daidzein

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

UK Releases the Updated Consolidated Cosmetic Regulation Online

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.

UK Upgrades the Function of Filling in Ingredient Information in Cosmetic Notification System

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.

OPSS Extends Responsible Person Labeling Deadline

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).

Brazil

Brazil Updates Technical Requirements for Labelling of Personal Hygiene Products, Cosmetics, and Perfumes

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.

Webinar Recommendation

Understanding Cosmetic Regulations in Turkey

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.

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