From January to August 2024, several significant regulatory developments occurred in the APAC region. Notably, China introduced a transition period along with several regulatory documents for safety assessments and amended the Safety and Technical Standards for Cosmetics. Taiwan eliminated the category of specific purpose cosmetics and implemented unified management for all cosmetics. Additionally, updates regarding cosmetic ingredients, particularly the prohibition of specific substances, remain a key focus across various countries. It is crucial for enterprises to stay informed about these changes and adjust their strategies to comply with regulatory requirements.

Here are brief updates on key developments.

1. China

1.1 NMPA Amends the Safety and Technical Standards for Cosmetics 2015

On March 21, 2024, NMPA announced significant amendments to the Safety and Technical Standards for Cosmetics (2015 Edition) (STSC). The updates include:

1. Addition of 5 newly prohibited ingredients: Bimatoprost, Tafluprost, Taflupamide, Travoprost, and Latanoprost;
2. Revision of 3 existing testing methods, including those for dioxane and other prohibited and restricted ingredients;
3. Introduction of 11 new testing methods, covering areas such as acute inhalation toxicity, skin sensitization, and reproductive toxicity.

The updated ingredient list is in effect immediately, while the revised testing methods will take effect on December 1, 2024.

1.2 China Sets Transition Period for Submitting Complete Safety Assessment Reports and Issues Multiple Regulatory Documents to Clarify Safety Assessment Requirements

Under CSAR framework, cosmetics registrants and notifiers are required to submit product safety assessment documents during registration and notification. Until May 1, 2024, they have the option to submit a simplified safety assessment report. However, from May 1, 2024 onwards, the full version of the assessment report must be submitted.

Considering industry challenges, China’s National Medical Products Administration (NMPA) has extended the transition period. Registrants and notifiers can still submit a simplified safety assessment report before May 1, 2025, as long as the assessment was started before May 1, 2024.

To guide companies, in April and July 2024, NMPA issued several new regulatory documents related to safety assessment. This includes guidelines that classify submission requirements based on risk management principles and provide self-examination points for the assessment reports.

ChemLinked Comments

With these supporting policies and optimization measures, the full safety assessment report system can be effectively implemented in China’s cosmetics industry.

Although the NMPA has provided a transition period for companies, it is advisable to proactively prepare for the full version of the report. This includes assembling qualified personnel, reviewing ingredients and addressing data gaps, and seeking expert consultants, etc.

2. Taiwan

2.1 TFDA Amends Cosmetic Ingredient Use Requirements

Taiwan Food and Drug Administration (TFDA) issued several announcements on December 13, 2023, January 4, 2024 and May 30, 2024, regarding the revision of prohibited and restricted ingredients for cosmetics. Please refer to the table below for the specific amendments.

2.2 Taiwan Cancels Specific Purpose Cosmetics Category and Implements Unified Management for All Cosmetics

On July 1, 2019, Taiwan enacted the Cosmetic Hygiene and Safety Act, its primary regulation for cosmetics. According to the Act, the category of specific purpose cosmetics was discontinued as of July 1, 2024. From that date, all cosmetics in Taiwan are regulated under a unified management system, resulting in changes to the scope of application and expressions of Taiwan’s cosmetic regulations, including ingredient lists, pre-market notification, Product Information Files (PIF), Good Manufacturing Practices (GMP), and product labeling.

Beginning July 1, 2024, manufacturers and importers of cosmetics previously classified as specific purpose must complete product notifications, establish product-specific PIFs, ensure GMP compliance, and meet updated labeling requirements before marketing their products in Taiwan.

3. South Korea

3.1 South Korea Bans THB in Cosmetics

On December 7, 2023, South Korean Ministry of Food and Drug Safety (MFDS) proposed an amendment to the Regulation on Safety Standards for Cosmetics. The purpose was to prohibit the use of 1,2,4-trihydroxy benzene (THB) as an ingredient in cosmetics. The decision was based on safety verification results from the Cosmetic Ingredient Safety Evaluation Committee, which indicated that the genotoxicity potential of THB cannot be ruled out.

The amendment was finalized on February 7, 2024, and MFDS officially implemented the ban on THB in cosmetics.

3.2 South Korea Consults on Cosmetic Safety Standard

On August 2, 2024, the Ministry of Food and Drug Safety (MFDS) released a notice to solicit public feedback of the modifications to Cosmetic Safety Standard till October 3, 2024. The authority proposed to designate one new UV filter, delete one UV filter, and enhance the usage limits of six restricted ingredients.

MFDS Consults on Cosmetic Safety Standard: Enhancing Management of UV filters, D4, D5, and Other Ingredients as below;

4. Japan

4.1 Japan Approves a New Ingredient for Rinse-off Hair Styling Products

On March 8, 2024, the Ministry of Health, Labour and Welfare (MHLW) of Japan released a proposal for the Standards for Cosmetics, inviting public consultation. The proposal requests the inclusion of “Cysteamine Hydrochloride” as an ingredient for rinse-off hair styling products. The proposal was finalized on July 12, 2024, and came into force upon issuance.

ChemLinked Comments

Cosmetic manufacturers and distributors are required to adhere to the updated guidelines, which may involve modifying product formulations, manufacturing processes, labeling, and quality control measures.

5. ASEAN

5.1 ASEAN Updates ASEAN Cosmetic Directive (ACD)’s Ingredient Annexes

The ASEAN Cosmetic Committee (ACC) and ASEAN Cosmetic Scientific Body (ACSB) hold meetings twice a year to discuss the latest developments in ASEAN cosmetic industry and related regulations, annexes related to ingredients.

On July 1, 2024, the Singapore Health Sciences Authority (HSA) issued the updated ingredient annexes approved during the 39^th ACSB meeting. The key amendments include:

1) Annex II – List of Prohibited Ingredients: 1 revised

2) Annex III – List of Restricted Ingredients: 3 revised, 1 added

3) Annex VI – List of Permitted Preservatives: 9 revised

4) Annex VII – List of Permitted UV Filters: 2 revised

In addition to the amendments mentioned above, there are also some updates to the CAS No. information for 56 entries in the annexes.

ChemLinked Comments

The amendments to the ingredient annexes of ACD apply to all ASEAN member states. However, the timeline for each member state to formally adopt these amendments may vary. So far, member states such as Malaysia, Singapore, Vietnam, and the Philippines have adopted these amendments.

6. Indonesia

6.1 Indonesia Proposes to Amend Cosmetic Ingredient Use Requirements

On March 1, 2024, the Indonesian Agency for Food and Drug Control (BPOM) released the amended draft of the Technical Requirements for Cosmetic Ingredients for public consultation until March 19, 2024. The proposed amendments include:

1) Deleting requirements specifically related to cosmetics containing alpha arbutin or beta arbutin;

2) Appendix I: List of Restricted Ingredients – 1 revised;

3) Appendix III: List of Permitted Preservatives – 2 deleted;

4) Appendix IV: List of Permitted Sunscreens – 1 revised;

5) Appendix V: List of Prohibited Ingredients – 75 added.

ChemLinked Comments

The proposed amendments to Indonesian cosmetic ingredients align with the amendments made to the ingredient annexes of the ASEAN Cosmetic Directive (ACD) during the 36^th, 37^th, and 38^th ACSB meetings.

For salicylic acid in Appendix I List of Restricted Ingredients, the only adjustment is the serial number in the usage requirements, which is a result of the removal of two preservatives from Appendix III. The usage limit and conditions for salicylic acid remain unchanged.

7. Thailand

7.1 Thailand Amends Cosmetic Ingredient Use Requirements

From January to August 2024, Thailand issued several announcements regarding revisions to the requirements for cosmetic ingredients. Some of these announcements were formal revisions, while others were drafts. The updates are as follows:

1) List of Prohibited Ingredients: 2 added, 1 revised, and 56 proposed for addition.

2) List of Restricted Ingredients: 8 added, 1 revised, 1 deleted, 3 proposed for addition, and 1 proposed for revision.

3) List of Permitted Colorants: 1 revised and 1 proposed for revision.

4) List of Permitted Preservatives: 1 revised.

5) List of Permitted Sunscreens: 1 added and 1 proposed for revision.

ChemLinked Comments

As a member of ASEAN, Thailand has been somewhat delayed in adopting the revisions to the ingredient use requirements outlined in the ACD. The above adjustments aim to align with previous updates from the ACD.

8. New Zealand

8.1 New Zealand EPA Bans PFAS in Cosmetics

On January 30, 2024, the New Zealand Environmental Protection Authority (EPA) announced a ban on PFAS in cosmetics. The ban, outlined in the updated “Cosmetic Products Group Standard,” reflects New Zealand’s precautionary approach to managing the potential risks associated with these chemicals.

To ensure compliance, the ban on PFAS in cosmetics includes the following transitional provisions:

1. Manufacture Ban: Starting from December 31, 2026, the manufacture and import of cosmetic products containing PFAS will be prohibited;
2. Sale Ban: As of December 31, 2027, the sale of cosmetic products containing PFAS will be banned;
3. Product Disposal: All remaining cosmetic products containing PFAS must be disposed of by June 30, 2028. This ensures the complete removal of these products from the market and minimizes potential PFAS exposure.

9. Australia

9.1 Australia Adopts Updated Sunscreen Standards

On April 11, 2024, the TGA announced the adoption of the Australian/New Zealand Standard: Sunscreen products – Evaluation and Classification (AS/NZS 2604:2021) (amended) into therapeutic goods legislation framework. This updated standard enhances testing and labeling requirements for sunscreens available in the Australian market. Notable changes compared to its predecessor include:

• Incorporation of the latest ISO Standards for sunscreen testing, including “ISO 24444:2019 Cosmetics—Sun Protection Test Methods—In Vivo Determination of the Sun Protection Factor (SPF),” “ISO Standard 24443:2021 Determination of Sunscreen UVA Photoprotection in Vitro,” and “ISO 16217:2020 Cosmetics—Water Immersion Procedure for the Determination of Water Resistance.”
• Introduction of a new flow chart to guide sponsors (product owners) in determining the applicable sections of the standard for primary and secondary sunscreens.
• Addition of labeling instructions for aerosol and spray pump pack sunscreens, advising consumers on the appropriate amount for effective protection against UV radiation, and cautioning against spraying these products on the face or in windy conditions to avoid product inhalation.

Further Reading

• China Expands Recognized Ingredient Safety Data for Safety Assessment Report
• Taiwan Restructures Cosmetic Ingredient Lists, Effective July 1, 2024
• Updates to ASEAN Cosmetic Directive (ACD)’s Ingredient Annexes: 15 Revised and 1 Added
• Australia Adopts Updated Sunscreen Standards

ChemLinked Cosmetic Portal (cosmetic.chemlinked.com) is a media platform operated by REACH24H Consulting Group. Our focus is on providing comprehensive one-stop-market access information services and solutions to members of the cosmetics industry, including domestic and foreign manufacturers, trade logistics, raw material companies, as well as government departments, industry associations, and research institutions.

We offer a wide range of global cosmetic market entry services, including Global News Alerts, Cosmetics Product Registration and Notification, New Cosmetic Ingredient (NCI) Registration/Notification, Regulatory Consultation, Customized Training, Market Research, and Branding Strategy. Please contact us to discuss how we can help you by cosmetic@chemlinked.com

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Recap and Latest Developments

Animal testing is banned in many countries. South Korea was one of the pioneers that protected animal rights since 2013. According to South Korea’s Cosmetics Act, no cosmetics or cosmetic ingredients for which animal testing was conducted, should be distributed in South Korea. The ban on animal testing also applies to imported cosmetics.

To guide cosmetic enterprises in smoothly conducting safety tests, the Korean authority has published twenty-nine guidelines on alternative animal testing methods. This article summarises all Korean officially published alternative animal testing methods, along with the latest developments.

Alternative Animal Testing Guidelines Published by MFDS

Exemptions from Animal Testing Ban

However, MFDS specifies six situations which animal testing can be adopted on cosmetics:

1. Situation when animal testing is needed to determine the standards for using raw materials requiring a specific restriction on usage, such as preservatives, coloring or sun-blocks, or to assess hazards of cosmetics raw materials, etc., posing risks to public health;
2. Situation when animal testing is needed because no alternative to animal testing exists;
3. Situation when animal testing is needed to export cosmetics following the statutes and regulations of the exporting country;
4. Situation when animal testing is needed for product development following the statutes and regulations of the importing country;
5. Situation when raw materials developed through animal testing conducted under other statutes and regulations are used for the manufacture, etc. of cosmetics;
6. Other cases prescribed by MFSD, where it is impractical to conduct alternatives to animal testing.

Latest Developments

On October 18, 2023, Ministry of Food and Drug Safety (MFDS) issued a new alternative animal testing guideline, named Guideline of Alternative Animal Testing Methods for Cosmetics: Eye Irritation(Acute Eye Damage or Irritation) Test using Reconstructed human Cornea-like Epithelium (RhCE)(인체각막유사 상피모델을 이용한 안 유해성 시험법). This guideline is established based on the latest OECD-approved alternative testing methods. The “eye damage or irritation” refers to harmful effects such as damage or irritation that occur when the test substance comes into contact with the eyes. RhCE eye irritation test method is expected to help enterprises develop safer cosmetic products without animal testing.

Further Reading

• South Korea Modifies the Cosmetic Safety Standard: Ingredients and CAS No.
• South Korea Revises Cosmetic Colorant Requirement
• Exploring the Use of Animal Testing in Japanese Cosmetics
• US Moves Towards National Ban on Cosmetic Animal Testing

ChemLinked Cosmetic Portal (cosmetic.chemlinked.com) is a media platform operated by REACH24H Consulting Group. Our focus is on providing comprehensive one-stop-market access information services and solutions to members of the cosmetics industry, including domestic and foreign manufacturers, trade logistics, raw material companies, as well as government departments, industry associations, and research institutions.

We offer a wide range of global cosmetic market entry services, including Global News Alerts, Cosmetics Product Registration and Notification, New Cosmetic Ingredient (NCI) Registration/Notification, Regulatory Consultation, Customized Training, Market Research, and Branding Strategy. Please contact us to discuss how we can help you by cosmetic@chemlinked.com

The home of K-Beauty, South Korea, has the smallest population amongst the world’s top 10 markets with only 50 million people, but it has the 8^th largest market size in the world (Euromonitor, 2022). K-Beauty became popular in the global market with the first ever introduction of 10-step routines, sheet masks, BB cream, CC cream and foundation cushions. Still, not many are aware that South Korea is the third largest cosmetic export country in the world after France and the United States, which placed ahead of Germany and Japan.

This small but mighty beauty powerhouse could not be free from the effects of the last three years of the pandemic. Multiple new trends and environmental changes have emerged due to the influence of Covid-19. The most dominant one is ‘sustainability’, with ‘clean beauty’ dominating the market in Korea. As a result of CMN’s expert survey (2022), “Clean Beauty” was selected as the first keyword in the market in 2023. Along with ‘vegan beauty’, words with eco-friendly images have formed the biggest trend.

These 38 CMN experts said that ‘core ingredients’ are the most searched for key word with 55.3%. Of those core ingredient searches, ‘hyaluronic acid’ was the most popular with 36.8%. Following that was ‘collagen’ (23.7%), ‘organic’ (18.4%), ‘ceramide’ (18.4%), ‘natural’ (15.8%), ‘vitamin’ (13.2%), ‘probiotics’ (13.2%), ‘peptide’ (10.5%), ‘fermentation’ (10.5%), ‘panthenol’ (10.5%), ‘tea tree’ (7.9%), and ‘centella asiatica’ (7.9%). In addition to ‘clean beauty’, plant extracts have been very popular searches in K-Beauty, with ‘collagen’, ‘centella asiatica’ and ‘houttuynia cordata’ all mentioned.

With these sustainability trends in mind, REACH24H Consulting Group Korea’s Seongmin (Mike) Sohn and Jaeyoung Kim interviewed 5 exhibitors for in-cosmetics Korea. The interviewed exhibitors are NB Bio Company, EastHill Corp., Opt-Bio, CoSeedBioPharm, and Smile Company.

Yeonjoo Ahn from NB Bio Company emphasized that most of the ingredient companies are fighting to follow the sustainability trend in Korea. They introduced PHYTO SILVER COLLA as a plant-derived collagen ingredients with upcycled materials made from coffee bean wastes, and their way of being more sustainable. EastHill also created Trascobic, a plant extract that promotes the differentiation of vitamin C transport proteins.

Both companies said that they create new products with ingredients that are already familiar to their consumers, but also look at finding Korea’s more unique raw materials to use. Jeju island is a well-known tourist spot in Korea and abundant with plant life, which has been used for some distinct plant extract ingredients. Jeju specialties are ‘camellia’, ‘citrus’, ‘green tea’, ‘rape’, ‘mulberry’, ‘turmeric’, ‘rock hydrangea’ and ‘evening primrose’.

CoSeedBioPharm is one of the leading Korean suppliers providing low molecular functional products by various plants and marine ingredients originating from Jeju. They have 70+ products; ‘Machilus Japonica’, ‘Ficus Oxyphylla’ and ‘Cornus Kousa’ to name a few. Seonwon Kim, manager of CoSeedBioPharm said that putting efforts into securing ingredients of Korean origin ingredients is very important but has become more difficult over time.

There are various protocols and regulations that have to be followed; like benefit-sharing with the Nagoya protocol, efficacy testing, safety testing, sustainability, technology (extraction, low molecularization, standardization), marketing (conceptual point, tools, measures), and most of all, complying with overseas regulations. With all the regulation and sustainability issues that have developed over the years, some Korean suppliers are seeking answers outside of Korea. “Smile Company” introduced herbs collected from Cyprus, a Mediterranean island south of Turkey. ‘Everlasting’, ‘Rockrose’, ‘Watermint’, and ‘Houttuynia cordata’ are ingredients strictly controlled by the Cyprus government and Research Team leader Hyungjung Han says that these collections of raw materials are limited to companies with licenses. They’re either hand-picked or scissors-cut so even without the typical Korean origin story, it still appeals to consumers. It has the added bonus of having lowered regulatory hurdles for ingredient suppliers.

There are many products that have a comparative advantage based on their superior quality and are easier to produce thanks to the advances in technology. With R&D there’s been some new production technologies, such a separation and refinement, that have helped bring the industry into the future. With these advances it’s ramped up international competitiveness by having higher levels of hardware and excellent production facilities in Korea. To gain competitiveness of high-end manufacturing system, EFfCI-GMP (European Federation for Cosmetic Ingredients-Good Manufacturing Practice) certification has been one of the key requirements to pass. OptBio, one of the leading extract manufacturers in Korea, has recently got certified for EFfCI-GMP for their second manufacturing site reaching up to 5,300㎡. Through this facility they introduced the GN Tannin Ampoule. It’s their unique product that has increased tannin content by 10 times compared to general extraction process through an eco-friendly method that destroys cell structure. This uses ultrasonic extraction, and it does not need the extra addition of solvents.

The Korean government’s interests, support policies, and public investment are needed for future K-beauty and raw material industries. It’s urgent to strengthen cosmetics regulations and support export licenses due to protectionism. To break the non-tariff barrier, two major approaches are executed; regulation monitoring with education and actual consulting service funding program to assist them for product registration in local markets. KCII, the only government body to promote K-Beauty industry has collaborated with REACH24H to provide regulatory updates, seminars and training and even published a guideline ‘How to comply with China cosmetic regulations’ in 2022.

In addition to the companies interviewed above, the 2023 in-cosmetics Korea is expected to exhibit many companies and products that reflect the latest Korean cosmetics raw material trends. There will also be seminars on the latest marketing trends and regulations to keep up with the ever-changing personal care industry.  

Register your interest to come to in-cosmetics Korea and see these products for yourself.

See the rest of the exhibitors in our Exhibitor Directory.

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In recent years, the increasing religious awareness of young Muslim consumers and the growing Muslim population around the world have led to an increasing trend of using Halal products all over the world. The Indonesian middle class now have very high purchasing power, especially in the cosmetics sector, and play an important role in influencing modern Indonesian society. It’s no wonder Indonesia is one of the countries with the highest consumption of Halal products in the world.

About Halal cosmetics in Indonesia.

Halal cosmetics have existed in Indonesia since 1995, starting with the brand Wardah which has been a pioneer of Halal cosmetics in Indonesia since. Wardah raised the initial awareness to Halal cosmetics, but it did not become mainstream until 2014.

Halal product regulation was started in 2014 by the Indonesian government and cosmetic products were affected domestically and those coming from overseas. To be Halal, the ingredient of their raw materials to finished products must follow Islamic law. This meant it must not contain ingredients derived from pigs, blood, human body parts, predatory animals and reptiles, and must comply sharia in accordance with the recommendations of The Institute of the Indonesian Ulema Council (MUI).

Overview of Halal cosmetics in Indonesia

Euromonitor shows a staggering 11.99% growth in sales of beauty products since 2017, contributing to IDR 19 trillion. According to statistical data, the growth of beauty products increased by around 6.46% in 2021 despite being affected by the Covid19 virus, with online sales dominating.

According to data from goodstats.id for the use of Halal cosmetics, Indonesia ranks second after India. Indonesia continues to grow rapidly and is said to have become the centre of the cosmetics industry due to government support and a large female population.

According to Muti Arintawati, president and director of the Ulema Council of Indonesia (MUI), there were only 64 cosmetic companies with Halal certification in 2017. The number has continued to grow rapidly, with 129 companies in 2018, 162 companies in 2019, and 214 companies in 2020.

Challenges of Halal cosmetics

These government regulations must be complied with by October 17, 2026, requiring all producers, both raw material suppliers and finished product manufacturers, to be Halal certified.

These regulations pose a major challenge for all raw material suppliers, especially from overseas. By the above dates, you should be able to obtain Halal certificates for the raw materials you export to Indonesia. Halal certification can be done in each country of raw material production by Halal certification providers cooperating with BPJPH (Badan Penyelenggara Jaminan Produk Halal).

But there is also good news, as the government has lowered the registration price for Halal certification of domestic products to $3 and provide convenience in carrying out Halal registration to cosmetic business actors in Indonesia by providing a short time in Halal registration services in 15 days and forming many organizations to verify Halal documents so that the process can be faster. According to the government, the aim is to promote the domestic production of beauty products.

PS: The future of halal beauty was discussed at the recent in-cosmetics Asia event in Bangkok – you can now download the presentation here 

Enjoyed this article? Get more by subscribing to our newsletter!The post Indonesia as the centre of Halal cosmetics in Asia first appeared on in-cosmetics Connect.]]> https://connect.in-cosmetics.com/news-region/asia/indonesia-as-the-centre-of-halal-cosmetics-in-asia/feed/ 0 18706 https://connect.in-cosmetics.com/news-category/celebrating-innovation-at-in-cosmetics-asia-innovation-zone-and-spotlight-on-formulation-award-winners-announced/ https://connect.in-cosmetics.com/news-category/celebrating-innovation-at-in-cosmetics-asia-innovation-zone-and-spotlight-on-formulation-award-winners-announced/#respond Wed, 02 Nov 2022 16:39:15 +0000 https://connect.in-cosmetics.com/?p=18588 Bangkok, 2 November 2022: The organisers of in-cosmetics Asia – the leading event in Asia Pacific for personal care ingredients, have announced this year’s 2022 Innovation Zone and Spotlight On Formulation Award winners. Announced on day two of the event, the awards honoured the best Innovation Zone ingredients and Spotlight On’s formulated ingredients, recognising companies […]

France is leading the charge in making GMP certificates easier to obtain in a bid to reduce the number of products that require animal testing when exported to China.

Last August and November, China released the first and second draft Instructions for Cosmetic Registration and Notification Dossiers which proposed that general cosmetics can be exempted from animal testing.

General cosmetics refer to all the products complying with the definition of cosmetics within the Cosmetic Supervision and Administration Regulation (CSAR), except for the special cosmetics namely hair dyes, hair perming products, freckle-removing and whitening products, sunscreens, anti-hair loss products and cosmetics claiming new efficacy. But it should be noted that the draft ‘Instructions’ regulate two preconditions and three exceptions for the animal testing exemption:

Preconditions:

Only by fulfilling both of the following two conditions can companies of general cosmetics apply for the exemption of animal testing:

1. General cosmetic manufacturers have obtained the GMP certificates issued by the competent authority of the country (region) where they are located
2. The safety assessment results can fully confirm the safety of products.

Exceptions:

As long as one of the following 3 conditions applies, companies are still required to conduct animal testing:

1. Products claim to be used by infants/children;
2. Products using new cosmetic ingredient during their 3 years of required monitoring;
3. The notifier/RP/manufacturer is listed as a key supervision target according to the results of the quantitative rating system established by the NMPA.

GMP Certificates

For the first precondition-submission of GMP certificates, ChemLinked commented that “some overseas cosmetic companies may face a barrier for the animal testing exemption as they may fail to submit the GMP certificate granted by the local government cosmetic authority. In some regions, like the EU, the government cosmetic authority won’t issue an official GMP certificate due to the local cosmetic regulatory scheme. The GMP certificates that can be provided are generally issued by cosmetic associations or international standardization organizations.”

However, it now appears that the official GMP certificates may not be a barrier. Recently France ANSM (National Agency for the Safety of Medicines and Health Products), the French health authority, announced that it would issue the GMP certificates for local cosmetic manufacturers and has already launched an online platform for them to obtain the certificates.

Additionally, more countries in Europe are considering joining the league. “The U.K. government is working closely with industry to create a certification system that will satisfy new Chinese regulations on cosmetics, following the removal of the requirement for animal testing on imported cosmetics,” said a U.K. Department of International Trade spokesperson.

Nevertheless, it’s an open question whether the Chinese government will recognize the GMP certificates.

Safety Assessment

Apart from the GMP certificates, safety assessment is also a mandatory condition for the animal testing exemption, which may pose a challenge for cosmetic companies as well.

China has released the draft Technical Guidelines for Cosmetic Safety Assessment for public consultation on July 29, 2020. However, the draft Guidelines introduce very strict requirements for safety assessment, such as:

• For finished products, the safety assessment shall not only focus on the assessment of all ingredients but also on the overall stability of the product, even the interaction of the packaging material and the content.
• Safety assessors are required to have a professional background, such as pharmacy, chemistry or toxicology, and at least 5 years of relevant working experience, and need to understand the cosmetic production process, quality and safety control requirements, toxicological assessment methods, etc.

Furthermore, the draft ‘Guideline’s haven’t clearly stated whether to recognise the safety assessment report issued by foreign institutions or foreign safety assessors.

As the ‘Guidelines’ haven’t been finalized, whether the safety assessment will still be subject to such strict requirements remains to be seen.

ChemLinked Comment

Now the animal testing exemption for general cosmetics is still on the drawing board. Once it is implemented, international cruelty-free brands will be able to tap into the Chinese cosmetic market under new conditions. Although there are great limitations and challenges, the exemption would undeniably be a great benefit for international cosmetic companies and also a big step taken by China towards reducing animal testing.

ChemLinked is a leading provider of Asia-Pacific regulatory information and market intelligence across Cosmetic, Chemical, Food and Agrochemical Industries. ChemLinked boasts a multidisciplinary team of scientists, compliance specialists and language experts backed by the vastly experienced technical teams at REACH24H, to ensure over 44,000 registered members to acquire authoritative information and dependable consultancy services. ChemLinked aims to remove any regulatory barriers that prevent you from exporting your products into China and other countries in the Asia-Pacific region

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China is speeding up the approval of new cosmetic ingredients under the CSAR. Four new ingredients, Ethyl Lauroyl Arginate HCL, Methoxy Peg-23 Methacrylate/Glyceryl Diisostearate Methacrylate Copolymer, Calcium Phosphoryl Oligosaccharides and Steareth-200, will be approved as existing cosmetic ingredients.

On December 2, 2020, China National Medical Products Administration (NMPA) opened a public consultation on the approval of Ethyl Lauroyl Arginate HCL, Methoxy Peg-23 Methacrylate/Glyceryl Diisostearate Methacrylate Copolymer, Calcium Phosphoryl Oligosaccharides and Steareth-200 as new cosmetic ingredients.

The basic information about the four new cosmetic ingredients are as follows:

1. ETHYL LAUROYL ARGINATE HCL

Chinese Name: 月桂酰精氨酸乙酯 HCl

CAS No.: 60372-77-2

Trade Name:

• LAE-P (The abbreviation of pure substance)
• LAE
• Lauric arginate
• Ethyl Lauroyl arginate
• Mirenat-N
• Aminat
• Lauramide arginine ethyl ester
• LAE TECNICO DESHIDRATADO

Source: Chemical Synthesis

Intended Use: Cosmetic Preservative

Application Scope: Apply to all kinds of cosmetics except lip products, oral hygiene products and spray products

Limit: 0.4%

2. METHOXY PEG-23 METHACRYLATE/GLYCERYL DIISOSTEARATE METHACRYLATE COPOLYMER

Chinese Name: 甲氧基 PEG-23 甲基丙烯酸酯/甘油二异硬脂酸酯甲基丙烯酸酯共聚物

CAS No.: /

Trade Name: ISPolymer

Source: High-Molecular Polymer

Intended Use: Skin Conditioning Agents and Humectant

Application Scope:

• Rinse-off skincare products: cleaning products, massage products.
• Leave-on skincare products: toner, lotion, cream, essence, facial mask, etc.
• Makeup cosmetics: foundation, various base creams

Limit: 2%

3. CALCIUM PHOSPHORYL OLIGOSACCHARIDES

Chinese Name: 磷酰基寡糖钙

CAS No.: 1124316-47-7

Trade Name: POs-Ca

Source: Potato Starch

Intended Use: Skin Conditioning Agents

Application Scope: Applies to all kinds of cosmetics used on face, scalp and whole body, except eye cosmetics

Limit: 5%

4. Steareth-200

Chinese Name: 硬脂醇聚醚-200

CAS No.: 9005-00-9

Trade Name: Brij S200

Source: High-Molecular Polymer

Intended Use: Emulsifier and Solubilizer

Application Scope: Hair cosmetics

Limit: 1% (When used with oxidized milk (“氧化乳” in mandarin Chinese) in oxidative hair dye, 1.0% shall be the maximum concentration after mixing)

ChemLinked Comments

The current registration process of new cosmetic ingredients in China is tedious as the compliance requirements are quite strict. From 2004 to 2014, only 10 new ingredients have been given the green light for use in cosmetics by the authority, and none since then. This not only hinders industry innovation but also fails to keep pace with consumer demands and global practices.

Approved New Cosmetic Ingredients (since 2004)

1. Alkyl (C12-C22) trimethyl ammonium, bromide and chloride (Jun 2004)
2. Potassium Methoxysalicylate (Apr 2007)
3. Methylisothiazolinone (May 2007)
4. Carnitine Tartrate (Jun 2008)
5. Lathyrus odoratus flower extract (Aug 2008)
6. Fructooligosaccharides (Aug 2008)
7. Dimethoxytolyl Propylresorcinol (Mar 2012)
8. Polymethacryloyl Lysine (Mar 2012)
9. Phenylethyl Resorcinol (Dec 2012)
10. Elaeagnus mollis Oil (Oct 2014)

However, the situation is about to change with the introduction of the Cosmetic Supervision and Administration Regulation (CSAR). As per the new regulation, management of cosmetic ingredients will be stratified based on their inherent risk level. Namely, high-risk ingredients such as preservatives, sunscreens, colourants, hair dyes and whitening agents will require registration with the NMPA and be subject to stringent supervision. In contrast, low-risk ingredients are available for use only after quick notifications.

China’s intention to approve the above four new ingredients after 6 years of stagnation is an active signal that the regulatory stance on new cosmetic ingredients is being softened and the classified management of such ingredients is being put in place. ChemLinked expects that more advanced ingredients can be approved and used legally in the Chinese market next year, and the industry will enter a new era of rapid development.

ChemLinked is a leading provider of Asia-Pacific regulatory information and market intelligence across Cosmetic, Chemical, Food and Agrochemical Industries. ChemLinked boasts a multidisciplinary team of scientists, compliance specialists and language experts backed by the vastly experienced technical teams at REACH24H, to ensure over 44,000 registered members to acquire authoritative information and dependable consultancy services. ChemLinked aims to remove any regulatory barriers that prevent you from exporting your products into China and other countries in the Asia-Pacific region

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In the recent non-special use cosmetics (Non-SUC) filing process in China, the review of trademarks in foreign languages has become stricter. We collected the most common review issues on trademarks and combined with relevant laws and regulations to summarize the Chinese labelling requirements of foreign trademarks.

Non-SUC Filing Review Opinions on Trademarks

1) Beijing MPA

Review Opinions

According to the latest instructions of the NMPA, whether it is the English trademark in the product name or on the label, the following Chinese interpretation must be labelled:

• **是注册商标，其含义是** (** is a registered trademark, and its meaning is **)
• **仅为注册商标，无具体含义 (** is only a registered trademark and has no specific meaning.)

Only marking ^® on the trademark or only submitting the trademark registration certificate will fail the filing review. All the English on the label must be explained in Chinese.

Failure Reasons

English trademarks without Chinese interpretation.

2) Shanghai MPA

Review Opinions

The interpretation of the trademark in the Chinese label contains exaggerated claims: “Dr. Deep” is the product brand name and a registered trademark. “Deep” represents that the product quality is worthy of deep trust. “Dr” represents the product is so professional that can be a doctor of family skincare. The brand is committed to selecting high-quality ingredients and developing safe and reliable cosmetics.

Failure Reasons

Trademark interpretation contains non-compliant claims.

3) Guangdong MPA

Review Opinions

Please provide the trademark registration certificate of “Nutribase” in the product name.

Failure Reasons

Without a valid trademark registration certificate.

Regulations on Trademark Labeling

CSAR Subsidiary Regulation: Administrative Measures on Cosmetics Labeling (Draft for Comments)

Article 7 (Requirements for Label Text) Standard Chinese characters shall be used in cosmetic labels. If other languages or symbols are used, standard Chinese characters shall be used on the product sales packaging to provide corresponding interpretations, except for websites, name and address of overseas enterprises, and conventional professional terms that must use other languages.

Article 8 (Requirements for Trade Name, Generic Name and Attribute Name) The name of a cosmetic product generally consists of three parts: a trade name, a generic name, and an attribute name, all of which shall meet the following requirements:

…

(II) The medical effect or the efficacy that the product does not have shall not be claimed by a trade name. Where the name of the ingredient or a term implying that it contains a certain ingredient is used as the trade name, and the ingredient appears in the product formula, the purpose of use shall be explained in the visual panel of the sales packaging; and the ingredient does not appear in the product formula, it shall be clearly labelled on the visible panel of the sales packaging that the product does not contain such ingredient, and the ingredient name is only used as a trade name.

Article 9 (Requirements for Labeling of Product Name)

Chinese names of cosmetics must not be named using letters, Chinese Pinyin, figures, symbols, etc., except for registered trademarks, sunscreen index, color numbers, serial numbers, or other letters or symbols that must be used. Where the letters, Chinese Pinyin, figures, symbols, etc. are used in the registered trademark in the Chinese name of a product, the meaning thereof shall be explained in the product label.

Labelling Requirements of Foreign Trademarks

Based on the above review opinions and regulations, trademarks in foreign languages should meet the following requirements.

1) Foreign trademarks must provide a valid trademark registration certificate during cosmetics filing or registration. Only marking ^® on the trademark or only submitting the trademark registration certificate will fail the filing review. The following Chinese interpretation must be labelled on the packaging:

• For registered trademarks with specific meanings, shall label “**是注册商标，其含义是**” (** is a registered trademark, and its meaning is **).

Examples:

LYMPHODIA is a registered trademark. “LYM” is the abbreviation of “Love You More”, which means to love you more. “PHO” means bright, and “DIA” is the abbreviation of the diamond. The overall meaning of the trademark is: based on the concept of love, our brand cares for the skin and brings a diamond-like lustre for the skin.

• For registered trademarks without specific meanings, shall label “**仅为注册商标，无具体含义” (** is only a registered trademark and has no specific meaning).

Examples:

P. Jentschura is the name of the brand founder, Peter Jentschura. P is an abbreviation of Peter, with no specific meaning.

1) Trademark interpretation must not contain non-compliant claims;

2) Pay attention to the new requirements in the draft labelling regulation. Where the ingredient name or a term implying an ingredient is used as the trade name:

• For products containing that ingredient, the purpose of use should be labelled on the packaging;
• For products without that ingredient, it shall be labelled on the packaging that the product does not contain such ingredient, and the ingredient name is only used as a trade name.

The new cosmetic overarching regulation CSAR will be implemented on Jan. 1, 2021, bringing more stringent requirements for cosmetics market entry and heavier penalties for non-compliance. We recommend you stay in touch with any CSAR updates, which you can find out more about here.

ChemLinked is a leading provider of Asia-Pacific regulatory information and market intelligence across Cosmetic, Chemical, Food and Agrochemical Industries. ChemLinked boasts a multidisciplinary team of scientists, compliance specialists and language experts backed by the vastly experienced technical teams at REACH24H, to ensure over 44,000 registered members to acquire authoritative information and dependable consultancy services. ChemLinked aims to remove any regulatory barriers that prevent you from exporting your products into China and other countries in the Asia-Pacific region

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The regulation stipulates the production, operation and supervision of cosmetics in China, covering cosmetics raw materials and products, production and operation, labelling and advertising, supervision and management, legal responsibilities and more. Taking several years to come to fruition, the new regulation is comprehensive, with six chapters and 80 articles and will radically change the way the Chinese cosmetics ingredient is managed.

Talking about the significance of the CSAR, Chen Shaojun, Chairman of the Council of China Association of Fragrance Flavour and Cosmetic Industries (CAFFCI) said: “Thanks to seven years of government and cosmetic enterprises’ joint efforts, the CSAR has aligned the regulatory regime with the current industry practices and global trends. The implementation of CSAR will be nonetheless a major milestone for China to the modernization of China’s cosmetic supervision. It will contribute to the healthy, orderly, and sustainable development of the cosmetic industry.”

The new regulation will bring about substantial changes to China’s cosmetics regulatory framework, aiming to closer align with current global industry practices. Some of the most notable updates include a new process for cosmetics ingredient registration and management and new rules on efficacy testing and claim substantiation. “2020 will be a big year for cosmetics regulation in China. The whole industry will be very busy complying with the new game rules” commented April Guo, General Manager, Personal Care Division at CIRS Group. So what could these changes mean for the industry?

The pace of innovation: registering ingredients made easy

For many, there will be fewer obstacles to register ingredients. High-risk ingredients – such as preservatives, sunscreens, hair dyes and whitening agents – require registration with the National Medical Products Administration (NMPA) and are subject to strict supervision. However, with the new regulation, low-risk ingredients do not need to be registered to launch into the market as long as they have been filed with the NMPA. If, after three years of being registered and filed, new ingredients continue to be used without safety concerns, they will be automatically added to the Inventory of Existing Cosmetic Ingredients (IECIC)⁴. By simplifying the procedures for cosmetic companies to introduce new ingredients, this new regulation will encourage innovation in the market at a much faster pace.  As a result, “more and more advanced ingredients can be placed in the Chinese market to promote industrial developments” commented April Guo.

“At present, the registration process is tedious and the requirements are quite strict. It generally takes several years for enterprises to register a new ingredient as the documents may need to be supplemented many times, even if it is only a high molecular polymer without transdermal absorption or edible ordinary vegetable oil. Under the new regulation, low-risk ingredients are available for use after quick notifications” according to Hedy He, Cosmetics Regulatory Analyst at ChemLinked.

She added: “Also, China has released two draft Instructions for Cosmetics and New Ingredient Registration and Notification Dossiers to further clarify the requirements and review key points. It is believed that the enterprises’ enthusiasm for new ingredients application will be significantly improved.”

Zhang Taijun, R&D Director at Quan Zhimei reflected this, stating that “using a triage approach involving the stratification of ingredients by risk can effectively manage ingredients and will promote R&D, usage, and circulation of the ingredients, and inject new life into the industry.”

Increased trust in products and brands with scientific claims

With the new regulation, any scientific claim would require sufficient evidence before being published on the official NMPA website and approved by the administration. These claims must be substantiated by published literature, research data or product efficacy evaluation data. As this part of the regulation becomes tighter, there will be increased consumer confidence that any product with a claim has been proven by scientific testing before reaching the market.

“In the past, only sunscreen products required detailed efficacy reports. Now efficacy verification reports are also mandatory for whitening products, freckle-removing products, or other functional cosmetics bearing efficacy claims on the label or other advertising material. Companies will be more cautious about using cosmetic efficacy claims. If no solid evidence supports the claim, they will be sanctioned for false advertising and face severe administrative penalties” commented Zhang Taijun.

Better regulation will also mean consumers can trust that ingredients are meeting the expected standards across the board. “The CSAR requires cosmetic ingredients and packaging materials in direct contact with cosmetics to comply with the mandatory national and technical standards. But the reality is that many cosmetic ingredients, such as plant extracts, lack corresponding mandatory national and technical standards. In the future, there will be more mandatory standards relating to cosmetic ingredients. The compliance responsibilities of enterprises are relatively heavier, but also clearer,” added Hedy He.

Further to this, the new regulation is likely to prompt ingredient suppliers and finished product manufacturers to conduct joint supervision of both ingredients and products, creating a unified system. At present, if a new ingredient registration is rejected by the government within the three-year monitoring period, then the registration of the finished product containing this ingredient would also be rejected accordingly. “This innovative twin-track supervision will further ensure the consumers’ safety,” according to Hedy He.

Ultimately, the increased focus on safety through regulations will further consumer confidence in the Chinese cosmetics market. “We can find see the core of CSAR is the management of safety. The new regulation requires companies to establish a complete management system, covering product safety assessment, quality management, efficacy verification, cosmetic circulation, and adverse reaction monitoring” comments Zhang Taijun.

The most debated question: animal testing

Finally, one of the most hotly debated aspects of the new regulation is whether the new regulation will see the end of controversial mandatory animal testing for imported cosmetics. Indeed, organisations like People for the Ethical Treatment of Animals (PETA) are “cautiously optimistic” that it would.

The question remains somewhat unanswered. However encouragingly, a draft subsidiary regulation of CSAR released on August 28 (Instructions for Cosmetic Registration and Notification Dossiers) introduced a policy shift towards animal testing management in China.

More specifically, according to this new document, companies can apply for exemption of animal testing for imported general cosmetics. Here, manufacturers are required to obtain the relevant certification of Good Manufacturing Practice (GMP) issued by the cosmetic regulatory authority of the country where they are located. In addition, safety assessment results must fully prove the safety of the ingredients intended for use.

However, the document also stipulates certain conditions where animal testing will still be required. This list includes products to be used by children, products using new cosmetic ingredients during their three years of required monitoring, if the notifier/RP/manufacturer is listed as a key supervision target according to the results of the quantitative rating system established by the NMPA, and if the notifier/RP/manufacturer has been previously investigated and penalised due to quality or safety issues. Should this draft come into play, if any of the above conditions apply, companies are required to still conduct animal testing.

With a clear focus on safety, the long-awaited Cosmetics Supervision and Administration Regulation is set to completely change the cosmetics ingredient landscape in China. With these changes, we can expect to see greater innovation in new product development as well as greater collaboration between manufacturers and formulators. Not least, with tighter regulation also comes increased consumer confidence which should be a big boost for the market.

Hear more from Hedy He, Cosmetics Regulatory Analyst at ChemLinked, in the in-cosmetics Asia ‘Meet the Speaker’ series, now available on the in-cosmetics Connect website here: Asia Pacific Cosmetics Regulations with Hedy HeThe post New regulations announced! Prepare for rapid cosmetic innovation in China first appeared on in-cosmetics Connect.]]> https://connect.in-cosmetics.com/regulations/new-regulations-announced-prepare-for-rapid-cosmetic-innovation-in-china/feed/ 0 12147 https://connect.in-cosmetics.com/testing-regulation-zone/two-policy-shifts-towards-animal-testing-in-chinas-cosmetic-sector/ https://connect.in-cosmetics.com/testing-regulation-zone/two-policy-shifts-towards-animal-testing-in-chinas-cosmetic-sector/#respond Tue, 29 Sep 2020 09:11:35 +0000 http://ec2-52-48-9-53.eu-west-1.compute.amazonaws.com/?p=12060 By Chemlinked China has started its cosmetic regulatory reform since the finalization of the overarching regulation- Cosmetic Supervision and Administration Regulation (CSAR) on June 29, 2020, and is releasing a series of subsidiary regulations to improve its new cosmetic regulation framework. Starting from the initiation of the cosmetic regulatory reform, whether China will soften its stance […]