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China Taiwan Cosmetics Regulation Guide

Roger Ying
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China Taiwan Cosmetics Regulation Guide

This article aims to provide you a general understanding of how China Taiwan cosmetics are regulated and also lists the resources that you can access to acquire the product’s compliance. Due to the major change of the overarching cosmetic regulation, “the Cosmetic Hygiene and Safety Act” , this article suits for the readers who are already in or planning to enter the Taiwan cosmetic market.

Taiwan Cosmetics Regulations

Overview of Taiwan Cosmetics Regulations

The current in forcing overarching cosmetic regulation in Taiwan is called the “Cosmetic Hygiene and Safety Act” which is published on 1st July 2019. It reshapes the structure of the cosmetic supervision system and comes into the new era of the Taiwan cosmetics act.

Since 1st July 2019, in order to enter Taiwan’s cosmetic markets, both general cosmetics and special cosmetics are required to do the product notification or TFDA registration first.

For general cosmetics, you need to fill the product information on the cosmetic notification system and to establish full product information files (PIF) for TFDA inspection. “Product information file” means a number of documents containing data about the quality, safety, and functions of cosmetics. Currently, the policy is still under a grace period that allows importing companies to adjusting the process but will come to mandatory on 1st July 2021.

For special cosmetics, it is required to complete the registration process before the market placement. But the notification policy is also on the way that they will be required to do the notification and PIF as will later on 1st July 2024.

Taiwan Cosmetics Regulatory Framework

The main authority to supervise the cosmetic market and regulatory affairs is the Taiwan Food and Drug Administration(TFDA).  The current general director is Shou-Mei Wu.

Overarching regulation: Cosmetic Hygiene and Safety Act, it provides definitions of cosmetic definition. General policy on cosmetic supervises, GMP, industry obligations, advertisements.

The rules to explain the overarching law and detailed the specific act: Enforcement Rules of Cosmetic Hygiene and Safety Act.

Regulations for notification of cosmetic products and Product Information File Management.

Classification of Cosmetics in Taiwan

Cosmetics Definition:

According to the Cosmetic Hygiene and Safety Act, “Cosmetics” means products applied externally to the human body, teeth, or oral cavity mucous membranes, and used to moisturize hair and skin, stimulate the sense of smell, improve body odors, change appearance, or cleanse the body. However, this is not applicable to those that are regarded as drugs in accordance with other laws or regulations.

Classification:

Based on the product’s function, TFDA defines cosmetics as general cosmetics and Specific Purpose Cosmetics (formerly named medicated cosmetics). The specific purpose of cosmetics includes sunscreen, hair-dyeing, permanent waving, antiperspirant, deodorant, tooth-whitening or other purposes. And all other types of cosmetics that fit the definition of cosmetics will be recognized as general cosmetics which may include: skincare, makeup, perfume, oral care products and so on.

 

The product compliance requirements for general and specific purpose cosmetics are different in the current regulatory framework.

 

General Cosmetics Notification + PIF (includes safety assessment reports) Mandatory on 1st July 2021
Specific Purpose Cosmetics Registration Shift to notification + PIF after 1st July 2024

 

Notification and PIF requirements for general cosmetics

The following information is required in order to complete the notification and PIF preparation.

Notification PIF (English version is accepted)
1. Number of products.

2. Chinese and English names of products

3. Category and usage of products.

4. Type of products. Model number and color code for series products.

5. Dosage of products.

6. Precautions of products.

7. Contact information of manufacturers or importers of products.

8. cosmetics Good Manufacturing Practice (GMP) information.

9. Full ingredients of products.

10. Other relevant descriptions.

 1. Basic information of the product: the name of the product, the category of the product, dosage form, purpose, the names and addresses of manufacturing facilities, information of product manufacturers or importers.

2. Evidentiary documents of completing product notification.

3. Full ingredient names and the individual content.

4. The outer packaging of the products, containers, labels or leaflets.

5. GMP compliance certificates or self-declarations which the manufacturing facilities comply with cosmetic Good Manufacturing Practice Regulations

6. Manufacturing methods and procedures.

7. Usage methods, body parts, dosage, frequencies and the targeted population.

8. Adverse effects of the product application.

9. Physical and chemical characteristics of the products and individual ingredients.

10. Toxicological data of the ingredients.

11. The product stability test reports.

12. The microbiological test reports.

13. The antimicrobial effectiveness test reports.

14. Supporting information of the functional assessments.

15. Information about the packaging materials which have contact with the products.

16. Product safety information: Safety evaluation conclusion and suggestion and Qualification certificates

 

 

Registration requirements for Specific Purpose Cosmetics

Once again, specific purpose cosmetics include sunscreen, hair-dyeing, permanent waving, antiperspirant, deodorant, tooth-whitening or other purposes. For imported cosmetics, you need to provide the following information to complete the registration.

  1. A copy of company registration or business registration certificate.
  2. Drafts of product labels, leaflets, and packaging.
  3. The authorization letter issued within the past two years.
  4. The MFSC issued within the past two years.
  5. An ingredient list issued within the past two years.
  6. The certificate of analysis.
  7. For the contract manufacturer, a certificate identifies the relationship between the hiring firm and contract manufacturer.

 

Cosmetics Labeling in Taiwan Cosmetics Regulation

In terms of Cosmetic Hygiene and Safety Act, the outer packaging or containers of cosmetics shall conspicuously label the following information:

  • Product name;
  • Function;
  • Usage and storage instructions;
  • Net weight, volume, or amount;
  • Full ingredient names. For specific purpose cosmetics, the content of specific purpose ingredients contained therein shall be labeled separately;
  • Precautions for use;
  • Name, address, and telephone number of manufacturer or importer; country of origin of the imported product;
  • Manufacturing date and shelf life, or manufacturing date and expiration date, or shelf life and expiration date;
  • Lot number;
  • Other information required to be labeled as per the public announcement of the central competent authority.

Note:

  1. The above requirements shall be provided in Chinese or internationally common symbols excerpt that point 5 may be listed in English.
  2. if it cannot be labeled due to the surface area of outer packaging or container being too small or other special circumstances, said information shall be stated on the label, in the leaflet, or by other means.

 

Ingredients compliance

Please check your ingredient’s compliance before initiate the regulatory compliance procedure. The following list you may need to self-check if your products contain the relevant ingredient types.

Prohibited and Restricted ingredients:

List of Prohibited Ingredients

List of Restricted Ingredients

Positive listing:

List of Preservatives

List of Colorants

Special Usage:

The standard for Usage of Antimicrobial Ingredients in Cosmetics

List of Micro-organisms Limits in Cosmetic Products

List of Specific Purpose Ingredients’ name and usage

 

Download in Taiwan Cosmetics Regulatory Database. ->

Animal Testing

In terms of the Cosmetic Hygiene Act, Taiwan bans cosmetic animal testing for both finished products and cosmetic ingredients since 2019.

Resources

TFDA 
Taiwan bans cosmetics animal testing

Japan Cosmetic and Quasi Drugs Regulation

Roger Ying
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0
Japan Cosmetic and Quasi Drugs Regulation

Japan Cosmetics Regulations

Overview of Japan Cosmetics Regulation

In Japan, cosmetic products are regulated by the Pharmaceutical and Medical Device Agency (PMDA) and the Ministry of Health, Labour and Welfare (MHLW). The PMDA is an independent agency that works together with the MHLW to assess the safety and effectiveness of quasi-drugs and cosmetics.

In November 2014, the Japanese cosmetic market experienced significant changes due to the replacement of the Japanese Pharmaceutical Affairs Law (JPAL) with the new Pharmaceutical and Medical Device Act (PMD Act). The PMD Act defines two categories of cosmetics with different requirements of regulatory compliance: cosmetics and quasi-drugs.

In the below chapters, you will find how cosmetics and quasi-drugs are regulated and what needs to do in order to comply with the law.

Cosmetics Definitions and Classifications

Cosmetic definition in Japan:  Articles with mild action on the human body, which are intended to be applied to the human body through rubbing, sprinkling or other methods, aiming to clean, beautify and increase the attractiveness, alter the appearance or to keep the skin or hair in good condition.

Quasi drug definition in Japan:

    1. Preventing nausea and other discomforts.
    2. Preventing heat rash, soreness, etc.
    3. Encouraging hair growth or removing hair, or
    4. Exterminating and preventing mice, flies, mosquitoes, fleas, etc.

 

As defined above, the act divides cosmetics based on the functions, the following table shows the main classification of cosmetics and quasi-drugs.

 

Cosmetics Quasi Drugs
Perfume and eau de cologne

Makeup cosmetics

Skin care cosmetics

Hair care products

Special-purpose cosmetics:

 

Sunscreen and shaving cream

Soaps

 Deodorants, depilatories, hair growth treatments, hair dyes, perm and straightening products, as well as medicated cosmetics, such as whitening products, anti-aging products and oily skin or acne treatment products.

How to import cosmetics to Japan

Before we talk about the procedures of the importing, it is important to arise your attention to a specific role: importers. It is crucial to understand that importers of your products shall assume all quality assurance and product liability for cosmetics, which means your primary importer will handle most of the compliance jobs locally before import products into Japan.

Therefore, picking up a right importer will be a key point to your successful importing cosmetics to Japan.

First of all, your primary importer should acquire a license called: “cosmetics manufacturing and sales license”. The sales business refers to the act of selling, renting, or lending of manufactured or imported cosmetics.

In order to obtain the license, the importer needs already built a product safety and quality management system for its company which shall be consisting of naming three persons(or one person with three titles) in charge (a Marketing Supervisor, a Quality Supervisor and a Safety Control Supervisor). Those persons have to implement a set of standards called Good Quality Practice (GQP) and a Good Vigilance Practice (GVP), as well as undertake appropriate actions for safety management.

After you appoint the importer of your products, we need to ensure that the products are in accordance with the law in Japan. This assessment is performed on samples of the products by “testing and inspection facilities” designated by the MHLW. It basically consists of checking the list of ingredients and analyzing the ingredients of cosmetics for safety.

Once the formula has been checked and products have been tested, the importer will fill three forms to competent authorities: a Manufacture and Sales of Cosmetics Notification, a Cosmetics Import Notification for Manufacture and Sales and the manufacturer’s or importer’s brand name. Those forms will be kept with a record of the testing and inspection results verifying that the product does not contain any prohibited combination.

After the three forms are prepared properly, your products will be ready for importing to Japan and the importer will handle the rest of the matters.

How to import Quasi-drugs to Japan

For the quasi-drugs are actually special functions of cosmetics in Japan, the application process for product compliance is almost the same with cosmetics but with more strict requirements on both products and your importers. You need to appoint your importer as a drug marketing authorization holder (MAH) in Japan who performs all procedures with the MHLW on behalf of the applicant for the application of the marketing approval. The MAH must have three persons as roles of quality representative, medical safety officer, and General manager who are qualified to take responsibility for selling the quasi-medical related products in Japan.

Therefore, you should be aware that an experienced distributor for your products importing to Japan is a vital initial.

Cosmetics Labeling

All the information must be expressed in Japanese and must be clearly and explicitly listed. Labeling with false or potentially misleading expressions, and unapproved claims of effect-efficacy in labeling are prohibited. The items that should be indicated for cosmetics are as follows:

  • Name and address of the importer
  • Address of the office where the Marketing Supervisor serves (if this office is
  • outside Japan: name and country of foreign approval holder; name and
  • address of the nominated importer).
  • Brand name Name for which notification has been posted for importation.
  • Manufacturing number or code
  • List of full ingredients (descending order by quantity)
  • Expiration date
  • Other items specified by the MHLW Ministerial Ordinance

Note: Ingredients’ names shall be translated into Japanese from the International Nomenclature of Cosmetic Ingredients (INCI) names as well. The Japan Cosmetic Industry Association (JCIA) offered a “List of Cosmetic Ingredient Label Names” in Japanese. This list is available in Japanese only here:
Access to Japan Cosmetics Regulatory Database. ->

Reference

List of Cosmetic Ingredient Label Names

 

Malaysia Cosmetic Regulation Guide

Roger Ying
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0
Malaysia Cosmetic Regulation Guide

Malaysia Cosmetics Regulation

Malaysia Cosmetics Regulations

Cosmetic products in Malaysia are regulated under the Control of Drugs and Cosmetics Regulations (CDCR) 1984 is associated with the agreement of the ASEAN Harmonized Regulatory Scheme and the regulation ASEAN Cosmetic Directive. Since 2008 January 1st, importing cosmetic products to Malaysia is required to complete a cosmetics notification procedure to the Director of Pharmaceutical Services (known as DPS) through the National Pharmaceutical Regulatory Agency (NPRA). False declaration or products do not make full compliance with the stipulated regulations and guidelines will be not allowed to sell in the market.

Cosmetics Notification

Cosmetic notification is submitted online via the Quest 3+ system. Notified cosmetics does not mean it is being approved. Product notification is a process that requires companies to be responsible for the product information submitted to NPRA on their products marketed in Malaysia.

Cosmetics Notification Holder

Similar to the EU responsible person, the company that notifies the products will be known as Cosmetic Notification Holder (CNH) who is responsible to ensure the products meet all stipulated regulations and guidelines for Cosmetics products. The responsibility also includes PIF holding (including updated information/document on product quality, safety and claimed benefit is available and accessible upon request.), post-market surveillance, product recall, etc.

The Guideline for Control of Cosmetic Products in Malaysia is available on the NPRA website or Malaysia Cosmetics Regulations Database.

Product Information File (PIF) and Safety Assessment

The PIF can be either in hardcopy or in an electronic format written by Bahasa Malaysia or English. Notification Holder shall keep it updated for all changes made to the notified product such as new ingredients, manufacturers, raw material suppliers, and production processes. Date of document revision, where appropriate shall be stated for verification.

Notification holder shall ensure the safety assessment has been conducted for each product to ensure the products must not cause damage to human health when applied under normal or reasonably foreseeable conditions of use.

Since ASEAN Cosmetic Directive has similar core features as EU regulation, most of the materials can be applied to the PIF includes safety assessment if you have done the EU notification.

Please refer to Annex I, part 12 – Guideline for Product Information File (PIF) and Annex I, part 6 for Guideline for Safety Assessment of Cosmetic Product, to make sure if any difference is required.

 

Labeling Requirements

Notification Holder shall ensure that the label of the cosmetic products complies with the labeling requirements as defined in Annex I, part 7: Cosmetic Labeling Requirements.

The information on the label shall be in Bahasa Malaysia and/or English, and the following is the list of the labeling requirements.

  1.  The name of the cosmetic product and its function
  2. Instructions on the use of the cosmetic product
  3. Full ingredient listing
  4. Country of manufacture;
  5. The name and address of Notification Holder
  6. weight or volume
  7. batch number
  8. The manufacturing or the expiry date of the product
  9. Special precautions to be observed in use
  10. The valid contact number of the CNH

Cosmetics Claims

The CNH shall provide scientifically accepted protocols or study designs in generating technical or clinical data with justification.

More importantly, the claims on medicinal in nature or beyond the cosmetic scope are not allowed on the label.

A guidance document on the cosmetic claim is available in Annex I, part 8: Cosmetic Claims Guideline.

Good Manufacturing Practice (GMP)

All cosmetic products must be manufactured in accordance with the Guidelines for Cosmetic Good Manufacturing Practice or its equivalent. For the foreign manufacturers, documentation to prove GMP compliance is to be made available upon request by the NPRA.

Post-Market Surveillance of Cosmetic Products

It is important to notice that the Malaysian government established post-market surveillance (PMS) to ensure the compliance and safety of cosmetics after sell on its markets.

The main PMS activities for cosmetics include:

  • Screening of product formulation and information to ensure that cosmetics do not contain any prohibited or harmful substances and all restricted ingredients are used within the allowable limits and conditions of use. Screening criteria also include the product name and its claimed benefits
  • Sample collection and testing
  • Monitoring of label compliance
  • Audit of premises for compliance to the Cosmetic GMP
  • Handling of product complaints
  • Monitoring of advertisements
  • Monitoring of adverse reactions
  • Audit on the PIF
  • Risk communication
  • Information sharing through ASEAN Post Marketing Alert System (PMAS)

If a product is found to be non-compliant to the stipulated guidelines and regulations, the NPRA will take necessary actions such as cancellation of the product’s notification and/or recall of the product from the market.

 

Access ASEAN Cosmetics Regulatory Database. ->

Access Malaysia Cosmetics Regulatory Database. ->

Reference

https://www.npra.gov.my/index.php/en/cosmetics-guideline-annex-i-vii

https://www.npra.gov.my/index.php/en/cosmetic-main-page.html

 

South Korea Cosmetic Regulation – The Cosmetics Act

CN.News
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South Korea Cosmetic Regulation – The Cosmetics Act

This article aims to provide you a general understanding of how South Korea cosmetics are regulated. Due to the major change of the overarching cosmetic regulation (South Korea Cosmetics Act) in 2019, this article suits the readers who is already in or planning to enter the South Korea cosmetics market.

Korea Cosmetics Regulations

Overview of the Cosmetics Act

The cosmetic products sold in South Korea are regulated by the Ministry of Food and Drug Safety (MFDS) under the regulation that it’s published: Cosmetics Act. It is the overarching regulation as well as with the Cosmetics notice from the Korean government.

According to the Cosmetic Act, cosmetic products in Korea are divided into General cosmetics and Functional cosmetics. Two categories are required to register in different authorities. South Korea Pharmaceutical Traders Association (KPTA) is responsible for general cosmetics registration and usually will take 7 days to complete the process. And Ministry of Food and Drug Safety (MFDS) is in charge of the functional cosmetics safety evaluation and registration which usually will take 4 to 6 months to complete the application.

An important role called Marketing Authorization Holder (MAH) is introduced in the article which will be responsible for all your importing and registration process.

 

Regulatory Framework

There are two major authorities you may be dealing with when importing cosmetics to South Korea. Ministry of Food and Drug Safety (MFDS) and South Korea Pharmaceutical Traders Association (KPTA). The cosmetics importing and trading will be governed by KPTA and the MFDS is responsible for make the cosmetic regulations and registering functional cosmetics.

Overarching regulation: Cosmetics Act, it provides definitions of cosmetic definition. General policy on cosmetic supervises, GMP, industry obligations, advertisements.

 

The rules to explain the overarching law and detailed the specific act:

  • Enforcement Decree of Cosmetics Act
  • Enforcement Rule of Cosmetics Act

Products and Ingredients safety rule:

  • Regulation on Safety Standards for Cosmetics

 

Cosmetics Definition in Cosmetics Act:

According to Cosmetics Act, the term “Cosmetics” defined as any item intended to be used by means of spreading, rubbing, spraying on or otherwise applied to the human body for cleansing, beautifying, promoting attractiveness or brightening the appearance, or maintaining or improving the health of skin and hair, which have light effects on the human body”.

The term “functional cosmetics” means cosmetics prescribed by Ordinance of the Prime Minister, falling under any of the following:

  • whitening of the skin;
  • improving wrinkles in the skin;
  • tanning skin gently or protecting skin from ultraviolet rays;
  • changing or removing the color of hair, or nourishing hair;
  • preventing or improving dryness, splits, loss, cornification, etc. resulting from weakened functions of skin or hair;

 

Classification:

In terms of the cosmetic definitions above, cosmetic products are divided into general cosmetics and functional cosmetics. The following table will help you to classify your products category.

General Cosmetics Skin Care

Hair Care
Functional cosmetics 1) Whitening product

2) Anti-wrinkle product

3) Sunscreen products

4) Hair Dye products (permanent hair dye products are excluded)

5) Other products fit the definition above

 

Besides, please be aware that some of the products may not fall into the cosmetics category and will be categorized as Quasi Drug which will show the following:

  • Sanitary napkins
  • Anti-hair fall products,
  • Hair dye (Permanent hair dye)
  • Toothpaste
  • Mouth Refreshers
  • Hand sanitizer
  • Antiperspirant Antiseptic

 

The role of Marketing Authorization Holder (IMPORTANT)

According to the Cosmetic Act, a Marketing Authorization Holder System has been introduced to charge of the cosmetic products registration, importing and marketing in South Korea Markets. The Marketing authorization holder (MAH) can be your primary importer or a third-party company like a registration agency or shipping and warehousing company but only they have granted the MAH License from MFDS.

Let’s take a look at how the Cosmetic Act defines the responsibility of the role of MAH:

(Article 11 of the Regulation)

  1. Marketing Authorization Holder shall comply with the Quality Control Standards
  2. Marketing Authorization Holder shall comply with the Good Safety Practice Standards
  3. Marketing Authorization Holder shall keep the product master file and quality control standards submitted by manufacturers.
  4. Marketing Authorization Holder shall prepare and keep import control records on imported cosmetics.
  5. Sales after quality control test by batch
  6. Import permission by KPTA through the electronic document interchange (EDI) method for customs clearance.
  7. New data and information obtained in regards to the safety and efficacy of products that can affect the public health (including case reports of side effects from using cosmetic products) shall be reported and necessary safety measures are taken.

 

Registration for General and Functional Cosmetics

 

Required Documents Authority Period Responsible Person
General Cosmetics Registration formula

Free sales certificate

BSE certificate

batch Nos

 KPTA 7 days MAH
Functional Cosmetics Specification of the finished product

Assay and identification method of active ingredients in the product

Samples

Formula

Efficacy Data

Other documents are required by MFDS

 MFDS 4~6 Months MAH

 

Ingredients Requirements in the Cosmetics Act

Negative ingredients list for cosmetics are provided as follows:

  • Forbidden ingredients
  • The restricted usage ingredients list of Sterilization & Preservative, UV filters, and Other functional ingredients.

Marketing Authorization Holders should annually report the ingredient list used in cosmetics to MFDS and MFDS develops Database on the ingredient list.

 

Labeling Requirements in the Cosmetics Act

Korean labeling with volume contents of 10g and less:

  1. Name of product
  2. Name of Marketing Authorization Holder and Manufacturer
  3. Lot No.
  4. Expiry date or PAO(In case of indicating PAO, mfg. date should be labeled together with PAO)

 

Korean labeling with volume contents over 10g:

  1. Name of product
  2. Name & address of MAH and Manufacturer
  3. Name of all ingredients (descending order) for exceeding 50ml(g)
  4. Name of designated ingredients* for exceeding 10ml(g) and 50ml(g) and less
  5. The volume or weight of contents (It should be ml or g.)
  6. Price
  7. In case of functional cosmetic, the word of “기능성화장품” (functional cosmetic)
  8. Cautions in use that is designated by enforcement regulation of cosmetic law
  9. In the case of functional cosmetic, efficacy, how to use, cautions approved by MFDS
  10. Bar code
  11. Call center information and homepage address and phrase(“Exchange or refund if the product has problems”)

 

Animal Testing

Animal testing on cosmetics and ingredients is banned in South Korea in 2017 under the law of the Cosmetics Act.

 

Download Cosmetics Act at South Korea Cosmetics Regulatory Database. ->

Reference

Korea MFDS

 

Philippines Cosmetic Regulation Guide

Maggie Cheung
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0
Philippines Cosmetic Regulation Guide

Philippines Cosmetics Regulations

Philippines Cosmetics Regulation

As a member of the ASEAN, the Philippines Cosmetics Regulation is under the ASEAN Harmonized regulatory Scheme and is required to implement the cosmetic notification and Product information files preparation under the supervision of the Philippine Food and Drug Administration (FDA).

It is important to know that businesses involved in the importation, exportation, trading, and distribution of food, drinks, drugs, pharmaceuticals, cosmetics, or medical devices in the Philippines need to obtain a license to operate (LTO) and a certificate of product registration (CPR) from the Food and Drug Administration (FDA).

What is an LTO?

An LTO allows you to legally import, distribute, sell and manufacture food, drugs, cosmetics, and medical devices. It is also a requirement before you can obtain a Certificate of Product Registration (CPR) that indicates the products complies with the health, safety, and technical standards of the Philippines FDA.

Operating without a license or violate the principle of LTO,  the business will be suspended and the LTO license may be canceled, or disapproved upon renewal. Existing licenses that were not renewed after 120 days from the date of expiration will be automatically canceled by the Philippines FDA.

Consider the company with LTO is like EU responsible person that required a certificate from FDA to operate cosmetic importing and distribution business. It could be your distributor or subsidiary in the Philippines.  Therefore, it is necessary to check the qualification of your distributor before making the decision to appointing any legal entity to represent your brands locally if you don’t have a subsidiary locally.

Cosmetics Notification and Registration

Exporting cosmetic products to the Philippines shall complete the online notification procedure first according to Philipines FDA before the products are placed in the market.

Submission of the cosmetics notification application shall be done using the FDA E-Portal, accessible through FDA official website https://ww2.fda.gov.ph. The process is necessary to be done by the LTO holders and to be ensured that the notified products meet the requirements of the ASEAN Cosmetic Directive, its annexes, and appendices.

Product Information File (PIF)

As mentioned above, the Philippines cosmetics regulation follows the ASEAN Cosmetic Directive (ACD) that requires the LTO to keep a Product Information File for the Philippines FDA inspection after the successful notification. The PIF can be recorded as a printed or digital version and necessary to be updated if any change of the notified product.

Please read the article of “ASEAN Cosmetics Directive Overview” to understand further of ASEAN Harmonized Regulatory Scheme that Philippine follows.

Cosmetics Labeling

The following information should be listed on the labels of the products:

  • Product content in weight/volume
  • Brand and product name along with the function
  • Batch number
  • Manufacturing/expiry date of the product in clear terms like month/year
  • Country of Manufacture
  • Instructions/Directions for use
  • List of all ingredients
  • Special precautions
  • Name and address of company or person who placed the product on the market

Cosmetics Ingredients

The cosmetics ingredients safety requirements of the Philippines are complete follows ASEAN cosmetic regulations. Please check the following links to download the ingredients lists requirements.

Access ASEAN Cosmetics Regulatory Database. ->

Access Philippines Cosmetics Regulatory Database. ->

Reference

  1. APPLICATION GUIDELINES FOR LICENSE TO OPERATE (LTO) FOR ENDS/ENNDS PRODUCTS
  2. Philippines Food and Drug Administration
  3. How to Apply for FDA LTO (License to Operate) in the Philippines

Vietnam Cosmetics Regulation Guide

Maggie Cheung
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0
Vietnam Cosmetics Regulation Guide

Vietnam Cosmetics Regulation

Vietnam Cosmetic Regulation completely follows the ASEAN Cosmetic Directive as a member country of ASEAN. The cosmetic products are regulated by the Drug Administration of Vietnam (DAV) under the Vietnam Ministry of Health (MOH).  To sell your products to the Vietnam market, you first need to go through a cosmetics registration procedure of proclamation and obtain a valid proclamation receipt number for each type of product.

Guide on Cosmetic Regulation in Vietnam

Cosmetics Definition in Vietnam

In Vietnam, Cosmetics are defined as substances or a preparation used for touch with the outer parts of a human body (skin, hair system, fingernails, toenails, lips, and external reproductive organs) or teeth and mouth mucous membrane, whose purpose is to cleanse, aromatize, change the external characteristics or form, adjust body smell, safeguard body, or maintain the human body to always be in a good condition.

If there are any differences in a cosmetic product’s shape, color, or ingredients, all variations need to be registered as separate items. For example, different shades of lipstick require separate registration.

Cosmetics Proclamation

Cosmetics proclamation in Vietnam can be done by a local business entity who is the brand owner or appointed a company by the brand owner with the function of the cosmetic business in Vietnam. In this case, for any foreign cosmetic brands, it is necessary to set your local subsidiary or appoint a local partner who has permission to trade cosmetic products in Vietnam.

Once you have set your local company or appoint a local partner, you can need to prepare and submit the following documents to proceed with your product registration in Vietnam:

  • Proclamation report of cosmetics
  • Company registration certificate (Copy)
  • The power of attorney of the producer/owner of the product (original or notarized copy)
  • Free sales certificate
  • Product Information File (PIF) for every product

The PIF includes:

  • Administrative documents and a summary of the product
  • Material quality
  • Product quality
  • Safety and efficiency

Once the proclamation is completed, the Ministry of Health will issue a cosmetic product proclamation receipt for each of the products. The registration number is valid for five years since the issuance date. If you wish to extend your product sales upon its expiration, you are required to register before the expiration date.

Vietnam Cosmetics Registration ProcessVietnam Cosmetics Registration Process

Labeling requirements

The labels must be written in English or Vietnamese and include the following information:

  • Name of the product and its functions
  • Usage instructions
  • The full formula of ingredients
  • Country of origin
  • Name of the distributor
  • Quantification
  • Batch number
  • Manufacturing or expiration date
  • Warnings and precautions

Products Safety Requirement

Cosmetics are necessary to be assessed and evaluated product safety following the ASEAN safety guideline and attributes specified in Annex 06-MP. There are restrictions set out for heavy metals and microbial parameters in cosmetic products. All other requirements concerning cosmetic ingredients can be found in the latest version of the ASEAN Cosmetic regulation. The organization or individuals who are responsible for putting products on the market are organizations are also responsible for the safety, effectiveness, and quality of the product.

Access ASEAN Cosmetics Regulatory Database. ->

Reference:

Vietnam DAV

ASEAN Cosmetic Directive

Roger Ying
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1
ASEAN Cosmetic Directive

ASEAN Cosmetic Directive (ACD) is a regulation that ASEAN members are agreed to harmonize the regulatory requirements for all cosmetics products in ASEAN area in order to keep the safety and quality of the products and to eliminate the trade barriers between countries.

What is ASEAN Cosmetic Directive?

The Association of Southeast Asian Nations (ASEAN) is a united trade group consists of 10 countries: Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand, and Vietnam.

ASEAN Cosmetics Directive

As a trade group, members are agreed to harmonize the regulatory requirements for all cosmetics products in ASEAN area in order to keep the safety and quality of the products and to eliminate the trade barriers between countries. Therefore, a regulation called ASEAN Cosmetic Directive has been published and came into force in 2008.

If you have experienced EU cosmetics, the ASEAN Cosmetic Directive is quite familiar to you for the regulation is referred to as some core features from EU Cosmetic Directive and the EU Cosmetic Regulation 1223/2009. It means you are capable to apply the EU technical documents directly to ASEAN cosmetic compliance such as product information files (PIF) along with Cosmetic safety assessment report (CPSR). But there are differences, unlike the EU, the ASEAN Cosmetic Directive is not directly regulated in each member countries and it allows themselves to implement under the regulatory schema. This will be causing potential inconsistencies in the directive implementation. And more importantly, Unlike in the EU, where one notification covers all of the EU countries, products are necessary to do the notification/registration separately in each country.

What kind of products are defined as Cosmetics in ASEAN Cosmetic Directive?

The ASEAN Cosmetic Directive defines cosmetic products as: “any substance or preparation intended to be placed in contact with the various external parts of the human body (epidermis, hair system, nails, lips, and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance and/or correcting body odors and/or protecting them or keeping them in good condition”.

Follow the above definition, there are some examples that will be categorized as cosmetic:

  • creams, emulsions, lotions, gels, and oils for the skin (such as the hands, face, and feet);
  • face masks (other than chemical peeling products);
  • tinted bases (liquids, pastes, and powders);
  • make-up powders, after-bath powders, and hygienic powders;
  • toilet soaps and deodorant soaps;
  • perfumes, toilet waters, and Eaux de cologne;
  • bath and shower preparations (such as salts, foams, oils, and gels);
  • depilatories;
  • deodorants and antiperspirants;
  • hair care products, including:
  • hair tints and bleaches;
  • products for waving, straightening and fixing;
  • setting products;
  • cleansing products (lotions, powders, and shampoos);
  • conditioning products (lotions, creams, and oils);
  • hairdressing products (lotions, lacquers and brilliantines);
  • shaving products (for example, creams, foams, and lotions);
  • products for applying make-up to, and removing it from, the face and eyes;
  • products intended for application to the lips;
  • products for teeth and mouth care;
  • products for nail care and make-up;
  • products for external intimate hygiene;
  • sunbathing products;
  • products for tanning without the sun;
  • skin-whitening products; and
  • anti-wrinkle products.

 

ASEAN Cosmetic Directive Compliance Framework

Basic of Cosmetics regulatory requirement

  • Must not cause damage to human health when applied under the normal or reasonably foreseeable condition of use
  • The manufacturer has to gather the necessary technical information
  • Component & finished product evaluated for the aspect of safety
  • Products produced under GMP
  • Safety data available
  • Labeling meets requirement

ASEAN Cosmetics Notification

Cosmetic brand owners, manufacturers, and importers must follow the specific member state’s procedures for product registration and notification. In order to comply with the requirements of importing and marketing of different countries, products need to notify the products in each country.

Responsible person

Like EU cosmetic standard, each product needs to have a responsible person that cooperates with the notification and takes responsibility for the safety of products and to keep the product information file readily accessible to the regulatory authority. Again, you need to appoint the responsible person for placing the cosmetic products on the market in each individual ASEAN member country. And the company must be located in that country and must notify the local regulatory authority of that country.

Product Information Files and Safety assessment

ASEAN has issued the ‘Guidelines for Product Information Files’ and ‘Guidelines for the safety assessment of a cosmetic product’ to aid the brands to comply with the regulation. Although most of the features are consistent with EU, you still should check with your local responsible person in each country to ensure the structure or supplement has slightly different.

Labeling requirements

The following names and claims should be put on the labels of products.

  1. Product name & its function
  2. Use instruction
  3. Ingredients listing
  4. Country of manufacturer
    Eg :  Made in Malaysia
    Manufactured in USA
    Country of origin:  Thailand
  5. Content (mg or ml)
  6. Batch number
  7. Mfg. or expiry date
  8. Additional statement
  9. Declaration of porcine and bovine origin.
    Eg : This product contains an ingredient of pork origin/beef origin

Animal Testing Status

Although ASEAN requires mandatory safety assessment like EU, it has no formal regulations on animal testing. The responsibility for the safety or any testing on cruelty-free or not totally relies on the company.  But each country may have its own policy regarding testing.

 

Access ASEAN Cosmetics Regulatory Database. ->

 

Reference:

HSA: ASEAN Cosmetic Directive

China Public consulting on microbeads ban in Cosmmetics

CN.News
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China Public consulting on microbeads ban in Cosmmetics

On April 10, the National Development and Reform Commission of China (NDRC) issued an announcement for public comment on the “Catalogue of Plastic Products Prohibited and Restricted for Production, Sales, and Use (Draft for Comment)”. In the draft for comments, daily chemical products containing plastic microbeads are listed as prohibited plastic products. In this action, the cosmetics products also will be categorized as daily chemical products and banned the microbeads being used in the products.

Any comments can be submitted through the NDRC website as the following links.

Source:

NDRC Comments Website

Catalogue of Plastic Products Prohibited and Restricted for Production, Sales, and Use (Draft for Comment)

Taiwan FDA Notice to amend the “Restriction of Use of Cosmetic Pigment/Colorants Ingredients”

CB Lab
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Taiwan FDA Notice to amend the “Restriction of Use of Cosmetic Pigment/Colorants Ingredients”

On 06, April 2020, Taiwan FDA releases the draft of the amendment on “Restriction of Use of Cosmetic Pigment (Colorants) Ingredients“.  Following changes will be implemented:

  • A total of 77 components such as CI 10006 were added.
  • A total of 35 components such as CI 10020 were revised.
  • Delete CI 21110, CI 45425, CI 45425: 1, CI 77013.
  • Add the “Restriction” field, add a new limit, and cannot be used in some product types.

If the color components of the original specific-purpose cosmetics do not comply with the revised “Restriction Form for the Use of Cosmetic Color Components”, the license holder shall complete the changes by June 30, 2010.

For any comments or amendments to the content of this announcement, please submit it at the following web within 60 days from the day after the announcement of this amendment.  (web1/web2)

 

Download the Original Copy Here. 

Taiwan FDA cease to apply 21 lists of ingredients usage standards

CN.News
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Taiwan FDA cease to apply 21 lists of ingredients usage standards

Due to the new cosmetic regulation and safety technical standards are taking effect, Taiwan FDA announces on April 1, 2020 that 21 lists of ingredients for the usage control standards such Polyacrylamides usage control standards are ceased to apply anymore.

Download the ceased 21 lists from TFDA here.

Check the new cosmetic regulation and ingredients safety standards in Asia Cosmetic regulatory database.

 

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