In order to promote the large demand for the importing of Hand sanitizers in Philippines, Philippines FDA introduces COSMETIC LABELLING REQUIREMENTS FOR RUBBING ALCOHOL AND HAND SANITIZERS. Please see the above pictures for details.
Or you can download the pictures from here.
As related to the previous announcement, the Ministry of Food and Drug Safety amends the Cosmetics Act (Act No. 16298, enacted on June 1, 2020), and as the obligation to prepare safety data for each product for infants and children。
The administrative notice of the proposed rule (draft) detailed on the necessary preparation and storage, etc. for the safety data of cosmetics used by infants and children.
If you have any opinions regarding the proposed notice (draft), please fill out the written opinion in the form of Attachment 2 until Tuesday, June 23, 2020. ( Assistant : Team Dahee Yang, e-mail: dhyang@kpta .or.kr ).
Attachment:
Access Korea Cosmetics Regulatory Database for more information.
The Ministry of Food and Drug Safety amends and implements the Cosmetics Act (‘20.3.14.’). In the amendment, the customized cosmetics sales business system was introduced, details such as reporting procedures and compliance matters for customized cosmetics sales targeting related businesses, etc.
In order to guide the business, KPTA prepared the “Customized Cosmetics Sales Guideline (Civil Complaint Guide)” as attached for the related business owners.
Tmall Global is one of the largest B2C Cross-border eCommerce platforms in China. It allows international brands to sell products under the Cross-border Trade policy which can be free from large time and cost consuming to overcome legal regulation barriers. It is a suitable channel for companies to test the brands in the China market and it also offers different business solutions for merchants entering the market with minimum cost and time-consuming.
Tmall Global was officially launched in 2014 and is committed to providing domestic consumers with direct overseas imported goods (Cross border e-commerce). At present, more than 25,000 international brands have settled in 92 countries and regions around the world, covering more than 5,100 categories such as maternal and child care, beauty, health care, and food.
In 2019, cross-border e-commerce ushered in a major outbreak. In response to the country ’s large import strategy and meeting the growing user demand, Tmall Global announced that it will continue to increase investment to achieve import coverage in more than 120 countries and regions within 5 years Commodities expanded from 4000 categories to more than 8000 categories.
With the fast growth of e-commerce and digitization payment, China becomes the largest online retail market in the world. Chinese consumers prefer to spend money on quality and cost-effective products. Therefore, the demand for good quality imported products has resulted in a booming cross border eCommerce (CBEC) market.
To expedite the growth of the cross border eCommerce market and eliminate the traditional trade barriers such as regulation registration, the Chinese government has been consistently working towards making the environment more favorable for cross border eCommerce in the last few years.
In 2018, the first grand opening of China International Import Expo, China government stated that it will be more than US$30 trillion worth of goods and US$10 trillion worth of services imported from oversea in the next 5 years.
Also, the decrease of regulation cost across import taxes, registration, Custom clearance, storage, and increasing the per-order purchase limit/ total purchase limit per year of a consumer is another effort from the Chinese government to boost the CBEC business in China.
Tmall Global with many other CBEC platforms was born under such an environment, the following article will fully explain the details of Tmall Global.
In general speaking, Tmall Global helps brands enter the Chinese market through cross-border e-commerce channels with limited regulation requirements and a minimum quantity of sales. Tmall Helps brands that are already established in China and looking for large sales to Chinese consumers. Following are listed the main differences:
After the outbreak of the COVID-19, the National Pharmaceutical Regulatory Division (NPRA), Ministry of Health Malaysia (MOH) regularly receives inquiries regarding hand sanitizer/hand rub. The following is a list of frequently asked questions and explanations of hand sanitizer.
Q1: What is the category of hand sanitizer product, is it classified as a cosmetic or generic product (Non-Scheduled Poison / OTC; Over-The-Counter)?
A1: Hand sanitizer can be divided into two categories depending on the following conditions:
hand sanitizer for the purpose of hand hygiene ( for general hand hygiene ) is classified as cosmetics. Here are the regulatory requirements that must be met before importing, manufacturing, or marketing cosmetics products:
iii) manufactured products that meet the requirements of Good Manufacturing Practices (APBs) for cosmetic or equivalent products.
Hand sanitizer/hand disinfectant/hand surgical scrub used in health facilities for use by health practitioners before or after performing treatment procedures is classified as a generic product (Non-Scheduled Poison / OTC). The following are the regulatory requirements that must be met before importing, manufacturing, or marketing OTC products:
iii) the indication sought based on the evidence documented in references such as standard pharmacopeia / standard pharmaceuticals reference and so on.
Q2: If my product is categorized as cosmetics, what should I do before importing, manufacturing, or marketing the product?
A2: The company must first notify the National Pharmaceutical Regulatory Division (NPRA), Ministry of Health (MOH). These notifications can only be done online using the QUEST3 + system.
The notification procedure can be found on the Guidelines for Control of Cosmetic Products in Malaysia (available for download from NPRA’s official portal, www.npra.gov.my).
In general, the notice period for cosmetic products is 1 day. However, the notification holder company is reminded to ensure that all documents especially regarding safety, quality and product effectiveness are available for further NPRA verification, if necessary. Failure to comply with this may result in the rejection or cancellation of the notification. For revoked notifications, the product is no longer allowed to be in the market.
Q3: What does a cosmetic product notification mean? Does this mean that my product has been approved by MOH?
A3: Notification means the declaration of compliance by the holding company to the rules, requirements, and guidelines set for cosmetic products. As such, the company takes the responsibility to ensure that the product is evaluated and made safe, quality, and effective before it is marketed. Therefore, it is not a form of approval by MOH. Informed Products will be monitored from time to time and regulatory actions will be taken against products that do not comply with the rules.
Q4: What active ingredients should be in hand sanitizer formulations that are classified as cosmetic products?
A4: Hand sanitizer for certified cosmetics should contain at least 60% alcohol (ethanol or ethyl alcohol). For non-alcohol based sanitizers, sufficient documentation and scientific evidence is required to support the claims made on the label. The failure of the company to submit supporting documents within the stipulated period will result in the refusal or cancellation of the notice. For revoked notifications, the product must be withdrawn from the market.
Q5: What are the permitted claims for hand sanitizer classified as cosmetic products?
A5: Hand sanitizer classified as cosmetics is for hygiene purposes. However, antibacterial claims are also allowed for cosmetic products as additional claims. However, claims such as disinfectant, antiseptic, antimicrobial, antivirus, antifungal, virucidal, reference to specific bacteria, or germicidal causes are not allowed for cosmetic products.
Q6: How to check if a product has been certified or registered with NPRA?
A6: Product notification/registration status checks can be made on the NPRA official portal www.npra.gov.my or through the NPRA Product Search application.
Q7: Are disinfectants used in tools or surfaces / workplaces also classified as cosmetic products?
A7: No. Products disinfectant used to disinfect the poultry or disinfecting medical devices are classified as medical device products. The product must obtain approval from the Medical Devices Authority (PBPP) before being allowed to go on the market. Products disinfectant used to disinfect all types of surfaces ( surfaces ) or the workspace is also classified as a general-purpose product ( general consumer product ).
Q8: What is the recommended use of hand sanitizer for users?
A8: Hand sanitizer is advised to use only when there is no soap and water. Handwashing with the right soap and technique for 20 seconds is very effective in maintaining hygiene while also helping to prevent the spread of diseases such as COVID-19.
Q9: If I have adverse effects or unwanted effects of using hand sanitizer, where can I report?
A9: Complaints of adverse effects or unwanted effects may be forwarded to [email protected] .
Source: Q & A Hand Sanitizer
Since the articles on Cosmetic Safety Standards were partially amended on October 17, 2019, Korea Pharmaceutical Traders Association(KTPA) notify the new amendment for the use of raw materials that cannot be used in cosmetics and restrictions on their use (such as methyl isothiazolinone ) have been applied and enforced as of April 18, 2020.
You should check the relevant regulations and report the standard customs clearance information (including raw material list report) in time.
Access Korea Cosmetics Regulatory Database for more information.
Importing cosmetics to Indonesia are controlled by the BPOM (Food and drug controlled board) under the agreement of the ASEAN Harmonized Regulatory Scheme and the regulation ASEAN Cosmetic Directive. It is regulated that cosmetic products, including personal care and toiletries, imported to and sold in Indonesia must be registered at BPOM first. And worth to mention that, as a Muslim country, to obtain a Halal certificate also is an important step to success in the market.
As regulated by BPOM, you must have an ONLY legal entity established under the Indonesian Law to register cosmetic products in Indonesia. The legal entity could be your local distributor or subsidiary with a registered import license for Indonesian customs.
Please be aware that the legal entity will be your only representor of your notified products in the Indonesian market during the effect time. This means, after notification, an automatic exclusivity on the products even there is no exclusive agreement signed. The product licenses will be granted to the company and no one can make another registration of the products on other distributors unless with the company’s approval. Therefore, choosing a correct local partner will be your crucial step if you don’t prefer to register a subsidiary in Indonesia.
In order to register your products and open an online application account, the local agency shall submit the following documents to BPOM, and some of them like GMP, COA, LOA will require your support.
After the successful registration of your products, you will receive a notification from the BPOM. BPOM will issue the notification number within 14 working days and it will be valid for three years. But please note that you must import the notified products within 6 months in order to keep your product registration valid. Also, you have to comply with further requirements such as preparing your product information database and labeling your products correctly before selling them in Indonesia.
For each notified product, a Document of Product Information (DIP) should be prepared in order for BPOM auditing.
DIP is the data about the quality, safety, and benefits of cosmetic products. It should be kept for a minimum of 4 (four) years after the cosmetics are manufactured or imported.
It consists of the following information in English or Indonesian:
Labeling on the package should be composed as the following format:
Note: Usage & direction of use should be in Indonesia language
Access ASEAN Cosmetics Regulatory Database. ->
Access Indonesia Cosmetics Regulatory Database. ->
In Singapore, cosmetic products are regulated by the Health Sciences Authority (HSA) under the Health Products Act and its Health Products (Cosmetic Products — ASEAN Cosmetic Directive) Regulations 2007. The Regulations are in line with the ASEAN Cosmetic Directive (ACD), which adopts similar regulatory principles and requirements as the European Union (EU) regulations on cosmetic products. Cosmetic products in Singapore must be notified to the HSA by submitting a Cosmetic Product Notification before entering its market. And a local responsible agent who dealing with cosmetic products shall directly responsible for the safety and quality of the products.
A “cosmetic product” in Singapore is defined as any substance or preparation that is intended to be placed in contact with the various external parts of the human body or with the teeth or the mucous membranes of the oral cavity with a view exclusively or mainly to:
Cosmetics that fall into the above definitions are required to do the cosmetic product notification. Manufacturers or Importers of the cosmetic products shall responsible for the notification before supplying them in Singapore.
Cosmetics product notification is required:
Cosmetics product notification is not required for the following products. However, you still need to comply with other requirements, such as labeling, ingredients, and adverse event reporting:
The key responsibilities of the notification handling company are as follows:
Before the notification, you should check that the ingredients in the cosmetic product comply with the requirements stated in the “Annexes of ASEAN Cosmetic Directive (ACD)”.
Safety Assessment Report on the formulation of your cosmetic product is a required document in your Product Information File (PIF). If you are already doing the EU cosmetic notification, similar materials in English shall be applicable for Singapore Cosmetics Notification.
The following details should appear on the outer packaging or on the immediate packaging of cosmetic products if there is no outer packaging. The details must be listed in English. Information in other languages, if any, may be used in addition to English and should be the same as the English version.
Note: The following are not regarded as ingredients:
If the size, shape or nature of the container or package does not permit the particulars above to be displayed, the use of leaflets, pamphlets, hang tags, display panel, shrink wrap, etc. is allowed. However, the following particulars at least should appear on small immediate packaging:
Access ASEAN Cosmetics Regulatory Database. ->
Access Singapore Cosmetics Regulatory Database. ->
Cosmetics in Hong Kong is governed by ‘Chapter 456 Consumer Goods Safety Ordinance. It is required that a person shall not supply, manufacture or import consumer goods unless the consumer goods comply with the general safety requirement for consumer goods or the consumer goods must satisfy an approved standard if applicable.
As a free trade city, pre-market authorization is considered as a barrier to free trade. Therefore, notification or registration of cosmetic products is not required. However, the products shall meet the safety requirements of the originally manufactured country or any safety standards regulated by U.S. Food and Drug Administration (FDA) and European Union (EU) Cosmetic Directive.
It is important to point out that safety is assured in the manufacturing process of the products. Many manufacturers adopted the standard used in leading manufacturing countries and export destinations such as the USA, EU, and Japan. Good Manufacturing Practice (GMP) is the main criterion that suggested to follow in order to keep the products safe.
The manufacture could use any ingredient to compose the cosmetic product, except the ingredients, are prohibited or restricted by US and EU.
The labeling information shall meet the policy of an originally manufactured country or meet the requirements of the US, EU, and China.
The company or person responsible for placing products on the market shall take full responsibility for the product’s safety. Failure to do so will face a penalty under the stipulations of Consumer Safety Goods Ordinance.
Download: Consumer Safety Goods Ordinance in English
Check More Resources at China Cosmetics Regulatory Database
The cosmetic control in Thailand has been implemented by the Cosmetic Act B.E. 2558 (2015) which is regulated by the Thailand FDA under the agreement of the ASEAN Harmonized Regulatory Scheme and the regulation called the ASEAN Cosmetic Directive.
According to the Cosmetic Act B.E. 2558, cosmetics are classified as general cosmetics, controlled cosmetics, and specially controlled cosmetics. Three categories of cosmetics will face different legal requirements. Following is their definitions and requirements:
| Cosmetic Classification | Description | Legal Requirements |
| General Cosmetics | The products which do not fall under specially controlled or controlled cosmetics. | Notification |
| Controlled Cosmetics | The products containing ingredients that may cause harmful effects if the used concentrations exceed the maximum allowable levels. | Notification |
| Specially controlled cosmetics | The products may cause serious harm to users or that contain toxic substances or other substances which cause serious harm to the health of users. | Registration |
The technical requirements cover the positive and negative listings of ingredients, labeling and claims, pre-marketing requirements, and Good Manufacturing Practices (GMP). These technical requirements serve as the guidelines for quality and safety control.
Manufacturers or importers of cosmetic products must notify the information of cosmetic products to the authority prior to producing or importing at the customs. The steps for notification are as follows.
Steps of Cosmetics Notification on General and Controlled Cosmetics
2.1 Information of the applicant such as name and address of manufacturer or importer or storage site
2.2 Information on cosmetic products such as name, Brand name ( Trade name), categories and ingredients.
2.3 Submitting a notifying form (Jor Kor)
If the manufacturing or storage sites are located in Bangkok, the manufacturers or the importers must notify at the Food and Drug Administration office. If the manufacturing or storage sites are located in other provinces, the manufacturers or the importers must notify at the provincial public health office where the sites are located. The manufacturers or the importers may also notify the information via the computer network of the Food and Drug Administration.
The labeling requirements endorsed by the Cosmetic Committee stipulate that all cosmetics must be labeled in the Thai language covering all aspects of information in compliance with the requirements.
| Labeling Requirements of Cosmetics |
| 1. Product name and Brands’ name |
| 2. Type of product, Catagories |
| 3. All ingredients |
| 4. Instructions for use |
| 5. Name and address of the manufacturer (Name and address of importer including the name of manufacturer and country of origin) |
| 6. Net contents |
| 7. Batch number |
| 8. Manufacturing date |
| 9. Expiry date |
| 10. Statutory warning |
| 11. Notification number |
Note: the words “Specially Controlled Cosmetics” & Registration number or “Controlled Cosmetics” shall be listed for the specific categories.
The labels of cosmetic products may present the claims of use within the scope of cosmetics similar to those claims presented in advertising. The manufacturers or importers must retain the profile of product information including the evidence supporting those claims. Claims must not indicate that the products have any pharmaceutical characteristics or capability to affect or alter the human body’s functions or structure. Additionally, these claims must not indicate that those cosmetic products have the capability which, in fact, does not exist (overclaim) or is the cause of misunderstanding in their quality (misleading).
Permission for manufacturing or importing samples of products for registration is required before the registration process begins. The manufacturer or importer shall submit an application with attachments to FDA for review.
After received the permission for manufacturing or importing the sample, a reasonable quantity of samples could be manufactured or imported; and then such samples shall be submitted as an attachment of the registration application. Basically, the registration of specially controlled is normally concluded within 30 working days.
The Requirements for Registration of Specially Controlled Cosmetics
ASEAN Cosmetics Regulatory Database. ->
Thailand Cosmetics Regulatory Database. ->
© COSMETICSBRIDGE All rights reserved. This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
