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China NMPA Issued Children’s Cosmetics Regulation

Announcement of the “Regulations on the Supervision and Administration of Children’s Cosmetics” (2021 No. 123)

In order to regulate the production and operation of children’s cosmetics, strengthen the supervision and management and ensure the safety of children’s cosmetics, the National Medical Products Administration (NMPA) formulated the “children’s cosmetics supervision and management regulations” (hereinafter referred to as “regulations”), are hereby promulgated, and to “require” the implementation of the relevant matters are announced as follows: 

1. In addition to labeling requirements, other regulations on children’s cosmetics will come into effect on January 1, 2022.

2. For the labeling requirement, starting from May 1, 2022, children’s cosmetics that apply for registration or filing must be labelled in accordance with the “Regulations”; for children’s cosmetics that have previously been applied for registration or filing, they have not been labelled in accordance with the “Regulations”. The registrant and recorder shall complete the update of the product label before May 1, 2023 to make it comply with the “Regulations.”

3. The mark of children’s cosmetics will be announced separately.

Attachment:

Regulations on Supervision and Administration of Children’s Cosmetics

China issues “Measures for Supervision and Administration of the Production and Operation of Cosmetics”

July 26, the 12th Executive Meeting of the State Administration for Market Regulation in 2021 reviewed and approved the “Measures for Supervision and Administration of the Production and Operation of Cosmetics” (hereinafter referred to as the “Measures”). The “Measures” will be implemented on January 1, 2022.

Cosmetics are consumer goods that meet people’s needs for beauty. They directly affect the human body, and their quality is related to the health of the people.

On June 16, 2020, Premier Li Keqiang signed State Council Order No. 727, promulgating the “Regulations on the Supervision and Administration of Cosmetics” (hereinafter referred to as the “Regulations”). In order to implement the “Regulations”, strengthen the supervision and management of cosmetics production and operation, ensure the safety of public makeup, and standardize and promote the healthy development of the cosmetics industry, the State Food and Drug Administration organized the drafting of the “Measures.”

9 Key Points for On-site Inspection of NMPA

Recently, Many domestic responsible persons for imported cosmetics in Shanghai have received on-site inspection notices and received the “Risk assessment on Quality Management and On-site Evaluation Guidelines for Domestic Responsible Persons of Imported General Cosmetics in Shanghai”.

The Guidelines evaluate the responsible person of General cosmetics from aspects like the basic information of responsible person, personnel and training, adverse reactions, procurement and acceptance, recall management, sample management, sales records and electronic case records.

Recently, CosmeticsBridge assists our clients to complete the on-site evaluation and summarize the main points of on-site inspection as follows:

 (1) Warehouse: need to provide the warehouse property certificate, or a valid lease contract or agreement; warehouse management documents; temperature and humidity record sheet; pest record sheet.

Thailand FDA is unlocking cannabis, hemp for use in health products, food, cosmetics, and herbal products.

A law has been passed to allow cannabis, hemp, can be used as an ingredient in food, cosmetics and herbal products in Thailand. 

For cosmetics products, The Ministry of Public Health has issued an announcement stipulating the conditions for the use of hemp oil or hemp seed extract including extracts containing cannabidiol (from cannabis and hemp) and for the safety of consumers The Cosmetics Commission has also issued a notice requiring a warning on the label of such cosmetics.

For food products, the FDA has issued a notification of the Ministry of Public Health (No. 424) B.E. 2021, regarding the prohibition of food production, importation, or distribution, effective on February 26, 2021 by unlocking marijuana, hemp, which is not a drug. Addiction to category 5 can be used in food. Notification of the Ministry of Public Health (No. 425) B.E. 2021 Re: Hemp Seeds, Hemp Seed Oil Hemp Seed Protein and food products containing hemp seeds Hemp seed oil or protein from hemp seeds to be able to use hemp seeds Hemp seed oil Hemp seed protein is used in the food industry such as cereal products, bakery products, beverages, snacks, dietary supplements, etc. 

Hemp seed oil is Used in the production of food supplements, oils, bread products, etc., provided that they are used in the amount according to the specified conditions. and is in the process of preparing (draft) Notification of the Ministry of Public Health Re: Food products containing cannabis or hemp components It is expected to be completed in June and (draft) the Ministry of Public Health’s announcement regarding food products containing cannabidiol extract as an ingredient. It is expected to be completed in July.

In terms of herbal products, there are recommendations for obtaining permission for 3 groups of herbal products:

1) herbal medicinal formulations containing cannabis leaves and branches, e.g. reclining medicine, insomnia drug / slimming yellow fever medicine. anti-wind medicine Hemorrhoids and skin diseases and antipsychotics

2) herbal products for external use that use leaves, stems, branches, stems, roots, cannabis extracts or hemp as non-active ingredients

3) herbal teas from hemp leaves, hemp

Game-Changing: China Passed two of New Cosmetic Ingredients

On June 29, NMPA (National Medical Products Administration) announced two new domestic cosmetics raw materials have been approved successfully which are Acetylneuraminic Acid and Lauroyl Alanine. 

This is the first successful case of New cosmetics ingredients notification under the “Cosmetics Supervision and Administration Regulation” (referred to as the “CSAR”) which just been implemented on May 1st, 2021. From now on, China officially loosens the leash on the cosmetics ingredients supervision for the first time in 30 years.

The Identities of Registrant, Filing person, and Responsible Person

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After the implementation of “Cosmetics Supervision and Administration Regulations”(CSAR) on January 1, 2021, there are two new legal concepts that jump into people’s attention: registrant and filing person. But do you really understand both concepts with their responsibilities? And What are they different with responsible during the cosmetics application. 

1. Registrant and filing person 

First of all, the concepts of registrant and filing person are derived from the regulatory requirement of general cosmetics and special cosmetics. For General cosmetics, it is required to fill(Notify) the products through the online system before put them to the markets. And the applicant should be called the filing person. And for special cosmetics, it is necessary to do the registration at the national NMPA, and the applicant should be called a registrant. 

According to the CSAR, cosmetics registrants and filing persons are not only responsible for product quality and safety, but also responsible for claims of efficacy and are the owners of the products. A company that only engages in the entrusted production of cosmetics is not the owner of the product.

The “CSAR” stipulates the requirements, responsibilities and obligations of cosmetics registrants and filing person. According to Article 18 of CSAR, cosmetics registration applicants and filing persons should have a quality management system, including the establishment of a quality management system and the SET a person in charge of quality and safety. 

Moreover, cosmetics registrants and filing persons also should establish the adverse effect monitoring system and responsible for product recall with the assistance of the responsible person.  

2. Responsible Person

According to the CSAR, If a Cosmetics registrant or filing person is located overseas, a domestic responsible person shall be designated within China to handle cosmetics registration and filing. Different from the responsible agent in previous regulations, the responsible person bears more responsibilities than ever before.

The main responsibilities of a responsible person:

  1. Apply for cosmetics registration and filing in the name of the registrant and filing person. 
  2. Assist in the monitoring of cosmetic adverse reactions, and implement product recalls. 
  3. In accordance with the agreement with the registrant and filing person, to take quality and safety responsibilities for the cosmetics placed on the China market;
  4. Cooperate with the supervision and monitoring work of the National Medical Products Administration 

It is worth to be noted that if an overseas registrant or filing person entrusts a domestic cosmetics manufacturer to produce cosmetics, the cosmetics are domestic cosmetics. But the oversea registrant and filing person are necessary to desinate an domestic responsible person as well;

But if a domestic registrant and filing party entrust an overseas factory to manufacture the products, the cosmetics should belong to imported cosmetics, but since the registrant and filing person is located in China, there is no need to designate a domestic responsible person.

Children’s Cosmetics Supervision and Administration Regulation (CCSAR) Draft is Just Released

On June 18, the National Medical Products Administration issued a public solicitation of opinions on the Draft of Children Cosmetics Supervision and Administration Regulation (CCSAR).

The CCSAR proposes that children’s cosmetics should be marked with the children’s cosmetics logo stipulated by the NMPA in a prominent position on the surface of the sales package; And encourage cosmetics sellers to actively prompt consumers to inquire about product registration information when selling children’s cosmetics.

The deadline for feedback is July 31. You can send your feedback to the mailbox: [email protected], and indicate “Children Cosmetics Supervision and Administration Regulation/儿童化妆品监督管理规定” in the subject of the email.

Attachment 1:

Children’s Cosmetics Supervision and Administration Regulation.doc (Chinese Version)

We are translating the English version, register an CosmeticsBridge account and keep getting updated.

Attachment 2

Opinions and Suggestions Feedback Form.doc

Attachment 3

Requirements for Collection of Children’s Cosmetics Marks.doc

Insights: The category you underestimated may becoming a hot territory in China

A Probiotic mouthwash line of an oral care brand has achieved sales of over 100 million RMB in 80 days.

Products such as cleaning, makeup removal, and oral care in the cosmetics field with fewer functions and normal attributes may not raise you much attention when you are developing products. However, such categories of products are about to become a huge opportunity territory and may generate a new batch of big brands in China.

Why are they?

Efficacy Testing Exemption

First of all, according to the Cosmetics supervision and administration regulation (CSAR) make it very clear that in the future, most of the cosmetics claims and functions are necessary to submit efficacy testing before going to market. However, the “Evaluation Standards for Cosmetic Efficacy Claims” indicate that cosmetics claims which can be directly identified by the senses such as vision and smell or through the simple physical covering, adhesion, friction, etc., and the effect occurs only as physical effects will be exempted from publishing a summary of the product efficacy claims.

Analysis of Non-entry importing cosmetics (Jan. to Apr. ) in China

After implementing the new “Cosmetics Supervision and Administration Regulation (CSAR)” in China, will it be more difficult for imported cosmetics to import customs clearance? 

The CosmeticsBridge brings you a summary and analysis of the reasons why cosmetics were not allowed to enter the country from January to April 2021. 

According to the official website of the General Administration of Customs, a total of 31 batches of imported cosmetics were not allowed to enter the country this year due to unqualified labels and other reasons. 

These products are produced in France, Thailand, South Korea, Israel, Japan, etc. The reasons for entry are shown in the figure below:

NMPA Issued the “Administrative Measures on Cosmetics Labeling”

In order to strengthen the supervision and management of cosmetics labels, regulate the use of cosmetics labels, and protect the legitimate rights and interests of consumers. NMPA issues the “Measures for the Administration of Cosmetics Labeling” (hereinafter referred to as the “Measures”). The relevant matters concerning the implementation of the “Measures” are hereby announced as follows: