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Title: Regulations for Cosmetics Recall CH
Announced Date: 2019-05-22
Category: Ministry of Health and Welfare(衛生福利部)
Article 1
The Regulations have been established according to Paragraph 4 of Article 17 of the Cosmetic Hygiene and Safety Act (the “Act”).
Article 2
Operational procedure of cosmetics recall shall be classified in three classes according to the risks to health as follows:
1. Class 1
(1) Violation of Paragraph 1 of Article 6 of the Act, which cosmetics contain mercury, lead, or other ingredients banned for use as per the public announcement of the central competent authority.
(2) Violation of Paragraph 3 of Article 6 of the Act, which cosmetics use ingredients that pose a hazard to human health or impact the hygiene and safety.
(3) Violation of Paragraph 1 of Article 8 of the Act, which cosmetics are manufactured by non-registered factories.
(4) According to Subparagraph 8 of Paragraph 1 of Article 17 of the Act, the product notification or license was revoked or rescinded by the central competent authority.
(5) According to Paragraph 2 of Article 17 of the Act, cosmetics that are of the unclear source; or pose hazards to hygiene and safety as per the public announcement of the central competent authority.
2. Class 2
(1) Violation of Paragraph 1 of Article 4 of the Act in failing to complete product notification or failing to establish the product information file that are made in accordance with Subparagraph 1 of Paragraph 1 of Article 17 of the Act in failing to make corrections within the time limit specified by the competent authority.
(2) Violation of the regulations prescribed pursuant to Paragraph 2 or Paragraph 3 of Article 4 of the Act, pertaining to the provisions of items, contents, modifications, or methods for establishment and maintenance, retention period, and location of product notification or information file that are made in accordance with Subparagraph 1 of Paragraph 1 of Article 17 of the Act in failing to make corrections within the time limit specified by the competent authority.
(3) Violation of Paragraph 1 or Paragraph 2 of Article 5 of the Act in failing to apply for a specific purpose cosmetics license or modifying the originally registered particulars without authorization that are made in accordance with Subparagraph 2 of Paragraph 1 of Article 17 of the Act in failing to make corrections within the time limit specified by the competent authority.
(4) Violation of Paragraph 3 of Article 5 of the Act on supplying, selling, publicly displaying, offering consumer trial, or altering the uses of said cosmetics that are made in accordance with Subparagraph 2 of Paragraph 1 of Article 17 of the Act in failing to make corrections within the time limit specified by the competent authority.
(5) Sellers of cosmetics violate Paragraph 5 of Article 7 of the Act, alter or modify the labels, leaflets, outer packaging, or containers of cosmetics for sale.
(6) Violation of the Establishment Standards for Cosmetics Manufactory specified in Paragraph 1 of Article 8 of the Act or the Good Manufacturing Practice Regulations specified in Paragraph 2, and said violation could possibly pose a hazard to hygiene and safety as determined by the competent authority.
(7) Violation Paragraph 1 or Paragraph 2 of Article 10 of the Act, the labels of cosmetics are deceptive, exaggerated or having medical efficacy.
3. Class 3: The outer packaging or containers of cosmetics violate Paragraph 1, Paragraph 2 or Paragraph 3 of Article 7 of the Act or public announcement of labeling regulations prescribed pursuant to Paragraph 4 of Article 7 of the Act.
Article 3
The deadlines for recall completion mentioned in Paragraph 1 and Paragraph 2 of Article 17 of the Act are as follows:
1. Class 1: Within one month after the next day of the date when cosmetics manufacturers or importers receive a notification from the competent authority. The competent authority may reduce to 14 days if necessary.
2. Class 2: Within two months after the next day of the date when cosmetics manufacturers or importers receive a notification from the competent authority.
3. Class 3: Within six months after the next day of the date when cosmetics manufacturers or importers receive a notification from the competent authority.
Article 4
Whenever the municipal or county (city) competent authority notifies a cosmetics manufacturer or an importer of the recall, it shall inform central and other municipal or county (city) competent authorities.
Article 5
For the recalled cosmetics, the competent authority may disclose the following information on the website of the authority or to the public media:
1. The name of the product.
2. Product notification number or license number.
3. Batch number or serial number for identification and coding of the product.
4. The name, address and telephone number of the manufacturer or importer.
5. The reason for the recall.
Article 6
Cosmetics manufacturers or importers shall establish the operating procedure of cosmetics recall, which content shall include the organization of the recall operation, designated personnel and their mission, the proposal of recall operation, notice of the recall messages and the report with documented operation procedures and results regarding recalled products from the market and in the warehouse.
Article 7
For the recall operation, the cosmetics manufacturer or importer shall inform sellers within seven days after the next day of receiving a notification mentioned in Article 3. For the Class 1 recall operation, the municipal or county (city) competent authority may notify the cosmetics manufacturer or importer that the period shall reduce to three days.
The notice in the preceding paragraph shall include the following information:
1. The name, address and telephone number of the manufacturer or importer.
2. The name of the product.
3. Product notification number or license number.
4. Batch number or serial number for identification and coding of the product.
5. The reason for the recall and damage it may cause.
6. Recall methods, time and location for the recalled product delivery.
7. The requirements shall be complied with by sellers.
The sellers in preceding two paragraphs shall be the receiver mentioned in Item 1 of Subparagraph 2 of Article 2 of the Regulations Governing the Source and the Flow Data of Cosmetic Products.
Cosmetics manufacturers or importers shall record the matter mentioned in Paragraph 1, notifiers, recipients, time and the methods for notifications, and keep the record at least five years.
Article 8
For the recall operation, the cosmetics manufacturer or importer shall submit a proposal of recall operation to the municipal or county (city) competent authority within 14 days after the next day of receiving a notification mentioned in Article 3. For the Class 1 recall operation, the municipal or county (city) competent authority may notify the cosmetics manufacturer or importer that the period shall reduce to seven days.
The proposal of recall operation shall include the following information:
1. The name, address and telephone number of the manufacturer or importer.
2. The name of the product.
3. Product notification number or license number.
4. Batch number or serial number for identification and coding of the product.
5. The total quantity, sales quantity, and inventory quantity of the product manufacture or import.
6. The name, address, and their individual sales quantity of the sellers.
7. The reason for the recall and damage it may cause.
8. The scheduled date for recall completion.
9. The methods, contents, and other related procedures taking indicate in the notification to the sellers.
If the proposal of recall operation is incomplete, the municipal or county (city) competent authority may notify the correction within the time limit.
Article 9
Cosmetics manufacturers or importers shall give identification and labels both on the recalled cosmetics and inventory and place them and the conforming products separately.
Article 10
The cosmetics manufacturer or importer which complies with the proposal of recall operation and completes the implementation, it shall draft and submit the report with documented operation procedures and results to the municipal or county (city) competent authority within 14 days after the next day of recall completion. For the Class 1 recall operation, the municipal or county (city) competent authority may notify the cosmetics manufacturer or importer that the period shall reduce to seven days.
The report with documented operation procedures and results shall include the following information:
1. The name, address and telephone number of the manufacturer or importer.
2. The name of the product.
3. Product notification number or license number.
4. Batch number or serial number for identification and coding of the product.
5. The total quantity, sales quantity, and inventory quantity of the product manufacture or import. They shall all be recorded separately into recalled and not recalled items and quantity.
6. The recall items and quantity lists from each recall targets.
7. Recall completion date, the storage location for recalled products, and the follow-up handling method and date.
8. If the recalled products have been destroyed, the report shall attach the photos or video of the destruction process.
9. Follow-up corrective and preventive actions for the reason of the recall.
If the report with documented operation procedures and results is incomplete, the municipal or county (city) competent authority may notify the correction within the time limit.
Article 11
The municipal or county (city) competent authority shall supervise the implementation of recall operation; After receiving the report with documented operation procedures and results, it may inspect the circumstance of the recall at the place of manufacturing, storage, and sale.
Article 12
The Regulations shall take effect on July 1, 2019, except for Item 5 of Subparagraph 2 of Paragraph 1 of Article 2 and Subparagraph 3 of Paragraph 1 of Article 2 shall take effect on July 1, 2021.
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