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Japan MHLW announce Partial revision of “Quasi-drug Ingredients Standard 2006”

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Japan MHLW announce Partial revision of “Quasi-drug Ingredients Standard 2006”

On September 12, 2019, a notice was posted on the Ministry of Health, Labor and Welfare database to indicate the Partial revision of “Quasi-drug raw material standard 2006”.  Along with the publication is the Application for Manufacturing and Marketing Approval of Quasi-drugs, etc.

In this partial revision, 48 ingredients are revised, check the list below and the details on the following download links.

  1. Dicocoyl Dimethyl Ammonium Chloride
  2. N-[2-Hydroxy-3-(cocoalkyldimethylammonio)propyl] Hydrolyzed Keratin Chloride
  3. N-[2-Hydroxy-3-(cocoalkyldimethylammonio)propyl] Hydrolyzed Wheat Protein Chloride Solution
  4. N-[2-Hydroxy-3-(cocoyldimethylammonio)propyl] Hydrolyzed Collagen Chloride
  5. N-[2-Hydroxy-3-(cocoalkyldimethylammonio)propyl] Hydrolyzed Silk Chloride Solution
  6. N-[2-Hydroxy-3-(cocoalkyldimethylammonio)propyl] Hydrolyzed Soybean Protein Chloride Solution
  7. Glyceryl Caprylate/Caprate/Cocoate
  8. Sodium Hydrogenated Glyceryl Cocoate Sulfate
  9. Higher Fatty Acid Pentaerythritol Citrate・Beeswax・Nonion Emulsifying Mixture
  10. Polyethylene Glycol･Epichlorohydrine･Cocoalkyl Amine･Dipropylene Triamine Condensate Solution
  11. Polyoxyethylene Glyceryl Monococoate
  12. Polyoxyethylene Cocoalkyl Amine
  13. Polyoxyethylene Cocoalkyl Dimethyl Amine Oxide Solution
  14. Polyoxyethylene Coconut Fatty Acid Amide (5E.O.)
  15. Disodium Polyoxyethylene Coconut Fatty Acid Isopropanolamide Sulfosuccinate Solution
  16. Polyoxyethylene Glyceryl Monococoate
  17. Polyoxyethylene Coconut Fatty Acid Monoethanolamide Sodium Sulfate Solution
  18. Polyoxypropylene Coconut Fatty Acid Monoisopropanolamide (1P.O.)
  19. Condensate of Methylsilanol and Polyoxyethylene Glyceryl Monococoate
  20. Cocoalkyl Dimethyl Amine Oxide Solution
  21. Cocoalkyl Dimethyl Glycine Solution
  22. Magnesium･Triethanolamine Coco Sulfate Solution
  23. Potassium Cocoyl Soap Solution
  24. Coconut Fatty Acid
  25. DL-Pyrrolidonecarboxylic Acid Salt of N-Cocoyl-L-Arginine Ethyl Ester
  26. Potassium N-Cocoyl-Hydrolyzed Yeast
  27. Sodium N-Cocoyl-N′-Carboxyethyl-N′-Hydroxyethyl Ethylenediamine
  28. Disodium N-Cocoyl- N′-Carboxyethoxyethyl-N′-Carboxyethyl Ethylenediamine Solution
  29. Disodium N-Cocoacyl-N-carboxymethoxyethyl-N-carboxy methylethylenediamine Polyoxyethylene Tridecyl Sulfate Solution
  30. Disodium N-Cocoyl-N-carboxymethoxyethyl-N-carboxymethylethylenediamine
  31. Disodium N-Cocoyl-N′-Carboxymethoxyethyl- N′-Carboxymethyl Ethylenediamine Lauryl Sulfate
  32. N-Cocoyl-L-Glutamic Acid
  33. Potassium N-Cocoyl-L-Glutamate
  34. Triethanolamine N-Cocoyl-L-Glutamate Solution
  35. Sodium N-Cocoyl-L-Glutamate
  36. Coconut Fatty Acid Amide
  37. Cocoyl Amide Propyldimethyl Glycine
  38. Cocoyl Amide Propyldimethyl Glycine Solution
  39. Sodium Cocoyl Ethyl Ester Sulfonate
  40. Hydrolyzed Collagen Cocoate Solution
  41. Coconut Fatty Acid Diethanolamide
  42. Sodium Cocoyl Taurate
  43. N-Cocoyl-N-methyl-β-alanine
  44. Sodium Cocoyl N-Methyl β-Alaninate Solution
  45. Coconut Fatty Acid N-Methylethanolamide
  46. Potassium N-Cocoyl-N-Methyl Taurate Solution
  47. Sodium N-Cocoyl-N-Methyl Taurate
  48. Magnesium Cocoyl Methyl Taurate Solution

 

Sources: Partial revision of “Quasi-drug raw material standard 2006 & Application for Manufacturing and Marketing Approval of Quasi-drugs

The documents also can be found in our Asian Cosmetic Regulatory Database with more resources for reference.

 

ASEAN Updates to the Annexes of the ASEAN Cosmetic Directive adopted at the 31st ASEAN Cosmetic Committee Meeting

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ASEAN Updates to the Annexes of the ASEAN Cosmetic Directive adopted at the 31st ASEAN Cosmetic Committee Meeting

On 06, Dec. 2019, ASEAN releases the updated Annexes of the ASEAN Cosmetic Directive (ACD) adopted in the 31st ACSB Meeting. The industry may provide your feedback on the implementation dates by 31 Dec 2019.

This time change involves three annexes: List of Prohibited Ingredients, List of Restricted Ingredients and List of Preservatives Allowed.

Table 1: Changes to List of Prohibited Ingredients (Annex II)

Substance CAS Number Ref. No
Mercury and its compounds 7439-97-6

54-64-8

 221
62-38-4/94-43-9

 

Table 2: Changes to List of Restricted Ingredients (Annex III)

Ref No ACD # (EU #) Substance Restrictions Conditions of use and warnings which must be printed on the labels
Field of application and/or use Maximum authorized concentration in ready for use preparation Other limitations and requirements
A B C D E F
288

(Annex VI

‐ 25)

 5‐Chloro‐2‐ (2,4‐ dichlorophenoxy) phenol

Triclosan

CAS No 3380‐34‐5

 

Singapore: Not permitted for non‐ preservative use.

 (a) Toothpastes Hand soaps

Body soaps/Shower gels Deodorants (non‐spray)

Face powders and blemish concealers Nail products for cleaning the fingernails and toenails before the application of artificial nail systems Shampoos

Hair Conditioners Facial Cleansers

 (a) 0.3 %
(b) Mouthwashes (b) 0.2 %

 

Table 3: Changes to List of Preservatives Allowed (Annex VI)

 

Reference number Substance Maximum authorised concentration Limitations and requirements Conditions of use and warnings which must be printed on the label
a b c d e
16 Entry deleted
17 Entry deleted
32 1‐(4‐Chlorophenoxy)‐1‐ (imidazol‐1‐yl)‐3,3‐ (a) 0.2% (a) Hair lotions
dimethylbutan‐2‐one (b) 0.2% (b) Face creams
Climbazole (c) 0.2% (c) Foot care products
CAS No 38083‐17‐9 (d) 0.5% (d) Rinse‐off shampoo

 

Click here to download details of the change.

Check more resources on our Asian Cosmetic Regulatory Database.

 

Taiwan Amended List of Preservatives Allowed in Cosmetic Products

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Taiwan Amended List of Preservatives Allowed in Cosmetic Products

On Dec. 05, 2019, Taiwan FDA amended the List of Preservatives Allowed in Cosmetic Products. It shall replace the version issued by Taiwan FDA on May 30, 2019. The new version eliminates 12 ingredients from the previous table.

You can find the amended version on: Asian Regulatory Database-Taiwan，or download directly from the following links.

Sources: TFDA News

Taiwan issues 3 Testing standards for Human Skin Patch Testing, Sunscreen Product Water Resistance testing and Human Skin Testing

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Taiwan issues 3 Testing standards for Human Skin Patch Testing, Sunscreen Product Water Resistance testing and Human Skin Testing

Announced by TFDA, in order to improve the industrial development of cosmetics in Taiwan and strengthen the management of cosmetics and ensure the safety of the subjects, Taiwan FDA issued three technical standards for cosmetic testing.

  1. Technical standard for sunscreen products’ Water Resistance Testing (Human Test)
  2. Technical standard for Cosmetic Human Skin Patch Testing
  3. Technical standard for Cosmetic Human Skin test

Download the original copy from Asian Cosmetic Regulatory Database or directly from the source below:

Source: FDA News

ASEAN releases the updated technical documents with 5 annexes

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ASEAN releases the updated technical documents with 5 annexes

On 05, Nov. 2019, ASEAN releases the updated technical documents with five annexes that are updated in 2019.

Click here to download the complete file of the technical documents.

Below is a list of downloadable updated Ingredient Annexes:

 

Check more resources on our Asian Cosmetic Regulatory Database.

 

China Bans Microbeads in Cosmetics

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China Bans Microbeads in Cosmetics

microbeads

Oregon State University on Flickr

On Oct. 30, China National Development and Reform Commission officially passed the Catalogue of Guidance on Industry Structure Adjustment (2019 Version) which is scheduled to be effective from Jan.1, 2020. Among the elimination articles of materials, the third type of elimination clearly stipulates that ‘daily chemical products containing plastic microbeads will be banned from production on December 31, 2020 and will not be sold on December 31, 2022.

Download source:

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Catalogue of Guidance on Industry Structure Adjustment (2019 Version) 0.00 KB 2 downloads

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MALAYSIA amends THE GUIDELINES FOR CONTROL OF COSMETIC PRODUCTS IN MALAYSIA

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MALAYSIA amends THE GUIDELINES FOR CONTROL OF COSMETIC PRODUCTS IN MALAYSIA

To associated with the ASEAN amendment on the revision of ASEAN Cosmetic Directive (ACD) on the 30th ASEAN Cosmetic Committee (ACC), Malaysia NPRA amends the Guidelines for Control of Cosmetic Products in Malaysia on 05, September 2019.

The involved change lists include the following:
Annex II (List of Prohibited Substances)
Annex III (List of Restricted Substances)
Annex VI (List of Preservatives)
Annex VII (List of UV Filters)

Download the UPDATED version of the above list in the Asian Cosmetic Regulatory Database-Malaysia.

Download the amendment copy from the following:

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Amendment on THE GUIDELINES FOR CONTROL OF COSMETIC PRODUCTS IN MALAYSIA 0.00 KB 0 downloads

Issued on 05,Sep. 2019 ...
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If you can not see the download links, please upgrade your membership level.

Related News: ASEAN Updates to the Annexes of the ASEAN Cosmetic Directive adopted at the 30st ASEAN Cosmetic Committee Meeting

 

Japan MHLW enhance the complaince obligation of Eyelash Serums

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Japan MHLW enhance the complaince obligation of Eyelash Serums

In response to the Japan National Consumer Affairs Center’s (NCAC) safety warning on the use of eyelash serum: “The harm caused by eyelash serum has rapidly increased!”. Japan Ministry of Health, Labour and Welfare (MHLW) issued new notes towards the compliance details of Eyelash Serums on August 08, 2019.

Several key points worth to pay attention:

  1. The hair repair agents are approved as quasi-drug which aims at preventing hair loss and hair growth. It can not be used in Eyelash serum products.
  2. Manufacturers and distributors of cosmetics that claim to be used as eyelash serums，The following items should be added to the instruction manual.
    “If any abnormalities appear, such as Redness, itching, pain, swelling, etc. due to irritation or allergy during or after use. Please discontinue use and consult a doctor. ”
    In Japanese 「使用中や使用後、刺激またはアレルギーによる赤み、かゆみ、痛み、腫れ等の異常が現れた場合、使用を中止し、医師にご相談ください。」
    The precautions for use should be written directly on the container or on the external envelope.

Sources: まつ毛美容液を標榜する化粧品等の安全性確保について

Check our Asian Cosmetic Regulatory Database with more resources for reference.

 

ASEAN Updates to the Annexes of the ASEAN Cosmetic Directive adopted at the 30st ASEAN Cosmetic Committee Meeting

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ASEAN Updates to the Annexes of the ASEAN Cosmetic Directive adopted at the 30st ASEAN Cosmetic Committee Meeting

In June. 2019, ASEAN releases the updated Annexes of the ASEAN Cosmetic Directive (ACD) adopted in the 30st ACSB Meeting. The industry may provide your feedback on the implementation dates by 31 Aug. 2019.

Type of change Annex of the ACD Entry No.

/Ref. No.

 Description of changes Implementation date
New Entry Annex II

Changes to List of Prohibited Ingredients

 1384 A new entry for 2‐chlorobenzene‐1,4‐diamine (2‐Chloro‐p‐Phenylenediamine), its sulfate and dihydrochloride salts is included into Annex II. 18 Jun 2020

(Companies can submit new notifications only for compliant products)

 

18 Dec 2020

(All non‐compliant products shall be withdrawn from the market)
New entry Annex III

Changes to List of Restricted Ingredients

 324 A new entry for Tagetes minuta flower extract/oil is included into Annex III. 19 Dec 2020
New entry Annex III

Changes to List of Restricted Ingredients

 325 A new entry for Tagetes patula flower extract/oil is included into Annex III. 19 Dec 2020
New entry Annex III

Changes to List of Restricted Ingredients

 326 A new entry for Climbazole is included into Annex III. Immediate
Amendment Annex III

Changes to List of Restricted Ingredients

 48 Silver nitrate is not allowed for colouring of eye brows and eyelashes and will be deleted from Annex III. As agreed in the 26th ACSB Meeting, the use of hair dyes for dyeing eyelashes and eyebrows shall not be permitted in ASEAN. Further

review of silver nitrate will be done in next ACSB meeting.

 Immediate
Amendment Annex VI

Changes to List of Preservatives Allowed

 7 The salts of Biphenyl‐2‐ol (o‐phneylpehol) will not be allowed to be used as preservatives and the maximum allowable concentration is reduced for leave‐on products. The entry is revised to delete the salts, reduce the maximum authorized concentrations for leave‐on products and include the requirement for a warning

label.

 18 Dec 2020
Amendment Annex VI

Changes to List of Preservatives Allowed

 32 The use of climbazole as a preservative is revised to limit its use to certain product types and the maximum allowable concentration is reduced. 18 Jun 2020

(Companies can submit new notifications only for compliant products)

 

18 Jun 2021

(All non‐compliant products shall be

withdrawn from the market)
New entry Annex VII

Changes to List of UV filters

 30 A new entry for Phenylene Bis‐Diphenyltriazine is included into Annex VII. Immediate

Click here to download details of the change.

Check updated above lists on our Asian Cosmetic Regulatory Database.

 

Attention: Taiwan announces a new requirement tawards labeling of imported cosmetics products

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Attention: Taiwan announces a new requirement tawards labeling of imported cosmetics products

On June 27, 2019, Taiwan FDA announces a new requirement on the imported products labeling.

The imported cosmetics that the external packaging or container contains “薬用”, “薬”, “医薬”, “Medicate” or any equivalent meaning in a foreign language, and the governed as OTC drug, quasi drug in original exporting countries, shall add additional warning sentence on the external packaging or container:”「本产品属化妆品，不具医疗效能。」”, which means: “This product is a cosmetic product and has no medical effect.”

This regulation comes into effect on July 1, 2019. Products imported before the effective date can continue to be sold within the originally recorded storage period and will expire five years from the date of implementation of the Cosmetics Health and Safety Management Law.

Source: TFDA News

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