Cosmetics

Question 1

Administrative Order No. 2005-015

Laws, Policies and Issuances

Answer 1

Adoption of the Association of Southeast Asian Nation (ASEAN) Harmonized Cosmetic Regulatory Scheme and ASEAN Common Technical Documents

Question 2

Administrative Order No. 2005-0025

Laws, Policies and Issuances

Answer 2

Implementation of the ASEAN Harmonized Cosmetic Regulatory Scheme and ASEAN Common Technical Documents

Question 3

FDA Circular No. 2016-004

Laws, Policies and Issuances

Answer 3

Procedure on the Use of the New Application Form for License to Operate (LTO) thru the Food and Drug Administration (FDA) Electronic Portal (e-Portal)

Question 4

FDA Memorandum Circular No. 2015-010

Laws, Policies and Issuances

Answer 4

Guidelines on the Issuance of Center for Cosmetics Regulation and Research (CCRR) User Account to Access e-Portal

Question 5

FDA Memorandum Circular No. 2015-011

Laws, Policies and Issuances

Answer 5

Guidelines for Electronic Notification of Cosmetic Products (Cosmetic e-Notification Version 2.0) Using the FDA e-Portal)

Question 6

FDA Circular No. 2018-001

Laws, Policies and Issuances

Answer 6

Reiterating the Mandatory Implementation of **Article 8 **of the ASEAN Cosmetic Directive “Product Information”

Question 7

FDA Circular no. 2021-004

Answer 7

Revised Interim Guidelines for the Issuance of License to Operate (LTO) and Certificate of Product Notification (CPN) for Manufacturers, Distributors and Traders of Rubbing Alcohol Products Under the Center for Cosmetics and Household/Urban Hazardous Substances Regulation and Research

Question 8

FDA Circular No. 2022-001

Laws, Policies and Issuances

Answer 8

Repealing FDA Circular No. 2021-004 “Revised Interim Guidelines for the Issuance of License To Operate (LTO) and Certificate of Product Notification (CPN) for Manufacturers, Distributors and Traders of Rubbing Alcohol Products Under the Center for Cosmetics and Household/Urban Hazardous Substances Regulation and Research”

Question 9

FDA Advisory No. 2022-0383

Laws, Policies and Issuances

Answer 9

Reiterating the Article 8 of the ASEAN Cosmetic Directive as per FDA Circular No. 2018-001 Mandating the “Product Information File”

Question 10

FDA Advisory No. 2022-1090

Laws, Policies and Issuances

Answer 10

Frequently-Asked Questions (FAQs) on FDA Circular (FC) No. 2022-001 “Repealing FDA Circular No. 2021-004 “Revised Interim Guidelines for the Issuance of License to Operate (LTO) and Certificate of Product Notification (CPN) for Manufacturers, Distributors and Traders of Rubbing Alcohol Products Under the Center for Cosmetics and Household/Urban Hazardous Substances Regulation and Research” dated 09 February 2021”

Question 11

Administrative Order No. 2020-0017

Laws, Policies and Issuances

Answer 11

Revised Guidelines on the Unified Licensing Requirements and Procedures of the Food and Drug Administration Repealing Administrative Order No. 2016-0003

Question 12

Validity of Cosmetic Product Notification

Answer 12

1, 2, 3 years (either initial or renewal)

Question 13

Standards for Labelling

Answer 13

Appendix II, ASEAN Cosmetic Directive

Question 14

Standards for Ingredients

Answer 14

Annex II, III, IV, VI, VII
ASEAN Cosmetic Directive

Question 15

Standards for Cosmetic Claim

Answer 15

Appendix III, ASEAN Cosmetic Directive

Question 16

Standards for Cosmetic Claim

Answer 16

Appendix III, ASEAN Cosmetic Directive

Question 17

Annex II

Answer 17

Banned Ingredients

Question 18

Annex III

Answer 18

Restricted Ingredients

Question 19

Annex IV

Answer 19

Colorants

Question 20

Annex VI

Answer 20

Preservatives

Question 21

Annex VII

Answer 21

UV Filters

Question 22

Phenoxyethanol

Annex and Percentage limits

Answer 22

Annex VI: Preservatives
1%

Question 23

Methylisothiazolinone
Methylchloroisothiazolinone

Annex and Percentage Limits

Answer 23

Annex III: Restricted
MIT/MCIT (3:1) - 0.00015%

Question 24

Opium Poppy

Annex and Percentage Limits

Answer 24

Annex II: Banned Ingredient

Question 25

Malachite Green | Annex and Percentage Limits

Answer 25

Annex II: Banned Ingredient

Question 26

HICC / Hydroxyisohexyl 3-cyclohexene carboxaldehyde | Annex and Percentage Limits

Answer 26

Annex II: Banned Ingredient

Question 27

Formaldehyde as Nail Hardener | Annex and Percentage Limit

Answer 27

Annex III: Restricted Ingredient 2.2%

Question 28

Salicylic Acid | Annex and Percentage Limit

Answer 28

Annex III: Restricted Ingredient 3.0% (Rinse Off) 2.0% (Leave-On)

Question 29

Zinc Oxide | Annex and Percentage Limit

Answer 29

Annex VII: UV Filter Restricted Ingredient 25%

Question 30

Glycolic Acid (w/ Lactic Acid) | Annex and Percentage Limits

Answer 30

Annex III: Restricted Ingredient Less than or equal to 10-20%

Question 31

Benzalkonium Chloride as Haircare | Annex and Percentage Limit

Answer 31

Annex III: Restricted Ingredient 3% (Rinse-Off) 0.1% (Other Products)

Question 32

Tagetes minuta Tagetes erecta Tagetes patula | Annex and Percentage Limit

Answer 32

Annex III: Restricted Ingredient 0.01% (Leave-On) 0.1% (Rinse-Off)

Question 33

Behentrimonium Chloride | Annex and Percentage Limit

Answer 33

Annex III: Restricted Ingredient 2.5%(Rinse-Off) 1.0% (Leave-On) 0.5% (Face Products)

Question 34

Cetrimonium Chloride | Annex and Percentage Limit

Answer 34

Annex III: Restricted Ingredient 5.0% (Rinse-Off) 3.0% (Leave-On)

Question 35

Commonly Noted claims requiring substantiation | Annex and Percentage Limit

Answer 35

Borderline Products Pimple Patches Whitening Tooth Pen (CCHUHSRR) with LED Lights (CDRRHR) Rubbing Alcohol (Sanitizing, Antibacterial, Antiseptic) Sebo De Macho (for endorsement to CDRR) Products with numerical claims

Question 36

Climbazole | Annex and Percentage Limit

Answer 36

Annex VI: Preservatives Restricted Ingredient 0.5% rinse-off shampoo 0.2% leave-on face cream, hair lotion, foot care

Question 37

Thiomersal and Phenylmercuric salts | Annex and Percentage Limit

Answer 37

Annex II: Banned Ingredient (Ref No. 221)

Question 38

Paraformaldehyde, Formaldehyde and Methylene Glycol | Annex and Percentage Limit

Answer 38

Annex II: Banned Ingredient

Question 39

Silver Nitrate | Annex and Percentage Limit

Answer 39

Annex II: Banned Ingredient

Question 40

Methoxypropylamino Cyclohexenylidene Ethoxyethylcyanoacetate or BC-3 | Annex and Percentage Limit

Answer 40

Annex VII: UV Filters Restricted Ingredient 3%

Question 41

Dibutyltin Hydrogen Borate | Annex and Percentage Limit

Answer 41

Annex II