Cosmetic Section, National Pharmaceutical Control Bureau, Ministry of Health Malaysia, Jalan Universiti 46200 Petaling Jaya, Selangor. MALAYSIA Tel : 603-78835400 Fax : 603-79556772 Website : www.bpfk.gov.my

WHO Collaborating Centre for Regulatory Control of Pharmaceuticals

Member of Pharmaceutical Inspection Cooperation Scheme

Certified to ISO 9001:2000 Cert. No: AR 2293 1

Guideline

Publication

Revision

Guideline for Control of

Cosmetic Products in

Malaysia

Initial Publication

-1st

January 2008

1st

Revision

- 2016

**not including revision on ingredient annexes i.e. Annex II-VII - ACC/ACSB decisions

VS.

OLD REVISED

GUIDELINE HISTORY NEW! PREAMBLE NEW! ABBREVIATIONS NEW! GLOSSARY NEW!

- Cosmetic Notification Holder - Cosmetic Product - Letter of Authorisation (LOA)/Letter of Declaration - Letter of Contract Manufacturing - Manufacturer - Assembler - Primary Assembler - Secondary Assembler - Product Name - Product Owner - Product Variant

1. INTRODUCTION 2. COSMETIC NOTIFICATION 3. REGULATORY REQUIREMENTS FOR COSMETIC PRODUCT 4. POST MARKET SURVEILLANCE (PMS) PROGRAMME – NEW! 5. REGULATORY ACTION 6. NOTIFICATION WITHDRAWAL 7. NOTIFICATION EXEMPTION 8. CERTIFICATE OF FREE SALE NEW! 9. HALAL NEW!

10. APPENDICES

Annex I, Part 1: Illustrative List Of Cosmetic Products By Categories

Annex I, Part 2: Non-permissible Product Name For

Cosmetic Product NEW!

Annex I, Part 3: Charges For Quest Membership NEW!

Annex I, Part 4: Guide Manual For Quest Online Submission Of Cosmetic Notification NEW!

Annex I, Part 5: Illustrative List of Types of Changes For Notified Product

Annex I, Part 6: Guideline For Safety Assessment of Cosmetic Products Annex I, Part 7: Cosmetic Labelling Requirements Annex I, Part 8: Cosmetic Claims Guideline Annex I, Part 9: Guideline For Cosmetic Advertisement

Annex I, Part 10: Guideline For Cosmetic Good Manufacturing Practice Annex I, Part 11: List of Equivalent Cosmetic GMP Guidelines Annex I, Part 12: Guideline For Product Information File (PIF) Annex I, Part 13: Guide Manual For Adverse Event Reporting Annex I, Part 14: Heavy Metal and Microbiological Test Limit For Cosmetic Product NEW!

Ingredient Annexes (Annex II-VII) Annex II: List of Substances Which Must Not Form Part of the Composition of Cosmetic Products Annex III: List of Substances Which Cosmetic Products Must Not Contain Except Subject to Restriction and Conditions Laid Down Annex IV: List of Colouring Agents Allowed for Use in Cosmetic Products Annex V: List of Excluded from the Scope of the Directive Annex VI: List of Preservatives Which Cosmetic Products May Contain Annex VII: List of UV Filters Which Cosmetic Products May Contain

Cosmetic products in Malaysia are regulated under the Control of Drugs

and Cosmetic Regulations (CDCR) 1984 which were promulgated under the Sale of Drugs Act 1952.

In agreement with the harmonisation of cosmetic through the ASEAN Cosmetic Directive (ACD), cosmetic products in Malaysia are controlled through notification procedure starting from 1st January 2008. The CNH is required to COMPLY with all requirements stated in this guideline and to make a declaration upon notification to the Director of Pharmaceutical Services (known as DPS) through National Pharmaceutical Control Bureau (NPCB). Regulatory action will be taken in the event of false declaration and/or product found to be non- compliant to the stipulated regulations and guidelines.

Under the CDCR 1984, Regulation 18A (1): No person shall manufacture, sell, supply, import, possesses any cosmetics unless the cosmetic is a notified cosmetic. It is an offence for anyone to conduct such activities without prior notification to the DPS.

APPLICATION PROCEDURES

1. Who shall submit for cosmetic notification

– locally registered company, CNH

2. Responsibility of the Cosmetic Notification Holder (CNH) NEW!

3. How to Submit for Notification Annex I, part 3: Charges for Quest Membership

–updated following GST implementation

(previously- Annex I, part 1-Membership Registration for Quest2 System)

Annex I, part 4: Guide Manual for Quest Online

Submission of Cosmetic Notification NEW!

4. Language- Bahasa Malaysia/English

5. Privacy Marking – all info is P&C

6. Fee – RM 50.00 per product/variant

7. Notification Validity Period – 2 years

8. Manufacture or Importation of Product

–after issuance of Notification Note

9. Changes in Notification Particulars

– i) amendment ii) new Notification

Annex I, part 5:Illustrative List of Types of Changes for

Notified Product

(previously Annex I, part 4)

10. Notification Number - NOTyymmxxxxxK

1. Product Particulars – notification submission

- Product name, type, intended use & presentation

- Name & add of the manufacturer (& assembler)

- Name, add, valid contact no. & e-mail of the CNH

- Name of person representing the CNH incl. valid contact

number

- Name & add of the importer(s), if any

- Full product ingredient list (restricted ingredients % to be

declared).

- LOA/LD/ Letter of Contract Manufacturing, if applicable.

2. Safety Requirements - no changes

Annex I, part 6 for Guideline for Safety Assessment of Cosmetic Product.

3. Cosmetic Ingredients – updated following ACC/ACSB decsion

refer to ingredient Annexes (Annex II – VII)

4. Labelling Requirements – Bahasa Malaysia and/or English

Annex I, part 7: Cosmetic Labelling Requirements

+ valid contact no. of the CNH on the label

5. Cosmetic Claims Annex I, part 8: Cosmetic Claims Guideline

(updated with more examples of unacceptable claims)

6. Cosmetic Advertisement ◦ Annex I, part 9: Guideline for Cosmetic Advertisement (previously Annex I, part 12:Cosmetic Advertisement Code)

+ 4.1 Impression of Professional Advice/Endorsement (a) Advertisements should not:-

(i) Have any visual and/or audio presentation of individual(s) with the impression of giving professional recommendation or endorsement; or

(ii) Contain statements giving the impression of professional by endorsement, advice or recommendation made by associations or persons who appear in the advertisements and who are presented either directly or by implication, as being qualified to give such endorsement, advice or recommendation.

(b) Advertisement may contain statements that are concluded from unbiased/ objective surveys/information, genuinely obtained from professionals. Care shall be taken, that the statements do not transgress any relevant regulations that the professionals institution to which they belong .

+ 4.6 Dangerous Practices or Disregard for Safety

Advertisement should not, without justifiable reason, show or refer to dangerous practices or manifest a disregard for safety. Special care should be taken in advertisements directed towards or depicting children or young people.

7. Good Manufacturing Practice (GMP) + For foreign manufacturer, documentation to prove GMP

compliance is required

Annex I, part 10: Guideline for Cosmetic GMP

Annex I, part 11: List of Equivalent Cosmetic GMP Guidelines

(updated- WHO GMP, TGA GMP, ISO Standard 22716)

8. Product Information File (PIF) – no changes

Annex I, part 12 - Guideline for PIF (previously Annex I, part 5: ASEAN Cosmetic Directive Guidelines for PIF)

9. Product Recall • required when the product has or may cause potential

risk to the user

• voluntarily by the CNH or as directed by the DPS.

• must first consult/inform NPCB.

• refer to Guidelines on Good Distribution Practice, Chapter 10 available at NPCB’s website.

10. Reporting of Adverse Event – no changes

• Annex I, part 13: Guide Manual for Adverse Event Reporting

(previously Annex I, part 11)

1. PMS Activities • Screening of product formulation and information

incl.product name & its claimed benefits • Sample collection & testing • Monitoring of label compliance • Audit of premises for compliance to the Cosmetic GMP • Handling of product complaints • Monitoring of advertisements • Monitoring of adverse reactions • Audit on the PIF • Risk communication • Information sharing through ASEAN Post Marketing

Alert System (PMAS)

2. Product Sampling Requirements • Must be from the same production batch • In its original marketed container/packaging and

unopened • The sample label and package insert (if any) must not

be taken out from the container/packaging • The expiry date ≥one year • Qtty. required- at least consist of 4 units/containers,

with a minimum total content of 40g/40ml (weight/volume of the product content without the container/packaging material)

- refer to Annex I, part 14 for limits used for heavy metal and microbial limit test

1. Rejection of Notification Submission – during ‘Auto-screening’ before NOT no. is issued

2. Cancellation of Notification Note 3. Punitive Action/Penalty - as stipulated under Section 30 (1) of the CDCR 1984.

CNH shall inform NPCB for decision to withdraw a notification of any cosmetic product before its validity expiry, with reason.

CNH is responsible to inform the manufacturer/ contract manufacturer on the withdrawal decision.

CNH shall not reinstate the withdrawn notification & its notification note is deemed invalid.

The product may be re-notified through a new notification submission.

1. Market Sampling - for the purpose of test market/aesthetic studies for product’s acceptance by potential group of consumers or manufacturers.

2. In–House Evaluation - product samples either from R&D/production line which are by the company for the purpose of product selection, in-house sampling or demonstration.

- may also of actual products that are readily available in the country of origin.

NOT INTENDED FOR COMMERCIAL SALE

3. Products For Export Only (FEO) or Re-Exporting

- Cosmetic products that are imported to be assembled, enclosed, packed or labelled solely for re-export or manufactured locally solely for export-only

4. In Transit

- products taken or sent from any country and brought into Malaysia by land, air or water, whether or not landed or transhipped in Malaysia, for the sole purpose of being carried to another country either by the same or another conveyance.

5. Products to Be Sold or Supplied in Free Trade Zone (FTZ) or International Carriage Entering or Leaving Malaysia - imported for sale/supply in the FTZ or international carriage by ships, aircraft or other forms of international public transport

Must apply for the permit- formal letter to NPCB

The company should maintain proper records and documents. These records should be readily available for inspection by NPCB when required.

Not a mandatory requirement

Serves as document which state that the product can be freely sold in Malaysia

Application through online submission

RM50.00 for each copy of the certificate.

CFS for a product and variant can be combined in one certificate provided that the latter is notified as a variant of the main product

Processed within 15 working days upon payment confirmation provided the product complies with notification requirements

The validity of the CFS is based on the validity period of the notified

product.

Halal logo may be used voluntarily on a notified cosmetic product

Certified & approved Halal by the Malaysia Department of Islamic Development (Jabatan Kemajuan Islam Malaysia, JAKIM) or any Islamic Body recognised by JAKIM.

Original 1st

Revision

Annex I, part 1 Membership registration DELETED

Illustrative List of

Cosmetic Products By

Categories

Annex I, part 2 Illustrative List of Cosmetic

Products By Categories

moved to Annex I, part 1

Non-Permissible Product

Name For Cosmetic

Product NEW

Annex I, part 3 Template for notification of cosmetic products DELETED

Charges For Quest

Membership NEW

Annex I, part 4 Illustrative List of Types of

Changes For Notified

Product

moved to Annex I, part 5

Guide Manual For

QuestOnline Submission NEW

Annex 1 : ORIGINAL vs. REVISED

Original 1st

Revision

Annex I, part 5 ASEAN Cosmetic Directive Guidelines For Product Information File (PIF) moved to Annex I, part 12

Illustrative List of Types of Changes For Notified Product

Annex I, part 6 (Changes to the Title)

ASEAN Guidelines For Safety Assessment Of Cosmetic Products

Guideline For Safety Assessment of Cosmetic Products

Annex I, part 7 (Changes to the Title)

ASEAN Cosmetic Labeling Requirements

Cosmetic Labelling Requirements

Annex I, part 8 (Changes to the Title)

ASEAN Cosmetic Claim Guideline

Cosmetic Claims Guideline

Annex I, part 9 ASEAN Guidelines For Cosmetic Good Manufacturing Practice moved to Annex I, part 10

Guideline For Cosmetic Advertisement

Annex 1 : ORIGINAL vs. REVISED

Original 1st

Revision

Annex I, part 10 List Of Equivalent Cosmetic

GMP Guidelines Recognized

by ASEAN moved to Annex I, part 11

Guideline For Cosmetic

Good Manufacturing

Practice

Annex I, part 11 A Guide Manual For Adverse

Event Reporting moved to Annex I, part 13

List of Equivalent Cosmetic

GMP Guidelines

Annex I, part 12 Cosmetic Advertising Code moved to Annex I, part 9

Guideline For Product

Information File (PIF)

Annex I, part 13 A Guide Manual For

Adverse Event Reporting moved from Annex I, part 11

Annex I, part 14 Heavy Metal And

Microbiological Test Limit

For Cosmetic Product NEW

Annex 1 : ORIGINAL vs. REVISED