WEBINAR Indonesian Cosmetics Regulatory Compliance and Import - - PowerPoint PPT Presentation

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WEBINAR Indonesian Cosmetics Regulatory Compliance and Import - - PowerPoint PPT Presentation

WEBINAR Indonesian Cosmetics Regulatory Compliance and Import Requirements PT Cekindo Business International Speaker: Ms. Nurmia Agustina (Director of PT Cekindo Business International) Date: August 21, 2019 Introduction of of Nurmia


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SLIDE 1

WEBINAR

Indonesian Cosmetics Regulatory Compliance and Import Requirements

PT Cekindo Business International Date: August 21, 2019 Speaker: Ms. Nurmia Agustina (Director of PT Cekindo Business International)

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SLIDE 2

Introduction of

  • f Nurmia Agustina

Nurmia Agustina INFO@CEKINDO.COM Director of PT Cekindo Business International Company: Cekindo Expertise: Regulatory Affairs, Product Registration (cosmetics, food supplement, food and beverage, medical devices, household products) and Halal Certification Bio: Nurmia Dwi Agustina oversees activities related to Market Entry Strategies, Legal Incorporation, Licenses, and Compliance of Indonesian entities. Nurmia emphasizes on building long-term partnerships with Cekindo’s clients and providing them with tailor-made solutions. Her company Cekindo, has successfully assisted many clients to enter the Indonesian market through our comprehensive business solutions, such as company registration and product registration. Having expanded to Vietnam, Cekindo can now assist clients that intend to set up a cosmetic business in the country. nd bev urmia Dwi rporat Dwi poratio ration,

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SLIDE 3

OUTLINE

01

Overview of Indonesian Cosmetic Market

02

Definition of Cosmetic Product

03

Classification of Cosmetic Products

04

Regulatory Framework (cosmetic products labeling, claim, etc.)

05

Competent Authority

06

Cosmetics Registration

07

Exporting Cosmetics to Indonesia

08

Halal Certification for Cosmetic metic metic Marke rket

05

Co Cosm Cosme finition of tion o ion of ion of Co Cos ewo ion of ework efinition

  • smeti

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SLIDE 4

01

OVERVIEW OF INDONESIAN COSMETIC MARKET

Indonesia’s cosmetic industry:

  • 29,668 registered cosmetic products were

sold in the 1st semester of 2019 (BPOM)

  • Remarkable growth at 12% with total sales

value of IDR 19 trillion (US$1.3 billion)

  • Exports have increased by almost 3.6% in

the last 5 years

  • Next 10-15 years: become top 5 Asian

markets were sales 3.6% in Asian $1.3 $1.3 bill alm almo almost lmost

  • st

$1.3 12% $1. 3.6% yea 15 Indone 29,66 ,668 668

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SLIDE 5

01

REASONS BEHIND THE SIGNIFICANT GROWTH

  • Indonesia: world’s 4th largest nation with > 260 million people
  • Growing middle class & prosperous consumers

A decade ago: only Indonesian upper-class can enjoy cosmetics & cosmetics sold only in major cities across Java & Sumatra

GROWTH OF MIDDLE – CLASS HOUSEHOLDS 2019 2030

20 million 23.9 million

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SLIDE 6

01

REASONS BEHIND THE SIGNIFICANT GROWTH

  • High penetration of smartphone and Internet usage in

Indonesia Smartphone penetration growth is estimated at 4% annually

  • Preference of overseas cosmetics over domestic ones

Indonesian people still tend to buy internationally recognized cosmetic products because of quality and prestige eas cos tend to tend to duct d to ducts ducts be ducts bec s bec cosme ten seas becaus becaus ige and imate imate mated at ated at d at nd a d at 4% 4% Sm Sm Sma annua Smar annua annual nnually artpho nnually nnually

ONS B NS BE

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SLIDE 7

01

COSMETICS BUSINESSES IN INDONESIA

Major sales in Indonesian cosmetic and personal care sector:

  • Hair care products (37%)
  • Skin care products (32%)
  • Make-up (10%)

Females in Indonesia are the main consumers for make-up products. Today, Indonesia’s female population comprises over 130 million. a are the are the m the m

  • day,

he m day, Indo day, Indo ises ov , Indone ises over s over 1 Indones ndones er 13 male p

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SLIDE 8

02

DEFINITION OF COSMETIC PRODUCT

Type of cosmetic products:

  • Skin care products for the epidermis, the
  • utermost layer of skin
  • Shampoo and hair conditioner for the hair
  • Nail coloring for the nails
  • Lipstick for the lips
  • Feminine hygiene products for outer genital
  • rgan
  • Toothpaste and mouthwash for the teeth and
  • ral mucosa

The purposes of cosmetic products:

  • To clean the body
  • To make the body smell good
  • To change appearance
  • To change body odor
  • To protect and/or maintain body

in good condition Cosmetic products are NOT medicines and CANNOT be used to cure a disease

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SLIDE 9

03

CLASSIFICATION OF COSMETIC PRODUCTS

Based on Characteristics and Preparation: Chemical materials Traditional Natural resources and based

  • n

recipes from generation to generation Modern Based on the Application: Cleanser, freshener, moisturizer, sun block cream, night cream, etc. Make-up Powder, BB cream, lipstick, etc. Skin Care nigh nigh gener gener up urces

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SLIDE 10

04

REGULATORY FRAMEWORK: COSMETICS LABELING

  • Label should not easily wear off, fade, or be separated from the packaging
  • Label should contain complete and clear information
  • Some information should be mentioned in Indonesian language, especially for

uses/claim, direction of use, and warning/caution

  • The use of a foreign language is OK as long as it is written using Latin letters and/or

Arabic numerals fa fade, fade, fade, or cle

  • r

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ULATO ULATORY ETICS LA ETICS LA ICS LA CS LAB ULATOR ULAT S LABELI

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SLIDE 11

04

REGULATORY FRAMEWORK: COSMETICS LABELING

  • Information on primary packaging (minimum):

Cosmetics name, batch number & net size/net weight

  • Information on secondary packaging/brochure/hanging tag/shrink wrap:

Uses, how to use, composition, name and country of origin, name and full address of the manufacturer, warning/attention

  • For composition: must use the International Nomenclature of Cosmetic

Ingredients (INCI), use genus and species name for raw materials, written from biggest to smallest concentration.

  • f Cosmetic

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SLIDE 12

04

REGULATORY FRAMEWORK: COSMETICS CLAIM STANDARDS & PROCEDURES

Claims that are prohibited in cosmetics include:

  • Using words as if they were medicine
  • Using words: "safe", "free", "harmless", "no side effects“
  • Using recommendations from healthcare workers
  • Using words such as “removing or killing bacteria”, “improving skin

texture”, “removing dandruff permanently Other important points:

  • Claims such as "whitening" are not allowed
  • Claim of "safe" is not permitted

“improving skin “remo dandr ndruff ndruff “remo dandruf “re uch

  • f "sa
  • f "safe" i

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  • ULATO

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SLIDE 13

04

REGULATORY FRAMEWORK: COSMETICS ADVERTISING STANDARDS

Cosmetics that are not registered with the BPOM are prohibited from advertising.

  • Cosmetic

advertising is not required to be registered at the BPOM.

  • Winning testimonials, award agency logo, logo of

health/professional organizations: permitted.

  • Religious leaders, healthcare professionals or

actors resemble healthcare personnel: not permitted. age agen agency tions: gency tions:

  • ns: per

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ULATO ULATORY TISING ISING SING S ING S ULATOR ULAT STAN

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SLIDE 14

05

COMPETENT AUTHORITY IN COSMETICS REGISTRATION IN INDONESIA

  • National Agency of Food and Drug Control (BPOM) is the relevant

authority for cosmetics registration.

  • BPOM is in charge of drafting the regulations

and implementing them.

  • Imported

cosmetic products imported to, distributed and sold in Indonesia must be registered with BPOM.

  • BPOM is also authorized to issue notification.

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SLIDE 15

06

COSMETICS REGISTRATION IN INDONESIA

Who can register cosmetic products? Only companies established under the Indonesian Laws. Most common options:

  • Foreign-owned company (PT PMA): limited liability company with foreign
  • shareholder. Reach out to Cekindo for information on its establishment.
  • Local company (PT): limited liability company with local shareholders. Reach out to

Cekindo for information on its establishment and nominee arrangement.

  • License holder by third party: without setting up a company, Cekindo can act as

license holder of your products. Import license is required to bring cosmetic products through Indonesian customs. ed liabi d liabili liability n its esta its establi stabli tabli withou without se without se ed liabi n its t se Cekindo ed ut setting t setting port port licen ms. ms. port lic holde

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SLIDE 16

06

COSMETICS REGISTRATION IN INDONESIA Which cosmetic products must be registered?

  • Every cosmetic
  • product. You must

register every variation (color, flavor, size, etc.) of your cosmetic product as a separate item.

  • Example: if you wish to sell body soaps
  • f different flavor, you need to register

each flavor with BPOM.

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SLIDE 17

06

COSMETICS REGISTRATION IN INDONESIA

How to register your cosmetics?

Import of products must be done within 6 months after receiving BPOM’s notification,

  • therwise product registration will be invalid

Legal entity registration through BPOM

  • nline system

Cosmetic product registration to BPOM Payment to BPOM Notification issued from BPOM Letter

  • f

Authorization from Principal, Certificate

  • f Free Sales, Good

Manufacturing Process Certificate The fee is applied per product based

  • n

the

  • rigin

country (ASEAN or

  • utside

ASEAN countries) Valid for 3 years & extendable Company incorporation documents, business license, import license 1 4 3 2

  • rizati

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SLIDE 18

07

EXPORTING COSMETICS TO INDONESIA

As soon as you receive notification from BPOM, you can start exporting, distributing and selling your cosmetic products in Indonesia. Advice for exporters:

  • Independent distributor: set up an Indonesian company.
  • Manufacturer or principal: engage an Indonesian distributor/agent (only under
  • ne Indonesian company).
  • Choose a reliable Indonesian partner: no agreement termination before 3

years.

  • Cosmetics registration process may take longer than expected.
  • Seek professional assistance for document review or guidance through the

registration process.

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SLIDE 19

08

HALAL CERTIFICATION FOR COSMETICS

  • Indonesia is a country with the largest percentage of Muslims in the

world.

  • Developing halal cosmetic products can help gain the trust of and

attract Indonesian customers.

Missing the deadline will cause a drop in sales.

Effective from 17 October 2019, all international halal cosmetic products that have not been certified in Indonesia will become non-halal. Musl Muslim uslim slims

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SLIDE 20

08

HOW TO REGISTER YOUR HALAL COSMETIC PRODUCTS

Relevant authorities:

  • National Body of Halal Assurance (BPJPH):

Halal certification to businesses

  • Council of Indonesian Ulama (MUI):

Halal fatwa and setting up halal compliance standards

  • Food, Drug and Cosmetics Assessment

Agency (LPPOM) & MUI Fatwa Committee: Halal audit, assessment, and declaration lama ( ng up ha ng up halal co lal co ssm ssmen ma (M ng up hala ssment Ulama ent LPPOM) t, assessm assessm essm POM) t, asse ug and (LPPOM) Releva Relevan Natio Natio Nation ationa Halal c ional B l cert l certi Releva l certif uncil of Re nal Bo ertific ertifica Ag Ag

W TO RE O REG ETIC P ETIC PR IC PRO C PRO W TO RE W TO R ODUC

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SLIDE 21

08

HOW TO REGISTER YOUR HALAL COSMETIC PRODUCTS

Halal certification process:

Prepare all documents required for halal certification application Fulfill HAS 23000 halal requirements and the implementation

  • f

Halal Assurance System (HAS) Fill out documents as required by the LPPOM-MUI during the registration process Products fulfil HAS requirements and LPPOM-MUI lab analysis Cekindo will provide guidance for pre- audit, audit, and post- audit assessments, as well as lab analysis to ensure conformity MUI approves the products or materials and LPPOM MUI or BPJPH issues the halal certificate that is valid for 4 years

1 3 2 4 6 5

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SLIDE 22

THANK YOU FOR JOINING THE WEBINAR

  • Cekindo

Tel: +6221 3006 1585 E-mail: INFO@CEKINDO.COM Website: WWW.CEKINDO.COM

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