Cosmetics Indonesia bpom Certification Guide

Cosmetics are a special commodity under strict control in Indonesia. The competent authority is Indonesia's national food and Drug Administration (bpom), which also manages food and beverage, health products, drugs and traditional medicines. Recently, bpom began to check the bpom certification of cross-border e-commerce. Many sellers consulted, and this article was specially launched for this purpose.

1 What is cosmetics?

Cosmetics refer to the ingredients and preparations used in the human body's appearance (such as epidermis, hair, nails, lips and external organs of genitalia), teeth and mouth. It is used to clean, fragrance, suppress black spots or keep the body in good condition.

There are 20 kinds of cosmetics, namely:

Serial number

type

Product category

one

Cream, liquid lotion, gel, oil

Baby cream, lotion and oil, moisturizer, day and night cream, foot care, etc

two

Facial mask

Facial mask, peeling facial mask, eye mask

three

Viscous liquid, paste, subpackage

Foundation cream, Concealer

four

Makeup powder and body powder, or antiseptic powder

Body powder, foot powder, baby talcum powder, antiseptic powder, etc

five

Bath soap

Solid bath soap, solid hand sanitizer, etc

six

Essence

Body essence, baby essence, perfume, etc

seven

Bathing substance

Bath liquid, bath oil, bath salt, etc

eight

Depilatory substance

Hair removal products

nine

Deodorant and antiperspirant

Deodorant and antiperspirant

ten

Hair substance

Hair dye, shampoo, dry cleaner, etc

eleven

Shaving substance

Shaving substance

twelve

Eye and face makeup

Eyeliner, powder, eye and face makeup remover, "stage" makeup, etc

thirteen

Lip care and makeup

Lipstick and lip gloss

fourteen

Dental and oral care

Toothpaste, mouthwash, tooth whitening agent, etc

fifteen

Nail care and makeup

Nail polish topcoat, nail polish primer, Nail Dryer

sixteen

External organ substance

External privacy and hygiene

seventeen

Sunbathing and sunscreen

Sunbathing and sunscreen

eighteen

No tanning substances

No tanning substances

nineteen

Brightening substance

Brightening eyelid cream, whitening skin

twenty

Anti wrinkle substance

Smooth wrinkles, anti wrinkle products, mask eye lines

Cosmetics containing mercury, retinoic acid, excessive hydroquinone, resorcinol and other bpom prohibited ingredients cannot be certified.

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II Cosmetics pollution

Pollution refers to certain factors that unintentionally and inevitably enter cosmetics during the processing, storage and / or transportation of raw materials. Restrictions on cosmetic contamination include:

a. Limitation of microbial contamination

Test limit

Cosmetics for:

Cosmetics except

a. Children under 3 years old

a. Children under 3 years old

b. Area around eyes

b. Area around eyes

c. Mucous membrane

c. Mucous membrane

Angka Lempeng Total

Total number of colonies

No more than 5x102 per gram or milliliter

Not more than 103 per gram or milliliter

Angka Kapang dan Khamir

Total number of molds and yeasts

No more than 5x102 per gram or milliliter

Not more than 103 per gram or milliliter

Pseudomonas aeruginosa

Pseudomonas aeruginosa

Every 0.1g or 0.1ml sample (test sample) is negative

Every 0.1g or 0.1ml sample (test sample) is negative

Staphylococcus aureus

staphylococcus aureus

Every 0.1g or 0.1ml sample (test sample) is negative

Every 0.1g or 0.1ml sample (test sample) is negative

Candida albicans

Candida albicans

Every 0.1g or 0.1ml sample (test sample) is negative

Every 0.1g or 0.1ml sample (test sample) is negative

b. Limitations of heavy metal pollution

Pollution type

limit

Mercury (Hg)

Not more than 1 mg / kg or 1 mg / L (1 ppm)

Lead (PB)

Not more than 20 mg / kg or 20 mg / L (20 ppm)

Arsenic (as)

Not more than 5 mg / kg or 5 mg / L (5 ppm)

Cadmium (CD)

Not more than 5 mg / kg or 5 mg / L (5 ppm)

c. Limitation of chemical pollution

Pollution type

limit

1,4-Dioxane*

1,4-dioxane

Not more than 25 mg / kg or 25 mg / L (25 ppm)

(*) cosmetics contain ingredients prepared by ethoxylation process, such as sodium lauryl sulfate or polyethylene glycol.

III Why must I register for bpom certification?

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Products that are not certified cannot be circulated in the Indonesian market. This rule has always existed. In the past, the management was not strict, but now it is more and more strict.

Large e-commerce platforms for products that have not obtained certification will not be allowed to sell on the shelves. In the past, platforms did not manage small and medium-sized sellers very well. Recently, because of the proliferation of unlicensed cosmetics on the Internet, local small and medium-sized enterprises have been impacted. The government requires all platforms to clean up unlicensed merchants.

Unlicensed products can not be imported formally, and can only be cleaned.

4 How to authenticate?

1. Document review:

Company documents

Local products

Local contract products

Imported products

Tax number (npwp), business license (siup) / Business Registration Certificate (NIB), ID card

Tax number (npwp), business license (siup) / Business Registration Certificate (NIB), ID card

Tax number (npwp), business license (siup) / Business Registration Certificate (NIB), ID card, import identification number (API)

Certificate of good manufacturing practice for cosmetics (cpkb)

Certificate of good manufacturing practice for cosmetics (cpkb) of the contracted factory

Good manufacturing practice (GMP) legalized by Indonesian Embassy

Trademark rights statement

Trademark rights statement

Certificate of free sale notarized by Indonesian Embassy

Brand certificate

Brand certificate

Brand certificate

Statement of directors and / or leaders of the cosmetics industry who are not involved in criminal acts in the cosmetics industry

Statement of directors and / or leaders of the cosmetics industry who are not involved in criminal acts in the cosmetics industry

Statement of directors and / or leaders of the cosmetics industry who are not involved in criminal acts in the cosmetics industry

Cooperation agreement approved by the notary (including brand / product name and validity)

Power of attorney (Loa)

*For the completeness and validity of other document information, you can consult shanhaitu.

2. Factory inspection / warehouse review

Bpom will conduct factory inspection on local manufacturers / warehouse audit on importers to ensure that the production or storage environment of cosmetics is safe and reliable. Information to be prepared by the importer:

1) Letter of appointment

2) Certificate of free sale (CFS) notarized by Indonesian Embassy

3) GMP or ISO 22716 notarized by Indonesian Embassy

4) Business license (manufacturing license) notarized by Indonesian Embassy

5) CoA of raw material

6) Finished product inspection report (COA of finished product)

7) MSDS Report

8) Standard operating procedure (SOP)

3. Open an account

Bpom certification can be applied online. Each company must register a company account to apply for certification. Shanhaitu can help register a company account.

4. Sample testing and product registration

After all the documents are submitted, the bpom number of the product can be obtained after the bpom review is passed, and the product can be distributed.

However, if bpom feels that the ingredients of your product need to be tested, it must be tested in the laboratory in Indonesia before issuing a certificate.

Serial number

Required information

one

Recipe data

two

Product manufacturing method

three

Batch number and expiry date information

four

CoA of raw material

five

CoA of finished product

six

MSDS Report

seven

Original package

eight

packing design

5. Product information document review (DIP)

This audit will be conducted within 6 months to 1 year after the product has obtained the bpom number. The purpose of dip audit is to track the supervision results during product circulation (post market). If the product receives reports / complaints from the public, it will also be audited.

V How should the product packaging of foreign products be designed?

Packaging compliance is the most difficult part in the certification process. Many people have been cheated in this aspect. Let's introduce it specifically. The purpose of cosmetic labels is to provide consumers with information about the cosmetics, including product names, uses, and even product ingredients. The information of the package may be pictures, words or other forms. The label can be directly affixed to the cosmetic package or printed on the product package. Labels can be in foreign languages, but some information must be added in Indonesian.

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Necessary information on the label of the package:

a. Product Name:

b. Batch No. / production code

c. Size, contents or net weight

d. Bpom distribution number

e. Name and address of manufacturer and importer

f. Name and address of distributor

g. Use

h. Usage:

i. Expiry date of the product

j. Material composition

k. Other labels related to safety and / or quality

Vi What kind of punishment will you face if you violate bpom regulations?

1. Written warning

2. Temporarily prohibit product distribution

3. Temporarily prohibit production activities

4. Product recall

5. Cancel distribution number

VII matters needing attention

1. The manufacturer must have a good production specification system, have GMP and ISO 2271 certificates, and obtain free sales certificate (CFS).

2. The importer of cosmetics must have a qualified warehouse.

3. The importer of cosmetics must have a technical director (PJT), with at least a bachelor's degree and a major in pharmaceutical science; Medical science; Biological science or chemistry.

4. Bpom certificate is valid for 3 years and can be extended before expiration; If you want to change the package or size, you can change it; If the composition of the product changes, it must be re registered.