Cosmetic Products Clearance

Requirements from Customs Ports

Executive Directorate of Cosmetics Products Safety
Drug Sector-SFDA
June 2015

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Guide Contents:
Title

Page Number

Requirements for Clearing Commercial

Quantities of Cosmetic Products.

Samples for personal use and items purchased

online or by post.

Samples for Laboratories Analysis in Saudi

Arabia.

Samples of advertising and Marketing.

Checking of Cosmetic Products Shipments

Procedure.

Transfer and Storage.

10

Importing empty bottles for cosmetic products

filling.

10

Frequently Asked Questions (FAQ).

11

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Introduction:
Clearance procedure is a basic and vital step in ensuring the safety of cosmetic products.
The requirements clarified in this guide aims to create the necessary balance and
harmonization between assuring the safety of cosmetic products and facilitating an easy
and effortless clearance procedures, taking into consideration all points and reviews raised
by importers and difficulties that hindered the process in the past .

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A: Requirements for Clearing Commercial Quantities of Cosmetic Products

There are 7 requirements to clear the cosmetic products in costumes:

Payment bill

Warehouse licensing
shipments can be relesed
with commitment from the
importer to license a
warehouse within specified
timeline

certificate of conformity.

certificate of origin

A bill of lading

Agency registration
certificate or an
Authorization letter from
the Manufacture .

Notify the product through eCosma

1. Warehouse licensing for cosmetic products:

Warehouse licensing for cosmetic products issued by SFDA the warehouse for
medicines, herbal and health products can be accepted with commitment to add the
cosmetic products in the license. Also the importer could get a license to store with
other party according to requirement guidelines to license the storage with other
party.

2. Certificate of Conformity:
Certificate of conformity is a proof that the imported products shipments with
known bill number and batch Number has been tested before importation to Saudi
Arabia, through a number of conformity bodies accredited by SFDA , to assure that
it meets the safety requirements issued by GSO. These companies are:
1. Intertek International Limited
2. SGS (Socirte Generale de Surveillance)
3. TUV Rheinland
4. Cotecna
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Any certificate issued by other than the above listed companies will not be
accepted, nor does a shipment that holds information that not match the attached
certificate. In addition, each shipment must be provided with its certificate of
conformity.
In the absence of the conformity certificate, the clearance employees shall withdraw
samples from the shipment and send it to SFDA labs for analysis. Analysis charges
will be covered by the importer through HTTP://DSIS.SFDA.GOV.SA in order to
verify product conformity according to Gulf Standard GSO 1943 (Safety
Requirements Guidelines of Cosmetic Products).

3. Payment Bill:
Payment bill must be issued from the manufacturing company and certified from
chambers of commerce of the origin country. In case of a bill issued form one of
the agents or distributors of the manufacturing company, it must provide a proof of
authorization from the manufacturing company from where the shipment was
purchased.
The payment bill should contain the following data:

Products name

Patch Number

Expiration Date

Manufacturer company name and nationality.

4. Certificate of origin:
The certificate of origin must be approved by chambers of commerce of origin
country, where 50% of product is manufacturing process takes place with exception
of packaging process. The manufacturing present on imported cosmetic product
label must match the origin country stated in origin certificate and it must relate to
the payment bill presented as in mentioning the payment bill number in the
certificate.
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5. Agency registration document or an Authorization letter from the

Manufacture.
A copy from agency Registration document issued by Ministry of Commerce and
Industry (MOCI) in Saudi Arabia or an original letter from the manufacturer
authorizing the importer to import and distribute their products in Saudi Arabia.
6. A bill of lading
The importer must present a copy of the bill of lading when the shipment arrives
at customs.
7. Notify imported products through the electronic notification

system (eCosma):
Cosmetic Products must be notified in the cosmetic products notification system
(eCosma) according to the notification plan mentioned in circular number 6395
issued by 24/02/1436H.

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B. Samples for personal use and items purchased online or by post:

For products purchased for personal use, please follow these instructions:
1- The amount of sample items must not exceed 20 items and weigh no more than 15kg.
2- Complete clearance form and its relevant requirements.
3- Send the form and signed declaration via e-mail or fax to the SFDA office at port
through, email and fax numbers that can be found on the following link:
http://www.sfda.gov.sa/ar/drug/about/sector_departments/Importing_Clearance/Pages/Dr
ug-dr.aspx

C. Samples for analysis in laboratories in Saudi Arabia:

Samples imported for the purpose of analysis, will be released by a letter from a private
laboratory indicating the amount of sample items and the purpose of analysis. The amount
of sample items should not exceed the samples for personal use.

D. Samples of advertising and marketing:

Refer to samples for personal use and items purchased online or by post requirements
mentioned in (B). If the quantity exceeds the samples for personal use limit, importer
should comply with requirements for clearing commercial quantities of cosmetic products
mentioned in (A).

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E. Checking of cosmetic products shipments procedure:

A. Checking of products label:
1. Label should match the one notified through eCosma, and the following
information should be included in the primary packaging label or in the outer
package:
Products name and brand name in Arabic or in both Arabic and
English.
Name and address of products manufacturer or name and address of the
importer.
Product Expiration date:
o Expiries in less than 30 months: Expiration month and year
should be written.
o Expiries in more than 30 months: Include Period After
Opening in addition to following symbol:

Period after opening should be

mentioned here e.g. 6 months

o List of ingredient, named according to the International

Nomenclature for cosmetic ingredients (INCI).
2. The function of product unless it is indicated by virtue of its presentation, in
Arabic or in both Arabic and English.
3. Storage conditions in Arabic or in both Arabic and English.
4. Production date or batch number.
5. Usage instructions, Cautions or precautions.
6. Country of manufacturing (If a product is manufactured in more than one
country, the country that holds most of manufacturing process is indicated on
label)
7. Package volume (packages of volume less than 5ml or gm is excluded and has
its requirements issued by SFDA)
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8. No medical or unacceptable claims are allowed, claims should comply with the
definition of cosmetic products stated in GSO Standard (GSO 1943/2009) , as
follows: (Any substance or preparation intended to be placed in contact with
the various external parts of human body (epidermis, hair system, nails, lips,
and external genital organs) or with the teeth and the mucous membranes of the
oral cavity with a view exclusively or mainly to cleaning them, perfuming
them, changing their appearance and/or correcting body odors and/or protecting
them or keeping them in good condition)
o Examples of non-allowed medical claims:

o Examples

Baldness treatment.
Wight Loss.
Sexual weakness treatments.
Pigmentation and acne treatments.
of claims compatible with cosmetic products

definition:
Preserving hair smoothness.
Nails strengthen.
Skin smoothing.
B. Clearance employees has the authority to withdraw samples (4 samples) from the
consignment and send it for evaluation and analysis, in case of:
1. Circulars and warnings were issued about some products.
2. In case he noticed a problem in the product at the time of inspection, such as,
change in external appearance or the product is different from the one notified
in eCosma.
3. The presence of medical or unacceptable claims.
4. Random inspection of Products imported to Saudi Arabia.
Note: The Importer can clear his shipment, after signing a pledge not to
dispose the pending products, in case samples were drawn for
evaluation and analysis, until results are issued and he receives an
informing letter from customs through SFDA.

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F. Transfer and Storage:

Importer has to ensure that Cosmetic products are being transferred in suitable transfer
facilities to keep products from damage.

G. Importing empty bottles for cosmetic products filling:

1. A licensed manufacture or factory for cosmetic products filling.
2. A commitment from the manufacture to comply with the labeling requirements stated
in the GSO 1943/2009 .

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Frequently Asked Questions (FAQ):

Q: Is it required to list (notify) cosmetic products at SFDA before importation?
Yes, The Saudi Food and Drug Authority represented by The Executive Department of
Cosmetic Products Safety requires all cosmetic products manufacturers and importers to
list (notify) their products through eCosma (the electronic system of cosmetic notification)
according to (Cosmetic notification implementation plane) mentioned in circular number
6395 issued by 24/02/1436H.
Q: We would like to know about the electronic system of cosmetic notification.
eCosma is an electronic system for licensing, notification and clearance cosmetic products
and manufactures. It requires you at the beginning to create an account through eCosma
website (https://ecosma.sfda.gov.sa). In addition, once it is approved, you can apply
for domestic manufacture and warehouse, or notify foreign manufacture. When the
requests approved, you can start notifying your products and complete clearance process.
For more information on how to use The Electronic System of Cosmetic Notification,
please read Cosmetic Products Notification System (eCosma) User Guide.
Q: Is it required to notify a product with each imported shipment?
No, the product is listed (notified) once in the system and you could import the product if
you fulfill clearance requirements.
Q: What are the requirements of the conformity certificates?
A: The certificate of conformity should be issued by an accredited conformation company
by SFDA. You could contact the conformity companies to find out what their requirements
are for issuing certificate of conformity.
Q: Is it possible to import products accompanied by certificate for standards other
than one which issued by GSO Standard?
A: It is not permitted to import cosmetic products unless the certificate of conformity states
that the product complies the safety requirements issued by GSO.
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Q: I would like to ensure compliance of the products label to what is approved by

SFDA?
A: Compliance of the product label can be ensured by implementing the requirements
(GSO 1943/2009) (Cosmetic Products The Cosmetic Product (Safety) Regulations).
These standards can be purchased directly from GCC Standardization Organization
website.
Q: I would like to import products but I am not entirely certain whether it is a
cosmetic product or medicine?
A: It can be ensured that the product to be imported are cosmetic products by implementing
the definition of cosmetic products in (GSO 1943/2009) (Cosmetic Products The
Cosmetic Product (Safety) Regulations), and it is possible to apply for a classification
(optional) at SFDA to determine whether it requires registration as pharmaceutical product
or listing (notification) as cosmetic product .

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