KINGDOM OF SAUDI ARABIA
Date: 17 February 2014
DATASHEET FOR EXPORTERS
For the attention of importers: This document is intended for exporters in order to explain how to comply
with Saudi Arabian Standards. It is the responsibility of importers to inform exporters of the existence of the
present procedure. Verifications are executed at origin on seller or exporter’s initiative; therefore importers
do not need to approach Cotecna.
1.
VERIFICATION OF CONFORMITY (VOC) PROGRAM FOR GOODS TO
SAUDI ARABIA (SFDA PROGRAM)
PROGRAM MANDATED BY
Saudi Food & Drug Authority (SFDA)
APPLICABLE REGULATION(S)
Royal Decree N°6 dated 25/01/1428H (1 January 2013)
STANDARDS
Please contact your closest Cotecna office to determine if your product
is subject or not to this program
STARTING DATE
1 of February 2014
APPOINTED COMPANIES
include COTECNA Inspection S.A. and affiliated companies
(hereinafter referred as Cotecna)
SELECTION OF INSPECTION
COMPANY
Exporter’s choice
SCOPE OF SFDA VOC
PROGRAM
st
st
- Documentation verification
- Laboratory testing in exporting country
- Physical inspection in exporting country
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Copyright © 2014 Cotecna - 17 February 2014
KINGDOM OF SAUDI ARABIA
2.
VOC PROCESS TO COMPLY WITH SFDA REQUIREMENTS
In order to clear their goods in the Kingdom of Saudi Arabia, importers need to present at Saudi Customs a
Certificate of Conformity (CoC) issued by Cotecna. CoCs are needed for every consignment and must cover
100% of goods to be shipped to Saudi Arabia and subject to the program.
The CoC can be obtained by exporters in the Country of Supply using one of the below methods of
compliance.
1. ROUTE A – For unregistered products
This route is recommended mainly for infrequent exporter/seller. Exporter/seller need to follow this
process for every shipment as a CoC is valid for one shipment only.
a. Documentation verification
Exporter/seller will provide Cotecna with following documents:

Request for Certification as per Cotecna template (please contact your closest Cotecna
office to get it)

Proforma invoice

Technical datasheet of the products

Packing list

Valid conformity documents (e.g. lab test reports, quality certificates or analysis reports)
Based on the documents received, Cotecna will verify the conformity of goods to the applicable
standards and decide if testing is required. Testing is not required when valid conformity documents
are presented to Cotecna.
(Please refer to section 3 of this document to learn more about what is considered as a valid
conformity document.)
b. Testing in exporting country
If no valid conformity documents are presented by exporter/seller, Cotecna will:

Collect samples

Have samples analyzed in an ISO 17025 accredited or otherwise qualified laboratory (as per
Cotecna/SFDA’s procedures)
c. Physical inspection in exporting country

Physically inspect the goods and/or supervise the container loading, as required

Seal the containers (for FCL), as required
d. Collect final documents
Exporter/seller will provide Cotecna with following documents:

Transport document (BL, AWB or Road Consignment)

Commercial Invoice
Cotecna will issue of Certificate of Conformity (CoC) if the exporter/seller meets the requirements. If
not Cotecna will issue Non Conformity Report (NCR).
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Copyright © 2014 Cotecna - 17 February 2014
KINGDOM OF SAUDI ARABIA
2. ROUTE B – For registered products
This route is recommended in case of regular shipments. Exporter/seller can apply for the registration of
the products in order to decrease the level of intervention of Cotecna on each shipment.
The registration is valid for one year and allows the exporter/seller to get a CoC for every shipment
without having a systematic physical inspection of their shipments.
The registration remains valid only if the registered products are not modified (composition and
packaging).
a. Conditions for registering products
The exporter can register his products with Cotecna when he complies with the following conditions:



The production unit should be covered by a quality system such as ISO 9001.
The products are covered by a technical datasheet.
A factory audit with satisfactory results is conducted by Cotecna. The factory audit is not
necessary if the producer can prove that he is certified ISO 22716.
b. Documentation verification
Exporter/seller will provide Cotecna with following documents/information:

Request for Registration as per Cotecna template (please contact your closest Cotecna
office to get it)

Technical datasheet of the products

Declaration of Conformity issued by the producer or the supplier

Valid test reports for all batches. Please refer to section 3 of this document to learn more
about what is considered as a valid conformity document.

Quality system certificate such as ISO 9001. It shall remain valid during the time of the
registration.
c. Testing in exporting country
During the registration validity, Cotecna might execute additional sampling and testing during the life
time of the registration to countercheck the results of the test reports provided with each shipment.
Registration will be canceled in case the counterchecks show non-compliant goods.
d. Physical inspection in exporting country
Cotecna might proceed to random physical inspection which represents around 25% of the
shipments to be sent.
e. Issuance of CoC
Exporter/seller need to apply for a CoC for every shipment. They will need to provide only the
following documents:

Transport document (BL, AWB or Road Consignment)

Commercial Invoice

Packing List
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Copyright © 2014 Cotecna - 17 February 2014
KINGDOM OF SAUDI ARABIA
DEFINITION OF “VALID CONFORMITY DOCUMENT”
3.
Exporter/seller might submit to Cotecna “Valid Conformity Documents”, such as test reports, quality
certificates and analysis reports. If they are not available, Cotecna will arrange for the necessary tests to be
performed.
A conformity document is valid when:

It has been issued by an ISO 17025 accredited laboratory.

We can establish traceability between the conformity document and the goods of the
consignment.

It covers the exact same production, meaning same batch, as the goods of the consignment.

It covers strictly 100% of the products of the consignment.

It is in compliance with Saudi Standards requirements.
4.
SPECIAL REQUIREMENTS ON LABELLING




Marking on the product’s package and on outer package shall include the following:
o
Product name and brand name or trade mark (In Arabic or both Arabic and English)
o
The name and address of the manufacturer
o
The name and address of the agent or the importer in KSA
o
List of ingredients comprising more than 1% from the overall weight of the products. It
should also be listed in descending order according to weight and shall follow the
International Nomenclature System (INCI).
o
The function of the product unless it is indicated from the way of its presentation.
o
Storage conditions
o
Batch number, manufacturing date/ expiry date or validity period
o
Cautions or precautions ( in Arabic or Arabic and English)
o
Usage instructions ( in Arabic or Arabic and English)
o
Country of origin
Non-existence of medical claims on the product, label, package or information leaflet. (The label
on the product shall not contain any medical or therapeutic claims; otherwise it will not be
released until it is registered with SFDA as a medicine.)
The products shall not be offensive to the Islamic religion. In particular they shall not contain any
pork, pork fat or pork derivatives or pictures of pigs, pig shapes or crosses.
Any imagery that may be offensive to the Islamic religion are forbidden on products and
packaging.
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Copyright © 2014 Cotecna - 17 February 2014
KINGDOM OF SAUDI ARABIA
PRODUCTS SUBJECT TO SFDA PROGRAM
5.
As per Royal Decree n°6 dated 25/1/1428H and Saudi Standard SASO 1953/2005, please find below a nonexhaustive list of products categories subject to SFDA program. In case of doubt, we strongly recommend
you to contact your closest Cotecna office which might help you to determine if your products are subject to
SFDA program or not.

Creams, emulsions, lotions, gels and oils for the skin (hands,face, feet, etc.).

Face masks (with the exception of peeling products).

Tinted bases (liquids, pastes, powders).

Make-up powders, after-bath powders, hygienic powders, etc.

Toilet soaps, deodorant soaps, etc.

Perfumes, toilet waters and eau de cologne.

Bath and shower preparations (salts, foams, oils, gels, etc.).

Depilatories.

Deodorants and anti-perspirants.

Hair care products:
o
Hair tints and bleaches,
o
Products for waving, straightening and fixing,
o
Setting products,
o
Cleansing products (lotions, powders, shampoos),
o
Conditioning products (lotions, creams, oils),
o
Hairdressing products (lotions, lacquers, brilliantine).

Shaving products (creams, foams, lotions, etc.).

Products for making up and removing make-up from the face and eyes.

Products intended for application to lips.

Products for care of teeth and mouth.

Products for nail care and make-up.

Products for external intimate hygiene.

Sunbathing products.

Products for tanning without sun.

Skin-whitening products.

Anti-wrinkle products.

Eye decorative cosmetic products (Eye shadow, mascara, brows, lids, pencil, lashes, cream and
athmad (Al-kohol)).
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Copyright © 2014 Cotecna - 17 February 2014
KINGDOM OF SAUDI ARABIA
6.
FEES PAID BY EXPORTER
Table 1.
Fees for non Registered Products in USD*
Minimum FOB
value **
Maximum FOB
value **
Applicable fee
(Pricing USD or %
of FOB value)
Min fee
Max fee
3’000
59’999
300
300
300
60’000
199’999
0.50%
300
900
200’000
599’999
0.45%
900
2’400
600’000
999’999
0.40%
2’400
3’500
1’000’000
More
0.35%
3’500
15’000
* Above mentioned fees are net of any duties and taxes
** It is the value of the goods without Customs fees nor the insurance nor the freight charges
Table 2.
Fees for Registered Products in USD*
Minimum FOB
value **
Maximum FOB
value **
Applicable fee
(Pricing USD or %
of FOB value)
Min fee
Max fee
3’000
59’999
210
210
210
60’000
199’999
0.35%
210
600
200’000
599’999
0.30%
600
1’500
600’000
999’999
0.25%
1’500
2’000
1‘000’000
More
0.20%
2’000
15’000
* Above mentioned fees are net of any duties and taxes
** It is the value of the goods without Customs fees nor the insurance nor the freight charges
The above-mentioned fees (tables 1 & 2) do not include the following:

Factory audit

Laboratory testing fees

Sample pick up

Other fees not mentioned above
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Copyright © 2014 Cotecna - 17 February 2014
KINGDOM OF SAUDI ARABIA
7.
CONDITIONS

Costs of the inspections, sealing, analysis and/or certification are borne by the exporter/seller
and are quoted at the time of nomination.

All costs incurred for presenting the goods for inspection, such as unpacking, handling,
repacking, are borne by the exporter/seller.

If the goods do not conform to the requirements, fees for physical inspection, testing and Non
Conformity Report issuance remain due to Cotecna.

This program is subject to the General Terms and Conditions of Cotecna
(http://www.cotecna.ch/COM/EN/terms_conditions.aspx).
_______________________
Disclaimer: This data-sheet has been prepared for information purpose only and is not intended to be nor
does it constitute the regulation of the country of importation. Every effort has been made by Cotecna to
ensure the accuracy of the information contained herein at the time of its issuance but Cotecna does not
guarantee its correctness and takes no responsibility for the contents of this data-sheet, makes no
representation as to its accuracy or completeness and expressly disclaims any liability whatsoever for any
loss howsoever arising from or in reliance upon the whole or any part of the contents of this data-sheet.
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Copyright © 2014 Cotecna - 17 February 2014