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Selling infant formula and baby food in Saudi Arabia

In Saudi Arabia, food for infants and children needs the consent of the Saudi Food and Drug Authority (SFDA) and goes through pre-registration evaluation. SFDA's guide for breastmilk substitutes, applied since 1 March 2020, adds licensed warehouses, listed exporting establishments, a statutory agent and recall duties, alongside the Ministry of Health's marketing regulation.

Updated · Each section links to the official source it comes from

Regulator
Saudi Food and Drug Authority (SFDA)
Scope of SFDA's guide
Birth to 36 months
In force
1 March 2020
Exporters
Only establishments listed by SFDA
Local representative
A statutory agent in Saudi Arabia
Marketing
Ministry of Health Regulation for Marketing of Breast Milk Substitutes

Before a product goes on sale

The questions to answer, in the order they usually come up.

  1. 1Is the foreign manufacturer registered with SFDA and on its list of establishments? Read more
  2. 2Is the product registered after SFDA's pre-registration evaluation? Read more
  3. 3Do you have a licensed warehouse and a statutory agent? Read more
  4. 4Which standards and certificates apply at clearance? Read more
  5. 5Can you trace and recall each lot? Read more

The rules, by area

What each area covers, the texts that set it, and what the official pages say.

Establishments, warehouses and the statutory agent

SFDA's controls on who may make, import and sell breastmilk substitutes and infant food.

  • SFDA's guide applies to breastmilk substitutes, complementary milk foods and infant formula for special medical use, from birth to 36 months, and came into force on 1 March 2020.
  • Importers hold a valid SFDA warehouse licence; domestic producers hold a valid SFDA factory licence.
  • Products are sold only from SFDA-authorised warehouses or sale points licensed by the relevant bodies.
  • Importers import only from establishments SFDA has listed for export to Saudi Arabia, and directly from the manufacturer; foreign manufacturers register with SFDA.
  • The establishment appoints a statutory agent qualified in science, who answers SFDA's requests, follows up registrations, and informs SFDA immediately of suspected non-compliance.

How we help: Compliant Always keeps the warehouse licence, the manufacturer's listing and the agent's appointment on record, dated, and shows what is expiring. Ask about this

Consent and product registration

How infant and child food is registered with SFDA.

  • Food for infants and children needs SFDA's consent (Article 46 of the Food Law's Implementing Regulation).
  • Infant and child food and food for special medical purposes are among the products SFDA evaluates before registration.
  • The importer or producer registers the product with SFDA after checking it conforms with SFDA's technical regulations and standards.
  • Detailed nutritional information on the products sold in Saudi Arabia is provided to SFDA, with periodic analyses by accredited laboratories.

How we help: Compliant Always keeps the registration file, nutritional data and laboratory analyses with the product, and shows which analyses are due. Ask about this

Standards and clearance

What SFDA checks when infant and toddler food is imported.

  • SFDA's clearance table lists infant formula alternatives, prepared baby foods and cereal-based baby foods against GSO 355, GSO 677, GSO 2106 and GSO 223.
  • A health certificate is required; a gluten-free claim needs a certificate under GSO 1021.
  • Where a halal logo, quality mark or organic claim is used, proof of the claim is required.
  • Food for special medical purposes is handled under SFDA.FD/GSO 1366, one of the general specifications applied at clearance.

How we help: Compliant Always keeps the health and gluten-free certificates with each lot, and shows which are missing before the shipment leaves. Ask about this

Labelling and marketing

The label rules and the Ministry of Health marketing regulation.

  • Labels follow SFDA.FD/GSO 9 in Arabic, with other languages identical to the Arabic.
  • SFDA's guide applies without prejudice to the Regulation for Marketing of Breast Milk Substitutes, as amended by Minister of Health decision No. (100493) of 19/2/1440 AH.
  • Advertising food without SFDA's consent is prohibited (Article 11 of the Food Law).

How we help: Upload the label and Compliant Always reads it against SFDA.FD/GSO 9 and sets the Arabic beside the other languages. Ask about this

Traceability and recall

What SFDA expects when a product has to come off the market.

  • A traceability system is in place from manufacture, and products have passed shelf-life testing.
  • Records identify the distribution zones; the importer or producer takes full responsibility, including the cost, for recalling products and announcing the recall in a local newspaper.
  • On knowing or suspecting that food breaches SFDA requirements, the operator recalls it immediately and notifies SFDA (Article 55 of the Regulation).

How we help: Compliant Always ties each lot to its distribution records and documents, so a recall starts from the record. Ask about this

Who answers for what

WhoWhat they answer forHow we help
ImporterAn SFDA warehouse licence, imports only from listed establishments direct from the manufacturer, and recalls.Licences and listings kept on record with their dates.
Foreign manufacturerRegistration with SFDA and listing by its home competent authority.Registration and listing evidence kept with each product.
Statutory agentAnswering SFDA, following up registrations, and reporting safety actions taken abroad.The product record ready when SFDA asks.
Domestic producerAn SFDA factory licence, registration, traceability and shelf-life testing.Analyses and shelf-life data kept with each lot.

Questions businesses ask

Does infant formula need SFDA approval in Saudi Arabia?
Yes. Food for infants and children needs SFDA's consent under Article 46 of the Food Law's Implementing Regulation, and goes through SFDA's pre-registration evaluation before it is registered.
Which ages does SFDA's breastmilk substitutes guide cover?
From birth to 36 months. It covers breastmilk substitutes, complementary milk foods and infant formula for special medical use.
Can I import infant formula from any manufacturer into Saudi Arabia?
No. Importers import only from establishments SFDA has listed for export to Saudi Arabia, and only directly from the manufacturer.
Does an infant formula importer need a licence in Saudi Arabia?
Yes. SFDA's guide requires a valid SFDA warehouse licence for importers and a factory licence for domestic producers.
Do foreign baby food makers need a Saudi agent?
SFDA's guide requires a statutory agent qualified in science to represent the company in Saudi Arabia, answer SFDA and report safety actions.
Where can infant formula be sold in Saudi Arabia?
Only from SFDA-authorised warehouses or sale points licensed by the relevant government bodies, under SFDA's guide.
Which standards apply to baby food at Saudi clearance?
SFDA's clearance table lists GSO 355, GSO 677, GSO 2106 and GSO 223, with a health certificate and, for gluten-free claims, a certificate under GSO 1021.
Are there marketing rules for breastmilk substitutes in Saudi Arabia?
Yes. SFDA's guide applies alongside the Ministry of Health's Regulation for Marketing of Breast Milk Substitutes, as amended by decision No. (100493).
Who pays for an infant formula recall in Saudi Arabia?
The importer or producer acknowledges full responsibility, including the financial cost, and announces the recall in a local newspaper.
Must baby food labels be in Arabic in Saudi Arabia?
Yes. SFDA.FD/GSO 9 requires labelling in Arabic, with any other language identical to the Arabic.
How does Compliant Always help with selling in Saudi Arabia?
Our team reads the rules for the markets you sell in, including SFDA and SASO requirements. Compliant Always shows which apply to your product, keeps the documents behind each one ready, and watches the sources for changes. It shows what the requirements say and what your documents show; you decide.

Sources

Compliant Always is a product of Lettuce Labs LLC. It shows what requirements say and what your documents show. It is not legal advice, and you decide.

Tell us what you make, and we will show you the rules for it.

Name the product and the markets you sell in. We will come back to you with what applies in Saudi Arabia and what your paperwork needs to show.

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