sfda_gov_sa · regulation · processed · 3 chunks
SFDA Kingdom of Saudi Arabia Saudi Food & Drug Authority Cosmetic product claims evaluation service Requirements and method of applying for the service Cosmetic product claims evaluation service Contents Introduction 02 Definition of cosmetic products 03 Cosmetic product claims 03 What are the claims? 03 What are medical/health claims 04 Claims evaluation service 04 How to submit the application 06 01 Cosmetic product claims evaluation service Introduction Reference to the Cosmetic Products law issued by Royal Decree No. M/49 dated 6/18/1436 AH and the Saudi Food and Drug Authority's approval of Technical Regulation No. "SFDA.CO/GSO 2528:2016 Cosmetics - List of cosmetic and personal care claims" which aims to clarify the basic standards for permitted claims for cosmetics. Claims are considered one of the methods used by cosmetic product companies and manufacturers to demonstrate the effect and benefits of a cosmetic product. In order to regulate the cosmetic products market and verify the compliance of claims with the technical regulations, the drug sector at the Saudi Food and Drug Authority is pleased to clarify process of submitting the cosmetic products claims evaluation request 02 Cosmetic product claims evaluation service Definition of cosmetic products: Any substance or mixture intended to be placed in contact with the external parts of the 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, protecting them, keeping them in good condition or correcting body odors. Cosmetic product claims What are claims? Any information about the nature, effect, effectiveness, and/or contents mentioned on the product, in advertising, or by any promotional means including images, graphics and symbols in any way that states, claims or implies that the cosmetic product has specific properties. 03 Cosmetic product claims evaluation service What are the health/medical claims? Claims that do not meet the definition of a cosmetic product and the basic standards of cosmetic claims include, but are not limited to: - Claims to treat medical conditions - Or a significant change in the body's physiological functions - Affecting the metabolism. Claims Evaluation Service: It is an optional service provided by the SFDA to companies and manufacturers of cosmetic products. It evaluates the claims of cosmetic products and ascertains their compliance with the requirements of the SFDA, as well as the specifications, regulations, and circulars of cosmetic products approved by the SFDA. Additionally, it issues a certificate if the product complies with the technical regulations and circulars issued by the SFDA. 04 Cosmetic product claims evaluation service Requirements for submitting a request to evaluate cosmetic product claims: Create an account in the cosmetics products listing system (GHAD) The product submitted for evaluation of its claims must be a cosmetic product If the product or its intended use is not cosmetic, the request will be rejected. Providing evidence and studies that support the cosmetic claim by the manufacturer, in accordance with article SFDA.CO/GSO 2528:2016 1/3/4 Fill out the form and attach the required documents. Pay the financial fees for the invoice issued in the SADAD system for drug sector services and attach a copy of the invoice. In case that the SFDA responds with comments to the application, the applicant shall complete the amendments within 90 days from the date of sending the comments. In case that the comments are not amended within this period, the application will be closed, provided that the application is evaluated once after amendments 05 Cosmetic product claims evaluation service How to submit the application 01 Fill out a request form to evaluate claims of a cosmetic product on the establishment's official documents (For establishments) signed by the owner or general manager (For companies). stamped by institution or company, and the product identification label is attached to it. 02 Attach the product's Artwork with a paper copy attached to the application form showing all the data to be evaluated. 03 Submit the application and send the form electronically in Word format, in addition to Artwork on the e-mail address: cosmetic@sfda.gov.sa, with the transaction registration number and date. 04 The SFDA reviews the completeness of the application and responds within 5 working days if The request is complete, a payment invoice is issued. Then contact the company to pay for the service (the validity period of the invoice is 30 days from the date of issuance). 05 Sending a payment invoice for a request to evaluate cosmetic product claims (2000 riyals for each request to evaluate product claims). 06 Issuing a scientific opinion and responding to the applicant within 15 working days. 06 Cosmetic product claims evaluation service Application form “Evaluation of Cosmetic Product Claims” Applicant information: <table><tr><td>Name</td><td></td><td></td><td></td></tr><tr><td>Commercial registration number</td><td></td><td>End date</td><td></td></tr><tr><td>City/Area</td><td></td><td>Neighborhood /street</td><td></td></tr><tr><td>Phone number/ext.</td><td></td><td>e-mail</td><td></td></tr><tr><td>zip code</td><td></td><td>Mailbox</td><td></td></tr></table> Product information: <table><tr><td>Product name</td><td></td><td></td><td></td></tr><tr><td>Company Name</td><td></td><td></td><td></td></tr><tr><td>Company’s Country/Address</td><td></td><td></td><td></td></tr><tr><td>Notification number (if the product is notified)</td><td></td><td></td><td></td></tr></table> Claims submitted for evaluation (as written on the label) <table><tr><td>1</td></tr><tr><td>2</td></tr><tr><td>3</td></tr><tr><td>4</td></tr></table> Information of the person authorized to communicate with the SFDA <table><tr><td rowspan="2">Authorized person information</td><td>Name</td><td>Mobile</td><td>E-mail</td></tr><tr><td></td><td></td><td></td></tr></table> 07 Cosmetic product claims evaluation service Pledges: I pledge to the truth and accuracy of the information provided in this application I pledge that the product attached to this application complies with the laws, regulations and circulars in force in the Kingdom of Saudi Arabia. I also pledge to adhere with any future regulations approved by the Saudi Food and Drug Authority. I pledge to afford full responsibility for any claims brought by the consumer or others and for any compensation awarded, and that the Saudi Food and Drug Authority is not responsible for any lawsuits, claims or compensation related to the safety of the cosmetic product. I pledge not to use this certificate for products not provided in the application. If otherwise, I acknowledge committing fraud in the documents and I afford the legal penalty. I pledge not to use this certificate for advertising or marketing purposes or indicate the authority's acceptance of these claims. Not requesting a refund after evaluating the application. Signature of the owner/general manager of the company 08 ○○○○○ Saudi_FDA www.sfda.gov.sa