Registering a cosmetic product in Egypt

• The cosmetics registration procedures guide (دليل الإجراءات المنظمة لتسجيل مستحضرات التجميل), version 1, 2020, on the EDA's website. It rests on Decree No. 151 of 2015 on cosmetic registration, the European cosmetics rules, the fee schedule No. 70 of 2020 and the decisions of the EDA's technical committee.
• The EDA Chairman's Decree No. 122 of 2022 on cosmetics notification and trading, and the Regulatory Guide for Cosmetics Notification (EDREX:GL.CAPP.009, version 1, effective 6 March 2023, on the EDA's website). These move filing onto an electronic platform and call it notification.

Where they differ, the newer documents describe the current process. The EDA revises its guides and fees: read the current versions before you file, and use this page as a map.

The 2020 guide defines a cosmetic as any product containing one or more substances meant for the external parts of the body (skin, hair, nails, lips, external genital organs), the teeth or the lining of the mouth, to clean, perfume, protect, keep in good condition, or change and improve their appearance or the body's odour. Its illustrative list opens with creams, emulsions, lotions, gels and oils for the skin, which may not be traded or imported until registered.

A peptide cream or serum applied to the skin sits inside that definition. A product meant for any other route sits outside it.

The guide defines the importer as a person or entity based in Egypt that places an imported cosmetic on the market; the product-owning company as the one that makes the product, has a factory make it, or sells it under its own name or trade mark; and the responsible entity as the one established in Egypt that answers for the product on the market.

Each company deals with the EDA through one registration representative, authorised in writing. Every request goes on company letterhead, stamped with the company seal, with the fee receipt attached.

• The composition statement (بيان التركيب): every ingredient by INCI name, with its quantity as % w/w or w/v and its function. For imports it is on the foreign company's letterhead, certified by the chamber of commerce, and every ingredient must appear in the EU's CosIng database at a permitted percentage. For local and toll products it is on the factory's letterhead, approved by the production or factory manager.
• The free sale certificate for imports, legalised by the Egyptian embassy or consulate, stating that each product is sold freely in the country of origin under the same name and composition.
• The shelf-life declaration: legalised for imports; for local products, signed by the factory's quality control manager.
• The pack or its mock-up (ماكيت). For local and toll products it shows the product name, main ingredients, method and purpose of use, space for batch number, dates, storage conditions and registration number, warnings and the factory's name, in Arabic and English.
• The company's papers: a current commercial register (السجل التجاري) and tax card (البطاقة الضريبية) with the activity the route needs: import, cosmetics manufacturing or toll manufacturing.
• Authorisations from the foreign owner to the Egyptian agent, legalised, and from the company to its representative.
• For the technical committee: the originals, and a scientific reference giving the function and properties of each ingredient.

Under the 2020 guide, the company emailed its first documents to the department for its route, which either asked for the full file on a shared drive or listed what was missing. The originals were inspected and the file went to the technical committee; after approval the EDA issued the registration notification (إخطار التسجيل). A refused file could go back to the committee on appeal, after the re-evaluation fee, within a working week.

Under the 2023 guide, the company opens an account on the EDA's electronic company profile, lists each factory once (approved within 3 working days) and submits the notification on the platform: trade name, company details, composition form, artwork, fee receipt, shelf life, and the free sale certificate, authorisation or toll contract that applies. Once the requirements are met and fees paid, the notification number is issued automatically within 10 working days, or 3 on the fast track.

Both guides give a registration or notification ten years. Renewal is requested in the final year, with the same papers and no change to the product. A notification left to expire lapses; under the 2020 guide, manufacture and sale must then stop.

The 2020 guide sends changes of composition, name, purpose of use or form back to the technical committee, and approves new artwork, origins, manufacturing sites, colours, fragrances, sizes, packs and shelf-life extensions directly. A longer shelf life for a local product needs a full stability study. A transfer of ownership needs an assignment registered with the notary (الشهر العقاري) and approved by the EDA's legal adviser, a manufacturing contract with storage and GMP clauses, and the new owner's commercial register and tax card.

The 2023 guide uses two lists instead: "Do & Tell" changes, such as sizes, cartons and shelf-life changes of up to five years, reported after they are made; and "Tell & Do" changes, including composition, form, origin, manufacturing site, colours and fragrances, which wait for approval.

Committee files also carried small stamp and postal fees. These are 2020 figures: check the EDA's current schedule before you budget.

For each peptide in your formula:

• The INCI name and CAS number, with the function recorded in CosIng, for the composition statement: Copper Tripeptide-1 (GHK-Cu), and Acetyl Octapeptide-3, known by the Lubrizol trade name SNAP-8.
• The certificate of analysis for your batch. The 2022 decree describes a supplier's raw-material certificate as giving the product name, batch number, production and expiry dates and test results, and stating conformity with the specification.
• The specification sheet and safety data sheet, on request, where the manufacturer issues them.
• The manufacturer's technical data, on request, where it publishes any: use level, pH range and storage, for your scientific references and safety report.

The decree also requires the company to keep a Product Information File (product description, safety report, manufacturing method with a GMP statement, proof of claims) for ten years after the last batch is marketed. If the EDA asks about an ingredient and our papers do not answer it, send us the question and we take it to the manufacturer.

• For cosmetic manufacturers and skincare brands
• Cosmetic-grade peptides
• Request a quote, and list the documents your file needs

We supply businesses only, never individuals, and deliver to your business address in Egypt.