Turkey and Israel cosmetics regulation: how to sell skincare legally

Turkey and Israel side by side

Both markets borrowed heavily from EU cosmetics law, so a formula and file built for the EU are a good base for either. Neither market approves cosmetics before sale. Both make one local company answerable for each product, and both ask for a notification before the first unit is sold. The table compares the two as of October 2026.

Turkey: the law and the regulator

Turkey replaced its 2005 Cosmetics Regulation with the Cosmetic Products Regulation (Kozmetik Ürünler Yönetmeliği), published in the Official Gazette on 8 May 2023 (No. 32184, repeated issue). It entered into force six months after publication, in November 2023, and was amended on 5 March 2024 (No. 32480). Article 37 states it was prepared to align with EU Regulation (EC) No 1223/2009, and the structure follows the EU text article by article. Products placed on the market under the old 2005 rules could stay on the market for 2 years after the new regulation took effect.

The regulator is TITCK (Türkiye İlaç ve Tıbbi Cihaz Kurumu), the Turkish Medicines and Medical Devices Agency. TITCK does not review formulas before sale. It runs the ÜTS database, publishes guidelines and inspects products already on the market, and it publishes inspection results each quarter. Because the rules mirror the EU, our EU cosmetics regulation guide explains most concepts used below in more depth.

Terms used in this part:

• Responsible person (sorumlu kişi): the company legally answerable for the product in Turkey.
• Responsible technical person (sorumlu teknik eleman): a qualified employee who checks that each product meets cosmetics law and good manufacturing practice.
• ÜTS (Ürün Takip Sistemi): the Product Tracking System, the national electronic database where companies and products are recorded.
• Product information file (ürün bilgi dosyası): the Turkish equivalent of the EU PIF.

Turkey: the responsible person and the technical person

Article 6 says a cosmetic may only be placed on the market if a natural or legal person established in Turkey is designated as responsible person. Who that is depends on how the product enters:

A Korean brand with no Turkish company therefore works through a Turkish importer or a Turkish company it appoints. That company's name and address go on the label, and it carries the same legal responsibility as a manufacturer under Law No. 7223.

Article 7 adds a rule the EU does not have: the responsible person must employ a responsible technical person. The regulation lists chemists, biochemists, chemical engineers, biomedical engineers, biologists, microbiologists and pharmacists as eligible. The responsible person can take the role itself if it holds one of those qualifications. TITCK updated its guideline on the technical person's duties on 1 October 2026 (KÜD-KLVZ-58).

Turkey: step by step to legal sale

The steps follow a 50 mL ceramide cream made in Korea and sold in Turkey through a Turkish importer and online shops.

1. Choose the Turkish responsible person

   Agree with your importer, or a Turkish company you appoint, that it will act as responsible person. Put it in writing, including who keeps the notification and file if you part ways.

2. Register the company in EBS and ÜTS

   The responsible person registers as a cosmetics importer through TITCK's electronic application system (EBS) and ÜTS, signs with a Turkish e-signature and pays the company registration fee (TL 9,117 in the 2026 tariff). Login works with e-Devlet, e-signature or mobile signature, so in practice this needs a Turkish company.

3. Register the responsible technical person in ÜTS

   TITCK's cosmetics page lists this as a step before any product notification.

4. Check the formula against the annexes

   The Turkish annexes follow EU Annexes II to VI (prohibited, restricted, colorants, preservatives, UV filters). Check every ingredient, including EU changes Turkey has taken over, such as the fragrance allergen list.

5. Build the safety report and product file

   A qualified safety assessor writes the safety report in the format of Annex I. The file adds the manufacturing description, GMP statement, claim evidence and animal testing data. Plan about 2 to 6 weeks if your test data is complete; it varies by assessor.

6. Approve the Turkish label

   Content, dates, precautions and function in Turkish, the responsible person's name and address, "Made in Korea" (origin), batch number and INCI list.

7. Notify in ÜTS

   Before the first unit is placed on the market, the responsible person enters the barcode, product details, the frame formulation as concentration ranges and uploads the original label, the Turkish label and a pack photo. Pay TL 536 per barcode (2026). If the cream contains a nanomaterial without an annex entry, notify it 6 months earlier.

8. Import and sell

   Customs clearance, duty and VAT go through your importer or customs broker. After launch, keep the file current and report serious undesirable effects.

Turkey: ÜTS notification and fees

Article 16 lists what the responsible person submits through the national electronic database before placing the product on the market:

• the product barcode, category and name;
• the name and address of the responsible person where the product file is kept;
• the country of origin for imports;
• a contact person for emergencies;
• any nanomaterials, with their identity and exposure conditions;
• the name and CAS or EC number of any CMR substance of category 1A or 1B;
• the formulation, with quantities given as ranges, for use by the poison center in an emergency;
• the original label, a Turkish label if the original has no Turkish text, and a pack image.

Two practical points from TITCK's notification page: changes to the product or the manufacturer after notification must be notified too, and TITCK issues no letter or certificate confirming that a notification was recorded. Each barcode is a separate notification, so three sizes of the same cream mean three fees.

Fees are paid through TITCK's own payment process with a reference number, not by ordinary bank transfer, and rejected applications are not refunded. TITCK updates the tariff every year, so check the current file before you budget.

At the border. Imported cosmetics are reported to go through the Ministry of Trade's product safety import inspection, with TITCK as the competent authority for cosmetics; ask your customs broker what the system will check for your shipment before it leaves Korea. Korea and Turkey have a free trade agreement in force, so ask your customs broker whether your product qualifies for the preferential rate and which origin proof it needs. Our HS codes and duties guide and export and import guide cover the shipping side.

Turkey: safety report, assessor and product file

Safety report (Article 13). Before placing a product on the market, the responsible person must have a safety assessment done and a safety report prepared in the format of Annex I, which follows the EU CPSR format: Part A with the safety data, Part B with the assessor's conclusion. The assessment must consider the intended use and systemic exposure to each ingredient, and the report must be kept up to date after launch.

Who may sign. Article 13(4) requires a diploma in pharmacy, toxicology, medicine or a similar discipline. TITCK's safety assessor guideline (KÜD-KLVZ-56, revised 11 September 2024) explains:

• pharmacists, toxicologists and physicians can sign without any extra certificate and attach their diploma to the report;
• chemists, chemical engineers, dentists, biologists, microbiologists, biochemists, biomedical engineers and bioengineers need a Cosmetic Product Safety Assessor Certificate, earned after at least 40 hours of training and an exam, from a certification body accredited by TÜRKAK under ISO/IEC 17024, unless they hold a relevant master's or doctorate that includes toxicology;
• for imported products, the report can be prepared in Turkey by a person who meets these conditions.

Can you reuse an EU CPSR? Often as a starting point. The Turkish Annex I follows the EU format, so the data in an EU CPSR (composition, stability, microbiology, exposure, toxicology) carries over. Whether the responsible person accepts the EU report as is, or has a qualified Turkish assessor review and sign it, is its decision; ask before you rely on it. The same applies to an EU PIF.

Product information file (Article 14). The responsible person keeps it at the address on the label for 10 years after the last batch is placed on the market, in Turkish or English. It contains a product description, the safety report, the manufacturing method with a statement of GMP compliance, proof of claimed effects where needed, and data on any animal testing, including tests done for other countries' laws.

GMP (Article 11). Manufacture must follow good manufacturing practice, presumed when the harmonized standard (EN ISO 22716) is followed. A copy of the manufacturer's ISO 22716 certificate supports the GMP statement in the file.

Animal testing (Article 21). Turkey bans placing on the market cosmetics whose final formulation or ingredients were tested on animals to meet the regulation where validated alternatives exist, and bans animal testing of finished cosmetics in Turkey. A "not tested on animals" claim is allowed only when neither the manufacturer nor its suppliers tested the product or its ingredients on animals (Article 23(3)).

Turkey: ingredient rules and fragrance allergens

Articles 17 to 20 work the same way as the EU: prohibited substances (Annex II), restricted substances with limits and warnings (Annex III), and positive lists for colorants, preservatives and UV filters (Annexes IV to VI). CMR substances are banned with narrow exceptions, and nanomaterials other than listed colorants, UV filters and preservatives need a separate notification 6 months before placing on the market (Article 19).

Turkey takes over EU annex changes by amending its own annexes, sometimes with its own dates. One example from 2026: TITCK's guideline on labeling fragrance allergens, announced on 11 June 2026, brings the number of fragrance allergens that must be named on the ingredient list to 82, in line with the EU list. Labels must comply from 31 July 2026, and products placed before that date that do not comply cannot stay on the market from 31 July 2028. These are the same dates as the EU. For other EU changes (vitamin A, arbutin, kojic acid, CMR omnibus acts, microplastics), check the current Turkish annexes rather than assuming the EU date applies. The EU guide lists the EU changes and dates.

Turkey: label summary

Article 22 mirrors EU Article 19. The container and outer pack must show, indelibly and legibly:

• the responsible person's name or registered name and address, and the country of origin for imports;
• the nominal content by weight or volume (not needed under 5 g or 5 mL, for free samples and single doses);
• the date of minimum durability, or the period after opening symbol for products lasting more than 30 months;
• precautions and warnings, including those required by Annexes III to VI;
• the batch number;
• the function, unless clear from the presentation;
• the ingredient list on the outer pack, in INCI names, headed "ürün bileşenleri" or an equivalent Turkish or English heading, with "(nano)" after nano ingredients.

Article 22(5) requires the nominal content, durability date, precautions and function, plus any leaflet text, in Turkish. A Korean pack with a Turkish sticker over the outer box is common for small runs, as long as the sticker is indelible and the information is on both the container and outer pack where required. Full detail by market is in our label requirements by country, and our label proof check covers Turkish label items.

Israel: the law and the regulator

Israel regulates cosmetics in a chapter of the Pharmacists Ordinance (New Version) 1981, which was rewritten in stages with amendments in 2017, 2022, 2023 and 2024. The detailed rules sit in the Pharmacists Regulations (Cosmetics) 2023, signed on 20 April 2023 and in force on publication. Questions about the 2016 reform you may read about refer to this same process: Israel moved from product licensing toward a notification system with a named responsible representative, and later added a route that relies on EU rules.

The Ordinance defines a cosmetic as a substance or mixture meant to contact the outer parts of the body (skin, hair, nails, lips, teeth, oral mucosa, external genitals), mainly to clean, perfume, change the appearance, protect or correct body odor. Drugs, medical devices, solid soap and perfume are outside the definition. The regulator is the Ministry of Health, acting through its Director.

Israel: registration and the responsible representative

Three registrations work together:

The responsible representative ensures the product complies and is safe, that the safety assessment and product file exist, files the notification, receives complaints and adverse effect reports, checks the labeling and claims, and follows the Director's instructions. For a Korean brand, this is in practice your Israeli importer or distributor, or a regulatory service company in Israel your importer appoints.

Israel: step by step to legal sale

The steps follow a 30 mL hyaluronic acid serum made in Korea and imported by an Israeli distributor.

1. Pick the importer and responsible representative

   Your Israeli importer registers in the register of cosmetics operators and names a responsible representative. Agree in writing who holds the notification and the file.

2. Check the formula

   Israel applies EU ingredient rules through its own schedules and regulations, so start from an EU-compliant formula and ask the representative to confirm Israeli specifics.

3. Prepare the safety report

   Regulation 12 requires a safety assessment and report before marketing, signed by a physician, a licensed pharmacist or a holder of a relevant degree (chemistry, chemical engineering, toxicology, life sciences or life sciences engineering). The report has three parts: product information, conclusions and the assessor's details. External lab tests done after notification must follow ISO/IEC 17025.

4. Build the product file

   Section 55a10 lists product photos, the safety report, the production method, a compliance declaration, evidence for marketing claims and a declaration on animal testing. Keep it 10 years after the last batch.

5. Approve the Hebrew label

   Product name, responsible representative and address, manufacturer or importer, net quantity, expiry date or period after opening, batch number and INCI list, in Hebrew except where English is allowed.

6. File the online marketing notification

   Manufacturer, product name and type, representative, production sites, ingredients with concentration ranges, pH, barcode, shades, pack photos, label details, purpose, instructions and target users. Nano ingredients need extra data (Regulation 16).

7. Import and sell

   Clearance, duty and VAT go through the importer and its customs broker. Korea and Israel have a free trade agreement; ask your customs broker which origin document it needs.

Fees and timelines. We could not confirm current Israeli notification or registration fees from the official sources we could reach in October 2026; the Ordinance lets the Minister set fees, and amounts change. Because the notification is confirmed automatically, the time to market depends mainly on how fast the safety report, file and Hebrew label are ready. Ask your representative for the current fee and its own lead time.

Israel: the European route and EU rules

The 2024 amendments, reported as part of Israel's "What's good for Europe is good for Israel" import reform, added three things to the cosmetics chapter:

• A European route for importers (section 55a12y and following). An importer registered in a separate importer register can bring in a cosmetic that is lawfully marketed in a "reliance state", buying from the manufacturer or a supplier in a recognized state, with a written agreement on recalls and safety information, a valid Certificate of Free Sale (or listed alternatives), a quality and safety control program and records kept for at least 10 years. Specialized products are excluded.
• EU rules applied by schedule (section 55a12yz). Provisions of the EU cosmetics rules apply in Israel to the extent a schedule to the Ordinance lists them, in their English text, with Hebrew translations published by the Ministry of Health. Where they conflict with the Ordinance on those matters, the EU provisions prevail.
• Parallel import against a reference cosmetic. Importers can bring in a product identical to a listed reference cosmetic, with a confirmation from an accredited laboratory.

What this means for a Korean brand: if your serum is already sold legally in the EU with an EU Responsible Person, CPSR and CPNP notification, the European route may shorten the Israeli process for your importer. Whether a Korean-made product sourced through your EU company qualifies depends on the lists of recognized and reliance states and the conditions in the schedules, which we could not read in full. Ask your Israeli importer which route it will use before you plan the timeline. A brand launching in Israel first uses the standard route described above.

Israel: label summary

Regulation 22 of the Pharmacists Regulations (Cosmetics) 2023 says labeling is in Hebrew unless the regulation provides otherwise. The primary or secondary pack shows:

• the product name;
• the responsible representative's name and address;
• the manufacturer or importer details;
• the net quantity;
• the expiry date, or the period after opening for products with a shelf life over 30 months (the Ordinance requires an expiry date at 30 months or less);
• the batch number;
• the ingredient list in English INCI names, headed "רכיבים" or "Ingredients", with fragrance as "Parfum" or "Fragrance" and colorants by Colour Index number where possible.

Small packs under 5 g or 5 mL, samples, gift sets and single-use products may leave out some items, and a leaflet can carry details that do not fit. For European route imports, the Ordinance asks for a Hebrew label with the representative's name and address and the importer's name and country of origin, and allows ingredients and use periods in English. The US government's guide to Israeli import labeling adds a general rule: Hebrew must be used, and English may be added if its letters are no larger than the Hebrew. Sunscreens may not claim "total block" or protection better than the skin's own, and SPF labeling follows a set scale (Regulation 24).

Claims and the drug borderline in both markets

Both markets ban claims that give a cosmetic properties it does not have. Turkey's Article 23 copies the EU rule and TITCK publishes a claims guideline based on the EU common criteria (Regulation (EU) No 655/2013): legal compliance, truthfulness, evidential support, honesty, fairness and informed decision-making. Israel's Ordinance makes attributing healing properties to a cosmetic an offense with administrative fines.

Sunscreens are cosmetics in both countries, as in the EU, with UV filters limited to the positive list. Products presented as treating or preventing disease leave the cosmetics rules: in Turkey TITCK publishes a guideline on products bordering on cosmetics, and in Israel they fall under the drug provisions of the same Ordinance. More examples are in our cosmetic vs drug claims guide, the claims guide and the sunscreen regulation guide.

Halal. Neither the Turkish regulation nor the Israeli rules make halal certification a condition of notification. If a halal logo or claim goes on the pack, it must be true and backed by a certificate from the certifier, like any other claim.

Post-market duties

• Turkey, serious undesirable effects (Article 26). The responsible person and distributors report every serious undesirable effect they know of, the product name and any corrective measures to TITCK and to the manufacturer without delay. TITCK's 2024 guideline on undesirable effect reporting gives the forms, and ÜTS has an adverse effect reporting module.
• Turkey, corrective action (Article 8). If a product is not compliant, the responsible person brings it into line, withdraws or recalls it, and informs TITCK at once where there is a health risk. It must give TITCK the documents it asks for, in Turkish or English.
• Israel, serious adverse effects (Regulation 33). The responsible representative reports to the Director without delay and no later than 5 working days after learning of the event, then sends an investigation report within 40 working days.
• Israel, complaints and recalls. The representative keeps complaints and adverse effect reports for at least 7 years. If a product is found harmful, the operator must act promptly, including withdrawal and public notice coordinated with the Director, who can also order these steps and publish warnings.
• Both markets. Update the safety report when the formula, a supplier or the safety data change, and keep the file ready for inspection at the address on the label.

Our recalls and adverse events guide gives an incident plan you can adapt.

What your local partner does and what we provide

Frequently asked questions

How do I notify cosmetics in Turkey (ÜTS)?

The responsible person established in Turkey registers the company in TITCK's EBS and ÜTS systems, registers a responsible technical person, and then notifies each product barcode in ÜTS before the first sale, uploading the original label, the Turkish label, a pack image and the formulation as concentration ranges. The 2026 fee is TL 536 per barcode.

Does Turkey follow the EU Cosmetics Regulation?

Largely yes. The Turkish Cosmetic Products Regulation of 8 May 2023 states it was prepared to align with EU Regulation (EC) No 1223/2009, with the same responsible person, safety report, product file, notification, annex and labeling structure. Turkey adds a responsible technical person and its own safety assessor certification rules.

Can a foreign brand be the responsible person in Turkey?

No. Article 6 requires a natural or legal person established in Turkey. For imported products the importer is the responsible person unless it authorizes another Turkish person by written agreement.

Can I use my EU CPSR in Turkey?

It is a strong starting point because the Turkish Annex I follows the EU format, but the Turkish responsible person decides whether to accept it or have a qualified Turkish assessor review and sign it. TITCK guidance says the report for imported products can be prepared in Turkey by an assessor who meets its qualification rules.

How do I notify cosmetics in Israel?

Your Israeli importer registers in the Ministry of Health register of cosmetics operators and names a responsible representative, who files an online marketing notification for each product before sale. A safety report and product file must exist first, and the notification is confirmed automatically.

Who can be the responsible representative in Israel?

An Israeli resident, or a company registered and operating in Israel, registered in the Ministry of Health database. It is the general manager of the manufacturer or importer or a person that manager appoints, and foreign manufacturers that market in Israel also need one.

Do cosmetic labels in Israel have to be in Hebrew?

Yes. The Pharmacists Regulations (Cosmetics) 2023 require labeling in Hebrew unless the regulation says otherwise, and the ingredient list is given in English INCI names under "רכיבים" or "Ingredients". English text may be added to the Hebrew.

Does Israel accept cosmetics that comply with EU rules?

Partly. Amendments from 2024 apply listed EU cosmetics provisions in Israel and add a European route for registered importers bringing in products lawfully sold in a reliance state, with a Certificate of Free Sale and a quality program. Check with your importer whether your product qualifies.

Is sunscreen a cosmetic in Turkey and Israel?

Yes, in both, as in the EU. UV filters must come from the positive list, SPF claims need test reports, and Israel bans claims such as "total block".

Can KoreanOEM register my products in Turkey or Israel?

The filing belongs to your Turkish responsible person or Israeli responsible representative. We prepare the documents it needs: full INCI list after the NDA, COA, MSDS, specification, ISO 22716 certificate copy, Certificate of Free Sale, Power of Attorney and Letter of Authorization drafts, and a label proof check.

Sources

• Mevzuat Bilgi Sistemi: Kozmetik Ürünler Yönetmeliği (Official Gazette 8 May 2023, No. 32184, amended 5 March 2024), Articles 6, 7, 11, 13, 14, 16, 19, 21 to 23, 26, 37 to 39
• TITCK: Cosmetic product notification (Bildirim) and TITCK: Company registration (Firma Kayıt İşlemleri)
• TITCK: Cosmetics legislation and guidelines
• TITCK: Service fee tariff (2026 tariff, updated 23 March 2026)
• TITCK: Guideline on cosmetic product safety assessors, training and certification (KÜD-KLVZ-56, rev. 11 September 2024)
• TITCK: Announcement on the fragrance allergen labeling guideline (June 2026) and TITCK: Updated responsible technical person guideline (1 October 2026)
• Pharmacists Ordinance (New Version) 1981, cosmetics chapter, sections 55a to 55h, consolidated Hebrew text (Wikisource)
• Pharmacists Regulations (Cosmetics) 2023, Hebrew text (Wikisource), Regulations 12, 15, 16, 22, 24, 33
• Israel Ministry of Health: Cosmetics marketing service page
• US International Trade Administration: Israel labeling and marking requirements and Israel trade standards and import reform
• EUR-Lex: Regulation (EC) No 1223/2009 on cosmetic products and Regulation (EU) No 655/2013 on claims

Checked against these sources in October 2026. Rules and fees change; check with the authority or your importer before you sell.