Article 13
Assessor signature
A qualified safety assessor reviews the draft, completes Part B and signs.
Cosmetic PIF · Responsible Person in Türkiye: We prepare your product file.
In Türkiye, we can be your Responsible Person too.
We prepare your cosmetic product file for the EU, the UK or Türkiye (Turkey). If you need one, we also become your Responsible Person in Türkiye and keep the file for you.
01/Two services
You stay the Responsible Person,
or we take on the role.
Product file
Your name on the label
For
Manufacturers, importers and brands that remain the Responsible Person.
Where
The EU, the UK and Türkiye.
What we do
We check the formula and label, complete the PIF, run the missing tests and hand everything over. In Türkiye, we also have the safety report signed.
What you do
The Responsible Person’s duties: the notification, your name on the label and keeping the file for ten years. In the EU and the UK, the safety report signature too.
Responsible Person
Our name on the label
For
Brands selling in Türkiye that want us to take on the role, whether the product is made here or imported.
Where
Türkiye.
What we do
The whole file, plus the written mandate, the ÜTS notification, our name on the label and answers to every question from TİTCK.
What you do
Send the formula and the documents you have, then approve the artwork.
Already selling in the EU? Here’s what Türkiye adds.
Türkiye’s cosmetics regulation follows Regulation (EC) No 1223/2009. We still check your formula against Türkiye’s own annexes first.
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EU
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Türkiye
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|---|---|---|
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Responsible Person
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Established in the EU
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Established in Türkiye
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Notification
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CPNP
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ÜTS
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Authority
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Each member state’s competent authority
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TİTCK
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File language
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A language the authority readily understands
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Turkish or English
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Label
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Each country’s own language rules
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Content, date, warnings and function in Turkish
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Technical officer
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Not required
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On the Responsible Person’s staff
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02/Why us
The team that prepares your file.
Our chemists, safety assessors and regulatory specialists work with EU, UK and Turkish rules every day.
2,700+
PIF files prepared a year
10+
years in cosmetic regulation
EU·UK·TR
rules, checked in-house
ISO/IEC 17025
Your tests, in an accredited laboratory.
Unique Analyse, our accredited partner laboratory, tests finished products and their raw materials. The reports go straight into the PIF.
- Microbiology and challenge test
- Stability and shelf life
- Heavy metals and banned substances
- Raw material identity and purity
03/Steps
Seven steps to market.
Only need the file? We do steps 02 to 04 for the EU, the UK or Türkiye and hand it over complete.
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Mandate
The manufacturer appoints us in writing, or the importer if the product is made abroad. Company Profile prints our name on every report.
Done when: The mandate is signed.
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Formula and label check
We check both against Türkiye’s annexes and labelling rules with Formula Check and Label Check. Each finding cites its rule.
Done when: Each finding is closed.
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PIF
We prepare the file from scratch or complete the one you have. PIF Files shows which documents are in and which are missing.
Done when: the safety report is signed and every document is in.
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Tests
Missing tests run at Unique Analyse, our accredited partner laboratory: microbiology, physical tests, preservative efficacy. The reports go into the PIF.
Done when: The reports are in the file.
Why: Article 6(5)
We notify only when the file is complete.
The work starts with the mandate. Before we notify the product and put our name on the label, three things must be true:
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The formula passes the annex checks.
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The safety report is signed.
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The test reports are in the file.
If anything is missing, we tell you first and complete it with you.
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Notification
We notify the product to TİTCK through ÜTS, in our name. The notification record goes into the PIF.
Done when: The product is in ÜTS.
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Label
Our name and address go on the box and the label. Before print, we run the final artwork through Label Check once more.
Done when: The artwork is approved for print.
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After launch
We keep the file for ten years after the last batch, answer TİTCK and report serious undesirable effects. Regulatory Watch flags changes in the EU, the UK and Türkiye; the Audit Log records every action.
Done when: ten years after the last batch.
04/The quote
Get a quote.
There is no price list, because the work depends on the file. A consultant reads your request and sends one quote for the whole job.
What the quote depends on
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The service
Product file Responsible Person + file Responsible Person -
Number of products
1 2–5 6–20 20+ -
Product type
Perfume Other cosmetics Both -
The file you have
Formula only CPSR + PIF -
Market
Türkiye EU UK Several
One-off or yearly
Your quote
Product file
One-off
Prepared and handed over complete. Yours from the day of delivery.
Responsible Person
Yearly
Our name on the label; we keep the file and answer TİTCK.
Safekeeping
For a term you choose
When you hold the role, we keep a copy of your file too.
Your request
Choose what applies on the left; your choices go with your request.
A few short questions, most answered with one click. We reply by email on working days.
Want to see the findings first? Run your formula through Formula Check for free and send us the result.
05/The file
Who keeps the file?
You decide.
A file you order as its own line on the quote is handed over complete and is yours from that day. A file under the mandate stays with us, and so does the duty to keep it.
Once
Product file
You remain the Responsible Person in the EU, the UK or Türkiye. The file is handed over complete and is yours from that day. Want us to keep a copy too? Add safekeeping for a term you choose.
Yearly + one-off
Responsible Person + file
We are your Responsible Person and keep the file at the address on the label. Add it as its own line on the quote and you receive a complete copy too.
Yearly
Responsible Person
We are your Responsible Person and the file stays under the mandate. We keep it and answer for it; there is nothing for you to store.
Whichever you choose, under the mandate you receive the signed mandate, the findings to act on, the approved artwork and the ÜTS notification record. Documents a supplier gives us in confidence remain theirs.
06/The rule
Who is the Responsible Person in Türkiye?
Under Article 6 of Türkiye’s Cosmetic Products Regulation, a cosmetic product can be placed on the market only once a person established in Türkiye is appointed as its Responsible Person. That person keeps the product information file, notifies the product to TİTCK and is named on the label.
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Article
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What the law requires
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With us
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| 6(1) |
A Responsible Person established in Türkiye
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Unique Alphabet®, by written mandate
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| 7 |
A responsible technical officer on the Responsible Person’s staff
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A chemist on our team
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| 13 |
A signed safety report before the product is sold
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Signed by your assessor, or ours
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| 14 |
A product file kept ten years after the last batch, in Turkish or English
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Kept at the address on the label
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| 16 |
Notification to TİTCK before the product is sold
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Notified by us in ÜTS
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| 22 |
The Responsible Person’s name and address on the label
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Our name, our address
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Cosmetic Products Regulation, Official Gazette of 8 May 2023, No. 32184 (repeated), as amended on 5 March 2024. Official text ↗
Need just one part, not the whole file?
Each part is quoted separately and handed over to you when it’s done.
Article 14
PIF completion
We collect the missing documents and complete the file.
Annexes II to VI
Formula and label check
Findings against Türkiye’s annexes and labelling rules, each citing its article.
Partner laboratory
Laboratory tests
Microbiology, physical tests and preservative efficacy at Unique Analyse, an accredited laboratory.
Up to 100 files
Migration
We move your files from spreadsheets and Word documents into Unique Alphabet® and set each one up as a product file: €990–2,990 for up to 100 files.
07/Four questions
Four questions to ask before you appoint anyone.
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Who is your responsible technical officer?
A chemist on our own staff, as Article 7 requires of every Responsible Person.
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How will I learn that a limit has changed?
When a change in Türkiye, the EU or the UK affects your formula, we tell you which product. Every amendment is also listed in the change log.
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Who checked my label, and against which rule?
Each finding cites its article or annex entry, and the check stays on record.
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Where are my tests run?
At Unique Analyse, accredited for microbiology, physical tests and preservative efficacy.
Common questions
What is a Responsible Person for cosmetics in Türkiye?
The Responsible Person is the company or person established in Türkiye that ensures a cosmetic product meets the Cosmetic Products Regulation. It keeps the product information file for ten years, notifies the product to TİTCK through ÜTS, and its name and address appear on the label (Articles 6, 14, 16 and 22).
My importer can be the Responsible Person. Why appoint Unique Alphabet®?
By default, the importer is the Responsible Person. The importer may appoint another person established in Türkiye by written agreement (Article 6(4)). Unique Alphabet® takes that appointment, so the notification and the file stay put when you change importer.
My product is sold in the EU. Do I need a new file for Türkiye?
Largely, no. Türkiye’s regulation follows Regulation (EC) No 1223/2009, and the product information file is accepted in Turkish or English. What Türkiye adds: a Responsible Person established in Türkiye, a notification in ÜTS, the mandatory label text in Turkish and a check against Türkiye’s own annexes.
What does the Responsible Person service include?
The written mandate; a formula and label check against Türkiye’s annexes; the product information file; missing tests at an accredited laboratory; the ÜTS notification; our name and address on the label. After launch, we keep the file for ten years, answer TİTCK and alert you when a limit change in Türkiye, the EU or the UK affects your formula.
Can you prepare the product file if I stay the Responsible Person?
Yes, for the EU, the UK or Türkiye. We check the formula and label, complete the file, run the missing tests and hand it over complete. In Türkiye, we can have the safety report signed; in the EU and the UK, your Responsible Person there does that. From then on, the file is yours.
Do I receive the product file if Unique Alphabet® is my Responsible Person?
Yes, if you want it. Add the file as its own line on your quote and it’s handed over complete, while we keep the Responsible Person’s copy. Under the mandate, it stays with us: we keep it and answer for it. Think you might change Responsible Person one day? Add the file to your quote.
How much does a Responsible Person in Türkiye cost?
There is no price list, because the work depends on the file: the number of products, their type, and which documents and tests are missing. A consultant reads your request and sends one itemised quote: the product file is charged once, the Responsible Person yearly, and safekeeping for a term you choose.
Tell us what you’re bringing to market.
We reply by email on working days.