Safety Assessment Dossier

According to the Cosmetics Regulations dated 26/06/12 number 60433 by Turkish Ministry of Health, every cosmetics and personal care product has to have a Safety Assessment Dossier before launching to the market.

With specialized personnel qualified for safety assessment, we are giving our customers Safety Assessment Dossier preparation service. It is very important that the Safety Assessment to be prepared by competent assessors. The acceptance of your Safety Assessment Dossier either for the Ministry of Health or for the exporting processes depends on the competency of the assessor. Safety Assessment Dossier is among the primary documents you will be asked for when exporting or selling your products.

The documents necessary for the Safety Assessment Dossier are as mentioned below:

1. Producer's and Distributor's address
2. GMP certification of the producer
3. Formula and INCI names of the ingredients
4. Specifications of the raw materials
5. Specifications of the packaging materials
6. Material Safety Data Sheet of raw materials
7. All allergens contained must be declared in MSDS especially for perfumes (Certificate of Allergens)
8. Production method, descriptive, not detailed
9. Specification of final product
10. Stability data of the final product
11. Challenge Test (Preservative Efficacy Test)
12. Dermatological Test (Patch Test)
13. Claim Substantiation Studies
14. Product labels

Product Information File (PIF)

When manufacturing cosmetic products, Product Information File must be presented to the Turkish Health Ministry.

In the Cosmetics Regulation dated 24/03/2005 and numbered 5324, 12th article involves the clauses about the Product Information File. The producer must declare the Product Information File of the product ready at the address mentioned on the label in three working days.

The producer may choose one accessible address for the PIF, but this address is not obliged to be the manufacturing address. In case there are more than one address mentioned on the label, the address where the PIF is accessible, should be indicated as underlined.

These informations might be shortened on the condition not to obstruct the access to the responsible.

Informations necessary for the Product Information File are as mentioned below;

1) Product name, code, name in local usage if available, products qualitative and quantitative structure; in case it contains perfume or perfume compound, compounds code and the suppliers identity must be stated. The information requested above must include the elements mentioned below:

• Reference number of the cosmetic product, trade mark, national code and the representation must be clear.
• Quantitative and qualitative information about the cosmetic products compound should be stated and the mentioned documents should have product compounds, INCI name and intended purpose must be declared.
• In case there are compounds among the cosmetic products components, the components of the compound should be declared by the usage rates from lower to higher in percentages.

2) Physico-chemical (factors like color, odor, temperature, density, viscosity, pH etc.) and microbiological specifications of the raw materials and the finished product, also the control criteria’s for microbiological and physico-chemical specifications convenience,

3) The explanation of the manufacturing methods which is comply with Good Manufacturing Practice (GMP); document stating compliance with Good Manufacturing Process (GMP); the education and the working documents of the producer stating professional sufficiency or necessary experience,

4) Cosmetic Product Safety Assessment Dossier to declare that a cosmetic product is safe,

5) Data’s about adverse effects about the usage of the products,

6) Cosmetic products specifications, structure or if necessary, the documents and information about the claims.

For more information on cosmetics manufacturing, please check the website of Health Ministry Pharmaceutical and Medical Devices Association