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FAQ
1- What is UTS?

Product Tracking System (ÜTS) is a platform where all medical devices, cosmetic products and biocidal products that come into contact with the human body (Type-1 / Type-19) produced or imported in Turkey are recorded. It is a recording and follow-up system in which effective market surveillance and inspection activities can be carried out for the products that are recorded and monitored for each product from the point of production - import to the point of sale or use.

In order to ensure product tracking before cosmetic products are placed on the market, they must be reported to the Ministry's Product Tracking System (ÜTS) platform in accordance with the Cosmetics Law No. 5324.

UTS aims to combat the informal economy, carry out effective inspection activities, facilitate access to safe products and support health initiatives.

2- What are the requirements for registering a company in UTS?

The documents required for company registration; company signature circular, tax plate, trademark registration certificate, trade registry gazette and activity certificate are required. In the trade registry gazette, there must be a field of cosmetic activity in the subject and purpose section.

3- What is the information that should be included on the packaging of a cosmetic product?
  • Brand and full name of the product
  • Company full title name and address
  • Ingredient list of the product
  • Ingredient list of the product
  • General features of the product, warnings and conditions of use (General features and usage information should include descriptive information such as the function of the product, its function, the shade information to be applied, the frequency of use, whether it is rinsable or not.)
  • Special warning symbols of the product (Symbols such as recycling symbol, lid open symbol (PAO), Made in Turkey symbol, flammable symbol, etc.)
  • Batch number of the product
4-What is the name INCI?
  • Standardisation for International Nomenclature Cosmetic Ingredients. They are the internationally accepted names of the components (raw materials) in the product.
5-Does the UTS system require the upload of "does not contain" claims?

If it is claimed that the cosmetic product does not contain a specific ingredient or components, an analysis report proving that the product does not contain the relevant substance or substances must be uploaded to the Department of Cosmetic Products at the application stage. This report must be obtained from a laboratory in accordance with TSE ISO IEC 17025 standards and should detail which components are not included in the product composition. Those who do not have the document in question or cannot provide evidence that it does not contain it cannot use the claim that it does not contain.

6-What are the Information/Documents Required for PIF/ÜBD/CPSR File?
  • Identification of the manufacturer and contract manufacturer (full title and address of the company, as well as authorized person, name, surname + tel + e-mail information).
  • Manufacturer's certificate of conformity to GMP (Quality certificates, GMP + ISO 9001 etc.)
  • Formulation of the product with proportions (INCI names and CAS numbers of raw materials and raw material documents, essence certificates if the product contains essences)
  • Identification of the product and 2 samples of the finished product (required for checking the labels, in the original packaging and as received by the consumer)
  • Finished product specifications (including chemical, physical and microbiological tests) Microbiological test, Challenge test and stability test reports (analysis report based on the claim if there is a claim on the product (e.g. dermatological test report regarding the claim that it has been dermatologically tested))
  • Product inner label image, box knife mark image and 3d mockup image
  • Production method / production process
7-How long should the Product Information File (PIF) be kept by the manufacturer?

From the date of placing the last batch of the relevant cosmetic product on the market, the manufacturer must keep the product information file for 10 years.

8-What is a Free Sale Certificate (FSC)? How to use?

The free sale certificate is a certificate that can be requested for cosmetic products registered in UTS. With this certificate, cosmetic products produced in our country can be exported abroad. In an FSC document, max. It can include up to 50 products. FSC application is made through UTS. The application has a reference number and a payment amount. This payment amount must be paid to the TİTCK within 1-2 days by reading the reference numbers at the Halk Bank counter. In order to complete our FSC application request, the payment information is synchronized with the TİTCK, and then the FSC document is sent to your registered address in ÜTS within 1-3 business days.

9-What are parabens? Can the paraben-free logo be used on the packaging of cosmetic products?

Parabens are widely used as preservatives in the cosmetic, food, and pharmaceutical industries. As stated in the Turkish Medicines and Medical Devices Agency Guideline Version 6.0 on the Claims of Cosmetic Products, "Some of the paraben group is safe if used in accordance with the Regulation. Given that all cosmetic products must be safe, the claim that "paraben-free" is not allowed. Because with this allegation, the entire paraben group is defamed." Therefore, even if paraben-free tests are performed, this claim cannot be carried on the cosmetic product label and on the box

10-What is the Material Safety Data Sheet (MSDS/SDS/GBF)?

MSDS, which is prepared under a total of 16 main headings, is a document used in product exports/transportation. It includes the product's hazard information, emergency information, storage conditions, physical chemical properties, toxicological and ecological information, and transportation information. This document can be prepared by chemical evaluation experts.

11-What are the mandatory analyzes for a cosmetic product? What are the situations in which it is not mandatory to have these analyzes?

Before the introduction of the cosmetic product to the market;

  • Microbiological analysis,
  • Scan-Challenge Test
  • and stability tests are 3 mandatory tests.

In the stability test, the product is analyzed in its original packaging at room temperature (25°C), in dark and bright environment, at 45°C and 4°C. Organoleptic properties, pH, viscosity and packaging interactions are tested.

With microbiological testing, the presence of Aerobic Colony Count, Mold Yeast Count, Pseudomonas aeruginosa, Candida albicans, Staphylococcus aureus, Escherichia coli is investigated.

On the other hand, the risk of microbial contamination is evaluated by exposing the finished product formula to artificial contamination.

Situations That Do Not Require Microbiological Testing:

  • Alcohol content more than 20≥ – perfume, edt, tonic, cologne, etc.
  • Organic solvent-based products- nail polish, etc.
  • pH ≤ 3 – chemical peelers, etc.
  • pH ≥ 10 – hair straightener, perm, depilatory, etc.
  • products that act by oxidation- hair dyes, etc.
  • Aluminum chlorhydrate content ≥ 25%- anti-perspirant products, etc.
  • production (filling) temperature ≥ 65 0C – products such as wax, lip balm, lip stick, etc.

Situations That Do Not Require Screening-Forcing Test:

  • Disposable or Non-Openable Products (packages dosed without contact with air)

Products packaged in the form of disposable wet wipes, cologne wipes, disposable skin masks, sprays, atomizers, roll ons .

12-What is the use of formalaldehyde in cosmetic products?

Formalaldehyde has a limited use in cosmetic products, preservatives or nail hardening products.

13-What is the final view on formaldehyde-releasing substances?

Formaldehyde is currently listed in Annex II (List of Prohibited Substances) of the UK Cosmetics Regulations. Previously, formaldehyde was included in Annex III and V of the EU cosmetic products regulation, but formaldehyde was removed from Annexes III and V in 2019 after being included in the Category 1B carcinogenic classification. It was simultaneously added to the list of prohibited substances.

There are formaldehyde excretors permitted in Annex V. Formaldehyde-releasing substances:

  • DMDM Hydantoin (CAS 6440-58-0, V/33)
  • Imidazolidinyl Urea ( CAS 39236-46-9, V27)
  • Polyoxymethylene Urea (CAS 68611-64-3 /9011-05-6)
  • Sodium hydroxymethylglycinate (CAS 70161-44-3, V/51)
  • Bronopol (CAS 52-51-7, V/21)
  • Benzylhemiformal (CAS 14548-60-8, V/55)
  • Methenamine (CAS 100-97-0, V/30)
  • Glyoxal (CAS 107-22-2, III 194)

Therefore, clause 2 in the preamble of Annex V reads as follows. "All finished products containing the substances in this Annex that release formaldehyde must be labelled with the warning that it contains formaldehyde, where the formaldehyde concentration in the finished product opens 0.05%. This label was introduced by the Eighth Commission Directive 86/199/EEC of 26 March 1986 in order to inform consumers of the presence of a substance that may cause allergy through the release of formaldehyde.

%It has been questioned that exposure to formaldehyde at levels below 0.05 may cause contact dermatitis in people with formaldehyde allergy, hence the above-described provisions regarding the labeling of formaldehyde-releasing substances listed in Annex V of the Cosmetic Regulation. Members concluded that the current 0.05% threshold for labeling formaldehyde-releasing preservatives is insufficient to protect consumers.

Members agreed that a threshold for labeling preservatives that release up to 10 ppm (0.001%) of formaldehyde that does not cause an allergic reaction would be sufficient to protect when used for authorized products. Members noted that such a level could be sufficiently protective in rinse-off products. This threshold level of up to 10 ppm (0.001%) is based on the Reopen Application Test (ROAT)3 performed by Hauksson et al.

14-What is the Green Dot symbol?

It is valid in 31 countries, the majority of which are members of the EU. In Turkey, the authority of the rights to use this symbol belongs to the ÇEVKO Foundation. The "Green Dot" mark on a package means that the economic enterprise that puts that packaged product on the market fulfills its legal obligations regarding the recovery of packaging wastes and contributes to the recycling system.

Green dot symbol

15-What is the Triman logo?

It is a warning symbol that France mandates and should be used for recyclable packaging. In the exports to be made, the place of production must use this symbol outside of France and indicate which material is recyclable next to the symbol. Under the name of the Italian UN/11686 standard, recyclable packaging is also available according to the type of material, such as corrugated cardboard for paper, non-corrugated cardboard and normal paper; For glass, warning numbers classified and coded according to the color of the glass must be present on the product packaging

Triman Logo For Cardboard And Glass:

Sample Label Warning Consisting of Glass and Corrugated Cardboard:

                BOTTLE GL 70                                 BOX PAP 20
Glazing Corrugated Cardboard
16-What is the difference between sunscreen with physical protection and sunscreen with chemical protection?

There are 2 types of sunscreens. It is divided into two as sunscreen with physical protection and sunscreen with chemical protection. There are 2 types of physical protective sunscreens. They are divided into sunscreens containing zinc oxide and sunscreens containing titanium oxide. These raw materials leave a white appearance on the skin. These sunscreens provide protection by reflecting the sun's rays directly from the skin. Chemical-containing sunscreens, on the other hand, have different protection mechanisms. These protectors allow the sun's rays to be absorbed into the skin, but they provide protection by making the sun's rays harmless with heat energy.

17-What is SPF and PA? How to calculate SPF and PA.

Both (SPF/PA) are used to refer to the level of protection that skincare products provide against skin damage from UV radiation.

SPF (Sun Protection Factor) is a measure of how well sunscreen will protect the skin from damaging rays. For example, if your skin's natural protection time is 10 minutes, this time will be 150 minutes with a product with an SPF 15 protection factor.

The PA value (UVA Protection Level) represents the proportion of time taken for tanning. For example, if PA values are less than 2, "PA" is used as an indicator. If the PA value is between 4 and 8, the indicator is "PA++". The test methods for SPF and PA calculations are based on two international standards for in-vivo evaluation: ISO-24442 and ISO-24444. These methods irradiate human skin with UV from an artificial sunlight source with 2 mg or 2 μL of sunscreen applied per 1 cm2. The minimum time until redness occurs is evaluated for the skin areas where the cream is applied and where it is not. However, these test methods are costly, and individual differences can contribute to a subjective variation in results. That's why JASCO has developed a sunscreen SPF/PA rating system based on ISO standards. The system is used to calculate SPF and PA values from the transmittance spectra of sunscreens using a UV-visible spectrophotometer.

PA values are divided into 5 classes according to their PA equivalent values and labeled in accordance with their classes.

PA <2
PA + + 2 – 4
PA ++ 4 – 8
PA +++ 8 – 16
PA ++++ 16<

 

The following examples were measured using the parameters in the Measurement conditions table:

Labeled and calculated SPF and PA sample values

18-Can there be a "Non-Allergen" claim on cosmetic product labels?

An "allergen-free" analysis should be carried out within the annexes of the relevant claim to show that the product composition does not contain any of the allergens restricted in the annexes to the Regulation. The appropriate "does not contain" analysis must be tested in laboratories that meet the requirements of TSE ISO IEC 17025.

19-What are the Cosmetic Product Complaint Channels?
  • CİMER
  • SABİM
  • UTS complaint applications
  • TİTCK – Press and Public Relations Unit (halkla.ilişkiler@titck.gov.tr)
  • Department e-mail applications (kozmetikpgd@titck.gov.tr) (biyosidalpgd@titck.gov.tr)
  • Written applications made to the institution
  • Prosecutors' Offices
  • Other Public Institutions and Organizations (Ministry of Commerce, Provincial Health Directorate)
  • RAPEX (Emergency Warning System for Non-Food Products)
20-Is it possible to add the claim "Not Tested on Animals" to the labels of cosmetic products?

According to the Cosmetic Regulation, testing on animals is prohibited. For this reason, it is obligatory not to conduct the experiment. For this reason, a claim such as "not tested on animals" should not be included on the label. However, if a certificate is obtained by the relevant organizations, logos showing that they are produced without testing on animals can be used.

Article 20 (3) of the Cosmetics Regulation No. 1223/2009 allows the Responsible Person to declare that a product has not been tested on animals.

  • 1223/2009 (AT) Article 20 (3)

The responsible person may refer, on the product packaging or in any document, notice, label, ring or collar accompanying or referring to the cosmetic product, to the fact that no animal tests have been carried out only if the manufacturer and his suppliers have not carried out or commissioned any animal tests on the finished cosmetic product, or its prototype, or any of the ingredients contained in it, or used any ingredients that have been tested on animals by others fort he purpose of developing new cosmetic products.

In order to use the symbols that are not tested on animals on your labels, you must go through certain inspection processes by the relevant organizations. You can get certification from the following organizations.

https://www.leapingbunny.org/

https://crueltyfreeinternational.org/

https://www.peta.org/

https://ethicalelephant.com/