DRAFT  
IMPLEMENTING REGULATION ON COSMET IC PRODUCT S 
 
CHAPTER ONE  
Objective, Scope, Legal Basis , and Definitions  
 
Objective  
Article  1-  (1) The objective of this Implementing Regulation is to determine principle s 
and procedures relevant to cosmetic products made available on the market to ensure a high 
level of protection of human health.  
Scope  
Article  2 - (1) This Implementing Regulation applies to cosmetic products.  
(2) This Implementing  Regulation does not apply to a substance or mixture intended to 
be ingested, inhaled, injected , or implanted into the human body for the purposes set out in 
point (ö) of Article (4)(1).  
Legal basis  
Article  3 – (1) This Implementing  Regulation has been drawn up based on  Article 7 of 
Law No 5324 on Cosmetic Products dated 24/3/2005 and Article 508 and 796 of Presidential 
Decree No 4  and Law No 7223 on Product Safety and Technical Regulations dated 05/03/2020.  
Definitions  
Article  4 – (1) For this Implementing  Regulation, the following definitions shall apply:  
a) Finished cosmetic product: Cosmetic product or its prototype in the form which is 
placed on the market or supplied to the end-user,    
b) Colorants: substances which are exclusively or mainly intended to colour the 
cosmetic product, the body as a whole or certain parts thereof, by absorption or reflection of 
visible light; in addition, precursors of oxidative hair colorants shall be deemed colorants;  
c) CAS number: the Chemical Abstracts Service number,  
ç) Serious undesirabl e effect: An undesirable effect which results in temporary or 
permanent functional incapacity, disability, hospitalis ation , congenital anomalies or an 
immediate vital risk or death , 
d) Frame formulation: a formulation which that lists the categor y or function of 
ingredients and their maximum concentration in the cosmetic product or gives relevant 
quantitative and qualitative information whenever a cosmetic product is not covered or only 
partially covered by such a formulation , 
e) Distributor : Any natural or legal person in the supply chain, other than the 
manufacturer or the importer, who makes a cosmetic product available on the market , 
f) EC number: The number designated by the European Commission according to the 
structural properties of the sub stance,  
g) Recall: means any measure aimed at achieving the return to economic operator of a 
cosmetic product that has already been made available to the end -user,  
ğ) IUPAC name: The name designated by the International  Union of Pure and Applied 
Chemistry,  
h) Economic operator: Manufacturer, responsible person, importer , and distributor,  ı) Manufacturer: Any natural or legal person who manufactures a cosmetic product or 
has such a product designed or manufactured, and markets that cosmetic product under his  own 
name or trademark , 
i) Undesirable effect: An adverse reaction for human health attributable to the normal 
or reasonably foreseeable use of a cosmetic product , 
j) Importer:    Any natural or legal person,  who places a cosmetic product on the market 
through  import ,              
k)  Good manufacturing practices: All planned and systematized activities which have 
been standardized to ensure the required quality level for the manufacturing, control, storage , 
and transportation of cosmetic products,  
l) Law:  Law No 5324 on Cosmetic Products published in the Official Gazette No 5324  
of 24/ 3/2005 , 
m) Mixture: a mixture or solution composed of two or more substances , 
n) Commission : European Commission , 
o) Preservatives: substances which that are exclusively or mainly intended to inhibit the 
development of micro -organisms in the cosmetic product,  
ö) Cosmetic product: means any substance or mixture intended to be placed in contact 
with the external parts of the human body (epidermis, hair system, nails, lips , and external 
genital organs) or with the teeth and the mucous membranes of the oral cavity with a view 
exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting 
them, keeping them in good condition or correcting body od ors, 
p) Agency: Turkish Medicine s and Medical Devices Agency , 
r) Substance: a chemical element and its compounds in the natural state or obtained by 
any manufacturing process, including any additive necessary to preserve its stability and any 
impurity deri ving from the process used but excluding any solvent which may be separated 
without affecting the stability of the substance or changing its composition , 
s) Nanomaterial: An insoluble or biopersistant and intentionally manufactured material 
with one or mor e external dimensions, or an internal structure, on a scale from 1 to 100 nm,  
ş) End-user: a consumer or professional using the cosmetic product , 
t) Making available on the market: any supply of a cosmetic product for distribution, 
consumption , or use on t he market in the course of commercial activity, whether in return for 
payment or free of charge , 
u) Withdrawal: any measure aimed at preventing the making available on the market of 
a cosmetic product in the supply chain , 
ü) Placing on the market: the first making available of a cosmetic product on the market , 
v) Prototype: a first model or design that has not been produced in batches, and from 
which the finished cosmetic product is copied or finally developed , 
y) Communique : Communique on Cosmetic Ingr edients published in the Official 
Gazette No … of …  
z) National electronic database: Electronic database which is administered by the 
Agency,  
aa) UV -filters: substances which are exclusively or mainly intended to protect the skin 
against certain UV radiation by absorbing, reflecting , or scattering UV radiation , bb) Harmonized Standard : A European standard adopted based on  a request made by 
the Commission for the application of Union harmonization legislation , 
cc) UZEM: National Poison Control Center,  which is responsible for counseling the 
calls of national poisoning cases and supplying antidote /antitoxins , and delivering them to 
patients.  
 
CHAPTER TWO  
Safety, Responsibility, Free Movement  
Safety  
Article  5- (1) A cosmetic product made available on the  market shall be safe for human 
health when used under normal or reasonably foreseeable conditions of use, taking account, in 
particular, of the following:  
a) Presentation including conformity with the Article 79 of Law No 6502 on Protect ion 
of Consumer published  in the Official Gazette No. 28835 of 28/11/2013,   
b) Labeling , 
c) Instructions for use and disposal,  
ç) Any other indication or information provided by the responsible person defined in 
Article 6.  
(2)The provision of warnings shall not exempt pe rsons defined in Article s 4 and 6 from 
compliance with the other requirements laid down in this Implementing  Regulation.  
Responsible person  
Article  6- (1) Cosmetic products may only be placed on the market if a legal or natural 
person located in Turkey is designated as re sponsible person.   
(2) For each cosmetic product placed on the market, the responsible person shall ensure 
compliance with the relevant obligations set out in this  Implementing  Regulation.  
(3) For a cosmetic product manufactured within Tur key: 
a) If the manufacturer is located in Turkey, the manufacturer shall be the responsible 
person. However, the manufacturer may designate, by written mandate, a person located in 
Turkey as the responsible person who shall accept in writing.  
b) If the man ufacturer is established outside of Turkey, he shall designate, by written 
mandate, a person located in Turkey as the responsible person who shall accept in writing.  
(4)  For an imported cosmetic product, each importer shall be the responsible person for 
the specific cosmetic product he places on the market. However, the manufacturer may 
designate, by written mandate, a person located in Turkey as the responsible person who shall 
accept in writing.  
 
(5) If the responsible person is a natural or legal person  appointed by the manufacturer 
or importer by a written agreement, the responsible person shall be legally responsible on the 
same basis as the manufacturer or importer within the scope of the Product Safety and Technical 
Regulations Law No. 7223.  
 
(6) The  distributor shall be the responsible person where he places a cosmetic product 
on the market under his name or trademark or modifies a product already placed on the market 
in such a way that compliance with the applicable requirements may be affected.  And it becomes legally responsible on the same basis as the manufacturer. The translation of 
information relating to a cosmetic product already placed on the market shall not be considered 
as a modification of that product of such a nature that compliance wit h the applicable 
requirements of this Implementing  Regulation may be affected.  
Responsible Technical Perso nnel 
Article  7 – (1) The responsible person shall employ a responsible technical perso nnel. 
(2) The responsible technical personnel is responsible for  checking the compliance of 
the product to be placed on the market with the cosmetic legislation, good manufacturing 
practices , and other relevant legislation.  
(3) Chemists, biochemists, chemical engineers,  chemistry teachers,  biomedical 
engineers,  biologists , and microbiologists with the condit ion of completing a training accepted 
by the Agency or pharmacists may be designated as a responsible technical personnel.  
Obligations of the responsible person  
Article  8- (1) Responsible persons shall ensur e compliance with Articles 5,  11, 13, 14, 
15, 16, 17, 18, 19, 20, 21, Article 22  (1), (2),  and (5), as well as Article 23, 24,  26 and 27.  
(2) Responsible persons who consider or have reason to believe that a cosmetic product 
which they have placed on the market is not in conformity with this Implementing  Regulation 
shall immediately take the corrective measures necessary to bring that produc t into conformity, 
withdraw it or recall it, as appropriate. Furthermore where the cosmetic product presents a risk 
to human health responsible persons shall immediately inform the Agency, in particular, of the 
non-compliance and of the corrective measures  taken.  
(3) Responsible person shall cooperate with the Agency, at the request of the latter, on 
any action to eliminate the risks posed by cosmetic products which they have made available 
on the market. In particular responsible persons shall, further to a request from the Agency, 
provide it with all the information and documentation necessary to demonstrate the conformity 
of specific aspects of the product, in Turkish or English.  
Obligations of distributors  
Article  9- (1) In the context of their activities, when making a cosmetic product 
available on the market, distributors shall act with due care in relation to applicable 
requirements.  
(2) Before making a cosmetic product available on the market distributors shall ve rify 
that: 
a) The labeling information provided for in Article 22 (1), (a), (d), (f), (g), (ğ), (h) and 
(ı), and Article 22 (3) and (4) is present,  
b) The languag e requirements provided for in A rticle 22 (5) are fulfilled , 
c) The date of minimum durability  specified, where applicable under Article 22 (1), has 
not passed.  
(3) Where distributors:  
a) consider or have reason to believe that a cosmetic product is not in conformity with 
the requirements laid down in this Implementing  Regulation,  they shall not make the product 
available on the market until it has been brought into conformity with the applicable 
requirements.  b) consider or have reason to believe that a cosmetic product which they have made 
available on the market is not in conformity with this  Implementing  Regulation, they shall make 
sure that the corrective measures necessary to bring that product into conformity, withdraw it 
or recall it, as appropriate, are taken.  
Furthermore, where the cosmetic product presents a risk to human health, distributors 
shall immediately inform the Agency and responsible person, giving details, in particular, of 
the non -compliance and of the corrective measures taken.  
(4) Distributors shall ensure that, while a product is under their responsibility, storage 
or transport conditions do not jeopardize its compliance with the requirements set out in this 
Implementing  Regulation.  
(5) Distributors shall cooperate with the Agency on any action to eliminate the risks 
posed by products that they have made available on the market. In particular, distributors shall, 
further to a request from the Agency, provide it with all the information and documentation 
necessary to demonstrate the conformity of the product with the requirements listed under 
paragraph 2, especially in Turkish or, where not possible, in English.  
Identification within the supply chain  
Article  10 – (1) At the request of the Agency, this obligation shall apply for a period of 
three years following the date on which the batch of the cosmetic product was made  available 
to the distributor.  
(a) Responsible persons shall identify the distributors to whom they supply the cosmetic 
product , 
(b) The distributor shall identify the distributor or the responsible person from whom, 
and the distributors to whom, the cosme tic product was supplied.  
Good manufacturing practice  
Article  11- (1) The manufacture of cosmetic products shall comply with good 
manufacturing practice with a view to ensure  the objectives of Article 1.  
(2) Compliance with good manufacturing practice shall be presumed where the 
manufacture is in accordance with the standards determined by the Agency under  the relevant 
harmonized standards published in the Official Journal of the European Union . 
Free movement  
Article  12- (1) Agency shall not, for reasons related to the requirements laid down in 
this Implementing  Regulation,  except for the matters not covered by this Implementing 
Regulation , refuse,  prohibit or restrict the making available on the market of cosmetic products 
which comply with the requirements of this Implementing Regulation . 
(2) If a cosmetic product export certificate is requested for a cosmetic product 
manufactured in Turkey, domest ic cosmetic product manufacturers, or the responsible person 
located  in Turkey shall apply via the national elec tronic database. The work and procedures 
regarding the application shall be carried out in accordance with the provisions of the relevant 
guidel ine which will be published in accordance with this Implementing  Regulation.  
 
 
 
 
 CHAPTER  THREE  
Safety Asse ssment, Product Information File, Notification  
 
Safety assessment  
Article  13- (1) In order to demonstrate that a cosmetic product complies with Article 5, 
the responsible person shall, prior to placing a cosmetic product on the market, ensure that the 
cosmetic product has undergone a safety assessment on the basis of the relevant information 
and that a cosmetic product safety report is set up in a ccordance with Annex I.  
(2) The responsible person shall ensure that for all cosmetic products, including those 
notified under  the Cosmetic Regulation published in Official Gazette No 25823  of 23/5/2005 : 
  a) the intended use of the cosmetic product and the anticipated systemic exposure to 
individual ingredients in a final formulation are taken into account in the safety assessment;  
b) an appropriate weight -of-evidence approach is used in the safety assessme nt for 
reviewing data from all existing sources;  
c) the cosmetic product safety report is kept up to date in view of additional relevant 
information generated subsequent to placing the product on the market.  
(3) Agency, shall adopt appropriate guidel ines t o enable undertakings to comply with 
the requirements laid down in Annex I.  
(4) The cosmetic product safety assessment, as set out in Annex I shall be carried out 
by a person in possession of a diploma or other evidence of formal qualifications awarded on  
completion of a university course of theoretical and practical study in pharmacy, toxicology, 
medicine or a similar discipline, or a course recogniz ed as equivalent by the Agency.  
(5) Non -clinical safety studies referred to in the safety assessment according to 
paragraph 1 shall be carried out  in accordance with the Regulation on Principles of Good 
Laboratory Practices, Harmonization of Test Units, Supervision of Good Laboratory Prac tices 
and Studies published on Official Gazette No. 27516 of 9 /3/2010 or with other international 
standards recognized as being equivalent by the Commission or the ECHA.  
Product information file  
Article  14 – (1) When a cosmetic product is placed on the mar ket, the responsible person 
shall be kept a product information file for a period of ten years following the date on which 
the last batch of the cosmetic product was placed on the market.  
(2) The product information file shall contain the following inform ation and data which 
shall be updated as necessary:  
a) a description of the cosmetic product which enables the product information file to 
be clearly attributed to the cosmetic product;  
b) the cosmetic product safety report referred to in Article 13 (1);  
c) a description of the method of manufacturing and a statement on compliance with 
good manufacturing practice referred to in Article 11;  
ç) where justified by the nature or the effect of the cosmetic product, proof of the effect 
claimed for the cosmetic p roduct ; 
d)  Data on any animal testing performed by the manufacturer, his agents , or suppliers, 
relating to the development or safety assessment of the cosmetic product or its ingredients, 
including any animal testing performed to meet the legislative or r egulatory requirements of 
countries other than Turkey and EU Member States.  (3) The responsible person shall make the product information file readily accessible in 
electronic or another format at his address indicated on the label to be presented to the A gency 
at the request of the Agency . 
(4)  The information contained in the product information file shall be available in 
Turkish or English.  
(5) The requirements provided in paragraphs (1) to (4)  of this Article shall also apply 
to cosmetic products that have been notified under the repealed Cosmetic Regulation.  
Sampling and analysis  
Article  15- (1)  Sampling and analysis of cosmetic products shall be performed in a 
reliable and reproducible manner.  
(2) Reliability and reproducibility shall be presumed if  the method used complies with 
the guidelines published by the Agency in accordance with the  relevant harmonized standards, 
the references of which have been published in the Official Journal of the European Union.  
Notification  
Article  16 – (1) Prior to pl acing the cosmetic product on the market the responsible 
person shall submit the following information to the Agency via the national electronic database  
including cosmetic products notified under the repealed Cosmetics Regulation : 
a) The barcode and the category of cosmetic product according to Annex 1 of the 
Communique and its name or names, enabling its specific identification ; 
b) the name and address of the responsible person where the product information file is 
made readily accessible;  
c) the country  of origin in the case of import , and the countries in which the product is 
placed on the market ; 
ç) the contact details of a physical person to contact in the case of necessity;  
d) the presence of substances in the form of nanomaterials and:  
1) their iden tification including the chemical name (IUPAC) and other descriptors as 
specified in Article 4 of the  Communique ; 
2) the reasonably foreseeable exposure conditions;  
e) the name and the Chemicals Abstracts Service (CAS) or EC number of substances 
classified  as carcinogenic,  mutagenic or toxic for reproduction (CMR), of category 1A or 1B, 
under Part 3 of Annex VI to Regulation on Classification, Labeling and Packaging of  Chemical 
Substances and Mixtures published on the repeated Official Gazette  No. 28848 o f 11/12/2013 ; 
f) Formulation in which volume or quantity ratios, including frame formulation, are 
specified in intervals to provide rapid and appropriate medical treatment in emergencies . 
(2) When the cosmetic product is placed on the market, the responsib le person shall 
notify the Agency via the national  electronic database  about the original labeling , Turkish label 
in cases where Turkish information is not i ncluded on the original label and the product 
packaging visual.  
(3) Agency shall, without delay,  make the information referred to in paragraphs  1, 2 
available  electronically to UZEM of the Ministry of Health for the purposes of medical 
treatment.  
(4) Where any of the information set out in paragraph 1 changes, the responsible person 
shall provide an u pdate without delay.  CHAPTER FOUR  
Restrictions for Substances  
 
 
Restrictions for substances listed in the Communique  
Article  17 – (1) Without prejudice to Article 5 of this  Implementing  Regulation , 
cosmetic  product shall  not contain  any of the following:  
a) Prohibited substances: prohibited substances listed in Annex II of  the Communique;  
b) Restricted substances: restricted substances which are not used in accordance with 
the restrictions laid down in Annex III of  the Communique;  
c) Colorants:  
1) Colorant s other than those listed in Annex IV of the  Communique and colorants 
which are listed there but not used in accordance with the conditions laid down in that Annex,  
except for hair colo uring products referred to in paragraph 2  
2) without prejudice to point  (b), (ç) (1) and (d) (1) , substances listed in Annex IV  of 
the  Communique but which are not intended to be used as colorants and which are not used in 
accordance with the conditions laid down in that Annex.  
ç) Preservatives:  
1) Preservatives other than those listed in Annex V  of the  Communique and 
preservatives which are listed there but not used in accordance with the conditions laid down 
in that Annex;  
2) without prejudice to point (b),  (c) (1), (d) (1),  substances listed in Annex V of the 
Communiq ue but which are not intended to be used as preservatives and which are not used in 
accordance with the conditions laid down in that Annex.  
d) UV -filters:  
1) UV -filters other than those listed in Annex VI  of the  Communique and UV -filters 
which are listed there  but not used in accordance with the conditions laid down in that Annex;  
2)without prejudice to point (b), (c) (1), (ç) (1) substances listed in Annex VI  of the 
Communique but which are not intended to be used as UV -filters and which are not used in 
accord ance with the conditions laid down in that Annex.  
(2) Cosmetic products shall not contain colorants intended to colo ur the hair, other than 
those listed in Annex IV of the Communique , and colorants intended to colo ur the hair which 
are listed there but not  used in accordance with the conditions laid down in that Annex.  
Substances classified as CMR substances  
  Article  18 – (1) The use in cosmetic products of substances classified as CMR 
substances, of category 2, under part 3 of Annex VI to  Implementing Regulation on the  
Classification, Labeling and Packaging of Substances and Mixtures shall be prohibited unless 
the Agency found that substance safe for use in cosmetic products.  
(2) The use in cosmetic products of substances classified as CMR  substances, of 
category 1A or 1B under Part  3 of Annex VI  to Implementing Regulation on the Classification, 
Labeling and Packaging of Substances and Mixtures shall be prohibited. However, such 
substances may be used in cosmetic products by way of exceptio n where, subsequent to their 
classification as CMR substances of category 1A or 1B under Part 3 of Annex VI to  the 
aforementioned Implementing Regulation , all of the following conditions are fulfilled:  a) They comply with the food safety requirements as d efined in Law No 5996 on 
Veterinary Services, Plant Health, Food and Feed published in the Official Gazette No 27610 
of 13/06/2010.  
b) There are no suitable alternative substances available, as documented in an analysis 
of alternatives;  
c) The application is made for a particular use of the product category with a known 
exposure,  
ç) They have been evaluated and found safe by the Co mmission for use in cosmetic 
products, in particular in view of exposure to these products and taking into consideration the 
overall exposure from other sources, taking particular account of vulnerable population groups.  
(3) Specific labelling in order to avoid misuse of the cosmetic product shall be provided 
in accordance with Article 5 of this  Implementing  Regulation, taking into  account possible risks 
linked to the presence of hazardous substances and the routes of exposure  
(4) The Agency shall re -evaluate those substances as soon as safety concerns arise, and 
update the relevant Annexes of the Communique taking into account the decision of the 
commission.  
 if necessary.   
Nanomaterials  
Article  19- (1) For every cosmetic product that contains nanomaterials, a high level of 
protection of human health shall be ensured.  
(2) The provisions of this Article do not apply to nanomaterials  used as colorants, UV -
filters or preservatives regulated under Article 17 unless expressly specified.  
(3) In addition to the notification under Article 16, cosmetic products containing 
nanomaterials shall be notified to the Agency via national electronic database by the responsible 
person six months prior to being placed on the market. This notification includes at least the 
followings:  
a) the identification of the nanomaterial including its chemical name (IUPAC) and other 
descriptors as specified in Article 4 (1)  (b), (h) (ğ) and (m) of the Communique,  
b) the specification of the nanomaterial including size of particles, physical and 
chemical properties;  
c) an estimate of the quantity of nanomaterial contained in cosmetic products intended 
to be pla ced on the market per year;  
ç) the toxicological profile of the nanomaterial;  
d) the safety data of the nanomaterial relating to the category of cosmetic product, as 
used in such products;  
e) The reasonably foreseeable exposure conditions.  
(4) The third  paragraph shall not apply to cosmetic products containing nanomaterials 
that are in conformity with the requirements set out in Annex III of the Communique.  
(5) The responsible person may designate another legal or natural person by written 
mandate for the notification of nanomaterials and shall inform the Agency thereof.  
(6)  In the event that concerns regarding the safety of a nanomaterial have arisen ,  the 
Agency shall evaluate the safety of such nanomaterial for use in the relevant categories of 
cosm etic products and on the reasonably foreseeable exposure conditions. To this end, the 
Agency may co nsult to the Advisory Commission established in accordance with Article 36. Where the necessary data is lacking, the Agency shall request the responsible person to provide 
such data.   The responsible person shall provide that data within 10 working days. If any tests 
and analysis require additional time, the Agency shall extend t his period only once.  
(7) The Agency, may at any time, invoke the procedure in paragraph 6 where it has any 
safety concerns, for example , due to new information supplied by a third party.  
(8) The Agency amends Annex II  and III of the Communique, taking into account the 
decision of the Commission where there is a potential risk to human health.  
(9) In cases where safety concerns are justified as a result of the assessment specified in 
paragraph 6, the Agency shall inform the Commission about its concerns regarding the use of 
the relevant nanomaterial.  
(10) The Agency, taking into account the catalog prepared by the Commission,  shall 
make available a catalogue of all nanomaterials used in cosmetic products placed on the market, 
including those used as colo rants, UV filters and preservatives in a separate section, indicating 
the categories of cosmetic products and the reasonably foreseeable exposure conditions. The 
Agency updates this catalog as the catalog prepared by the Commission is updated.  
Traces of pr ohibited substances  
Article  20 – (1) The non -intended presence of a small quantity of a prohibited substance, 
stemming from impurities of natural or synthetic ingredients, the manufacturing process, 
storage, migration from packaging, which is technically unavoidable in good manufacturing 
practice, shall be permitted provided that such presence is in conformity with Article 5.  
 
CHAPTER FIVE 
Animal Testing  
 
Animal testing  
Article  21 – (1) Without prejudice to the general obligations deriving from Article 5, 
the following shall be prohibited:  
a) the placing on the market of cosmetic products where the final formulation, in order 
to meet the requirements of this Implementing Regulation, has been the subject of animal 
testing using a method other than an alternative method after such alternative method has been 
validated with due regard to the development of validation within the OECD and adopted by 
the Agency,  
b) the placing on the market of cosmetic products containing ingredients or 
combinations of ingr edients,  which, in order to meet the requirements of this Implementing 
Regulation, have been the subject of animal testing using a method other than an alternative 
method after such alternative method has been validated with due regard to the development o f 
validation within the OECD and adopted by the Agency,  
c) the performance within Turkey of animal testing of finished cosmetic products in 
order to meet the  requirements of this Implementing Regulation,  
ç) the performance of animal testing of ingredients  or combinations of ingredients in 
order to meet the requirements of this  Implementing  Regulation, after the date on which such 
tests are required to be replaced by one or more validated alternative methods listed in 
Regulation on Test Methods to be Applie d for Determination of Physico -Chemical, Toxicological and Ecotoxicological Properties of Substances and Mixtures  in the Official  
Gazette No. 28848 of 11.12.2013  or Annex III of this  Implementing  Regulation , 
(2) In exceptional circumstances,  where seriou s concerns arise as regards the safety of 
an existing cosmetic product ingredient, if the following conditions are met, the Agency may 
grant a derogation from the first paragraph by specifying its purpose, duration and scope and 
notify the Commission throu gh the Ministry of Trade:  
a) the ingredient is in wide use and cannot be replaced by another ingredient capable of 
performing a similar function;  
b) the specific human health problem is substantiated and the need to conduct animal 
tests is justified and is  supported by a detailed research protocol proposed as the basis for the 
evaluation.  
 
CHAPTER SIX 
Consumer Information  
 
Labeling  
Article  22 - (1) Without prejudice to other provisions in this Article, cosmetic products 
shall be made available on the market only where the container and packaging of cosmetic 
products bear the following information in indelible, easily legible and visible letter ing. 
a) the name or registered name and the address of the responsible person. Such 
information may be abbreviated in so far as the abbreviation makes it possible to identify that 
person and his address. If several addresses are indicated, the one where th e responsible person 
makes readily available the product information file shall be highlighted. The country of origin 
shall be specified for imported cosmetic products , 
b) the nominal content at the time of packaging, given by weight or by volume, except 
in the case of packaging containing less than five grams or five milliliters , free samples and 
single -application packs; for pre -packages normally sold as a number of items, for which details 
of weight or volume are not significant, the content need not be given provided the number of 
items appears on the packaging. This information need not be given if the number of items is 
easy to see from the outside or if the product is normally only sold individually.  
c) the date until which the cosmetic product, store d under appropriate conditions, will 
continue to fulfi ll its initial function and, in particular, will remain in conformity with Article 5 
(‘date of minimum durability’).  
1) The date itself or details of where it appears on the packaging shall be preceded by 
the sy mbol shown in point 3 of Annex II or the words: ‘best used before the end of’.  
2) The date of minimum durability shall be clearly expressed and shall consist of either 
the month and year or the day, month and year, in that order. If necessary, thi s information shall 
be supplemented by an indication of the conditions which must be satisfied to guarantee the 
stated durability.  
3) Indication of the date of minimum durability shall not be mandatory for cosmetic 
products with a minimum durability of mor e than 30 months. For such products, there shall be 
an indication of the period of time after opening for which the product is safe and can be used 
without any harm to the consumer. This information shall be indicated, except where the concept of durabilit y after opening is not relevant, by the symbol shown in point 2 of Annex II 
followed by the period (in months and/or years) , 
ç) Particular precautions to be observed in use, and at least those listed in Annexes III 
to VI of the Communique and any special precautionary information on cosmetic products for 
professional use , 
d) The batch number of manufacture or the reference number assigned by the 
manufacturer for identifying the cosmetic product. Where this is impossible for practical 
reasons because the co smetic products are too small, such information  need  appear only on the 
packaging , 
e) The function of the cosmetic product unless it is clear from its presentation , 
f) A list of ingredients shall be indicated on the container. In addition , it may be indica ted 
on the packaging. The list shall be preceded by the term ‘ingredients’ or a term with the same 
meaning in Turkish or English.  
For the purpose of this Article, an ingredient means any substance or mixture 
intentionally used in the cosmetic product durin g the process of manufacturing. The following 
shall not, however, be regarded as ingredients:  
1) impurities in the raw materials used , 
2) subsidiary technical materials used in the mix ture but not present in the finished 
cosmetic  product  
g) Perfume and aromatic compositions and their raw materials shall be referred to by 
the terms ‘ perfume or ‘aroma’. Moreover, the presence of substances, the mention of which is 
required under the column ‘Other’ in Annex III of the Communique, shall be indicated in the 
list of ingredients in addition to the terms perfume or aroma.  
ğ)The  list of ingredients shall be established in descending order of weight of the 
ingredients at the time they are added to the cosmetic product. Ingredients in concentrations of 
less than 1 % may be listed in any order after those in concentrations of more t han 1 %.  
h) All ingredients present in the form of nanomaterials shall be clearly indicated in the 
list of ingredients. The names of such ingredients shall be followed by the word ‘nano’ in 
brackets.  
ı) Colorants other than colorants intended to colo ur the hair may be listed in any order 
after the other cosmetic ingredients. For decorative cosmetic products marketed in several 
colour shades, all colorants other than colorants intended to colour the hair used in the range 
may be listed, provided that the wor ds ‘may contain’ or the symbol ‘+/ -’ are added. The CI 
(Colour Index) nomenclature shall be used, where applicable.  
(2)Where it is impossible for practical reasons to label the information mentioned in 
points (ç), (f), (g), (ğ), (h) and (ı) of paragraph 1 as provided, the following applies:  
a) The information shall be mentioned on an enclosed or attached leaflet, label, tape, tag 
or card , 
b) Unless impracticable, this information shall be referred to by abbreviated information 
or the symbol given in point 1  of Annex II of this Implementing Regulation, which must appear 
on the container or packaging for the information referred in point (ç) of paragraph 1 and on 
packaging for the information referred in point (f), (g), (ğ), (h) and (ı) of paragraph 1 . 
(3) In the case of soap, bath balls and other small products where it is impossible for 
practical reasons for the information referred to in point (f), (g), (ğ), (h) and (ı ) of paragraph 1 to appear on a label, tag, tape or card or in an enclosed leaflet, this in formation shall appear on 
a notice in immediate proximity to the container in which the cosmetic product is exposed for 
sale. 
(4) Cosmetic products that are not pre -packaged, are packaged at the point of sale at the 
purchaser’s request or are pre -packaged for immediate sale shall be presented to the end-user 
in accordance with the requirements of this Implementing Regulation  and with an information 
card containing the information referred to in the first paragraph.  
(5) The language of the information mentio ned in points (b), (c), (ç) and (e) of paragraph 
1 and in paragraphs (2), (3) and (4) shall be in Turkish . 
(6) The information mentioned in point (f),(g), (ğ), (h) and (ı)of paragraph 1 shall be 
expressed by using the common ingredient name set out in the glossary provided for in Article 
33. In the absence of a common ingredient name, a term as contained in a generally accepted 
nomenclature shall be used.  
Product claims  
Article  23 – (1)  In the labeling, making available on the market and advertising of 
cosmetic products, text, names, trademarks,  registered trademarks, pictures and figurative or 
other signs shall not be used to imply that these products have characteristics or functions which 
they do not have.  
(2) The Agency shall establish a list of common criteria for claims, based on the 
common criteria published by the Commission, which may be used in respect of cosmetic 
products, and take appropriate measures to ensure compliance of cosmetic products which are 
not in conformity with the common criteria.  
(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 supp liers 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 for the purpose of developing new cosmetic products.  
Access to information for the public  
Article  24 – (1) Without prejudice to the protection, in particular, of commercial secrecy 
and of intellectual property rights, the responsible person shall ensure that the qualitative and 
quantitativ e composition of the cosmetic product and, in the case of perfume and aromatic 
compositions, the name and code number of the composition and the identity of the supplier, 
as well as existing data on undesirable effects and serious undesirable effects resul ting from use 
of the cosmetic product are made easily accessible to the public by any appropriate means.  
(2) The quantitative information regarding the composition of the cosmetic product 
required to be made publicly accessible shall be limited to hazardou s substances in accordance 
with Article 5 of Implementing Regulation on Classification, Labelling and Packaging of 
Chemical Substances and Mixtures published in the repeated Official Gazette No 28848 of 
11/12/2013 . 
 
 
 
 CHAPTER SEVEN  
Market Surveillance  
 
In-market control  
Article  25 – (1) The Agency shall monitor if the cosmetic products made available on 
the market are in compliance with this Implementing Regulation  and do not endanger human 
and public health and safety via in -market controls of the cosme tic products made available on 
the market. The Agency shall perform appropriate checks of cosmetic products and checks on 
the economic operators on an adequate scale, through the product information file and, where 
appropriate, physical and laboratory chec ks on the basis of adequate samples.  
(2) The Agency shall also monitor compliance with the principles of good 
manufacturing practices.  
(3) The Agency determines production site inspections of cosmetic products, sampling, 
warning, withdrawal from the market , disposal, rehabilitation and closure of the production site 
within the scope of market surveillance and inspection.  
(4) The Agency periodically reviews its market surveillance activities annually and 
reports the results to the Commission and EU Member States through the Ministry of Trade. 
This review is made available to the public electronically and, if necessary, by other means.  
Communication of serious undesirable effects  
Article  26 – (1) In the event of serious undesirable effects, the responsible p erson and 
distributors shall without delay notify the following to the Agency and the manufacturer:  
a) all serious undesirable effects which are known to him or which may reasonably be 
expected to be known to him , 
b) the name of the cosmetic product concer ned, enabling its specific identification , 
c) the corrective measures taken by him, if any.  
(2) Where the responsible person reports serious undesirable effects to the Agency, the 
Agency shall immediately transmit the information referred to in paragraph 1  to the competent 
authorities of the EU Member States through the Ministry of Trade.  
(3)  Where distributors, end-users or health professionals report serious undesirable 
effects to the Agency, the Agency shall immediately transmit the information referred  to in 
paragraph (1) to the responsible person and EU Member States through the Ministry of Trade.  
(4) The Agency may use the information referred to in this Article for the purposes of 
in-market surveillance, market analysis, evaluation and consumer infor mation in the context of 
Articles 28, 29 and 30.  
Information on substances  
Article  27 – (1) In the event of serious doubt regarding the safety of any substance 
contained in cosme tic products, the Agency may request the responsible person to submit a list 
of all cosmetic products for which he is responsible and which contain this substance. The list 
shall indicate the concentration of this substance in cosmetic products. The Agency may use 
the information referred to in this Article for the purposes of in -market surveillance, market 
analysis, evaluation and consumer information in the context of Articles 28, 29 and 30.  
 
 
 CHAPTER E IGHT  
Non-Compliance, Safeguard Clause, Administrative Enforcements  
 
Non-compliance by the responsible person  
Article  28 – (1) Without prejudice to paragraph 3 the Agency shall require the 
responsible person to take all appropriate measures, including corrective actions bringing the 
cosmetic product into conformity, the withdrawal of the product from the market or its recal l, 
within an expressly mentioned time limit, commensurate with the nature of the risk, where there 
is non -compliance with any of the following:  
a) the good manufacturing practice referred to in Article 11 , 
b) the safety assessment referred to in Article 13 , 
c) the requirements for the product information file referred to in Article 14 , 
ç) the provisions on sampling and analysis referred to in Article 15 , 
d) the notification requirements referred to in Articles 16 and 19 , 
e) the restrictions for substances r eferred to in Articles 17, 18 and 20 , 
f) the animal testing requirements referred to in Article 21 , 
g) the labeling requirements referred to in Article 22(1), (2), (5) and (6) , 
ğ) the requirements related to product claims set out in Article 23 , 
h) the acc ess to information for the public referred to in Article 24 , 
ı) the communication of serious undesirable effects referred to in Article 26 , 
i) the information requirements on substances referred to in Article 27 . 
(2) The responsible person shall ensure that the measures referred to in paragraph 1 are 
taken in respect of all the products concerned.  
(3)In case of serious risks to human health, where the Agency considers that the non -
compliance is no t limited to the territory of Turkey, the Agency shall inform the Co mmission 
and the EU Member States of the measures which it has required the responsible person to take 
through the Ministry of Trade.  
Non-compliance by distributors  
Article  29 – (1) The Agency shall require distributors to take all appropriat e measures, 
including corrective actions bringing the cosmetic product into conformity, the withdrawal of 
the product from the market or its recall  or its disposal , within a given reasonable time limit, 
commensurate with the nature of the risk, where there  is non -compliance with obligations laid 
down in Article 9.    
Safeguard clause  
Article  30 – (1) In the case of products meeting the requirements listed in Article 28(1), 
where the Agency ascertains or has reasonable grounds for concern, that a cosmetic pro duct or 
products made available on the market present or could present a serious risk to human health, 
it shall take all appropriate provisional measures in order to ensure that the product or products 
concerned are withdrawn, recalled or their availabilit y is otherwise restricted.  
(2) The Agency shall share with the Commission and the competent authorities of the 
EU Member States the measures taken and any supporting data through the Ministry of Trade  
where necessary . 
 
 Administrative enforcements  
Article  31- (1) Any decision taken by the Agency pursuant to Articles 28 and 30 shall 
be notified without delay to the responsible person with the exact grounds on which it is based.  
(2) Except in the case where immediate action is necessary for reasons of seriou s risk to 
human health, the responsible person shall have the opportunity to put forward his viewpoint 
to Agency before any decision is taken.  
(3) Where applicable, the provisions mentioned in paragraphs 1 and 2 shall apply with 
regard to the distributor f or any decisions taken pursuant to Articles 29 and 30.  
(4) The Agency shall take all appropriate measures to prohibit or restrict the making 
available on the market of the cosmetic product or to withdraw the product from the market or 
to recall it , and when it is impossible to m ake the products safe, partially or completely dispose  
of the products commensurate with the nature of the risk, costs to be borne by the economic 
operator, in the following cases:    
a) where an immediate action is necessary in th e event of serious risk to human health; 
or, 
b) where the responsible person does not take all appropriate measures within the time 
limit referred to in Article 28 (1).  
(5) The economic operator shall make an announcement regarding the products, with 
risk in accordance with Article 18 of the Product Safety and Technical  Regulations Act by itself 
or upon the request of the Agency.  
Cooperation  
Article  32- (1) The Agency participates in the organization of the Commission for the 
necessary information exchange in order to allow the uniform implementation of this 
Implementing Regulation  and cooperates with the competent authorities of the EU Member 
States and t he Commission in this direction.  
(2) Upon a request made by the competent authority of any Member State where the 
cosmetic product is made available, without undue delay and taking into account the degree of 
urgency, the Agency shall inform the requesting competent authority whether the product 
information file satisfies the requir ements referred to in Article 14  (2) and whether the 
information set out therein provides evidence of the safety of the cosmetic product.  The 
requesting competent authority shall provide a motivation for the request.  
(3) The Agency may request the same procedure described in paragraph (2) from the 
competent authority of any Member State in which the responsible person based, for a cosmetic 
product made available  on the market.  
Glossary of common ingredient names  
Article  33-(1) The Agency shall compile and update a glossary of common ingredient 
names. To this end, the Agency shall take account of internationally recognized nomenclatures 
including the International Nomenclature of Cosmetic Ingredients (INCI). That glossary shall 
not constitute a list of the substances authorized for use in cosmetic products.  
National Poison Control Center  
Article  34- (1) The Agency notifies t he Commission with the contact details of the 
UZEM . 
 
 Penalties for infringement of the provisions of this Implementing Regulation   
Article  35- – (1) For those who infringe the provisions of this Implementing Regulation  
and legislation that put into force to implement this Implementing Regulation , relevant 
provisions of Cosmetic Law No. 5324 dated 24/3/2005 and Law No: 7223 on Technical 
Regulations for Products Safety dated 05/3/2020 and Turkish Criminal Code Law No. 523 7 
shall apply in accordance with the nature of the action.  
(2) In the event that the responsible person violates his obligations under this 
Implementing Regulation , the responsible person shall be legally responsible on the same basis 
as the manuf acturer o r importer  within the scope of the Product Safety and Technical 
Regulations Act.  
(3) If the responsible person is a legal or natural person designated by a written mandate 
by the manufacturer or the im porter, the provisions in the first paragraph are shall  apply to him . 
 
 
Advisory commissions  
Article  36- (1) The Agency may establish temporary or permanent advisory 
commissions in addition to technical and advisory commissions within its organization, if 
necessary.  The procedures and principles of advis ory commissions and their duties, 
authorizations and responsibilities shall be determined by the Agency.  
Compliance with the European Union legislation  
Article  37-(1) This Implementing Regulation  is prepared according to Regulation (EC) 
No 1223/2009 of the Eur opean Parliament and of the Council as part of compliance  with the 
European Union legislation.  
Repealed Regulation  
Article  38- Cosmetic Products Regulation published in the Official Gazette No. 25823  
of 23/05/2005 has been repealed.  
Transitional provisions  
Article  39-(1) Cosmetic products which made available on the market before the date 
this Implementing Regulation  enters into force and are compliant with the repealed Cosmetic 
Products Regulation may be made available on the market for 2 years a fter this Implementing 
Regulation  enters into force.  
(2) Within the time frame specified in the paragraph (1), the notification made according 
to Article 16 of this Implementing Regulation  shall be accepted as compliant with Article 14 of 
the repealed Cosm etic Products Regulation.  
References  
Article  40-(1) References to the repealed Cosmetic Products Regulation published in 
the Official Gazette No  25823  of 23/05/2005 in other regulations shall be understood as 
references to this Implementing Regulation . 
Entry into force and date of application  
Article  41- (1) This Implementing Regulation shall enter into force six months after the 
date of its publication.  
(2) Article 16 of this Implementing Regulation  shall apply on the date of its publication.  
 
 Execution  
Article  42-(1) Provisions of this Implementing Regulation  shall be  executed by the 
President of the Agency.  
 
ANNEX I  
COSMETIC PRODUCT SAFETY REPORT  
 
The cosmetic product safety report shall, as a minimum, contain the following:  
PART A – Cosmetic  product safety information  
1. Quantitative and qualitative composition of the cosmetic product  
The qualitative and quantitative composition of the cosmetic product, including the 
chemical identity of the substances (incl. chemical name, INCI, CAS, EINECS/ELI NCS, where 
possible) and their intended function. In the case of perfume and aromatic compositions, 
description of the name and code number of the composition and the identity of the supplier.  
2. Physical/chemical characteristics and stability of the cosmetic product  
The physical and chemical characteristics of the substances or mixtures, as well as the 
cosmetic product.  
The stability of the cosmetics product under reasonably foreseeable storage conditions.  
3. Microbiological quality  
The microbiologica l specifications of the substance or mixture and the cosmetic 
product.  Particular attention shall be paid to cosmetics used around the eyes, on mucous 
membranes in general, on damaged skin, on children under three years of age, on elderly people 
and person s showing compromised immune responses.  
Results of preservation challenge test.  
4. Impurities, traces, information about the packaging material  
The purity of the substances and mixtures.  
In the case of traces of prohibited substances, evidence for their te chnical unavoidability.  
The relevant characteristics of packaging material, in particular purity and stability.  
5. Normal and reasonably foreseeable use  
The normal and reasonably foreseeable use of the product. The reasoning shall be 
justified in particula r in the light of warnings and other explanations in the product labeling.  
6. Exposure to the cosmetic product  
Data on the exposure to the cosmetic product taking into consideration the findings 
under Section 5 in relation to  
1) The site(s) of application;  
2) The surface area(s) of application;  
3) The amount of product applied;  
4) The duration and frequency of use;  
5) The normal and reasonably foreseeable exposure route(s);  
6) The targeted (or exposed) population(s). Potential exposure of a specific population 
shall also be taken into account.  
The calculation of the exposure shall also ta ke into consideration the toxi cological 
effects to be considered (e.g. exposure might need to be calculated per unit area of skin or per 
unit of body weight). The pos sibility of secondary exposure by routes other than tho se resulting from direct appli cation should also be considered (e.g. non -intended inhalation of sprays, non -
intended ingestion of lip products, etc.).  
 Particular consideration shall be given to any po ssible impacts on exposure due to 
particle sizes.  
7. Exposure to the substances  
Data on the exposure to the substances contained in the cosmetic product for the relevant 
toxicological endpoints taking into account the information under Section 6.  
8. Toxicological profile of the substances  
Without prejudice to Article 18, the toxicological profile of substance contained in the cosmetic 
product for all relevant toxicological endpoints.     A particular focus on local toxicity evaluation 
(skin and eye ir ritation), skin sensitization , and in the case of UV absorption photo -induced 
toxicity shall be made.  
All significant toxicological routes of absorption shall be considered as well as the 
systemic effects and margin of safety (MoS) based on a no observed a dverse effects level 
(NOAEL) shall be calculated. The absence of these considerations shall be duly justified.  
Particular consideration shall be given to any possible impacts on the toxi­cological profile due 
to 
- particle sizes, including nanomaterials,  
- impurities of the substances and raw material used, and  
- interaction of substances.  
Any read -across shall be duly substantiated and justified.  
The source of information shall be clearly identified.  
9. Undesirable effects and serious undesirable effects  
All available data on the undesirable effects and serious undesirable effects to the 
cosmetic product or, where relevant, other cosmetic products. This includes statistical data.  
10. Information on the cosmetic product  
Other relevant information, e.g. exist ing studies from human volunteers or the duly confirmed 
and substantiated findings of risk assessments carried out in other relevant areas.  
 
PART B – Cosmetic product safety assessment  
1. Assessment conclusion  
Statement on the safety of the cosmetic product in relation to Article 3.  
2. Labeled  warnings and instructions of use  
Statement on the need to label any particular warnings and instructions of use in 
accordance with Article 19(1)(d).  
3. Reasoning  
Explanation of the scientific reasoning leading to the assessment conclusion set out 
under Section 1 and the statement set out under Section 2. This explanation shall be based on 
the descriptions set out under Part A .  Where relevant, margins of safety sha ll be assessed and 
discussed.  
There shall be inter alia a specific assessment for cosmetic products intended for use on 
children under the age of three and for cosmetic products intended exclusively for use in 
external intimate hygiene.  Possible interactio ns of the substances contained in the cosmetic product shall be 
assessed.  
The consideration and non -consideration of the different toxicological profiles shall be 
duly justified.  
Impacts of the stability on the safety of the cosmetic product shall be duly considered.  
4. Assessor's credentials and approval of part B  
Name and address of the safety assessor. Proof of qualification of safety assessor. Date 
and signature of safety assessor.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
ANNEX II 
SYMBOLS USED ON PACKAGING/CONTAINER  
 
1. Reference to enclosed or attached information.  
 
2. Period -after-opening  
 
 
3. Date of minimum durability  
 
 
 
 
 
 
 
 
ANNEX III  
LIST OF VALIDATED ALTERNATIVE METHODS TO ANIMAL TESTING  
 
This Annex lists the alternative methods validated by the European Centre on Validation 
of Alternative Methods (ECVAM) of the Joint Research Centre available to meet the 
requirements of this Implementing Regulation  and which are not listed in  Physico -Chemi cal, 
Toxicological and Mixtures Of Substances And Mixtures It Will Be Applied In The 
Determination Of Ecotoxicological Characteristics Regulation On Test Methods Regulation 
11/12/2013 dated on official ga zette 28848.  
As animal testing may not be replaced c ompletely by an alternative method, it should 
be mentioned in Annex VIII whether the alternative method fully or partially replaces animal 
testing.  
 
Reference number  Validated alternative 
methods  Nature of replacement full or 
partial  
A B C