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Turkey - Regulation

On June 23, 2017 the Turkish Ministry of Environment and Urbanization (MoEU) published a regulation named Kimyasalların Kaydı, Değerlendirilmesi, İzni ve Kısıtlanması Hakkında Yönetmelik (Bylaw on Registration, Evaluation, Authorization and Restirction of Chemicals) on Official Gazette Rep. No: 30105 for the management of substances, very similar to the EU REACH

Regulation, (EC) No 1907/2006.

The KKDIK regulation came into effect on December 23, 2017.

KKDIK-TURKEY REACH replaces three existing Regulations:

 SR NO

 Regulations

 Effective date

1

The inventory and Control of Chemicals (CICR) was immediately replaced by KKDIK Regulation

June 23, 2017

2

 The Restrictions Relating to the production, Supply to the market and Use of Certain Harzadous Materials, Products and Goods

December 23, 2017

3

The preparation and Distribution of safety data sheets for hazardous materials and products

December 31, 2023

The purpose of KKDIK is:

  • To regulate the administrative and technical procedures and principles regarding the registration, evaluation, authorization and restriction of
  • To ensure a high level of protection of human health and the
  • To promote use of alternative methods for assessment of hazards of substances while enhancing competitiveness and

Scope of KKDIK:

KKDIK covers manufacturing, placing on the market or use of the substances on their own, in a mixture or in an article and placing the mixtures on the market unless they are:

  • Wastes
  • Radioactive materials and wastes
  • Substances used in defense industry
  • Non-isolated intermediates
  • Substances under transport and subject to customs
  • Substances in freezones or temporary storage waiting to be re-exported

All substances that are in scope of KKDIK have to be registered and pre-registered if they are produced or imported more than 1 ton per year unless they are exempt. Substances that are not pre-registered until the deadline will not be allowed to be placed in the Turkish market until their registration is complete.  Substances that are not registered in time will not be allowed to be placed in the market

Who can register?

  • Manufacturers
  • Importers
  • Non-Turkey manufacturers can appoint an “Only Representative (OR)” similar to EU REACH for the pre- registration and registration

Applicable Deadlines:

  • Pre-registration under the KKDIK has to be completed by 31st December
  • The tonnage bands for registration are similar to EU REACH (1-10; 10-100; 100-1000 and 1000+ tons/year for full registration and <1000 or >1000 tons/year for intermediate registration).
  • The deadline for the final registration within KKDIK is 31st December 2023. Registration deadline is not affected by the tonnage band

Only representatives have to be :
  • A natural person or legal entity established physically in TURKEY
  • Equipped with sufficient knowledge in the practical handling of the substances and information related to them (CICR/KEK, CLP/SEA, SDS/GBF, TURKEY-REACH/KKDIK, BPR, PPPR, related TR )
  • Appointed by a mutual agreement with a manufacturer, formulator or article producer, established outside Turkey
  • Responsible for complying with the legal requirements for importers under TURKEY-REACH (KKDIK)
  • Only representatives can represent more than one non-TR supplier, but must keep the information related to each of them
  • The non-TR company has to inform the importer (s) within the same supply chain of your appointment as an only These importers are then regarded as downstream users for TURKEY-REACH.

Classification :

  • Use of harmonized classification if possible;
  • Propose harmonized classification when appropriate;
  • Notify classification and labelling info to the Ministry of Environment and Urbanization (MoEU);

Labelling Requirements in Turkey :

  • Standard GHS label elements;
  • Language: in Turkish
  • Additional info: nominal quantity needs to be displayed on labels;
  • Words such as "non-toxic or not harmful" are not

SDS Requirements in Turkey:

  • Standard 16-section SDSs;
  • Must be prepared in Turkish
  • Must be prepared by certified SDS experts in Turkey;
  • A copy of SDSs shall be submitted to the Ministry of Environment and Urbanization (MoEU). Note: an expert holding a current certificate cannot prepare new SDSs before he/she receives new
GHS Implementation in Turkey:

Turkey has implemented GHS with different deadlines set for substances and mixtures. Chemical Classification criteria, labeling and SDS requirements are mainly set by the following two regulations:

  • Regulation on the Classification, Packaging and Labeling of Hazardous Materials and Products - Turkish CLP Regulation;
  • Regulation on the Preparation and Distribution of Safety Datasheet for Hazardous Materials and Products - Turkish SDS Regulation;

MoEU Fees:

Fees will be determined annually and published at the website

of the Ministry of Environment and Urbanization (MoEU).

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Plant Protection Products (PPPs) are registered according to PPPs regulation; 27885/25.03.2011 in TURKEY. The regulatory body of the turkey is the General Directorate of Food and Control (DGFC) of the Ministry of Agriculture and Forestry (MinAF), is the authority responsible for implementing the policies related to the plant protection products, (PPP) should be first approved by the committee set up by the DGFC. Plant protection product authorization, manufacturing, importing, marketing, and monitoring measures in Turkey are typical per EU laws. The Ministry of Food Agriculture and Livestock has had a “Plant Protection Products Data Base Software” since 2014, and this program contains all required information for roughly 4643 authorized PPP.   

Plant Protection Products (PPPs) are registered according to PPPs regulation; 27885/25.03.2011.  
1. According to the above regulation, applicants must receive a certificate showing their commercial activity in the Pesticides Industry from the Ministry of Food, Agriculture, and Livestock.  

Certificate requirements are given below-  

a)Contact information  

b) Commercial Registry Gazette showing that the activities in the plant protection industry.  

c) Authorized signature list  

d) The document that can be received from the Social Insurance Institution indicates the employment of a minimum of one agricultural engineer or chemist responsible for pesticide registration.  

e) Written engagement document (or contract)  

f) Tax chart  

g)The document which can be received from the Ministry of Finance shows a minimum of three offices in different geographic regions of Turkey.  

Certificated applicants should prepare the dossier of the PPPs and apply to the Ministry of Food, Agriculture, and Livestock for registration.  In TURKEY, Plant Protection Products are registered according to the types of pesticide formulations 

There are three types of registration procedures according to the regulation on PPP:27885/ 25.03.2011.  

  1. The first is when a formula is presented with the latest active ingredients. Applicants for this sort of application should also produce documentation that encompasses all toxicological and biological data related to human and environmental health, as well as residual food data. Subsequently, The applicants must perform at least two outdoor experiments on the plants in two different geographical areas of Turkey and submit the required information to the Ministry of Food, Agriculture, and Livestock for registration.  

  2. The second one is to add a new pest (insect, disease, or weed) to a PPP that has already been listed. Registrants have been Asked to complete two different trials at plants in two other geographical regions of Turkey to establish the facts related to new ingredients. 

  3. In the third one, the "Precedent Registration of PPP" technique is used to register a PPP. the correct formulation type and percentage of active ingredients must be used. Furthermore, it should have the same biological activity as the original PPP on the same pests. The pesticide's active compound, which will be used in the previous PPP, should not be patented. 

License Application:  Article 17-   

1.The license application files are submitted by the company to the General Directorate on a product-by-product basis.  

2. The information provided in these files can be readily accessible during the assessment, taking into account the annexes, company information, label information, biological activity, residue studies, toxicological and ecotoxicological data, and other intricate information.  

3. The General Directorate authorizes a license application if the information and papers required for the plant protection goods for which the application is made complete.  

4. If the Ministry provides the required infrastructure stipulated in the Act for electronic application, plant protection product commerce, and transactions can be conducted electronically. 

It is generally expected that the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) will be adopted for pesticides. The biggest impact of GHS on pesticides will be pesticide classification and product labels. While GHS has been adopted for industrial chemicals in workplace by a significant number of countries, many of them still follow the FAO Guidelines on Pesticide Registration and the FAO Guidelines on Good Labelling Practice for Pesticides (rather than GHS) to carry out pesticide hazard classification and prepare pesticide labels. In this article, we have analyzed how GHS may impact pesticide labelling and classification and analyzed the current situation of GHS adoption in pesticides sector. 

Turkish Implementation 

Turkey has implemented GHS with different deadlines set for substances and mixtures. Chemical classification criteria, labelling and SDS requirements are mainly set by the following two regulations: 

  • Regulation on the Classification, Packaging and Labeling of Hazardous Materials and Products - Turkish CLP Regulation; and 

  • Regulation on the Preparation and Distribution of Safety Datasheet for Hazardous Materials and Products - Turkish SDS Regulation; 

Both regulations align Turkish SDS and labelling requirements with that of EU REACH & CLP regulation. However, Turkey has set its own additional requirements on SDSs and labels. 

Critical Dates of Turkey GHS Implementation 

Substances 

1 June 2015 

Mixture 

1 June 2016 

Classification 

  • Use of harmonized classification if possible. 

  • Propose harmonised classification when appropriate. 

  • Notify classification and labelling info to the Ministry of Environment and Urbanization (MoEU); 

Labelling Requirements in Turkey 

  • Standard GHS label elements; 

  • Language: in Turkish 

  • Additional info: nominal quantity needs to be displayed on labels; 

  • Words such as "non-toxic or not harmful" are not allowed. 

SDS Requirements in Turkey 

  • Standard 16-section SDSs; 

  • Must be prepared in Turkish and provided free of charge; 

  • Must be prepared by certified SDS experts in Turkey; 

  • A copy of SDSs shall be submitted to the Ministry of Environment and Urbanization (MoEU). 

*Note: An expert holding a current certificate cannot prepare new SDSs before he/she receives new accreditations. 

Information Disclosure on Labels and in SDSs 

If a hazardous substance needs to be hidden on labels or in SDSs for confidentiality reasons, companies shall submit a request to MoEU to obtain an approval of using an alternative name. Such an alternative name can only be used for 6 years. Certain conditions have to be met first. 

  • Standard 16-section SDSs; 

  • Must be prepared in Turkish and provided free of charge; 

  • Must be prepared by certified SDS experts in Turkey; 

  • A copy of SDSs shall be submitted to the Ministry of Environment and Urbanization. 

  • Identification of compliance requirements under various guidelines including all data requirements.​ 

  • Data gap analysis and pre-assessment support​ 

  • Technical documentation support​ 

  • Pre and post submission support and technical liaison with authorities.

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