Turkey Reach Regulation for Various Sectors

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 

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. 

Plant Protection Products (PPPs) in Turkey are regulated with the Regulation on keeping records and monitoring of plant protection products (PPPs) used in plant protection (27885), which became effective on 25 November 2011. Registries for Plant Protection Products are maintained in accordance with this PPP regulation.

The regulatory body in Turkey is the General Directorate of Food and Control (DGFC) of the Ministry of Food,  Agriculture, and Livestock (MFAL). This is the authority in charge of implementing the policies for all plant protection products, including pesticides. The Regulation states that PPPs can only be marketed if the manufacturer or  impoter has received a license, or an approval, from a committee, constituted under the DGFC. The Regulation on "Licensing of Plant Protection Products" governs the licensing and marketing of plant protection products used in Turkey's fight against pests in agriculture.

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 Program” since  2014, and this program, which also has an English version, contains all the required information for roughly 4643 authorized PPPs.   

The registration of Plant Protection Products (PPPs) is regulated under Regulation 27885/25.03.2011.  The Ministry of Food, Agriculture, and Livestock is required by regulation to issue a certificate attesting to their business activities in the pesticides industry to the applicants. To apply for this certificate, the applicant must provide the following information:

• Applicant's contact details
• An employment contract for an agricultural engineer or a chemist/chemical engineer appointed to be in charge of licensing
• A signed contract by an authorized person in the company with detailed information about the registration
• A document from the Ministry of Finance listing a minimum of three offices spread out across Turkey
• Employment contract stating the employment of at least one agricultural engineer who is a graduate from a plant protection department or graduated from other departments with a specialization or doctorate in plant protection, or has at least 3 years of experience in plant protection
• A sample of the Trade Registry Gazette stating that the applicant is active in plant protection products
• Tax Certificate showing that the applicant is a taxpayer

After the applicants become certified a PPP dossier must be submitted to the Ministry of Food, Agriculture, and Livestock before being registered. If the licensing criteria stay the same for ten years, Plant Protection Products may be used and sold in Turkey.

License Application:  

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 must 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, are 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. 

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

• The first type of registration procedure occurs when a formula is presented with the latest active ingredients. For this sort of application documentation that encompasses all toxicological and biological data related to human and environmental health and residual food data should be produced by the applicant. Thereafter, at least two outdoor experiments must be performed on plants in two different geographical areas of Turkey and the required information must be submitted to the Ministry of Food, Agriculture, and Livestock for registration.  

• In the second type of registration a new pest (insect, disease, or weed) is added to a PPP that has already been listed. İn this case registrants must complete two different trials on plants in two other geographical regions of Turkey to establish the facts related to the new ingredients. 

• In the third type 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.