Turkey Regulatory News

On June 26th 2022, the Ministry of Environment, Urbanisation, and Climate Change, Turkey announced an update for the KKDIK registration regarding the languages of the reports to be submitted. Impo...

On June 26th 2022, the Ministry of Environment, Urbanisation, and Climate Change, Turkey announced an update for the KKDIK registration regarding the languages of the reports to be submitted.

Importers or manufacturers residing in Turkey and Only Representatives residing in Turkey appointed by manufacturers residing outside of Turkey should submit the technical dossier including the main information for the substances above 1 TPA.

In the announcement, the Ministry indicated that Full Study Reports and other attachment documents can be uploaded in English to the Chemical Registration System. However, other fields in the system such as "Robust Study Summaries" and "Study Summaries," remain to be Turkish only.

The deadline for final registration under KKDIK is 31st December 2023. Substances not registered after 31st December 2023 will not be able to enter the Turkish market.

The Ministry of Environment, Urbanization and Climate Change of Turkey has developed a new website to search for information regarding the inventory of chemicals called Chemicals Data System (KIMVES...

The Ministry of Environment, Urbanization and Climate Change of Turkey has developed a new website to search for information regarding the inventory of chemicals called Chemicals Data System (KIMVES). While the system resembles the substance search features of ECHA’s website, only the data regarding CLP notification is currently available.

Users can search substances by name, CAS number or EC number and view the notified classification and labeling information provided by the manufacturers or importers of the substance. Information such as how many companies have notified in a specific classification or non-classification group, and how many different categories of companies have notified for the specific substance is available on the system.

It has been a question in the previous years whether the Ministry would publish any information regarding the notifications and registrations under KKDIK and CLP regulations like ECHA does, and this website seems to be the answer to such questions. Although currently, only CLP notification information is available, there hasn’t been any mention in the announcement about what other data might be published in this system and if it’s only limited to CLP notification or not.

The system is only accessible from Turkey, however, it is expected to be accessible worldwide shortly. You can check the website out yourself from the link here: https://kimves.cevre.gov.tr/KIMVES

The directorate of the Revolving Fund of the Ministry of Environment and Urbanization has published the 2022 KKDİK fee on its website. Compared to 2021, the fees have increased by 20%. In 2021, th...

The directorate of the Revolving Fund of the Ministry of Environment and Urbanization has published the 2022 KKDİK fee on its website.

Compared to 2021, the fees have increased by 20%. In 2021, the joint submission fee was lesser than individual submission. The registration fee currently varies from 60 TL/€4  (for SME companies that jointly register 1-10 tonnage) to 18,000 TL/€ 1167 (for large size companies that individually register 1000+ tonnage substance) depending on tonnage band, the size of the company, and whether it is a joint or individual submission. This indicates the importance of joint registration for companies.

If you haven't pre-registered your substances yet, kindly do, so you can be part of SIEF and also to participate in joint registration.

Last Update: 2022-01-18

As published on the website of the official gazette, the Turkey cosmetic regulations’ annexes were amended in September. The parts that were amended include: Annex 2 (List of forbidden sub...

As published on the website of the official gazette, the Turkey cosmetic regulations’ annexes were amended in September. The parts that were amended include:

• Annex 2 (List of forbidden substances)Annex 3 (List of substances that cosmetic products shouldn't contain above determined amount)
• Annex 4 (List of colorants allowed in cosmetic products)
• Annex 5 (List of allowed preservatives in cosmetic products
• Annex 6 (List of UV filters allowed in cosmetic products)

The amendments state that:

1. Hair and eyelash dye products that contain Benzene-1,2,4-triol, 6-amino-m-cresol, and 2-((4-amino-2-nitrophenyl)amino)benzoic acid can’t be put into the market anymore (applicable from 3rd of September 2021). According to hazard classification and labeling of ECHA, those substances cause serious eye damage, skin irritation and may cause respiratory irritation. Additionally, products with these substances can stay in the market until the 3rd of June, 2022. 
2.  Products that contain 2-hydroxyethyl methacrylate which causes serious eye damage, and 7,7,9-trimethyl-4,13-dioxo-3,14-dioxa-5,12-diazahexadecane-1,16-diyl bismethacrylate which is harmful to aquatic life can’t be sold in the market anymore (applied from 3rd of September 2021). These substances are mainly used in nail products. 

 To find out more about Turkey cosmetic regulations and for other related inquiries, contact compliance@gpcregulatory.com

Latest update: 2021-10-20

On the 27th of September 2021, the new Turkish Food Codex Maximum of Pesticides Residual Limits Regulation was published on the official gazette, after a public consultation on the draft in 2020....

On the 27th of September 2021, the new Turkish Food Codex Maximum of Pesticides Residual Limits Regulation was published on the official gazette, after a public consultation on the draft in 2020. 

Like the Turkish Food Codex Maximum of Pesticides Residual Limits Regulation 2016, this regulation aims to protect consumers by regulating maximum pesticides residues in plants and animal source foods. 

In summary of the regulation for imported goods, firstly, product code can be found in Annex 1. By using that product code, MRL (Maximum Residue Level) or LOD(Limit of Determination) should be found in Annex 3 for specific pesticides and you should comply with those. If pesticides can’t be found in Annex 3 then 0,01* mg/kg calculation applies. 

Forbidden pesticides are listed in Annex 4. If pesticides listed in Annex 5 are found in imported products, then no MRL is required.  

That regulation entered into force on the publication date, 27th of September, 2021, and the previous regulation is revoked by the new one. The provisions of this regulation are executed by the Minister of Agriculture and Forestry. 

Latest Update: 2021-10-20

The Ministry of Health, Turkey published on their webiste the draft regulation on the amendment of Turkish Biocidal Product Regulation.  Current Biocidal regulation came into force on 31.12....

The Ministry of Health, Turkey published on their webiste the draft regulation on the amendment of Turkish Biocidal Product Regulation.

 Current Biocidal regulation came into force on 31.12.2009 in Turkey. The regulation aims to assess the effects of biocidal products on humans, animals, and the environment while regulating the classification, labeling, packaging requirements, exports, licensing for biocidal products, and conditions for putting products into the market.  

To prevent confusion and to make regulation more practical, this draft is prepared to amend articles regarding application for license and registration and definition of the authorized laboratory. With this amendment, this regulation will be in line with European Union Biocidal Regulation. According to this amendment, pre-application is no longer needed, and the definition of the authorized laboratory has been changed. 

 Interested people can submit their opinion through an official form to hsgm.cevre@saglik.gov.tr by 10.09.2021.  

The Ministry of Environment and Urbanization in Turkey published an announcement about new functions added to the chemical registration system on February 15, 2021.  With the new change, t...

The Ministry of Environment and Urbanization in Turkey published an announcement about new functions added to the chemical registration system on February 15, 2021. 

With the new change, the voting function will be integrated into the KKS so that potential registrants can vote for the candidate through the system. Unless there is more than one candidate or ministry requires it, appointing Lead Registrant (LR) by voting is not mandatory. Candidates should communicate with other potential registrants for LR. 

After appointment, lead registrants can start notifying the Ministry about their positions from March 1st, 2021. 

The fee calculator function has been added to the system. The fee is calculated depending on the size of the firm, tonnage range, and joint/separate submission. 

Currently, on the system, all firms are regarded as big size firms, therefore, to benefit from a reduced fee, companies should change the size of the company and upload SME certificates that can be obtained from KOSGEB (Small and Medium Industry Development Organization website. After listing firms as small or medium-sized, it can benefit from a reduced registration fee. For foreign companies, it will require documents that show the numbers of employees and annual turnover. The fee can be paid through the online system and the Ministry is automatically notified.

GPC can undertake LR role to facilitate the registration process and communicate with other registrants. If you haven’t pre-registered your substance, please contact us and we will facilitate your participation in SIEF (including appointing LR and reduced registration cost, etc.). As your seamless extension in global regulatory compliance, GPC will act for your best interests. 

Update: 2021-02-15