Implementation of KKDIK in Turkey
İlkay Çetin , managing director of Greenovation Consulting , overviews the challenges posed by Turkey ’ s equivalent of REACH
Chemical safety is a global concern that necessitates robust regulations to protect human health and the environment . Turkey , recognising the significance of this issue , introduced the KKDIK ( also sometimes known as TurkREACH ) regulation , which was directly inspired by EU REACH , on 23 December 2017 .
KKDIK plays a vital role in ensuring the safe use of chemicals within Turkey ’ s borders . It covers a wide range of chemical substances , including those used in industrial processes , as well as chemicals present in finished products that are available to consumers . The purpose of KKDIK is to regulate the administrative and technical procedures and principles regarding the registration , evaluation , authorisation and restriction of chemicals , and to ensure a high level of protection of human health and the environment . This includes the promotion of alternative methods for the assessment of the hazards of substances , while enhancing competitiveness and innovation .
KKDIK covers the 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 more than 1 tonne / year . It places obligations on manufacturers , importers , downstream users and distributors to ensure compliance with registration and authorisation requirements .
Roles & responsibilities in registration
The KKDIK regulation places obligations on manufacturers , importers , downstream users and distributors to ensure compliance with registration and authorisation requirements . To ensure effective compliance , it designates distinct roles in the registration process ( Figure 1 ).
Correctly determining your role within KKDIK is indeed crucial , particularly for global companies with offices in Turkey . The regulation stipulates that each registration must be made in the name of the company , granting the registered company the right to sell the registered substance in the market . This means that if registrations are conducted in the name of a non-Turkey based company , the registered substance can be sold to any buyer in Turkey .
However , if registrations are carried out in the name of the Turkish entity , only the Turkish entity will have the authority to sell the product . This implies that if a non-Turkey-based entity cannot sell the product directly to the Turkey-based company . Instead , it would need to invoice the Turkish entity first and then sell the product to the Turkish buyer through the Turkish entity .
Therefore , choosing your correct role within the registration process will also impact business operations . It is essential to consider the implications of registration in the name of either the non-Turkey based entity or the Turkish entity , as it determines the flexibility and options available for selling the registered substances to buyers in Turkey . This decision should align with the company ’ s overall business strategy and ensure compliance with the regulations while facilitating smooth operations and sales in the Turkish market ( Figure 2 ).
Only Representatives
KKDIK recognises the importance of international collaboration . By introducing the concept of Only Representatives ( ORs ), it allows non- Turkish manufacturers to appoint representatives within Turkey .
ORs fulfill the registration obligations on behalf of the manufacturers , ensuring compliance with KKDIK . This concept enables seamless communication and streamlines the registration process for non-Turkish entities . When selecting an OR , several factors need to be considered :
• Location & legal entity : The OR must be a natural person or a legal entity physically established in Turkey
• Knowledge & expertise : The OR should possess sufficient knowledge and expertise in handling the substances and the relevant regulations , including the Classification , Inventory & Control of Chemicals Regulation , Classification , Labelling & Packaging / Safety Data Sheets & Emergency Action , Safety Data Sheets / Güvenlik Bilgi Formu , KKDIK , the Biocidal Products Regulation , the Plant Protection Products Regulation and related Turkish regulations . This expertise is crucial for effectively managing compliance on behalf of non- Turkish suppliers
• Appointment : The OR is appointed through a mutual agreement with the manufacturer , formulator or article producer established outside Turkey . It is essential to establish clear terms of the agreement , specifying the roles , responsibilities and obligations of both parties
32 SPECIALITY CHEMICALS MAGAZINE ESTABLISHED 1981