Frequently Asked Questions About KKDIK VIII

14.1 What are my obligations as a sub-user of a substance that requires an extended safety data sheet?

As a downstream user, you should follow the risk management recommendations and conditions of use set out in the exposure scenario in the extended safety data sheet you receive from your supplier. If relevant, communicate these recommendations to those in the downstream supply chain. If you are a downstream user producing a mixture, make sure that all the information you receive from your suppliers on the components that make up the mixture is included in the extended safety data sheet for the mixture. This new element under the KKDIK Regulation is to obtain and communicate use-specific risk management advice and risk management measures related to the exposure of people or the environment.

If, as a downstream user, you receive information from your customers to make a use known, you should pass this information on to your supplier in your upstream supply chain or assess whether the current exposure scenario for the mixture covers the use in question and eventually complete your own downstream chemical safety assessment. If, as a downstream user, you have information that calls into question hazard or risk management information from a supplier, you should communicate this information to your supplier.

14.2 What are my obligations as a downstream user if the Extended Safety Data Sheet does not cover my use?

If you, as a downstream user, use the substance outside of the conditions communicated to you in the expanded SDS (on its own or in a mixture), or if your use is not included in the expanded SDS at all, you can choose one of the following options:

Observe the conditions of use described in the extended Safety Data Sheet,
Practice or recommend an exposure scenario that includes at least the conditions described in the exposure scenario you have received,
Based on the manufacturer's chemical safety assessment, report your use to the supplier with a view to making it a 'designated use',
Create your own chemical safety assessment for this specific use (if the total amount used is 1 ton/year or more) and record it in the chemical safety report. Report your use to the Ministry according to Article 34(2) of the KKDIK Regulation.
If there is another supplier who has included your area of use in the extended Safety Data Sheet, start working with that supplier.

If, as a downstream user, you have received information from your customers to make a use known, you should pass this information up the supply chain to the supplier or determine whether that use has been included in the exposure scenario prepared for the mixture and finally conduct your own ‘downstream chemical safety assessment’.

If you, as a sub-user, have information that questions the hazard and risk management information from your supplier, you should communicate this information to your supplier. Section 6 – Deciding whether the use is covered by the exposure scenario in the Technical Guide for sub-users describes how to decide whether your own use is included in the exposure scenario.

Information on how to prepare the sub-user chemical safety report is described in Chapter 7 – Preparation of sub-user chemical safety report in the same guide.

14.3 What are my obligations as a downstream user if I use authorized substances?

If the substance is subject to authorization (Annex 17): You must use the substance in question according to the conditions of the authorization granted to an upstream actor in your own supply chain for a specific use, or apply for an authorization yourself if your own use(s) are not covered by your supplier’s authorization. Notification must be made to the Ministry within 3 months of the first supply when the authorized substance is used.

If the substance is subject to restriction: You must comply with the restrictions on the placing on the market or use of substances listed in Annex 17 of the KKDIK Regulation. Possible obligations of downstream users regarding authorization,

The Technical Guidance for Sub-Users can be found in Chapter 12-‘Compliance with permit requirements’.

14.4 How can I be sure whether I have a registration or notification obligation?

Only manufacturers of substances in Turkey or importers of substances, mixtures or articles from outside Turkey, manufacturers of articles or Sole Representatives have the obligation to register. The role of your company in this context may vary depending on the different substances used, for example, a legal entity is likely to have multiple obligations under KKDIK depending on its activities, especially when it has activities involving many different substances and/or articles. Therefore, in determining whether firms have a registration or notification obligation – for example, because they import a substance – it is important that firms carefully identify the suppliers of all the substances they use.

The necessary information and documents can be accessed through the Chemicals Help Desk web page, which is designed to help companies identify their roles and duties and define their obligations under KKDIK for the substance(s) they use. Technical Guidance for Sub-users Title 2.5- Defining Roles and Responsibilities can be used to help companies distinguish between different roles under the KKDİK Regulation.

14.5 When do I need to notify the Ministry about the use of my substance as a sub-user?

Situations that require you to notify the Ministry:

When it is necessary to report to the Ministry, you do not need to include specific uses of less than 1 ton per year, unless you have not prepared the Chemical Safety Report for some reason other than the total amount used is less than 1 ton per year. Otherwise all uses must be reported.

Registration numbers must be notified to the Ministry within 6 months after submission of the safety data sheet with the exposure scenario attached.

14.6 When can the sub-user use the substance for a USOAG activity?

The sub-user may use substances in two different situations for the PPORD activity, as described in the Guidelines for Scientific Research and Development (SR&D) and Product and Process Oriented Research and Development (PPORD) Guidelines for Scientific Research and Development and Product and Process Oriented Research and Development (SR&D) Guidelines for Scientific Research and Development and Guidelines for Product and Process Oriented Research and Development 1.2.3.2.

When the substance is registered according to Article 7 of KKDIK, the downstream user may use the substance for product and process-oriented research and development. In such cases, it should inform the supplier of the registered substance about the use included in the SDS as specified in Article 33(2) of KKDIK. If the sub-user does not declare the use for product and process-oriented research and development activity to its supplier or if the use is not defined and therefore not specified in the SDS, the sub-user will be required to prepare a chemical safety report according to Article 33(4) of the KKDIK Regulation. However, the sub-user is exempt from its obligation if it adequately controls the risk to human health and the environment for product and process-oriented research and development uses in accordance with Article 33(4)(e) of the KKDIK Regulation in accordance with the legal requirements for the protection of worker health and the environment. In order for the sub-user to be exempt from the obligation to prepare a chemical safety report, it will need to notify the Ministry of its use according to Article 34(1)(b) of the KKDIK Regulation.
If the substance has been notified according to Article 10 of the KKDIK Regulation and is therefore exempt from registration, the downstream user may take part in product and process-oriented research and development activities if the manufacturer or importer mentions him/her in the ÜSOAG notification by name and address. The downstream user cannot submit the ÜSOAG notification on its own because the ÜSOAG notification provides an exemption from registration and the downstream user is not subject to the registration obligation.

14.7 Is a downstream user or distributor obliged to check the registration status of the substances supplied to the market alone or in a mixture according to the KKDIK Regulation?

Sub-users and distributors are required to check the registration status information of the substances supplied to the Turkish market alone or in a mixture in accordance with Article 6 of the KKDIK Regulation in order to fulfill the registration requirement under KKDIK.

Manufacturers and importers of the substance alone or in a mixture are encouraged to communicate with sub-users or distributors of the substance to investigate alternative supply of sub-users or distributors, if necessary, on whether and when the substances are registered. When the substance is registered, the supplier is obliged to transmit the registration number down the supply chain by indicating it in the SDS according to Article 27 of the KKDİK Regulation or, if appropriate, according to Article 28.

15.1 Are substances classified as carcinogenic, mutagenic and toxic to the reproductive system (CMR) and included in Annex 6 of the SEA Regulation but not yet included in entries 1-6 of KKDIK Annex 17 covered by the restrictions of entries 28-30 of KKDIK Annex 17?

No, only the substances listed in the relevant entries (1-6) of Annex 17 are covered by the restrictions in entries 28-30.

15.2 Which type of organo tin compounds are covered by entry 20 of KKDIK Annex-17?

Organo-tin compounds included in Annex-17, entry 20 of the KKDIK Regulation must contain a carbon-tin bond. Substances in which tin, such as tin salts or organo tin compounds, is bonded to another atom separately from carbon (e.g. hexanoic acid, 2-ethyl-, tin (+2) salt (CAS No: 301-10-0), are not covered by KKDIK Regulation Annex-17 entry 20.

15.3 According to paragraph 10 of entry 23 of Annex 17 of KKDIK, cadmium may not be used or placed on the market in concentrations equal to or greater than 0.01 % by weight in the metal in the metal components of jewelry. Does this threshold limit apply to each metal component of a single product or to the whole jewelry?

In Annex 17, entry 23 of the KKDIK Regulation, the cadmium threshold concentration is applied to each metal part of the jewelry. According to the legislation, for example, ‘metal parts of jewelry and imitation jewelry’ means that each metal part is relevant, so in this case it must be done for each metal part to determine whether the restriction applies to the calculation of the concentration. Therefore, if the inner (metallic) surface of the jewelry has several layers of metal as a coating, these should be considered as an integral part of the metal part and the concentration limit of 0.01 % should be calculated for the entire metal part. If the interior is not metal but the coating consists of metal layers, this coating is treated as a metal part. Where the jewelry contains several layers of metal, each of them must meet the concentration limit.

Doruk Sistem - TURK / REACH

KKDIK(TURK REACH) FAQ