Frequently Asked Questions About KKDIK I
1.1 What is TURKREACH KKDIK and where can I find information about TURKREACH KKDIK ?
TURKREACH KKDIK is abridgment of Registration, Evaluation, Authorization and Restriction of Chemicals in Turkey.
TURKREACH KKDIK Regulation entered into force to improve and arrange previous legal regulation related to chemicals. The MoEU manages registration, evaluation, authorization and restriction processes of the chemicals to provide to be adapted to TURKREACH KKDIK Regulation.
TURKREACH KKDIK Regulation and the other related regulation can be found in helpdesk of the MoEU. The helpdesk of the MoEU is found at https://kimyasallar.csb.gov.tr website. Guide documents of the regulation provide explanatory and integrative information related to legal text. Guide documents can be found at https://kimyasallar.csb.gov.tr/rehber-dokumanlar/18 website in helpdesk
1.2 Who is responsible for the implementation of TURKREACH KKDIK regulation?
Provisions of TURKREACH KKDIK Regulation are applied by MoEU according to Article 61 of TREACH Regulation. Inspections related to provisions of this regulation are conducted by related establishments within own legislation according to Article 62 of TREACH Regulation. You can contact with helpdesk for more information
1.3 With whom can I contact related to TURKREACH KKDIK Regulation?
You should contact with helpdesk for questions about TURKREACH KKDIK Regulation firstly. Helpdesk which can be found at https://kimyasallar.csb.gov.tr website provides service in Turkish and has information about conditions (legislation, organization of the related establishment).
2.1 Does TURKREACH KKDIK apply to substances (either on their own, in mixtures or in articles) manufactured or imported in volumes below 1 tonne per year??
Yes, because besides registration there are several obligations under TURKREACH KKDIK that apply irrespective of tonnage. These include restrictions, authorisation and communication in the supply chain (such as the provision of safety data sheets). The one tonne and above per year threshold applies to registration only..
2.2 Do substances used in biocides and plant protection products (PPP) have to be registered under TURKREACH KKDIK ?
Active substances for use in biocidal products are regarded as already registered, as biocidal products and their active ingredients are covered by Biocidal Products Directive. However, several conditions have to be fulfilled to benefit from the exemption. These conditions are laid down in Article 16(2) of the TURKREACH KKDIK Regulation and explained in section 2.2.4.1- ‘Substance for use in biocidal products’ of the Guidance on registration.
Active substances for use in Plant Protection Products (PPPs) are regarded as registered as the plant protection products and their active ingredients are covered by Directive on Procedures and Principles of Plant Protection Products. This is further explained in section 2.2.4.2- ‘Substance for use in plant protection products’ of the Guidance on registration.
It is important to note, that only the quantities of the active substance for use in biocidal products and for use in PPPs are considered registered under TURKREACH KKDIK . Thus, if the substance is not used as an active ingredient in a biocidal product or a PPP, then the exemption would not apply to this other use and the quantity of the substance for the non-biocidal or non-PPP use would have to be registered.
2.3 Does TURKREACH KKDIK apply to substances occurring in nature?
Yes, TURKREACH KKDIK applies both to substances occurring in nature, as defined by Article 4(h) of TURKREACH KKDIK . However, Annex V of TURKREACH KKDIK states that the following substances occurring in nature are exempted from registration if they are not chemically modified: minerals, ores, ore concentrates, raw and processed natural gas, crude oil and coal.
Other substances occurring in nature are also exempted from registration if they are not chemically modified, unless:
- they meet the criteria for classification as dangerous according to the TR-CLP Regulation, or
- they are persistent, bioaccumulative and toxic or very persistent and very bioaccumulative in accordance with the criteria set out in Annex XIII, or
- they were identified in accordance with Article 47(e) at least two years previously as substances giving rise to an equivalent level of concern as set out in Article 49(1). ‘Chemically unmodified substance’ term is defined in Article 4(z) of TURKREACH KKDIK Regulation.
Further explanations and background information on the different exemptions in Annex V are included in section 1.6.4.4 – ‘Substances covered by Annex V of the TURKREACH KKDIK Regulation’ of the Guidance on registration.
For particular guidance on polymer substances occurring in nature, see section 3.2.1.3 – ‘Case of a natural polymer or a chemically modified natural polymer’ of the Guidance for monomers and polymers.
Frequently asked questions 6.3.3 provides guidance for substances obtained through the extraction process in nature.
2.4 Are modified substances derived from substances listed in Annex IV also exempt from registration?
Substances listed in Annex IV of TREACH are exempt from registration according to Article 2(5)(a). Modified substances derived from these substances are also exempt if the modified substance is still covered by the same EINECS entry; whether the same EINECS entry applies is a case by case decision. For example, for plant oils such as soybean oil (EINECS no 232-274-4; CAS no 8001-22-7) the physically modified derivatives are explicitly covered in the EINECS entry. Whereas chemical modification (e.g. hydrogenation) is not mentioned and hence considered not to be covered. For further information, see Article 4(z) of TREACH and Section 1.6.4.3- ‘Substances included in Annex IV of the TREACH Regulation’ of the Guidance on registration.
2.5 Synthetic analogues of substances in nature is exempt from registration according to Article 2 and Annex V?
No. In order to benefit from exemption under this regulation according to Article 2 and Annex V in section 8, existing of the substances in nature are necessary as described in Article 4(f).
Annex V of TREACH states that the following substances occurring in nature are exempted from registration if they are not chemically modified: minerals, ores, ore concentrates, raw and processed natural gas, crude oil and coal. These substances can only be processed by certain means (e.g. dissolution in water, flotation), which are specified in Article 4(h) of TREACH and do not include chemical modification (Article 4(z)).
Since the synthetic analogues of naturally occurring substances do not meet the criteria for substances, any manufacturer or importer of these substances in quantities of one tonne or more per year is required to register them.
2.6 Do substances at nano-scale fall under the scope of TURKREACH KKDIK ?
Yes, they do and their health and environment properties must be assessed according to the provisions of the TURKREACH KKDIK Regulation.Potential registrants should first consider whether they have obligations under TURKREACH KKDIK , irrespective of the particle size of the substances. Once it is established that the substance falls within the scope of TURKREACH KKDIK , further investigation of the detailed provisions of TURKREACH KKDIK may indicate that different provisions apply according to the hazard properties associated with the particle size of the substances. The evolving science of nanotechnology may necessitate further requirements in the future to reflect the particular properties of nano particles.
Click here for the next part.