The responsibility for fulfilling the requirements of KKDIK and SEA, such as registration or labelling, lies with the importers established in TURKIYE, or for KKDIK obligations, with the Only Representative (OR) of a non-TR manufacturer established in TURKIYE.
The responsibility for fulfilling the requirements of KKDIK and SEA, such as registration or labelling, lies with the importers established in TURKIYE, or for KKDIK obligations, with the only representative of a non-TR manufacturer established in TURKIYE.
Importers in the TR however need to turn to their non-TR suppliers and request information that they need to fulfil their regulatory obligations. As a non-TR manufacturer, you should support your customers further, i.e. importers established in TURKIYE, by appointing an only representative to fulfil the obligations of importers under the KKDIK Regulation.
As a first step, it is advisable to make yourself aware of the relevant KKDIK and SEA obligations. This includes in particular:
TURKREACH KKDIK is the most comprehensive and stringent Turkish chemical legislation to date. TURKREACH KKDIK requires all companies producing chemical substances in Turkey or importing them in quantities over one tonne per year to register these substances with the Turkish Ministry of Environmental, Urbanisation and Climate Change (MoEUCC).
The registration is only one aspect of the Regulation, Evaluation and Authorisation/Restriction being the complementary ones.
Pre-registration and registration obligations under KKDIK always refer to substances. A substance is defined as a chemical element and its compounds in the natural state or obtained by any manufacturing process, including any additive necessary to preserve its stability and any impurity deriving from the process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition (see Article 2(1) of KKDIK). A substance as obtained from a manufacturing process can consist of one or more constituents, impurities and/or additives. Manufacturing means the production or extraction of substances in their natural state.
The registration and notification obligations under KKDIK refer to a substance as such, a substance in a mixture or a substance in an article. There are different registration obligations depending on the point in time when the substance was manufactured, imported or placed on the TR market for the first time.
If your product falls under one of the following categories you may wish to check in more depth whether it is exempted from all or certain KKDIK obligations. If you click one of the following categories, a brief overview on the exemption will be displayed .
According to Article 2(3)(a) of the KKDIK Regulation, substances used in medicinal products for human or veterinary use within the scope of the relevant TR legislation are exempted from the Registration Title of the KKDIK Regulation (Title II).
Substances fulfilling the conditions of Article 2(3)(a) of the KKDIK Regulation are also exempt from the titles on downstream users, evaluation and authorisation (Titles V, VI and VII of the regulation).
Importantly, substances are exempted from these titles only to the extent that they are used in medicinal products. Quantities of the same substance used for a different purpose are not exempted.
The same exemption applies whether a substance is manufactured in TURKIYE and used in TURKIYE or exported to a third country. Imports of substances for that use from a third country are also covered by the same exemption and do not have to be registered under KKDIK.
Intermediates that are used for the production of medicines are not exempted from registration.
According to Article 2(3)(b) of the KKDIK Regulation, substances used in food or feedingstuffs in accordance with Regulations (TR) 28157 and (TR) 28155, including amongst others, are exempted from registration, evaluation and authorisation as well as from downstream user obligations.
Food or feedingstuff mixtures in the finished state, intended for the final user, are exempted from the provisions on information in the supply chain. (Article 2(4)(ç&d) of the REACH Regulation).
The reason for these exemptions is that Regulation 27009 on food safety already requires that food for humans and feed for animals cannot be placed on the market unless they are safe. KKDIK does not affect the application of the TR legislation on foodstuffs.
Annex IV to the KKDIK Regulation lists a number of substances that are exempted from the registration requirements, the obligations for downstream users and the provisions on substance and dossier evaluation. These substances are assumed to cause a minimum risk based on well-known information. Please consult Annex IV for detailed information on these substances.
Annex V to the REACH Regulation lists types of substances that are exempted from the registration requirements. Registration is deemed inappropriate or unnecessary for these substances. The Annex includes minerals, ores or concentrates, cement clinkers, natural gases, liquefied petroleum gas, natural gas condensates, process gases and components thereof, crude oil, coke, coal, if they are not chemically modified.
Please consult Annex V for detailed information on these substances.
Substances on their own or in mixtures, registered in accordance with Title II of the KKDIK Regulation, exported from TURKIYE by an actor in the supply chain and re-imported into the TR by the same or another actor in the same supply chain, are exempted from registration.
The main purpose of this exemption is to avoid duplication of the registration of the same substance within the same supply chain.
Plant Protection Products
An active substance for use in plant protection products which fulfils the conditions specified in Article 16(1) of the KKDIK Regulation is regarded as registered for the purposes of KKDIK. In principle, this substance will undergo a thorough assessment based on information submitted under the legislation on plant protection products.
Co-formulants for plant protection products are mentioned in Article 16(1) of the KKDIK Regulation. Similarly to the provisions for active substances, co-formulants can be considered registered for the purposes of KKDIK.
At this time, co-formulants are not listed in this legislation and are therefore treated as other substances for the purposes of KKDIK. Thus, a manufacturer or importer of these substances on their own, in mixtures, or in articles, in amounts of one tonne or more per year must register them.
Biocides
An active substance that is manufactured or imported for use in biocidal products only and fulfils the conditions referred to in Article 16(2) of the KKDIK Regulation is regarded as registered for the purposes of KKDIK. In principle, these substances will undergo a thorough assessment based on information submitted under the legislation on biocidal products.
Co-formulants used in biocides are subject to the normal obligations under KKDIK, unless they are exempted on other grounds, such as Annex IV or V. A manufacturer or importer of these substances on their own, in mixtures or in articles in amounts of one tonne or more per year must therefore register these substances.
For both Biocidal and Plant Protection Products
When an active substance has a dual use in biocidal products/plant protection products and for other purposes, the quantity of the active substance used for purposes other than in a biocidal product or plant protection product is subject to the normal obligations under KKDIK. Thus, the manufacturer or importer of these substances on their own, in mixtures or in articles in amounts of one tonne or more per year must register them.
Waste
The definition of waste also applies under KKDIK. Waste is any substance or object that the holder discards, or intends or is required to discard. This may be waste from households (e.g. newspapers or clothes, food, cans or bottles) or from professionals or industry (e.g. filter dust, slag or spray-paint sludge). The KKDIK Regulation does not exempt waste from its provisions, but clarifies that waste is not a substance, a mixture or an article within the meaning of KKDIK. Thus, importing waste into TURKIYE processing waste is an activity to which REACH does not apply.
It is however important to note that once waste is recovered, and in this recovery process a substance, mixture or article is produced, the KKDIK rules will in principle apply, as they would to any other substance, mixture or article manufactured, produced or imported in the TR. In specific cases, where a recovered substance is the same as a substance which has already been registered, an exemption from the registration obligation may apply.
The waste life stage of a substance and the related risk management measures are also to be addressed in the chemical safety assessment of the registrant, if such an assessment is required (see Article 15 of KKDIK).
The obligations of the TR-based importer depend on whether it imports a substance on its own, in a mixture or in an article. If you click on the relevant link below, a brief overview on obligations of the importer or the only representative, timelines and further information will be displayed.
Importers of substances at an annual volume of one tonne or more must register the substance (before they start importing it).
The TR-importer of a mixture must register all substances contained in that mixture if the annually imported amount of that substance is one tonne or more. The importers will have to aggregate amounts of the substance that they import in different mixtures or on its own.
A substance contained in several mixtures (and possibly also imported on its own) is to be registered only once, but based on the total volume of the same substance imported by that registrant in mixtures or on its own.
Importers of an article containing a substance, which is intended to be released from the article under normal or reasonably foreseeable conditions of use, are required to register the substance, if:
An importer of an article, who is established in the TR, may have information and notification obligations, if the article contains a substance of very high concern included in the Candidate List of substances for inclusion in Annex XIV to the KKDIK Regulation.
The non-TR producer of articles may be contacted by the TR-importer for information on SVHCs in the imported articles. It is recommended that the non-TR companies take note of the Candidate List as well as the registry of intentions to include substances on the Candidate List.
If the substance is present in the article in a concentration above 0.1 % weight by weight (w/w), the importer of an article will need to inform its customers of the presence of any substances included in the Candidate List present in the article and provide information to ensure safe use of the article. There is no tonnage trigger for this obligation (i.e. it also applies below one tonne per year).
Unless the substance has already been registered for the particular use or the importer can exclude exposure to humans or the environment during normal or reasonably foreseeable conditions of use, the importer is also obliged to notify the presence of an SVHC in articles to the MoEUCC if:
Importers of polymers may be required to register the monomers or other substances used as building blocks of the polymer. Exemptions based on their intermediate use do not apply and should therefore be registered as any other substance.
Information on how importers established in TURKIYE should identify the polymers and monomers; and their tasks and obligations is available in the Guidance for monomers and polymers.
Each legal entity established in TURKIYE that imports a substance on its own, in a mixture or in an article into the TR will need to comply with the KKDIK obligations and in particular with the duties briefly outlined above. These companies may approach you seeking assistance in compiling the relevant information needed for registration.
A non-TR manufacturer may find it more convenient/efficient to get its substances pre-registered and registered in the TR through an Only Representative, in accordance with Article 9 of the KKDIK Regulation.
An only representative is a natural or legal person established in the TR, appointed by a non-TR manufacturer by mutual agreement. As an only representative, this natural or legal person would fulfil the obligations of companies importing a substance on its own, in mixtures or in articles. It thereby alleviates the regulatory obligations resting on importers. Non-TR manufacturers may also want to choose this possibility if they consider that communication of information needed by the importers would require the disclosure of confidential business information.
If you wish to make use of the only representative mechanism, please observe the rules outlined below. In addition, please consult the Guidance on registration to find a more in depth explanation on requirements related to only representatives.
The only representative must be established in TURKIYE. TR Government will then enforce the requirements related to your substance when imported into TURKIYE.
It will be the task of the only representative to comply with all the obligations with which the importers of your products would have to comply. This includes submitting a pre-registration and a registration dossier for the substance imported into the TR to the Turkish Ministry of Environmental, Urbanisation and Climate Change (MoEUCC) before the relevant deadlines expire. It will also be the task of the only representative to keep the information available and update on i) the quantities imported and ii) the importers covered by the appointment, as well as to iii) supply the latest update of the safety data sheet. The only representative must therefore have a sufficient background in the practical handling of substances and the information related to them.
Only representatives need to be able to document for the enforcement authorities that they have been appointed by your company and for which substance and volume the appointment applies. They may also indicate in the registration dossier by whom they were appointed. They need to be able to document that your company has informed the importers who are covered and who may benefit from the only representative having fulfilled the importers’ obligations.
Only representatives can represent more than one non-TR manufacturer for one or more substances. However, they have to submit separate individual registrations for each substance and each non-TR manufacturer.
The registration by an only representative can cover volumes of a substance imported into the TR both directly from non-TR manufacturers and via non-TR distributors or formulators. Thus, as long as your company can keep track and document the channels through which the substance or mixture is imported into the TR, the volumes can be covered by the only representative. Non-TR manufacturers can change their only representative. Pre-registration and registration requires the (pre-)registrant to sign-up to the KKS system. Only legal entities established in the customs territory of the TR can sign-up to KKS.
The obligation to ensure that a product is classified, labelled and packaged in accordance with the SEA Regulation lies with the TR-importer. However, the non-EU manufacturer of a substance or a mixture should cooperate with their importer to check the relevant requirements regarding the packaging and labelling of their product. They should also cooperate to ensure proper hazard classification of the product.
Read more about TURKREACH & Registration