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TURKREACH KKDIK FAQ

TURKREACH KKDIK FAQ in Turkey

TURKREACH KKDIK FAQ provides answers to common questions about registration, evaluation, authorisation, SIEF processes and compliance requirements in Turkey.

SECTION - 1

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 mainly be found in helpdesk of the MoEU. The helpdesk web site of the MoEU is at the following link

Kimyasallar Yardım Masasi / Chemicals Helpdesk website.

Guide documents of the regulation provide explanatory and integrative information relatedto legal text. Guide documents can also be found at the following link

Rehber Dokumanlar (Guidence Documents)

You can also visit regulations part of our web site menu to find all related documents. We are continuing to prepare EN versions.

Provisions of TURKREACH KKDIK Regulation are applied by MoEU according to Article 61 of TURKREACH KKDIK Regulation.

Inspections related to provisions of this regulation are conducted by related establishments within own legislation according to Article 62 of TURKREACH KKDIK Regulation.

You can directly contact with MoEU helpdesk for more information.

Also our team can contact you for your further information needs.

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 mainly be found in helpdesk of the MoEU. The helpdesk web site of the MoEU is at the following link

Kimyasallar Yardım Masasi / Chemicals Helpdesk website.

Guide documents of the regulation provide explanatory and integrative information relatedto legal text. Guide documents can also be found at the following link

Rehber Dokumanlar (Guidence Documents)

You can also visit regulations part of our web site menu to find all related documents. We are continuing to prepare EN versions.

SECTION - 2

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.
Active substances for use in biocidal products are regarded as already registered, as biocidal products and their active ingredients are covered by Turkish Biocidal Products Regulation. However, several conditions have to be fulfilled to benefit from the exemption. These conditions are laid down in Article 16 of the TURKREACH KKDIK Regulation and explained in section 2.6.2.1- ‘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 Turkish By-Law on Procedures and Principles of Plant Protection Products. This is further explained in section 2.6.2.2- ‘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.
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 SEA 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 2.5.3.4 – ‘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 4.2.1.2 – ‘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.
Substances listed in Annex IV of TURKREACH KKDIK 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 TURKREACH KKDIK and Section 2.5.3.4 – ‘Substances covered by Annex V of the TURKREACH KKDIK Regulation’ of the Guidance on Registration
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 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. These substances can only be processed by certain means (e.g. dissolution in water, flotation), which are specified in Article 4(h) of TURKREACH KKDIK 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.
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.

SECTION - 3

Manufacturers established outside of Turkey do not have direct obligations under TURKREACH KKDIK.

Non-TR companies exporting substances to Turkey can (but are not obliged to) appoint an “Only Representative” to fulfil the obligations of importers according to Article 9 of TURKREACH KKDIK.

Stationary importer in Turkey must fulfill the obligations of TURKREACH KKDIK Regulation. A manufacturer is identified as stationary real person or legal entity in Turkey who manufactures a substance in Turkey according to Article 4(p) of TURKREACH KKDIK.

More guidance on only representatives can be found in FAQ section 4 or in section 2.3.1 – ‘Only representative of a “non-TR manufacturer”‘ of the Guidance on Registration

You can contact to us for our well organised “Only Representative Services”.
Under some circumstances article importers have to register or notify substances in articles to MoEU (see Article 8 of TURKREACH KKDIK); these obligations are in general the same as for producers of articles. When placing articles on the market in the Turkey, importers of articles may also have to communicate information on substances in their articles to their customers.

In order to establish whether registration, notification or communication duties apply, any importer of articles is advised to follow first the Guidance in a Nutshell on requirements for substances in articles.

SECTION - 4

According to Article 9(1) of TURKREACH KKDIK, a natural or legal person established outside of the TR who manufactures substances (to be used on their own, in mixtures and/or to produce articles), formulates mixtures or produces articles, can nominate an only representative located within the TR to carry out the required registration of their substances that are imported (as such, in mixtures and/or in articles) into the TR.

Distributors are not mentioned in Article 9(1) of TURKREACH KKDIK and thus cannot appoint an only representative.

The only representative will have to fulfil the registration obligations of importers and comply with all other obligations of importers under the TURKREACH KKDIK Regulation.

More information on the only representative role is provided in section 2.3.1 – ‘Only representative of a “non-TR manufacturer”‘ of the Guidance on Registration.

Please contact to Doruksistem for well organised “Only Representative Services

A non-TR company (that can appoint an only representative, see FAQ 4.1) may, by mutual agreement, appoint a natural or legal person established in Turkey to act as his only representative. According to Article 9(2) of TURKREACH KKDIK this representative shall comply with all obligations of importers under TURKREACH KKDIK.

Therefore the Only Representative is required to have sufficient background in the practical handling of substances and the information related to them.

More information on the only representative is also provided in section 2.3.1 – ‘Only representative of a “non-TR manufacturer”‘ of the Guidance on Registration.

There are no detailed requirements or criteria regarding what is regarded as “sufficient background in the practical handling of substances and the information related to them” other than what is laid down in Article 9(2) of TURKREACH KKDIK.

Only representatives have to be:

    • A natural person or legal entity established physically in TURKEY
    • Equipped with sufficient knowledge in the practical handling of the substances and information related to them (CICR/KEK, CLP/SEA, SDS/GBF, TURKREACH/KKDIK, BPR, PPPR, related TR Reg.)
    • Appointed by a mutual agreement with a manufacturer, formulator or article producer, established outside Turkey
    • Responsible for complying with the legal requirements for importers under TURKREACH (KKDIK)
    • Only representatives can represent more than one non-TR supplier, but must keep the information related to each of them separate.
    • The non-TR company has to inform the importer(s) within the same supply chain of your appointment as an only representative. These importers are then regarded as downstream users for TURKREACH.



And the following criterias are important for the appointed Only Representative (OR) in Turkey.

      • OR Should have minimum 5 years experiences in Turkish Chemical Regulations published after 2008 (CICR/KEK, SDS/GBF, DSD-DPD/SAE, CLP/SEA, BPR, PPPR, etc)
      • Sufficient Knowledge related to KKDIK
      • Regulatory Compliance in Control
      • Easy to crossbridge the questions between EU-REACH & KKDIK (TURKREACH) in Turkish & Englsh
      • Having Valid Certificates (SDS,CSAE)
      • Well experienced technical staff having capability to use IUCLID 5 (at least),6 and MoEU/CRS easily
      • International References
      • Trusted in CBI Concerns
      • Well prepared OR Agreement
      • Well experienced certificated

experts in SDS Compliance and Management

  • Good communications with Industry, Associations, Authorities, International Network, Global Organisations, etc.

 



Please contact to Doruksistem for well organised “Only Representative Services

The issue of becoming an only representative is a question of mutual agreement between the “non-TR manufacturer” and the natural or legal person established in the TR who is being appointed as an only representative.

“Non-TR manufacturers” need to send a letter confirming this appointment to their only representative who must have it available in case of inspection by the relevant authority.


More information on the duties of the only representative is provided in section 2.3.1 – ‘Only representative of a “non-TR manufacturer”‘ of the Guidance on Registration.

In addition the “non-TR manufacturer” shall inform the importer(s) within the same supply chain of the appointment of the only representative according to Article 9(3) of the TURKREACH KKDIK Regulation. These importers shall be regarded as downstream users.

Yes, an only representative can represent one or several non-TR companies that manufacture substances, formulate mixtures or produce articles which are exported to the Turkey, even for the same substance.

More information on the duties of the only representative is provided in section 2.3.1 – ‘Only representative of a “non-TR manufacturer”‘ of the Guidance on Registration.

The importer or the only representative is responsible for submitting a registration dossier or a pre-registration (pre-sief registration) the registration deadlines for substances. In order to assist these actors under TURKREACH KKDIK, the “non-TR manufacturer” may wish to make himself aware of the information requirements laid down in TURKREACH KKDIK and start to collect the relevant information.

This may include correct identification (CAS or EC) number and naming of the substance and information on its composition. This is explained in more detail in the Guidance for identification and naming of substances under TURKREACH KKDIK and TR-CLP SEA.

The “non-TR manufacturer” may also assist in providing all available information regarding the intrinsic properties of the substances (see Annex VII to XI of TURKREACH KKDIK).

However, these supporting measures of the “non-TR manufacturer” cannot relieve the Only Representative or the importer from the duty to comply with all relevant obligations of the TURKREACH KKDIK Regulation.

An Only Representative must be able to document who he is representing (i.e. the name of the non-TR manufacture should be given in Chemical Registration System) and is advised to attach a document from the “non-TR manufacturer” appointing him as only representative in CRS (Chemical Registration System of MoEU).

It is not mandatory to include this information in the registration dossier, but it needs to be presented to the enforcement authorities upon request.

Furthermore an only representative is advised to include the “list of importers” in CRS.

The change of importers of a substance supplied by a non-TR manufacturer who appointed an only representative to register this substance does not trigger the requirement to update the list of importers indicated in Chemical Registration System (CRS) dossier.

However, the only representative is required, in accordance with Article 9(2) of TURKREACH KKDIK, to keep available and up-to-date information on quantities imported and customers sold to.

Information on the importers may be reported in CRS. The update of this list of importers is not subject to any fee.

SECTION - 5

Pre-registration is not done as in EU-REACH Pre-registration Practice.

But Pre-SIEF registrations can be accepted as pre-registration.

SECTION - 6

Only a natural or legal person established within TR can be a registrant. Registration must take place when this person:

  • manufactures a substance within the TR in quantities of 1 tonne or more per year;
  • imports a substance into the TR of quantities of 1 tonne or more per year; or
  • has been appointed as an only representative according to Article 9 of TURKREACH KKDIK (see FAQs on Only Representative of non-TR manufacturer).
A private label manufacturer is normally understood to be a company that manufactures a substance (on its own, in a mixture or in an article) in its own technical facilities following the instructions of a third party in exchange for an economic compensation. The substance is generally put on the market by the third party. This construction is, for example, used for an intermediate step in the production process for which sophisticated equipment is needed (distillation, centrifugation etc.). According to the TURKREACH KKDIK Regulation, manufacturers of substances are required to register the substances they manufacture above one tonne per year. From this point of view the toll manufacturer is a manufacturer and has to register the substance according to Article 4(p).
International companies sometimes have several daughter companies in the TR, often spread over several countries. If these subsidiaries of the parent company are separate legal entities from it, (a natural or legal person as defined under applicable national law), then each of those must determine if they qualify as registrant according to Article 4(ü) in TREACH Regulation
Registration is required for all substances:

  • as defined in Article 4(çç) of TURKREACH KKDIK;
  • manufactured in or imported into the TR in quantities of 1 tonne or more per registrant per year;
  • unless they are exempted from registration or regarded as being already registered, according to provisions in Articles 2, 10 and 16 of the TURKREACH KKDIK Regulation;
  • irrespective of whether they are classified as dangerous or not.


If you want to know whether you have to register a substance you should first consult section 1.6- ‘What to register?’ of the Guidance on registration. There you will also find information on substances exempted from registration.
The TREACH Regulation refers to alloys as “mixtures”. Therefore, alloyS are to be treated in the same way as other mixtures under TREACH, which means that the alloy as such is not subject to registration but the alloying elements (e.g. metals), irrespectively of the production process of the alloy are. However, components which are not important for the properties of the alloy should be considered as impurities (i.e. they are part of a substance in the mixture) and therefore need not be registered separately. Please note that intermetallic compounds are often wrongly regarded as alloys, although they have a well defined stoichiometry. Such substances are listed in EINECS (e.g. “aluminium, compound with iron (1:1)”, “iron, compound with titanium (2:1)”, etc.) and cannot be regarded as mixtures, therefore these intermetallic compounds have to be registered as such. This means that e.g. separate (pre-)registrations of the substances Al and Fe do not cover the substances “aluminium, compound with iron (1:1)” or “aluminium, compound with iron (1:3)”. For each intermetallic compound with a different metal ratio a separate (pre-)registration is required
It depends under which type of intermediate as described under Article 4(c) of the TREACH Regulation your intermediate falls, whether you have registration obligations or not.

Non-isolated intermediates:

For the use of a substance as a non-isolated intermediate, there are no obligations under the TREACH Regulation.

On-site isolated intermediates:

A manufacturer of on-site isolated intermediates in quantities of 1 tonne or more per year needs to register their substances (if they are not otherwise exempted from registration (see FAQ 6.3). However registrants of on-site isolated intermediates can provide reduced registration information according to Article 17(2) of the TREACH Regulation if they confirm that the substance is manufactured and used under strictly controlled conditions as described under Article 17(3) of TREACH.

Transported isolated intermediates:

A manufacturer or importer of transported isolated intermediates in quantities of 1 tonne or more per year needs to register his substances if they are not otherwise exempted from registration (See FAQ 6.3). However, a registrant of transported isolated intermediates can provide reduced registration information according to Article 18(2) and Article 18(3) of the TREACH Regulation if he confirms that he is manufacturing and/or using the substance under strictly controlled conditions and if he confirms or states that he has received confirmation from the user that the substance is used under strictly controlled conditions as described under Article 18(4) of TREACH. In this case, both the registrant and the users are each liable for their own statement regarding the strictly controlled conditions.

When and how the specific provisions for the registration of intermediates under TREACH can be used are described in the Guidance for intermediates.
Substances occurring in nature are exempted from the duty to register in accordance with Article 2 and Annex V, paragraph 8 of TREACH, as long as they are not chemically modified, not classified as dangerous in accordance with CLP, nor substances of very high concern, such as PBT or vPvB substances. If a process is applied to extract such a substance, it has to be verified whether the process applied is one of those listed in Article 4(h) of the TREACH Regulation. If this is the case, the substance still qualifies as substance that occurs in nature that does not have to be registered.

The processes mentioned in Article 4(h) of TREACH are manual, mechanical or gravitational processes, dissolution in water, flotation, extraction with water, steam distillation, heating solely to remove water and extraction from air. Please note that extraction with solvents other than water, like e.g. hexane or ethanol, are not covered by Article 4(h) of TREACH. Substances which are extracted with these solvents do not qualify as a substance that occurs in nature and cannot be exempted from registration on the basis of Annex V, paragraph 8 of TREACH.

Lavender oil, for example, is extracted from flowers of certain species of lavender (which occur in nature) by means of steam distillation. The subsequent spontaneous separation of oil and water allows an easy isolation of the lavender oil. As this extraction process is mentioned in Article 4(h) of TREACH, the lavender oil can be regarded as a substance that occurs in nature. On the contrary, chrysanthemum oil, for example, which is extracted from chrysanthemum blossoms and leaves (which occur in nature) with a solvent mixture of water and ethanol (1:10), cannot be regarded as a substance that occurs in nature.

In general, it is important to remember that it is up to the manufacturer to assess the process applied and to determine if the definition of Article 4(h) of TREACH is applicable or not.
According to Article 4(ll) of the TURKREACH KKDIK Regulation PPORD is defined as “any scientific development related to product development or the further development of a substance, on its own, in preparations or in articles in the course of which pilot plant or production trials are used to develop the production process and/or to test the fields of application of the substance”.Any scientific development of a substance consisting of, for example, campaign(s) for the scaling-up, improvement of a production process in a pilot plant or in the full-scale production, or the investigation of the fields of applications for that substance, falls under the definition of PPORD irrespective of the tonnage involved.

In order to promote innovation, Article 10 of the TURKREACH KKDIK Regulation specifies that substances manufactured or imported on their own or in mixtures, as well as substances incorporated in articles or imported in articles for the purpose of PPORD can be exempted from the duty to register for a period of 5 years. To be exempted a company needs to submit a PPORD notification to the MoEU. Upon request, ECHA may further extend this exemption for up to another 5 years, or 10 years for the development of medicinal products (for human or veterinary use) as well as for substances that are not placed on the market. Further information is provided by the specific Guidance on Scientific Research and Development (SR&D) and Product and Process Oriented Research and Development (PPORD).
Yes. Article 7 of the TURKREACH KKDIK Regulation requires a manufacturer of a substance in quantities of more than 1 tonne per year to submit a registration, irrespective of whether this substance will subsequently be exported to abroad. Therefore, substances manufactured in Turkey above this limit that do not meet any of the criteria for exemption from registration in accordance with Article 2 of the TURKREACH KKDIKRegulation and which are subsequently exported to abroad must be registered. The rationale for this duty is that the exposure resulting from manufacture and any other activity before export could be relevant for workers and the environment in abroad.
The surface treatment of a substance is a “two dimensional” modification of macroscopic particles. A “two dimensional” modification means a chemical reaction between the functional groups only on the surface of a macroscopic particle with a substance which is called a surface treating substance. By this definition it becomes clear that this kind of modification means a reaction of only a minor part (surface) of a macroscopic particle with the surface treating substance, i.e. most of the macroscopic particle is unmodified.

Therefore a chemically surface treated substance cannot be regarded as a mixture nor be defined by the criteria of the Guidance for identification and naming of substances under TURKREACH KKDIK.

With the same reasoning, a chemically surface treated substance could not be reported for EINECS nor be notified according to Directive 67/548/EEC (CPL) because it was covered by the separate EINECS entries of both the basis substance (macroscopic particle) and the surface treating substance. Taking this decision up under TURKREACH KKDIK means a consequent continuation of former decisions. Using the same line of arguments, chemically surface treated substances should not be registered as such under TURKREACH KKDIK, but the following requirements should be fulfilled:

  • Registration of the basis substance (macroscopic particle)
  • Registration of the surface treating substance
  • Description of the use “surface treatment” in the registration dossier of the surface treating substance and in the registration dossier of the basis substance
  • Any specific hazards or risks of the surface treated substance should be appropriately covered by the classification and labelling and by the chemicals safety assessment and resulting exposure scenarios.
According to Article 2(3)(a) of the TREACH 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 TREACH Regulation. More explanation is provided for in Section 1.6.4.2- ‘Medicinal products’ of the Guidance on registration.

Substances fulfilling the conditions of Article 2(3)(a) of the TREACH 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 in accordance with Regulation of the substances used in medicinal products for human or veterinary use within the scope of the relevant. Quantities of the same substance used for other purposes are not exempted.

The exemption covers the manufacture (in the TR) of substances in medicinal products that are exported; and the manufacture (in the TR) of active substances within the scope of TR legislation on medicinal products that are exported. The exemption also applies to imports of substances in medicinal products and imports of active substances within the scope of the TR rules on medicinal products.

Intermediates that are not present in the medicinal product (as defined in Regulation of the substances used in medicinal products for human or veterinary use within the scope of the relevant) are not exempted from registration.
The answer to this question depends on your role at the time when the registration obligation applies.

Article 6 of TURKREACH KKDIK imposes registration obligations only on manufacturers or importers (and, in specific cases, on producers or importers of articles). It does not on downstream users, distributors or suppliers of substances. Therefore, the registration obligation does not apply to you if you have:

  • manufactured or imported pre-registered substances before the registration deadline; and
  • ceased such activities and simply acted as a supplier after that.


If you have not ceased your activities before the relevant registration deadline, you must submit a registration dossier for all quantities of the substance manufactured or imported before and after the respective registration deadline.

In any case, any actor down the supply chain who is not subject to the registration obligation may continue to use and/or supply quantities of the substance that you have supplied to them before the registration deadline in accordance with Article 7,8,17 and 18 of TURKREACH KKDIK.
According to Annex V, paragraph 6 of the TURKREACH KKDIKRegulation hydrates of a substance or hydrated ions, formed by association of a substance with water are exempted from registration, provided that the substance (i.e. the anhydrous form) has been registered by its manufacturer or importer.

Hydrates of a substance are characterised by the fact that water molecules are linked by molecular interactions, in particular by hydrogen bonds, to other molecules or ions of the substance. For the purposes of Annex V, hydrates and water free forms (anhydrous) of compounds shall be regarded as the same substance (e.g. CuSO4.5H2O and CuSO4).

In contrast, a metal hydroxide (e.g. Ca(OH)2) and a metal oxide (e.g. CaO) cannot be regarded as the same substance as both substances have different structures, regardless of the manufacturing process. The formation of the hydroxide involves forming new covalent bonds, which is different from forming a hydrate which only involves weak intermolecular bonds. Therefore a metal hydroxide manufactured from the metal oxide is not covered by the exemption from registration in Annex V, paragraph 6.
Yes. Substances are not exempted from registration on the grounds that they are within the scope of Regulation on substances that deplete the ozone layer. FAQ 6.3 explains which substances have to be registered.
There is no explicit legal obligation for registrants to update their registration dossier every time an import is made from a new non-TR source. However, according to Article 22(1)(b) of TREACH, there is a legal obligation to update the composition of the substance as given in Section 2 of Annex VI. The registrant has to assess the sameness of the substance every time an import of the substance is made from a new source, according to Guidance for identification and naming of substances.

There are two possible outcomes of this assessment:

  • Registrants find that the substance has the same impurity profile as previous imports and is already registered by them. They do not have to update the registration dossier for the substance.
  • Registrants find that the substance has a different impurity profile from previous imports. They then have to update the relevant sections of the registration dossier (e.g. concentration ranges or changes in Classification&Labelling) with the new composition of the substance.
Ionic substances in an aqueous solution are exempted from registration only if:

  • All starting substances (salts, acids and bases) of the aqueous solution are registered;
  • None of the salts in the aqueous solution is isolated from the solution; and
  • The salts remain in their ionic form in the solution.


    • In this particular case, the third condition is not fulfilled, since the salts do not remain in their ionic form in the complex. Therefore, this exemption does not apply and the complex would be subject to registration. This case is discussed in Attachment 1 ‘Ionic Mixtures’ of the Guidance document to Annex V.
Various aspects need to be taken into account when considering the registration deadlines. These include tonnage, dangerous properties, and whether it is a phase in or a non-phase in substance. Information on these aspects is provided in Chapter 2 of TURKREACH KKDIK Regulation.
Each registrant has to calculate the yearly tonnage for the registration dossier. The yearly tonnage is calculated as the volume per manufacturer/importer per calendar year, unless stated otherwise in Turkey. For substances that have been imported or manufactured for at the least three consecutive years, quantities are calculated on the basis of the average production or import volumes for the three preceding calendar years (Article 4(öö) of the TURKREACH KKDIK Regulation). Detailed guidance and practical examples are provided in ‘Calculation of the volume to be registered’ of the Guidance on registration.
Yes. Companies are free to register a substance for a tonnage band which is above the actual tonnage of the substance. This is also reflected in Section 1.6.2.2- ‘Calculation of the total volume’ of the Guidance on registration.

This section clarifies that companies are free to register a substance for the intended tonnage band. A registration at a higher tonnage band will trigger a higher registration fee. In addition, the technical dossier will need to comprise all the information required for the registered tonnage band
All registrations shall be submitted to MoEU. CRS provides online service to be delivered data .For more information please visit Chemical Registration System(CRS) page of MoEU website: http://online.cevre.gov.tr/
The registration fee for a substance depends on the tonnage of registration, size of the company and the type of submission. Additionally:

  • Lower fees and charges apply to joint submissions as compared to separate submissions. This does not apply in case you opt out of the joint submission;
  • SMEs benefit from a reduced fee in all categories;
  • An additional fee is levied for confidentiality.


All these provisions for fees are specified in Article 59 of TURKREACH KKDIK. Fee which is indicated in bill of quantities that is published in website of the MoEU every year and will be applied in circulating capital enterprise is payed for registration.

According to Article 59;

(1) The processes in the scope of Article 7(1), Article 8(1) and (5), Article 10(2), Article 12, Article 17(2), Article 18(2), Article 19, Article 22(1), Article 51, Article 52 and Article 61(2) are subject to fees.

(2) The fees that shall be paid in the scope of this Bylaw, is determined annually and published at the website of the Ministry in the circulating capital enterprise unit price list.

(3) No fee shall be taken for the substances in the 1-10 tonnage band which have all of the information according to Annex 7 in their registration dossier.
No. The obligation to register a substance applies only to actors established within Turkey. Thus, the registration of substances imported into Turkey on their own, in mixtures or, in certain cases, in articles will have to be done by the importer established in the Turkey. This implies that each individual importer needs to register the substance. However, according to Article 9(1) of the TURKREACH KKDIK Regulation manufacturers of substances, formulators of mixtures or producers of articles established outside Turkey, can nominate an only representative established within Turkey to carry out the required registration. This will relieve the individual TR importers within the supply chain of that non-TR manufacturer from their registration obligations for these substances. They will be regarded as downstream users of this only representative.

More information on the only representative role can be found in FAQ Section 4 and in ‘Only representative of a “non-TR manufacturer’ of the Guidance on Registration.
To fulfil his duties as a registrant an TR-based importer of mixtures has to have information on the composition of the mixtures he imports into the TR. This obligation already existed under the previous legislation as regards substances to be classified as dangerous. Under TREACH, an importer needs to know at least the identity and percentage content of all substances in the mixtures he imports that could exceed the amount of one tonne/year.

If the non-EEA supplier is not willing or not able to provide the required information, the importer has the following options:

  • identify the formulator of the mixture (if different from the supplier) and ask him directly for the required information,
  • propose to the non-TR formulator that he appoints an only representative in accordance with Article 9 of the TREACH Regulation,
  • establish the composition of the mixture by analytical means,
  • find an alternative supplier who is prepared to provide all required information for the mixture.
No, according to Article 5 of TURKREACH KKDIK, a third party representative can be appointed by a manufacturer, importer or downstream user for data sharing issues and discussions with other manufacturers, importers or, where relevant, downstream users for all processes in accordance with Article 12, Article 19, Section 3 (Data Sharing and Avoidance of Unnecessary Testing) and Article 44. Unlike an only representative, a third party representative only plays a part in the negotiations between the (potential) registrants, while the appointing company remains responsible for complying with its registration obligations under TURKREACH KKDIK.
If a registration for a substance has been submitted, the obligations to update the registration (Article 22) and to keep information (Article 32) apply. This means that a registrant ceasing manufacture and import of this substance has to inform the MoEU about the new total tonnage manufactured and imported (in this case zero t/a).

Furthermore this registrant has to keep available all the information he required to carry out his duties under TURKREACH KKDIK for a period of at least 10 years after he last manufactured, imported, supplied or used the substance (as such or in a mixture). In this regard, the period of at least 10 years does not start if the registrant, who ceased manufacture and import, still supplies or uses the substance.
A manufacturer or importer who has registered an isolated intermediate pursuant to Article 17(2) or Article 18(2) of TURKREACH KKDIK does in general not have to update this registration in case of a change of tonnage band. However, such a registration would have to be updated due to a change of tonnage band in two cases.

Case 1: Where the registration is for a transported isolated intermediate and the 1000 t/a threshold is reached, the registrant must update his registration dossier by submitting the information specified in Annex VII of the TURKREACH KKDIK Regulation, if not already included in the dossier.

Case 2: Where the registrant ceases manufacture and import of the isolated intermediate, he has the duties described in FAQ ID=6.12, which include an update of the registration.
After you have submitted your registration dossier you may realise that your registration dossier has to be corrected or modified for reasons other than those triggering the need for an update of the registration according to Article 22 of the TURKREACH KKDIK Regulation. This might be the case, for example, if you accidentally introduced faulty information in the dossier (e.g. incorrect information in one of the study summaries, which however does not affect the assessment of the substance made) and noticed this only after you submitted the dossier to MoEU. In this case you should make a spontaneous dossier update, indicating in the dossier header the reason(s) why you are spontaneously updating it as well as the references of the previous valid submission (i.e. the “last submission number”). Such an update would not be subject to a fee.

If the mistake leads to a failure in the business rule verification, then instead of a spontaneous update submission an initial submission has to be made, as if it was the first dossier submission.
In case the registrant fails to complete his/her registration for the second time within the deadline set, the MoEU will reject the registration and the registration fee will not be reimbursed. According to Article 7 of the TURKREACH KKDIK Regulation, substances may not be manufactured, or placed on the market unless they have been registered.
In case the manufacture or import is only to be started, e.g. in case of a non phase-in substance, the waiting period must be respected.

On the other hand, there is no requirement to interrupt manufacture or import of phase-in substances during the TCC. However, when the initial submission of a substance was incomplete, MoEU will give the registrant a deadline to complete the dossier. Until the end of this deadline, the registrant is allowed to continue his activities. If the registrant updates his dossier, the registrant can continue the manufacture or import of the substance until he receives the decision by MoEU on the outcome of the completeness check. If he receives a decision rejecting his registration, he must cease manufacture or import of the substance.
TURKREACH KKDIK does not provide for the assignation of registration numbers to active substances in biocidal products. It is reminded that registration numbers are assigned exclusively for substances where complete registration dossiers were submitted to MoEU by the registrant according to Article 20 of TURKREACH KKDIK.

Regarding the information on active substances in biocidal products, this is held by the European Commission, and certain information is publicly available via its website at https://echa.europa.eu/information-on-chemicals/biocidal-products
If a registrant changes its TPR, the new TPR will have to create a CRS account.

In case of a change of TPR, the following steps shall be taken by the registrant in order to update the details of its TPR:

  • Include the new TPR in the CRS company information section. The registrant should select < Company > – < View > and add the TPR in the TPR tab.
  • Select manually the new TPR for every single pre-registration and Joint Submission


Object (JSO) where a registration dossier has not been submitted yet using the pre-registration and JSO functionalities respectively. If a registration number had already been assigned to a specific substance, the registrant will not be able to modify the TPR of its pre-registration but he is able to update its TPR in the JSO.

Since the inclusion of a TPR in a registration dossier is not required by TURKREACH KKDIK during the submission of a registration dossier, an update of the TPR related to a registration is also not legally required. Article 22 of TURKREACH KKDIK does not include the update of a TPR as a case where the registrant shall be responsible for update on his own initiative. However, if the registrant wishes to communicate a change of TPR for a specific registration, i.e. while submitting a registration dossier update for any of the reasons established in Article 22 of TURKREACH KKDIK, they may do so.

No fee is required if the TPR is updated in a registration dossier.

SECTION - 7

According to Article 7(2) of TURKREACH KKDIK polymers do not have to be registered, but according to Article 7(3), the monomer substance(s) and other substances of the polymers that have not already been registered by an actor up the supply chain, are to be registered if both the following conditions are met:

  • the polymer consists of 2 % weight by weight (w/w) or more of such monomer substance(s) or other substance(s) in the form of monomeric units and chemically bound substance(s) (i.e. free or unbound monomers shall not be considered when checking this condition);
  • the total quantity of such monomer substance(s) or other substance(s) makes up 1 tonne or more per year (the total quantity in this context is the total quantity of monomer or other substance ending up in the final polymer unbound or chemically bound to the polymer)



The TURKREACH KKDIKRegulation defines polymers in Article 4(hh) and monomers in Article 4(gg).

The MoEU may present legislative proposals with requirements for the registration of polymers once a practicable and cost-effective way of selecting polymers for registration on the basis of sound technical and valid scientific criteria can be established.

Detailed guidance and practical examples are provided in the Technical Guidance for Monomers and Polymers.

According to Article 7(2) of TREACH, the reduced registration provisions with regard to on-site isolated and transported intermediates do not apply to monomers. This means that a full registration dossier must be submitted even if a monomer is used as an intermediate under strictly controlled conditions.

An impurity in a polymer is defined as an unintended constituent present in the manufactured polymer substance. It may originate from the starting materials, such as the monomers or any other reactants, or be the result of secondary or incomplete reactions during the production process. While it is present in the final substance it was not intentionally added. Examples of impurities in a polymer include unreacted monomers or other reactants, residual polymerisation catalyst, or any contaminant from the manufacturing process. The definition and detailed guidance on how to handle impurities can be found in Title 4.2.- ‘Substances of well defined composition’, Title 4.3.- ‘UVCB substances’, and ‘Criteria for checking if substances are the same’ of the Guidance for identification and naming of substances.

Some substances are commonly added to polymers for the purpose of adjusting or improving their appearance and/or the physicochemical properties of polymeric material.

Additives which are necessary to preserve the stability of a polymer must be regarded as a part of the polymer in accordance with Article 4(çç) of TREACH. Any other unbound “additive” must be regarded as a component of a mixture and not as an additive.


Thus, the importer of a polymer containing additives does not need to register these additives provided that the additives are added to preserve the stability of the polymer. Note however that there is the general obligation to register substances imported in a polymer mixture in quantities of at least 1 tonne per year. Detailed guidance and practical examples are provided in the Technical Guidance for Monomers and Polymers.

The provisions under the TURKREACH KKDIK Regulation with regard to information in the supply chain (Title IV), authorisation (Title VII) and restrictions (Title VIII) may also apply to polymers. Further information on this issue is provided in ‘Application for authorisation’, ‘Compliance with restrictions’, ‘Classification and labelling’, and Section ‘Information down the supply chain’ of the Technical Guidance for Monomers and Polymers.

Natural polymers are understood as polymers which are the result of a polymerisation process that has taken place in nature, independently of the extraction process with which they have been extracted (i.e. they may or may not fulfil the criteria)

Following Article 2(7)(a) of the TURKREACH KKDIK Regulation, any polymer meeting the criteria of Article 4(hh) of the TURKREACH KKDIK Regulation does not have to be registered.

According to Article 7(3) of the TURKREACH KKDIKRegulation any manufacturer or importer of a polymer shall submit a registration for the monomer substance(s) or any other substance(s) that meet the criteria mentioned in the respective article. However, monomer substance(s) or other substance(s) in the form of monomeric units and chemically bound substance(s) in natural polymers can, for practical reasons, be treated as “non-isolated intermediates” and do not have to be registered.

Natural polymers are understood as polymers which are the result of a polymerisation process that has taken place in nature, independently of the extraction process with which they have been extracted (i.e. they may or may not fulfill the criteria).

Following Article 2(7)(a) of the TURKREACH KKDIK Regulation, any polymer meeting the criteria of Article 4(hh) of the TURKREACH KKDIK Regulation does not have to be registered. This includes natural polymers which are chemically modified (e.g. post-treatment of natural polymers).

Monomer substance(s) or other substance(s) in the form of monomeric units and chemically bound substance(s) originating from the natural polymer can for practical reasons be treated as “non-isolated intermediates” and do not have to be registered. The substances used to chemically modify the natural polymer and which are chemically bound within the final polymer need to be registered according to the TURKREACH KKDIK requirements

Yes. The registration of a monomer or other substance chemically bound to a polymer shall include spectral data and a chromatogram of the original monomer or other substance used in the manufacture of the polymer. If it is not technically possible, or if it does not appear scientifically necessary to include this information, the reasons shall be clearly stated. Generic spectral data or a generic chromatogram cannot be accepted as this would not reflect the actual composition of the monomer or other substance used in the manufacture of the polymer.

It may be the case that a company imports a type of polymer from different sources, and thus a monomer or other substance used in the manufacture of this polymer probably also stems from different sources. Even when a company imports a polymer from just one source, it can happen that a monomer or other substance used in the manufacture of this polymer stems from different sources. In these cases the importer of the polymer is responsible for assessing the sameness of the monomer or other substance from the different sources. If he considers that the substances from the different sources are the same, he shall submit just one registration for this substance with one set of spectral data and one representative chromatogram. In this process he might still have found out that the substance from the different sources has different impurity profiles. He shall then refer to these different compositions of the substance in his registration dossier.

SECTION - 8

The registration requirement for substances in articles (as required by Article 8(1) and Article 8(6) of TURKREACH KKDIK) applies only if all the following conditions are met:

  • the substance is intended to be released during normal and reasonable foreseeable conditions of use; and
  • the total amount of the substance present in the article exceeds one tonne per producer or importer per year; and
  • the substance has not yet been registered for that specific use. Pre-registrations, however, do not relieve you from the obligation to register.
Substances meeting the criteria outlined in Article 47 of the TURKREACH KKDIK Regulation are commonly referred to as substances of very high concern (SVHC). Notification is required under Article 8(2) of the TURKREACH KKDIK Regulation for SVHC present in articles and for which the following conditions are met:

  • the substance has been included in the candidate list of SVHC for authorisation: https://echa.europa.eu/candidate-list-table and
  • the substance is present in articles above a concentration of 0.1% weight by weight (w/w) and
  • the total amount of the substance in those articles (i.e. those containing more than 0.1% (w/w) of the SVHC) exceeds one tonne per producer or importer per year and
  • the substance has not yet been registered for that specific use.


As indicated in Article 8(7) of the TURKREACH KKDIK Regulation the notification of a SVHC in articles shall be made at the latest 6 months after it has been included on the candidate list for authorisation but only starting from 1st June 2011. Information on a substance on the candidate list contained in articles is to be forwarded by the supplier of the articles to the recipients as soon as possible after the substance is included in that list (Article 29). The candidate list will be updated continuously when substances have been identified as meeting the criteria of Article 47 of the TURKREACH KKDIKRegulation.
Provided that the substance has been registered by any manufacturer/importer for that specific use, paragraphs 1 to 5 of Article 8 of the TURKREACH KKDIKRegulation shall not apply. This means that it is not relevant whether the registration was done within the same supply chain or within another supply chain.
A substance is intended to be released from articles if it fulfils an accessory function which would not be achieved if the substance were not released. Scented children’s toys, for example, are articles with intended release of substances, because fragrance substances contained in the toys are released in order to fulfil an accessory function, namely to scent. Consequently, substances that are released because of ageing of articles, because of wear and tear or as an unavoidable side-effect of the functioning of the article, are generally not intended releases, as the release as such does not provide a function in itself.

An intended release of a substance from an article has furthermore to occur under normal or reasonably foreseeable conditions of use. This means that the substance release has to occur during the service life of the article. Hence, a substance release during the production or disposal phase of the article’s life cycle is not an intended release. Similarly, a release in an accident or due to any form of misuse which is not in accordance with the use instructions or functionality of the article, does not occur under normal or reasonably foreseeable conditions of use and is therefore not considered to be an intended release.
The transition point of steel and steel semi-finished products from substances/mixtures to articles during processing is to be determined by comparing the importance of physical and chemical characteristics for achieving the object’s function. If it can be unambiguously concluded that the shape/surface/design are more relevant for the function than the chemical composition, the object that it is assessed is an article. If the shape, surface or design is of equal or less importance than the chemical composition, it is a substance or mixture. To determine whether or not steel semi-finished products constitute an article one can use the indicative questions given in ‘Deciding whether an object is an article or not’ of the Guidance on requirements for substances in articles.<
There is no fee charged for the notification of SVHC in articles.
If the production/import ended before the SVHC was included in the Candidate List or before the notification obligation starts to apply then you do not have to notify.

However, you may still have obligation, under Article 29 of TURKREACH KKDIK, to provide the recipient of the article, or the consumer upon request, with sufficient information to allow safe use of the article, including, as a minimum, the name of that substance
For articles which have been produced/imported for at least three consecutive years, the tonnage to be reported must correspond to the average tonnage of the substance in the article produced/imported during these three full years. If the substance in the article has only been produced or imported for two full years, the average of these two full years must be notified.

However, if the substance in the article has been produced or imported only since the previous calendar year, the tonnage will be calculated based on the previous calendar year only and no averaging will be made.

For instance, substances that had been placed on the Candidate List before 31 December 2023 must have been notified by the producer or importer of the article by 1 June 2024. The producer or importer should have provided the average tonnage of the three or two preceding years, or the tonnage of 2023, depending on for how many consecutive years they had imported or produced the article.

Thus, there are situations, where volumes of the substance predating the inclusion in the candidate list are considered in the tonnage calculation for the notification of a substance in an article.

Where production/import of the article starts in the current year, you are advised to notify as soon as the 1 tonne threshold is exceeded. In that case please indicate an expected tonnage range for the whole year.
While registrations of substances in articles must be updated with relevant new information, there is no legal requirement to update a “notification of substances in articles” dossier. However, The MoEU recommends that notifiers update their notification dossier whenever there is a change in the information that was notified. Furthermore, it is also in the interest of the notifier to maintain an updated dossier, because based on the notification, The MoEU may take a decision according to Article 8(5) of TURKREACH KKDIKto require producers or importers of articles to submit a registration.
The possibilities that companies have to verify whether a substance has been registered for a particular use are clarified in the Guidance on requirements for substances in articles. It should be noted that the sameness of both the substance identity and the use must be ensured. The Guidance on requirements for substances in articles is available on helpdesk.

Sources of such information are e.g. the safety data sheets, supply chain communication and trade associations. The amount of available information for producers of articles will often be larger than for importers of articles. Thus it may often be easier – particularly for importers of articles – to notify an SVHC in an article than to document that the substance has already been registered for the particular use in the specific article.

SECTION - 9

Rules related to data sharing and avoiding unnecessary tests are explained in Section 3 of TURKREACH KKDIK Regulation. As it is mentioned in Article 23 and Section 3,the purpose of these rules is to reduce and avoid the repetition of the tests applied to vertebrate animal (which should be applied only if it is the last solution). In this way, the industrial cost will be lessened and the productivity of the registration system will be increased.
The aims of the SIEF are to:

  • Facilitate data sharing for the purposes of registration, thereby avoiding the duplication of studies, and
  • Agree on the classification and labelling of the substance concerned where there is a difference in the


classification and labelling of the substance between the potential registrants.

In addition, participants in a SIEF are free to organise themselves as they see fit to carry out their duties and obligations under TURKREACH KKDIK, i.e. to share data, especially those involving vertebrate animal testing. The organisation used for the SIEF co-operation may also be used to jointly submit the relevant information. The choice of the form of cooperation between SIEF participants is based on the principle of contractual freedom
Communication within a Substance Information Exchange Forum (SIEF) is greatly facilitated if one participant agrees to play the role of a co-ordinator. The co-ordinator can propose means of organising exchange of information on the substance. The SIEF can already at an early stage agree that one company takes over the organisation of the information exchange and the preparation of the joint submission according to Article 12 of TREACH.

Where the information for exchange is considered commercially sensitive by one or more potential registrants (e.g. because of an impurity content that can give indication on a production process), they can, for example, propose a confidentiality agreement or the use of an independent Third Party or trustee who can handle the confidential information on behalf of the potential registrants. Any other form of organisation is equally possible as long as it is agreed by all SIEF participants.

Detailed information on how to organise the SIEF and facilitate communication within SIEFs can be found in Title 3.10 and in Section ‘SIEF Formation Facilitator’ of the Guidance on data sharing.
TURKREACH KKDIK provides for the formation of “Substance Information Exchange Forums” (SIEFs) to share data among manufacturers and importers of pre-registered phase-in substances as well as allowing downstream users and other stakeholders (data holders) who have relevant information (and are willing to share it in exchange for fair compensation) to share this information with potential registrants. A SIEF will be formed for each pre-registered substance when the discussion on the sameness confirms that the participants have indeed the same substance and when they agreed on the chemical identifier to be used. As indicated in its name, a SIEF is a forum to share data and other information on a given substance. The Guidance on data sharing explains in more detail how and when a SIEF is formed in “Formation of SIEF”.

TURKREACH KKDIK Regulation provides that all potential registrants and data holders for the “same” phase-in substance must be participants in a SIEF. The TURKREACH KKDIK Regulation leaves the responsibility for defining “sameness” to SIEF participants. Similarly the regulation does not foresee any formal step to confirm the formation of the SIEF.

The assessment of the exact nature of an CAS/EINECS entry and the different substances it may cover must be carried out by the manufacturers or importers who should be aware of the composition of the substance. It is, therefore, up to them to take the responsibility of defining precisely the substance for which a SIEF will be formed.

In order to reach an agreement on the sameness of a substance, potential registrants must enter into pre-SIEF discussions. As a consequence, a SIEF is formed when the potential registrants of a substance in the pre-registration list agree that they effectively manufacture, intend to manufacture or import a substance that is sufficiently similar to allow a valid joint submission of data.

Due to the fact that data holders are not able to view the details of the potential registrants who have preregistered under the same identifier, it is the role of the potential registrant(s) to decide whether the available data are relevant to its substance(s) and to communicate further including with data holders, in order to gather the missing data.

Following the sameness review, three situations are possible:

(i) all potential registrants agree that their substances are the same; or

(ii) one or more potential registrants consider that their substance is not the same as substance(s) preregistered by the other participant(s), in which case the other participant’s(s’) data may not be relevant to describe their substance’s profile. In this case, it is for potential registrants to decide among themselves what SIEF(s) are to be formed to represent each of the substances so identified. In this context, the main criteria for deciding on the sameness of a substance should be those laid down in the “Guidance for identification and naming of substances under TURKREACH KKDIK” and whether or not data sharing would give a meaningful result that can be used throughout the SIEF. It is important to underline that the formation of several SIEFs is only possible when the substances are indeed different.

(iii) one or more potential registrants consider that their substance is the same as one or several substances pre-registered under (an)other identity code(s) to conclude that these substances are sufficiently similar to allow data sharing within one SIEF. If SIEF participants disagree on substance identity/sameness and a participant considers that it should be part of a SIEF created by other parties for a given substance, that participant has the possibility to formally request to join the SIEF and request the right to use or refer to the data he is missing to proceed with his Registration.

The substance identifiers often correspond to an existing EINECS or CAS entry or similar numerical identifiers but there are also cases where one EINECS entry covers several substances or where several EINECS entries may correspond to one and the same substance for the purposes of TURKREACH KKDIK. There are also phase-in substances for which no EINECS/CAS entries or numerical identifiers exist. This may trigger the splitting or merging of pre-SIEF. When this is the case, it is advisable to inform MoEU.

Rejection of data sharing in SIEF in some cases may lead to failure of substance registration. If it necessary, one EINECS entry is splitted into several substances and this situation may cause invalid registrations. Furthermore, it requires preparation and submission of registration dossiers for all related substances and payment of fee for registration again. Therefore, it is advised that data which will be used in EINECS entry is shared widely if it is possible, description of the substance is commented within limit at the same time. In other words, submission of more than one and separate dossier is recommended.

When it is decided not to get separated for the EINECS entries, please note that submitted data or information for all variables and substance forms whether it is sufficient or not.

It is advised that you should apply to the MoEU to explain the issue clearly if big problems occur.
MoEU provides substance web pages which support pre-Substance Information Exchange Forums (pre-SIEFs). These pages have two free-text fields for the posting of information on the creation of SIEFs. The first field is for the SIEF Formation Facilitator, (SFF) who can use this to post messages on the creation of a SIEF and to give contact details and information on further communication tools (e.g. dedicated industry websites). The second field is for all pre-registrants of the substance. All messages are the exclusive responsibility of the authors and the MoEU will not verify, approve or disapprove of their contents.

Potential registrants should work towards forming SIEFs as soon as possible, in order to ensure that sufficient time remains available to organise data sharing and prepare the registration dossiers. The Guidance on data sharing explains in more detail how and when a SIEF is formed.

It is recommend use the first field to SIEF formation facilitator in order to transmit messages related to SIEF formation and give information and communication details of subsequent communication instruments. The second field enables comment of the other pre-registrants. Because of that both of field allow usage of the limited character, these fields shall be used for only key messages, communication details and/or communication instruments. Moreover, pre-registrants may report that they are not related to registration by exiting from pre-SIEF. (See FAQ 9.14).

Potential registrants should work towards forming SIEFs as soon as possible, in order to ensure that sufficient time remains available to organise data sharing and prepare the registration dossiers.

The Guidance on Data Sharing explains in more detail how and when a SIEF is formed.
A data holder is any person holding information/data relevant to a phase-in substance and willing to share it. Data holders include:

  • Manufacturers, importers and only representatives of a non-TR manufacturer of phase-in substances in quantities of less than 1 tonne per year who have not pre-registered,
  • Downstream Users of phase-in substances,
  • Third Parties holding information on phase-in substances,
  • Any party for which MoEU has information submitted in the framework of the Plant Protection Product Directive or the Biocidal Product Directive that meet the conditions established in Article 16 of TREACH
  • Any manufacturer or exporter who had registered substances before 1 June 2018 or only representative of the manufacture in outside Turkey or the manufactures or importers who produce article is intended to be released under normal or reasonably foreseeable conditions of use


Data holders can sign-up in CRS with a view of becoming a participant in the SIEF for that substance and can provide information to other SIEF members by submitting to MoEU. More information can be found in Title 4.2 – ‘The SIEF Participants’ of the Guidance on data sharing.
The previous registrant and potential registrant(s) shall make every effort to ensure that the costs of sharing the information are determined in a fair, transparent and nondiscriminatory way according to Article 24(3) of TURKREACH KKDIK. This may be facilitated by following cost sharing guidance based on those principles which is adopted by the MoEU. Registrants are only required to share in the costs of information that they are required to submit to satisfy their registration requirements. As a result of the decision of MoEU, cost sharing information of required tests can be found in Article 44 of TURKREACH KKDIK Regulation.

Therefore agreement on cost sharing requires parties to agree on:

  • the reliability, relevance and adequacy of the data (“Data Quality”)
  • the economic value of the data (“Data Valuation”), and
  • how the agreed value is shared among parties (“Cost Allocation and Compensation”)


The elements discussed below are neither intended to be prescriptive nor mandatory. They should serve rather primarily as a checklist in order to ensure that all interested parties identify the relevant factors when organising a data quality review and related cost sharing activities.

Registrants need to share the costs of information that they are required to submit to satisfy their registration requirement. Companies cannot be forced to pay for studies that they do not need, nor can they be forced to pay before they actually need them in their respective tonnage band. Whenever the (potential) registrant requests data earlier, they need to pay on receipt of the data. Other elements might be considered as well. In general, it is recommendable that an agreement on cost sharing is reached before disclosing available information.

Cost sharing related to Article 24 and 26 of TURKREACH KKDIK Regulation can be found in Guidance on cost sharing and Guidance on data sharing – “Cost Sharing”.
For non phase-in substances and for phase-in substances that have not been pre-registered, a duty to inquire before registration applies. In particular, potential registrants need to inquire from MoEU whether a submission for the same substancehas already been made. This is to ensure that data are shared by all registrants of the same substance, and that the joint submission obligation can be met. In accordance with TURKREACH KKDIK, studies involving vertebrate animals should not be repeated and available studies need to be shared.

Before testing is carried out in order to meet the information requirements for the purposes of registration, a SIEF participant shall inquire whether a relevant study is available by communicating within his SIEF. If a relevant study involving tests on vertebrate animals is available within the SIEF, a participant of that SIEF shall request that study. If a relevant study not involving tests on vertebrate animals is available within the SIEF, a SIEF participant may request that study according to Article 24 of TURKREACH KKDIK.

Please note that SIEF will carry on the activities until 31/12/2025. Thus, the communication between new registrant and SIEF is provided to ease the data sharing. new registrant.
Participation in a Substance Information Exchange Forum (SIEF) is mandatory for actors specified in Article 25 of TURKREACH KKDIK, whereas membership in a consortium or any other form of cooperation is voluntary. Consortia are a more formal type of co-operation between registrants.

It is often claimed that “consortium” must be formed (or consortium agreements signed) to organise the activities within a SIEF such as data sharing and the joint submission of data. However, neither the use of a full “consortium agreement” nor the use of another formal written agreement is legally required by TURKREACH KKDIK.

If some or all participants of one or more SIEF(s) decide to form a consortium, they are free to determine their arrangements regarding scope, purpose, duration, conditions for membership or leaving etc. as long as these do not contravene the Community competition rules. In addition, the members of the consortium must cooperate with any SIEF members that are not participants in the consortium or agreement. Additional information on forms of cooperation can be found in the Guidance on data sharing.
Consortiums are forms of more official cooperation between the registrants in order to provide pratical helps data sharing obligations and prepare the registrations. Formation of a consortium is usually required for organization of the activities in SIEF such as data sharing and joint submission of the data. Consortium agreement or written agreement is not required according to TURKREACH KKDIK Regulation legally. Nonetheless, the agreement must be made between different parties about different issues such as sameness of the substances, classification and labelling, data and cost sharing, conservancy of the joint study, selection of the leader registrant between different parties.

When the agreements make, the parties who attend agreement have to be careful in terms of intellectual property rights confidental information, competition legislation. Therefore, it is advisable that, whatever the form of the cooperation chosen, the parties agree in writing (this can be by means of a contract but also even by email) on the main rules of data sharing and at least on the ownership of the studies jointly developed, and the sharing of costs. More information on possible forms of cooperation in the scope of TURKREACH KKDIK Regulation can be found in Guidance on data sharing – ‘Forms of cooperation’.
You can not leave a SIEF. Even if your company ceases its activities with respect to the substance, you still remain a participant of the SIEF. You are required to share information that you hold in accordance with the data sharing provisions of TURKREACH KKDIK. However, you are not required to participate in any submission (or update) made by the members of the SIEF, nor to participate in any additional related costs.

During the pre-SIEF phase you can de-activate yourself from the pre-SIEF to indicate that you are not interested in registering the substance. Even as a non-active participant, you may still be required to share your data
Yes and, in practice, when you pre-registered phase-in substances with either the same name or same chemical identifiers as other potential registrants, CRS automatically placed you in the same pre-SIEF with them. SIEF is formed when the pre-registrants agree that they are intending to register the same substance according to Article 25 of TURKREACH KKDIK.

If you register a before 23 June 2017 without previously pre-registering it, you will also enter the corresponding Substance Information Exchange Forum (SIEF).

If you are a potential registrant of a substance but have not pre-registered, you must submit a registration for pre-sief to MoEU. Information on the Substance Information Exchange Forum (SIEF) participants and their obligations is given in the Guidance on Data sharing.

When a substance is intended to be manufactured by one or more manufacturers and/or imported by one or more importers, lead registrant must submit his registration dossier and agreement of the other registrants who give consent to lead registrant jointly. This agreement is necessary under SIEF.CRS provides that companies which pre-registered the substance with the same name and code communicate each other. Therefore, CRS lists required contact information of companies. It is indicated that registrants who register pre-SIEF of the same substance will be participant of SIEF in Article 25 of TURKREACH KKDIK Regulation. More information can be found in Guidance on data sharing – ‘SIEF Participants’.
Yes, you will be a member of the SIEF. CRS lists required contact information of companies which pre-registered the substance with the same name and chemical description for providing communication. As a result of determination of the substane identity in detail, companies in pre-SIEF have to decide that whether the substance which pre-registered is the same. Because, they who registered pre-SIEF will form a SIEF together. If you are pre-SIEF member and you do not think that you will register, you indicate potential registrants which want to form the SIEF for joint submission this situation and you must exit from pre-SIEF member.
MoEU has no role in the formation of Substance Information Exchange Forums (SIEFs), neither confirming nor rejecting the creation of a particular SIEF. It is the SIEF participants’ responsibility to define precisely the substance for which a SIEF will be formed.

In addition, the choice of the form of cooperation between SIEF participants is based on the principle of contractual freedom.
In order to initiate and facilitate discussions after pre-registration and the exchange of the information, one SIEF participant may volunteer to be the “SIEF Formation Facilitator” (SFF). The company which wants to be SIEF formation facilitator has to communicate with other participants in own pre-SIEF on the purpose of SIEF formation. In contrast to SIEF formation facilitator has an important role in the period from the pre-SIEF stage to the formation of SIEF, lead registrant has a role in SIEF and joint submission according to Article 12(1) of TURKREACH KKDIK Regulation. Please note that there are many differences between the roles of SIEF formation facilitator and Lead Registrant (LD). There is no formal recognition for SIEF formation facilitator in TURKREACH KKDIK Regulation, while the roles for lead registrant are foreseen in SIEF and in the scope of joint submission.

This means that potential registrants have no obligation to use a SFF to form a SIEF. They may even bypass the SFF in order to commence pre-SIEF discussions, if the SFF does not act. In contrast, the SIEF must select a LR who submits the joint registration before the other registrants in the SIEF can submit their individual (“member”) dossiers for registration.

One of the biggest differences is between lead registrant and SIEF formation facilitator is ability of having these roles for potential registrant. In order to be SIEF formation facilitator, potential registrant has to be volunteer through CRS. On the contrary, lead registrant is active through the agreement of the other registrants who register the same substance. Therefore, if a registrant is approved by the other SIEF members, he can be lead registrant. TURKREACH KKDIKRegulation does not explain rules related to how lead registrant must be selected and assigned. However, it is advised that the registrants who selected as lead registrant give information to MoEU by using the lead registrant section in CRS. More information on SIEF formation facilitator’s duties can be found in Guidance on data sharing in – ‘SIEF Formation Facilitator’.
A SIEF Formation Facilitator (SFF) cannot demand fees for their services unless this has been mutually agreed. A SIEF Formation Facilitator is expected to contact other participants in the pre-SIEF in order to facilitate the exchange of information and data which is required in order to form a SIEF. SFFs have no management role beyond facilitating discussions, and they have no legal basis to force other pre-SIEF participants to cooperate with them.
TURKREACH KKDIK Regulation obligates the multiple registrants of the same substance to data sharing and joint submission. Therefore, if a registration includes information which was not submitted by the another registrant before, even if this registration is promoted for reduction of animal testing and cost of the compliance with the obligations by TURKREACH KKDIK, the participants in different SIEF do not have to share data.

Each request for access to studies in different SIEF must be negotiated on a case by case basis by the concerned companies in different SIEF. MoEU is not responsible for this matter.

In addition, Guidance on Inter-SIEF rules (grouping, read-across) can be found in Guidance on data sharing Title 4.6.
1. If pre-SIEF of the substances has not registered;

If there is a disagreement on data sharing or costs between the registrant who has registered before and potential registrant, although the potential registrant makes an effort to come to agreement, if the other part do not support him, the potential registrant may want to be allowed himself from MoEU to refer to data. In this case, the potential registrant informs the MoEU about data sharing issue. Besides, after the issue is transmitted to MoEU, either side has to continue looking for deal.

2. If pre-SIEF of the substances has registered;

2.1 If the joint registration dossier has submitted before and unless the registrants(or their representatives) share submitted data, the potential registrant who thinks that he makes an effort to come to agreement may want to be allowed himself from MoEU to refer to testing on vertebrate which must be submitted by himself in joint registration.

2.2 If there is joint registration that has not been submitted and if a dossier is being prepared, the owner of the tests applied to vertebrate animals will not be willing to share the data available in SIEF or when the owner refuses to prove his own costs, the other potential registrants may get permission from MoEU to continue without having completed the necessary information about their registration. Moreover, even if after issue is transmitted to MoEU, both sides should continue looking for the ways of coming to agreement.

2.3 In case there is a joint registration dossier which has not been prepared, the participants in the SIEF who need this information (due to their own tonnage band necessities) can apply to the MoEU to assign one of their participants to do the missing tests although the missing data is determined by the participants of SIEF and no one of the potential registrants wants to do the important tests.
The MoEU will review Bakanlık, all claims which are submitted himself (FAQ 9.20).

However, applier must show that he makes an effort to provide reconciliation about data to justify claims. This covers request of information overtly, overcoming the unpleasant answers, creating a solution to the dispute, giving required time to the other parties in order to refer to their argument and offer.

When applier transmits his justifications to MoEU, he must provide all support documents (such as SIEF agreement) and explain this situation to MoEU.
You can have further duties to share data after you have submitted your registration. This can happen when:

  • new potential registrants join the Substance Information Exchange Forum (SIEF) as late pre-registrants of a phase-in substance;
  • the potential registrant of a non phase-in substance or a potential registrant of a phase-in substance who did not pre-register is informed of the previous and other potential registrants (and vice versa) by MoEU following an inquiry;
  • after the successful submission of the registration dossier whenever new information becomes available. In such a case, according to Article 22 of TURKREACH KKDIK, the registrants will have to update the joint registration dossier. This may require prior data sharing and may have an impact on decisions on the classification and labelling. It can also lead to the need to change the CSR.
  • as a consequence of the submitted dossier evaluation by MoEU (compliance check or the assessment of a testing proposal) or the substance evaluation. These processes may lead to a request to submit further information, which would need to be addressed among all registrants of the same substance. They should agree on the generation and sharing of data and costs. Therefore, data sharing does not only apply to “existing” studies but also to studies which will be needed for ensuring that the registration is compliant with TURKREACH KKDIK.

SECTION - 10

A lead registrant should create the joint submission object (JSO) in CRS as soon as he is nominated by the SIEF. For this the lead will have to decide on the JSO name and will be responsible for creating and distributing the token.

A company which has received the JSO name and token from the lead registrant has to bear in mind that:

  • the token needed to confirm the membership in CRS has a validity of 30 days only (the lead registrant can always generate a new token);
  • the company has to confirm its membership of the joint submission before submitting its member dossier; and
  • its member dossier has to be submitted, after the lead dossier but before the registration deadline relevant for the member registrant (see FAQ ID=6.4).
Information relating to the receipt and processing of the lead dossier is sent by MoEU only to the lead registrant. As a member registrant, you do not receive this information from MoEU.

The MoEU recommends that member registrants develop contractual arrangements with their lead registrant specifying the items about which the lead registrant must keep them informed (e.g. the submission of the lead dossier) and by which means (e.g. postal or electronic mail).

In any case, the “lead dossier status”, which member registrants can see on the joint submission details page in CRS, indicates whether the lead dossier has been accepted for processing by MoEU (status depicted by a green tick) or not (status depicted by a red cross).
An overview of what shall and what may be jointly submitted for registration based on Article 12 of the TREACH Regulation is provided in Title 8.1- ‘Overview of the part of the technical dossier that may be jointly submitted for Registration’ of the Guidance on data sharing.

Some information of the registration has to be submitted jointly whereas other information needs to be submitted separately. Additionally, there is information the registrant(s) may decide themselves whether to submit jointly or separately, according to the criteria defined in Article 12(3) of TREACH.

The following information shall be submitted jointly: information on the classification and labelling of the substance, (robust) study summaries and an indication as to which of the submitted information on classification and labelling, study summaries and robust study summaries has been reviewed by an assessor. Under specific conditions, which should be explained in the dossier, a separate submission of these data is allowed (see FAQ ID=10.4 and FAQ ID=10.5).

Additionally each registrant shall submit individually: the identity of the manufacturer or importer, the identity of the substance, information on the manufacture and use(s), exposure information for substances in quantities of 1 to 10 tonnes and an indication of which of the submitted information on manufacture and use has been reviewed by an assessor. The registrants may decide to submit the following information jointly or separately: guidance on safe use of the substance, a Chemical Safety Report (CSR) when required and an indication which of the information submitted for the CSR has been reviewed by an assessor.
Member registrants are allowed to submit some of the information specified in Article 11(a)(4), (6), (7) and (9) of TREACH separately (“opt-out”) under the specific conditions listed in Article 11(3) of the TREACH Regulation. Such an “opt out” can only cover some of the endpoints submitted by the lead registrant on behalf of all member registrants. However, the member registrants have to remain part of the joint submission.
The TREACH Regulation, and in particular Article 12 of TREACH, is based on the “one substance one registration” principle. In line with this principle Article 12(3) of TREACH provides that part of the information, but not the whole dossier, may under certain conditions be submitted separately. From this, it follows that member registrants who opt out must submit their registration dossier as part of the joint submission (see FAQ ID=10.3), even if they opt out for all information specified in Article 11(a)(4), (6), (7) and (9) of TREACH.
According to Article 25(2) of the TREACH Regulation, one of the main aims of the SIEF is to agree on classification and labelling where there is a difference in the classification and labelling of the substance between potential registrants. Nevertheless if all member registrants agree, the lead registrant may include different classifications of the substance in the joint part of the registration dossier, e.g. if different impurity profiles lead to different classifications. In this case, member registrants should leave empty the pertinent section of their member dossier in order to avoid being treated as an opt-out for the classification and labelling of the substance.

If no agreement is reached among the member registrants on the inclusion of all different classifications of the substance in the joint part of the registration dossier, one or more of the member registrants may decide to provide their substance classification separately (by filling in the respective section in their member dossier), in which case a justification in accordance with Article 12(3) of TREACH is required. In addition, in cases where a harmonised C&L for a substance is provided in Annex VI of the CLP Regulation, then that harmonised C&L must be used.
Yes. According to Annex VI of the TREACH Regulation any physicochemical, toxicological and ecotoxicological information that is available and relevant shall be provided in the registration dossier. In practice, after gathering and assessing all existing information, the registrant has to select the information that is reliable, relevant and adequate. For key studies, robust study summaries have to be provided; for supporting studies, study summaries are sufficient.

Further guidance on Information gathering and evaluation is also provided in chapters R.3 and R.4 of the Guidance on information requirements and chemical safety assessment.

More information on the reliability, relevancy and adequacy of the selected information is provided in the section 2.1.1-‘Obligation to submit “all available and relevant information’ of Practical Guide 4.
According to Article 12(1) of the TREACH Regulation, the information specified in Article 11(a)(2), i.e. details on the substance identity including spectral data and chromatograms, have to be submitted separately by each member registrant of a joint submission.

This information is necessary in order for ECHA to be able to check the sameness of the substance submitted by the different member registrants. Therefore, generic spectral data or chromatograms must not be used. Each member registrant of a joint submission has to provide his specific spectral data and chromatograms for the substance he intends to register.
Registrants of the same substance are obliged to be part of the joint submission.

If the company only wants to join the respective joint submission, and does not upgrade its tonnage nor add any chargeable additional confidentiality claims, then MoEU will not issue an additional invoice for the change from an individual registrant to a member of a joint submission.

Due to the technical implementation in CRS, the change from an individual registration to a joint submission requires registrants to submit an update. They indicate ‘change in tonnage’ as a reason for the update, although the tonnage of the registration does not change.

SECTION - 11

Article 13(3) of the TREACH Regulation requires that new tests shall be carried out in accordance with the test guidelines in accordance with other international test methods recognised by MoEU. In addition, in Annexes VII to X on standard information requirements, the use of various OECD test guidelines is required in cases where no EU test method exists.

Article 13(4) of TREACH also specifies that information may be generated using other methods provided the conditions defined in Annex XI of the TREACH Regulation are met. These include inter alia that the result is sufficient for the purposes of classification and labelling and/or risk assessment, and that adequate and reliable documentation of the applied method is provided (see Annex XI of the TREACH Regulation for more information).

Moreover, a specific requirement is introduced in Article 14(4) of the TREACH Regulation for ecotoxicological and toxicological tests. new tests of this kind have to be carried out in compliance with the principles of Good Laboratory Practice (GLP) as no other international standard has so far been recognised as being equivalent. In case of physico-chemical testing it may be desirable but it is not mandatory to have tests performed according to GLP standard.

The Guidance on information requirements and chemical safety assessment contains specific Integrated Testing Strategies for each endpoint (e.g. for aquatic toxicity, mutagenicity), which should be consulted before new tests are performed.
For the time being, no “other international test methods” within the meaning of Article 14(3) of the TREACH Regulation have been recognised by the MoEU.
In general, there is the possibility to use data from reliable, scientifically accepted reference literature or databases, provided that the substance to be registered and the substance described in the reference are comparable with regard to homogeneity, impurities, particle size etc. References to literature or databases often use secondary data sources. When such data is used, the original source should be cited and checked by an expert.
Some useful reference books and data compilations containing peer reviewed data are listed under each endpoint in the Guidance on information requirements and chemical safety assessment, Chapters R.7a, b, c.
The OECD decision on Mutual Acceptance of Data (MAD) provides for data generated by testing of chemicals in an OECD member country in accordance with OECD test guidelines and OECD Principles of Good Laboratory Practice to be accepted in other member countries for purposes related to the protection of human health and the environment. This system also covers non-OECD countries which have requested adherence to the OECD GLP and to join the MAD system. These non-OECD countries can be divided in two groups:

  • Countries which are full adherents to the OECD MAD system.
  • Countries which are provisional adherents to the OECD MAD system.


Countries which are full adherents to the OECD MAD system will accept data from OECD member countries and other adhering countries generated under MAD conditions. In addition non-clinical safety data developed in these countries must be accepted by OECD and adhering countries.

Countries which are provisional adherents to the OECD MAD system need to accept data from OECD member countries and other adhering countries generated under MAD conditions. However, during the period of provisional adherence, GLP monitoring activities conducted by the GLP MA located in the country of the provisional adherence do not have to be accepted by the full members of the OECD MAD Decision.
In general, MoEU accepts data as GLP data where this data comes (i) from countries which are OECD member states or full adherents to the OECD Mutual Acceptance of Data (MAD) system and (ii) from countries which are provisional adherents to the OECD MAD system and in which laboratories have been inspected jointly by the GLP Monitoring Authority concerned and by an OECD GLP Monitoring Authority.

Studies that are conducted in a laboratory situated in a country which has not joined the OECD MAD system can be accepted by MoEU as GLP compliant studies under the following conditions:

  • Prior to the performance of the study the GLP compliance of the laboratory has been inspected by: an GLP Monitoring authority or GLP Monitoring Authorities with whom holds Mutual Recognition Agreements or other GLP Monitoring Authorities of OECD member states or full adherents to the OECD Mutual Acceptance of Data (MAD) system on a case-by-case basis and
  • The laboratory has been found to be operating in compliance with GLP principles.
Interim RMM are to be included into the Chemical Safety Report (CSR) and to be communicated to the users of the substance (either under Article 27 or 28 of TREACH, in form of Exposure Scenario (ES) or otherwise). Such RMMs need to describe how to handle a substance in an appropriate way in the absence of sufficient toxicological information and while waiting for the results of proposed testing for long-term hazards. If no Derived No-Effect Level (DNEL) is available, the registrant is expected to carry out a qualitative risk characterisation referring to the identified uses and the expected exposure and justifying that the measures are sufficient to control the risks (based on the available knowledge). Typical RMM applicable in such case are listed in the Table E.3-1 of Part E: Risk Characterisation of the Guidance on information requirements and chemical safety assessment.

Where no or not enough hazard information on the substance is available, the registrant should demonstrate control of risks by minimizing the emission and/or exposure to the substance. In doing so, he can use a combination of containment and/or Local Exhaust Ventilation (LEV) and/or Personal Protective Equipment (PPE) as interim RMM to protect workers from exposure. Due to the interim nature of the measures, PPE may play a more prominent role compared to what is suggested in table E.3-1 of the abovementioned Guidance.

The registrant may need to update his CSR and ES once he receives the result of the test proposal and is able to derive a DNEL (or identify that minimisation of emission/exposure is required if “no threshold” effects had been identified in the testing). This applies in particular if the interim measures had been based on PPE instead of containment or other engineering measures.

SECTION - 12

Yes. The List of Substances Subject to Authorisation (Annex XIV of the TREACH Regulation) includes several substances.

Substances are regularly added to Annex 14 of TREACH Regulation, on the basis of recommendations issued by MoEU. The link to the updated Annex 14 can be found on MoEU’s website.

Further details on the procedure for the inclusion of substances to Annex 14 of the TREACH Regulation are available in FAQ ID=12.4, as well as on MoEU’s website.
The Candidate List of Substances of Very High Concern (SVHC) for authorisation (Candidate List) is available on MoEU’s website.

Additional substances are regularly included in the Candidate List, once these have been identified as SVHC.
When the European Commission or a Member State considers that a substance may meet the criteria for identification as SVHC pursuant to Article 47 of TREACH, MoEU prepares an Annex 15 SVHC dossier. With this Annex 15 dossier MoEU proposes the inclusion of the substance in the Candidate List by outlining the scientific evidence for identifying the substance as a SVHC.

MoEU’s website includes a public registry of intentions in order to allow interested parties to be aware of the substances for which the authorities intend to submit Annex 15 dossiers and thus facilitates timely preparation of the interested parties for commenting later in the process.

Once an Annex 15 SVHC dossier has been prepared, a consultation of related establishments and interested parties is required, as specified in Article 49 of TREACH. Further details on this consultation process are available on the MoEU website.

Following this consultation, the substance may be included in the Candidate List. The Candidate List is made available on MoEU’s website.
Substances included in the Candidate List may be prioritised for inclusion in Annex 14 of the TREACH Regulation (the so called “Authorisation List”). The Authorisation List contains all substances which, after a certain deadline, may only be used and/or placed on the market after a specific authorisation has been granted. Related parties are invited for taking their opinions throughout process. After, MoEU decides that which of the proposed article will be included in Annex 14, besides it indicates transition arrangements. In the related case, exemptions and review periods are indicated.

Further details on the procedure for inclusion of substances in Annex 14 of the TREACH Regulation are available on MoEU’s website.
Applications for authorisation need to be made within the deadline (the so called “latest application date”) that is specified in the “Authorisation List” for the corresponding substance if the applicant wishes to use the substance without interruption after the sunset date. Authorisation applications need to be submitted to MoEU. Third parties can provide information on alternative substances and technologies during public consultations on the uses that authorisation has been applied for. These are made available on MoEU’s website. MoEU makes Risk Assesstment and Socioeconomic Analysis and reports its opinions. MoEU has third parties or committees which are formed by specialist related to this issue do Risk Assessment and Socioeconomic Analysis. The MoEU Committees for Risk Assessment (RAC) and Socioeconomic Analysis (SEAC) give draft opinions on the application. Applicants will have the opportunity to comment on these draft opinions. RAC and SEAC form final opinions and send them to MoEU. The MoEU decides, using the comitology procedure, whether an authorisation is granted or refused. The MoEU publishes available decisions on MoEU’website. Further details on the application for authorisation procedure are available on MoEU’s website.
Applications for authorization have to be submitted to MoEU in Turkish.
Authorisation is required for the use of a substance included in Annex 14 of TREACH, either on its own or in a mixture. If a substance is used as such, this is a use of the substance on its own, and the exemptions in Article 46(6)(a) and (b) of TREACH cannot be applied. If the substance is used in a mixture, then the aforementioned exemptions may be applied.

SECTION - 13

Downstream users can use substances, irrespectively of whether they have been registered or not. In this regard use means any processing, formulation, consumption, storage, keeping, treatment, filling into containers, transfer from one container to another, mixing, production of an article or any other utilisation. Placing on the market is however not to be regarded as a use.

Please note that for the use of substances (whether registered or not) certain requirements related to restrictions, authorisation and risk management may apply. Guidance on how to comply with these requirements is provided in the Guidance for downstream users.
Yes, according to Articles 27 and 28 of TREACH Regulation some changes in the Safety Data Sheet (SDS) are required. However, the duties and responsibilities for Safety Data Sheets (SDSs) remain largely the same. Guidance for the compilation of Safety Data Sheets is given in Annex II of the TREACH Regulation.

The following list summarises the main changes:

  • The risk management measures for the identified uses with regard to human health and the environment are to be summarised in section 8 (and 7). This includes consumer related measures communicated to a downstream user producing consumer preparation or articles. Also the relevant Derived No-Effect Levels (DNELs) and Predicted No-Effect Concentrations (PNECs) should be presented here.
  • The information on physicochemical properties, toxicology and eco-toxicology in the SDS is to be updated in line with the information requirements of Annex VI to XI of the TREACH Regulation.
  • The results of the PBT and vPvB assessment are to be presented in section 12.
  • The information on uses advised against in section 16 of the SDS may need to be updated depending on the outcome of the manufacturer’s Chemicals Safety Assessment (CSA).
  • Where Exposure Scenarios (ES) are developed as a result of conducting a chemical safety assessment in accordance with Article 15 of the TREACH Regulation they must be annexed to the SDS and thereby be appropriately passed down the supply chain. The information on uses of the substance in Title 1.2 of the SDS must be consistent with the short titles of the ES in the annex, indicating which uses are covered by the ES.
  • Since TREACH includes a requirement to include the waste disposal considerations into the manufacturer’s chemicals safety assessment, section 13 of the SDS may need to be updated with substance specific waste management advice as contained in the ES.


It is important to note that now SDSs are additionally required for substances assessed to be PBTs (Persistent, Bioaccumulative and Toxic) or vPvBs (very Persistent and very Bioaccumulative), for substances included in the candidate list for potential inclusion in Annex XIV of the TREACH Regulation, as well as for mixtures containing any of these substances.

Further information can be found in the Guidance on the compilation of safety data sheets available on MoEU’s website at: https://kimyasallar.csb.gov.tr/rehber-dokumanlar/18

You may also consult the Guidance on registration and its section 3.1.1-‘Provide a Safety Data Sheet (SDS) to customers’.
According to Article 27(5) of the TREACH Regulation, the safety data sheet (SDS) shall be supplied in Turkish.
The carriage of dangerous substances and dangerous preparations by rail, road, inland waterway, sea or air is exempted from the scope of the TREACH Regulation (see Article 2(a)(4)). Transporting activities (including loading and unloading) by transport companies are not “uses” under TREACH.

The loading and unloading operations performed by the workers of the transport company are covered by the Carriage of Dangerous Goods legislation, and hence they are outside of the scope of the TREACH Regulation. Compared to that, the site related activities before loading and after unloading will often be “uses” under TREACH which may need an exposure scenario and a chemicals safety assessment.

It is also important to note that the transfer of substances and preparations occurring exclusively within an industrial plant is covered by TREACH, even if this includes transportation carried out by an external company.
Downstream users may make uses known to the suppliers in their supply chain, before the manufacturer or importer submits his registration, with the aim of making these uses identified uses. This right is enshrined in Article 33(2) of the TREACH Regulation. In making a use known, the downstream user must provide sufficient information to allow the manufacturer, importer, downstream user or distributor who has supplied the substance to prepare an exposure scenario for his use. This does not necessarily require disclosure of technical details of the use, as the use can be described in a generic way using the use descriptor system introduced in chapter R.12-‘Use descriptor system’ of the Guidance on information requirements and chemicals safety assessment’.

In some situations communicating uses up the supply chain may be best done as a collective action in a sector facilitated by sector organizations. However, where a company is not part of a trade association or where very specific uses need to be addressed, direct communication between a downstream user and his supplier may be required.

More detailed information on requesting that a use becomes an identified use can be found in section 8-‘Collecting and communicating information on your uses of chemical substances’ in the Technical Guidance for downstream users.
For a substance or mixture requiring a Safety Data Sheet (SDS) according to Article 27 of the TREACH Regulation, Annex II of TREACH requires that the registration number assigned in accordance with Article 20 of TREACH be given in the SDS when it is available.

Article 27(9) of TREACH gives specific occasions on which an updated SDS should be supplied without delay. Receipt of a registration number per se is not listed as one of these occasions. However as the assignment of a registration number is of major potential interest to downstream users of the substance it may be recommendable to send existing customers an updated SDS either immediately or on the next supply of the substance or of a mixture containing it. The SDS should of course be updated to incorporate the registration number(s) for customers who are going to receive the substance or mixture for the first time. Note in particular that the final sentence of Article 27(10) requires that “any updates following registration shall contain the registration number” (Please note that there are detailed provisions in the Regulation (EU) No 453/2010 amending Annex II of the TREACH Regulation concerning when the part of the registration number referring to the individual registrant of a joint submission (the last four digits of the original full registration number) may be omitted by a supplier who is a distributor or a downstream user).

Similarly, Article 28(1)(a) of TREACH indicates that when registration numbers have to be communicated to customers according to Article 28 (Communication duties for substances and mixtures not requiring an SDS) the registration number, if available, should be supplied. The occasions on which an update without delay is required are given in Article 28(3) of TREACH. Again, receipt of a registration number per se is not listed as one of these occasions. For similar reasons it may be deemed to be desirable to nonetheless send updated information. Note again that the last sentence of Article 28(4) of TREACH also requires that “any updates following registration shall contain the registration number”.

The provisions of Articles 27 and 28 of TREACH apply irrespectively of whether the relevant registration deadline is still to come or has already elapsed.
There is no obligation under TREACH for suppliers of substances and mixtures meeting the criteria in Article 27 to provide a SDS to their non-TR customers. Article 27(1) refers to “recipients of the substance or mixture”. Article 4(dd) of TREACH defines a “recipient of a substance or a mixture” as being downstream user or a distributor being supplied with a substance or a mixture. Both downstream users and distributors are, in line with their respective definitions in Article 4(b) and 4(ğ), natural or legal persons established in Turkey. The obligation of Article 27 of TREACH to provide an SDS therefore applies only to the recipients of the substance or mixture established in Turkey.

However, it is notable that the obligation to provide a TREACH compliant SDS to non-TR customers, in the context of export, may arise pursuant to other pieces of legislation. For example, Article 16(3) of Regulation (EC) No 689/2008 concerning the export and import of dangerous chemicals, implementing the Rotterdam Convention within the EU, requires companies exporting certain hazardous chemicals within the scope of this Regulation to provide a TREACH compliant SDS when exporting them outside the TR.
Yes, they should. According to Article 27(5) of TREACH, the SDS shall be written in Turkish. Therefore, substances currently listed in Turkish only in Section 3 of Annex VI to CLP regulation.
No, it is not. Regarding section 2 of the SDS, either the full wording of the hazard classes or the hazard class and category code(s) may be used. If the full wording is used, it needs to be in the language of the SDS. If the hazard class and category code(s) are used, it is important to note that the abbreviations given for each hazard class are actually codes which cannot be translated. The codes must thus remain as they are given in Annexes VI and VII to CLP. If codes, other abbreviations and acronyms are used, their full text and explanation must be given in section 16 of the SDS, in the language of the SDS.

For mixtures, the codes as given in Annexes VI and VII to CLP can be used in section 3.2.3. Again, section 16 needs to contain the full wording.
No, manufacturers or importers do not have the obligation to inform downstream users that they have submitted a notification to the C&L Inventory. Furthermore, there is no need for downstream users to receive confirmation from upstream suppliers that substances have been notified to the C&L Inventory in order to continue the use of the substances in their own products. Similar to the TREACH pre-registration number, the C&L notification number is for internal use for the importer/manufacturer as receipt/proof of notification. It does not need to be communicated to the DU/distributor.

A notification number cannot be considered as an identifier according to Article 20 of CLP Regulation and it is not the inventory reference number published in the C&L Inventory.
Substances e.g. registered, inquired or notified to the C&L Inventory with only a CAS number or without any numerical identifier are automatically assigned a list number. In contrast to the EINECS, ELINCS and NLP entries, the list numbers and the list inventory are not based on a legal act or requirement, and they have not been published in the Official Journal. Therefore, the list numbers do not have the same significance as EC numbers but have only the numerical format in common. Most importantly, the vast majority of list numbers and their connected substance identification have never been checked for correctness, validity or whether the conventions outlined in the Guidance for Identification and naming of substances under TREACH have been kept.

Therefore, industry is advised not to use list numbers in their documents.

However, when a supplier wishes to include a list number on a document, e.g. Safety Data Sheet, it shall be clearly indicated that this number is not an EC number and has no legal significance.
Distributors/formulators can truncate the registration number (omit the last four digits) of their suppliers’ registration numbers in the SDS in accordance with points 1.1 and 3.2.4 of Annex II of TREACH.

The first part of the registration number is the same for a given substance if the registrants have jointly submitted their registrations. Therefore, only one truncated registration number needs to be included. However, if a registrant has not registered in the context of the joint submission, this registration number is different. Therefore, all relevant (truncated) registration numbers should be mentioned in the SDS.
In this case, manufacturers need to mention their full registration number (with the last four digits) in the SDS, because a manufacturer is not allowed to truncate it. However, being at the same time a distributor of the same substance manufactured by others, they should also indicate the truncated registration number of their suppliers whenever its first part differs from the first part of their own registration number, i.e. if one of their suppliers or they themselves have not registered in the context of the joint submission.
Yes it does. Ceasing the supply of a substance or mixture does not relieve a supplier from its duty to comply with TREACH or its duty to pass on updated information within the supply chain. Therefore, an updated SDS with new information that could affect risk management measures, or new information on hazards, or the outcome of authorisation or restriction processes, shall be provided by that supplier to all recipients to whom the substance or mixture was supplied within the preceding 12 months. As such, an updated SDS shall be provided without delay by that supplier. This duty shall be understood as a duty to actually deliver the SDS on paper or electronically.
Substances included in Annex IV and substances covered by Annex V are exempted from the registration requirement (Article 2(5) of TREACH). Annex IV lists substances for which sufficient information is available to consider them as causing minimum risk to human health and the environment. Annex V covers 13 categories of substances for which registration is deemed to be inappropriate or unnecessary, if the conditions described therein are fulfilled. Recovered substances fulfilling the conditions of Article 2(5) of TREACH are also exempted from the registration requirement. A recovery operator who establishes the sameness of a substance with one already registered and who possesses the required information according to Articles 27 and 28 of TREACH is exempted from registration of that substance.

Manufacturers or importers that fall under any of these exemptions need not submit a registration dossier. In such a situation, the manufacturer or importer will not obtain a registration number and consequently will not be able to communicate such a registration number in the supply chain. In order to avoid confusion an explanation as to why there is no registration number for that substance may be given in the safety data sheet as explained in section 4.1 of the Guidance on the compilation of safety data sheets.

Companies that wish to benefit from such an exemption must assess whether their substances qualify for the exemption. They also have to provide the authorities (on request) with appropriate information to prove that their substances fulfil the exemption conditions.

Further information can be found in the factsheet providing key information for recipients of substances covered by Article 2(5) of TREACH, covering what information they can generally expect from their supplier.
No, there is no obligation to report the registration number for that corresponding substance in the mixture(s) SDS where an alternative name has been granted by MoEU. First, it is important to note that Title 1.1. of the SDS needs to be applied according to the Technical Guidance on the compilation of safety data sheet in the sense that the requirement to publish registration numbers as a product identifier is only applicable to an SDS for substances and not for mixtures. Second, for registered substances contained in mixtures, there is the general requirement in section 3.2.4 of the SDS to include the registration number, EC number and other precise chemical identifier for the registered substances. However, if an alternative name under Article 26 of CLP Regulation, only the alternative chemical name of the registered substance with its corresponding classification needs to be included.

SECTION - 14

As a downstream user you should follow the risk management advice and the operational conditions of use described in the extended safety data sheet (eSDS) received from the supplier, including the exposure scenarios. If relevant, forward the advice to actors further down the supply chain. If you as a downstream user produce a mixture, you must ensure that the eSDS for that mixture includes all relevant information received from the suppliers of the individual components. Please note: This was also a duty of downstream users under previous legislation. The new element under TREACH is the receiving and forwarding of use-specific risk management advice and risk management measures relating to exposure to humans or the environment.

If as a downstream user you receive information from your customers intended for the purpose of making a use known, you should forward this information to the supplier up the supply chain or assess if the use is covered in the existing exposure scenario for the preparation and eventually carry out your own downstream user Chemical Safety Assessment.

If you as a downstream user hold information that puts into question the hazard or risk management information received from a supplier, you should communicate this information to the supplier.
If as a downstream user you use the substance (as such or in a mixture) outside the conditions communicated to you in the extended safety data sheet (eSDS), or the use is not covered at all in the eSDS, you may choose one of the following options:

  • Adapt the conditions of use to those described in the eSDS.
  • Implement or recommend an exposure scenario which includes as a minimum the conditions described in the exposure scenario communicated to you.
  • Make the use known to the supplier with the aim of making it an identified use based on the manufacturer’s chemical safety assessment.
  • Perform your own chemical safety assessment for that particular use and record it in a Chemical Safety Report – CSR (if the total amount used is 1 tonne/year or more). Notify your use, including the information specified in Article 34(2) of the TREACH Regulation to MoEU.
  • Switch to another supplier of the substance if that supplier covers your specific use in his eSDS.
  • Substitute the substance with a different substance for which an exposure scenario is not required or where an exposure scenario(s) is available which covers your conditions of use. Alternatively, substitute the process with a process not requiring the substance.


If as a downstream user you receive information from your customers intended to make a use known you should forward this information to the supplier up the supply chain or assess if the use is covered in the existing exposure scenario for the mixture and eventually carry out your own downstream user Chemical Safety Assessment (CSA).

If as downstream user you hold information that puts into question the hazard or risk management information received from the supplier you need to communicate this information to the supplier.

An overview of how to decide whether or not your use is covered by the exposure scenario can be found in section 6-‘Deciding if the use is not covered by the exposure scenario’ in the Guidance for downstream users. Information on how to make a downstream user chemical safety report is given in Section 7-‘Making a downstream user chemical safety report’ of the same guidance.
If a substance is subject to authorisation (Annex XIV):

You must use the substance according to the conditions laid down in the authorisation granted for that specific use to an actor up your supply chain or apply for an authorisation yourself if the authorisation of your supplier does not cover your use(s);

You must notify to MoEU within 3 months after first supply, the use of the substance subject to authorisation.

If a substance is subject to restrictions: Comply with the restrictions for placing on the market or use of substances as listed in Annex XVII of the TREACH Regulation.

An overview of the possible obligations of the downstream users related to authorisation can be found in section 12-‘Compliance with requirements
You do not have registration or notification obligations, for example, if all your suppliers are located within the Turkey or have appointed an only representative, and you do not produce any new substance or article. However, there are also various other cases in which no registration and notification obligations apply.

In order to check whether in your particular supply chain situation you have registration or notification obligations or not you should use the Chemicals Helpdesk on the MoEU’s website. This helpdesk is designed to help companies to determine their obligations under TREACH. In addition, Technical Guidance for downstream users Title 2.5 – Identification of roles and responsibilities can be used.
You have to report to MoEU when you:

  • Need to prepare a downstream user chemical safety report; or
  • Wish to benefit from the exemption to prepare a chemical safety report either because:
  • You use the substance in total less than 1 tonne per year; or
  • You use the substance for product and process oriented research.


    • If reporting to MoEU is required, specific uses of less than 1 tonne per year do not need to be included in the report except from the following situation:

    if the reason you do not need to prepare a chemical safety report is that the total quantity you use is below 1 tonne, then all uses are to be reported.

    You have six months to report to MoEU from the date you receive an extended safety data sheet with a registration number.
There are two different situations where a DU can use a substance for a PPORD activity as described in section 1.2.3.2 of the Guidance on Scientific Research and Development (SR&D) and Product and Process Oriented Research and Development (PPORD):

1. Where a substance has been registered under Article 7 of TREACH, a DU can use that substance for the purposes of a PPORD activity on his own initiative. In such cases, he can inform his supplier of the registered substance about this use with the aim of having the use included in the SDS pursuant to Article 33(2) of TREACH. If a DU does not want to disclose the PPORD use to his supplier, or if the use is not an identified use and therefore not indicated in the SDS, the DU would need to prepare a CSR pursuant to Article 33(4) of TREACH. However, a DU is exempted from this obligation for PPORD uses according to Article 33(4)(e) of TREACH, if the risks to human health and the environment are adequately controlled in accordance with the requirements of legislation for the protection of workers and the environment. If a DU relies on this exemption from the obligation to prepare a CSR, he will need to report the use to ECHA under Article 34(1)(b) of TREACH.

2. Where a substance has been notified under Article 10 of TREACH and thereby exempt from registration, a DU can participate in a PPORD activity of the manufacturer or importer if the manufacturer or importer mentioned him, including his name and address, in its PPORD notification as listed customer. A DU himself can not submit a PPORD notification because the PPORD notification provides for an exemption from the registration requirement and DUs are not subject to the registration requirement.
Downstream users or distributors must check the registration status of the substances on their own or in a mixture they place on the market, in order to comply with the obligation imposed by Article 6 of TREACH to place on the market only substances that comply with the registration requirements under TREACH.

Manufacturers and importers of a substance on its own or in a mixture are encouraged to communicate with the downstream users or distributors of the substance with regard to whether and by when they intend to register the substance to enable the downstream user or distributor to seek alternative sources of supply if necessary. Once the substance has been registered, there is an obligation for the supplier to communicate the registration number down the supply chain either in the safety data sheet according to Article 27 or, if applicable, according to Article 28 of TREACH.

SECTION - 15

No, only substances listed in the relevant Appendices (1 – 6) of Annex 17 are covered by the restrictions in entries 28 – 30.
Organostannic compounds covered by entry 20 in Annex 17 to TREACH, must contain a carbon-tin bond. Substances like tin salts or organotin compounds, for which tin is bound to an atom other than carbon (for example hexanoic acid, 2-ethyl-, tin(2+) salt (CAS-No: 301-10-0)) are not covered by entry 20 in Annex 17 to TREACH.
The concentration threshold of cadmium applies in each metal part of jewellery in entry 23 of Annex 17 of TREACH Regulation. The wording used by the legislator, i.e. “metal parts of the jewellery and imitation jewellery” implies that each metal part is relevant; therefore in order to determine if the restriction applies the calculation of the concentration in this case is to be done for each metal part. Therefore, if there are several metal layers as coatings on the surface of an inner (metallic) part of the jewellery these should be regarded as integral part of the metal part and the concentration limit of 0,01% is calculated for this whole metal part. In case the inner part is not metal, but the coating is made of metal layers, this coating is regarded as one metal part. If the jewellery article contains several metal parts, each of them should comply with the concentration limit.

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