5.1 Is pre-registration done?
Pre-registration is not done.
6.1 Who has to register the substances?
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).
They are the companies that import from abroad, which must fulfill the obligations of the TREACH Regulation. However, they may decide to appoint an 'Only Representative' to alleviate the obligations of importers of non-resident manufacturers or importers in Turkey of articles (Look at FAQs Part 4).
6.1.1 Who is the registrant in case of private label manufacturing of substances?
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 TREACH 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).
6.2 In case of an international company, who is the registrant?
International companies sometimes have several daughter companies in 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 TURKREACH KKDIK Regulation. Review FAQs Part 4.
6.3 Which substances have to be registered?
Registration is required for all substances whether they are hazardous or not:
- 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.
6.3.1 Do I have to register alloys?
The TURKREACH KKDIK Regulation refers to alloys as "mixtures". Therefore, alloyS are to be treated in the same way as other mixtures under TURKREACH KKDIK , 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
6.3.2 Do I have to register intermediates?
It depends under which type of intermediate as described under Article 4(c) of the TURKREACH KKDIK 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 TURKREACH KKDIK 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 TURKREACH KKDIK Regulation if they confirm that the substance is manufactured and used under strictly controlled conditions as described under Article 17(3) of TURKREACH KKDIK .
- 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 TURKREACH KKDIK 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 TURKREACH KKDIK . 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 TURKREACH KKDIK can be used are described in the Guidance for intermediates.
6.3.3 Do I have to register a substance occuring in nature if I have to apply a process to extract this substance?
Substances occurring in nature are exempted from the duty to register in accordance with Article 2 and Annex V, paragraph 8 of TURKREACH KKDIK , 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 TURKREACH KKDIK 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 TURKREACH KKDIK 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 TURKREACH KKDIK . 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 TURKREACH KKDIK .
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 TURKREACH KKDIK , 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 TURKREACH KKDIK is applicable or not.
6.3.4 What falls under the definition of PPORD (Product and Process Oriented Research and Development)?
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).
6.3.5 Will a registration under the TREACH Regulation be required for substances that are manufactured within the Turkey but exported 100% outside of Turkey?
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 KKDIK Regulation 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.
6.3.6 Do I have to register chemically surface treated substances?
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:
1. Registration of the basis substance (macroscopic particle)
2. Registration of the surface treating substance
3. Description of the use "surface treatment" in the registration dossier of the surface treating substance and in the registration dossier of the basis substance
4. 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.
6.3.7 Do I have to register substances used in medicinal products?
According to Article 2(3)(a) of the TURKREACH KKDIK Regulation substances used in medicinal products for human or veterinary use within the scope of the relevant TR legislation are exempted from the Registration Title of the TURKREACH KKDIK Regulation. More explanation is provided for in Section 184.108.40.206- 'Medicinal products' of the Guidance on registration.
Substances fulfilling the conditions of Article 2(3)(a) of the TURKREACH KKDIK Regulation are also exempt from the Titles on Downstream Users, Evaluation and Authorisation (Titles V, VI and VII of the Regulation).
Importantly, substances are exempted from these Titles only to the extent that they are used in medicinal products 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.
6.3.8 May pre-registered substances that are manufactured or imported before the relevant registration deadline be placed on the market after this deadline without a 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 .
6.3.9 Is a metal hydroxide manufactured from the metal oxide covered by the exemption from registration in Annex V, paragraph 6 of the TURKREACH KKDIK Regulation?
According to Annex V, paragraph 6 of the TURKREACH KKDIK Regulation 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.
6.3.10 Are substances that are banned in scope of the substances that deplete the ozone layer subject to registration?
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..
6.3.11 Is a registrant required to update their registration dossier with a new analysis dataset each time the substance is imported from a new non-resident manufacturer in Turkey?
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 TURKREACH KKDIK , 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:
1. 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.
2. 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.
6.3.12 Within a solution of a complexing agent and a metal salt, a metal-complex will be formed. This complex remains in solution and will not be isolated at any time. Does this complex have to be registered?
Ionic substances in an aqueous solution are exempted from registration only if:
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.
- 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.
6.4 When do I have to register my substance?
Registration is done according to Section 2 provisions of the regulation.
6.5 How do I calculate the tonnage?
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 Section 1.6.2- 'Calculation of the volume to be registered' of the Guidance on registration
6.6 Can I register for a tonnage band higher than the actual tonnage of the substance ?
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 220.127.116.11- '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
6.7 How can I register my substances and do I need any computer program?
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/
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