| # | Title | Type | Source | Description |
|---|---|---|---|---|
| 1 |
What is the role of an Only Representative (OR)? |
Regulatory Regions | gpcgateway.com | Only Representatives (OR) are: 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, |
| 2 |
What are the differences between TII and Full registration? |
Regulatory Regions | gpcgateway.com | Enterprises need to do TII registration if their registered chemicals are considered as intermediates. Buyers have to provide a declaration regarding the use of the chemical, often under strictly controlled conditions. Registrants can do self-decla |
| 3 |
How is tonnage calculated under Turkey-REACH? |
Regulatory Regions | gpcgateway.com | The annual tonnage is calculated as the volume per manufacturer/importer per calendar year. For substances that have been imported/manufactured over the past three years consecutively, the tonnage is calculated as the mean of three years. For o |
| 4 |
Do substances used in biocides and plant protection products (PPP) have to be registered under Turkey-REACH? |
Regulatory Regions | gpcgateway.com | Substances actively used in biocidal products are regarded as already registered, as biocidal products and their active ingredients are covered by Biocidal Products Directive. However, several conditions have to be fulfilled to benefit from the |
| 5 |
Is Turkey-REACH applicable to chemical substance (as substance, in mixtures or in articles) with manufactured/imported tonnage below 1 ton per year? |
Regulatory Regions | gpcgateway.com | Under Turkey-REACH, registrants have obligations regardless of tonnage. These include restrictions, authorization and communication within supply chain (such as the provision of Safety Data Sheets). The one ton and above per year thresho |
| 6 |
Does Turkey-REACH regulate substances occurring in nature? |
Regulatory Regions | gpcgateway.com | Yes, Turkey-REACH applies to substances occurring in nature, as defined by Article 4(h) of Turkey REACH. However, Annex V of Turkey REACH states that the following substances occurring in nature are exempted from registration if they are not chemi |
| 7 |
Do I have to register polymers? |
Regulatory Regions | gpcgateway.com | According to Article 7 of Turkey REACH, polymers do not have to be registered, but the monomer substance(s) and other substances of the polymers that have not been registered by an actors within the supply chain, can be registered with followin |
| 8 |
What are the similarities and differences between Turkey REACH and EU REACH? |
Regulatory Regions | gpcgateway.com | Items EU-REACH Turkey REACH Registration Target New substance (>=1T/Y); Existing Substance (>= 1T/Y) All substances (>= 1T/Y) regardless phase |
| 9 |
What is the scope of application under K-REACH? |
Regulatory Regions | gpcgateway.com | All chemical substances except the following are subject to K-REACH. Radioactive material defined in subparagraph 5 of Article 2 of the Nuclear Safety Act; Drugs defined in subparagraph 4 of Article 2 of the Pharmaceutical Affairs Act and |
| 10 |
Does the existing chemical that is used for cosmetics need pre-registration? |
Regulatory Regions | gpcgateway.com | As per K-REACH Article 3(2), Cosmetics defined in subparagraph 1 of Article 2 of the Cosmetics Act and raw materials used for cosmetics are not subject to pre-registration. |
| 11 |
What is the definition of polymer under K-REACH? |
Regulatory Regions | gpcgateway.com | The term "polymer" under K-REACH refers to chemical substances satisfying all the following requirements. It shall be composed of molecules in which at least one kind of monomer unit is continuously repeated; It shall represent the characteri |
| 12 |
Why do companies need to pre-register the existing chemicals? |
Regulatory Regions | gpcgateway.com | According to the K-REACH Article 10, those who intend to manufacture or import more than one ton per year need to register substance. After pre-registration, companies can get a grace period that allows manufacturer and importer to continue their bus |
| 13 |
Do companies need to pre-register if the substances manufactured or imported is below 1 ton? |
Regulatory Regions | gpcgateway.com | According to the K-REACH Article 10, a person who intends to manufacture and import a existing chemical substance more than one ton per year needs to register before manufacture or import. To get the grace period, the pre-registration is required. Ho |
| 14 |
Is it possible to manufacture and import without pre-registration? |
Regulatory Regions | gpcgateway.com | No, pre-registration is necessary if a person has manufactured and imported the existing substance for more than 1 ton per year in 2016, 2017 and 2018. While proceeding the pre-registration, the person can continue to manufacture and import the conc |
| 15 |
After pre-registration deadline, can companies who intend to manufacture or import more than one ton per year get a grace period? |
Regulatory Regions | gpcgateway.com | Those who intend to manufacture and import existing chemical substances more than one ton per year may be subject to the grace period after the pre-registration deadline (2019.6.30) once completing the late pre-registration. However, in order to fac |
| 16 |
Are new chemical substances subject to pre-registration? |
Regulatory Regions | gpcgateway.com | New chemical substances are not subject to pre-registration. During the grace period, one must report (less than 100kg per year) or register (more than 100kg per year) before manufacture and import. |
| 17 |
What is the registration procedure when an overseas manufacturer and importer wants to appoint an OR? |
Regulatory Regions | gpcgateway.com | Foreign manufacturers and producers can register through appointing an OR in accordance with Article 38 of the 「Act on Registration and Evaluation of Chemical Substances」. When an importer imports more than 1 ton of registered chemical subst |
| 18 |
Who has an obligation to notify the chemical under Swiss Chemical regulation? |
Regulatory Regions | gpcgateway.com | The new substances should be notified before placing into the market by Swiss manufacturer, Importer Only Representative can notify the substances on behalf of Non Swiss Manufacturer |
| 19 |
Do I have to register finished cosmetic products? |
Regulatory Regions | gpcgateway.com | As per the Official Guideline on Registration Heading 2.5.1 in KKDIK, the ingredients in the finished cosmetic products also need to be registered, as cosmetic products can be defined under the term "mixture" and ingredients of a mixture must be regi |
| 20 | Chemspec Europe | Events | gpcgateway.com | lobal Product Compliance (GPC), being a service provider in the chemical industry, will |
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