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Frequently Asked Questions of the KKDIK Regulation (Turkey REACH)

With the pre-registration deadline for KKDIK quickly approaching on the 31st of December 2020, we at CIRS are busy monitoring the latest updates and preparing you to fulfil all the necessary obligations. Completion of the pre-registration obligation provides you with a grace period for registration until the end of 2023 after which all chemical substances manufactured/imported to Turkey in one ton/year must be fully registered.

To make this process easier for you, we have gathered all the most frequently asked questions from our practical experience to-date with the KKDIK regulation.

  1. If pre-registration is completed within C&L notification, then why should a foreign enterprise do the pre-registration themselves and not through a TR-importer?

If a TR-importer does C&L notification, they select the role of ‘importer’. The pre-registration will also have been completed under an importer. This may result in the following scenarios (a) higher cost for registration (b) the TR-importer may not do the registration and choose a supplier which has registered their substance with an OR (c) If the TR-importer does the registration, then they can buy the substance from any supplier they want as they will have the registration number. The result is an overall loss of commercial power in Turkey

  1. How is the pre-registration/registration of a polymer processed according to the KKDIK regulation?

Article 4 (hh) of KKDIK: Polymer means a substance consisting of molecules characterised by the sequence of one or more types of monomer units, distributed over a range of molecular weights wherein differences in the molecular weight are primarily attributable to differences in the number of monomer units and comprising of the following:

1) A simple weight majority of molecules containing at least three monomer units which are covalently bound to at least one other monomer unit or other reactant; and

2) Less than a simple weight majority of molecules of the same molecular weight

According to the KKDIK regulation, polymers are themselves exempt from registration. In the same way as EU REACH, it is the monomer unit and any other substances which are present in 1 ton/year or greater which require pre-registration/registration.

  1. For C&L notification of chemicals delivered in mixtures, does each individual substance require notification?

The way a mixture is classified is if the mixture contains a substance which is classified as hazardous and it is above the appropriate concentration limit (varies depending on the substance in question), then the mixture is classified as hazardous. If a mixture meets hazardous criteria, then C&L notification is required. Classification is the same as EU REACH.

  1. Is it possible to transfer completed pre-registrations?

Currently, the online platform for submitting pre-registration/registration dossiers is updating. This is the KKS tool (IUCLID and REACH-IT hybrid). This may take some time to complete. The OR transfer function will be available after the update is complete.

  1. According to KKDIK, all substances manufactured/imported into Turkey in 1 ton/year should be pre-registered. If my substance is less than 1 ton/year can it still be pre-registered?

Yes, it is still possible to pre-register substances which are less than 1 ton/year. This will also cover future business if annual tonnages rise to the 1 ton/year mark or above in the period of three years. If pre-registration is not completed before Dec. 31st 2020 and tonnages rise above the 1 ton/year threshold, then full registration will be required which will be far costlier.

  1. Is there a system of reporting dispatches into Turkey after pre-registration is completed?

Currently, there is not such a system in place for reporting dispatches

  1. When dealing with a mixture, if a raw material is pre-registered under the supplier, can the pre-registration be used by the formulator of the mixture?

This is the decision of the supplier who obtained the pre-registration number and whether he grants access to the formulator to use the pre-registration number.

  1. Who may register in the case of a multinational company/group companies?

This depends on whether each company within the same parent company are defined as ‘registrant’ according to Article 4(ü) of the KKDIK regulation. If multiple companies are under the same legal entity, then just one company needs to act as the registrant. In the case of a separate legal entity, such as a sister company, they should also register.

  1. How are alloys registered?

According to the KKDIK regulation, alloys are treated in the same way as mixtures. Therefore, each individual substance i.e. each metallic substance must be registered individually.

  1. If the tonnage band is expected to increase in the future, can the higher tonnage band be registered under instead?

Companies may register under higher tonnage bands if they expect their annual tonnage to increase. The higher registration fee must also be paid. Furthermore, the registration dossier must include all the required information for the higher tonnage band as data requirements differ between tonnage bands.

  1. If a company is importing a mixture to Turkey, how can they find out if the individual components have already been registered in Turkey by the supplier, if the supplier is refuses to share the information?

The options are to (a) Contact the formulator where the supplier is not the same entity as the formulator. The formulator may be more willing to share the composition information. (b) Take analytical measurements to determine the composition of the mixture or (c) Find an alternative supplier of the same substance who is willing to share the information

  1. Our substance only has a CAS No. and no EC No. is available, can we process pre-registration only with CAS No.?

Yes, there is no problem to process pre-registration without EC No.

  1. We are a distributor located outside Turkey, can we appoint an OR and process pre-registration?

No. It’s same as EU REACH. Only foreign manufacturers can appoint an OR and process pre-registration.

  1. Is there a definition of “new chemical” in the KKDIK regulation?

No. The regulation is only about the substance. There is no specific definition of Existing Chemical and New Chemical. CIRS suggests companies to process pre-registration of all their substances.

  1. If the manufacturer completes the pre-registration, can the local importer take C&L notification with this pre-registration No.?

No, if the importer processes C&L Notification, they have to firstly complete pre-registration by themselves.

  1. Our product contains a raw material which has not been reacted. The tonnage of this raw material is more than 1 ton/year. Are we still required to process pre-registration of this raw material?

It’s similar as EU REACH. If the raw material is not residual on purpose, it can be regarded as an impurity and pre-registration will not be required.

  1. We are a Turkish legal entity which owns several factories in different sites, how shall we process the pre-registration?

According to KKDIK regulation, registrant shall be the natural or legal person in Turkey. If the company has one individual legal entity which own different factories, and the factories have no individual legal entity, only one pre-registration is enough, and all factories will be covered.

If you have any further questions, please do not hesitate to contact us:

Julie Harrington, Regulatory Affairs Consultant

julie@cirs-reach.com

+353 0 87 197 2618

https://www.linkedin.com/in/julie-harrington-14270a160/

Metal Recycles Forever

80% of all metal ever produced is still in circulation today.

Recycling and sustainability

The UK metal packaging industry, along with its European counterparts, spearheads the continual drive to not only produce the most material efficient metal packaging possible, but also to provide packaging that offers other significant benefits such as significantly reducing food waste and producing paint cans that are still fully recyclable despite contamination from paint.

 

The industry’s recycling infrastructure, developed over many decades, has resulted in a UK recycling rate for steel packaging of 71 per cent and aluminium (primarily beverage cans) of 76 per cent.

 

The sector’s target of a 100 per cent recycling rate for metal is a real possibility thanks to metal’s easy separation from the waste stream, either by consumers at home or by magnetic extraction and eddy currents further down the line. And it’s a fact that all metal collected for recycling, is recycled and is reused.

 

Metal is officially recognised as a permanently available material (British Standard 8905) – a material whose inherent properties are not changed by repeatedly being recycling into new products. Metal can be recycled an infinite number of times with no loss of quality, and it’s estimated that 80 per cent of all metal ever produced is still in circulation today.

 

Metal’s sustainability credentials are captured in just three words: Metal Recycles Forever.

 

“Metal can be recycled again and again with no loss of quality, and when it is recycled it saves significant amounts of primary raw materials, energy and CO2. Once primary ore is converted into metal, as long as we look after it, we will have it forever.  This infinite recyclability is key to reducing the pressure on the world’s natural resources and why recycling metal is so important. Our vision is for a 100 percent metal packaging recycling rate,” said Robert Fell, Director and CEO, MPMA.

Safety, Regulatory and Safe Handling of Chemicals

Safety, Regulatory and Safe Handling of Chemicals are topics that constantly challenge the global Chemicals industry at all times.
There is a need for companies to understand the correct regulatory, classification, symbols and pictograms.  It’s not just enough to write SDSs ‘in-house’ without employing proper tools or knowledge resources or simply copy-pasting safety data sheets from competitors, suppliers or from the internet as these could be quite misleading!  Yet another requirement for companies aspiring to get various types of Quality, Compliance, other certifications is to have proper systems in place including those of Safety, Regulatory and Safe handling of Chemicals regardless of being hazardous, non-hazardous chemicals or both.

 SIAM SL, Spain based in the world famous La Rioja wine region of Spain develops IT Solutions and Software for the automatic Classification, Formulation and Authoring of Safety Data Sheets for single substances and mixtures falling under CLP and GHS regulations.  SIAM provides a highly versatile software (CHEMETER) for preparing multilingual SDS in over 55 world regulatory/languages and multilingual product labelling and provides SDS AREA, a platform for easy distribution and management of Safety Data Sheets.
Both CHEMETER and SDS AREA solutions offer major time-savings to companies over traditional methods of authoring SDSs as well as using old software since both solutions come with latest features suited to the current and evolving safety regulations in over 55 countries.   CHEMETER software is easy to understand, open and flexible and built-up in a modular fashion to suit your exact needs at any given time.

1000+ clients across 45 countries that use CHEMETER software and SDS AREA include a variety of manufacturers, exporters, importers, distributors, traders, MSME’s, OEM’s into all kinds of Chemicals, API’s and Plastics and coming from all walks of industry including CASE, Petrochemicals, Pigments, Resins & Additives, Dyes & Dispersions, Textile and Leather Chemicals, Cleaning & Construction Chemicals, Lubes & Greases, Cosmetics, Solvents, Rubber, Plastics, Detergents, Flavours & Fragrances, Water Treatment Chemicals, Agro Chemicals, Monomers and Polymers, Resins and more.

Come 1st November 2020 and CHEMETER software will offer its users an additional module specially designed to help users manage the EU’s new regulation of UFI (Unique Formula Identifier) Code in order to comply with the EU’s new Poison Centre Notification (PCN) requirements for hazardous mixtures being supplied into the EU.   The module automatically creates PCN dossiers for harmonised notifications and within a few minutes, users can upload files with all necessary documentation, automatic UFI code generation, toxicological information, complete chemical composition, etc.   It is a simplified and easy step-by-step process and significant time-saver compared to the 2-3 hours odd it otherwise takes to generate PCN for a single product using the official portal.

You can get more information about SIAM’s Regulatory IT Solutions on https://www.siam-it.com or by sending an email to:

Nirav Banker
(UK, Asia & Middle-East Business Head)

Email: n.banker@siam-it.com
UK Mobile: (+44) 747 096 4875