Compliance with the Turkish REACH By-Law "KKDIK"



Dear KKDIK Registrant,


Compliance with the Turkish REACH By-Law KKDIK regulation is mandatory for any company with the aim to continue selling chemical substances in Turkey (TR). Companies located outside the TR need to have an Only Representative (OR) in Turkey in order to be able to register their substances as known.


We, as DORUKSISTEM, can offer Only Representative (OR) service and regulatory monitoring service for companies exporting chemical substances to Turkey. Our Only Representative services allow Non- TR companies to take part in the Turkish REACH KKDIK registration process. We act as their OR carrying out all the CLP and Pre-SIEF registrations (known as pre-registration) and registration work needed to submit a successful registration dossier to MoEU. In addition, we provide a long-term legal presence, client representation and carry out all the mandatory continuous data collection tasks required. As OR, we take care of the substance identification, best registration strategy, a thorough evaluation of existing data, the identification of data gaps and a precisely fitting proposal of testing strategies with due regard to scientific as well as economic aspects in order to close these gaps.


We assist our clients with a complete Chemical Safety Report prepared by the certified ‘Chemical Assessment Specialists (CAS)’ (Compliance with KKDIK Annex-18) and necessary collection of information in the supply chain, handling of third-party access rights and financial transactions, completing the technical dossier and submitting it to MoEU as OR. TR-CLP notification, preparation and update of safety data sheets (SDS) and archiving and keeping information/data up-to-date complete the technical service. We also provide resources and expertise for the hazard assessment, exposure assessment and risk characterization when needed.


We can offer a service to facilitate consortia/SIEF joint registration activities (e.g. data/cost sharing, consortium, monitoring, registration, liaising fees) as well. DORUKSISTEM provides support for Consortia with the legal staff drafting the necessary documentation to get client’s consortium running. We offer managerial support to Consortia under KKDIK. We ensure that the companies fulfil on time the KKDIK obligations, and we also facilitate communication and exchange information within the SIEF and within the members of the consortium. In addition, we take care of the financial management agreed within the parties. We perform the technical services in toxicological testing, assessing and compiling environmental effects and data packages compiling and assessing human health, and exposure data, evaluating hazard classification and labelling, exposure scenarios, risk and characterization and preparing chemical safety reports. We assist our clients in the formation of consortium, the setup of a consortium agreement, the organisation of meetings and conference calls and all communication related to the dossier preparation and the joint registration process. We also offer support for the sometimes-complicated data- and cost sharing.

Doruksistem is the leader consultant company starting Consortia and SIEF joint registration activities and communications first in Turkey by forming www.turkreach.com.tr (or www.kkdik.eu) web site media. Our consortia management web pages will be available soon within this web site.


On the other hand, we can prepare registration dossiers (data, hazard assessments, risk assessments) in accordance with the complete requirements of KKDIK with all our certified experts trained by the ministry registered trainers. Our company Doruksistem is also appointed as legal KDU (CAS - Chemical Assessment Specialist) training company by MoEU as well. You can review our CAS Trainings web site www.kkdikegitim.com (in Turkish Only).

Providing a detailed answer covering details on lead-time need to assemble registration data, dossier, compliance translations and rates for all the different tonnage bands, update registration, simplified and exemption (polymer, R&D) notification schemes will take time according to your substances, classifications, and tonnage bands, etc. But you can be sure that we can plan and present all detailed information you need whenever you want including your detailed questions about KKDIK.


We have capability to support you by preparing the KKS (Online Chemical Registration System of MoEU) dossiers in Turkish with crossword translations of your current IUCLID (5 or 6) dossiers if you already have a REACH dossier for a substance in EU.

We already have other services in place to deal with: potential translations, legal support, substance identification needs, SDS & eSDS compliance in Turkish with certified experts, our SDS management portal, 7/24 emergency number in Turkish & English, label validation in Turkish, TR Infocards, ADR/ADN/IMDG/IATA documentation & classification support, supply chain communication, CLP/GHS management support, upcoming UFIs and Poison Centre notifications/registrations, Article Communication, SVHC declarations, import quantity monitoring, communications with legal authorities, etc. By the way, we completed hundreds of CICR (Chemical Inventory Control Regulation) Notifications last 8 years and CLP registration with pre-SIEF registrations last 3 years for international as OR and local companies as TPR (Third Party Representative). More than 45000 SDSs are compiled and prepared according to local regulations in Turkish by DORUKSISTEM. Our www.msds.com.tr web site is very popular in Turkey.

Doruksistem is the oldest chemical control regulatory compliance consultant company in Turkey. Our company is established in 2005 and we are focusing on chemical regulations developments in Turkey after starting the conversations in between EU & TR in this area since 2005.

First Turkish REACH like Regulation(s) are published at the end of 2008 as you know and we are working with the ministry, industry, academic world, civil society organizations, Trade & Industry Chambers, related professionals, TUBITAK, etc since 2008.

Shortly, Doruksistem involvement in the TURKISH REACH Law KKDIK development process is very strong and simply we can say that “DORUKSISTEM can support you as your OR with a well experienced and certified team”.

In the light of these explanations we can quote you if you please send us the following required information to kkdik@doruksistem.com.tr


- Number of Non-TR Legal Entity (LE) you have (number of non-TR manufacturers export to TR)

+ Do you have any LE in TR?

- Number of Substances potentially you want to register in Turkey (annual tonnage>1 Mt but you can add the substances having potential >1 Mt/year within next 5 years)

o What are the annual tonnage bands of each LE? (1-10; 10-100, 100-1000; >1000)

o How many of these substances will potentially be registered as Lead Registrant (LR)

o How many of these substances will potentially be >10 tons/year and hazardous (for CSA and CSR)

o Do you have any info as Data Holder? If yes how many substances will be represented as DATA HOLDER in related SIEFs?

o How many of these potential substances are registered during EU-REACH process and have registration dossiers?

o How many Safety Data Sheets (SDS) will be compiled to TR SDS regulation as final product? (Substances, preparations, formulations, articles etc.)

- Number of Importers in Turkey (Note: We will need their LE names and contact info and VAT numbers during pre-registration process)

DORUKSISTEM services for KKDIK, SEA and related regulations:

• On-call access to KKDİK Turkish REACH experts for support of KKDİK registration related questions,

• Determination of the company role and responsibilities under KKDIK

• Managing the full process for substances under the scope of KKDIK

• Determination of chemical characterization of the substances

• To be done pre-registration

• Participation in the SIEF, including contact and coordination with SIEF members,

• Data exchange and evaluation,

• Join and follow-up all activities in pre-SIEF and SIEF

• Negotiation with SIEF and Consortium members,

• Following up consortium activities

• Authorized negotiations with Turkish Ministry of Environment,

• Notification to the MoEU of quantities of products manufactured/imported and related risk assessments

• Collection and submission of technical dossiers,

• Data management and data-gap analysis

• Translations, preparation and compilation of registration dossier

• Submission of registration applications,

• CSR authoring

• Uploading registration dossier to KKS by the chemical assessment specialists

• Creation and submission of KKDİK compliant Safety Data Sheets (SDS),

• High-level discussions about risk assessments and use of information,

• Communication concerning substances to downstream users,

• Classification of substances/mixtures supplied to the market

• Labelling and packaging of harmful substances/ mixtures

• Determination of label and packaging dimensions of hazardous substances and mixtures.

• Notification of hazardous substances to C&L (SEA) inventory through KKS

• Follow up the updated information of the substances

• Preparation of Safety Data Sheets

• Extended-SDS compilation services,

• Establishing of the substance inventory list under Annex-17

A brief assessment for the short, mid and long-term plans during the KKDIK process will be shared with you after having the above information we need.

Please do not hesitate to contact for further info you need or questions you have. Thank You and Best Regards.



DORUKSISTEM AS

Regulatory Compliance Department

kkdik@doruksistem.com.tr Tell: +90 850 5323597

www.kkdik.eu

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