Questions You May Have

KKDİK is the regulation on the registration, evaluation, authorisation and restriction of chemicals in Türkiye. Obligations for substances manufactured or imported in Türkiye are assessed according to the type of substance, annual tonnage, use, exemption status and the timeline in force.

Not always. Whether a pre-registration, a provisional registration or a previously prepared dossier meets the current obligations must be checked separately. The company’s role, substance identity, tonnage and dossier status are reviewed together.

They refer to different stages and obligations. Which action is required is determined by assessing the substance’s placing-on-the-market status, the company’s role, tonnage and the applicable provisions. The same path may not apply to every substance.

The party that coordinates the dossier in a joint registration process. The appointment and duties of the lead are handled within the relevant legislation and KKS processes. Whether a company becomes the lead is assessed according to the substance and the existing registration group.

The MBDF (Substance Information Exchange Forum, SIEF) is the forum in which registrants of the same substance coordinate information sharing and joint registration processes. Participation and obligations should be assessed according to the substance’s identity, registration status and the relevant legislation.

The KKS (Chemical Registration System) continuing to accept submissions does not in itself mean that all legal deadlines have been extended. For each substance and obligation, the current Ministry announcements and the timeline in force should be used as the basis. In Kİ-Chem’s announcements, dates and scope information should be shared together with the up-to-date source.

Generally, the substance identity and composition, annual tonnage, areas of use, supply chain information, existing test/data documents and the company’s role under the legislation are assessed. The exact document list is drawn up once the scope of the substance and dossier has been determined.

The duration varies depending on data availability, the clarity of the substance identity, the need for data sharing, tonnage and the complexity of the dossier. After a preliminary review, a work plan and an estimated timeline are shared.

EU REACH and UK REACH are separate regulatory systems applied in the European Union and on the relevant United Kingdom market respectively. An action taken in one market does not automatically satisfy the obligations in the other; the target country and supply chain must be assessed separately.

It depends on the destination country, whether the product is a substance or a mixture, its composition, intended use and the importer’s role. Separate assessments may be needed for markets such as the EU, the United Kingdom, Korea or Ukraine.

Depending on the legislation of the country concerned, work may include obligation analysis, registration strategy, assessment of data needs and review of local representation/importer arrangements. The exact scope is determined per country and product.

In some regulations, it is a representative mechanism that can assume certain importer obligations on behalf of a manufacturer in a country that meets the relevant conditions. Conditions vary by country and regulation; the same model should not be assumed to apply in every market.

Kİ-Chem aims to offer international solutions by reviewing the target market’s legislation and whether a representation mechanism is applicable. The legal scope of the service depends on whether a representation model exists in the country concerned and on local requirements.

Sharing existing test data and studies on the same substance can be important for reducing duplicate testing and carrying out joint registration processes. Data access, usage rights and costs must also be assessed separately.

A Letter of Access (LoA) is an arrangement that documents the right to access certain data or dossiers under certain conditions. Its scope, validity and pricing may vary depending on the data owner and the terms of the agreement.

Whether a CSR is required depends on the applicable regulation, the properties of the substance, tonnage and use scenarios. The requirement and the scope of the report are determined on a dossier basis.

Existing information and documents are compared with the information the regulation requires. Gaps, possible data sources, priorities and next steps are identified, and a registration or compliance plan is drawn up.

A Safety Data Sheet provides information on a chemical’s hazards, safe use, storage, transport and emergency measures. The obligation to prepare and supply it is determined by the product and the applicable regulatory conditions.

Classification is the basis for determining a product’s hazard properties and for creating appropriate labelling and safety communication. Composition, available data and the applicable criteria must be taken into account.

Depending on the applicable regulation, a label may include the required hazard pictograms, signal word, hazard and precautionary statements, and product and supplier information. Requirements should be checked against the product’s classification and the market.

A UFI is a unique formula identifier that links the formulation information of certain hazardous mixtures to the relevant poison centre notifications. Use of the UFI depends on the requirements applicable to the mixture and the target market.

A PCN is the submission of the composition and other required information on certain mixtures to poison centres under the relevant regulation. The scope and format of the notification and who the obliged party is are assessed according to the market and product conditions.

No. Generating a UFI and preparing and submitting the PCN notification to the relevant system are separate steps. Linking the UFI to the correct product, the scope of the notification and the validity of the submission must be checked together.

This depends on the country where the company is established, the placing of the product on the EU/EEA market and the role of the obliged party defined in the legislation. A company outside the EU/EEA should not be assumed to be able to act directly as the obliged party; the notification structure and the appropriate EU/EEA party should be verified in advance.

Kİ-Chem’s service scope includes assessing regulatory requirements for biocidal products, cosmetic products and detergents, and planning compliance steps. The exact service scope is determined after the product and target market have been reviewed.

PIC rules concern export notification and prior informed consent procedures in the international trade of certain hazardous chemicals. Applicability is checked according to the chemical’s status on the lists and the export conditions.

First, the product, substance/mixture information, target markets, the company’s role in the supply chain and existing documents are reviewed. Then the needs analysis, scope, required inputs, estimated timeline and a quote are shared.

If possible, share the product name and type, target country/market, annual tonnage or estimated quantity, the company’s manufacturer/importer role and existing documents. Confidential or commercially sensitive documents can be sent once a secure sharing method has been agreed.

Fees and duration are determined by the number of products, the target market, the regulatory scope, the adequacy of existing data and the amount of work required. After the dossier has been reviewed, a quote with a clearly defined scope is provided.