KKDİK Glossary

A

Article

An object which, during production, is given a special shape, surface or design more determinative of its function than its chemical composition.

Authorisation

The process by which substances on the authorisation list (Annex 14) may be used for specific uses only with special permission.

C

CAS Number

A unique identifying number assigned to every chemical substance by the Chemical Abstracts Service.

CMR

Carcinogenic, Mutagenic or toxic to Reproduction substances; Category 1A/1B classification moves the KKDİK registration deadline forward.

CPSR

Cosmetic Product Safety Report; the EU equivalent of Turkey's cosmetic product safety assessment.

D

Data Sharing

The principle whereby test data is shared among registrants of the same substance without the need for duplicate testing.

Downstream User

A supply-chain actor, other than the manufacturer or importer, who uses the substance in their own industrial or professional activity.

E

EC Number

The European Commission's substance inventory (EINECS/ELINCS/NLP) identification number.

G

SDS

Safety Data Sheet; the standard 16-section document on the safe use of hazardous substances and mixtures.

GHS

The UN Globally Harmonized System of Classification and Labelling; the basis of both SEA and CLP.

I

Interim Registration

An interim registration mechanism that allows companies that have made a pre-MBDF notification to remain on the market before full registration.

IUCLID

The International Uniform Chemical Information Database; the software format in which registration dossiers are prepared.

K

KKDİK

Regulation on the Registration, Evaluation, Authorisation and Restriction of Chemicals; Turkey's adaptation of REACH.

KKS

Chemical Registration System; the online platform through which registrations and notifications are submitted to the Ministry.

Restriction

Making the manufacture, placing on the market or use of certain substances conditional or prohibited (Annex 17).

L

Lead Registrant

The company that submits the lead dossier of the joint submission on behalf of the registrants of the same substance.

LoA

Letter of Access; a document granting the right of access to joint registration data.

M

MBDF

Substance Information Exchange Forum; the mandatory platform through which data sharing and joint submission is carried out for the same substance.

MoS

Margin of Safety; in cosmetic safety assessment, the ratio between exposure and the toxicological threshold.

O

Only Representative

A Turkey-based representative appointed by a foreign manufacturer to take on their KKDİK obligations.

Pre-MBDF Notification

A pre-notification process carried out by phase-in substances to benefit from the right to interim registration.

P

P Statement

Precautionary statement; describes the measures to be taken against a hazard (e.g. P280).

PBT / vPvB

Persistent, Bioaccumulative and Toxic / very Persistent and very Bioaccumulative substances; among the SVHC criteria.

PIC

Prior Informed Consent; a notification and consent mechanism for the export of hazardous chemicals (Rotterdam Convention).

Pictogram

A red-bordered, diamond-shaped label symbol that visually communicates a hazard.

PT (Product Type)

The 22-category classification system by which biocidal products are grouped according to their intended use.

Q

QSAR

Quantitative structure-activity relationship modelling; a scientific method used for prediction in the absence of test data.

R

Read-Across

Adapting data from structurally similar substances to a substance with a data gap, based on scientific justification.

REACH

The EU chemicals regulation (1907/2006/EC); the regulation on which KKDİK is based.

S

SEA

Regulation on the Classification, Labelling and Packaging of Substances and Mixtures; Turkey's adaptation of CLP.

SVHC

Substance of Very High Concern; CMR, PBT/vPvB or equivalent-concern substances placed on the candidate list.

T

Tonnage Band

The annual quantity range that determines registration requirements and timeline (1-10, 10-100, 100-1000, 1000+ t/y).

U

UZEM

National Poison Advice Centre; the authority to which hazardous mixture notifications are made.

CSR

Chemical Safety Report; a report documenting the life-cycle risk assessment of a substance for registrations above 10 t/year.

Cosmetic Product Safety Report

The mandatory safety report required before a cosmetic product is placed on the market in Turkey (the Turkish national equivalent of the EU's CPSR).

ÜTS

Product Tracking System; the national platform through which cosmetic product notifications are made.

H Statement

Hazard statement; describes the nature and degree of a hazard (e.g. H400).

Z

Hazard Class

The nature of a physical, health or environmental hazard (e.g. flammable liquids, skin corrosion, aquatic toxicity).