The Korea Chemicals Management Association (KCMA) issued the guidance on data and cost sharing for joint registration under the Act on the Registration and Evaluation of Chemical Substances (K-REACH).
Contents:
Chapter 1 Introduction
1. Meaning and purpose
2. Structure of guidebook
Chapter 2 Major legal matters
1. Overview
2. Method for submitting data when applying for registration of phase-in substance
3. Joint use of phase-in registration application data
4. Special case on vertebrate animal test data
Chapter 3 How to submit data when applying for registration of phase-in substances
1. Identification of chemical substances
2. Formation of consortium among obligators of joint submission of registration application data
3. Selection of lead registrant
4. Data sharing for joint submission of registration application data
5. Confirming individual submission of registration application data
Chapter 4 Joint use of existing data
1. Method of joint use of existing registration application data
2. Special cases on vertebrate animal test data
Chapter 5 Calculation and sharing of costs
1. Fair and transparent basis
2. Evaluation of test data
3. Method of cost sharing
2. Excerpt from the relevant legislation
3. Sample Agreement for Joint Submission of Chemical Substance Registration Application Data