Chemical Compliance
Intelligence & Solutions
Guidance on Data and Cost Sharing
Local Title:
등록신청자료 공유와 비용분담에 관한 안내서
Country/Region:
South Korea
Competent Authority:
Korea Chemicals Management Association
Type:
Regulation
Status:
In force
Release Date:
2015-01-07
Implementation Date:
2015-01-07
Document
Language Source Title Access
KO
Official Guidance on Data and Cost Sharing_Draft_Korean
KO
Official Guidance on Data and Cost Sharing_Final ver._Korean
South Korea: Guidebook on Registration Data Sharing and Cost Sharing
File Language : EN
$ 649
Summary

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

Obligations