Existing test data for the Act on Registration & Evaluation, etc. of Chemical Substances

Article information

Environ Health Toxicol. 2015;30.e2015017

Publication date (electronic) : 2015 December 23

doi : https://doi.org/10.5620/eht.e2015017

Bong-In Choi¹, Byung-Taek Ryu¹, Suk-Hyun Na², Seon-Yong Chung^,2

¹Environmental Safety Center, Korea Environmental Corporation, Incheon, Korea

²Department of Environment and Energy Engineering, Chonnam National University, Gwangju, Korea

Correspondence: Seon-Yong Chung 77 Yongbong-ro, Buk-gu, Gwangju 61186, Korea Tel: +82-62-530-1858 Fax: +82-62-530-0742 Email: sychung@jnu.ac.kr

Received 2015 October 6; Accepted 2015 December 23.

Abstract

Introduction

The “Act on the Registration and Evaluation, etc. of Chemical Substances (K-REACH)” was enforced on January 1, 2015. Pursuant to the Act, any person who produces or imports over 1 ton of an existing chemical substance subject to registration, or any quantity of a new chemical substance, should register that chemical with the National Institute of Environmental Research [1]. The existing chemical substances subject to registration are expected to number approximately 2000 species, and the test data that should be submitted for registration vary according to the tonnage produced or imported (15 items required for 1 to 10 tons, 26 items for 10 to 100 tons, 37 items for 100 to 1000 tons, and 47 items for over 1000 tons) [2]. If these test data were all commissioned to test agencies, it is expected that the following expenses would be incurred: about 35 million Korean won (KRW) per substance for 1 to 10 tons; 96 million KRW per substance for 10 to 100 tons; 410 million KRW per substance for 100 to 1000 tons; and about 1.03 billion KRW per substance for over 1000 tons [3,4]. In order to minimize the expenses of registering existing chemical substances, the K-REACH only requires data for a single substance to be acquired once, and that data can be used across several registrations for that particular substance. Furthermore, previously generated test data can be used for registration if permission is granted from the owner of the test data, either for a fee or free of charge Meanwhile, non-testing data (test results predicted through Read Across, Quantitative Structure- Activity Relationships [QSARs], etc.) can also be used as registration data [5]. Considering that most of the existing chemical substances subject to registration have been produced or imported in excess of 1000 tons, the cost of producing test data for 2000 existing chemical substances subject to registration is expected to be nearly 2.06 trillion KRW. The extent to which this expense could be reduced depends on the amount of test data that already exists and the cost of using such data. In this regard, we examined 510 existing chemical substances that are subject to registration as notified in July 1, 2015, to identify the amount of existing test data that could be utilized when registering chemical substances in accordance with the K-REACH [6].

Materials and Methods

Results

Applicability of Existing Test Data for Health Hazards

Among the existing test data for health hazards, 6.5% of the required data was present at reliability 1, 30.2% was at reliability 2, 0.2% was at reliability 3, and for 63.1%, there was no existing test data. Under the assumption that only existing test data with reliability 1 would be recognized for registration according to the K-REACH, the applicability of existing test data for health hazards would be 6.5% (Table 1).

Table 1.

Analysis of existing test data for health hazards

Applicability of Existing Test Data for Environmental Hazards

Among the existing test data on environmental hazards, 5.4% of the required data was present at reliability 1, 17.3% was present at reliability 2, 0.1% was present at reliability 3, and for 77.2% no test data was available. It was assumed that existing test data with reliability 1 and 2 would be recognized as registration data for hydrolysis according to the pH and confirmation of degradation products, adsorption/desorption screening, additional information on the behavior/dynamics of degradation products, and additional information on adsorption/desorption, in accordance with the K-REACH. For other test data, only existing data with a reliability of 1 would be recognized as registration data. On this basis, the applicability of existing test data for environmental hazards would be 9.6% (Table 2).

Table 2.

Analysis of existing test data for environmental hazards

Discussion

The applicability of using existing test data based on 16 reference DBs from Korea and elsewhere was analyzed for 510 chemical species notified as being subject to registration in July 2015. Physicochemical properties were confirmed to have 48.4% applicability, which is somewhat high, while health hazards had 6.5% applicability and environmental hazards has 9.6%. Most of the existing test data provided by the reference DBs are not owned by the institutes providing the relevant DBs, who provide a summary and source of the test results. Thus, if the scope of this study is limited to the reference DBs identified, more existing test data may be utilized than is reported here. However, considering that currently about 350 of 510 species are registered in EU-REACH, more existing test data might be utilized in addition to that identified here, since some existing test data was not within the scope of this study (e.g., EU registration data). Furthermore, the K-REACH regulates non-test data (test results predicted through Read Across, QSARs, etc.), and the weight of evidence (test results predicted based on test data with low reliability) can also be utilized as registration data. It is therefore necessary to actively review the methods for utilizing such data. For reference, among the EU-REACH registration data (166876 cases as of October 1, 2013, announced by Eurpean Chemical Agency), test data were only submitted as registration data for 46.2% health hazards and 32.5% environmental hazards. Based on these considerations, chemical companies aiming to register existing chemical substances under the K-REACH would be able to reduce registration expenses by using a range of methods to utilize existing test data and non-testing data (Read Across, QSARs, etc.).

Supplementary Material

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