녹색화학 관리기술 개발(I)

Abstract

○ 연구개발의 목적 및 필요성 < 화평법 등록대상물질 유해성정보지원시스템 > 화평법에 따른 등록대상 기존화학물질이 등록될 때 함께 제출되는 시험자료의 적합성 등을 판단하는 하는 참고자료로 활용하기 위해 (예상)등록대상 기존화학물질 1,530종에 대한 인체유해성, 환경유해성 및 물리화학적특성 자료를 수집/분석/평가하고, 그 결과를 DB로 구축 < 화학물질 사회경제성평가기법 개발 > 화학물질의 제한금지 제도는 화학물질 노출로 인해 위해도를 초과하는 경우, 또는 위해 관리 조치를 취했으나 위해도가 잘 관리되지 않는 경우, 물질, 혼합물 또는 완제품내의 물질 등의 제조, 유통, 사용을 제한하고자 하는 제도임. 이러한 제도를 통해 물질을 제한 또는 금지시킴으로써, 경제적·기술적으로 가능한 범위내에서 덜 위험한 물질 또는 덜 위험한 기술로의 대체를 궁극적인 목표로 삼고 있으며, 더 나아가 이 제도를 통해 화학물질의 위해로부터 사전 예방 원칙에 따라 국민의 건강 및 환경을 보호하고자 하는 위해 관리 수단임. 현재 국내에는 제한금지물질 지정을 위한 공식적인 기법(절차나 방법)이 부재한 상태임. 그동안은 과학적이고 표준화된 절차에 의해 지정을 했다기보다는 전문가적 논의를 통해 지정을 해왔음. 따라서 제한금지물질 지정과 관련한 근거 자료를 찾아볼 수 없는 상태임. 그러므로 보다 투명하고 객관적인 지정 절차나 방법이 필요함. 그러한 절차를 통해 지정되어야만 화학물질 사용 제한에 대해 산업체에 설득력 있고 객관적 자료를 제시할 수 있음. 2015년부터 국내에서는 EU REACH 에 상당하는 화학물질 등록 및 평가 등에 관한 법률(화평법)이 시행되고 있으며, 화평법 내의 제한금지물질의 지정에 대한 법을 이행하기 위해서는 반드시 지정 기법이나 적용에 대한 연구가 필요한 시점임. 그동안, EU REACH 제도하의 제한금지 제도가 논의되면서, 그에 유사한 수준의 제한금지물질 기법들이 검토되어왔으나, 아직까지 국내에서 적용 가능한 기법이 완전히 정립되어 있지 않고, 실제 사례 연구를 통해 기법을 적용한 사례도 없는 실정임. ○ 연구개발의 내용 및 범위 < 화평법 등록대상물질 유해성정보지원시스템 > 시험자료 구축대상 기존화학물질은 2015년 7월에 등록대상으로 고시된 510종은 물론 향후 등록대상으로 추가될 가능성이 높은 기존화학물질 1,530종을 선정 데이터베이스로 구축하고자 하는 시험자료는 화평법과 EU REACH에서 요구하는 65개 항목(물리화학적 특성 16개, 환경유해성 29개, 인체유해성 20개)을 대상으로 결정 시험자료 수집을 위한 Reference DB는 국립환경과학원과 협의를 통해 국내외 DB 16개를 선정하여 추진하였으며 수집한 시험자료의 신뢰도평가는 EU REACH 등에서 일반적으로 적용하고 있는 기준을 적용 < 화학물질 사회경제성평가기법 개발 > 국내 사회경제성평가(SEA) 적용을 위한 상세 기법 검토 및 사례 연구 (1차년도)로 국내 제한/금지물질 지정을 위한 사회경제성평가(SEA)의 국외 기법 검토 및 요소기술목록 도출. 2종 사례물질(CMR, R50~53)에 대한 SEA 평가를 통한 국내 자료 및 기술의 information&technology gap 분석. 제한금지물질 지정을 위한 SEA 기반 구축 (2차년도)으로 국내 SEA 도입을 위해 1차년도에 도출된 국내 관련 information&technology gap 최소화 방안 수입. 수입된 방안에 따른 국내 관련 SEA 자료 구축 및 요소 기술 개발. 제한금지물질 지정을 위한 SEA 시스템 개발 (3차년도)로 SEA를 위한 비용추정 기술 및 편익추정 기법 표준화. K-REACH를 위한 SEA표준프로토콜 제안 및 범용 프로그램(K-SEA) 개발. SEA를 통한 제한금지물질 지정 및 대체물질 적용성 평가 (4차년도)로 제한/금지에 따른 위해 관리 평가시 개발된 SEA 프로그램 적용성 평가. PFOS 및 대체물질에 대한 K-SEA 프로그램 적용성 및 신되로 분석. K-REACH에 적용할 수 있는 사회경제성분석 시스템 구축 (5차년도)으로 K-REACH 내 제한/금지물질 선정을 위한 사회경제성분석시스템(K-SEA System) 구축. K-SEA System 프로그램을 이용한 PFOS 및 대체물질의 제한금지물질 선정결과 제시. ○ 연구개발 결과 < 화평법 등록대상물질 유해성정보지원시스템 > 1차 년도에는 1그룹 물질 372종 중 80종에 대한 유해성정보를 수집？분석？평가하여 DB로 구축. 2차 년도에는 1그룹 물질 292종과 2그룹 물질 791종 중 108종에 대한 유해성정보를 DB로 구축하였으며 1그룹에 대한 자료 수집 및 평가를 완료. 3차 년도에는 2그룹 물질 중 350종에 대한 유해성정보를 구축. 4차 년도에는 2그룹 물질 일부(333종)와 사전예고 된 등록대상기존화학물질 일부(17종)에 대한 유해성정보를 구축하였고, 그간 엑셀파일형태로 구축된 DB의 활용성을 제고하기 위해 유해성정보지원시스템(Hazard Information Support System, HISS)을 개발. 5차 년도에는 3그룹 물질과 사전예고 된 등록대상기존화학물질 350종에 대한 유해성정보를 수집？ 분석？평가하여 DB를 구축하였으며 4차 년도 및 5차 년도에 엑셀기반으로 구축된 자료를 유해성정보지원시스템에 업로드 하였음. 연구 성과물은 국내 논문 1편(한국환경보건학회지, 2015.12월, Volume: 30, Article ID: e2015017, Existing test data for the Act on Registration & Evaluation, etc. of Chemical Substances)을 게재하였으며 지적재산권 등록 2건(프로그램 등록 2014년 12월 14일, HISS(유해성정보지원시스템), 제 C-2015-000183 호), 데이터베이스 등록 2014년 12월 15일, HISS(유해성정보지원시스템 데이터베이스), 제 D-2015-000001 호)이 있음. < 화학물질 사회경제성평가기법 개발 > 화평법 관리 하 화학물질의 제한/금지를 위한 평가 tool로써 사회경제성평가는 필요하며 그에 따른 한국형 사회경제성평가 프로그램을 도출하였으며, 관련하여 지침서를 작성하였다. 프로그램 내 세부 평가 항목으로써는 편익과 비용이며, 편익은 화학물질 사용으로 인해 인체에 영향을 미칠 수 있는 발암, 비발암 영향에 대해 제시하였다. 비용은 대상물질의 제한/금지 시 대체 화학물질 개발 및 공정, 설비 개선 비용 등에 대해 제시하였으며, 최종적으로 편익과 비용에 대한 B/C ratio를 확인할 수 있도록 하였다. 요소 기술들을 적용함으로써 프로그램을 제작하였으며, 큰 의미에서의 지침서를 작성함으로써 사회경제성평가 수행 시 적용 가능한 방법에 대해 도출하였다. 정부 및 업체 차원에서의 사회경제성 평가 수행을 위한 자료로써 사용에 대한 기여도가 클 것으로 판단된다. ○ 연구개발결과의 활용계획(기대효과) < 화평법 등록대상물질 유해성정보지원시스템 > 연구 성과물은 다음과 같이 4가지 분야에서 활용될 수 있을 것으로 예상됨 ① 등록대상기존화학물질 선정 시 활용(화평법에 따른 선정) ② 등록대상 화학물질 등록자료 면제여부 결정시 활용(화평법에 따른 결정) ③ 등록자료로 제출된 시험자료의 신뢰성 검토(화평법에 따른 검토) ④ 등록된 화학물질에 대한 유해성심사(화평법에 따른 심사) < 화학물질 사회경제성평가기법 개발 > 추가 연구의 필요성으로 연구를 통해 개발한 사회경제성평가 프로그램을 실제 사례에 대해 평가하고, 프로그램 적용 관련 과제를 도출할 수 있다. 타 연구에의 응용으로 기 수행되고 있는 화학물질 사회경제성평가 관련 과제에서의 응용이 가능하고 국내 편익 및 비용 추정 기법 연구 과제 등에서의 응용이 가능하다.

Ⅰ. Title ？ Total Prodect Name : Hazard Information Support System for Substances subject to Registration under the Act on Registration and Evaluation, etc. of Chemical Substances ("ARECs") (Subtitle: Data Collection and Evaluation of Toxicity, Physical, and Chemical Properties for Substances Subject to Registration) ？ (Commissioned Project 1) Project Title: Development of alternatives and socioeconomic analysis for designation as restricted or prohibited substances Ⅱ. Objectives & Necessity of the Research < Hazard Information Support System for Substances Subject to Registration under ARECs > To be used as reference materials for appropriateness evaluation of test materials submitted for registration on existing chemical substances under the ARECs, human risk, environmental damage, and physical & chemical properties data for 1,530 existing chemical substances subject to (expected) registration have been collected/analyzed/assessed with the results being established as database. < Development of Socioeconomic Analysis of Chemical Substances > The Restriction and prohibition system of chemical substances is a system to restrict manufacturing, distribution, and use of substances, or substances in a mixture or finished product, which may exceed risk level due to chemical substance exposure or of which the risk is not properly managed even with risk control measures. Based on this system, substances are to be restricted or prohibited, and by doing so, within an economically and technologically possible scope, substances or technologies will be replaced with those that are less riskier and it is the ultimate objective. Furthermore, it is a control vehicle to protect public health and environment in accordance with the precautionary principle against risk of chemical substances based on this system. Currently in Korea, there is no official technique (process or method) for designation of restricted or prohibited material. Until now, the designation has been done based on expert discussions, instead of following scientific and standardized procedures. Accordingly, it is not possible to look up to evidentiary material related to designation of restricted or prohibited substances. Going forward, more transparent and objective designation procedure or method will be required. Only when the designation is done through a procedure it will become possible to present persuasive and objective data to industries on restriction of chemical substance use. Since 2015, the legal system (the Act on Registration and Evaluation, etc. of Chemical Substances) on registration and assessment of chemical substances, which is equivalent to EU REACH, has come into effect in Korea. To implement the law on designation of restricted or prohibited substances under the ARECs, researches on designation technique or application must be required. At present, discussions have been made on restriction and prohibition system under the EU REACH system, and similar techniques on restricted or prohibited materials have been reviewed. However, a technique that can be applied in Korea has not yet been completely established and there is no case to which a technique has been applied based on actual case studies. Ⅲ. Contents and Scope < Hazard Information Support System for Substances Subject to Registration under ARECs > As for existing chemical substances subject to accumulation of test data, 510 substances that were notified as registration targets in July 2015 as well as 1,350 existing chemical substances, which are highly likely to be added as registration targets in the future, were selected. A decision was made on test data to be included in the database, and 65 items (16 physical and chemical properties, 29 environment risk, and 20 human risk-related items) that are required under the ARECs and EU REACH were selected. As for reference DB for collection of test data, 16 domestic and foreign databases were selected based on discussions with the National Institute of Environmental Research, and for reliability assessment of collected test data, general standards that are applied under the EU REACH, were used. < Development of Socioeconomic Analysis of Chemical Substances > As part of the efforts for detailed technology review and case researches (Year 1) for application of domestic socioeconomic analysis (SEA), foreign SEA technique review was done for designation of domestic restricted/prohibited substances together with identification of component technology list. Based on SEA on two case substances (CMR and R50~53), domestic data and information & technology gap analysis were conducted. To introduce SEA in Korea by setting up SEA basis (Year 2) for designation of restricted/prohibited substances, a method to minimize the information and technology gap in Korea identified in Year 1 was imported, and in line with the imported method, relevant SEA data and component technology were developed domestically. To set up the SEA system (Year 3) for designation of restricted/prohibited substances, the cost and benefit estimation technology for SEA was standardized. The SEA standard protocol was proposed and common program (K-SEA) was developed for K-REACH. For designation of restricted/prohibited substances based on SEA and applicability assessment of alternative substances (Year 4), applicability of SEA program, which was developed for hazard control assessment from restriction/prohibition, was reviewed. Applicability and reliability of K-SEA program on PFOS and alternative substances were analyzed. To establish socioeconomic analysis system (Year 5) to be applied for K-REACH, the K-SEA System was set up for selection of restricted/prohibited substance under K-REACH. By using the K-SEA System program, selection result of PFOS and restricted/prohibited substances by using K-SEA System program was presented. Ⅳ. Results < Hazard Information Support System for Substances Subject to Registration under ARECs > In Year 1, hazard information for 80 substances out of 372 in Group 1 were collected, analyzed and assessed and a database was set up. In Year 2, hazard information on 292 substances in Group 1 and 108 substances out of 791 in Group 2 were collected to build a database, and data collection and assessment for Group 1 was completed. In Year 3, hazard information on 350 substances among Group 2 substances was built. Then in Year 4, some (333) substances in Group 2 and part of existing chemical substances (17) subject to registration with advance notice were included for hazard information build-up, and to enhance utilization of DB, built as an excel format, the Hazard Information Support System (HISS) was developed. In Year 5, hazard information on substances in Group 3 and 350 existing chemical substances subject to registration were collected, analyzed and assessed and the database was set up, and excel-based data built in Year 4 and 5 was up-loaded in the Hazard Information Support System. As for research product, one paper was presented domestically (Korean Journal of Environmental Health, December 2015, Volume: 30, Article ID: e2015017, Existing test data for the Act on Registration & Evaluation, etc. of Chemical Substances), with two cases of the intellectual property rights registration (program registration on December 14, 2014, HISS, No. C-2015-000183, and database registration on December 15 2014, HISS, No. D-2015-000001). < Development of Socioeconomic Analysis of Chemical Substances > In Year 1, as part of the efforts for detailed technology review and case researches for application of domestic socioeconomic analysis (SEA), foreign SEA technique review was done for designation of domestic restricted/prohibited substances together with identification of component technology list. Based on SEA on two case substances (CMR and R50~53), domestic data and information & technology gap analysis were conducted. In Year 2, to introduce SEA in Korea by setting up SEA basis for designation of restricted/prohibited substances, a method to minimize the information and technology gap in Korea identified in Year 1 was imported, and in line with the imported method, relevant SEA data and component technology were developed domestically. In Year 3, to set up SEA system for designation of restricted/prohibited substances, cost and benefit estimation technology for SEA was standardized. SEA standard protocol was proposed and common program (K-SEA) was developed for K-REACH. In Year 4, for designation of restricted/prohibited substances based on SEA and applicability assessment of alternative substances, applicability of SEA program, which was developed for hazard control assessment from restriction/prohibition, was reviewed. Applicability and reliability of K-SEA program on PFOS and alternative substances were analyzed. In Year 5, to establish socioeconomic analysis system to be applied for K-REACH, the K-SEA System was set up for selection of restricted/prohibited substance under K-REACH. By using K-SEA System program, selection result of PFOS and restricted/prohibited substances by using K-SEA System program was presented. Ⅴ. Business Application Based on the Outcomes < Hazard Information Support System for Substances Subject to Registration under ARECs > It is expected that the research output can be utilized in the following four areas: ① Selection of existing chemical substances subject to registration (decision based on ARECs) ② Decision on registration data waiver for chemical substances subject to registration (decision based on ARECs) ③ Reliability review of test data submitted as registration data (decision based on ARECs) ④ Review of registered chemical substance hazard (decision based on ARECs) < Development of Socioeconomic Analysis of Chemical Substances > With additional researches required, actual cases on SEA program is to be assessed through researches, and program application-related tasks can be identified. As for application to other researches, it can be leveraged in SEA-related initiatives on chemical substances, and also in researches on cost-benefit estimation method in Korea.