"危险成本效益分析"能否改善REACH下化学品的风险管理?
Jean-Marc Brignon1, Jean-Christophe Vergnaud2, Sandrine Andres1
1INERIS, Parc Technologique ALATA, BP 2, 60550, Verneuil-en-Halatte, France.
Regulatory toxicology and pharmacology : RTP
|January 21, 2024
概括
基于危险的成本效益分析 (CEA) 将化学危险数据纳入政策决策中. 这种方法提高了一致性,并简化了REACH法规下化学品的决策.
科学领域:
- 环境科学 环境科学
- 风险评估 风险评估
- 化学政策 化学政策
背景情况:
- 根据欧盟REACH法规,目前的成本效益分析 (CEA) 不包括化学危险概况,这可能会限制政策相关性.
- 在REACH中使用不同的经济决策支持方法 (PBT/vPvB的CEA,其他人的CBA),造成不一致.
- 对于化学品政策优先级的统一和危险意识框架的需求是显而易见的.
研究的目的:
- 开发和测试"危险"CEA框架,将化学危险得分纳入效果指标.
- 评估不同危险评分方法对PBT和非PBT化学品CEA结果的影响.
- 建议在REACH下为化学品监管提供一致和改进的决策工具.
主要方法:
- 通过将危险评分 (持久性,生物积累, (生态) 毒性) 整合到CEA影响指标中来定义"危险"CEA.
- 测试了各种危险CEA设计和参数化,使用REACH下对PBT和非PBT化学品的过去社会经济评估.
- 分析了危险评分权衡,值和评分方法设计对危险CEA结果的影响.
主要成果:
- 危险评分方法的设计显著影响危险CEA结果,而权重和值的影响最小.
- 建议采用基于风险原则的综合,未加权的评分方法,使用乘法公式.
- 危险CEA证明了对PBT和非PBT化学品的适用性,这表明统一的方法是可行的.
结论:
- 通过整合危险信息,危险CEA为REACH下化学品政策决策提供了一个一致的框架.
- 拟议的危险CEA方法可以简化监管机构的决策过程.
- 通过危险CEA可能会导致更明智和更协调的化学品优先级和政策.
更多相关视频
06:25Author Spotlight: High-Throughput Toxicity Screening Using Zebrafish Embryo Startle Response Assay
Published on: January 12, 2024
1.5K
10:13Eye Irritation Test EIT for Hazard Identification of Eye Irritating Chemicals using Reconstructed Human Cornea-like Epithelial RhCE Tissue Model
Published on: August 23, 2015
37.8K
相关概念视频
Hazard Ratio
128
The hazard ratio (HR) is a widely used measure in clinical trials to compare the risk of events, such as death or disease recurrence, between two groups over time. It reflects the ratio of hazard rates—the instantaneous risk of the event occurring—between a treatment group and a control group. This measure provides valuable insights into the relative effectiveness of a treatment by assessing how the risk of an event differs between the two groups.
For example, in a clinical trial...
For example, in a clinical trial...
128
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
129
Biopharmaceutical studies constitute a vital field aiming to enhance drug delivery methods and refine therapeutic approaches, drawing upon diverse interdisciplinary knowledge. In research methodologies, the choice between controlled and non-controlled studies significantly influences the study's reliability and accuracy.
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
129
Pharmacovigilance
835
Post-marketing surveillance is a critical component of pharmaceutical regulation, often uncovering unanticipated adverse drug reactions (ADRs) once a drug is widely used over an extended period.
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
835
Relative Risk
174
Relative risk (RR) is a statistical measure commonly used in epidemiology to compare the likelihood of a particular event occurring between two groups. This metric is important for evaluating the relationship between exposure to a specific risk factor and the probability of a particular outcome. It plays a crucial role in medical research, public health studies, and risk assessment. Relative risk quantifies how much more (or less) likely an event is to occur in an exposed group compared to an...
174
Drug Regulation
1.4K
Drug regulation encompasses the management of drug usage by evaluating its safety and efficacy through assessments conducted by regulatory authorities. Regrettably, the history of drug regulation is marred by several catastrophic events. One such incident is the Elixir Sulfanilamide tragedy, in which the toxic compound diethyl glycol was included in a sweet-tasting medication, leading to numerous fatalities. This event prompted the enactment of the Food, Drug, and Cosmetic Act in 1938. Under...
1.4K
Effects of Chemicals: Overview
1.3K
Drugs, encompassing various chemical compounds from natural sources, lab synthesis, or genetic engineering, elicit different biological responses in living organisms. Some of these responses are desirable or therapeutic, while others are undesirable. The primary goal of administering a drug is to achieve a therapeutic effect, that is, to address a specific disease or health condition. Any concurrent effects outside of this therapeutic outcome are considered undesirable. These undesirable...
1.3K
