Part.3 - How the EU ensures the safety of plastics
04.
When it comes to better understanding the fate and the effects of a given chemical on the body, there are generally three kinds of scientific studies : Exploratory studies, regulatory studies, and epidemiological studies.
Research on emerging questions that haven’t been studied yet, e.g. clarifying pathways (absorption, metabolism, excretion) or developing new predictive test methods.
Their goal is not to determine if a product is safe under real life conditions, but to fill a knowledge gap in science.
These are called EXPLORATORY STUDIES.
Often, these experiments are conducted to highlight effects in specific situations which are not necessarily reflective of the actual conditions of use by humans.
For example, isolated cells, tissues or animals, are exposed to various doses, for very long periods, or by direct intravenous injection, which never happens in real life.
The limitations of exploratory studies are usually known, as they can be drawn from the publication itself : unrealistic protocols, low statistical power (lack of controlled factors, small number of samples or data…), need for replication of the study…
01. What studies are behind the regulations?
04.
When it comes to better understanding the fate and the effects of a given chemical on the body, there are generally three kinds of scientific studies : Exploratory studies, regulatory studies, and epidemiological studies.
Research on emerging questions that haven’t been studied yet, e.g. clarifying pathways (absorption, metabolism, excretion) or developing new predictive test methods.
Their goal is not to determine if a product is safe under real life conditions, but to fill a knowledge gap in science.
These are called EXPLORATORY STUDIES.
Often, these experiments are conducted to highlight effects in specific situations which are not necessarily reflective of the actual conditions of use by humans.
For example, isolated cells, tissues or animals, are exposed to various doses, for very long periods, or by direct intravenous injection, which never happens in real life.
The limitations of exploratory studies are usually known, as they can be drawn from the publication itself : unrealistic protocols, low statistical power (lack of controlled factors, small number of samples or data…), need for replication of the study…
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