Test methods and validation
Bureau REACH and the Ministry of Infrastructure and Water Management created this animation on a European strategy for test methods and validation. This strategy is needed to make test methods more quickly available and acceptable within the legal requirements.
Chemical substances are all around us in every product.
For good reason. They improve these products.
By giving them color,
making them resistant to decay by UV,
fire, grease and dirt, organisms,
or adding other functionalities that enhance the product.
But chemical substances can also cause negative impacts.
They can be toxic.
Or do not break down in the environment.
Chemical substances can be toxic in many different ways.
Some may lead to organ failure or damage the nervous system.
Others may cause cancer or interrupt reproduction.
Some can cause an allergy or disrupt the endocrine system.
To get information on the hazards and risks
of chemical substances tests are performed.
Each hazard needs its own tests.
However, development of new tests is necessary
with increased relevance for upcoming challenges.
to be able to test new types of negative
impacts like endocrine disruption,
methods that are suitable for advanced materials
and methods that do not need laboratory animals.
To change from supply-driven to a
need-based test development process.
Luckily, new and updated methodologies are promising
and in various stages of development.
But all methods have limitations, new or old.
The biological and regulatory relevance
of the test methods needs to be established.
Therefore relevance, is a first important step for validation.
As a second step in validation, reliability
of a test needs to be determined.
Results of a test may differ under different conditions.
To learn if a new test method is reliable,
the test methods need to be able to reproduce
the same results under different conditions.
It should not matter who performs
the test or where it is carried out,
similar results should be obtained.
Together, well-established testing conditions
that produce reliable and relevant results
create trust in new testing methods.
Validated test methods are needed to
assess the safety of chemical substances
to avoid risks for health and environment.
Investing in timely validation is
essential for ongoing safety assessments.
An EU Strategy to ensure test method development
that reflects regulatory needs and ensures validation
would improve the societal impact of public spending.
This will also help prioritization
and coordination on EU level,
building trust among stakeholders,
and a level playing field.