The Importance of Ecotoxicology Testing
Ecotoxicology testing, or environmental toxicity testing, detects the effects of a substance on non-target organisms. Due to the complexity and importance of these studies, it’s essential to find an ecotoxicology testing partner with the experience, skills, and regulatory knowledge to successfully deliver accurate results on time.
Data from ecotoxicology studies has many uses, one of which is for classification and labelling whether that be through ECHA’s CLP (classification, labelling, and packaging) regulations or similar systems like United Nation’s GHS (Global Harmonised Systems). Ecotoxicology studies also form one part of an environmental risk assessment.
Ecotoxicology Studies with Regulatory Support
Timing is of the essence when it comes to having the right testing data and it’s important to understand the nuances of when your study data is needed. Our regulatory services team can ensure you have the right regulatory knowledge to guide your testing program.
Re-examining DART Dose Level Selection for ECHA Submissions
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Data Submission for Ecotoxicology Studies
Ecotoxicology testing for agrochemicals and biocides needs to be completed before substances are permitted on the market. Data needs to be submitted to EFSA for active agrochemical substances, ECHA for biocide active substances, and EU member states for both sets of finished products. Testing of pharmaceuticals is also required before the submission of a Marketing Application for Authorization (MAA) to the European Medicines Agency (EMA), or a new drug application (NDA) to the Food and Drug Administration (FDA).
However, when it comes to industrial chemicals, substances need to be registered and do not require an authorization before being placed on the market. For these chemicals, risk mitigation measures are needed in case a risk is identified. Data from ecotoxicology studies for chemical substances are submitted to REACH, UK REACH, US/CA/Australia (EPA), and/or other global regulatory bodies.
Ecotoxicology studies fall into two groups; aquatic ecotoxicology and terrestrial ecotoxicology.
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