The European Medicines Agency (EMA) requires an Environmental Risk Assessment (ERA) for any human or veterinary product you want to market. The ERA will be part of the assessment report that needs to be submitted. An ERA is required for:
- All new marketing authorisation applications.
- Variations (type II).
- Line extensions (for medicinal products for human use if there is an increase in environmental exposure, e.g. a new indication may result in a significant increase in the extent of the use).
The ERA process consists of two phases:.
ERA phase 1 for veterinary products can be completed by answering questions in a decision tree. For medicinal products for human use, phase 1 is an exposure driven screening phase. When phase 1 shows that no environmental risk is expected, phase 2 is generally not necessary and the ERA is completed at this point. For some veterinary products and for substances that may affect the reproduction of vertebrates or lower animals at concentrations lower than a threshold value, phase 2 is always required!
ERA phase 2 is a full risk assessment based on environmental fate and effect data using a tiered approach. In tier A, a basic data set on environmental fate and effects is used to calculate no-effect concentrations. In tier B, the assessment is further refined when considered necessary. Also selection and assignment of appropriate control measures (risk mitigation measure) are to be considered.
ARCHE can help you in your preparation of the ERA and offers you the following services:
- Data evaluation and regulatory support
- Evaluating the risk to the aquatic and terrestrial environment
- Development of emission scenarios and exposure pathways
- Modelling the potential for environmental exposure of fish medicines used in aquaculture
- Calculation of predicted environmental concentrations (PECs) following the use of products in livestock
- Higher-tier aquatic and terrestrial field studies
- Identifying risk reduction strategies
- Liaison with the authorities
Endocrine disruptors are described as substances that may affect the production, release, transport, metabolism, binding, action, or elimination of hormones in the body.
The international community is involved in the evaluation and potential regulation of chemicals designated as endocrine disruptors. Chemicals are designated as such based on Tier 1 EDSP assays or other testing, and may be vulnerable in the EU; the new Pesticides Authorisation Regulation (EC 1107/2009, replacing directive 91/414/EEC) includes endocrine disruption as an exclusion criterion. Similar wording is under consideration in revision of the Biocides Directive (98/8) and the EU REACH regulation requires that endocrine disruptors progress to the stage of “authorisation” as substances of very high concern. Overall, being labeled as a potential endocrine disruptor based on screening results alone, without confirmatory Tier 2 testing, could result in increased regulatory pressure, market deselection, and or restrictions within the U.S. and abroad.
ARCHE expert scientists have been invited participants at workshops, conferences, and other scientific forums on endocrine disruption. Our experience and accomplishments include conducting and evaluating significant endocrine studies.
Our endocrine disruption consultation includes the following services:
- Identification of potential endocrine disruption issues in the environment
- Development of testing strategy
- Representation to national and international regulatory authorities
- EU REACH, Agrochemicals, and Biocides vulnerability and registration strategy
- Critical assessment of published chemical-specific literature compared to GLP study data