Pharmaceuticals in the environment
Environmental Risk Assessment to fulfill EMA requirements
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
Emerging issues: endocrine disruption
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
brochure
Download our pharmaceuticals in the environment brochure
Keep track of our latest news
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BIOCIDES 2011 conference in Vienna
ARCHE attended the 14th International annual conference in Vienna (Austria) (28-30th November 2011). The conference is organized by Feierl-Herzele GmbH, that also operates the European Biocides Information Network (https://www.europeanbiocides.net). This fully booked conference is greatly appreciated by participants by its interactive nature and the presence of both industry and government representatives. Click to the right to read on.
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EQSPAE conference in Hong-Kong
ARCHE presented at the International EQSPAE Conference 2011. With this conference, Hong Kong University and SETAC aim to provide an international platform for sharing knowledge on the advancement in the scientific derivation of EQ benchmarks for the protection for aquatic ecosystems and human health. Click to the right to read on.
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The launch of our new website
As you may have noticed by now, we have a new website. And we're quite happy about it too! Click on the arrow on the right for more information.
Meet us at these upcoming events
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VLARIP EVENT REACH: de uitdagingen voor 2012
ARCHE is exhibiting at the yearly VLARIP networking event to be held on 2 February 2012 in Zwijnaarde
Topic: REACH: de uitdagingen voor 2012/the challenges for 2012
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QSAR Workshop
ARCHE invites you to join us at a QSAR workshop to be held 16 February 2012 in Ghent.
Topic: Save resources using QSARs in fulfilling your 2013 registration testing obligations under REACH.
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6th SETAC World Congres
ARCHE is exhibiting at the 6th SETAC World Congress to be held 20-24 May 2012 in Berlin. In addition we are co-chairing a session on "Collection and use of monitoring data for environmental risk assessment of chemicals" scheduled on wednessday 23 May in the morning.
Topic: Securing a sustainable future: integrating science, policy and people
