Environmental risk assessment

Environmental risk assessment (ERA) The process of assessing potential harm to the environment caused by a substance, activity or natural occurrence. This may include the introduction of GM plants, the use of pesticides, or the spread of plant pests is a scientific process for identifying and evaluating threats to the environment, living organisms and their habitats, and ecosystems.

Some of those threats may come, for instance, from the introduction of genetically modified (GM) plants, the spread of plant pests, the application of pesticides or the use of certain substances in food and feed.

EFSA’s assessments of environmental risks inform the decisions taken by policy makers at EU and national level to protect the environment.

EFSA's role

We carry out environmental risk assessments for plant pests and regulated substances and products such as pesticides, GMOs and feed additives.

The environmental safety of these substances and products must be assessed before they can be authorised for use on the EU market.

We also assess risks that may enter the food chain through chemical contaminants and microbiological hazards already present in the environment.

Plant pests

EFSA’s Panel on Plant Health (PLH) is responsible for evaluating how plant pests may affect biodiversity A term used to describe the variety of living organisms existing in a specific environment and ecosystems.

We have also developed and tested a methodology to assess the effects of plant pests on ecosystem services Benefits to human or animal populations provided by an ecosystem, such as food or fuel provision, natural medicinal ingredients, and maintenance of soil fertility.

This approach is particularly useful for comparative assessments involving multiple pest A living organism (e.g. an insect, rodent, weed, fungus or virus) that is harmful to plants and/or their products (e.g. seeds, fruits)  species A subdivision of the genus, a species is a group of closely related and similar-looking organisms; for example, in the case of Homo sapiens (humans), the second part of the name (sapiens) represents the species and is now available for wider application.

Milestones for the ERA Environmental risk assessment (ERA) is the process of assessing potential harm to the environment caused by a substance, activity or natural occurrence. This may include the introduction of GM plants, the use of pesticides, or the spread of plant pests of plant pests

EU framework for the ERA of plant pests

Regulation (EU) 2016/2031 sets out rules for protective measures against plant pests.

Pesticides

The ERA of pesticides assesses the impact that the use of pesticides may have on non-target organisms (such as birds, mammals, aquatic organisms, bees, arthropods, soil organisms, flora) and on soil, water and air.

Genetically modified organisms (GMOs)

Our Panel of scientists examine whether genetically modified organisms (GMOs) could harm non-target species, become more invasive than conventional counterparts, or affect biodiversity.

We also evaluate ERAs submitted by companies seeking market authorisation for GM plants (mostly for import and processing) and microorganisms. We may potentially also be required to evaluate ERAs for GM animals in the future.

EU legislation requires companies to monitor and report any environmental effects of GMOs after their release, and we review the quality of these monitoring plans during the authorisation process.

We also evaluate annual reports on post-market environmental monitoring.

Milestones for the ERA of GMOs

EU framework for the ERA of GMOs

• Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms
• Regulation No 1829/2003 on genetically modified food and feed
• Commission Directive (EU) 2018/350 on the environmental risk assessment of genetically modified organisms
• European Commission: Europe 2020

Feed additives

EFSA’s Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) has a dedicated working group of experts for the ERA of feed additives.

They assess the safe release of these additives into the environment through animal faeces and urine.

Milestones in the ERA of feed additives

EU framework for the ERA of feed additives

• Regulation No 1831/2003 on additives for use in animal nutrition
• Regulation 429/2008 on the preparation and the presentation of applications and the assessment and the authorisation of feed additives