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. considers the impact on the environment caused by, for example, the introduction of GM plants, the use of certain substances in food, feed and plant protection products, or the introduction and spread of plant pests.

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In specific fields, such as GMOs or pesticides, EFSA is requested by EU legislation to carry out 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..

In addition to ERA, EFSA also assesses the risks posed to human and animal health by chemical contaminants or microbiological hazards which may be present in the environment and consequently may enter the food chain.

ERA helps policy makers and regulators take sound decisions that protect the environment.

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In July 2021, work started on a roadmap that will guide EFSA’s Building a European Partnership for Environmental Risk Assessment project (PERA). As a first step in the development of the roadmap, EFSA and its external contractor are reaching out to interested parties to gather their views, insights and advice. The aim of PERA is to facilitate the transition to more integrated – or systems-based – environmental risk assessment A specialised field of applied science that involves reviewing scientific data and studies in order to evaluate risks associated with certain hazards. It involves four steps: hazard identification, hazard characterisation, exposure assessment and risk characterisation. that addresses societal needs and policy targets in the European Union.

EFSA's role

EFSA provides independent scientific advice on all matters with a direct or indirect impact on food safety. Over time, the sustainability of food production practices has become an important concern. This is reflected in EU legislation, which increasingly request EFSA to include environmental risk assessment in its work, particularly for regulated substances and products such as GMOs, food additives and pesticides.
EFSA takes into account ERA in several fields.

Plant health

Council Directive 2000/29/EC establishes protective measures against the introduction into the EU of organisms harmful to plants or plant products and against their spread within the European Union. It contains lists of harmful organisms that threaten plant health in the European Union.

The PLH (Plant Health) Panel is currently developing a guidance document for the assessment of environmental risks posed by plant pests. Once finalised, the guidance will set out the methodology to be followed in carrying out ERA.

ERA in plant health will allow EFSA to assess the threat that plant pests, such as invertebrates, diseases and plants, pose to plant health in Europe. It will also help identify possible risk management The management of risks which have been identified by risk assessment. It includes the planning, implementation and evaluation of any resulting actions taken to protect consumers, animals and the environment. options and evaluate their effectiveness in reducing the risks to the environment.

Pesticides

Active substances used in pesticides can be authorised only if they have no harmful effects on human and animal health and do not cause unacceptable effects on the environment, considering in particular the contamination of water and the impact on non-target organisms (such as birds, mammals, aquatic organisms, bees, arthropods, soil organisms, flora). The ERA of pesticides assesses the impact that the use of pesticides has on non-target living organisms and on soil, water, and air.

EFSA coordinates the peer review of active substances used in pesticides in the European Union. Member States evaluate data submitted by companies applying for an authorisation and carry out the ERA. The draft assessment report is submitted to EFSA by a rapporteur Member State. Then EFSA reviews the ERA in close collaboration with scientific experts from the Member States and with input from the European Commission and the company. The public is also allowed to provide comments during the peer review through a public consultation launched on the EFSA website.

EFSA’s Panel on Plant Protection Products and their Residues (PPR) provides scientific advice on issues that cannot be resolved within the peer review of active substances, or when further scientific guidance is needed on more generic issues, commonly in the field of toxicology, eco-toxicology, fate and behaviour of pesticides. The Panel also reviews and updates existing guidance and develops new guidance documents for pesticides risk assessment.

Genetically modified organisms (GMO)

As part of its work on the safety assessment of GMOs, EFSA assesses for all GM applications not only possible adverse effects on human and animal health, but also the impact on the environment. This arises from the legal framework for the release of GMOs into the environment.

EFSA’s GMO Panel evaluates the ERA of GM plants and GM microorganisms, carried out by companies asking for a market authorisation. In the future EFSA’s GMO Panel may also become involved in such evaluations for GM animals.

The GMO Panel considers, for example, if GM plants have adverse effects on non-target organisms; if they are more persistent and/or invasive than their conventional counterparts, or what their impact on the biodiversity A term used to describe the variety of living organisms existing in a specific environment. would be.

The GMO Panel developed a guidance document for the risk assessment of GM plants and derived food and feed, that assists applicants in the preparation of their applications. The GMO Panel has updated its 2006 guidance with respect to environmental risk assessment, strengthening the requirements for GM applications submitted to EFSA for evaluation with respect to data generation, collection and analysis. In addition, specific guidance has been developed on the evaluation of possible effects of GM plants on non-target organisms. The revised guidelines are the result of two years’ work by scientists from all over Europe and demonstrate EFSA’s commitment to staying at the forefront of recent developments in the field of GM plant environmental risk assessment.

The GMO legislation requires applicants to monitor for possible environmental effects associated with the cultivation of GMOs following their introduction in the EU and to report findings on a regular basis to the Member States and the European Commission. During the pre-market risk assessment phase, EFSA’s GMO Panel looks at the scientific quality of the post-market environmental monitoring plan proposed by the applicant. Such a plan must be part of the application for a GMO intended for cultivation in the EU. The Panel has also published a scientific opinion Opinions include risk assessments on general scientific issues, evaluations of an application for the authorisation of a product, substance or claim, or an evaluation of a risk assessment. providing guidance to applicants on how to develop such plan. For those GMOs which were approved for cultivation, EFSA’s GMO Panel will also be able to assess the annual reports containing information gathered from the monitoring of GM plants authorised for cultivation in the EU.

To effectively assess the safety of GM animals for the environment, the GMO Panel will develop specific guidance for GM fish, GM insects, and GM mammals and birds.

Feed additives

Feed additives are products intentionally added to animal nutrition The science of how diet relates to the body's need for sustenance. for purposes of improving the quality of feed, the quality of food from animal origin, or to improve the animals’ performance and health. They can be released in the environment through animal faeces and urine.

Before being authorised, all feed additives must undergo a safety assessment, to make sure that they do not have adverse effects on animal health, human health or the environment.

To determine the environmental impact of feed additives, EFSA’s Panel on Additives and products or substances used in animal feed (FEEDAP) follows a stepwise approach.

A FEEDAP guidance document lists all information on the ERA of feed additives for aquatic and terrestrial environments. Its purpose is to provide support to the applicants for the preparation of dossiers and, at the same time, it lays down in a transparent way the principles FEEDAP follows in the environmental risk assessment of feed additives.

EU framework

ERA plays a key role in reaching the objectives of Europe 2020, a strategy put forward by the Commission that sets out a vision of Europe’s social market economy for the 21st century. One of the main goals of this strategy is environmental protection and ERA helps to inform decision making in this regard.

In the European Union, ERA is carried out by different advisory bodies under specific legal frameworks. EFSA carries out ERA for some products authorised under EU food law, such as pesticides, additives in animal feed, or GM food and feed which may involve risks to the environment. This risk assessment should be done in accordance with the relevant legislation.