The ERA has to take into account the relevant technical and scientific details regarding characteristics of:

The ERA may identify risks that require measures to manage them, and a risk management strategy should be defined.

The ERA provides the basis for the monitoring plans, which focus on adverse effects on human health and the environment.

This guidance note supplements Annex II to Directive 2001/18/EC and outlines the objectives and principles as well as the methodology for the ERA, in order to assist notifiers, to facilitate the performance by the competent authorities of a comprehensive and appropriate ERA under Directive 2001/18/EC and to make the process of ERA transparent to the general public.

Those notifications should contain a technical dossier of information including a full ERA in accordance with Article 6(2) and Article 13(2) of the Directive, the amount of detail needed to substantiate any point depending on its importance in the ERA.

The ERA therefore covers deliberate release (Part B) and placing on the market (Part C) as referred to in Directive 2001/18/EC.

The ERA should be carried out in a scientifically sound and transparent manner based on available scientific and technical data.

Notifiers must submit a notification including an ERA for deliberate release under Article 6(2) or for placing on the market under Article 13(2).

If new information on the GMO and its effects on human health or the environment becomes available, the ERA may need to be re-addressed in order to:

Information from releases of similar organisms and organisms with similar traits and their interaction with similar environments can assist the ERA.

The ERA should be conducted with a view to identifying if there is a need for risk management and if so, the most appropriate methods to be used (1).

But it is necessary, wherever possible, to have ERA results which are relative (compared with a non-GM reference, for instance), even if they are qualitative.

At this stage of the ERA, however, it is only necessary to consider the hazards introduced as a result of genetic modification that could cause adverse effects.

A general principle for ERA is also that an analysis of the 'cumulative long-term effects' relevant to the release and the placing on the market is to be carried out.

The ERA will serve as the basis for identifying the need for risk management and, if so, the most appropriate methods to be used, and for focused monitoring (see Chapter 3).

The result will depend on the circumstances of the case and the weighting of certain factors by the notifier, all of which should be set out clearly and justified in the recorded ERA.

In general there may be a difference between the ERA for deliberate release and that for placing on the market, due, for example, to the differences in existing data, time-scale and area.

Any reviews should consider the effectiveness, efficiency and accuracy of the ERA and risk management, taking account of data from research, other deliberate releases and monitoring data.

- an environment risk assessment (ERA) report prepared on basis of the information specified in Annexes III and IV of Directive 2001/18/EC and in accordance with Annex II of Directive 2001/18/EC;

The ERA should use the case-by-case principle because of the broad range of individual characteristics of different organisms (GMO by GMO) and different environments (site by site and region by region).

Phenotypic instability could result from interaction with the environment during cultivation, so the effects of environmental and agronomic factors on expression of transgenes should be considered in the ERA.

In accordance with the Commission communication on the principles and guidelines for the Community's audiovisual policy in the digital era fn, it is not for the Commission to judge on the fulfilment of quality standards:

As a general principle, the ERA should include the results of adequate research into the potential risks involved in the deliberate release or placing on the market of GMOs, along with any clearly documented comparable experience.

provide its expertise, submit ideas and make available its good offices and assistance to the core parties of the Peace Process in order to facilitate the conclusion of peace agreements and help prepare the "post peace era" in the Middle East,

Networking activities to create a broad knowledge base and, in the spirit of the European Research Area (ERA), more closely associate Member State laboratories, industry and regulators in the S& T support provided to the European Union policies.

The ERA should be carried out on a case by case basis, meaning that the required information may vary depending on the type of the GMOs concerned, their intended use and the potential receiving environment, taking into account, inter alia, GMOs already in the environment.

Environmental risk assessment (ERA) is defined in Article 2(8) of Directive 2001/18/EC as 'the evaluation of risks to human health and the environment, whether direct or indirect, immediate or delayed, which the deliberate release or the placing on the market of GMOs may pose'.

In the case of new information, irrespective of whether immediate measures need to be taken, there may have to be a new ERA to assess the need to change the terms of authorisation for the GMO's release or placing on the market, or to adjust risk management measures (see also Chapter 6).

Annex II describes in general terms the objective to be achieved, the elements to be considered and the general principles and methodology to be followed to perform the ERA, taking into account the impact on human health and the environment according to the nature of the organism introduced and the receiving environment.

In accordance with Annex II to Directive 2001/18/EC, the objective of an ERA is, on a case by case basis, to identify and evaluate potential adverse effects of the GMO, either direct and indirect, immediate or delayed, on human health and the environment which the deliberate release or placing on the market of GMOs may have.

Whereas an arrangement providing for cooperation in the peaceful applications of atomic energy would initiate a fruitful exchange of experience and technical development, open a new era for mutually beneficial action on both the governmental and industrial level, and reinforce solidarity within Europe and across the Atlantic;

- taking into account the above information and the ERA, a conclusion which proposes an appropriate risk management strategy which includes, as relevant to the GMO and product in question, a post-market monitoring plan and the identification of any special particulars which need to appear in the Summary of Product Characteristics, labelling and package leaflet;

On the basis of an ERA, carried out in accordance with the general principles and methodology outlined in sections 3 and 4, information on the points listed in sections D1 or D2 of Annex 11 to Directive 2001/18/EC should be included, as appropriate, in notifications with a view to assisting in drawing conclusions on the potential environmental impact from the release or the placing on the market of GMOs.

Council Directive 2000/79/EC of 27 November 2000 concerning the European Agreement on the Organisation of Working Time of Mobile Workers in Civil Aviation concluded by the Association of European Airlines (AEA), the European Transport Workers' Federation (ETF), the European Cockpit Association (ECA), the European Regions Airline Association (ERA) and the International Air Carrier Association (IACA) (Text with EEA relevance)

Whereas the Commission having examined the dossier and having taken into account all the information submitted by the authorities of the Member States, including extensive evidence of testing, has found that the potential risks for human health and the environment presented by the use of the genetically modified virus contained in Raboral V-RG (Vaccinia virus, Copenhagen strain, tk-phenotype, expressing glycoprotein G of the rabies virus, ERA strain) when used as an oral live antirabies vaccine for foxes and administered in bait, are not expected to be significant;

European Regions Airline Association (ERA)

The six steps in the ERA are set out in Chapter 4.2.

Ambrisentan is a non-sulphonamide (proprionic acid) ERA.

In drawing conclusions for the ERA referred to in Articles 4, 6, 7 and 13 of Directive 2001/18/EC, the following points should be addressed as main steps in the ERA.

contribute to the establishment of common scientific and technical reference systems within the ERA.

Ambrisentan is an orally active, propanoic acid-class, ERA selective for the endothelin A (ETA) receptor.

Bosentan is a dual endothelin receptor antagonist (ERA) with affinity for both endothelin A and B (ETA and ETB) receptors.

The development of common European systems of scientific and technical reference, as foreseen in the ERA, is an important step in this direction.

A general principle for ERA is also that an analysis of the "cumulative long-term effects" relevant to the release and the placing on the market is to be carried out.

an environment risk assessment (ERA) report prepared on basis of the information specified in Annexes III and IV of Directive 2001/18/EC and in accordance with Annex II of Directive 2001/18/EC;

While it is important to define the hazard as accurately as possible, it will, in many cases, be useful to consider hazards under the headings set out below, and then to specify the particular hazard identified for the purposes of ERA (for example, if in a specific case a potential for adverse effects on human health - allergenicity and toxigenicity - were identified, these should be considered separately in the ERA).

In accordance with the Commission communication on the principles and guidelines for the Community's audiovisual policy in the digital era(17), it is not for the Commission to judge on the fulfilment of quality standards:

the Association of European Airlines (AEA), the European Transport Workers' Federation (ETF), the European Cockpit Association (ECA), the European Regions Airline Association (ERA) and the International Air Carrier Association (IACA).

All parameters in the model were in line with those considered acceptable in the CVMP guideline (Environmental Impact Assessment for Veterinary Medicinal Products in support of the VICH guidelines GL6 and GL38 (EMEA/ CVMP/ ERA/ 418282/ 2005)).

In an open label study (AMB222), Volibris was studied in 36 patients to evaluate the incidence of increased serum aminotransferase concentrations in patients who had previously discontinued other ERA therapy due to aminotransferase abnormalities.