Commission Decision of 13 October 2009 establishing standard reporting formats for presenting the monitoring results of the deliberate release into the environment of genetically modified organisms, as or in products, for the purpose of placing on the market, pursuant to Directive 2001/18/EC of the European Parliament and of the Council (notified under document C(2009) 7680) (Text with EEA relevance) (2009/770/EC)

A. General comments

Case-specific monitoring should be carried out in accordance with the conditions set out in the consent/authorisation and in accordance with the monitoring plan specified in the notification.

General surveillance for unanticipated or unforeseen adverse effects should also be considered as a compulsory part of the monitoring plan.

Adverse effects should be considered in the light of the crop, the new trait, the receiving environment as well as the conclusions of the environmental risk assessment which is carried out on a case-by-case basis. The following constitutes a non-exhaustive list of effects and consequences or outcomes that could result in adverse environmental effects:

(a)

persistence and invasiveness, selective advantage or disadvantage, including:

• increased occurrence of volunteers,

• increased establishment of the genetically modified (GM) plant outside of the fields,

• increased spread, persistence and accumulation of the GM plant in the environment (including out-crossing with wild relatives),

• increased spread of GM plant products in the environment;

(b)

altered gene transfer:

• potential reduction of pollination,

• increased frequency of horizontal gene transfer from plant to microbial populations;

(c)

interaction between GM plant and target organisms:

• reduced abundance and diversity of weeds,

• development of resistance in pest populations,

• development of resistance in plants,

• development of secondary pests;

(d)

interaction between GM plant and non-target organisms:

• direct/indirect impact on non-target organisms,

• changes in susceptibility to non-target pests and diseases;

• impact on habitat diversity and biodiversity;

(e)

changes in biogeochemical processes;

(f)

changes in cultivation practices;

(g)

impact on human and animal health resulting from environmental exposure.