Changes from adopted text to adopted text

RemovedInformation shall be provided on the likelihood of each identified potential adverse effect. This shall be evaluated taking into consideration, as relevant, the characteristics of the receiving environment(s), the intended function, the dietary role, the expected level of use of the food and feed in the EU and the scope of the application for authorisation.

Removed(c) risk characterisation

RemovedThe applicant shall base its risk characterisation of NGT plants and foods and feed on information from hazard identification, hazard characterisation and exposure assessment. The risk shall be characterised by combining, for each potential adverse effect, the magnitude with the likelihood of that adverse effect occurring to provide a quantitative or semi quantitative estimation of the risk. Where relevant, the uncertainty for each identified risk shall be described.

RemovedAny information on hazard identification and characterisation specified under Parts 2 and 3 shall only be required if the specific characteristics and the intended use of the category 2 NGT plant or category 2 NGT food or feed give rise to a plausible risk hypothesis that can be addressed utilising the specified information.

RemovedPart 2 – Specific information for the environmental risk assessment of category 2 NGT plants concerning hazard identification and characterisation

Removed(1) Analysis of agronomic, phenotypic and compositional characteristics

Removed(2) Persistence and invasiveness

Removed(3) Potential gene transfer

Removed(4) Interactions of the NGT plant with target organisms

Removed(5) Interactions of the NGT plant with non-target organisms

Removed(6) Impacts of the specific cultivation, management and harvesting techniques

Removed(6a) Impacts on organic cultivation [Am. 79]

Removed(7) Effects on biogeochemical processes

Removed(8) Effects on human and animal health

Removed(8a) Effects on protecting and conserving biodiversity [Am. 80]

RemovedPart 3 – Specific information for the safety assessment of category 2 NGT food and feed concerning hazard identification and characterisation

Removed(1) Analysis of agronomic, phenotypic and compositional characteristics

Removed(2) Toxicology

Removed(3) Allergenicity

Removed(4) Nutritional assessment

RemovedAnnex III

RemovedTraits referred to in Article 6 and Article 22 [Am. 81]

RemovedPart 1

RemovedTraits justifying the incentives referred to in Article 22:

Removed(1) yield, including yield stability and yield under low-input conditions, provided that those traits also contribute to either point (2), (3) or (4) of this Annex; [Am. 82]

Removed(2) tolerance/resistance to biotic stresses, including plant diseases caused by nematodes, fungi, bacteria, viruses and other pests;

Removed(3) tolerance/resistance to abiotic stresses, including those created or exacerbated by climate change;

Removed(4) more efficient use of resources, such as water and nutrients;

Removed(5) characteristics that enhance the sustainability of storage, processing and distribution;

Removed(6) improved quality or nutritional characteristics;

Removed(7) reduced need for external inputs, such as plant protection products and fertilisers, if it does not contradict with Annex III, part 2. [Am. 83]

RemovedPart 2

RemovedTraits excluding the application of the incentives referred to in Article 22: tolerance to herbicides.