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PRINCIPLES FOR THE ENVIRONMENTAL RISK ASSESSMENT This Annex 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 environmental risk assessment (e.r.a.) referred to in Articles 4 and 13. Technical guidance notes may be developed in accordance with the regulatory procedure referred to in Article 30(2) in order to facilitate the implementation and explanation of this Annex. With a view to contributing to a common understanding of the terms ‘direct, indirect, immediate and delayed’ when implementing this Annex, without prejudice to further guidance in this respect and in particular as regards the extent to which indirect effects can and should be taken into account, these terms are described as follows:

— ‘direct effects’ refers to primary effects on human health or the environment which are a result of the GMO itself and which do not occur through a causal chain of events;

— ‘indirect effects’ refers to effects on human health or the environment occurring through a causal chain of events, through mechanisms such as interactions with other organisms, transfer of genetic material, or changes in use or management. Observations of indirect effects are likely to be delayed;

— ‘immediate effects’ refers to effects on human health or the environment which are observed during the period of the release of the GMO. Immediate effects may be direct or indirect;

— ‘delayed effects’ refers to effects on human health or the environment which may not be observed during the period of the release of the GMO, but become apparent as a direct or indirect effect either at a later stage or after termination of the release.

A general principle for environmental risk assessment 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. ‘Cumulative long-term effects’ refers to the accumulated effects of consents on human health and the environment, including inter alia flora and fauna, soil fertility, soil degradation of organic material, the feed/ food chain, biological diversity, animal health and resistance problems in relation to antibiotics. A. Objective The objective of an e.r.a. 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 the placing on the market of GMOs may have. The e.r.a. 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. B. General Principles In accordance with the precautionary principle, the following general principles should be followed when performing the e.r.a.:

— identified characteristics of the GMO and its use which have the potential to cause adverse effects should be compared to those presented by the non-modified organism from which it is derived and its use under corresponding situations;

— the e.r.a. should be carried out in a scientifically sound and transparent manner based on available scientific and technical data;

— the e.r.a. 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, i.a., GMOs already in the environment;

— if new information on the GMO and its effects on human health or the environment becomes available, the e.r.a. may need to be readdressed in order to:

— determine whether the risk has changed;

— determine whether there is a need for amending the risk management accordingly. C. Methodology Guidance issued by the European Food Safety Authority is available for the implementation of this section for Part C notifications. C.1. General and specific considerations for the e.r.a.

1. Intended and unintended changes

As part of the identification and evaluation of the potential adverse effects referred to in Section A, the e.r.a shall identify the intended and unintended changes resulting from the genetic modification and shall evaluate their potential to cause adverse effects on human health and on the environment. Intended changes resulting from the genetic modification are changes that are designed to occur and which fulfil the original objectives of the genetic modification. Unintended changes resulting from the genetic modification are consistent changes which go beyond the intended change(s) resulting from the genetic modification. Intended and unintended changes can have either direct or indirect, and either immediate or delayed effects on human health and on the environment.

2. Long-term adverse effects and cumulative long-term adverse effects in the e.r.a. of Part C notifications Long-term effects of a GMO are effects resulting either from a delayed response by organisms or their progeny to long-term or chronic exposure to a GMO or from an extensive use of a GMO in time and space.

The identification and evaluation of the potential long-term adverse effects of a GMO on human health and on the environment shall take into account the following:

(a) the long-term interactions of the GMO and the receiving environment;

(b) the characteristics of the GMO which become important on a long-term basis;

(c) data obtained from repeated deliberate releases or placings on the market of the GMO over a long period. The identification and evaluation of the potential cumulative long-term adverse effects referred to in the introductory part of Annex II shall also take into account the GMOs deliberately released or placed on the market in the past.

3. Quality of the data In order to carry out an e.r.a. for a notification under Part C of this Directive, the notifier shall collate already available data from scientific literature or from other sources, including monitoring reports, and shall generate the necessary data by performing, where possible, appropriate studies. Where applicable, the notifier shall justify in the e.r.a. why generating data by studies is not possible.

The e.r.a. for notifications under Part B of the Directive shall be based at least on already available data from scientific literature or from other sources and may be supplemented by additional data generated by the notifier. Where data generated outside Europe is provided in the e.r.a., its relevance to receiving environment(s) in the Union shall be justified. Data provided in the e.r.a for notifications under part C of this Directive shall comply with the following requirements:

(a) where toxicological studies carried out to assess risk to human or animal health are provided in the e.ra., the notifier shall provide evidence to demonstrate that they were conducted in facilities which comply with:

(i) the requirements of Directive 2004/10/EC; or (ii) the ‘OECD Principles on Good Laboratory Practice’ (GLP), if carried out outside the Union;

(b) where studies other than toxicological studies are provided in the e.r.a., they shall:

(i) comply with the principles of Good Laboratory Practice (GLP) laid down in Directive 2004/10/EC, where relevant; or (ii) be conducted by organisations accredited under the relevant ISO standard; or (iii) in the absence of a relevant ISO standard, be conducted in accordance with internationally recognised standards;

(c) information on the results obtained from the studies referred to in points (a) and (b) and on the study protocols used shall be reliable and comprehensive and shall include the raw data in an electronic format suitable for carrying out statistical or other analysis;

(d) the notifier shall specify, where possible, the size of effect that each study performed intends to detect and justify it;

(e) the selection of sites for field studies shall be based on relevant receiving environments in view of the potential exposure and impact that would be observed where the GMO may be released. The selection shall be justified in the e.r.a.;

(f) the non-genetically modified comparator shall be appropriate for the relevant receiving environment(s) and shall have a genetic background comparable to the GMO. The choice of the comparator shall be justified in the e.r.a.

4. Stacked transformation events in Part C notifications The following shall apply to the e.r.a. of a GMO containing stacked transformation events in Part C notifications:

(a) the notifier shall provide an e.r.a. for each single transformation event in the GMO or refer to already submitted notifications for those single transformation events;

(b) the notifier shall provide an assessment of the following aspects:

(i) the stability of the transformation events;

(ii) the expression of the transformation events;

(iii) the potential additive, synergistic or antagonistic effects resulting from the combination of the transformation events;

(c) where the progeny of the GMO can contain various subcombinations of the stacked transformation events, the notifier shall provide a scientific rationale justifying that there is no need to provide experimental data for the concerned subcombinations, independently of their origin, or, in the absence of such scientific rationale, shall provide the relevant experimental data. C.2. Characteristics of the GMO and of the releases The e.r.a. shall take into account the relevant technical and scientific details regarding characteristics of:

— the recipient or parental organism(s),

— the genetic modification(s), be it insertion or deletion of genetic material, and relevant information on the vector and the donor,

— the GMO,

— the intended release or use including its scale,

— the potential receiving environment(s) into which the GMO will be released and into which the transgene may spread, and — the interaction(s) between these characteristics.