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)

C. Confidentiality

Confidential parts of the report should be submitted in separate documents.

C.1. Applications submitted pursuant to Directive 2001/18/EC

Without prejudice to the provisions of Article 25 of Directive 2001/18/EC, the information provided in this report is not considered confidential.

This does not prevent the competent authority that issued the consent in accordance with Article 19 of Directive 2001/18/EC and the Commission from requesting additional information from the notifier, both confidential and non-confidential.

As far as possible, the report should not contain confidential data. In the case of confidential data, it should be provided in an Annex to the report, with a non-confidential summary or general description of these data, which will be made available to the public.

C.2. Applications submitted pursuant to Regulation (EC) No 1829/2003

As far as possible, the report should not contain confidential data. The report should clearly state which parts of the information provided are considered to be confidential, together with a verifiable justification for confidentiality in accordance with Article 30 of Regulation (EC) No 1829/2003. A non-confidential summary or general description of these data should be provided in the Annex to the report which will be made available to the public.

1. GENERAL INFORMATION

Where a crop is cultivated and processed or used for food/feed purposes, within the EU, a monitoring report for Cultivation must also be completed.

The decisions concerning 1507 maize (OJ L 291, 5.11.2005), MON 863 maize (OJ L 207, 10.8.2005) and NK603 maize (OJ L 295, 18.9.2004) were adopted pursuant to Directive 2001/18/EC for import and use as any other maize excluding cultivation.

2. EXECUTIVE SUMMARY

A summary of the monitoring results obtained and the overall conclusions drawn should be provided. Any proposed adaptation of the monitoring plan and associated methodology on the basis of these results and conclusions should be described.

3. GMO USES OTHER THAN CULTIVATION

3.1. Commodity imports into the Community

3.1.1. Commodity Crop (GM + non-GM) imports into the Community by country of origin

3.1.2. Commodity Crop (GM + non-GM) imports into the Community by country of destination

Details of the following should be provided in Tables 3.1.1 and 3.1.2. Actual data should be provided as opposed to estimated data (with the exception of GMO share in imports into the Community):

(a)

exporting country where GM crop is cultivated;

(b)

quantity in tons of commodity crop (GM + non-GM) exported;

(c)

Community Member States into which the commodity crop (GM + non-GM) is imported;

(d)

quantity in tons of commodity crop (GM + non-GM) imported.

3.1.3. Analysis of data provided in tables 3.1.1 and 3.1.2

Such analysis should outline the source of the data provided, whether the imports have increased or decreased on previous years and the reasons for any change, the largest suppliers of extra-Community crops to the Community as well as the main importers of extra-Community crops into the Community, any alteration in trends in relation to significant import markets compared to previous years and the reasons therefore.

3.2. General surveillance

3.2.1. Description of general surveillance

A description of the general surveillance carried out, including but not limited to details of all methodologies used including parameters observed, data collection methodologies, types of location.

3.2.2. Details of industry, environmental, food and/or feed related surveillance networks

Details of industry, environmental, food and/or feed-related surveillance networks used during the course of the general surveillance carried out should be provided. The following information in relation to each surveillance network identified should be provided:

(a)

name, identifying whether it is an industry, environment, food and/or feed related network;

(b)

Member States where the surveillance network is active and whether it is active at local, regional or national level;

(c)

website address;

(d)

protection goal;

(e)

how the network collects information relevant to general surveillance;

(f)

procedure for notifying adverse effects to the authorisation/consent holder;

(g)

criteria used to select the surveillance network.

3.2.3. Details of information and/or training provided to importers, traders, handlers, processors, etc.

Details of the information made available to importers, traders, handlers, processors etc., when and how this information was made available and the provisions for keeping the aforementioned user groups abreast of any changes to existing information or new information should be provided.

3.2.4. Results of general surveillance

Results of the general surveillance carried out including direct, indirect, delayed and/or cumulative effects observed, and in particular the nature of any adverse effects observed and conclusions drawn should be provided. The observed parameters for all monitoring methodologies should be analysed, interpreted and discussed in detail, while simultaneously demonstrating how these results support the overall conclusions arrived at by the authorisation/consent holder. This section of the report should be as detailed as possible to allow proper interpretation of the data.

3.2.5. Additional information

Where adverse or unanticipated effects were observed, additional information should be provided, such as the relevant region or location, steps taken to confirm the adverse effect, remedial action or risk-reducing measures that have been or will need to be implemented in view of the adverse effect, consequent implications for the environmental risk assessment and any other conclusions drawn. This section of the report should be as detailed as possible to allow proper interpretation of the data.

3.2.6. Review of peer-reviewed publications — Appendix

Peer-reviewed publications including peer-reviewed journal articles, conference proceedings, review papers and any additional studies or other sources of information relevant to the importation and processing and to food and/or feed use of the crop/trait combination for which the report is being drafted, should be considered and analysed in the context of the monitoring results and the monitoring plan. These publications should be listed, summarised and details provided as per the Appendix. The literature review should identify all relevant publications which have emerged during the reporting period. Conference proceedings, review papers and additional studies carried out by the consent holder which have not been subject to peer review may be provided where they are deemed to be relevant.

3.3. Case-specific monitoring

3.3.1. Results of case-specific monitoring (if applicable)

Case-specific monitoring requirements identified in the environmental risk assessment (ERA) and the corresponding decision, and the results of the case-specific monitoring carried out should be outlined including detailed information on the methodology, frequency, duration, monitoring results, analysis and conclusions. Under this section the authorisation/consent holder should demonstrate how the information was gathered and analysed in order to support the conclusions arrived at. This section of the report should be as detailed as possible to allow proper interpretation of the data.

3.3.2. Processing (if applicable)

The information set out in this section should only be provided where the authorisation or the monitoring plan requires the monitoring of accidental spillage and:

(a)

where processing takes place at sites other than within the confines of the port of importation; or

(b)

in respect of processing locations for GM crops cultivated within the Member State/the Community.

3.3.3. Monitoring and reporting of adverse effects resulting from Accidental Spillage (if applicable)

An overview of the measures taken to monitor accidental spillage should be provided where the authorisation/consent or the current monitoring plan requires such monitoring, e.g. the frequency with which monitoring is carried out, monitoring methodologies used, measures employed to minimise spillage and the clean-up procedures in place. In addition, any unusual, adverse or GMO-related effects observed should be noted. This information should be provided in respect of the following:

(a)

ports through which the GM crops are being imported and where processing takes place within the port boundaries;

(b)

those processing sites identified under Section 3.3.2.

3.4. Concluding remarks

Documentation received from surveillance networks or other surveillance methods in support of any aspect of the monitoring carried out should be annexed to the report and where relevant cross-referenced within the report. A summary of the monitoring results obtained via networks, the literature review and the overall conclusions drawn should be provided.

4. SUMMARY OF RESULTS AND CONCLUSIONS

A summary of the monitoring results obtained and the overall conclusions drawn should be provided. The summary should clearly demonstrate how the findings of the monitoring carried out and the interpretation of data support those conclusions.

5. ADAPTATION OF THE MONITORING PLAN AND ASSOCIATED METHODOLOGY FOR FUTURE YEARS

An assessment of the monitoring plan and associated methodology used for the purposes of the report should be provided. The effectiveness and limitations of the methodologies used to detect adverse effects should be considered and it should be specified whether the monitoring plan and the associated methodology may need to be modified or adapted in light of the monitoring information with respect to relevance and quality of the data collected and uncertainty of the results presented in the report.