2009/770/EC: 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)

• CELEX: Directive 2001/18/EC
• Articles: 4

Article 1

The reporting formats set out in Annexes I and II shall be used as technical guidance notes in order to facilitate the implementation and explanation of Annex VII to Directive 2001/18/EC.

Article 2

This Decision is addressed to the Member States.

Schedules & Appendices

ANNEX I

ANNEX I

MONITORING REPORT FOR CULTIVATION

Format for presenting the monitoring results for the Cultivation of genetically modified organisms in accordance with: Articles 19(3), 20(1) and Annex VII to Directive 2001/18/EC and Articles 9(1) and 21(1) of Regulation (EC) No 1829/2003

1.    General information

1.1.

Crop/trait(s): …

1.2.

Decision authorisation number pursuant to Directive 2001/18/EC, and number and date of consent pursuant to Directive 2001/18/EC: …

1.3.

Decision authorisation number and date of authorisation pursuant to Regulation (EC) No 1829/2003: …

1.4.

Unique identifier: …

1.5.

Reporting period from xx/xx/xx to xx/xx/xx

1.6.

Other monitoring reports have been submitted in respect of:

Import and processing

:

Yes



No



Food/Feed

:

Yes



No



2.    Executive summary

3.    Monitoring results

The following sections should be completed in accordance with Appendix 2

3.1.   General surveillance

3.1.1.

Description of general surveillance

3.1.2.

Details of surveillance networks used to monitor environmental effects during general surveillance and description of other methodologies

3.1.3.

Details of information and/or training provided to operators and users, etc.

3.1.4.

Results of general surveillance

3.1.5.

Additional information

3.1.6.

Review of peer-reviewed publications — Appendix

3.2.   Case-specific monitoring

3.2.1.

Description and results of case-specific monitoring (if applicable)

3.2.2.

Monitoring and reporting of adverse effects resulting from accidental spillage (if applicable)

3.3.   Concluding remarks

4.    Summary of results and conclusions

5.    Adaptation of the monitoring plan and associated methodology for future years

Signed: …

Date: …

ANNEX II

ANNEX II

MONITORING REPORT FOR GMO USES OTHER THAN CULTIVATION

Format for presenting the monitoring results for GMO uses other than cultivation in accordance with: Articles 19(3), 20(1) and Annex VII to Directive 2001/18/EC and Articles 9(1) and 21(1) of Regulation (EC) No 1829/2003

1.    General information

1.1.

Crop/trait(s): …

1.2.

Decision authorisation number pursuant to Directive 2001/18/EC and number and date of consent pursuant to Directive 2001/18/EC: …

1.3.

Decision authorisation number and date of authorisation pursuant to Regulation (EC) No 1829/2003: …

1.4.

Unique identifier: …

1.5.

Reporting period from xx/xx/xx to xx/xx/xx

1.6.

Other monitoring reports have been submitted in respect of:

Cultivation

:

Yes



No



2.    Executive summary

The following sections must be completed in accordance with Appendix 2 .

3.    Uses of GMOs other than cultivation

Please note that this section relates to the monitoring of the environmental effects of GMO uses other than cultivation. Such uses include the use of Food and Feed containing or consisting of GMOs (living organisms).

3.1.   Commodity imports into the Community

3.1.1.

Commodity crop (GM + non-GM) imports into the Community by country of origin

Country of origin

Quantity

(tons)

Estimated data of GMO share in imports

(where not possible approximate share of cultivation in the country of origin)

3.1.2.

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

Country of destination

Quantity

(tons)

3.1.3.

Analysis of data provided in tables 3.1.1 and 3.1.2

3.2.   General surveillance

3.2.1.

Description of general surveillance

3.2.2.

Details of industry, environmental, food and/or feed related surveillance networks used during general surveillance

3.2.3.

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

3.2.4.

Results of general surveillance

3.2.5.

Additional information

3.2.6.

Review of peer-reviewed publications — Appendix

3.3.   Case-specific monitoring

3.3.1.

Description and results of case-specific monitoring (if applicable)

3.3.2.

Processing (if applicable)

EU Member State

Point of entry/site of cultivation

Point of processing

Distance from point of entry/site of cultivation

Transport used

3.3.3.

Monitoring and reporting of adverse effects resulting from accidental spillage (if applicable)

3.4.   Concluding remarks

4.    Summary of results and conclusions

5.    Adaptation of the monitoring plan and associated methodology for future years

Signed: …

Date: …