COMMISSION DECISION of 11 February 1992 concerning the summary notification information format referred to in Article 12 of Council Directive 90/220/EEC (92/146/EEC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Economic Community,

Having regard to Council Directive 90/220/EEC of 23 April 1990 on the deliberate release into the environment of genetically modified organisms (1), and in particular Article 12 thereof,

Whereas the competent authorities appointed by the Member States shall forward to the Commission dossiers for notifications received under Part C of Directive 90/220/EEC;

Whereas each dossier forwarded to the Commission shall include a summary of the notification;

Whereas the Commission is required to establish, before 23 October 1991, the format of this summary;

Whereas the provisions of this Decision have received the favourable opinion of the Committee of Member State Representatives in accordance with the procedure laid down in Article 21 of Directive 90/220/EEC,

HAS ADOPTED THIS DECISION:

Article 1

The competent authorities appointed by Member States under Directive 90/220/EEC must use the annexed Summary Notification Information Format when sending to the Commission the summary of a notification received, as specified under Part C of Directive 90/220/EEC.

Article 2

This Decision is addressed to the Member States. Done at Brussels, 11 February 1992. For the Commission

Carlo RIPA DI MEANA

Member of the Commission

(1) OJ No L 117, 8. 5. 1990, p. 15.

ANNEX

SUMMARY NOTIFICATION INFORMATION FORMAT FOR PRODUCTS CONTAINING GENETIALLY MODIFIED ORGANISMS (GMOS)

in accordance with Article 12 of Directive 90/220/EEC

INTRODUCTION

The present document is designed to serve as the format of the summary of the dossier submitted to the Commission for the placing on the market of a product containing GMOs (Part C, Article 12 (3) of Directive 90/220/EEC) and does not prejudice the provisions of Directive 90/220/EEC. The summary notification information format for products containing GMOs when completed will contain a summary of the information entered under the corresponding points of the full dossier. It is, therefore, recognized that the risk assessment stipulated by Directive 90/220/EEC, Article 12, cannot be carried out on the basis of the summary. A. GENERAL INFORMATION 1. Details of notification

(a) Member State of notification

(b) Notification number

(c) Name of the product (commercial and other names)

(d) Date of acknowledgement of notification

2. Notifier / manufacturer / importer

(a) Name of notifier

(b) Address of notifier

(c) The notifier is:

domestic manufacturer

importer

(d) In case of import

(i) Name of manufacturer

(ii) Address of manufacturer

3. Characterisation of the GMOs contained in the product

Indicate the name and nature of each type of GMO contained in the product

4. General description of the product

(a) Type of product

(b) Composition of the product

(c) Specificity of the product

(d) Types of users

(e) Exact conditions of use and handling

(f) Geographical areas for which the product is intended

(g) Type of environment for which the product is suited

(h) Annual estimated production in and/or imports into the Community

5. Has the combination of GMOs contained in the product been notified under part B of Directive 90/220/EEC?

Yes No

(i) If yes, give country and notification number:

(ii) If no, refer to risk analysis data on the basis of the elements of Part B of Directive 90/220/EEC.

6. Is the product being simultaneously notified to another Member State?

Yes No

If yes, please specify

7. Has another product with the same combination of GMOs been placed on the EC market by another notifier?

Yes No Not known

If yes, please specify

8. Information on releases of the same GMOs or of the same combination of GMOs previously or currently notified and/or carried out by the notifier either inside or outside the Community

9. Specify instructions and or recommendations for storage and handling

10. Proposed packaging

11. Proposed labelling

12. Measures to take in case of unintended release or misuse

13. Measures for waste disposal and treatment

B. NATURE OF THE GMOS CONTAINED IN THE PRODUCT INFORMATION RELATING TO THE RECIPIENT OR PARENTAL ORGANISM(S) FROM WHICH THE GMO IS DERIVED

14. Scientific name and other names

15. Phenotypic and genetic traits

16. Geographical distribution and natural habitat of the organisms

17. Genetic stability of the organism and factors affecting it

18. Potential for genetic transfer and exchange with other organisms

19. Information concerning reproduction and factors affecting it

20. Information on survival and factors affecting it

21. Ways of dissemination and factors affecting it

22. Interactions with the environment

23 (a) Detection techniques

23 (b) Identification techniques

24. Classification under existing Community rules concerning the protection of human health and/or the environment

25 (a) Pathogenic characteristics

25 (b) Other harmful characteristics of the organism living or dead, including its extracellular products

26. Nature and description of known extrachromosomal genetic elements

27. History of previous genetic modifications

INFORMATION RELATING TO THE GENETIC MODIFICATION

28. Methods used for the genetic modification

29. Characteristics of the vector

(a) Nature and source of the vector

(b) Description of the vector construction

(c) Genetic map and/or restriction map of the vector

(d) Sequence data

(e) Information on the degree to which the vector contains sequences whose product or function area is not known

(f) Genetic transfer capabilities of the vector

(g) Frequency of mobilization of the vector

(h) Part of the vector which remains in the GMO

30. Information on the insert

(a) Methods used to construct the insert

(b) Restriction sites

(c) Sequence of the insert

(d) Origin and function of each constituent part of the insert in the GMO

(e) Information on the degree to which the insert is limited to the required function

(f) Location of the insert in the GMO

INFORMATION ON THE ORGANISM(S) FROM WHICH THE INSERT IS DERIVED (DONOR)

31. Scientific and other names

32 (a) Pathogenic characteristics of the donor organism

32 (b) Other harmful characteristics of the organism living or dead, including its extracellular products

33. If the door organism has any pathogenic or harmful characteristics, indicate whether the donated sequences are in any way involved in them

34. Classification under existing Community rules relating to the protection of human health and the environment

35. Potential for natural exchange of genetic material between the donor(s) and recipient organism

INFORMATION RELATING TO THE GMO(S) CONTAINED IN THE PRODUCT

36. Description of genetic traits or phenotypic characteristics and in particular any new traits and characteristics which may be expressed or no longer expressed

37. Genetic stability of the GMO

38. Rate and level of expression of the new genetic material

39. Activity of the expressed proteins

40 (a) Description of detection techniques for the GMO in the environment

40 (b) Description of identification techniques

41. Health considerations

(a) toxic or allergenic effects of the non-viable GMOs and/or their metabolic products

(b) product hazards

(c) comparison of the GMO with the donor, recipient or parental organism regarding pathogenicity

(d) capacity for colonization

(e) If the organism is pathogenic to humans who are immuno-competent, supply the information specified in Annex II, Part II C 2 (i) (v)

INTERACTIONS OF THE GMO WITH THE ENVIRONMENT 42. Survival, multiplication and dissemination of the GMO(s) in the environment

43. Interactions of the GMOs with the environment

44. Environmental impacts of the GMO(s)

C. PREDICTED BEHAVIOUR OF THE PRODUCT 1. ENVIRONMENTAL IMPACT OF THE PRODUCT 2. HUMAN HEALTH EFFECTS OF THE PRODUCT D. INFORMATION RELATING TO PREVIOUS RELEASES I. HISTORY OF PREVIOUS RELEASES NOTIFIED UNDER PART B OF THE DIRECTIVE 1. Notification number:

2. Release site:

3. Aim of the release:

4. Duration of the release:

5. Duration of post-release monitoring:

6. Aim of post-release monitoring:

7. Conclusions of post-release monitoring:

8. Results of the release in respect to any risk to human health and the environment (submitted to the competent authority according to Article 8 of Directive 90/220/EEC): II. HISTORY OF PREVIOUS RELEASES CARRIED OUT INSIDE OR OUTSIDE THE COMMUNITY 1. Release country:

2. Authority overseeing the release:

3. Release site:

4. Aim of the release:

5. Duration of post-release monitoring:

6. Aim of post-release monitoring:

7. Conclusions of post-release monitoring:

8. Results of the release in respect to any risk to human health and the environment:

III. HISTORY OF PREVIOUS WORK RELEVANT TO RISK ASSESSMENT PRIOR TO COMMERCIALIZATION