# CE2004078EN.01015201.xml

| 27.3.2004 | EN | Official Journal of the European Union | CE 78/152 |
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27.3.2004

EN

Official Journal of the European Union

CE 78/152

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(2004/C 78 E/0157)

WRITTEN QUESTION P-2693/03

by Caroline Lucas (Verts/ALE) to the Commission

(2 September 2003)

Subject:   GMOs

Subject:

A number of Member States have invoked Article 16 of Directive 90/220/EC (1) (now replaced by Directive 2001/18/EC (2)) in respect to the following Part C marketing consents:

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| — | C/F/95/12/07: T25 and T14 Maize — Austria (28 April 2000), Italy (4 August 2000); |
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C/F/95/12/07: T25 and T14 Maize — Austria (28 April 2000), Italy (4 August 2000);

| — | C/UK/95/M5/1: Topas 19/2 Oilseed rape — Greece (3 November 1998), France (16 November 1998); |
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C/UK/95/M5/1: Topas 19/2 Oilseed rape — Greece (3 November 1998), France (16 November 1998);

| — | C/GB/94/M1/1: MS1 and RF1 Oilseed rape — France (18 November 1998); |
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C/GB/94/M1/1: MS1 and RF1 Oilseed rape — France (18 November 1998);

| — | C/F/94/11-03: CG00526-176 (aka Bt-176) Maize — Austria (13 February 1997), Luxembourg (28 February 1997), Germany (31 March 2000); |
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C/F/94/11-03: CG00526-176 (aka Bt-176) Maize — Austria (13 February 1997), Luxembourg (28 February 1997), Germany (31 March 2000);

| — | C/F/95/12/02: MON810 Maize — Austria (2 June 1999), Italy (4 August 2000); |
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C/F/95/12/02: MON810 Maize — Austria (2 June 1999), Italy (4 August 2000);

| — | C/F/95/12-01/B: MON809 Maize — Italy (4 August 2000). |
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C/F/95/12-01/B: MON809 Maize — Italy (4 August 2000).

Would the Commission please indicate the current status of the measures imposed by Member States on the basis of Article 16 of Directive 90/220/EEC. Have they been upheld or overturned by the European Union?

Would the Commission also indicate the specific reasons given by the Member States for imposing these measures and release copies of the documentation provided by these Member States or justification for invoking Article 16?

Answer given by Mrs Wallström on behalf of the Commission

(28 October 2003)

(28 October 2003)

Article 16 of Council Directive 90/220/EEC of 23 April 1990 on the deliberate release into environment of genetically modified organisms, replaced on 17 October 2002 by Directive 2001/18/EC of the Parliament and the Council of 12 March 2001, was invoked by six Member States in nine cases which concerned five authorisations of genetically modified plant products. Italy has not invoked Article 16 under Directive 90/220/EEC, but has taken safeguard measures relating to certain products authorised under Regulation (EC) No 258/97 of the Parliament and of the Council of 27 January 1997, concerning novel foods and novel food ingredients (3).

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The Commission submitted the documents Member States had provided to justify measures taken according to Article 16 of Directive 90/220/EEC to the Scientific Committee(s). In all cases the Committee(s) concluded, after examination of the reasons and information submitted by Member States, that they did not provide new scientific evidence to change the original risk assessment on the grounds of which the products concerned had been authorised.

In the case of Bt-176 maize (C/F/94/11-03) consultations of the Regulatory Committee were launched end of 1997, according to Article 21 of Directive 90/220/EEC. The Regulatory Committee failed to deliver an opinion on the draft decisions of the Commission in April 1998. These were subsequently transmitted to the Council. The Council did not have the qualified majority to act on the proposed decisions within the statutory three-month period. In the other Article 16 cases, the Regulatory Committee consultation is pending.

The reasons given by the Member States for imposing measures taken according to Article 16 are as follows:

| — | Concerning male sterile and herbicide (glufosinate) tolerant oilseed rape MS1, RF1 (C/UK/94/M1/1),
  France raised questions and stressed the need of further research in order to answer these questions on dissemination, volunteers, rate and consequences of intra- and interspecific geneflow, accumulation and possible loss of effectiveness of herbicide tolerance genes, management of weeds and volunteers. |
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Concerning male sterile and herbicide (glufosinate) tolerant oilseed rape MS1, RF1 (C/UK/94/M1/1),

France raised questions and stressed the need of further research in order to answer these questions on dissemination, volunteers, rate and consequences of intra- and interspecific geneflow, accumulation and possible loss of effectiveness of herbicide tolerance genes, management of weeds and volunteers.

| — | Concerning insect resistant (Bt toxin), herbicide (glufosinate) tolerant and antibiotic (ampicillin) resistance marker gene carrying maize Bt 176 (C/F/94/11-03),
  Austria put forward the potential risk of the antibiotic resistance gene to be transferred to bacteria, especially in the intestine of humans or animals, thereby possibly inactivating important antibiotics used in human and veterinary therapy; the need to evaluate the possible role of multiresistance plasmids and transposons in the spread of antibiotic resistance genes; the potential risk of the Bt-toxin to non-target (soil) organisms; possible accumulation of the Bt-toxin in soils; development of resistance to the Bt-toxin in target organisms; need of mandatory resistance management programmes; unclear possibility to use the herbicide tolerance in cultivation; the use of this gene as a marker would not correspond to the state of the art in genetic engineering; insufficient labelling.
  Luxembourg raised essentially the same issues as Austria concerning the antibiotic resistance gene, possible resistance development in target organisms and the need for a mandatory resistance management programme. Luxembourg stressed that genetically modified organisms should only contain the minimum of transgenes needed for their desired functioning.
  Germany raised essentially the same issues as Austria concerning enhanced antibiotic resistance development, potential impact on non-target organisms, possible resistance development in target organisms and accumulation of Bt-toxin in soils. |
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Concerning insect resistant (Bt toxin), herbicide (glufosinate) tolerant and antibiotic (ampicillin) resistance marker gene carrying maize Bt 176 (C/F/94/11-03),

Austria put forward the potential risk of the antibiotic resistance gene to be transferred to bacteria, especially in the intestine of humans or animals, thereby possibly inactivating important antibiotics used in human and veterinary therapy; the need to evaluate the possible role of multiresistance plasmids and transposons in the spread of antibiotic resistance genes; the potential risk of the Bt-toxin to non-target (soil) organisms; possible accumulation of the Bt-toxin in soils; development of resistance to the Bt-toxin in target organisms; need of mandatory resistance management programmes; unclear possibility to use the herbicide tolerance in cultivation; the use of this gene as a marker would not correspond to the state of the art in genetic engineering; insufficient labelling.

Luxembourg raised essentially the same issues as Austria concerning the antibiotic resistance gene, possible resistance development in target organisms and the need for a mandatory resistance management programme. Luxembourg stressed that genetically modified organisms should only contain the minimum of transgenes needed for their desired functioning.

Germany raised essentially the same issues as Austria concerning enhanced antibiotic resistance development, potential impact on non-target organisms, possible resistance development in target organisms and accumulation of Bt-toxin in soils.

| — | Concerning herbicide (glufosinate) tolerant oilseed rape Topas 19/2 (C/UK/95/M5/1),
  Greece claimed that seeds would be lost, even if cultivation is not intended; spreading would be facilitated because of the mild climate in Greece which allows for overwintering; outcrossing into weedy wild variants and relatives, which are used as food, with unpredictable health effects; at a later stage risk of multiresistant weeds; loss of effectiveness of herbicides; spreading into natural habitats with unpredictable consequences; lack of risk assessment of progeny resulting from crosses between Topas 19/2 and non-GM (genetically modified) oilseed rape.
  France raised the same issues as for oilseed rape MS1, RF1 (C/UK/94/M1/1). |
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Concerning herbicide (glufosinate) tolerant oilseed rape Topas 19/2 (C/UK/95/M5/1),

Greece claimed that seeds would be lost, even if cultivation is not intended; spreading would be facilitated because of the mild climate in Greece which allows for overwintering; outcrossing into weedy wild variants and relatives, which are used as food, with unpredictable health effects; at a later stage risk of multiresistant weeds; loss of effectiveness of herbicides; spreading into natural habitats with unpredictable consequences; lack of risk assessment of progeny resulting from crosses between Topas 19/2 and non-GM (genetically modified) oilseed rape.

France raised the same issues as for oilseed rape MS1, RF1 (C/UK/94/M1/1).

| — | Concerning insect (Bt-toxin) resistant maize Mon 810 (C/F/95/12-02),
  Austria put forward potential unintended effects on non-target organisms; possible resistance development in target insects; lacking proof of the resistance management's effectiveness; insufficient scope of the monitoring plan. |
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Concerning insect (Bt-toxin) resistant maize Mon 810 (C/F/95/12-02),

Austria put forward potential unintended effects on non-target organisms; possible resistance development in target insects; lacking proof of the resistance management's effectiveness; insufficient scope of the monitoring plan.

| — | Concerning herbicide (glufosinate) tolerant Maize T25 (C/F/95/12-07)
  Austria stressed the lack of a monitoring plan; lack of protection of ecological sensitive areas; lack of evaluation of herbicide application under realistic conditions; outcrossing into surrounding non-GM maize fields.
  United Kingdom claimed the possibility to grow organically pure maize as well as to protect the integrity of other non-GM maize crops in Wales. |
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Concerning herbicide (glufosinate) tolerant Maize T25 (C/F/95/12-07)

Austria stressed the lack of a monitoring plan; lack of protection of ecological sensitive areas; lack of evaluation of herbicide application under realistic conditions; outcrossing into surrounding non-GM maize fields.

United Kingdom claimed the possibility to grow organically pure maize as well as to protect the integrity of other non-GM maize crops in Wales.

The opinions of the Scientific Committees are publicly available on line at http://europa.eu.int/comm/food/ fs/sc/scp/outcome_gmo_en.html and at (http://europa.eu.int/comm/food/fs/sc/oldcomm7/out02_en.html). The national safeguard measures can be found in the Official Journals of the above mentioned Member States.

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(1)  OJ L 117, 8.5.1990, p. 15.

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(2)  OJ L 106, 17.4.2001, p. 1.

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(3)  OJ L 43, 14.2.1997.

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