# C_2009139EN.01000201.xml

| 19.6.2009 | EN | Official Journal of the European Union | C 139/2 |
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19.6.2009

EN

Official Journal of the European Union

C 139/2

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Notification pursuant to Article 95, paragraph 5 of the EC Treaty — Authorisation to introduce national measures being more stringent than provisions of an EC harmonisation measure

(Text with EEA relevance)

2009/C 139/03

| 1. | By letter of 5 May 2009, the Republic of Portugal informed the Commission about its intention to declare the Autonomous Region of Madeira as an area free of the cultivation of varieties of genetically modified organisms (GMOs). The draft regional legislative decree would deviate from the provisions of Directive 2001/18/EC on the deliberate release into the environment of GMOs and Regulation (EC) No 1829/2003 on GM food and feed. |
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1.

By letter of 5 May 2009, the Republic of Portugal informed the Commission about its intention to declare the Autonomous Region of Madeira as an area free of the cultivation of varieties of genetically modified organisms (GMOs). The draft regional legislative decree would deviate from the provisions of Directive 2001/18/EC on the deliberate release into the environment of GMOs and Regulation (EC) No 1829/2003 on GM food and feed.

| 2. | Directive 2001/18/EC is based on Article 95 of the EC Treaty. The Directive establishes a system for the authorisation of release of GMOs into the environment for commercial or experimental purposes, including for cultivation, at Community level. This authorisation takes place on a case-by-case basis for every GMO and after a risk assessment with regards to its potential adverse effects on human and animal health and the environment. If a written consent has been given for the placing on the market of a GMO, this product may be used without further notification throughout the Community in so far as the specific conditions of use and the environments and/or geographical areas stipulated in these conditions are strictly adhered to. Member States may not prohibit, restrict or impede the placing on the market of GMOs which comply with the requirements of the Directive. A Member State may provisionally restrict or prohibit the use and/or sale of an individual authorised GMO only if it has detailed grounds for considering that this GMO constitutes a risk to human health or the environment, and on the basis of new scientific information made available since the date of the consent. |
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2.

Directive 2001/18/EC is based on Article 95 of the EC Treaty. The Directive establishes a system for the authorisation of release of GMOs into the environment for commercial or experimental purposes, including for cultivation, at Community level. This authorisation takes place on a case-by-case basis for every GMO and after a risk assessment with regards to its potential adverse effects on human and animal health and the environment. If a written consent has been given for the placing on the market of a GMO, this product may be used without further notification throughout the Community in so far as the specific conditions of use and the environments and/or geographical areas stipulated in these conditions are strictly adhered to. Member States may not prohibit, restrict or impede the placing on the market of GMOs which comply with the requirements of the Directive. A Member State may provisionally restrict or prohibit the use and/or sale of an individual authorised GMO only if it has detailed grounds for considering that this GMO constitutes a risk to human health or the environment, and on the basis of new scientific information made available since the date of the consent.

| 3. | Regulation (EC) No 1829/2003 on GM food and feed covers also seeds and other plant-propagating material for the purpose of cultivation (‘GMO that may be used as a source material for the production for food/feed’). As the Directive, the Regulation also establishes a system for the authorisation of GM seeds at Community level on a case-by-case basis and after a risk assessment with regards to its potential adverse effects on human and animal health and the environment. Member States may not prohibit or restrict the cultivation of GMOs which comply with the requirements of the Regulation. A Member State may modify or suspend the authorisation of an individual GMO under the Regulation, only where it is evident that it is likely to constitute a serious risk to human health, animal health and the environment and on the basis of new scientific evidence made available since the authorisation. |
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3.

Regulation (EC) No 1829/2003 on GM food and feed covers also seeds and other plant-propagating material for the purpose of cultivation (‘GMO that may be used as a source material for the production for food/feed’). As the Directive, the Regulation also establishes a system for the authorisation of GM seeds at Community level on a case-by-case basis and after a risk assessment with regards to its potential adverse effects on human and animal health and the environment. Member States may not prohibit or restrict the cultivation of GMOs which comply with the requirements of the Regulation. A Member State may modify or suspend the authorisation of an individual GMO under the Regulation, only where it is evident that it is likely to constitute a serious risk to human health, animal health and the environment and on the basis of new scientific evidence made available since the authorisation.

GMO that may be used as a source material for the production for food/feed

| 4. | The draft Decree of Portugal would introduce a breach of the harmonised authorisation procedures of the Directive and the Regulation, as it would introduce a general ban of all GMOs, including those authorised under the above two acts. According to the Portuguese notification, the Autonomous Region of Madeira has an immense plant genetic wealth (not only in terms of ornamental and forest species, but also in terms of varieties of agronomic species). This genetic wealth has existed for centuries and its scientific and economic value is undisputable. That is why the introduction of material containing GMOs could have disastrous consequences, due to the likelihood that these GMOs will alter certain environmental aspects and may interfere with the valuable genetic heritage of the particular Region. The notification contains a list of arguments which refer to:






  — | agricultural reasons (including reasons related to distance between fields, border strips, sowing varieties with different growth cycles, refuge areas), |
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4.

The draft Decree of Portugal would introduce a breach of the harmonised authorisation procedures of the Directive and the Regulation, as it would introduce a general ban of all GMOs, including those authorised under the above two acts. According to the Portuguese notification, the Autonomous Region of Madeira has an immense plant genetic wealth (not only in terms of ornamental and forest species, but also in terms of varieties of agronomic species). This genetic wealth has existed for centuries and its scientific and economic value is undisputable. That is why the introduction of material containing GMOs could have disastrous consequences, due to the likelihood that these GMOs will alter certain environmental aspects and may interfere with the valuable genetic heritage of the particular Region. The notification contains a list of arguments which refer to:

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agricultural reasons (including reasons related to distance between fields, border strips, sowing varieties with different growth cycles, refuge areas),

| — | natural reasons (including reasons related to the invasive capacity of GMOs, capacity to cross-pollinate, parallel effects with other species, production of toxins, collateral interactions, effects connected with genetic alterations and gene transfer). |
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natural reasons (including reasons related to the invasive capacity of GMOs, capacity to cross-pollinate, parallel effects with other species, production of toxins, collateral interactions, effects connected with genetic alterations and gene transfer).

| 5. | The Commission will process this notification in accordance with Article 95(5) and (6) of the EC Treaty. Article 95(5) of the EC Treaty provides that if, after the adoption of a Community harmonisation measure, a Member State deems it necessary to introduce national provisions based on new scientific evidence relating to the protection of the environment or the working environment on grounds of a problem specific to that Member State arising after the adoption of the harmonised measure, it shall notify the Commission of the envisaged provisions as well as the grounds for introducing them. Following the notification of the Portuguese provisions the Commission has six months to approve or reject them. In this period the Commission shall assess whether the introduction of the Portuguese provisions is justified after having verified that they do not constitute a means of arbitrary discrimination or a disguised restriction on trade and that they do not create an unnecessary and disproportionate obstacle to the functioning of the internal market. |
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5.

The Commission will process this notification in accordance with Article 95(5) and (6) of the EC Treaty. Article 95(5) of the EC Treaty provides that if, after the adoption of a Community harmonisation measure, a Member State deems it necessary to introduce national provisions based on new scientific evidence relating to the protection of the environment or the working environment on grounds of a problem specific to that Member State arising after the adoption of the harmonised measure, it shall notify the Commission of the envisaged provisions as well as the grounds for introducing them. Following the notification of the Portuguese provisions the Commission has six months to approve or reject them. In this period the Commission shall assess whether the introduction of the Portuguese provisions is justified after having verified that they do not constitute a means of arbitrary discrimination or a disguised restriction on trade and that they do not create an unnecessary and disproportionate obstacle to the functioning of the internal market.

| 6. | Any party who wishes to provide comments on this notification must send them to the Commission within 30 days from the publication of this notice. Any comment submitted after this period will not be taken into account. |
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6.

Any party who wishes to provide comments on this notification must send them to the Commission within 30 days from the publication of this notice. Any comment submitted after this period will not be taken into account.

| 7. | Further details about the Portuguese notification can be obtained from:





  European Commission |
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| Directorate-General for the Environment |
| DG ENV.B.3 — Biotechnology, Pesticides and Health |
| Mr Yannis Karamitsios |
| Tel. +32 22983089 |
| Electronic address: yannis.karamitsios@ec.europa.eu |

7.

Further details about the Portuguese notification can be obtained from:

European Commission

Directorate-General for the Environment

DG ENV.B.3 — Biotechnology, Pesticides and Health

Mr Yannis Karamitsios

Tel. +32 22983089

Electronic address: yannis.karamitsios@ec.europa.eu

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