# L_2016199EN.01002801.xml

| 26.7.2016 | EN | Official Journal of the European Union | L 199/28 |
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26.7.2016

EN

Official Journal of the European Union

L 199/28

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COMMISSION IMPLEMENTING DECISION (EU) 2016/1217

of 22 July 2016

authorising the placing on the market of products containing, consisting of, or produced from genetically modified soybean MON 87705 × MON 89788 (MON-877Ø5-6 × MON-89788-1) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council

(notified under document C(2016) 4582)

(Only the Dutch and French texts are authentic)

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed (1), and in particular Articles 7(3) and 19(3) thereof,

Whereas:

| (1) | On 11 August 2011, Monsanto Europe S.A. submitted to the competent authority of the Netherlands an application in accordance with Articles 5 and 17 of Regulation (EC) No 1829/2003 for the placing on the market of foods, food ingredients, and feed containing, consisting of, or produced from MON 87705 × MON 89788 soybean (‘the application’). |
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(1)

On 11 August 2011, Monsanto Europe S.A. submitted to the competent authority of the Netherlands an application in accordance with Articles 5 and 17 of Regulation (EC) No 1829/2003 for the placing on the market of foods, food ingredients, and feed containing, consisting of, or produced from MON 87705 × MON 89788 soybean (‘the application’).

| (2) | The application also covers the placing on the market of genetically modified soybean MON 87705 × MON 89788 in products consisting of it or containing it for other uses than food and feed as any other soybean, with the exception of cultivation. |
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(2)

The application also covers the placing on the market of genetically modified soybean MON 87705 × MON 89788 in products consisting of it or containing it for other uses than food and feed as any other soybean, with the exception of cultivation.

| (3) | In accordance with Articles 5(5) and 17(5) of Regulation (EC) No 1829/2003, the application includes the data and information required by Annexes III and IV to Directive 2001/18/EC of the European Parliament and of the Council (2) and information and conclusions about the risk assessment carried out in accordance with the principles set out in Annex II to that Directive. It also includes a monitoring plan for environmental effects conforming with Annex VII to Directive 2001/18/EC. |
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(3)

In accordance with Articles 5(5) and 17(5) of Regulation (EC) No 1829/2003, the application includes the data and information required by Annexes III and IV to Directive 2001/18/EC of the European Parliament and of the Council (2) and information and conclusions about the risk assessment carried out in accordance with the principles set out in Annex II to that Directive. It also includes a monitoring plan for environmental effects conforming with Annex VII to Directive 2001/18/EC.

| (4) | On 16 July 2015, the European Food Safety Authority (‘EFSA’) gave a favourable opinion in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003 (3). It concluded that genetically modified soybean MON 87705 × MON 89788, as described in the application, is as safe as its non-genetically modified counterpart and other non-genetically modified soybean reference varieties with respect to potential adverse effects on human and animal health and the environment in the context of the scope of the application. |
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(4)

On 16 July 2015, the European Food Safety Authority (‘EFSA’) gave a favourable opinion in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003 (3). It concluded that genetically modified soybean MON 87705 × MON 89788, as described in the application, is as safe as its non-genetically modified counterpart and other non-genetically modified soybean reference varieties with respect to potential adverse effects on human and animal health and the environment in the context of the scope of the application.

| (5) | In its opinion, EFSA considered all the specific questions and concerns raised by the Member States in the context of the consultation of the national competent authorities as provided for by Articles 6(4) and 18(4) of Regulation (EC) No 1829/2003. |
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(5)

In its opinion, EFSA considered all the specific questions and concerns raised by the Member States in the context of the consultation of the national competent authorities as provided for by Articles 6(4) and 18(4) of Regulation (EC) No 1829/2003.

| (6) | In its opinion, EFSA also concluded that the monitoring plan for environmental effects, consisting of a general surveillance plan, submitted by the applicant is in line with the intended uses of the products. |
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(6)

In its opinion, EFSA also concluded that the monitoring plan for environmental effects, consisting of a general surveillance plan, submitted by the applicant is in line with the intended uses of the products.

| (7) | In addition, EFSA recommended a post-market monitoring plan to be implemented, focusing on the collection of consumption data for the European population. |
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(7)

In addition, EFSA recommended a post-market monitoring plan to be implemented, focusing on the collection of consumption data for the European population.

| (8) | Taking into account those considerations, authorisation should be granted to the products containing, consisting of, or produced from genetically modified soybean MON 87705 × MON 89788. |
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(8)

Taking into account those considerations, authorisation should be granted to the products containing, consisting of, or produced from genetically modified soybean MON 87705 × MON 89788.

| (9) | A unique identifier should be assigned to each genetically modified organism (hereinafter ‘GMO’) as provided for in Commission Regulation (EC) No 65/2004 (4). |
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(9)

A unique identifier should be assigned to each genetically modified organism (hereinafter ‘GMO’) as provided for in Commission Regulation (EC) No 65/2004 (4).

| (10) | Food, food ingredients and feed containing, consisting of, or produced from MON 87705 × MON 89788 soybean should be labelled in accordance with the requirements provided for in Article 13(1) and Article 25(2) of Regulation (EC) No 1829/2003. |
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(10)

Food, food ingredients and feed containing, consisting of, or produced from MON 87705 × MON 89788 soybean should be labelled in accordance with the requirements provided for in Article 13(1) and Article 25(2) of Regulation (EC) No 1829/2003.

| (11) | On the basis of the EFSA opinion, confirming that fatty acid composition of the seeds of MON 87705 × MON 89788 soybean and derived oil has been changed in relation to the conventional counterpart, a specific labelling appears to be necessary in accordance with Articles 13(2)(a) and 25(2)(c) of Regulation (EC) No 1829/2003. |
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(11)

On the basis of the EFSA opinion, confirming that fatty acid composition of the seeds of MON 87705 × MON 89788 soybean and derived oil has been changed in relation to the conventional counterpart, a specific labelling appears to be necessary in accordance with Articles 13(2)(a) and 25(2)(c) of Regulation (EC) No 1829/2003.

| (12) | Regulation (EC) No 1830/2003 of the European Parliament and of the Council (5) lays down labelling requirements in Article 4(6) for products containing or consisting of GMOs. Traceability requirements for those products are laid down in paragraphs 1 to 5 of Article 4 and traceability requirements for food and feed produced from GMOs are laid down in Article 5 of that Regulation. |
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(12)

Regulation (EC) No 1830/2003 of the European Parliament and of the Council (5) lays down labelling requirements in Article 4(6) for products containing or consisting of GMOs. Traceability requirements for those products are laid down in paragraphs 1 to 5 of Article 4 and traceability requirements for food and feed produced from GMOs are laid down in Article 5 of that Regulation.

| (13) | In order to ensure the use of the products within the limits of the authorisation provided for by this Decision, the labelling of products containing or consisting of the GMO for which authorisation is requested, with the exception of food products should be complemented by a clear indication that the products in question must not be used for cultivation. |
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(13)

In order to ensure the use of the products within the limits of the authorisation provided for by this Decision, the labelling of products containing or consisting of the GMO for which authorisation is requested, with the exception of food products should be complemented by a clear indication that the products in question must not be used for cultivation.

| (14) | The authorisation holder should submit annual reports on the implementation and the results of the activities set out in the monitoring plan for environmental effects. Those results should be presented in accordance with Commission Decision 2009/770/EC (6). The EFSA opinion does not justify either the imposition of specific conditions or restrictions for the placing on the market and/or the use and handling of the food and feed, including post-market monitoring requirements or specific conditions for the protection of particular ecosystems/environment and/or geographical areas, as provided for in Articles 6(5)(e) and 18(5)(e) of Regulation (EC) No 1829/2003. |
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(14)

The authorisation holder should submit annual reports on the implementation and the results of the activities set out in the monitoring plan for environmental effects. Those results should be presented in accordance with Commission Decision 2009/770/EC (6). The EFSA opinion does not justify either the imposition of specific conditions or restrictions for the placing on the market and/or the use and handling of the food and feed, including post-market monitoring requirements or specific conditions for the protection of particular ecosystems/environment and/or geographical areas, as provided for in Articles 6(5)(e) and 18(5)(e) of Regulation (EC) No 1829/2003.

| (15) | The authorisation holder should also submit annual reports on the implementation and the results of the activities set out in the post-market monitoring plan. |
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(15)

The authorisation holder should also submit annual reports on the implementation and the results of the activities set out in the post-market monitoring plan.

| (16) | All relevant information on the authorisation of the products should be entered in the Community register of genetically modified food and feed provided for in Regulation (EC) No 1829/2003. |
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(16)

All relevant information on the authorisation of the products should be entered in the Community register of genetically modified food and feed provided for in Regulation (EC) No 1829/2003.

| (17) | This Decision is to be notified through the Biosafety Clearing-House to the Parties to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity, pursuant to Articles 9(1) and 15(2)(c) of Regulation (EC) No 1946/2003 of the European Parliament and of the Council (7). |
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(17)

This Decision is to be notified through the Biosafety Clearing-House to the Parties to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity, pursuant to Articles 9(1) and 15(2)(c) of Regulation (EC) No 1946/2003 of the European Parliament and of the Council (7).

| (18) | The Standing Committee on Plants, Animals, Food and Feed has not delivered an opinion within the time-limit laid down by its Chairman. An implementing act was deemed to be necessary and the chair submitted the draft implementing act to the appeal committee for further deliberation. The appeal committee did not deliver an opinion, |
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(18)

The Standing Committee on Plants, Animals, Food and Feed has not delivered an opinion within the time-limit laid down by its Chairman. An implementing act was deemed to be necessary and the chair submitted the draft implementing act to the appeal committee for further deliberation. The appeal committee did not deliver an opinion,

HAS ADOPTED THIS DECISION:

Article 1

Genetically modified organism and unique identifier

Genetically modified soybean (Glycine max (L.) Merr.) MON 87705 × MON 89788, as specified in point (b) of the Annex to this Decision, is assigned the unique identifier MON-877Ø5-6 × MON-89788-1, as provided for in Regulation (EC) No 65/2004.

Glycine max

Article 2

Authorisation

The following products are authorised for the purposes of Articles 4(2) and 16(2) of Regulation (EC) No 1829/2003 in accordance with the conditions set out in this Decision:

| (a) | foods and food ingredients containing, consisting of, or produced from MON-877Ø5-6 × MON-89788-1 soybean; |
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(a)

foods and food ingredients containing, consisting of, or produced from MON-877Ø5-6 × MON-89788-1 soybean;

| (b) | feed containing, consisting of, or produced from MON-877Ø5-6 × MON-89788-1 soybean; |
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(b)

feed containing, consisting of, or produced from MON-877Ø5-6 × MON-89788-1 soybean;

| (c) | MON-877Ø5-6 × MON-89788-1 soybean in products containing it or consisting of it for any other use than those provided in points (a) and (b), with the exception of cultivation. |
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(c)

MON-877Ø5-6 × MON-89788-1 soybean in products containing it or consisting of it for any other use than those provided in points (a) and (b), with the exception of cultivation.

Article 3

Labelling

1.   For the purposes of the labelling requirements laid down in Article 13(1) and Article 25(2) of Regulation (EC) No 1829/2003 and in Article 4(6) of Regulation (EC) No 1830/2003, the ‘name of the organism’ shall be ‘soybean’.

2.   For the purposes of the labelling requirements laid down in Article 13(2)(a) and Article 25(2)(c) of Regulation (EC) No 1829/2003, the words ‘with increased monounsaturated fat and reduced polyunsaturated fat’ shall appear after the name of the organism on the label or, where appropriate, in the documents accompanying the products.

3.   The words ‘not for cultivation’ shall appear on the label of and in the documents accompanying products containing or consisting of MON-877Ø5-6 × MON-89788-1 soybean, with the exception of products referred to in point (a) of Article 2.

Article 4

Monitoring for environmental effects

1.   The authorisation holder shall ensure that the monitoring plan for environmental effects, as set out in point (h) of the Annex, is put in place and implemented.

2.   The authorisation holder shall submit to the Commission annual reports on the implementation and the results of the activities set out in the monitoring plan in accordance with Decision 2009/770/EC.

Article 5

Post-market monitoring in accordance with Article 6(5)(e) of Regulation (EC) No 1829/2003

1.   The authorisation holder shall ensure that the post-market monitoring plan of the MON-877Ø5-6 × MON-89788-1 soybean oil, as set out in point (g) of the Annex, is put in place and implemented.

2.   The authorisation holder shall submit to the Commission annual reports on the implementation and the results of the activities set out in the post-market monitoring plan for the duration of the authorisation.

Article 6

Community register

The information set out in the Annex to this Decision shall be entered in the Community register of genetically modified food and feed, as provided for in Article 28 of Regulation (EC) No 1829/2003.

Article 7

Authorisation holder

The authorisation holder shall be Monsanto Europe S.A., Belgium, representing Monsanto Company, United States of America.

Article 8

Validity

This Decision shall apply for a period of 10 years from the date of its notification.

Article 9

Addressee

This Decision is addressed to Monsanto Europe S.A., Avenue de Tervuren 270-272, B-1150 Brussels, Belgium.

Done at Brussels, 22 July 2016.

For the Commission

Vytenis ANDRIUKAITIS

Member of the Commission

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(1)  
  OJ L 268, 18.10.2003, p. 1.

1

(2)  Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC (OJ L 106, 17.4.2001, p. 1).

2

(3)  Scientific Opinion on application (EFSA-GMO-NL-2011-110) for the placing on the market of the herbicide-tolerant, increased oleic acid genetically modified soybean MON 87705 × MON 89788 for food and feed uses, import and processing under Regulation (EC) No 1829/2003 from Monsanto. EFSA Journal 2015; 13(7):4178, 30 pp. doi:10.2903/j.efsa.2015.4178

3

(4)  Commission Regulation (EC) No 65/2004 of 14 January 2004 establishing a system for the development and assignment of unique identifiers for genetically modified organisms (OJ L 10, 16.1.2004, p. 5).

4

(5)  Regulation (EC) No 1830/2003 of the European Parliament and of the Council of 22 September 2003 concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms and amending Directive 2001/18/EC (OJ L 268, 18.10.2003, p. 24).

5

(6)  Commission Decision 2009/770/EC 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 (OJ L 275, 21.10.2009, p. 9).

6

(7)  Regulation (EC) No 1946/2003 of the European Parliament and of the Council of 15 July 2003 on transboundary movements of genetically modified organisms (OJ L 287, 5.11.2003, p. 1).

7

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ANNEX

| (a) | Applicant and Authorisation holder:








  Name | : | Monsanto Europe S.A. |
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| Address | : | Avenue de Tervuren 270-272, B-1150 Brussels — Belgium |

(a)

Applicant and Authorisation holder:

Name

:

Monsanto Europe S.A.

Address

:

Avenue de Tervuren 270-272, B-1150 Brussels — Belgium

On behalf of Monsanto Company — 800 N. Lindbergh Boulevard — St. Louis, Missouri 63167 — United States of America.

| (b) | Designation and specification of the products:







  (1) | foods and food ingredients containing, consisting of, or produced from MON-877Ø5-6 × MON-89788-1 soybean; |
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(b)

Designation and specification of the products:

(1)

foods and food ingredients containing, consisting of, or produced from MON-877Ø5-6 × MON-89788-1 soybean;

| (2) | feed containing, consisting of, or produced from MON-877Ø5-6 × MON-89788-1 soybean; |
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(2)

feed containing, consisting of, or produced from MON-877Ø5-6 × MON-89788-1 soybean;

| (3) | MON-877Ø5-6 × MON-89788-1 soybean in products containing it or consisting of it for any other use than those provided in points (1) and (2), with the exception of cultivation. |
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(3)

MON-877Ø5-6 × MON-89788-1 soybean in products containing it or consisting of it for any other use than those provided in points (1) and (2), with the exception of cultivation.

The genetically modified MON-877Ø5-6 × MON-89788-1 soybean, as described in the application, has a reduced expression of fatty acid Δ12-desaturase (FAD2) and palmitoyl acyl carrier protein thioesterase (FATB) enzymes, which results in increased oleic acid and reduced linoleic acid profile and expresses the CP4 EPSPS protein which confers tolerance to glyphosate herbicides.

| (c) | Labelling:







  (1) | For the purposes of the labelling requirements laid down in Article 13(1) and Article 25(2) of Regulation (EC) No 1829/2003, and in Article 4(6) of Regulation (EC) No 1830/2003, the ‘name of the organism’ shall be ‘soybean’; |
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(c)

Labelling:

(1)

For the purposes of the labelling requirements laid down in Article 13(1) and Article 25(2) of Regulation (EC) No 1829/2003, and in Article 4(6) of Regulation (EC) No 1830/2003, the ‘name of the organism’ shall be ‘soybean’;

| (2) | For the purposes of the labelling requirements laid down in Article 13(2)(a) and Article 25(2)(c) of Regulation (EC) No 1829/2003, the words ‘with increased monounsaturated fat and reduced polyunsaturated fat’ shall appear after the name of the organism on the label or, where appropriate, in the documents accompanying the products; |
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(2)

For the purposes of the labelling requirements laid down in Article 13(2)(a) and Article 25(2)(c) of Regulation (EC) No 1829/2003, the words ‘with increased monounsaturated fat and reduced polyunsaturated fat’ shall appear after the name of the organism on the label or, where appropriate, in the documents accompanying the products;

| (3) | The words ‘not for cultivation’ shall appear on the label of and in the accompanying documents of the products containing or consisting of MON-877Ø5-6 × MON-89788-1 soybean with the exception of products referred to in point (a) of Article 2. |
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(3)

The words ‘not for cultivation’ shall appear on the label of and in the accompanying documents of the products containing or consisting of MON-877Ø5-6 × MON-89788-1 soybean with the exception of products referred to in point (a) of Article 2.

| (d) | Method for detection:







  (1) | Event specific real-time quantitative PCR based methods for MON-877Ø5-6 and MON-89788-1 soybeans; the detection methods are validated on the single-trait events and verified on genomic DNA extracted from seeds of MON-877Ø5-6 × MON-89788-1 soybean; |
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(d)

Method for detection:

(1)

Event specific real-time quantitative PCR based methods for MON-877Ø5-6 and MON-89788-1 soybeans; the detection methods are validated on the single-trait events and verified on genomic DNA extracted from seeds of MON-877Ø5-6 × MON-89788-1 soybean;

| (2) | Validated by the EU Reference Laboratory established under Regulation (EC) No 1829/2003, published at http://gmo-crl.jrc.ec.europa.eu/statusofdossiers.aspx; |
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(2)

Validated by the EU Reference Laboratory established under Regulation (EC) No 1829/2003, published at http://gmo-crl.jrc.ec.europa.eu/statusofdossiers.aspx;

| (3) | Reference Material: AOCS 0210-A and AOCS 0906-A (for MON-877Ø5-6) and AOCS 0906-B and AOCS 0906-A (for MON-89788-1) are accessible via the American Oil Chemists Society at http://www.aocs.org/LabServices/content.cfm?ItemNumber=19248. |
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(3)

Reference Material: AOCS 0210-A and AOCS 0906-A (for MON-877Ø5-6) and AOCS 0906-B and AOCS 0906-A (for MON-89788-1) are accessible via the American Oil Chemists Society at http://www.aocs.org/LabServices/content.cfm?ItemNumber=19248.

| (e) | Unique identifier:

  MON-877Ø5-6 × MON-89788-1 |
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(e)

Unique identifier:

MON-877Ø5-6 × MON-89788-1

| (f) | Information required under Annex II to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity:

  [Biosafety Clearing-House, Record ID number: published in the Community register of genetically modified food and feed when notified]. |
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(f)

Information required under Annex II to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity:

[Biosafety Clearing-House, Record ID number: published in the Community register of genetically modified food and feed when notified].

| (g) | Conditions or restrictions on the placing on the market, use or handling of the products:


  Post-market monitoring in accordance with Article 6(5)(e) of Regulation (EC) No 1829/2003







  (1) | The authorisation holder shall collect the following information:






  (i) | Quantities of MON-877Ø5-6 × MON-89788-1 soybean oil and MON-877Ø5-6 × MON-89788-1 soybeans for oil extraction, imported into the European Union for the placing on the market as or in products for food; |
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(g)

Conditions or restrictions on the placing on the market, use or handling of the products:

Post-market monitoring in accordance with Article 6(5)(e) of Regulation (EC) No 1829/2003

(1)

The authorisation holder shall collect the following information:

(i)

Quantities of MON-877Ø5-6 × MON-89788-1 soybean oil and MON-877Ø5-6 × MON-89788-1 soybeans for oil extraction, imported into the European Union for the placing on the market as or in products for food;

| (ii) | In case of import of products mentioned under (i), results of database searches in the FAOSTAT database on the quantities of vegetable oil consumption by Member State, including shifts in quantities between the different types of oils consumed. |
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(ii)

In case of import of products mentioned under (i), results of database searches in the FAOSTAT database on the quantities of vegetable oil consumption by Member State, including shifts in quantities between the different types of oils consumed.

| (2) | The authorisation holder shall, based on the information collected and reported, review the nutritional assessment conducted as part of the risk assessment. |
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(2)

The authorisation holder shall, based on the information collected and reported, review the nutritional assessment conducted as part of the risk assessment.

| (h) | Monitoring plan for environmental effects:

  Monitoring plan for environmental effects conforming with Annex VII to Directive 2001/18/EC.
  [Link: plan published in the Community register of genetically modified food and feed] |
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(h)

Monitoring plan for environmental effects:

Monitoring plan for environmental effects conforming with Annex VII to Directive 2001/18/EC.

[Link: plan published in the Community register of genetically modified food and feed]

Note: links to relevant documents may need to be modified over the time. Those modifications will be made available to the public via the updating of the Community register of genetically modified food and feed.

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