2010/136/: Commission Decision of 2 March 2010 authorising the placing on the market of feed produced from the genetically modified potato EH92-527-1 (BPS-25271-9) and the adventitious or technically unavoidable presence of the potato in food and other feed products under Regulation (EC) No 1829/2003 of the European Parliament and of the Council (notified under document C(2010) 1196) (Text with EEA relevance)

• CELEX: Regulation (EC) No 1829/2003
• Articles: 9

Article 1 Genetically modified organism and unique identifier

Genetically modified potato ( Solanum tuberosum L.) EH92-527-1, as specified in point (b) of the Annex, is assigned the unique identifier BPS-25271-9, as provided for in Regulation (EC) No 65/2004.

Article 2 Authorisation

The following products are authorised for the purposes of Article 4(2) and Article 16(2) of Regulation (EC) No 1829/2003, according to the conditions specified in this Decision:

(a)

feed produced from BPS-25271-9 potato;

(b)

foods containing, consisting of, or produced from BPS-25271-9 potato resulting from the adventitious or technically unavoidable presence of this GMO in a proportion no higher than 0,9 % of the food ingredients considered individually or food consisting of a single ingredient;

(c)

feed containing or consisting of BPS-25271-9 potato resulting from the adventitious or technically unavoidable presence of this GMO in a proportion no higher than 0,9 % of the feed and of each feed of which it is composed.

Article 3 Labelling

For the purposes of the labelling requirements laid down in Article 25(2) of Regulation (EC) No 1829/2003, the ‘name of the organism’ shall be ‘amylopectin starch potato’.

Article 4 Monitoring for environmental effects

1.   The monitoring plan for environmental effects provided for in Article 4 of Decision 2010/135/EU shall be considered as also applicable for the purpose of this Decision.

2.   The authorisation holder shall submit to the Commission annual reports on the implementation and the results of the monitoring activities.

Those reports shall clearly state which parts of the reports are considered to be confidential, together with a verifiable justification for confidentiality in accordance with Article 30 of Regulation (EC) No 1829/2003.

Confidential parts of such reports shall be submitted in separate documents.

Article 5 Community register

The information 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 6 Authorisation holder

The authorisation holder shall be BASF Plant Science GmbH, Germany.

Article 7 Validity

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

Article 8 Addressee

This Decision is addressed to BASF Plant Science GmbH, Carl-Bosch-Straße 38, 67056 Ludwigshafen, Germany.

Schedules & Appendices

ANNEX

ANNEX

(a)    Applicant and Authorisation holder:

Name

:

BASF Plant Science GmbH

Address

:

Carl-Bosch-Straße 38, 67056 Ludwigshafen, Germany

(b)    Designation and specification of the products:

1.

feed produced from BPS-25271-9 potato;

2.

foods containing, consisting of, or produced from BPS-25271-9 potato resulting from the adventitious or technically unavoidable presence of this GMO in a proportion no higher than 0,9 % of the food ingredients considered individually or food consisting of a single ingredient;

3.

feed containing or consisting of BPS-25271-9 potato resulting from the adventitious or technically unavoidable presence of this GMO in a proportion no higher than 0,9 % of the feed and of each feed of which it is composed.

The genetically modified potato BPS-25271-9, as described in the application, has an altered starch composition (higher amylopectin/amylose ratio). The modification implies inhibition of the expression of granule bound starch synthase protein (GBSS) responsible for amylose biosynthesis. As a result, the starch produced has little or no amylose and consists of amylopectin which modifies the physical properties of the starch. An nptII gene, conferring kanamycin resistance, was used as a selectable marker in the genetic modification process.

(c)    Labelling:

For the purposes of the labelling requirements laid down in Article 25(2) of Regulation (EC) No 1829/2003, the ‘name of the organism’ shall be ‘amylopectin starch potato’.

(d)    Method for detection:

—

Event specific real-time quantitative PCR based method for genetically modified potato BPS-25271-9.

—

Validated by the Community reference laboratory established under Regulation (EC) No 1829/2003, published at http://gmo-crl.jrc.it/statusofdoss.htm

—

Reference Material: ERM®-BF421 accessible via the Joint Research Centre (JRC) of the European Commission, the Institute of Reference Materials and Measurements (IRMM) at http://www.irmm.jrc.be/html/reference_materials_catalogue/index.htm

(e)    Unique identifier:

BPS-25271-9

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

Biosafety Clearing House, Record ID: see [ to be completed when notified ].

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

Not required.

(h)    Monitoring plan:

Monitoring plan for environmental effects provided for in Article 4 of Decision 2010/135/EU.

(i)    Post market monitoring requirements for the use of the food for human consumption:

Not required.

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.