(1)

Commission Decision 2009/184/EC (2) authorised the placing on the market of food and feed containing or produced from genetically modified oilseed rape T45 (‘T45 oilseed rape’). The scope of that authorisation also covered the placing on the market of products, other than food and feed, containing T45 oilseed rape for the same uses as any other oilseed rape with the exception of cultivation.

(2)

The applicant indicated in its applications and in communications to the Commission that the commercialisation of T45 oilseed rape seeds was stopped after the 2005 planting season.

(3)

Therefore, the only purpose of these applications was to cover the presence of T45 oilseed rape resulting from its past cultivation in third countries.

(4)

Following the monitoring requirements set in Decision 2009/184/EC, the applicant has shown that minute traces of T45 oilseed rape are still present in commodity rapeseed in third countries and being imported into the Union.

(5)

As a result, on 9 January 2018, the authorisation holder Bayer CropScience AG submitted to the Commission an application, in accordance with Articles 11 and 23 of Regulation (EC) No 1829/2003, for the renewal of that authorisation.

(6)

The applicant reconfirmed in its application that the purpose of the application was to cover the presence of T45 oilseed rape in food and feed, resulting from its cultivation in third countries until 2005.

(7)

On 14 February 2019, the European Food Safety Authority (‘the Authority’) published a comprehensive favourable opinion (3) on T45 oilseed rape in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003. It concluded that the renewal application did not contain evidence for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on T45 oilseed rape, adopted by the Authority in 2008 (4).

(8)

In its opinion of 14 February 2019, the Authority considered all the questions and concerns raised by the Member States in the context of the consultation of the national competent authorities as provided for in Articles 6(4) and 18(4) of Regulation (EC) No 1829/2003.

(9)

The Authority also concluded that the monitoring plan for the environmental effects, consisting of a general surveillance plan, submitted by Bayer CropScience AG, is in line with the intended uses of the products.

(10)

Taking into account those conclusions, the authorisation for the placing on the market of food and feed containing or produced from T45 oilseed rape and of products other than food and feed, containing T45 oilseed rape for the same uses as any other oilseed rape, with the exception of cultivation, should be renewed.

(11)

On the basis of the opinion of the Authority, no specific labelling requirements appear to be necessary for the products covered by this Decision. Pursuant to Articles 12(2) and 24(2) of Regulation (EC) No 1829/2003 and to Article 4(7) of Regulation (EC) No 1830/2003 of the European Parliament and of the Council (5), general traceability and labelling requirements do not apply to the adventitious or technically unavoidable presence of genetically modified food or feed in a proportion not exceeding 0,9 %.

(12)

In order to continue monitoring the phasing out of T45 oilseed rape, its presence in imported products should continue to be regularly reported as provided in Decision 2009/184/EC.

(13)

By letter dated 1 August 2018, Bayer CropScience AG requested that the Commission transfers their rights and obligations pertaining to all authorisations and pending applications for genetically modified products, to BASF Agricultural Solutions Seed US LLC. By letter dated 19 October 2018, BASF Agricultural Solutions Seed US LLC confirmed this transfer and authorised BASF SE to act as its representative in the Union.

(14)

On 17 May 2019, the applicant requested the Commission to restrict the scope of the Decision of renewal to allow the presence of T45 oilseed rape in food and feed in a proportion not exceeding 0,9 %. Following this request, the scope of this decision is restricted to a maximal level of 0,9 % of presence of T45 oilseed rape in food and feed.

(15)

A unique identifier has been assigned to T45 oilseed rape, in accordance with Commission Regulation (EC) No 65/2004 (6), in the context of its initial authorisation by Decision 2009/184/EC. That unique identifier should continue to be used.

(16)

The authorisation holder should submit annual reports on the implementation and on the results of the activities set out in the monitoring plan. Those results should be presented in accordance with the requirements laid down in Commission Decision 2009/770/EC (7).

(17)

The opinion of the Authority does not justify the imposition of specific conditions or restrictions for the placing on the market, for the use and handling, including post-market monitoring requirements regarding the consumption of the food and feed containing or produced from genetically modified oilseed rape T45, or 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.

(18)

All relevant information on the authorisation of the products should be entered in the Community register of genetically modified food and feed referred to in Article 28(1) of Regulation (EC) No 1829/2003.

(19)

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 (8).

(20)

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