On 20 September 2007, Pioneer Overseas Corporation submitted an application for the placing on the market of foods, food ingredients, and feed containing, consisting of, or produced from 305423 × 40-3-2 soybean (‘the application’) to the national competent authority of the Netherlands in accordance with Articles 5 and 17 of Regulation (EC) No 1829/2003. The application also covered the placing on the market of genetically modified soybean 305423 × 40-3-2 in products consisting of it or containing it for other uses than food and feed as any other soybean, with the exception of cultivation.

In accordance with Article 5(5) and Article 17(5) of Regulation (EC) No 1829/2003, the application included information and conclusions about the risk assessment carried out in accordance with the principles set out in Annex II to Directive 2001/18/EC of the European Parliament and of the Council2 and the data and information required by Annexes III and IV to that Directive. It also included a monitoring plan for environmental effects set out in Annex VII to that Directive.

On 18 August 2016, the European Food Safety Authority (‘EFSA’) gave a favourable opinion3 in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003. EFSA concluded that genetically modified soybean 305423 × 40-3-2, as described in the application, is as safe as the non-genetically modified comparator and other non-genetically modified conventional soybean varieties as regards the potential effects on human and animal health and the environment in the context of the scope of the application.

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 Article 6(4) and Article 18(4) of Regulation (EC) No 1829/2003.

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.

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

Taking into account those considerations, authorisation should be granted to the products containing, consisting of, or produced from genetically modified soybean 305423 × 40-3-2.

A unique identifier should be assigned to each genetically modified organism (‘GMO’), in accordance with Commission Regulation (EC) No 65/20044.

Food, food ingredients and feed containing, consisting of, or produced from 305423 × 40-3-2 soybean should be labelled in accordance with the requirements laid down in Article 13(1) and Article 25(2) of Regulation (EC) No 1829/2003.

On the basis of the EFSA opinion confirming that fatty acid composition of the seeds of 305423 × 40-3-2 soybean and derived oil has been changed in relation to the conventional counterpart, specific labelling should be included in accordance with Article 13(2)(a) and Article 25(2)(c) of Regulation (EC) No 1829/2003.

On the basis of the EFSA opinion, no specific labelling requirements, other than those laid down in Article 13(1) and in Article 25(2) of Regulation (EC) No 1829/2003 and in Article 4(6) of Regulation (EC) No 1830/2003 of the European Parliament and of the Council5, appear necessary for the products covered by this Decision. However, 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.

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 the standard reporting format requirements laid down in Commission Decision 2009/770/EC6.

The EFSA opinion does not justify either the imposition of specific conditions for the protection of particular ecosystems/environments or geographical areas, as provided for in Article 6(5)(e) and Article 18(5)(e) of Regulation (EC) No 1829/2003.

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.

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

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 Article 9(1) and Article 15(2)(c) of Regulation (EC) No 1946/2003 of the European Parliament and of the Council7.

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,