Pursuant to Directive 2001/18/EC, the placing on the market of a product containing or consisting of a genetically modified organism or a combination of genetically modified organisms is subject to written consent being granted by the competent authority of the Member State that received the notification for the placing on the market of that product, in accordance with the procedure laid down in that Directive.
(2)
A notification (Reference C/SE/96/3501) concerning the placing on the market of a genetically modified potato product (Solanum tuberosum L. line EH92-527-1) was submitted by BASF Plant Science (formerly Amylogen HB) to the competent authority of Sweden.
(3)
The notification originally covered the placing on the market of Solanum tuberosum L. line EH92-527-1 for cultivation and processing into industrial starch, as well as use in feed in the Community.
(4)
In accordance with the procedure established by Article 14 of Directive 2001/18/EC, the competent authority of Sweden prepared an assessment report, which concluded that there is no scientific evidence to indicate that the placing on the market of the Solanum tuberosum L. line EH92-527-1 poses any risk to human and animal health or the environment for the requested uses.
(5)
The assessment report was submitted to the Commission and the competent authorities of the other Member States, which raised and maintained objections to the placing on the market of the product.
(6)
On 9 December 2005, BASF Plant Science informed the Swedish competent authority of its intention to exclude feed uses from the notification under Directive 2001/18/EC, limiting its scope to cultivation of the Solanum tuberosum L. line EH92-527-1 and production of starch for industrial uses.
(7)
An application for the placing on the market of feed and food containing, consisting of, or produced from Solanum tuberosum L. line EH92-527-1 was submitted, on 25 April 2005, by BASF Plant Science under Regulation (EC) No 1829/2003 of the European Parliament and of the Council (2).
(8)
The opinions of the European Food Safety Authority concerning the placing on the market of Solanum tuberosum L. line EH92-527-1 for cultivation and industrial starch production under Directive 2001/18/EC and feed and food under Regulation (EC) No 1829/2003, published on 24 February 2006, concluded that the product is unlikely to have an adverse effect on human and animal health or the environment in the context of its proposed uses.
(9)
An examination of each of the objections maintained by the Member States in the light of Directive 2001/18/EC, of the information submitted in the notification and of the opinion of the European Food Safety Authority, discloses no evidence to believe that the placing on the market of Solanum tuberosum L. line EH92-527-1 is likely to cause adverse effects on human and animal health or the environment in the context of its proposed uses.
(10)
On 26 February 2007, in the light of a report published by the World Health Organisation listing kanamycin and neomycin as ‘critically important antibacterial agents for human medicine and for risk management strategies of non-human use’, the European Medicines Agency issued a statement highlighting the therapeutic relevance of both antibiotics in human and veterinary medicine. On 13 April 2007, taking into account this statement, EFSA indicated that the therapeutic effect of the antibiotics at stake will not be compromised by the presence of the nptII gene in GM plants. This is due to the extremely low probability of gene transfer from plants to bacteria and its subsequent expression and to the fact that this antibiotic resistant gene in bacteria is already widespread in the environment. It thus confirmed its previous assessment of the safe use of the antibiotic resistance marker gene nptII in genetically modified organisms and their derived products for food and feed uses.
(11)
On 14 May 2008, the Commission sent a mandate to EFSA, with a request: (i) to prepare a consolidated scientific opinion taking into account the previous opinion and the statement on the use of ARM genes in GM plants intended or already authorised to be placed on the market and their possible uses for import and processing and for cultivation; (ii) to indicate the possible consequences of this consolidated opinion on the previous EFSA assessments on individual GMOs containing ARM genes. The mandate brought to the attention of EFSA, inter alia, letters by the Commission from Denmark and Greenpeace.
(12)
On 11 June 2009, EFSA published a statement on the use of ARM genes in GM plants which concludes that the previous assessment of EFSA on Solanum tuberosum L. line EH92-527-1 is in line with the risk assessment strategy described in the statement, and that no new evidence has become available that would prompt EFSA to change its previous opinion.
(13)
A unique identifier should be assigned to the Solanum tuberosum L. line EH92-527-1 for the purposes of 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 (3) and 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 (4).
(14)
The proposed labelling, on a label or in an accompanying document, of products containing or consisting of Solanum tuberosum L. line EH92-527-1 should include wording to inform operators and final users that such material cannot be used for human or animal consumption.
(15)
Feed produced from Solanum tuberosum L. line EH92-527-1 as well as the adventitious or technically unavoidable presence of the potato in food and other feed products have been authorised under Commission Decision 2010/136/EU (5) under Regulation (EC) No 1829/2003.
(16)
Member States should utilise the registers established, in accordance with Article 31(3)(b) of Directive 2001/18/EC, for recording the location of GMOs grown under Part C of the Directive, inter alia, to facilitate monitoring and general surveillance and for the purpose of inspection and control.
(17)
In view of the opinion of EFSA, it is not necessary to establish specific conditions for the intended uses with regard to the handling or packaging of the product and the protection of particular ecosystems, environments or geographical areas.
(18)
In order to complement existing field studies carried out in northern Europe, which indicated that the cultivation of Solanum tuberosum L. line EH92-527-1 is unlikely to have adverse effects on the environment, additional measures to monitor potato-feeding organisms in the fields and their vicinity where Solanum tuberosum L. line EH92-527-1 is commercially cultivated should be put in place as part of the monitoring programme.
(19)
Prior to the placing on the market of the Solanum tuberosum L. line EH92-527-1, the necessary measures to ensure its labelling and traceability at all stages of its placing on the market, including verification by appropriate validated detection methodology, should be applicable.
(20)
A detection method for the Solanum tuberosum L. line EH92-527-1 has been validated by the Community Reference Laboratory as referred to in Article 32 of Regulation (EC) No 1829/2003, in accordance with Commission Regulation (EC) No 641/2004 of 6 April 2004 on detailed rules for the implementation of Regulation (EC) No 1829/2003 of the European Parliament and of the Council as regards the application for the authorisation of new genetically modified food and feed, the notification of existing products and adventitious or technically unavoidable presence of genetically modified material which has benefited from a favourable risk evaluation (6).
(21)
The Committee established under Article 30(1) of Directive 2001/18/EC has not delivered an opinion within the time-limit laid down by its Chairman.
(22)
At its meeting on 16 July 2007, the Council was unable to reach a decision by qualified majority either for or against the proposal. It is accordingly for the Commission to adopt the measures,
