4.3.2010   

EN

Official Journal of the European Union

L 53/1

(1)

In accordance with the first subparagraph of Article 8(2) of Regulation (EC) No 509/2006, and pursuant to Article 19(3) of the same Regulation, the application submitted by Slovenia to register the name ‘Belokranjska pogača’ was published in the Official Journal of the European Union  (2).

(2)

As no objection pursuant to Article 9 of Regulation (EC) No 509/2006 has been received by the Commission, this name should be entered in the register.

(3)

The application also requested protection pursuant to Article 13(2) of Regulation (EC) No 509/2006. That protection should be granted to the name ‘Belokranjska pogača’ in so far as, in the absence of objections, it could not be demonstrated that the name is used in a lawful, renowned and economically significant manner for similar agricultural products or foodstuffs,

4.3.2010   

EN

Official Journal of the European Union

L 53/3

4.3.2010   

EN

Official Journal of the European Union

L 53/5

(1)

The representative prices and additional duties applicable to imports of white sugar, raw sugar and certain syrups for the 2009/10 marketing year are fixed by Commission Regulation (EC) No 877/2009 (3). These prices and duties have been last amended by Commission Regulation (EU) No 180/2010 (4).

(2)

The data currently available to the Commission indicate that those amounts should be amended in accordance with the rules and procedures laid down in Regulation (EC) No 951/2006,

4.3.2010   

EN

Official Journal of the European Union

L 53/7

(1)

In accordance with Article 6(2) of Directive 91/414/EEC France received on 9 May 2006 an application from Elicityl SA for the inclusion of the active substance heptamaloxyloglucan in Annex I to Directive 91/414/EEC. Commission Decision 2007/560/EC (2) confirmed that the dossier was ‘complete’ in the sense that it could be considered as satisfying, in principle, the data and information requirements of Annexes II and III to Directive 91/414/EEC.

(2)

For that active substance, the effects on human health and the environment have been assessed, in accordance with the provisions of Article 6(2) and (4) of Directive 91/414/EEC, for the uses proposed by the applicant. The designated rapporteur Member State submitted a draft assessment report on 26 July 2007.

(3)

The assessment report was peer reviewed by the Member States and the EFSA and presented to the Commission in the format of the EFSA Scientific Report for heptamaloxyloglucan on 17 July 2009 (3). This report was reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised on 27 November 2009 in the format of the Commission review report for heptamaloxyloglucan.

(4)

It has appeared from the various examinations made that plant protection products containing heptamaloxyloglucan may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) and Article 5(3) of Directive 91/414/EEC, in particular with regard to the uses which were examined and detailed in the Commission review report. It is therefore appropriate to include heptamaloxyloglucan in Annex I to that Directive, in order to ensure that in all Member States the authorisations of plant protection products containing this active substance may be granted in accordance with the provisions of that Directive.

(5)

Without prejudice to the obligations defined by Directive 91/414/EEC as a consequence of including an active substance in Annex I, Member States should be allowed a period of six months after inclusion to review existing provisional authorisations of plant protection products containing heptamaloxyloglucan to ensure that the requirements laid down by Directive 91/414/EEC, in particular in its Article 13 and the relevant conditions set out in Annex I, are satisfied. Member States should transform existing provisional authorisations into full authorisations, amend them or withdraw them in accordance with the provisions of Directive 91/414/EEC. By derogation from the above deadline, a longer period should be provided for the submission and assessment of the complete Annex III dossier of each plant protection product for each intended use in accordance with the uniform principles laid down in Directive 91/414/EEC.

(6)

It is therefore appropriate to amend Directive 91/414/EEC accordingly.

(7)

The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

(a)

in the case of a product containing heptamaloxyloglucan as the only active substance, where necessary, amend or withdraw the authorisation by 30 November 2011 at the latest; or

(b)

in the case of a product containing heptamaloxyloglucan as one of several active substances, where necessary, amend or withdraw the authorisation by 30 November 2011 or by the date fixed for such an amendment or withdrawal in the respective Directive or Directives which added the relevant substance or substances to Annex I to Directive 91/414/EEC, whichever is the latest.

4.3.2010   

EN

Official Journal of the European Union

L 53/10

(1)

By Commission Decision 2006/473/EC of 5 July 2006 recognising certain third countries and certain areas of third countries as being free from Xanthomonas campestris (all strains pathogenic to Citrus), Cercospora angolensis Carv. et Mendes and Guignardia citricarpa Kiely (all strains pathogenic to Citrus) (2) New South Wales, South Australia and Victoria in Australia are recognised as being free from Xanthomonas campestris (all strains pathogenic to Citrus).

(2)

Australia has submitted detailed technical information, based on results of the disease management and eradication programmes and of multiannual official surveys, showing that an outbreak of Xanthomonas campestris in Queensland was successfully eradicated and that the Northern Territory and Western Australia were free from Xanthomonas campestris. The freedom from that harmful organism should therefore be recognised for all citrus-growing areas of continental Australia.

(3)

Decision 2006/473/EC should therefore be amended accordingly.

(4)

The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on Plant Health,

‘(a)

Australia: New South Wales, the Northern Territory, Queensland, South Australia, Victoria and Western Australia;’.

4.3.2010   

EN

Official Journal of the European Union

L 53/11

(1)

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,

(a)

Cassette 1:

an nptII-type kanamycin resistance gene originating from Tn5, under the regulation of a nopaline-synthase promoter for expression in plant tissue and terminated by a polyadenylation sequence from the Agrobacterium tumefaciens nopaline-synthase gene;

(b)

Cassette 2:

a segment of the potato gbss gene encoding for granule bound starch synthase protein inserted in reversed orientation under the control of the gbss-promoter isolated from potato, and terminated by a polyadenylation sequence from the Agrobacterium tumefaciens nopaline-synthase gene.

(a)

in accordance with Article 15(4) of Directive 2001/18/EC, the period of validity of the consent shall be 10 years starting from the date at which the consent for Solanum tuberosum L. line EH92-527-1 is issued;

(b)

the unique identifier of the products shall be BPS-25271-9;

(c)

without prejudice to Article 25 of Directive 2001/18/EC, the consent holder shall make available positive and negative control samples of the product and its genetic materials and reference materials to the competent authorities and to inspection services of Member States as well as to the Community control laboratories on request;

(d)

a detection method specific to Solanum tuberosum L. line EH92-527-1, validated by the Community Reference Laboratory as referred to in the Annex to Regulation (EC) No 1829/2003 is available for the purpose of inspection and control;

(e)

without prejudice to specific labelling requirements provided by Regulation (EC) No 1829/2003, the words ‘This product contains genetically modified organisms’ or ‘This product contains genetically modified EH92-527-1 potato’ and the words ‘not for human consumption’ shall appear either on a label or in a document accompanying the product;

(f)

it shall also be indicated on the label, or in an accompanying document, that the product contains an altered starch composition;

(g)

throughout the validity of the consent, the consent holder when placing Solanum tuberosum L. line EH92-527-1 on the market in a Member State shall directly inform operators and users on the safety and general characteristics of the product, and of the legal requirements for the placing on the market of material harvested from crops containing this line;

(h)

in view that this Decision covers only cultivation and industrial use, the consent holder shall ensure that potato tubers of Solanum tuberosum L. line EH92-527-1 are:

(a)

the consent holder shall ensure that the monitoring plan, to monitor for any adverse effects on human and animal health or the environment arising from handling or use of the product, is put in place and implemented. This monitoring plan includes case-specific monitoring, general surveillance and an Identity Preservation System (IPS), as contained in the notification and may be subject to further modifications as laid down in this Article;

(b)

the consent holder shall ensure that monitoring includes data as to the area of land cultivated with Solanum tuberosum L. line EH92-527-1 and the quantity of harvested material;

(c)

the consent holder shall be in the position to give evidence to the Commission and the competent authorities of the Member States:

(d)

the consent holder shall extend the existing monitoring networks, to include all growers of Solanum tuberosum L. line EH92-527-1, on the basis of the questionnaire and reporting system detailed in the notification;

(e)

the consent holder shall carry out specific field studies to monitor potential adverse effects on potato-feeding organisms in the fields and their vicinity where Solanum tuberosum L. line EH92-527-1 is cultivated in accordance with the requirements laid down in Annex.

4.3.2010   

EN

Official Journal of the European Union

L 53/15

(1)

On 28 February 2005, BASF Plant Science GmbH, submitted to the competent authorities of the United Kingdom an application, in accordance with Articles 5 and 17 of Regulation (EC) No 1829/2003, for the placing on the market of genetically modified potato EH92-527-1 for food and feed uses, food and feed containing, consisting, or produced from potato EH92-527-1, with the exception of cultivation.

(2)

It follows from the application that feed produced from genetically modified potato EH92-527-1 is, as for any conventional starch potato, a by-product of the starch processing and is the only intended use in the food and feed chains.

(3)

On 10 November 2006, the European Food Safety Authority (EFSA) gave a favourable opinion in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003 and concluded that it is unlikely that the placing on the market of the products containing, consisting, or produced from potato EH92-527-1 (2) as described in the application (the products) will have adverse effects on human or animal health or the environment. 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 that Regulation.

(4)

Accordingly, EFSA advised that no specific labelling requirements other than those provided for in Articles 13(1) and 25(2) of Regulation (EC) No 1829/2003 are necessary. EFSA also considered that no specific conditions or restrictions for the placing on the market and/or specific conditions or restrictions for the use and handling, including post-market monitoring requirements, and no specific conditions for the protection of particular ecosystems/environment and/or geographical areas, as provided for in point (e) of Articles 6(5) and 18(5) of the Regulation, had to be applied.

(5)

In its opinion, EFSA concluded that the environmental monitoring plan submitted by the applicant is in line with the intended uses of the products. This environmental monitoring will be carried out for the purpose of Commission Decision 2010/135/EU of 2 March 2010 concerning the placing on the market, in accordance with Directive 2001/18/EC of the European Parliament and of the Council, of a potato product (Solanum tuberosum L. line EH92-527-1) genetically modified for enhanced content of the amylopectin component of starch (3).

(6)

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.

(7)

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.

(8)

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 genetically modified potato 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.

(9)

In the light of the above considerations, authorisation should be granted.

(10)

The authorisation for the cultivation and industrial use of potato EH92-527-1 is provided by Decision 2010/135/EU that is providing for conditions for use and handling that aim to avoid any co-mingling with material derived from conventional potatoes intended for food or feed.

(11)

Despite the application of these measures, it can not be excluded that the genetically modified potato and some products of the starch processing may be present in food or feed. Such a presence should be considered adventitious or technically unavoidable and can be accepted provided it is in a proportion no higher than 0,9 %.

(12)

A unique identifier should be assigned to each GMO as provided for in 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).

(13)

All information contained in the Annex to this Decision on the authorisation of the products should be entered in the Community register of genetically modified food and feed as provided for in the Regulation.

(14)

In accordance with Articles 4(2) and 16(2) of the Regulation, the conditions for authorisation of the products bind all persons placing them on the market.

(15)

This Decision should 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 Council of 15 July 2003 on transboundary movements of genetically modified organisms (5).

(16)

The Standing Committee on the Food Chain and Animal Health has not delivered an opinion within the time limit laid down by its Chairman.

(17)

At its meeting on 18 February 2008, 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,

(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.

4.3.2010   

EN

Official Journal of the European Union

L 53/19