30.6.2012

Official Journal of the European Union

L 171/2

COMMISSION IMPLEMENTING REGULATION (EU) No 578/2012

of 29 June 2012

concerning the non approval of the active substance diphenylamine, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (1), and in particular Article 13(2) thereof,

Whereas:

(1)

In accordance with Article 80(1)(c) of Regulation (EC) No 1107/2009, Council Directive 91/414/EEC (2) is to apply, with respect to the procedure and the conditions for approval, to active substances for which completeness has been established in accordance with Article 16 of Commission Regulation (EC) No 33/2008 of 17 January 2008 laying down detailed rules for the application of Council Directive 91/414/EEC as regards a regular and an accelerated procedure for the assessment of active substances which were part of the programme of work referred to in Article 8(2) of that Directive but have not been included into its Annex I (3). Diphenylamine is an active substance for which completeness has been established in accordance with that Regulation.

(2)

Commission Regulations (EC) No 451/2000 (4) and 1490/2002 (5) lay down the detailed rules for the implementation of the second and third stages of the programme of work referred to in Article 8(2) of Directive 91/414/EEC and establish a list of active substances to be assessed, with a view to their possible inclusion in Annex I to Directive 91/414/EEC. That list included diphenylamine. By Commission Decision 2009/859/EC (6) it was decided not to include diphenylamine in Annex I to Directive 91/414/EEC.

(3)	In agreement with the original notifier, another person (hereinafter ‧the applicant‧) submitted a new application pursuant to Article 6(2) of Directive 91/414/EEC requesting the accelerated procedure to be applied, as provided for in Articles 14 to 19 of Commission Regulation (EC) No 33/2008.

(4)

The application was submitted to Ireland, which had been designated rapporteur Member State by Regulation (EC) No 1490/2002. The time period for the accelerated procedure was respected. The specification of the active substance and the supported uses are the same as were the subject of Decision 2009/859/EC. That application also complies with the remaining substantive and procedural requirements of Article 15 of Regulation (EC) No 33/2008.

(5)	Ireland evaluated the additional data submitted by the applicant and prepared an additional report. It communicated that report to the European Food Safety Authority (hereinafter ‘the Authority’) and to the Commission on 3 December 2010.

(6)

The Authority communicated the additional report to the other Member States and the applicant for comments and forwarded the comments it had received to the Commission. In accordance with Article 20(1) of Regulation (EC) No 33/2008 and at the request of the Commission, the Authority presented its conclusion on the risk assessment of diphenylamine to the Commission on 5 December 2011 (7). The draft assessment report, the additional report and the conclusion of the Authority were reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised on 1 June 2012 in the format of the Commission review report for diphenylamine.

(7)

The additional data and information provided by the applicant did not permit to eliminate the specific concerns that led to the non-inclusion. In particular, it was not possible to perform a reliable consumer exposure assessment because information concerning residues in raw and processed apples was missing and because the presence of nitrosamines in apples could not be excluded. Specifically, three metabolites could not be identified and, consequently, their toxicological properties could not be assessed. Furthermore, the processing study submitted by the applicant was not representative of the standard hydrolytic conditions and did not allow to identify breakdown and reaction products including the three unknown metabolites. Finally, the additional evidence submitted on nitrosamines was inconclusive as the analytical method was not validated and had an insufficient resolution and a lack of selectivity.

(8)

The Commission invited the applicant to submit its comments on the conclusion of the Authority. Furthermore, in accordance with Article 21(1) of Regulation (EC) No 33/2008, the Commission invited the applicant to submit comments on the draft review report. The applicant submitted its comments, which have been carefully examined.

(9)

However, despite the arguments put forward by the applicant, the concerns referred to in recital 7 could not be eliminated. Consequently, it has not been demonstrated that it may be expected that, under the proposed conditions of use, plant protection products containing diphenylamine satisfy in general the requirements laid down in Article 5(1)(a) and (b) of Directive 91/414/EEC.

(10)	Diphenylamine should therefore not be approved pursuant to Article 13(2) of Regulation (EC) No 1107/2009.

(11)	In the interest of clarity, Decision 2009/859/EC should be repealed.

(12)	This Regulation does not prejudice the submission of a further application for diphenylamine pursuant to Article 7 of Regulation (EC) No 1107/2009.

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

HAS ADOPTED THIS REGULATION:

Article 1

Non approval of active substance

The active substance diphenylamine is not approved.

Article 2

Repeal

Decision 2009/859/EC is repealed.

Article 3

Entry into force

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 29 June 2012.

For the Commission

The President

José Manuel BARROSO

(1) OJ L 309, 24.11.2009, p. 1.

(2) OJ L 230, 19.8.1991, p. 1.

(3) OJ L 15, 18.1.2008, p. 5.

(4) OJ L 55, 29.2.2000, p. 25.

(5) OJ L 224, 21.8.2002, p. 23.

(6) OJ L 314, 1.12.2009, p. 79.

(7) European Food Safety Authority; Conclusion on the peer review of the pesticide risk assessment of the active substance diphenylamine. EFSA Journal 2012; 10(1):2486 [59 pp.]. doi:10.2903/j.efsa.2012.2486. Available online: www.efsa.europa.eu/efsajournal.htm

30.6.2012

Official Journal of the European Union

L 171/4

COMMISSION IMPLEMENTING REGULATION (EU) No 579/2012

of 29 June 2012

amending Regulation (EC) No 607/2009 laying down certain detailed rules for the implementation of Council Regulation (EC) No 479/2008 as regards protected designations of origin and geographical indications, traditional terms, labelling and presentation of certain wine sector products

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Council Regulation (EC) No 1234/2007 of 22 October 2007 establishing a common organisation of agricultural markets and on specific provisions for certain agricultural products (Single CMO Regulation) (1), and in particular Article 121, first paragraph, point (m), in conjunction with Article 4 thereof,

Having regard to Directive 2000/13/EC of the European Parliament and of the Council of 20 March 2000 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs (2) and in particular point (a) of the second subparagraph of Article 6(3a) thereof,

Whereas:

(1)	For beverages containing more than 1,2 % by volume of alcohol, the first subparagraph of Article 6(3a) of Directive 2000/13/EC provides for the obligation to label all ingredients defined in paragraph 4(a) of that Article and listed in Annex IIIa to that Directive.

(2)

The exemption from this obligation as regards wines, within the meaning of Annex XIb to Regulation (EC) No 1234/2007, placed on the market or labelled before 30 June 2012 until stocks are exhausted, as provided for in Commission Directive 2007/68/EC (3), as amended by Regulation (EU) No 1266/2010 (4), will no longer apply as from 30 June 2012.

(3)

It is therefore necessary to establish detailed rules for labelling these beverages, including a mention of the substances referred to in Annex IIIa to Directive 2000/13/EC and used when making the beverages, if their presence can be detected in the final product using the analysis methods referred to in Article 120g of Regulation (EC) No 1234/2007 and if they consequently must be considered ingredients within the meaning of Article 6(4)(a) of Directive 2000/13/EC.

(4)	In a multilingual context, labelling products using pictograms may improve the readability of the information provided to consumers and offer better guarantees for consumers. Therefore operators should be given the possibility of complementing written information with pictograms.

(5)	Commission Regulation (EC) No 607/2009 (5) should therefore be amended accordingly.

(6)	In order to prevent the new rules from affecting the marketing of products that are already labelled, it should be specified that they apply only to wines made completely or partially from grapes harvested in 2012 or later and labelled after 30 June 2012.

(7)	The measures provided for in this Regulation are in accordance with the opinion of the Management Committee for the Common Organisation of Agricultural Markets,

HAS ADOPTED THIS REGULATION:

Article 1

Regulation (EC) No 607/2009 is amended as follows:

(1)

Article 51 is replaced by the following:

‘Article 51

Application of certain horizontal rules

1. For the purposes of indicating the ingredients as referred to in Article 6(3a) of Directive 2000/13/EC, the terms concerning sulphites/sulfites, milk and milk-based products and eggs and egg-based products that must be used are those listed in part A of Annex X.

2. The terms referred to in paragraph 1 may be accompanied, as applicable, by one of the pictograms shown in part B of Annex X.’;

(2)	Annex X is replaced by the contents of the Annex to this Regulation.

Article 2

This Regulation shall enter into force on the third day following that of its publication in the Official Journal of the European Union.

It is applicable, as regards the terms concerning milk and milk-based products and eggs and egg-based products referred to in Article 51(1) of Regulation (EC) No 607/2009, as amended by this Regulation, to the wines referred to in Annex XIb to Regulation (EC) No 1234/2007, made completely or partially from grapes harvested in 2012 or later and labelled after 30 June 2012.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 29 June 2012.

For the Commission

The President

José Manuel BARROSO

(1) OJ L 299, 16.11.2007, p. 1.

(2) OJ L 109, 6.5.2000, p. 29.

(3) OJ L 310, 28.11.2007, p. 11.

(4) OJ L 347, 31.12.2010, p. 27.

(5) OJ L 193, 24.7.2009, p. 60.

ANNEX

‘ANNEX X

PART A

Terms referred to in Article 51(1)

Language	Terms concerning sulphites/sulfites	Terms concerning eggs and egg-based products	Terms concerning milk and milk-based products
in Bulgarian	„сулфити“ or „серен диоксид“	„яйце“, „яйчен протеин“, „яйчен продукт“, „яйчен лизозим“ or „яйчен албумин“	„мляко“, „млечни продукти“, „млечен казеин“ or „млечен протеин“
in Spanish	«sulfitos» or «dióxido de azufre»	«huevo», «proteína de huevo», «ovoproducto», «lisozima de huevo» or «ovoalbúmina»	«leche», «productos lácteos», «caseína de leche» or «proteína de leche»
in Czech	„siřičitany“ or „oxid siřičitý“	„vejce“, „vaječná bílkovina“, „výrobky z vajec“, „vaječný lysozym“ or „vaječný albumin“	„mléko“, „výrobky z mléka“, „mléčný kasein“ or „mléčná bílkovina“
in Danish	»sulfitter« or »svovldioxid«.	»æg«, »ægprotein«, »ægprodukt«, »æglysozym«, or »ægalbumin«	»mælk«, »mælkeprodukt«, »mælkecasein« or »mælkeprotein«,
in German	„Sulfite“ or „Schwefeldioxid“	„Ei“, „Eiprotein“, „Eiprodukt“, „Lysozym aus Ei“ or „Albumin aus Ei“	„Milch“, „Milcherzeugnis“, „Kasein aus Milch“ or „Milchprotein“
in Estonian	„sulfitid” or „vääveldioksiid”	„muna”, „munaproteiin”, „munatooted”, „munalüsosüüm” or „munaalbumiin”…	„piim”, „piimatooted”, „piimakaseiin” or „piimaproteiin”
in Greek	«θειώδη», «διοξείδιο του θείου» or «ανυδρίτης του θειώδους οξέος»	«αυγό», «πρωτεΐνη αυγού», «προϊόν αυγού», «λυσοζύμη αυγού» or «αλβουμίνη αυγού»	«γάλα», «προϊόντα γάλακτος», «καζεΐνη γάλακτος» or «πρωτεΐνη γάλακτος»
in English	‘sulphites’, ‘sulfites’, ‘sulphur dioxide’ or ‘sulfur dioxide’	‘egg’, ‘egg protein’, ‘egg product’, ‘egg lysozyme’ or ‘egg albumin’	‘milk’, ‘milk products’, ‘milk casein’ or ‘milk protein’
in French	«sulfites» or «anhydride sulfureux»	«œuf», «protéine de l'œuf», «produit de l'œuf», «lysozyme de l'œuf» or «albumine de l'œuf»	«lait», «produits du lait», «caséine du lait» or «protéine du lait»
in Italian	«solfiti», or «anidride solforosa»	«uovo», «proteina dell’uovo», «derivati dell’uovo», «lisozima da uovo» or «ovoalbumina»	«latte», «derivati del latte», «caseina del latte» or «proteina del latte»
in Latvian	“sulfīti” or “sēra dioksīds”	“olas”, “olu olbaltumviela”, “olu produkts”, “olu lizocīms” or “olu albumīns”	“piens”, “piena produkts”, “piena kazeīns” or “piena olbaltumviela”
in Lithuanian	„sulfitai“ or „sieros dioksidas“	„kiaušiniai“, „kiaušinių baltymai“, „kiaušinių produktai“, „kiaušinių lizocimas“ or „kiaušinių albuminas“	„pienas“, „pieno produktai“, „pieno kazeinas“ or „pieno baltymai“
in Hungarian	„szulfitok” or „kén-dioxid”	„tojás”, „tojásból származó fehérje”, „tojástermék”, „tojásból származó lizozim” or „tojásból származó albumin”	„tej”, „tejtermékek”, „tejkazein” or „tejfehérje”
in Maltese	“sulfiti”, or “diossidu tal-kubrit”	“bajd”, “proteina tal-bajd”, “prodott tal-bajd”, “liżożima tal-bajd” or “albumina tal-bajd”	“ħalib”, “prodotti tal-ħalib”, “kaseina tal-ħalib” or “proteina tal-ħalib”
in Dutch	„sulfieten” or „zwaveldioxide”	„ei”, „eiproteïne”, „eiderivaat”, „eilysozym” or „eialbumine”	„melk”, „melkderivaat”, „melkcaseïne” or „melkproteïnen”
in Polish	„siarczyny”, „dwutlenek siarki” or „ditlenek siarki”	„jajo”, „białko jaja”, „produkty z jaj”, „lizozym z jaja” or „albuminę z jaja”	„mleko”, „produkty mleczne”, „kazeinę z mleka” or „białko mleka”
in Portuguese	«sulfitos» or «dióxido de enxofre»	«ovo», «proteína de ovo», «produto de ovo», «lisozima de ovo» or «albumina de ovo»	«leite», «produtos de leite», «caseína de leite» or «proteína de leite»
in Romanian	„sulfiți” or „dioxid de sulf”	„ouă”, „proteine din ouă”, „produse din ouă”, „lizozimă din ouă” or „albumină din ouă”	„lapte”, „produse din lapte”, „cazeină din lapte” or „proteine din lapte”
in Slovak	„siričitany“ or „oxid siričitý“	„vajce“, „vaječná bielkovina“, „výrobok z vajec“, „vaječný lyzozým“ or „vaječný albumín“	„mlieko“, „výrobky z mlieka“, „mliečne výrobky“, „mliečny kazeín“ or „mliečna bielkovina“
in Slovene	„sulfiti“ or „žveplov dioksid“	„jajce“, „jajčne beljakovine“, „proizvod iz jajc“, „jajčni lizocim“ or „jajčni albumin“	„mleko“, „proizvod iz mleka“, „mlečni kazein“ or „mlečne beljakovine“
in Finnish	”sulfiittia”, ”sulfiitteja” or ”rikkidioksidia”	”kananmunaa”, ”kananmunaproteiinia”, ”kananmunatuotetta”, ”lysotsyymiä (kananmunasta)” or ”kananmuna-albumiinia”	”maitoa”, ”maitotuotteita”, ”kaseiinia (maidosta)” or ”maitoproteiinia”
in Swedish	”sulfiter” or ”svaveldioxid”	”ägg”, ”äggprotein”, ”äggprodukt”, ”ägglysozym” or ”äggalbumin”	”mjölk”, ”mjölkprodukter”, ”mjölkkasein” or ”mjölkprotein”

PART B

Pictograms referred to in Article 51(2)

’

30.6.2012

Official Journal of the European Union

L 171/8

COMMISSION IMPLEMENTING REGULATION (EU) No 580/2012

of 29 June 2012

establishing the standard import values for determining the entry price of certain fruit and vegetables

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Commission Implementing Regulation (EU) No 543/2011 of 7 June 2011 laying down detailed rules for the application of Council Regulation (EC) No 1234/2007 in respect of the fruit and vegetables and processed fruit and vegetables sectors (2), and in particular Article 136(1) thereof,

Whereas:

(1)

Implementing Regulation (EU) No 543/2011 lays down, pursuant to the outcome of the Uruguay Round multilateral trade negotiations, the criteria whereby the Commission fixes the standard values for imports from third countries, in respect of the products and periods stipulated in Annex XVI, Part A thereto.

(2)

The standard import value is calculated each working day, in accordance with Article 136(1) of Implementing Regulation (EU) No 543/2011, taking into account variable daily data. Therefore this Regulation should enter into force on the day of its publication in the Official Journal of the European Union,

HAS ADOPTED THIS REGULATION:

Article 1

The standard import values referred to in Article 136 of Implementing Regulation (EU) No 543/2011 are fixed in the Annex to this Regulation.

Article 2

This Regulation shall enter into force on the day of its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 29 June 2012.

For the Commission, On behalf of the President,

José Manuel SILVA RODRÍGUEZ

Director-General for Agriculture and Rural Development

(1) OJ L 299, 16.11.2007, p. 1.

(2) OJ L 157, 15.6.2011, p. 1.

ANNEX

Standard import values for determining the entry price of certain fruit and vegetables

(EUR/100 kg)
CN code	Third country code (1)	Standard import value
0702 00 00	TR	52,3
0702 00 00	ZZ	52,3
0707 00 05	TR	103,7
0707 00 05	ZZ	103,7
0709 93 10	TR	99,0
0709 93 10	ZZ	99,0
0805 50 10	AR	72,8
	UY	89,3
	ZA	95,0
	ZZ	85,7
0808 10 80	AR	114,7
	BR	93,7
	CL	107,8
	NZ	136,1
	US	180,9
	UY	57,1
	ZA	107,3
	ZZ	113,9
0809 10 00	TR	193,2
0809 10 00	ZZ	193,2
0809 29 00	TR	421,8
0809 29 00	ZZ	421,8

(1) Nomenclature of countries laid down by Commission Regulation (EC) No 1833/2006 (OJ L 354, 14.12.2006, p. 19). Code ‘ ZZ ’ stands for ‘of other origin’.

30.6.2012

Official Journal of the European Union

L 171/10

COMMISSION IMPLEMENTING REGULATION (EU) No 581/2012

of 29 June 2012

fixing the import duties in the cereals sector applicable from 1 July 2012

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Commission Regulation (EU) No 642/2010 of 20 July 2010 laying down detailed rules for the application of Council Regulation (EC) No 1234/2007 in respect of import duties in the cereals sector (2), and in particular Article 2(1) thereof,

Whereas:

(1)

Article 136(1) of Regulation (EC) No 1234/2007 states that the import duty on products covered by CN codes 1001 19 00 , 1001 11 00 , ex 1001 91 20 (common wheat seed), ex 1001 99 00 (high quality common wheat other than for sowing), 1002 10 00 , 1002 90 00 , 1005 10 90 , 1005 90 00 , 1007 10 90 and 1007 90 00 is to be equal to the intervention price valid for such products on importation and increased by 55 %, minus the cif import price applicable to the consignment in question. However, that duty may not exceed the rate of duty in the Common Customs Tariff.

(2)	Article 136(2) of Regulation (EC) No 1234/2007 lays down that, in order to calculate the import duty referred to in paragraph 1 of that Article, representative cif import prices are to be established on a regular basis for the products in question.

(3)

Under Article 2(2) of Regulation (EU) No 642/2010, the price to be used for the calculation of the import duty on products covered by CN codes 1001 19 00 , 1001 11 00 , ex 1001 91 20 (common wheat seed), ex 1001 99 00 (high quality common wheat other than for sowing), 1002 10 00 , 1002 90 00 , 1005 10 90 , 1005 90 00 , 1007 10 90 and 1007 90 00 is the daily cif representative import price determined as specified in Article 5 of that Regulation.

(4)	Import duties should be fixed for the period from 1 July 2012 and should apply until new import duties are fixed and enter into force.

(5)	Given the need to ensure that this measure applies as soon as possible after the updated data have been made available, this Regulation should enter into force on the day of its publication,

HAS ADOPTED THIS REGULATION:

Article 1

From 1 July 2012, the import duties in the cereals sector referred to in Article 136(1) of Regulation (EC) No 1234/2007 shall be those fixed in Annex I to this Regulation on the basis of the information contained in Annex II.

Article 2

This Regulation shall enter into force on the day of its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 29 June 2012.

For the Commission, On behalf of the President,

José Manuel SILVA RODRÍGUEZ

Director-General for Agriculture and Rural Development

(1) OJ L 299, 16.11.2007, p. 1.

(2) OJ L 187, 21.7.2010, p. 5.

ANNEX I

Import duties on the products referred to in Article 136(1) of Regulation (EC) No 1234/2007 applicable from 1 July 2012

CN code	Description	Import duties (1) (EUR/t)
1001 19 00 1001 11 00	Durum wheat, high quality	0,00
	medium quality	0,00
	low quality	0,00
ex 1001 91 20	Common wheat seed	0,00
ex 1001 99 00	High quality common wheat other than for sowing	0,00
1002 10 00 1002 90 00	Rye	0,00
1005 10 90	Maize seed other than hybrid	0,00
1005 90 00	Maize other than seed (2)	0,00
1007 10 90 1007 90 00	Grain sorghum other than hybrids for sowing	0,00

(1) The importer may benefit, under Article 2(4) of Regulation (EU) No 642/2010, from a reduction in the duty of:

—	EUR 3/t, where the port of unloading is located on the Mediterranean Sea (beyond the Strait of Gibraltar) or on the Black Sea, for goods arriving in the Union via the Atlantic Ocean or the Suez Canal,

—	EUR 2/t, where the port of unloading is located in Denmark, Estonia, Ireland, Latvia, Lithuania, Poland, Finland, Sweden, the United Kingdom or on the Atlantic coast of the Iberian Peninsula, for goods arriving in the Union via the Atlantic Ocean.

(2) The importer may benefit from a flat-rate reduction of EUR 24/t where the conditions laid down in Article 3 of Regulation (EU) No 642/2010 are met.

ANNEX II

Factors for calculating the duties laid down in Annex I

15.6.2012-28.6.2012

Averages over the reference period referred to in Article 2(2) of Regulation (EU) No 642/2010:

(EUR/tonne)
	Common wheat (1)	Maize	Durum wheat, high quality	Durum wheat, medium quality (2)	Durum wheat, low quality (3)
Exchange	Minnéapolis	Chicago	—	—	—
Quotation	258,64	192,65	—	—	—
Fob price USA	—	—	235,23	225,23	205,23
Gulf of Mexico premium	—	23,48	—	—	—
Great Lakes premium	43,36	—	—	—	—

Averages over the reference period referred to in Article 2(2) of Regulation (EU) No 642/2010:

Freight costs: Gulf of Mexico-Rotterdam:	17,04 EUR/t
Freight costs: Great Lakes-Rotterdam:	52,19 EUR/t

(1) Premium of EUR 14/t incorporated (Article 5(3) of Regulation (EU) No 642/2010).

(2) Discount of EUR 10/t (Article 5(3) of Regulation (EU) No 642/2010).

(3) Discount of EUR 30/t (Article 5(3) of Regulation (EU) No 642/2010).

30.6.2012

Official Journal of the European Union

L 171/13

COMMISSION IMPLEMENTING DECISION

of 28 June 2012

authorising the placing on the market of products containing, consisting of, or produced from genetically modified soybean MON 87701 × MON 89788 (MON-877Ø1-2 × MON-89788-1) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council

(notified under document C(2012) 4312)

(Only the Dutch and French texts are authentic)

(Text with EEA relevance)

(2012/347/EU)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed (1), and in particular Article 7(3) and Article 19(3) thereof,

Whereas:

(1)

On 14 August 2009, Monsanto Europe SA submitted to the competent authority of the Netherlands an application, in accordance with Articles 5 and 17 of Regulation (EC) No 1829/2003, for the placing on the market of foods, food ingredients, and feed containing, consisting of, or produced from MON 87701 × MON 89788 soybean (‘the application’).

(2)	The application also covers the placing on the market of MON 87701 × MON 89788 soybean as present in products other than food and feed containing or consisting of MON 87701 × MON 89788 soybean for the same uses as any other soybean with the exception of cultivation.

(3)

In accordance with Article 5(5) and Article 17(5) of Regulation (EC) No 1829/2003, the application includes the data and information required by Annexes III and IV to Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC (2) and information and conclusions about the risk assessment carried out in accordance with the principles set out in Annex II to Directive 2001/18/EC. It also includes a monitoring plan for environmental effects conforming with Annex VII to Directive 2001/18/EC.

(4)

On 15 February 2012, the European Food Safety Authority (‘EFSA’) gave a favourable opinion in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003. It concluded that soybean MON 87701 × MON 89788, as described in the application, is as safe as its non-genetically modified counterpart with respect to potential effects on human and animal health or the environment (3).

(5)	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 that Regulation.

(6)	In its opinion, EFSA also concluded that the environmental monitoring plan, consisting of a general surveillance plan, submitted by the applicant is in line with the intended use of the products.

(7)

Taking into account those considerations, authorisation should be granted for MON 87701 × MON 89788 soybean and all products containing it or consisting of it and for food and feed produced from it as described in the application (‘the products’). Products other than food and feed produced from MON 87701 × MON 89788 soybean do not fall under the scope of Regulation (EC) No 1829/2003 and are not covered by this authorisation.

(8)	A unique identifier should be assigned to each genetically modified organism (‘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).

(9)

On the basis of the EFSA opinion, no specific labelling requirements other than those provided for in Article 13(1) and Article 25(2) of Regulation (EC) No 1829/2003, appear to be necessary for foods, food ingredients and feed containing, consisting of, or produced from MON 87701 × MON 89788 soybean. However, in order to ensure the use of the products within the limits of the authorisation provided for by this Decision, the labelling of feed containing or consisting of the GMO and products other than food and feed containing or consisting of the GMO for which authorisation is requested should be complemented by a clear indication that the products in question must not be used for cultivation.

(10)

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 (5), lays down labelling requirements in Article 4(6) for products containing or consisting of GMOs. Traceability requirements for products containing or consisting of GMOs are laid down in paragraphs 1 to 5 of Article 4 and for food and feed produced from GMOs are laid down in Article 5 of that Regulation.

(11)

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 Commission Decision 2009/770/EC of 13 October 2009 establishing standard reporting formats for presenting the monitoring results of the deliberate release into the environment of genetically modified organisms, as or in products, for the purpose of placing on the market, pursuant to Directive 2001/18/EC of the European Parliament and of the Council (6). The EFSA opinion does not justify the imposition of 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 for the use of the food and feed, or of specific conditions for the protection of particular ecosystems/environment and/or geographical areas, as provided for in point (e) of Article 6(5) and Article 18(5) of Regulation (EC) No 1829/2003.

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

(13)

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 point (c) of Article 15(2) 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 (7).

(14)	The applicant has been consulted on the measures provided for in this Decision.

(15)

The Standing Committee on the Food Chain and Animal Health has not delivered an opinion within the time limit laid down by its Chairman. An implementing act was deemed to be necessary and the chair submitted the draft implementing act to the appeal committee for further deliberation. The appeal committee did not deliver an opinion,

HAS ADOPTED THIS DECISION:

Article 1

Genetically modified organism and unique identifier

Genetically modified soybean MON 87701 × MON 89788 is assigned the unique identifier MON-877Ø1-2 × MON-89788-1, 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 in accordance with the conditions set out in this Decision:

(a)	foods and food ingredients containing, consisting of, or produced from MON-877Ø1-2 × MON-89788-1 soybean;

(b)	feed containing, consisting of, or produced from MON-877Ø1-2 × MON-89788-1 soybean;

(c)	MON-877Ø1-2 × MON-89788-1 soybean present in products other than food and feed containing it or consisting of it, for the same uses as any other soybean with the exception of cultivation.

Article 3

Labelling

1. For the purposes of the labelling requirements laid down in Article 13(1) and Article 25(2) of Regulation (EC) No 1829/2003 and in Article 4(6) of Regulation (EC) No 1830/2003, the ‘name of the organism’ shall be ‘soybean’.

2. The words ‘not for cultivation’ shall appear on the label of and in documents accompanying products containing or consisting of MON-877Ø1-2 × MON-89788-1 soybean referred to in points (b) and (c) of Article 2.

Article 4

Monitoring for environmental effects

1. The authorisation holder shall ensure that the monitoring plan for environmental effects, as set out in point (h) of the Annex, is put in place and implemented.

2. The authorisation holder shall submit to the Commission annual reports on the implementation and the results of the activities set out in the monitoring plan in accordance with Decision 2009/770/EC.

Article 5

EU register

The information set out in the Annex to this Decision shall be entered in the EU 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 Monsanto Company, United States, represented by Monsanto Europe SA, Belgium.

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 Monsanto Europe SA, Avenue de Tervuren/Tervurenlaan 270-272, 1150 Bruxelles/Brussel, BELGIQUE/BELGIË.

Done at Brussels, 28 June 2012.

For the Commission

John DALLI

Member of the Commission

(1) OJ L 268, 18.10.2003, p. 1.

(2) OJ L 106, 17.4.2001, p. 1.

(3) http://registerofquestions.efsa.europa.eu/roqFrontend/questionLoader?question=EFSA-Q-2009-00761

(4) OJ L 10, 16.1.2004, p. 5.

(5) OJ L 268, 18.10.2003, p. 24.

(6) OJ L 275, 21.10.2009, p. 9.

(7) OJ L 287, 5.11.2003, p. 1.

ANNEX

(a) Applicant and authorisation holder

Name	:	Monsanto Company
Address	:	800 N. Lindbergh Boulevard, St Louis, Missouri 63167, UNITED STATES OF AMERICA

Represented by Monsanto Europe SA, Avenue de Tervuren/Tervurenlaan 270-272, 1150 Bruxelles/Brussel, BELGIQUE/BELGIË.

(b) Designation and specification of the products

(1)	Foods and food ingredients containing, consisting of, or produced from MON-877Ø1-2 × MON-89788-1 soybean.

(2)	Feed containing, consisting of, or produced from MON-877Ø1-2 × MON-89788-1 soybean.

(3)	Products other than food and feed containing or consisting of MON-877Ø1-2 × MON-89788-1 soybean for the same uses as any other soybean with the exception of cultivation.

The genetically modified MON-877Ø1-2 × MON-89788-1 soybean, as described in the application, is produced by crosses between soybean containing MON-877Ø1-2 and MON-89788-1 events and expresses the Cry1Ac protein which confers protection against certain lepidopteran pests and CP4 EPSPS protein which confers tolerance to the glyphosate herbicide.

(1)	For the purposes of the specific labelling requirements laid down in Article 13(1) and Article 25(2) of Regulation (EC) No 1829/2003, and in Article 4(6) of Regulation (EC) No 1830/2003, the ‘name of the organism’ shall be ‘soybean’.

(2)	The words ‘not for cultivation’ shall appear on the label of and in documents accompanying products containing or consisting of MON-877Ø1-2 × MON-89788-1 soybean referred to in points (b) and (c) of Article 2 of this Decision.

(d) Method for detection

—	Event specific real time PCR-based method for the quantification of MON-877Ø1-2 × MON-89788-1 soybean,

—	validated on seeds by the Community Reference Laboratory established under Regulation (EC) No 1829/2003, published at http://gmo-crl.jrc.ec.europa.eu/statusofdoss.htm

—	reference material: AOCS 0809-A and AOCS 0906-A (for MON87701) and AOCS 0906-B and AOCS 906-A (for MON89788) accessible via the American Oil Chemists Society at http://www.aocs.org/tech/crm

(e) Unique identifier

MON-877Ø1-2 × MON-89788-1

(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 conforming with Annex VII to Directive 2001/18/EC.

[Link: plan published on the internet]

(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 time. Those modifications will be made available to the public via the updating of the EU register of genetically modified food and feed.

		ISSN 1977-0677 doi:10.3000/19770677.L_2012.171.eng
Official Journal of the European Union		L 171

English edition	Legislation	Volume 55 30 June 2012

Contents		II Non-legislative acts	page
		REGULATIONS
	*	Council Regulation (EU, Euratom) No 577/2012 of 26 June 2012 adjusting the correction coefficients applicable to the remuneration and pensions of officials and other servants of the European Union	1
	*	Commission Implementing Regulation (EU) No 578/2012 of 29 June 2012 concerning the non approval of the active substance diphenylamine, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market ( 1 )	2
	*	Commission Implementing Regulation (EU) No 579/2012 of 29 June 2012 amending Regulation (EC) No 607/2009 laying down certain detailed rules for the implementation of Council Regulation (EC) No 479/2008 as regards protected designations of origin and geographical indications, traditional terms, labelling and presentation of certain wine sector products	4
		Commission Implementing Regulation (EU) No 580/2012 of 29 June 2012 establishing the standard import values for determining the entry price of certain fruit and vegetables	8
		Commission Implementing Regulation (EU) No 581/2012 of 29 June 2012 fixing the import duties in the cereals sector applicable from 1 July 2012	10
		DECISIONS
		2012/347/EU
	*	Commission Implementing Decision of 28 June 2012 authorising the placing on the market of products containing, consisting of, or produced from genetically modified soybean MON 87701 × MON 89788 (MON-877Ø1-2 × MON-89788-1) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (notified under document C(2012) 4312) ( 1 )	13