C 185 Official Journal

ISSN 1725-2423

Official Journal C 185

of the European Union

Volume 54 English edition Information and Notices 25 June 2011

Notice No Contents Page

II Information

INFORMATION FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

2011/C 185/01 Explanatory Notes to the Combined Nomenclature of the European Union ...... 1

IV Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

2011/C 185/02 Euro exchange rates ...... 2

2011/C 185/03 Commission communication in the framework of the implementation of the Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices ( 1 ) (Publication of titles and references of harmonised standards under the directive) ...... 3

Price: 1 EN EUR 3 ( ) Text with EEA relevance (Continued overleaf) Notice No Contents (continued) Page

V Announcements

ADMINISTRATIVE PROCEDURES

European Investment Bank

2011/C 185/04 Call for proposals — The European Investment Bank proposes three new EIBURS sponsorships within its EIB-Universities Research Action ...... 7

OTHER ACTS

European Commission

2011/C 185/05 Publication of an application pursuant to Article 6(2) of Council Regulation (EC) No 510/2006 on the protection of geographical indications and designations of origin for agricultural products and foodstuffs ...... 10

2011/C 185/06 Publication of an application pursuant to Article 6(2) of Council Regulation (EC) No 510/2006 on the protection of geographical indications and designations of origin for agricultural products and foodstuffs ...... 14

2011/C 185/07 Publication of an application pursuant to Article 6(2) of Council Regulation (EC) No 510/2006 on the protection of geographical indications and designations of origin for agricultural products and foodstuffs ...... 18

EN 25.6.2011 EN Official Journal of the European Union C 185/1

(Information)

INFORMATION FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

EUROPEAN COMMISSION

Explanatory Notes to the Combined Nomenclature of the European Union (2011/C 185/01)

Pursuant to Article 9(1)(a), second indent, of Council Regulation (EEC) No 2658/87 of 23 July 1987 on the tariff and statistical nomenclature and on the Common Customs Tariff ( 1 ), the Explanatory Notes to the Combined Nomenclature of the European Union ( 2) are amended as from 1 July 2011 as follows:

On page 342: the Explanatory Note for CN code 8521 90 00 is deleted.

On page 347: the Explanatory Notes for CN codes 8528 71 13, 8528 71 19 and 8528 71 90 are deleted.

( 1 ) OJ L 256, 7.9.1987, p. 1. ( 2 ) OJ C 137, 6.5.2011, p. 1. C 185/2 EN Official Journal of the European Union 25.6.2011

(Notices)

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

EUROPEAN COMMISSION

Euro exchange rates ( 1) 24 June 2011 (2011/C 185/02)

1 euro =

Currency Exchange rate Currency Exchange rate

USD US dollar 1,4220 AUD Australian dollar 1,3473 JPY Japanese yen 114,06 CAD Canadian dollar 1,3961 DKK Danish krone 7,4587 HKD Hong Kong dollar 11,0767 GBP Pound sterling 0,88855 NZD New Zealand dollar 1,7482 SEK Swedish krona 9,1802 SGD Singapore dollar 1,7597 KRW South Korean won 1 534,15 CHF Swiss franc 1,1902 ZAR South African rand 9,7683 ISK Iceland króna CNY Chinese yuan renminbi 9,2059 NOK Norwegian krone 7,7825 HRK Croatian kuna 7,3740 BGN Bulgarian lev 1,9558 IDR Indonesian rupiah 12 232,84 CZK Czech koruna 24,378 MYR Malaysian ringgit 4,3300 HUF Hungarian forint 269,50 PHP Philippine peso 61,765 LTL Lithuanian litas 3,4528 RUB Russian rouble 40,1300 LVL Latvian lats 0,7093 THB Thai baht 43,627 PLN Polish zloty 3,9919 BRL Brazilian real 2,2707 RON Romanian leu 4,2240 MXN Mexican peso 16,8867 TRY Turkish lira 2,3207 INR Indian rupee 63,9830

( 1 ) Source: reference exchange rate published by the ECB. 25.6.2011 EN Official Journal of the European Union C 185/3

Commission communication in the framework of the implementation of the Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices (Text with EEA relevance) (Publication of titles and references of harmonised standards under the directive)

(2011/C 185/03)

Date of cessation of presumption of Reference and title of the harmonised standard Reference of superseded ESO (1 ) First publication OJ conformity of superseded (and reference document) standard standard Note 1

CEN EN 556-1:2001 31.7.2002 EN 556:1994 + A1:1998 Date expired Sterilization of medical devices - Requirements for medical Note 2.1 (30.4.2002) devices to be designated ‘STERILE’ - Part 1: Requirements for terminally sterilized medical devices

EN 556-1:2001/AC:2006 15.11.2006

CEN EN 556-2:2003 9.8.2007 Sterilization of medical devices - Requirements for medical devices to be designated ‘STERILE’ - Part 2: Requirements for aseptically processed medical devices

CEN EN 980:2008 23.7.2008 EN 980:2003 Date expired Symbols for use in the labelling of medical devices Note 2.1 (31.5.2010)

CEN EN ISO 11737-2:2009 7.7.2010 Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2009)

CEN EN 12322:1999 9.10.1999 In vitro diagnostic medical devices - Culture media for microbiology - Performance criteria for culture media

EN 12322:1999/A1:2001 31.7.2002 Note 3 Date expired (30.4.2002)

CEN EN ISO 13485:2003 2.4.2004 EN ISO 13488:2000 Date expired Medical devices - Quality management systems - Requirements EN ISO 13485:2000 (31.7.2009) for regulatory purposes (ISO 13485:2003) Note 2.1

EN ISO 13485:2003/AC:2009 7.7.2010

CEN EN 13532:2002 17.12.2002 General requirements for in vitro diagnostic medical devices for self-testing

CEN EN 13612:2002 17.12.2002 Performance evaluation of in vitro diagnostic medical devices

EN 13612:2002/AC:2002 2.12.2009

CEN EN 13640:2002 17.12.2002 Stability testing of in vitro diagnostic reagents

CEN EN 13641:2002 17.12.2002 Elimination or reduction of risk of infection related to in vitro diagnostic reagents

CEN EN 13975:2003 21.11.2003 Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects C 185/4 EN Official Journal of the European Union 25.6.2011

CEN EN 14136:2004 15.11.2006 Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures

CEN EN 14254:2004 28.4.2005 In vitro diagnostic medical devices - Single-use receptacles for the collection of specimens, other than blood, from humans

CEN EN 14820:2004 28.4.2005 Single-use containers for human venous blood specimen collection

CEN EN ISO 14937:2009 7.7.2010 EN ISO 14937:2000 Date expired Sterilization of health care products - General requirements for Note 2.1 (30.4.2010) characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2009)

CEN EN ISO 14971:2009 7.7.2010 EN ISO 14971:2007 Date expired Medical devices - Application of risk management to medical Note 2.1 (21.3.2010) devices (ISO 14971:2007, Corrected version 2007-10-01)

CEN EN ISO 15193:2009 7.7.2010 In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for content and presentation of reference measurement procedures (ISO 15193:2009)

CEN EN ISO 15194:2009 7.7.2010 In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for certified reference materials and the content of supporting documen tation (ISO 15194:2009)

CEN EN ISO 15197:2003 28.4.2005 In vitro diagnostic test systems - Requirements for blood- glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2003)

EN ISO 15197:2003/AC:2005 2.12.2009

CEN EN ISO 17511:2003 28.4.2005 In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values assigned to calibrators and control materials (ISO 17511:2003)

CEN EN ISO 18113-1:2009 7.7.2010 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009)

CEN EN ISO 18113-2:2009 7.7.2010 EN 375:2001 31.12.2012 In vitro diagnostic medical devices - Information supplied by Note 2.1 the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2009)

CEN EN ISO 18113-3:2009 7.7.2010 EN 591:2001 31.12.2012 In vitro diagnostic medical devices - Information supplied by Note 2.1 the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2009) 25.6.2011 EN Official Journal of the European Union C 185/5

CEN EN ISO 18113-4:2009 7.7.2010 EN 376:2002 31.12.2012 In vitro diagnostic medical devices - Information supplied by Note 2.1 the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2009)

CEN EN ISO 18113-5:2009 7.7.2010 EN 592:2002 31.12.2012 In vitro diagnostic medical devices - Information supplied by Note 2.1 the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009)

CEN EN ISO 18153:2003 21.11.2003 In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values for catalytic concentration of enzymes assigned to calibrators and control materials (ISO 18153:2003)

CEN EN ISO 20776-1:2006 9.8.2007 Clinical laboratory testing and in vitro diagnostic test systems - Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices - Part 1: Reference method for testing the in vitro activity of anti microbial agents against rapidly growing aerobic bacteria involved in infectious diseases (ISO 20776-1:2006)

Cenelec EN 61010-2-101:2002 17.12.2002 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment IEC 61010-2-101:2002 (Modified)

Cenelec EN 61326-2-6:2006 27.11.2008 Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment IEC 61326-2-6:2005

Cenelec EN 62304:2006 27.11.2008 Medical device software - Software life-cycle processes IEC 62304:2006

EN 62304:2006/AC:2008 18.1.2011

Cenelec EN 62366:2008 27.11.2008 Medical devices - Application of usability engineering to medical devices IEC 62366:2007

(1 ) ESO: European Standards Organisation: — CEN: Avenue Marnix 17, 1000 Bruxelles/Brussel, BELGIQUE/BELGIË, Tel. +32 25500811; Fax +32 25500819 (http://www.cen.eu) — Cenelec: Avenue Marnix 17, 1000 Bruxelles/Brussel, BELGIQUE/BELGIË, Tel. +32 25196871; Fax +32 25196919 (http://www.cenelec.eu) — ETSI: 650 route des Lucioles, 06921 Sophia Antipolis, FRANCE, Tel. +33 492944200; Fax +33 493654716 (http://www.etsi.eu)

Note 1: Generally the date of cessation of presumption of conformity will be the date of withdrawal (‘dow’), set by the European Standardisation Organisation, but attention of users of these standards is drawn to the fact that in certain exceptional cases this can be otherwise. Note 2.1: The new (or amended) standard has the same scope as the superseded standard. On the date stated, the superseded standard ceases to give presumption of conformity with the essential requirements of the directive. Note 2.2: The new standard has a broader scope than the superseded standard. On the date stated the superseded standard ceases to give presumption of conformity with the essential requirements of the directive. C 185/6 EN Official Journal of the European Union 25.6.2011

Note 2.3: The new standard has a narrower scope than the superseded standard. On the date stated the (partially) superseded standard ceases to give presumption of conformity with the essential requirements of the directive for those products that fall within the scope of the new standard. Presumption of conformity with the essential requirements of the directive for products that still fall within the scope of the (partially) superseded standard, but that do not fall within the scope of the new standard, is unaffected. Note 3: In case of amendments, the referenced standard is EN CCCCC:YYYY, its previous amendments, if any, and the new, quoted amendment. The superseded standard (column 3) therefore consists of EN CCCCC:YYYY and its previous amendments, if any, but without the new quoted amendment. On the date stated, the superseded standard ceases to give presumption of conformity with the essential requirements of the directive. NOTE: — Any information concerning the availability of the standards can be obtained either from the European Standardisation Organisations or from the national standardisation bodies of which the list is annexed to the Directive 98/34/EC of the European Parliament and Council ( 1 ) amended by the Directive 98/48/EC ( 2 ). — Harmonised standards are adopted by the European Standardisation Organisations in English (CEN and Cenelec also publish in French and German). Subsequently, the titles of the harmonised standards are translated into all other required official languages of the European Union by the National Standards Bodies. The European Commission is not responsible for the correctness of the titles which have been presented for publication in the Official Journal. — Publication of the references in the Official Journal of the European Union does not imply that the standards are available in all the Community languages. — This list replaces all the previous lists published in the Official Journal of the European Union. The Commission ensures the updating of this list. — More information about harmonised standards on the Internet at http://ec.europa.eu/enterprise/policies/european-standards/harmonised-standards/index_en.htm

( 1 ) OJ L 204, 21.7.1998, p. 37. ( 2 ) OJ L 217, 5.8.1998, p. 18. 25.6.2011 EN Official Journal of the European Union C 185/7

(Announcements)

ADMINISTRATIVE PROCEDURES

EUROPEAN INVESTMENT BANK

Call for proposals — The European Investment Bank proposes three new EIBURS sponsorships within its EIB-Universities Research Action (2011/C 185/04)

The European Investment Bank channels most of its institutional relations with universities through an EIB- Universities Research Action consisting of three different programmes:

— EIBURS, the EIB University Research Sponsorship Programme,

— STAREBEI (STAges de REcherche BEI), a programme for financing young researchers working on joint EIB-University projects, and

— EIB University Networks, a cooperation mechanism for university networks showing characteristics that are of particular relevance to supporting the objectives of the EIB Group.

EIBURS provides grants to University Research Centres working on research topics and themes of major interest to the Bank. EIB sponsorships, of up to EUR 100 000 per year for a period of three years, are awarded through a competitive process to interested university departments or research centres, associated with universities of EU, candidate countries or potential candidate countries, with recognised expertise in EIB-selected areas, so they can expand their activities in these areas. The successful proposal will entail the delivery of a variety of outputs (research, organisation of courses and seminars, networking, dissemination of results, etc.) that will be the subject of a contractual agreement with the Bank.

For the academic year 2011/2012, the EIBURS programme has selected three new lines of research:

European IP regimes and their impact on Technology Transfer/IP finance Global policy discussions increasingly focus on innovation and knowledge economy as a driver for long- term sustainable growth. In this context, the design of new financing instruments and attracting private investors to Knowledge/Technology Transfer (TT) are necessary yet challenging tasks. There is a need for more understanding amongst those who undertake TT, of the relationship between the Intellectual Property (IP) legal and regulatory systems and how they impact this field. This need extends further, to a better understanding of the public policy incentives targeting research centres/universities and the variety of financial instruments (funds, partnerships, translational labs etc.) dedicated to the commercialisation of research. Issues such as Professor’s privilege, EU Patent law and its application by national reviewing bodies and government incentives are seen to have a strong impact, on the exploitation of early-stage assets, however no systematic review and comparison is available. This is a rapidly changing area and it is C 185/8 EN Official Journal of the European Union 25.6.2011

important to take into account recent/current developments. Ideally the project would provide a compre hensive review of these issues across all Member States, however a deliverable covering the main EU innovation and IP markets would also be acceptable.

The aim of the project is to review the legal, regulatory and public policy measures in European Member States and their impact on the willingness/readiness of academic institutions to involve outside financial entities (i.e. funds, foundations and other sources of external capital) in the establishment of partnerships to both accelerate their TT/IP operations and boost the commercialisation of institution-led research. Where applicable, policy measures and suggestions to improve Knowledge Transfer in EU should be included and substantiated.

Deliverables:

The study could encompass a review of existing material in this area on ‘broad trends’ of the factors (eg. protocols, forms and conditions) that have an impact on the commercialisation of research. The work should, however, execute case studies concerning institutions that partner with financial investors (EIF can facilitate access to some of its investees but additional examples should be targeted). One area for review is the contractualisation of the relationships between research institutions and financial investors — an area which is covered for the relationship between research organisations and corporates but not in detail for the interface between research organisations and financial entities. As this is a three year study, the applicants are encouraged to propose timelines for the delivery of interim data. The project may involve any additional activity that the University Centre would be ready to undertake with the sponsorship in the line of research, including:

— Organization of courses, summer schools, conferences and seminars

— Creation of databases

— Surveys

This project would be complementary to the EC-funded (DG ENT) feasibility study on ‘Creating a financial market for IPR’ EU-Tender No 3/PP/ENT/CIP/10/A/NO2S003.

Analysis of investment needs in infrastructure sectors Understanding current and future investment needs is critical to designing well targeted public policies that support infrastructure investment. Having said this, there seems to be no unified body of work on metho dological issues in forecasting investment needs. The university research centre receiving support under the EIBURS would be expected to set up a research programme focused on reviewing existing methodologies and forecasts on infrastructure investment needs, to develop a unified methodology for forecasting infra structure investment needs and to forecast investment needs in economic infrastructure in Europe. The line of research should be limited to economic infrastructure only — that is transport, energy, water and ICT.

The project may involve any additional activity that the University Centre would be ready to undertake with the sponsorship in the line of research, including:

— Organization of courses and seminars

— Creation of databases

— Surveys

The rising of credit risk in microcredit: origins, warning signals, current state and future prospects In the last decade, the rapid growth in the provision of microcredit services to low-income households and entrepreneurs has led to a saturation of some markets such as Morocco, Bosnia and Herzegovina, Bolivia and India (in the specific State of Andra Pradesh). Where some borrowers could get access to several loans from a number of lending institutions, they have taken on too much credit and have ended up over- indebted. Over-indebtedness of micro borrowers is detrimental to the microcredit industry at large not only for its financial and reputational consequences but also for the social and psychological harm it potentially does to an already vulnerable population. 25.6.2011 EN Official Journal of the European Union C 185/9

Degradation in the asset quality of microfinance loan portfolio has in fact multiple origins and drivers among which the economic environment, political interferences, inadequate regulatory framework, aggressive lending methods from Microfinance Finance Institutions, concentration in urban areas, or inad equate product offering. The high repayment rates historically demonstrated by the microfinance industry have been severely affected in some countries or regions, and the potential for large loan losses in some markets is now high. Credit risk related to client over-indebtedness is also seen by practitioners as one of the fastest rising risks. Unfortunately, too often only once the repayment crisis burst out healing measures are taken. This is how investors have become more responsible when placing funds and some international initiatives promoting client protection principles and transparency of practices and interest rates have emerged to prevent markets from overheating.

In this context, EIB invites research proposals which seek to address the following questions:

Under what conditions can microcredit maintain sound asset quality and sustainability while expanding its outreach to markets with demand? What is the current state of credit risk, including the level of client over- indebtedness, in Africa and other countries identified as being at most risk? Could there be any warning signals to prevent a potential repayment crisis before it actually emerges? What can we learn from the recent crises in microfinance (Morocco, Bosnia, Andra Pradesh, etc.)? What countries, in Africa especially, are the most at risk and could be ‘next on the list’?

The regional focus of the proposals would be focussed but not limited to the African region (including the MENA region).

The project may involve any additional activity that the University Centre would be ready to undertake with the sponsorship in the line of research, including:

— Organisation of dissemination events

— Creation of additional databases

— Surveys

Proposals should be submitted in English or French and the deadline for presentation of proposals is 16 September 2011. Proposals submitted after this date will not be considered. Proposals should be sent to:

Electronic copy: [email protected]

and

Hard copy: EIB-Universities Research Action 100, boulevard Konrad Adenauer 2950 Luxembourg LUXEMBOURG

To the attention of Ms Luísa Ferreira, Co-ordinator.

For more exhaustive information on the EIBURS selection process and on the other programmes and mechanisms, please visit: http://www.eib.org/universities C 185/10 EN Official Journal of the European Union 25.6.2011

OTHER ACTS

EUROPEAN COMMISSION

Publication of an application pursuant to Article 6(2) of Council Regulation (EC) No 510/2006 on the protection of geographical indications and designations of origin for agricultural products and foodstuffs (2011/C 185/05)

This publication confers the right to object to the application pursuant to Article 7 of Council Regulation (EC) No 510/2006 ( 1 ). Statements of objection must reach the Commission within six months of the date of this publication.

SINGLE DOCUMENT COUNCIL REGULATION (EC) No 510/2006 ‘SUSINA DI DRO’ EC No: IT-PDO-0005-0779-30.06.2009 PGI ( ) PDO ( X )

1. Name: ‘Susina di Dro’

2. Member State or Third Country: Italy

3. Description of the agricultural product or foodstuff: 3.1. Type of product: Class 1.6. Fruit, vegetables and cereals, fresh or processed

3.2. Description of product to which the name in (1) applies: The ‘Susina di Dro’ protected designation of origin protects the fresh fruit of the local Prugna di Dro (‘Dro plum’) cultivar, commonly known as ‘Susina di Dro’.

When released for consumption, the fresh fruit must be whole, fresh and healthy looking, clean, free of foreign substances and odours, oval-shaped and slightly elongated; it must have firm flesh and be covered in the characteristic whitish wax bloom.

The coloration of the fresh fruit is typically as follows:

— skin ranging from purplish red to dark blue/purple, with the presence of a wax bloom and sometimes small greenish areas,

— yellow or green/yellow flesh.

( 1 ) OJ L 93, 31.3.2006, p. 12. 25.6.2011 EN Official Journal of the European Union C 185/11

Chemical properties:

Sugars — minimum value when harvested: 9,0 °Brix

Polyphenols — minimum value: 900 mg/kg

In terms of its organoleptic characteristics, ‘Susina di Dro’ PDO is distinguished by its delicate and aromatic sweet and sour flavour and its pleasant soft texture.

3.3. Raw materials (for processed products only): —

3.4. Feed (for products of animal origin only): —

3.5. Specific steps in production that must take place in the identified geographical area: The fruit must be grown, cleaned and packaged in the geographical area identified in point 4 in order to prevent spoiling and mould and because a short production chain helps to maintain the char acteristic wax bloom layer that covers the fruit.

3.6. Specific rules concerning slicing, grating, packaging, etc.: ‘Susina di Dro’ PDO is to be packaged in accordance with the legislation in force. All types of packaging will be closed by means of a net, film or cover.

3.7. Specific rules concerning labelling: Packages in which the product is sold must feature the words ‘DOP Susina di Dro’ (‘Susina di Dro PDO’) and the logo as described below. The logo is a stylised purple plum with green leaves. The words ‘SUSINA DI DRO DOP’ appear in white in the centre of the plum, with the words ‘DENOMINAZIONE DI ORIGINE PROTETTA’ (‘protected designation of origin’) on its outer edge.

Logo:

No indication of origin not expressly provided for or additional wordings likely to mislead consumers may be added to the designation.

4. Concise definition of the geographical area: The production area of ‘Susina di Dro’ PDO comprises the following municipalities in the Autonomous Province of Trento: Arco, Bleggio Inferiore, Bleggio Superiore, Calavino, Cavedine, Fiavè, Dorsino, Drena, Dro, Lasino, Lomaso, Nago-Torbole, Padergnone, Riva del Garda, San Lorenzo in Banale, Stenico, Tenno, Terlago, Vezzano and Trento (limited, for the municipality of Trento, to the districts of Cadine, Sopramonte, Sant'Anna, Vigolo Baselga and Baselga del Bondone).

5. Link with the geographical area: 5.1. Specificity of the geographical area: The production area of ‘Susina di Dro’ PDO is marked by distinctive climate characteristics resulting mainly from the proximity to Lake Garda. Indeed, even though it is located in the heart of the Alpine region, the area enjoys particularly mild temperatures, with an annual average of 12,4 °C. The area also enjoys long periods of brightness owing to the almost constantly clear skies: on average it experiences C 185/12 EN Official Journal of the European Union 25.6.2011

10 hours of light per day, or 36 000 seconds of total accumulated sunshine (average figure as of 21 June each year). Even in the winter months — which, in the Alpine foothills of Italy as in central and western Europe, are very foggy — the area enjoys 100-120 hours of sun each month, an average of 3-4 hours a day. This phenomenon is primarily due to the periodic wind system, i.e. the alternation of currents descending from the valleys and ascending (the ‘Òra del Garda’) from the lake. The latter is particularly important: a sort of warm wind that keeps the skies clear, in winter it counterbalances the cold northern winds while in summer it has a beneficial mitigating effect on the maximum afternoon temperatures, which would otherwise have a detrimental effect on the phenol content of the fruit and on the accumulation of sugar. Accordingly, the production area of ‘Susina di Dro’ PDO has particularly mild winters, while its summers are only occasionally marked by periods of drought and excessive temperatures. In addition to these characteristics, the area's soils, the geological origins of which are marine sediments, are of high quality. The soils in practically the entire area are moderately alkaline, which helps ensure that minerals are available and effective, particular in terms of the absorption of phosphorus, calcium and magnesium.

5.2. Specificity of the product: ‘Susina di Dro’ is a native cultivar with a long tradition, which has been grown over time in the valleys of the River Sarca, becoming genetically stable.

The particular merit of ‘Susina di Dro’ PDO is linked to its polyphenol content; indeed, its polyphenols have a decisive influence on its organoleptic characteristics, colour and flavour and are very interesting from a pharmacological viewpoint.

Another distinguishing characteristic of the fruit is its minimal sugar content, which is a decisive factor in the typical sweet and sour flavour of this local ecotype.

The interest in this fruit's distinctive polyphenol and sugar content is reflected in studies published since 1975. This bibliography, together with some more recent characterisation studies, demonstrate that the properties of ‘Susina di Dro’ have long been tangibly recognised and have since been further confirmed.

5.3. Causal link between the geographical area and the quality or characteristics of the product (for PDO) or a specific quality, the reputation or other characteristic of the product (for PGI): The ‘Prugna di Dro’ local cultivar has been bred over the centuries thanks to the agricultural expertise of farmers in the production area, who derived their seedlings mainly from seeds or root suckers and subjected the plum trees to ongoing monitoring and pressure for mass genetic improvement based on observation of its phenotypic characteristics linked in particular to the productive characteristics of the trees and the organoleptic characteristics of the fruit.

The development and accumulation of the polyphenols and sugars found in ‘Susina di Dro’ PDO correlate strongly with the climate of the production area and, in particular, the quantity of sunlight to which the trees are exposed and the ambient temperatures. These factors play a key role in the level and pace of activity of the enzymes involved in the phenolic metabolism and photosynthesis mechanisms that are crucial for the accumulation of carbohydrates and thus of sugars.

These biological phenomena are correlated with the particularly favourable environmental conditions of the production area as they are linked to the mitigating effects of Lake Garda, the largest lake in Italy, and its winds. Particularly important is the area's distinctive ‘Òra del Garda’ wind that blows in the afternoon, thereby keeping the skies clear and attenuating the maximum summer temperatures.

The accumulation in the fruit's skin of the anthocyanin pigments responsible for its purplish blue colour is dependant largely on the incident radiation hitting the fruit, while the sugar content is linked to the ambient temperatures, which are mitigated by the winds and thus do not subject the crops to stress.

In the ‘Susina di Dro’ PDO production area, this crop also has fundamental socio-economic importance, comparable to that of vines and apple trees.

Indeed, over the centuries plum growing has become strongly anchored in the culture of the area, as attested to by references to it in the 42 sections of the Carte di Regola (‘Charters’) for the Sarca Plain dating back to 1284. 25.6.2011 EN Official Journal of the European Union C 185/13

In more recent times, the entire community of the Valle del Sarca, which has always been sensitive to making best use of the specific quality profile of ‘Susina di Dro’ PDO, has been active on the cultural level, pursuing synergy between tourism, the land, and the agrifood sector. Important initiatives are the ‘Settimana del Prugno Fiorito di Dro’ (‘Dro Plum Trees in Bloom Week’), a recurrent event since the beginning of the 1970s and its more modern successor, the August event known as ‘Dro: il tempo delle prugne’ (‘Dro: Prune Season’).

Reference to publication of the specification: (Article 5(7) of Regulation (EC) No 510/2006)

The Ministry launched the national objection procedure with the publication of the proposal for recognising ‘Susina di Dro’ as a protected designation of origin in Official Gazette of the Italian Republic No 100 of 2 May 2009.

The full text of the product specification is available on the following web site:

http://www.politicheagricole.it/DocumentiPubblicazioni/Search_Documenti_Elenco.htm?txtTipoDocumento= Disciplinare%20in%20esame%20UE&txtDocArgomento=Prodotti%20di%20Qualit%E0>Prodotti%20Dop, %20Igp%20e%20Stg

by going directly to the home page of the Ministry of Agricultural, Food and Forestry Policy (http://www. politicheagricole.it) and clicking on ‘Prodotti di Qualità’ (on the left of the screen) and finally on ‘Disciplinari di Produzione all'esame dell'UE [regolamento (CE) n. 510/2006]’. C 185/14 EN Official Journal of the European Union 25.6.2011

This publication confers the right to object to the application pursuant to Article 7 of Council Regulation (EC) No 510/2006 ( 1). Statements of objection must reach the Commission within six months from the date of this publication.

SUMMARY COUNCIL REGULATION (EC) No 510/2006 ‘TOLMINC’ EC No: SL-PDO-0005-0422-29.10.2004 PDO ( X ) PGI ( )

This summary sets out the main elements of the product specification for information purposes.

1. Responsible department in the Member State:

Name: Ministry of Agriculture, Forestry and Food Address: Dunajska cesta 22 SI-1000 Ljubljana SLOVENIJA Tel. +386 14789109 Fax +386 14789055 E-mail: [email protected]

2. Applicant:

Name: Sirarsko društvo Tolminc (Tolminc cheese association) Address: Rutarjeva 35 SI-5220 Tolmin SLOVENIJA Tel. +386 53891075 Fax — E-mail: [email protected] Composition: Producers/processors ( X ) Other ( )

3. Type of product: Class 1.3. Cheeses

4. Specification: (summary of requirements under Article 4(2) of Regulation (EC) No 510/2006)

4.1. Name: ‘Tolminc’

4.2. Description: ‘Tolminc’ is classified as a hard, full-fat cheese. The raw material for the production of ‘Tolminc’ is raw or thermised cow’s milk produced within the defined geographical area.

Form and dimensions: a 3,5-5 kg round wheel of diameter 23-27 cm and height 8-9 cm.

( 1 ) OJ L 93, 31.3.2006, p. 12. 25.6.2011 EN Official Journal of the European Union C 185/15

External appearance: the rind of the cheese is smooth and straw-coloured.

Cross-section: the interior of the cheese is flexible, yellow in colour, with occasional lentil- or pea-sized eyes.

Taste and smell: the smell is distinctive and free from foreign odours, and the taste sweet and piquant.

Chemical composition: at least 60 % dry matter and at least 45 % fat by weight in dry matter.

The cheese must mature for at least 60 days.

4.3. Geographical area: The production of milk and the manufacture of ‘Tolminc’ take place in the Zgornje Posočje area, encompassing the municipalities of Kobarid, Tolmin and Bovec.

The geographical area is delimited on the western side by the Italian border and elsewhere by the outer limits of the settlements running from Kamno to Log pod Mangartom, as follows: Kamno, Volče, Čiginj, Volčanski Ruti, Sela pri Volčah, Gorenji Log, Tolminski Lom, Dolgi Laz, Kanalski Lom, Grudnica, Slap ob Idrijci, Dolenja Trebuša, Gorenja Trebuša, Stopnik, Daber, Gorski Vrh, Bukovski Vrh, Grahovo ob Bači, Hudajužna, Porezen, Podbrdo, Petrovo Brdo, Bača pri Podbrdu, Kal, Stržišče, Rut, Grant, Knežke Ravne, Ljubinj, Tolminske Ravne, Čadrg, Krn, Soča, Trenta, Log pod Mangartom.

The settlements mentioned are themselves situated within the defined geographical area.

4.4. Proof of origin: The following procedures or measures are conducted in order to guarantee the traceability of ‘Tolminc’.

Milk production: The milk must be produced in the defined geographical area. The keeping of a herd book ensures that the breed composition of the herd is appropriate. Farms also keep records of feed rations and the purchase of feedingstuffs or feed materials.

Collection of milk: The milk intended for the production of ‘Tolminc’ must be collected and stored separately from other milk. Records are kept of the quantities of milk purchased per day, with a breakdown by farm.

Manufacture of dairy products: The producers of ‘Tolminc’ keep records of the quantities of milk processed per day and of the quantities of cheese produced per day by batch. A batch means the quantity of cheese that is made from a single coagulation of milk. If only one batch of cheese was produced on a given day, the production date of the cheese also constitutes the batch designation.

Ripening of the cheese: In order to ensure that each batch of cheese ripens for at least 60 days, producers keep records of the ripening of cheese. The production date of the cheese is also the date on which the ripening of the cheese starts.

4.5. Method of production: ‘Tolminc’ is made from raw or thermised (57-68 °C) cow’s milk produced in the defined geographical area. At least 80 % of the milk for the production of ‘Tolminc’ must be obtained from cows of the brown breed. The cows are fed with bulk fodder (pasture, hay, silage) from the geographical area, which must account for at least 75 % of the dry matter of the daily ration.

In order to produce ‘Tolminc’, use is made of matured milk to which fresh milk may be added before coagulation. The ripening of milk lasts for at least 12 hours; this develops the autochthonous microflora and ensures that the milk has an appropriate level of acidity. In order to speed up fermentation, it is permitted to use home-made starter cultures (the ripening of a small quantity of milk at quite a high temperature for at least 12 hours) or selected cultures. The addition of rennet is followed by coagulation of the milk, which lasts 25-35 minutes at a temperature of between 32 °C and 34 °C. Manipulating the coagulum accelerates the process of whey extraction and enables curd grains of an appropriate size to be produced. In the first phase, the hard coagulum is cut up suitably, first into large squares. Next, the curd grain is broken down into hazelnut-sized pieces. The correct curd grain C 185/16 EN Official Journal of the European Union 25.6.2011

consistency is obtained by heating and drying. The curd grain is heated to 44-48 °C and then dried, with constant stirring, until the appropriate consistency is obtained. The formation of the cheese and the separation of the curd from the whey may be done in different ways depending on the possibilities and the technical equipment available to individual dairies. Pressing of the cheese takes 6 to 12 hours in appropriately heated premises. Turning the cheese over during pressing is intended to speed up the extraction of whey, distribute the water contained in the cheese evenly and give the cheese a better shape. ‘Tolminc’ is salted in brine for between 24 and 48 hours.

After salting, each wheel is marked with the date of the start of the maturing of the cheese or the batch designation. ‘Tolminc’ must mature for at least two months. It is very important that the cheese is looked after (turned, wiped, cleaned) while maturing.

4.6. Link: H i s t o r y a n d t r a d i t i o n o f c h e e s e - m a k i n g i n t h e g e o g r a p h i c a l a r e a The first records mentioning ‘Tolminc cheese’ date back to the 13th century, when it was mentioned as a means of payment for the taxes due to the lord of the land of the time. It first appeared with the name ‘Formaggio di Tolmino — Tolminski sir’ (cheese from Tolmin) in 1756 on a price list for cheese in the town of Udine.

Great contributions to the quality of ‘Tolminc’ were made by various master cheese-makers, who as far back as the late 19th century, under the auspices of the Farm Association in Gorica, came to the Tolmin area and helped the locals solve their cheese-making problems. It was on the Razor mountain pasture under the leadership of Thomas Hitz from Switzerland that hard cheeses were produced in 1886. ‘Tolminc’ has developed over centuries and has thus become part of the tradition and culture of the people who have always produced it and who still produce it.

‘Tolminc’ has a very long and rich tradition, which goes hand in hand with the beginnings of pasturing in high-mountain pastures. In the mountain pastureland, cattle are circulated seasonally between the valley and the high-mountain pastures, a movement which established the basis of the feeding methods. This economic cycle began every year with the movement of cattle from the valley villages to the ‘lower’ or hay field slopes. At the end of June, the cattle were driven onto the high mountains, where they were grazed and cheese was made until the beginning of September, when the return to the lower slopes began. The cattle remained here until the first snows. The aforementioned economic cycle is still today the standard practice of cattle farmers in Zgornje Posočje.

N a t u r a l c o n d i t i o n s Zgornje Posočje stands at something of a meeting point between the influences of the Mediterranean and the Alpine climates. It is precisely for this reason that Zgornje Posočje has specific natural conditions, which through the bulk fodder produced in the geographical area are reflected in the milk and, thereafter, in the final product after processing.

Zgornje Posočje is the area with the highest rainfall in Slovenia, the main reason for which is the rise of humid air arriving over Slovenia from the Mediterranean Sea at the relatively high mountainous barrier formed by the western Julian Alps. The openness of the space along the Soča river valley towards the Mediterranean Sea further guarantees the influence of the sea. In Tolmin, the average annual air temperature is around 11 °C, the average temperature in January is around 1 °C and in July over 18 °C.

The warmer sub-Mediterranean climate has a major influence on the composition of the vegetation, giving the Alpine vegetation in the Posočje area a particular appearance. The distinctive characteristics of the vegetation on account of the sub-Mediterranean climate are also evident in the steep Alpine cliffs, which, unlike those of the Gorenjska area, are overgrown and, in short, quite special and with a powerful scent of the wild. The flora of the mountain and sub-Alpine meadows of Zgornje Posočje is extremely rich and varied. The reasons for this diversity of species lie in the recent geological past (this position on the southern edge of the ice-age ice cover), the composition of the stone (limestone or dolomite, occasionally mixed with marl, claystone and chert) and the climate (humid, relatively warm mountain climate). The most distinctive feature of the local vegetation is the occurrence of species unique to the area. Some of the grasslands (pastures, hay fields, sub-Alpine and Alpine meadows) of Zgornje Posočje are also characterised by the presence of certain rare species. Thanks to the influence of the sub-Mediterranean climate, more temperate species also flourish in the high mountain hay fields. 25.6.2011 EN Official Journal of the European Union C 185/17

The rich microflora also plays an important role in the production of ‘Tolminc’. Thanks to the ripening of the raw milk or the use of home-made starter cultures, the environment makes its mark on the cheese, and the beneficial autochthonous microflora hampers the development of harmful micro organisms.

4.7. Inspection body:

Name: Bureau Veritas d.o.o. Address: Linhartova cesta 49a SI-1000 Ljubljana SLOVENIJA Tel. +386 14757600 Fax +386 14747601 E-mail: [email protected]

4.8. Labelling: Cheeses which meet all the requirements of the specification are marked with the name of the producer, the ‘Tolminc’ name and logo (reproduced below), the corresponding EU mark and the national quality symbol. The labelling must also state whether the cheese was produced from raw or thermised milk.

Producers may place additional labelling on the cheese if it was matured for more than two months, the cows were not fed silage or the cheese was produced in a mountain dairy. C 185/18 EN Official Journal of the European Union 25.6.2011

This publication confers the right to object to the application pursuant to Article 7 of Council Regulation (EC) No 510/2006 ( 1). Statements of objection must reach the Commission within six months from the date of this publication.

SINGLE DOCUMENT COUNCIL REGULATION (EC) No 510/2006 ‘ARMAGH BRAMLEY APPLES’ EC No: UK-PGI-005-0792-16.10.2009 PGI ( X ) PDO ( ) 1. Name: ‘Armagh Bramley Apples’

2. Member State or third country: United Kingdom

3. Description of the agricultural product or foodstuff: 3.1. Type of product: Class 1.6: Fruits Vegetables and Cereals, fresh or processed.

3.2. Description of product to which the name in (1) applies: The Armagh Bramley Apple is a large green fresh culinary apple. It has a reddish flush and its flesh is white with a tinge of green. The apples are large in size ranging between 60-120 mm in diameter. They are rounded with less uniformity of shape than other Bramley Apples, flat sided, with a ribbed apex, and large eye which is part opened.

They are solid green colour with reddish blush, the sepals are brown and downy and the Stalk is short and thick.

Inside, the flesh is white with a tinge of green and its texture is firm and moist.

3.3. Raw materials (for processed products only): N/A

3.4. Feed (for products of animal origin only): N/A

3.5. Specific steps in production that must take place in the identified geographical area: The apples must be grown in the designated area.

Armagh Bramley Apples are grown in the highly fertile, silt-loam or clay-loam soils of the region. In all orchards, the field boundary is maintained as a substantial hedgerow and windbreak of mixed woody plant species, this provides protection from the chill northerly or north-easterly winds which arise during some spring periods.

Regardless of tree age or size, all summer and winter pruning is carried out manually. The management of these trees for consistent crop yield and quality requires those skills gained from many years’ experience in shaping the frame and canopy through winter and summer pruning.

( 1 ) OJ L 93, 31.3.2006, p. 12. 25.6.2011 EN Official Journal of the European Union C 185/19

Armagh growers pride themselves on observing Good Agricultural Practice in the production of Armagh Bramley apples. Pollination by honeybees is commonly employed during the blossom period and all spray applications are undertaken with due diligence to the welfare of these and other beneficial insects, as well as careful regard to the wider environment.

Widespread use is made of foliar nutrition in Armagh Bramley orchards; both ‘straight’ (single) nutrients and seaweed-derived fertiliser blends are incorporated into the regular spray programme.

Apples are harvested by hand between early September and late October. Time of picking is dependent on season, market, fruit maturity and tree age and rootstock type. Growers often concur on the start date for picking relevant to the size of the apples and their rate of growth during the late summer/early autumn. Most apples are harvested once they have achieved a minimum average diameter of 75 mm, but before they have matured beyond the stage where > 20 % of the stored carbohydrate has been converted from starch to sugar.

As well as the orchards being pruned manually, all fruit is picked and graded by hand. Pickers are trained in handling fruit to avoid skin marking and flesh damage, which is particularly critical for this variety, since a significant proportion of the crop is stored in controlled atmosphere conditions for supply to market throughout the year.

3.6. Specific rules concerning slicing, grating, packaging, etc.: N/A

3.7. Specific rules concerning labelling: N/A

4. Concise definition of the geographical area: Armagh Bramley Apples are grown in the following traditional apple growing parishes in the Arch diocese of Armagh, which covers the counties of Armagh and Tyrone and part of county Londonderry:

Ballygawley, Beragh, Bessbrook, Cloghogue, Clonoe, Coagh, Coalisland, Cookstown, Crossmaglen, Cullyhanna, Donaghmore, Dromintree, Dungannon, Eglish, Keady, Derrynose & Madden, Kildress, Killcluney, Killeeshill, Kilmore, Lissan, Loughgall, Magherafelt, Middletown, Middle Killeavy, Moneymore, Moy, Mullaghbawn, Newbridge, Pomeroy, Portadown, Tandragee, Termonmaguirc, Whitecross.

5. Link with the geographical area: 5.1. Specificity of the geographical area: The defined area is subject to climatic influences including an annual rainfall of up to 80 inches derived from the Atlantic weather system, and an average temperature of 3 °C (winter) to 18 °C (summer) arising from the influence of the Gulf Stream. This, combined with the soil quality in the defined area, which is rich, fertile and particularly high in calcium, contributes to the specificity of the area.

Due to the northerly location, there is less light than other Bramley growing areas and so photosyn thesis dictates a lower tree density, allowing for lateral growth. The colder climate than other Bramley growing areas means that there is less uniformity of growth in the Armagh Bramley Apple and also means that there is less insect pressure and so insecticides require application once per season. This reduced insecticide application is reflected in low residue levels. The lower temperatures also mean that that there is a longer growing season. The designated area is characterised by drumlin hills with numerous small rivers. The rich soil and higher precipitation also means that there is no requirement for artificial irrigation.

5.2. Specificity of the product: The designated area’s climate and soil have a direct influence on the reputation of the product. The longer growing season arising from the lower temperatures characteristic of the area results in larger fruit with less uniformity of shape, a high acid quality suitable for a culinary apple and a stronger distinctive flavour. C 185/20 EN Official Journal of the European Union 25.6.2011

Armagh Bramley Apples have a reputation of holding their flavour and being firmer in texture than other Bramley Apples which is maintained when cooked. This also contributes to its reputation of better keeping quality and as such has longer storability characteristics (12-13 months) than Bramleys from other regions.

Armagh Bramley Apples also differ from other Bramley Apples in that they are green with an occasional reddish flush, but do not develop defined stripes. In addition the Armagh Bramley Apple has a less rounded shape than others due to the cooler climate and the resulting irregular growth patterns. The Apples have a stronger, pronounced flavour.

5.3. Causal link between the geographical area and the quality or characteristics of the product (for PDO) or a specific quality, the reputation or other characteristic of the product (for PGI): The Bramley apple was first brought to Armagh in 1884, when 60 Bramley seedlings were introduced them to Northern Ireland. By 1921, 7 000 acres had been planted and Bramley had become the principal variety grown in Armagh. Processing of the apple started in 1903 and Northern Ireland’s leading processors are still based in County Armagh, near their main supply, the orchards of the county.

The Bramley apple has a unique texture and flavour that assures its position as the king of culinary apples. It retains its strong, tangy flavour throughout the cooking process. The Bramley apple is the only apple in the world with these properties. The Armagh Bramley Apple has a reputation for being firmer in texture, which means that they can be stored for longer and hold their texture for longer when cooking.

The colder climate also accounts for the less rounded shape than other Bramleys. The cooler weather leads to uneven pollination across the ovaries of individual fruit. The ovaries that are fertilised first will swell and develop before the others, which means that the Armagh Bramley Apples develop a char acteristic non-round shape.

The Armagh Bramley apple orchards are unusual in their northerly location and as a result of the climate the apples produced are fewer in number but richer in flavour. The cost of producing Bramley, as a result, is high.

The unique growing conditions in Armagh result in a firmer, more dense fruit than would be grown elsewhere. Aided by a rich, fertile soil that is high in calcium and essential nutrients with a pure and abundant water supply.

Armagh is known throughout Ireland as the Orchard County, with apples having grown in the county for 3 000 years. St Patrick is said to have planted an apple tree at Ceangoba, an ancient settlement east of Armagh City.

The reputation of Armagh as the Orchard County is solely due to the Armagh Bramley Apple. 99 % of all top fruit grown in Northern Ireland is Bramley Apple, and 95 % of all top fruit grown in Northern Ireland is in Armagh.

Armagh is referred to as the Orchard County throughout the culture and customs of the area, from traditional folk songs to local sporting teams.

The term ‘Orchard’ is synonymous with Armagh only as a result of the Armagh Bramley Apple, yet many companies in the designated area unrelated to the Bramley, use the name ‘Orchard’ due to the instant recognition that it gives to the area due to the importance of the Armagh Bramley Apple.

Local restaurants actively promote dishes made from the local Armagh apples, such as Armagh Bramley apple pie, Armagh Bramley Apple Sorbet and Armagh Bramley Apple Crumble. Armagh Bramley Recipe competitions are held with recipes for starters (e.g. Bramley Apple Soup or Ulster Delight), main courses (e.g. Pork with Bramley Apple Stuffing) and desserts (e.g. Armagh Bramley Apple Cake, Bramley Toffee Pudding, Armagh East Coast Soufflé); there is even a local potter who has a Bramley Apple Range, inspired by the nearby orchards. 25.6.2011 EN Official Journal of the European Union C 185/21

The importance of the Armagh Bramley Apple to the region is reflected not only in the fact that up to 1 500 local people are employed in the industry, but also that traditional events still take place, such as Apple Week, and the Apple festival in October. The last Sunday in May is designated Apple Blossom Sunday, as the local orchards are a sea of pink and white flowers. Tourists can take tours of the orchards, complete with Armagh Bramley apple pies, washed down with Armagh cider at the region’s Apple Blossom Fair.

Reference to publication of the specification: (Article 5(7) of Regulation (EC) No 510/2006)

http://www.defra.gov.uk/foodfarm/food/industry/regional/foodname/products/documents/ armaghbramleyapples.pdf

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