3.7.2008

Official Journal of the European Union

C 168/3

Communication from the Commission regarding the guideline on the data fields contained in the clinical trials database provided for in Article 11 of Directive 2001/20/EC to be included in the database on medicinal products provided for in Article 57 of Regulation (EC) No 726/2004

(2008/C 168/02)

1. INTRODUCTION

Article 57 of Regulation (EC) No 726/2004 (1) provides for the European Medicines Agency to establish a database on medicinal products authorised in the Community to be accessible to the general public — the so-called EudraPharm database (2). This provision also stipulates that, where appropriate, the database shall also include references to data on clinical trials currently being carried out or already completed, contained in the clinical trials database provided for in Article 11 of Directive 2001/20/EC (3) — the so-called EudraCT database (4).

The same provision requires that the Commission issues guidelines on the clinical trials data fields which could be included and which may be accessible to the public, by identifying the data fields from the clinical trials database corresponding to the information that may be included in EudraPharm.

This information is of potential value to patients, their carers and the health professions, who have a potential interest in ongoing or completed trials. At the same time, more transparent information can contribute to the development of further research helping to ensure that better trials are designed, requiring fewer patients and avoiding unnecessary duplication. The pharmaceutical industry, academia and the scientific community and regulators are other potential users of this type of information.

The EudraCT database includes clinical trials on medicinal products for human use, with at least one site in the Community, and which commenced in at least one Member State following the transposition of Directive 2001/20/EC. Clinical trials commencing prior to that point and clinical trials with no site in the Community are not included in EudraCT and cannot therefore be referenced by EudraPharm (except for those third country paediatric clinical trials that are included in a Paediatric Investigation Plan in accordance with Regulation (EC) No 1901/2006. Publication of information on paediatric clinical trials is to be the subject of a separate guideline).

The purpose of this guideline is to identify the data elements from the EudraCT database corresponding to the information to be included in EudraPharm, to identify the trials which will be included and to set out the criteria for the update of this data. The overall purpose is to provide relevant information to the public in the interests of public health.

At the time of publication of this guideline the EudraCT data fields are for the most part consistent with international initiatives relating to clinical trial registries, e.g. WHO International Clinical Trials Registry Platform (ICTRP) and the International Committee of Medical Journal Editors (ICMJE). Although EudraCT may have additional fields, the convergence of the information to be made public with the WHO ICTRP facilitates the work of sponsors and researchers submitting information to different registries for different purposes, and facilitates the access of patients, health professionals and citizens in general to this information.

2. DEFINITIONS

Applicable definitions will be those contained in Directive 2001/83/EC and Directive 2001/20/EC.

3. SCOPE

Taking into consideration that the EudraCT database is only accessible to the competent authorities of the Member States and the European Medicines Agency in order to ensure that the confidentiality of the data is strictly observed and to protect the legitimate interests of sponsors, the information to be made publicly available keeps the balance between this principle and the need to inform the public in the interests of public health and transparency.

With these objectives in mind the information to be made available needs to be meaningful for the public, also by following agreed standards at international level. Moreover, phase I trials, certain details of the characterisation of the investigational medicinal products, certain details of the clinical trial design, information on batch release aspects, legal status of the sponsor, clinical trial sites and any personal related information are excluded from publication.

The information referred to in Section 4 to be included in the EudraPharm database shall cover clinical trials of phases II, III and IV, regardless of whether the medicinal product concerned has already received a marketing authorisation in the Community or not.

Each clinical trial will be listed as ‘ongoing’ or ‘ended’. This status will be listed for each Member State with the relevant dates.

Clinical trials which have received a decision from the Competent Authority and/or a favourable opinion from the Ethics Committee, in the Member State in question, will be identified in the EudraPharm database. Once the clinical trial has been approved it will be listed as ‘ongoing’. This listing will change to ‘ended’ once the clinical trial has been registered as ended in EudraCT.

4. INFORMATION ELEMENTS TO BE INCLUDED IN THE EUDRAPHARM DATABASE

The information to be published in the EudraPharm database will consist of data fields on the clinical trial including the following elements:

(a)

Identification of the clinical trial and the sponsor:

—	EudraCT number for the clinical trial,

—	sponsor's designation and protocol code number,

—	full title of the trial,

—	the International Randomised Standard Clinical Trial Number (IRSCTN) where available in EudraCT,

—	other international identifier(s) to be defined,

—	contact point(s) for further information.

(b)

Identification of the medicinal product:

The medicinal product will be identified by as much of the following that is available in EudraCT (the nature of the clinical trial may mean that some items are not present in EudraCT):

—	name of the medicinal product,

—	active substance(s),

—	route of administration,

—	therapeutic classification code,

—	appropriate international identifiers.

(c)

Identification of the indication under study in the clinical trial and of orphan designation:

The indication(s) will be described in accordance with the agreed international terminology at the level used in the clinical trial application.

Where a product has been designated as an orphan medicinal product for the indication under study this will be indicated and the designation number provided.

(d)

General descriptive information on the clinical trial and the patient population included:

—	major objective,

—	principal inclusion and exclusion criteria of the clinical trial,

—	phase of the clinical trial,

—	design (e.g. randomised, controlled),

—	comparators (medicines/other treatments) if this is part of the clinical trial,

—	number of patients anticipated in the clinical trial,

—	age range(s),

—

gender.

Taking in consideration the ongoing developments of the EudraCT database, as a result of international convergence and the implementation of Regulation (EC) No 1901/2006, publication of clinical trial results, both positive and negative, will be included as the information becomes available on the database and will need to be provided in accordance with the guidance on the clinical trial application form and the declaration of the end of a clinical trial form, as published by DG ENTR in Volume 10 of EudraLex (5).

5. GUIDANCE ON IMPLEMENTATION

A glossary will be provided in an appropriate location on the database website, explaining the relevant technical and regulatory terms and acronyms for the benefit of the general public.

DG Enterprise and Industry will publish detailed data elements corresponding to the information that is to be included in EudraPharm.

The actual physical and logical data models to be used in implementing this guideline will be drawn up through object modelling. Other functionalities will have to be defined by technical specifications to be prepared when this guideline is implemented.

(1) OJ L 136, 30.4.2004, p. 1.

(2) http://eudrapharm.eu

(3) OJ L 121, 1.5.2001, p. 34.

(4) http://eudract.emea.europa.eu

(5) http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/homev10.htm

3.7.2008

Official Journal of the European Union

C 168/6

Information communicated by Member States regarding State aid granted under Commission Regulation (EC) No 1857/2006 on the application of Articles 87 and 88 of the EC Treaty to State aid to small and medium-sized enterprises active in the production of agricultural products and amending Regulation (EC) No 70/2001

(2008/C 168/04)

Aid No: XA 285/07

Member State: Republic of Slovenia

Region: Območje občine Borovnica

Title of aid scheme or name of company receiving individual aid: Programi ohranjanja in razvoja kmetijstva in podeželja v občini Borovnica 2007–2013

Legal basis: Pravilnik o dodeljevanju pomoči za ohranjanje in razvoj kmetijstva ter podeželja v občini Borovnica (II. poglavje)

Annual expenditure planned under the scheme or overall amount of individual aid granted to the company:

2007: EUR 12 000

2008: EUR 12 000

2009: EUR 12 500

2010: EUR 13 200

2011: EUR 14 000

2012: EUR 15 000

2013: EUR 15 000

Maximum aid intensity:

1. Investment in agricultural holdings for primary production:

—	up to 50 % of eligible costs in less-favoured areas and up to 40 % of eligible costs in other areas,

—

in the case of investments made by young farmers within five years of setting up, the intensity of the aid is increased by 10 percent (to 60 % or 50 % respectively) (these investments must be set out in a business plan as provided for by Article 22(c), and the conditions laid down in Article 22 of Regulation (EC) No 1698/2005 must be met).

The purpose of the aid is investment to restore farm features and to purchase equipment to be used for agricultural production, to invest in permanent crops, to improve farmland and to manage pastures.

2. Conservation of traditional landscapes and buildings:

—	for non-productive features, up to 100 % of actual costs,

—	for investment in productive assets on farms, up to 60 % of actual costs, or 75 % in less-favoured areas, provided that the investment does not entail any increase in the production capacity of the farm,

—	additional aid may be granted at a rate of up to 100 % to cover the extra costs incurred by using traditional materials necessary to preserve the heritage features of buildings,

—	up to EUR 10 000 per year for work undertaken by the farmer for investment in non-productive heritage.

3. Relocation of farm buildings in the public interest:

—	up to 100 % of actual costs where the relocation simply consists of the dismantling, removal and re-erection of existing facilities,

—

where the relocation results in the farmer benefiting from more modern facilities, the farmer must contribute at least 60 %, or 50 % in less-favoured areas, of the increase in the value of the facilities concerned after relocation. If the beneficiary is a young farmer, this contribution is to be at least 55 % or 45 % respectively,

—

where the relocation results in an increase in production capacity, the contribution from the beneficiary must be at least 60 %, or 50 % in less-favoured areas, of the expenses relating to this increase. If the beneficiary is a young farmer, this contribution is to be at least 55 % or 45 % respectively.

4. Aid towards the payment of insurance premiums:

—	the amount of municipal co-financing is the difference between the amount of co-financing of insurance premiums from the national budget and up to 50 % of eligible costs of an insurance premium for insuring crops and fruit and insuring livestock against disease.

5. Aid for land reparcelling:

—	up to 100 % of actual legal and administrative costs incurred.

6. Aid to encourage the production of quality agricultural products:

—	up to 100 % of eligible costs in the form of subsidised services; this must not involve direct payments of money to producers.

7. Aid for providing technical support in the agricultural sector:

—

up to 100 % of eligible costs concerning education and training of farmers, consultancy services, the organisation of forums, competitions, exhibitions and fairs, publications, catalogues and websites, and the dissemination of scientific knowledge. The aid is to be granted in the form of subsidised services and must not involve direct payments of money to producers

Date of implementation: October 2007 (The aid will not be granted until a summary has been published on the European Commission's website)

Duration of scheme or individual aid award: Until 31.12.2013

Objective of the aid: To support SMEs

Reference to Articles in Regulation (EC) No 1857/2006 and eligible costs: Chapter II of the draft Rules on granting aid for preserving and developing agriculture and rural areas in the municipality of Borovnica includes measures constituting State aid in accordance with the following Articles of Commission Regulation (EC) No 1857/2006 of 15 December 2006 on the application of Articles 87 and 88 of the Treaty to State aid to small and medium-sized enterprises active in the production of agricultural products and amending Regulation (EC) No 70/2001 (OJ L 358, 16.12.2006, p. 3):

Article 4: Investment in agricultural holdings,

Article 5: Conservation of traditional landscapes and buildings,

Article 6: Relocation of farm buildings in the public interest,

Article 12: Aid towards the payment of insurance premiums,

Article 13: Aid for land reparcelling,

Article 14: Aid to encourage the production of quality agricultural products,

Article 15: Provision of technical support in the agricultural sector

Economic sector(s) concerned: Agriculture

Name and address of granting authority:

Občina Borovnica

Paplerjeva 22

SLO-1353 Borovnica

Website: http://www.uradni-list.si/1/ulonline.jsp?urlid=2007122&dhid=93740

Other information: The measure for the payment of insurance premiums to insure crops and fruit includes the following adverse climatic events which can be assimilated to natural disasters: spring frost, hail, lightning, fire caused by lightning, storm and floods.

The municipality's Rules meet the requirements of Regulation (EC) No 1857/2006 relating to the measures to be adopted by the municipality and the general provisions applicable (steps preceding grant of aid, cumulation, transparency and monitoring of aid)

Podpis odgovorne osebe občine Borovnica

Andrej OCEPEK

Aid No: XA 286/07

Member State: Slovenia

Region: Območje občine Renče-Vogrsko

Title of aid scheme or name of company receiving individual aid: Pomoči za programe in investicije v kmetijstvu v občini Renče-Vogrsko 2007–2013

Legal basis: Pravilnik o dodeljevanju finančnih pomoči za programe in investicije v kmetijstvu v občini Renče-Vogrsko

Annual expenditure planned or overall amount of individual aid granted to the company: The average annual amount of aid available between 2007 and 2013 is EUR 12 500

Maximum aid intensity:

1. Investment in agricultural holdings:

—	up to 40 % of the costs of investment,

—	up to 50 % of the costs of investment, in the case of investments made by young farmers within five years of setting up.

The purpose of the aid is to invest in the restoration of farm features, to purchase equipment to be used for agricultural production, to invest in permanent crops, to improve farmland, to provide private access ways on farms and to manage pastures.

2. Aid towards the payment of insurance premiums:

—	the amount of municipal support is the difference between the amount of co-financing of insurance premiums from the national budget and up to 50 % of eligible costs of insurance premiums for insuring crops and fruit and for insuring livestock against disease.

3. Aid for land reparcelling:

—	up to 100 % of eligible legal and administrative costs incurred.

4. Aid to encourage the production of quality agricultural products:

—	up to 100 % of actual costs incurred; the aid is to be provided in the form of subsidised services and must not involve direct payments of money to producers.

5. Provision of technical support:

—	up to 100 % of costs concerning education and training of farmers and the organisation of forums, competitions, exhibitions, fairs, publications, catalogues and websites. The aid is to be granted in the form of subsidized services and must not involve direct payments of money to producers

Date of implementation: October 2007 (The aid will not be granted until a summary has been published on the European Commission's website)

Duration of scheme or individual aid award:

Objective of aid: To support SMEs

Reference to Articles in Regulation (EC) No 1857/2006 and eligible costs: Chapter II of the draft Rules on granting financial aid for programmes and investment in agriculture in the municipality of Renče-Vogrsko includes measures constituting State aid in accordance with the following Articles of Commission Regulation (EC) No 1857/2006 of 15 December 2006 on the application of Articles 87 and 88 of the Treaty to State aid to small and medium-sized enterprises active in the production of agricultural products and amending Regulation (EC) No 70/2001 (OJ L 358, 16.12.2006, p. 3):

Article 4: Investment in agricultural holdings,

Article 12: Aid towards the payment of insurance premiums,

Article 13: Aid for land reparcelling,

Article 14: Aid to encourage the production of quality agricultural products,

Article 15: Provision of technical support in the agricultural sector

Economic sector(s) concerned: Agriculture

Name and address of granting authority:

Občina Renče-Vogrsko

Bukovica 43

SLO-5293 Volčja Draga

Website: http://www.rence-vogrsko.si/images/glasila_pdf/obcinski_list_8.pdf

The municipality's Rules meet the requirements of Regulation (EC) No 1857/2006 concerning the measures to be adopted by the municipality and the general provisions applicable (steps preceding grant of aid, cumulation, transparency and monitoring of aid)

Aleš BUCIK

Župan

Aid No: XA 287/07

Member State: Republic of Slovenia

Region: Občina Slovenska Bistrica

Title of aid scheme or name of company receiving individual aid: Pomoči za ohranjanje in razvoj kmetijstva ter podeželja v občini Slovenska Bistrica

Legal basis: Pravilnik o dodeljevanju državnih pomoči, pomoči de minimis in izvajanju drugih ukrepov za ohranjanje in razvoj kmetijstva ter podeželja v občini Slovenska Bistrica

Annual expenditure planned under the scheme or overall amount of individual aid granted to the company:

2007: EUR 140 000

2008: EUR 140 000

2009: EUR 145 000

2010: EUR 145 000

2011: EUR 145 000

2012: EUR 145 000

2013: EUR 145 000

Maximum aid intensity:

1. Investment in agricultural holdings for primary production:

—	up to 50 % of eligible costs in less-favoured areas,

—	up to 40 % of eligible costs in other areas,

—	up to 60 % of eligible costs in less-favoured areas, and up to 50 % of eligible costs in other areas, in the case of investments made by young farmers within five years of setting up.

2. Conservation of traditional landscapes and buildings:

—	up to 100 % of actual costs for investment in non-productive features,

—	for investment in productive assets on farms, up to 60 % of eligible costs, or up to 75 % in less-favoured areas, provided that the investment does not entail any increase in the production capacity of the farm,

—	additional aid may be granted at a rate of up to 100 % to cover the extra costs incurred by using traditional materials.

3. Aid towards the payment of insurance premiums:

—	municipal support plus national funding may not exceed 50 % of the costs of insurance premiums for agricultural production for the current year.

4. Aid for land reparcelling:

—	up to 100 % of eligible legal and administrative costs.

5. Aid to encourage the production of quality agricultural products:

—	up to 100 % of costs incurred; the aid is to be provided in the form of subsidised services and must not involve direct payments of money to producers.

6. Provision of technical support in the agricultural sector:

—

up to 100 % of costs concerning education and training of farmers, consultancy services, the organisation of forums, competitions, exhibitions, fairs, publications, catalogues and websites, and the costs of replacement services. The aid is to be granted in the form of subsidised services and must not involve direct payments of money to producers

Date of implementation: October 2007 (The aid will not be granted until a summary has been published on the European Commission's website)

Duration of scheme or individual aid award: Until 31.12.2013

Objective of the aid: To support SMEs

Reference to Articles in Regulation (EC) No 1857/2006 and eligible costs: The Rules on granting State aid and de minimis aid and implementing other measures for preserving and developing agriculture and rural areas in the municipality of Slovenska Bistrica include measures constituting State aid in accordance with the following Articles of Commission Regulation (EC) No 1857/2006 of 15 December 2006 on the application of Articles 87 and 88 of the Treaty to State aid to small and medium-sized enterprises active in the production of agricultural products and amending Regulation (EC) No 70/2001 (OJ L 358, 16.12.2006, p. 3):

Article 4: Investment in agricultural holdings,

Article 5: Conservation of traditional landscapes and buildings,

Article 12: Aid towards the payment of insurance premiums,

Article 13: Aid for land reparcelling,

Article 14: Aid to encourage the production of quality agricultural products,

Article 15: Provision of technical support in the agricultural sector

Economic sector(s) concerned: Agriculture

Name and address of granting authority:

Občina Slovenska Bistrica

Kolodvorska 10

SLO-2310 Slovenska Bistrica

Website: http://www.uradni-list.si/1/ulonline.jsp?urlid=2007122&dhid=93740

Županja

Irena MAJCEN

3.7.2008

Official Journal of the European Union

C 168/10

Summary of notifications received in 2007 by the Commission pursuant to Article 5 of Regulation (EC) No 258/97 of the European Parliament and of the Council

(2008/C 168/05)

Between 1 January 2007 and 31 December 2007 the Commission had received 42 notifications of placing on the market novel foods or novel food ingredients pursuant to Article 5 of Regulation (EC) No 258/97 of the European Parliament and of the Council (1).

Applicant

Description of food or food ingredient

Scientific evidence

Notification

Transmission to Member States

Cognis Deutschland GmbH & Co. KG

Postfach 13 01 64

D-40551 Düsseldorf

Henkelstraße 67

D-40589 Düsseldorf

Phytosterol esters for the addition to: (i) milk type products and yoghurt type products; and (ii) yellow fat spreads as described by Council Regulation (EC) No 2991/94, excluding cooking and frying fats and spreads based on butter or other animal fat

and

FSA (2) (UK) Request for an opinion on the substantial equivalence of phytosterols and their esters

23 July 2004

4 August 2004

Plantsterols and plantsterol esters for the addition to yellow fat spreads (excluding cooking and frying fats and spreads based on butter or other animal fat), salad dressings including mayonnaise and milk type products as specified by Commission Decision 2004/333/EC, spicy sauces as specified by Comission Decision 2004/334/EC and milk based fruit drinks as specified by Commission Decision 2004/336/EC

and

NFB (3) (FIN) Opinion on the substantial equivalence of plant sterols, phytosterolesters and foods enriched with these (Cognis Deutschland GmbH & Co)

20 April 2005

29 June 2005

Rye bread with added phytosterol esters and/or phytosterols

The requirements laid down in Article 2 of the aforementioned Decisions apply

NFB (3) (FIN) Opinion on substantial equivalence for rye bread enriched with Cognis plant sterol ingredient (Cognis Deutschland GmbH & Co)

23 May 2006

9 June 2006

31n

E. de Mûelenare

NV VANDEMOORTELE

Prins Albertlaan 12

B-8870 Izegem

Yellow fat spreads excluding cooking and frying fats and spreads based on butter or other animal fat with added phytosterols

A portion will not contain more than 3 g (in case of one portion per day) or more than 1 g (in case of 3 portions per day) of added phytosterol esters

The phytosterols are provided by Cognis and/or Cargill

9 January 2007

31 January 2007

31p

Dr Maurizio Roberti

Nutrition & Santé Italia S.p.A.

Soggetta a direzione e coordinamento di Sanutri AG

Lgo Umberto Boccioni 1

I-21040 Origgio (VA)

Beverages based on fermented milk with added phytosterols

A portion will not contain more than 3 g (in case of one portion per day) or more than 1 g (in case of 3 portions per day) of added phytosterols.

A container of beverages will not contain more than 3 g of added phytosterols

The phytosterols are provided by Cognis

12 February 2007

15 March 2007

31q

Waldemar Taciak

Elmilk Sp. z o.o.

Yellow fat spreads excluding cooking and frying fats and spreads based on butter or other animal fat with added phytosterols

A portion will not contain more than 3 g (in case of one portion per day) or more than 1 g (in case of 3 portions per day) of added phytosterol esters

The phytosterols are provided by Cognis

7 February 2007

27 March 2007

31r

Edoardo Roncadin

Bofrost Distributzione Italia S.p.a.

Via Clauzetto, 4

I-33078 San Vito al Tagliamento (PN)

Beverages based on skimmed milk with added phytosterols

A portion will not contain more than 3 g (in case of one portion per day) or more than 1 g (in case of 3 portions per day) of added phytosterols.

A container of beverages will not contain more than 3 g of added phytosterols

The phytosterols are provided by Cognis

17 April 2007

7 May 2007

31s

Caroline Calin

Lactalis Nestlé Chilled Dairy Co. Ltd

St. George'd House

Croydin, Surrey CR9 1NR

United Kingdom

Products based on milk with fruits and added phytosterol esters

A portion will not contain more than 3 g (in case of one portion per day) or more than 1 g (in case of 3 portions per day) of added phytosterols.

A container of beverages will not contain more than 3 g of added phytosterols

The phytosterol esters are provided by Cognis

5 June 2007

12 July 2007

31t

Luc Gerardy

Corman Miloko Factory

Carrick on Suir

Co. Tipperary

Ireland

Yellow fat spreads excluding cooking and frying fats and spreads based on butter or other animal fat with added phytosterols

A portion will not contain more than 3 g (in case of one portion per day) or more than 1 g (in case of 3 portions per day) of added phytosterol esters

The phytosterol esters are provided by Cognis

7 August 2007

9 August 2007

31u

Irene Pateras

Elbisco S.A.

21st km Marathon Ave.

GR-19009 Pikermi

Attica — Greece

Rye bread with flour containing ≥ 50 % rye and ≤ 30 % wheat; and with ≤ 4 % sugar but no fat added

with added phytosterols

A portion will not contain more than 3 g (in case of one portion per day) or more than 1 g (in case of 3 portions per day) of added phytosterols/phytostanols

The phytosterol esters are provided by Cognis

6 September 2007

12 October 2007

Cargill

15407 McGinty Road

MS 110

Wyazata, MN 55391

USA

Foods with added phytosterols:

yellow fat spreads excluding cooking or frying fats and spreads based on butter or other animal fat,

salad dressings, mayonnaise and spicy sauces,

milk-type drinks with fruit and/or cereals, milk-based fruit drinks, fermented milk type products, where the milk fat and/or protein has been partly or fully replaced by vegetable fat or protein and soy drinks,

cheese type products (fat content ≤ 12 g per 100 g), where the milk fat and/or protein has been partly or fully replaced by vegetable fat or protein.

NFB (3) (FIN) Opinion on substantial equivalence in the case of plant sterol/plant stanol ingredient intended to be used in foods (Cargill Incorporation)

24 October 2004

13 December 2004

Cargill R&D Centre Europe

Havenstraat 84

B-1800 Vilvoorde

Rye bread with added phytosterols

A portion will not contain more than 3 g (in case of one portion per day) or more than 1 g (in case of 3 portions per day) of added phytosterols/phytostanols.

A container of beverages will not contain more than 3 g of added phytosterols/phytostanols

NFB (3) (FIN) Opinion on substantial equivalence for rye bread enriched with Corowise™ plant sterol/plant stanol ingredient (Cargill)

4 September 2006

12 September 2006

38b

R.M. Gutjahr

Health Concern BV

Reactorweg 9a

3542 AD Utrecht

Nederland

P.O.Box 40376

3504 AD Utrecht

Nederland

Yellow fat spreads excluding cooking or frying fats and spreads based on butter or other animal fat

A portion will not contain more than 3 g (in case of one portion per day) or more than 1 g (in case of 3 portions per day) of added phytosterols/phytostanols

The phytosterol ingredient is the one that was notified by Cargill

11 December 2007

18 December 2007

Forbes Medi-Tech Inc.

750 West Pender Street

Vancouver B.C. V6C 2T8

Canada

Foods listed in Article 1 of Commission Decision 2000/500/EC and in Annex 1 of Commission Decisions 2004/333/EC, 2004/334/EC, 2004/335/EC and 2004/336/EC (yellow fat spreads, salad dressings, fermented milk type products, soya drinks, cheese type products, yoghurt type products, spicy sauces, milk based fruit drinks) with added phytosterols/phytostanols (Reducol™)

NFB (3) (FIN) Opinion on the substantial equivalence of foods enriched with Forbes phytosterols/phytostanols (Forbes Medi-Tech Inc.) of 28 February 2005

22 April 2005

6 June 2005

Rye bread

NFB (3) (FIN) Opinion on substantial equivalence for rye bread enriched with Reducol™ plant sterol ingredient

12 June 2006

3 August 2006

Cheese products (fat content < 12 g per 100 g) with added phytosterols and/or phytosterol esters

Letter of 6 September 2006 by the FSAI (4) (IRL) concerning the substantial equivalence

3 October 2006

6 November 2006

41k

Aimo Jussila

Linkosuo Oy

PO Box 77

Mannakorventie 1, Kangasala

FIN-33101 Tampere

Rye bread with flour containing ≥ 50 % rye and ≤ 30 % wheat; and with ≤ 4 % sugar but no fat added

with added phytosterols

The phytosterols are provided by Forbes Medi-Tech

23 April 2007

15 May 2007

Vitae-Caps S.A.

Polígono Industrial Torrehierro

c/ Gutemberg 356

E-45600 Talavera de la Reine (Toledo)

Yellow fat spreads as defined by Council Regulation (EC) No 2991/94, excluding cooking and frying fats and spreads based on butter or other animal fat

milk type products, and

yoghurt type products

AESA (5) (ES) Opinion about the application presented by the company Vitae-Caps SA to register its phytosterols and its phytosterol esters (Vitasterol S-80 non GMO) according to the process of substantial equivalence according to the procedure established in Article 3(4) and Article 5 of Regulation (EC) No 258/97

30 January 2006

21 February 2006

Yellow fat spreads; milk type products; fermented milk type products; cheese type products, salad dressings; and soya drinks

AESA (5) (ES) Opinion on the application submitted by the company Vitae-Caps SA, to record its phytosterols and phytosterol esters under the substantial equivalence process of Regulation (EC) No 258/97 in accordance with the procedure provided in Article 5 of the same Regulation (4 May 2006)

22 June 2006

27 September 2006

Spicy sauces; rye bread with flour containing ≥ 50 % rye (wholemeal rye flour, whole or cracked rye kernels and rye flakes) ≤ 30 % wheat and with ≤ 4 % sugar but no fat added

with added phytosterols.

A portion will not contain more than 3 g (in case of one portion per day) or more than 1 g (in case of 3 portions per day).

A container of beverages will not contain more than 3 g of added phytosterols/phytostanols.

Salad dressing will be packed as single portions

AESA (5) (ES) Opinion about the application presented by the Company Vitae-Caps SA to register its phytosterols and its phytosterol esters according to the process of substantial equivalence according to the procedure established in Article 5 of Regulation (EC) No 258/97 (27 July 2006)

26 October 2006

16 November 2006

57c

Véronique Boyer

Senoble France

30, rue des Jaques

F-89150 Jouy

Products based on fermented milk

A portion will not contain more than 3 g (in case of one portion per day) or more than 1 g (in case of 3 portions per day) of added phytosterols/phytostanols.

A container of beverages will not contain more than 3 g of added phytosterols/phytostanols

The phytosterols are the same as notified by Vitae-Caps SA

31 May 2007

13 June 2007

57d

Juliana Kives Ostronoff

Quesos Forlasa S.A.

Avda. Reves Católios, 135

Apartado de correos 43

E-02600 Villarrobledo (Albacete)

Cheese type products (fat content ≤ 12 g per 100 g) with added phytosterols

A portion will not contain more than 3 g (in case of one portion per day) or more than 1 g (in case of 3 portions per day) of added phytosterols/phytostanols of added phytosterols/phytostanols

The phytosterols are the same as notified by Vitae-Caps SA, Cognis or Lipofoods

4 June 2007

13 June 2007

57e

Artemis Chatzigeorgiou

VIVARTIA S.A.

Dairy & Drinks Division

10, Ziridi

GR-15123 Marousi/Attiki

Products based on fermented milk with added phytosterol esters

A portion will not contain more than 3 g (in case of one portion per day) or more than 1 g (in case of 3 portions per day) of added phytosterols/phytostanols.

A container of beverages will not contain more than 3 g of added phytosterols/phytostanols

The phytostereol esters are the same as notified by Vitae-Caps SA

27 July 2007

9 August 2007

Oy Foodfiles Ltd

Neulaniementie 2 L 6

FI-70210 Kuopio

On behalf of: Arboris LLC

Yellow fat spreads as defined by Council Regulation (EC) No 2991/94, excluding cooking and frying fats and spreads based on butter or other animal fat; milk type and fermented milk type products; yoghurt type products; cheese type products; soya drinks and salad dressings and spicy sauces

NFB (3) (FIN) Opinion on substantial equivalence for Arboris® sterol AS-2™ plant sterol ingredient and foods enriched with it (Arboris® LLC)

5 April 2006

27 April 2006

Rye bread with flour containing ≥ 50 % rye and ≤ 30 % wheat; and with ≤ 4 % sugar but no fat added

with added phytosterols.

A portion will not contain more than 3 g (in case of one portion per day) or more than 1 g (in case of 3 portions per day) of added phytosterols/phytostanols.

A container of beverages will not contain more than 3 g of added phytosterols/phytostanols.

Salad dressings and spicy sauces will be packed as single portions

7 December 2006

19 February 2007

62a

Mr Emmanouil Karamolegos

Karamolegos Bakery & Confeectionary Industry S.A

Thessi Tzima

Koropi

GR-194 00 Greece

Rye bread with flour containing ≥ 50 % rye and ≤ 30 % wheat; and with ≤ 4 % sugar but no fat added

with added phytosterols.

A portion will not contain more than 3 g (in case of one portion per day) or more than 1 g (in case of 3 portions per day) of added phytosterols/phytostanols

The phytosterols are provided by Arboris

10 August 2007

4 September 2007

Fenchem Enterprises Ltd.

1911-1915 Fortune Building No. 359

Hongwu Rd

Nanjing, 210002

China

Yellow fat spreads as defined by Council Regulation (EC) No 2991/94, excluding cooking and frying fats and spreads based on butter or other animal fat; milk type products such as skimmed and semi skimmed milk type products, possibly with the addition of fruits and/or cereals, fermented milk type products, such as yoghurt and cheese type products (fat content ≤ 12 g per 100 g) where the milk fat and or protein has been fully or partly replaced by vegetable fat or protein; milk based fruit drinks

Salad dressings and spicy sauces; rye bread with flour containing ≥ 50 % rye (wholemeal rye flour, whole or cracked rye kernels and rye flakes) ≤ 30 % wheat and with ≤ 4 % sugar but no fat added

with added phytosterols.

A portion will not contain more than 3 g (in case of one portion per day) or more than 1 g (in case of 3 portions per day) of added phytosterols/phytostanols.

A container of beverages will not contain more than 3 g of added phytosterols/phytostanols; spicy sauces and salad dressings will be packed as single portions

NFB (3) (FIN) Opinion on substantial equivalence for Cholevel™ plant sterol ingredient and foods enriched wit hit (Fenchem Enterprises Ltd)

1 November 2006

16 November 2006

74a

Tamás Szakács

HAJDÚSÁGI SÜTÖDÉK Zrt

Hösök Útja 1-3

H-4027 Debrecen

with added phytosterols.

A portion will not contain more than 3 g (in case of one portion per day) or more than 1 g (in case of 3 portions per day) of added phytosterols/phytostanols.

A container of beverages will not contain more than 3 g of added phytosterols/phytostanols; spicy sauces and salad dressings will be packed as single portions

The phytosterols are provided by Fenchem Enterprises

12 November 2007

5 December 2007

Elena Razvodoskaia

FORLIVE srl

Via Ravegna, 456

I-47100 Forli (FC)

Noni juice (juice of the fruits of Morinda citrifolia)

Opinion by DSPVNSA (6)

4 January 2007

31 January 2007

Allessandro Mazzola

Istituto Pirri srl

Via Cavour 7

I-20052 Monza

On behalf of: Innomark Inc.

Noni juice (juice of the fruits of Morinda citrifolia)

Opinion by DSPVNSA (6)

21 December 2006

31 January 2007

Javier Jiménez Madrid

Láctea Antequerana S.L.

Polígono Industrial

Avda. El Romeral, 3

E-29200 Antequera, Málaga

Fermented milk type products with added phytosterols

A portion will not contain more than 3 g (in case of one portion per day) or more than 1 g (in case of 3 portions per day) of added phytosterols/phytostanols.

A container of beverages will not contain more than 3 g of added phytosterols/phytostanols

The phytosterols are the same as authorised by Commission Decision 2004/336/EC

2 January 2007

25 January 2007

78a

Theo Knöps

Uniekaas Nederland B.V.

Belgiëstraat 6

5171 PN Kaatsheuvel

Nederland

Postbus 14

5170 AA Kaatsheuvel

Nederland

Fermented milk type products (cheese type products with fat content ≤ 12 g per 100 g) with added phytosterols

A portion will not contain more than 3 g (in case of one portion per day) or more than 1 g (in case of 3 portions per day) of added phytosterols/phytostanols.

A container of beverages will not contain more than 3 g of added phytosterols/phytostanols

The phytosterols are the same as authorised by Commission Decision 2004/336/EC

8 January 2007

14 February 2007

Kart Cahill

AgroLabs Inc.

805 Port America Place

Suite 200

Grapevine Tx 76051

USA

Noni juice (juice of the fruits of Morinda citrifolia)

FSA (2) Opinion on the equivalence of ‘Naturally Noni’ produced by AgroLabs Inc.

23 January 2007

8 February 2007

Laurent Depelley

Lipofoods

Calle Issac Peral, 17

E-08850 Gavà (Barcelona)

Yellow fat spreads as defined by Council Regulation (EC) No 2991/94, excluding cooking and frying fats and spreads based on butter or other animal fat; products based on milk, such as products based on skimmed and semi- skimmed milk, possibly with the addition of fruits and/or cereals, fermented milk type products, such as yoghurt and cheese type products (fat content ≤ 12 g per 100 g) where the milk fat and or protein has been fully or partly replaced by vegetable fat or protein; milk based fruit drinks

Salad dressings and spicy sauces; soya drinks with added phytosterols.

A portion will not contain more than 3 g (in case of one portion per day) or more than 1 g (in case of 3 portions per day) of added phytosterols/phytostanols.

A container of beverages will not contain more than 3 g of added phytosterols/phytostanols; spicy sauces and salad dressings will be packed as single portions

ACNFP (7) (UK) Opinion on substantial esquivalence of phytosterols considered under Article 5 of the Novel Foods Regulation (FSA (2), 15 February 2007; NFU 632)

16 February 2007

12 March 2007

Dr. Gerald Cysewski

Cyanotech Corporation

73-4460 Queen Kaahumanu Highway

102 Kailua-Kona

HI 96740

USA

Food supplements with Astaxanthin-rich oleoresin extracted from Haematococcus Pluvialis

FSA (2) (UK) Request for an opinion on substantial equivalence of Astaxanthin-rich extract from Haematococcus Pluvialis algae

7 March 2007

13 March 2007

Oy Foodfiles Ltd

Neulaniementie 2 L 6

FI-70210 Kuopio

For Phyto-Source L.P.

Spreadable fats, as defined by Council Regulation (EC) No 2991/94, Annex 1, points B and C, excluding cooking and frying fats and spreads based on butter or other animal fat. Milk based products, such as products based on semi-skimmed and skimmed milk products, possibly with the addition of fruits and/or cereals, products based on fermented milk such as yoghurt and cheese based products (fat content ≤ 12 g per 100 g), where possibly the milk fat has been reduced and the fat or protein has been partly or fully replaced by vegetable fat or protein. Soya drinks. Spicy sauces and salad dressings including mayonnaise. Rye bread with flour containing ≥ 50 % rye (wholemeal rye flour, whole or cracked rye kernels and rye flakes) and ≤ 30 % wheat; and with ≤ 4 % added sugar but no fat added with added phytosterols

NFB (3) (FIN) Opinion on the substantial equivalence of Phyto-S-Sterol™ (Phyto-Source L.P.)

14 May 2007

1 June 2007

Aziz Chair

Oleador

Gustav-Adolf-Str. 27

D-30167 Hannover

Argan oil

The DGCCRF (8) (F) confirmed that the previously issued opinion by AFSSA (14) was also applicable to the Argan oil placed on the market by Oleador

9 July 2007

9 August 2007

Freank D'Fonseca

PURAVITTA

Vuurwerekerweg 13

1032 KN Amsterdam

Nederland

Noni juice (juice of the fruits of Morinda citrifolia)

NFU (9) (NL) Noni juice (5) Assessment of the substantial equivalence for a notification, in accordance with Regulation (EC) No 258/97 concerning novel foods and novel food ingredients

16 August 2007

24 August 2007

Danuta Stróżyk

PARADA

ul. M. C. Skłodowskiej 91

PL-42-700 Lubliniec

Noni juice (juice of the fruits of Morinda citrifolia)

IZIZ (10) (PL) has delivered an opinion on the substantial equivalence of the Noni juice that is placed on the market by Parada

20 August 2007

4 September 2007

Wojciech Mieszalo

POLFIT Sp. z o.o.

ul. Zeusa 1

PL-01-497 Warszawa

Noni juice (juice of the fruits of Morinda citrifolia)

IRPZ (11) (PL) Opinion about the significant equivalence of ‘Polinesian Noni juice’ with ‘Tahitian Noni®’ authorised by Commission Decision 2003/426/EC

27 August 2007

6 September 2007

Christine Herrmann

Pojektmanagement Beratung

Am Hardtberg 3

D-76593 Gernsbach

Argan oil

The DGCCRF (8) (F) confirmed that the previously issued opinion by Agence francaise de sécurité sanitaire des aliments (AFSSA) (14) was also applicable to the Argan oil placed on the market by Projektmanagement Beratung

29 August 2007

13 September 2007

Doris Maiwald

Argania Gold GmbH

Waldstr. 18

D-55767 Abentheuer

Amin Aouda

Argania Gold SARLAU

Avenue Mouktar Sousi N 299

80352 Dcheira — Inezgane

Marocco

Argan oil

The DGCCRF (8) (F) confirmed that the previously issued opinion by AFSSA (14) was also applicable to the Argan oil placed on the market by Argania Gold

11 September 2007

25 September 2007

Hafid Frigini

Frigini's Kaskade

Feldstr. 14

D-46499 Hamminkeln

Argan oil

The DGCCRF (8) (F) confirmed that the previously issued opinion by AFSSA (14) was also applicable to the Argan oil placed on the market by Frigini's Kaskade

7 September 2007

25 September 2007

Benoit Robinne

Absim France SAS

123 avenue Joseph Kessel

F-78960 Voisins le Bretonneux

Argan oil

The DGCCRF (8) (F) confirmed that the previously issued opinion by AFSSA (14) was also applicable to the Argan oil placed on the market by Absim France

5 September 2007

1 October 2007

Béatrice Petit

S.I.R.H. SA

41, bd de la République

F-76400

Argan oil

The DGCCRF (8) (F) confirmed that the previously issued opinion by AFSSA (14) was also applicable to the Argan oil placed on the market by S.R.H.I. SA

12 October 2007

23 October 2007

Atika El Kaddouri

Noumidia Caftan International

Weinstraße 3

D-4032 Düsseldorf

Argan oil

The DGCCRF (8) (F) confirmed that the previously issued opinion by AFSSA (14) was also applicable to the Argan oil placed on the market by Noumidia Caftan International

15 October 2007

23 October 2007

Gilles Zapke

Arganenoel

Am Tannenstumpf 71a

D-63303 Dreieich-Offenthal

Argan oil

The DGCCRF (8) (F) confirmed that the previously issued opinion by AFSSA (14) was also applicable to the Argan oil placed on the market by Arganenöl

9 October 2007

23 October 2007

Michael Vorderburg

Leap of Faith Farms

Box 94

Conception, Chiriqui

Republic of Panama

Noni juice (juice of the fruits of Morinda citrifolia)

ACNFP (7) (UK) Opinion on Substantial equivalence of Noni juice produced by Leap of Faith Farms considered under Article 5 of the Novel Foods Regulation

15 October 2007

22 October 2007

TNO Quality of Life

Utrechtseweg 48

PO Box 360

3700 AJ Zeist

Nederland

On behalf of: Mitsui Sugar Co Ltd, Japan

Isomaltulose

NFU (9) (NL) Isomaltulose (2) Assessment of substantial equivalence for a notification in accordance with Regulation (EC) No 258/97 concerning novel foods and novel food ingredients

1 November 2007

30 November 2007

P. Stuart

Noni de Tahiti Ltd.

Falkeners House

Rectory Lane

Bramshott

Liphook

Hampshire UKGU30 7QZ

United Kingdom

Noni juice (juice of the fruits of Morinda citrifolia)

FSA (2) (UK) Opinion on the equivalence of ‘Tahitian Noni Juice’ by Noni de Tahiti Ltd

14 November 2007

30 November 2007

Mohammed Hassani

Mogador Naturprodukte

Am Heilbrunnen 47

D-72766 Reutlingen

Argan oil

The DGCCRF (8) (F) confirmed that the previously issued opinion by AFSSA (14) was also applicable to the Argan oil placed on the market by Mogador Naturprodukte

2 November 2007

5 December 2007

Catherine Phin

Alter Eco

36, boulevard de Bastille

F-75012 Paris

Argan oil

The DGCCRF (8) (F) confirmed that the previously issued opinion by AFSSA (14) was also applicable to the Argan oil placed on the market by Alter Eco

22 October 2007

6 December 2007

Chantal Rousseau

Bio Planète

Huilerie F.J. Moog SARL

Route de Limoux

F-11150 Bram

Argan oil

The DGCCRF (8) (F) confirmed that the previously issued opinion by AFSSA (14) was also applicable to the Argan oil placed on the market by Huilerie F.J. Moog SARL

5 November 2007

10 December 2007

100

Jan-Olof Lidefelt

Aarhus Karlshamn Sweden AB

S-374 82 Karlshamn

with added phytosterols.

A portion will not contain more than 3 g (in case of one portion per day) or more than 1 g (in case of 3 portions per day) of added phytosterols/phytostanols.

A container of beverages will not contain more than 3 g of added phytosterols/phytostanols; spicy sauces and salad dressings will be packed as single portions

NFB (3) (FIN) Opinion on substantial equivalence for phytosterol product VIVIDOL® (Aarhus Karlshamn Sweden AB)

3 December 2007

12 December 2007

101

Abdullah Saber

Perle d'Argan

155, Boulevard Léopold II

B-1080 Bruxelles

Argan oil

CSS (12) (B) No 8342 Opinion on the substantial equivalence of Argan oil

17 December 2007

10 January 2008

102

Foscon

On behalf of:

Emsland Stärke GmbH

Emslandstr. 58

D-49428 Emlichheim

Potato protein

BVL (13) (DE) Opinion on the substantial equivalence pursuant to Article 3(4) of Regulation (EC) No 258/97 of the ‘potato protein F7020’ produced by the Foscon company (Haigernstrasse 47, D-74223 Flein) for Emsland-Stärke GmbH, to the ‘coagulated potato proteins’ produced by the firm AVEBE and authorised as novel food ingredients pursuant to Regulation (EC) No 258/97

8 December 2007

18 January 2008

(1) OJ L 43, 14.2.1997, p. 1.

(2)

FSA

Food Standards Agency (UK)

(3)

NFB

Novel Food Board (FIN)

(4)

FSAI

Ford Safety Authority of Ireland (IRL)

(5)

AESA

Agencia Española de Seguridad Alimentaria (ES)

(6)

DSPVNSA

Ministero della Salute — Dipartimento per la sanità pubblica veterinaria, la nutrizione e la sicurezza degli alimenti (I)

(7)

ACNFP

Advisory Committee on Novel Foods and Processes (UK)

(8)

DGCCRF

Direction générale de la concurrence, de la consommation et de la répression des fraudes (F)

(9)

NFU

Novel Foods Unit (NL)

(10)

IZIZ

Instytut Żywności I Żywienia (PL)

(11)

IRPZ

Instytut Roślin i Przetworów Zielarskich (PL)

(12)

CSS

Conseil supérieur de la santé (B)

(13)

BVL

Bundesamt für Verbraucherschutz und Lebensmittelsicherheit (DE)

(14)

AFSSA

Agence française de sécurité sanitaire des aliments (F).

		ISSN 1725-2423
Official Journal of the European Union		C 168

English edition	Information and Notices	Volume 51 3 July 2008

Notice No	Contents	page
	II Information
	INFORMATION FROM EUROPEAN UNION INSTITUTIONS AND BODIES
	Commission
2008/C 168/01	Authorisation for State aid pursuant to Articles 87 and 88 of the EC Treaty — Cases where the Commission raises no objections ( 1 )	1

2008/C 168/02	Communication from the Commission regarding the guideline on the data fields contained in the clinical trials database provided for in Article 11 of Directive 2001/20/EC to be included in the database on medicinal products provided for in Article 57 of Regulation (EC) No 726/2004	3

	V Announcements
	PROCEDURES RELATING TO THE IMPLEMENTATION OF THE COMPETITION POLICY
	Commission
2008/C 168/06	Prior notification of a concentration (Case COMP/M.5109 — Danisco/Abitec) ( 1 )	23

Date of adoption of the decision	20.5.2008
Reference number of the aid	N 537/07
Member State	Finland
Region	—
Title (and/or name of the beneficiary)	Harkinnanvarainen lehdistötuki; Selektivt presstöd
Legal basis	1481/2001 Valtioneuvoston asetus sanomalehdistön tuesta; Statsrådets förordning om stöd för tidningspressen
Type of measure	Aid scheme
Objective	Sectoral development
Form of aid	Direct grant
Budget	Annual budget: EUR 0,5 million
Intensity	40 %
Duration	—
Economic sectors	Media
Name and address of the granting authority	Liikenne- ja viestintäministeriö; Kommunikationsministeriet
Other information	—

	Currency	Exchange rate
USD	US dollar	1,5806
JPY	Japanese yen	168,41
DKK	Danish krone	7,4579
GBP	Pound sterling	0,79520
SEK	Swedish krona	9,4538
CHF	Swiss franc	1,6135
ISK	Iceland króna	123,54
NOK	Norwegian krone	8,0400
BGN	Bulgarian lev	1,9558
CZK	Czech koruna	23,865
EEK	Estonian kroon	15,6466
HUF	Hungarian forint	236,30
LTL	Lithuanian litas	3,4528
LVL	Latvian lats	0,7048
PLN	Polish zloty	3,3575
RON	Romanian leu	3,6359
SKK	Slovak koruna	30,302
TRY	Turkish lira	1,9661
AUD	Australian dollar	1,6438
CAD	Canadian dollar	1,6142
HKD	Hong Kong dollar	12,3267
NZD	New Zealand dollar	2,0833
SGD	Singapore dollar	2,1531
KRW	South Korean won	1 640,66
ZAR	South African rand	12,4020
CNY	Chinese yuan renminbi	10,8319
HRK	Croatian kuna	7,2399
IDR	Indonesian rupiah	14 565,23
MYR	Malaysian ringgit	5,1749
PHP	Philippine peso	71,340
RUB	Russian rouble	37,0330
THB	Thai baht	52,800
BRL	Brazilian real	2,5231
MXN	Mexican peso	16,3900

	IV Notices
	NOTICES FROM EUROPEAN UNION INSTITUTIONS AND BODIES
	Commission
2008/C 168/03	Euro exchange rates	5

	NOTICES FROM MEMBER STATES
2008/C 168/04	Information communicated by Member States regarding State aid granted under Commission Regulation (EC) No 1857/2006 on the application of Articles 87 and 88 of the EC Treaty to State aid to small and medium-sized enterprises active in the production of agricultural products and amending Regulation (EC) No 70/2001	6

2008/C 168/05	Summary of notifications received in 2007 by the Commission pursuant to Article 5 of Regulation (EC) No 258/97 of the European Parliament and of the Council	10


	(1) Text with EEA relevance