15.6.2007

EN

Official Journal of the European Union

L 155/1

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COMMISSION REGULATION (EC) No 655/2007

of 14 June 2007

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

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Commission Regulation (EC) No 3223/94 of 21 December 1994 on detailed rules for the application of the import arrangements for fruit and vegetables (1), and in particular Article 4(1) thereof,

Whereas:

(1)	Regulation (EC) No 3223/94 lays down, pursuant to the outcome of the Uruguay Round multilateral trade negotiations, the criteria whereby the Commission fixes the standard values for imports from third countries, in respect of the products and periods stipulated in the Annex thereto.

(2)	In compliance with the above criteria, the standard import values must be fixed at the levels set out in the Annex to this Regulation,

HAS ADOPTED THIS REGULATION:

Article 1

The standard import values referred to in Article 4 of Regulation (EC) No 3223/94 shall be fixed as indicated in the Annex hereto.

Article 2

This Regulation shall enter into force on 15 June 2007.

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(1)  OJ L 337, 24.12.1994, p. 66. Regulation as last amended by Regulation (EC) No 386/2005 (OJ L 62, 9.3.2005, p. 3).

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15.6.2007

EN

Official Journal of the European Union

L 155/3

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COMMISSION REGULATION (EC) No 656/2007

of 14 June 2007

amending Regulation (EC) No 586/2001 on implementing Council Regulation (EC) No 1165/98 concerning short-term statistics as regards the definition of main industrial groupings (MIGS)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Council Regulation (EC) No 1165/98 of 19 May 1998 concerning short-term statistics (1), and in particular Article 3 and Article 17(c) thereof,

Whereas:

(1)	The definition of main industrial groupings (MIGS) laid down in Commission Regulation (EC) No 586/2001 (2) is based on the statistical classification of economic activities in the European Community (NACE) (3).

(2)	A new version of NACE (NACE Rev. 2) was introduced by Regulation (EC) No 1893/2006, which also specifies that short-term statistics governed by Regulation (EC) No 1165/98 shall be produced in accordance with NACE Rev. 2 from 1 January 2009 onwards.

(3)	The measures provided for in this Regulation are in accordance with the opinion of the Statistical Programme Committee,

HAS ADOPTED THIS REGULATION:

Article 1

Regulation (EC) No 586/2001 is amended as follows:

1.	in Articles 1 and 2 all references to ‘NACE Rev. 1’ are replaced by ‘NACE Rev. 2’;

2.	in Article 3 ‘not later than three months after the present Regulation enters into force’ is replaced by ‘as from 1 January 2009’;

3.	the Annex is replaced by the text in the Annex to this Regulation.

Article 2

This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union.

It shall apply as from 1 January 2009.

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(1)  OJ L 162, 5.6.1998, p. 1. Regulation as last amended by Regulation (EC) No 1893/2006 of the European Parliament and of the Council (OJ L 393, 30.12.2006, p. 1).

(2)  OJ L 86, 27.3.2001, p. 11.

(3)  OJ L 293, 24.10.1990, p. 1.

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15.6.2007

EN

Official Journal of the European Union

L 155/7

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COMMISSION REGULATION (EC) No 657/2007

of 14 June 2007

implementing Council Regulation (EC) No 1165/98 concerning short-term statistics as regards the establishment of European sample schemes

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Council Regulation (EC) No 1165/98 of 19 May 1998 concerning short-term statistics (1), and in particular Article 17(j) thereof,

Whereas:

(1)	Regulation (EC) No 1165/98 established a common framework for the production of short-term Community statistics on the business cycle.

(2)

Regulation (EC) No 1158/2005 of the European Parliament and of the Council of 6 July 2005 amending Council Regulation (EC) No 1165/98 concerning short-term statistics (2) imposed an obligation on Member States to supply a new indicator (import prices in the industry sector) and to transmit data on non-domestic indicators according to the distinction into euro area and non-euro-area. As a consequence, substantial costs could have been created for national statistical systems.

(3)

Regulation (EC) No 1158/2005 introduced the possibility of establishing European sample schemes in order to reduce the costs for national statistical systems, to ensure that European data requirements are met and to enable the Commission (Eurostat) to produce credible European estimates for the indicators concerned.

(4)	The measures provided for in this Regulation are in accordance with the opinion of the Statistical Programme Committee,

HAS ADOPTED THIS REGULATION:

Article 1

European sample schemes may be applied when compiling statistics that distinguish between the euro area and non-euro-area for the following three variables specified in Annex A to Regulation (EC) No 1165/98:

Variable	Name
132	Non-domestic new orders
312	Output prices of the non-domestic market
340	Import prices

Article 2

Member States participating in the European sample scheme referred to in Article 1 shall transmit data to the Commission (Eurostat) for at least the NACE Rev. 1.1 activities, for variables Nos 132 and 312, and CPA products, for variable No 340, specified in the Annex.

Article 3

Member States participating in the European sample scheme for variable No 340 may limit the scope of the transmitted data for that variable to the import of products from non-euro-area countries.

Article 4

The terms of the European sample schemes set out in the Annex may be adapted to changes of the base year or of the classification system or to important structural changes in the euro area.

Article 5

Each new member of the euro area may enter any of the European sample schemes referred to in Article 1 upon joining the euro area. The Commission, after consultation with the Member State concerned, shall specify the NACE activities and CPA products for which data are to be transmitted, in order for that Member State to comply with Regulation (EC) No 1165/98 in the framework of the European sample schemes.

Article 6

This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union.

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(1)  OJ L 162, 5.6.1998, p. 1. Regulation as last amended by Regulation (EC) No 1893/2006 of the European Parliament and of the Council (OJ L 393, 30.12.2006, p. 1).

(2)  OJ L 191, 22.7.2005, p. 1.

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15.6.2007

EN

Official Journal of the European Union

L 155/10

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COMMISSION REGULATION (EC) No 658/2007

of 14 June 2007

concerning financial penalties for infringement of certain obligations in connection with marketing authorisations granted under Regulation (EC) No 726/2004 of the European Parliament and of the Council

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (1), and in particular the first subparagraph of Article 84(3) thereof,

Whereas:

(1)

In order to ensure the enforcement of certain obligations connected with marketing authorisations for medicinal products granted in accordance with Regulation (EC) No 726/2004, Article 84 of that Regulation empowers the Commission, at the request of the European Medicines Agency, hereinafter ‘the Agency’, to impose financial penalties on the holders of marketing authorisations.

(2)

Infringements of obligations laid down in connection with marketing authorisations granted in accordance with Regulation (EC) No 726/2004 which may lead to the application of a financial penalty should concern the content of a marketing authorisation and post-marketing requirements linked to a marketing authorisation, including the requirements of Community law relating to pharmacovigilance and market surveillance.

(3)

Moreover, in view of the provision made by Article 84(1) of Regulation (EC) No 726/2004, under which the Member States are to determine the penalties to be applied for infringement of the provisions of that Regulation or the Regulations adopted pursuant to it and to take the necessary measures for their implementation, action at Community level should be taken only in cases where the interests of the Community are involved. In that way, the effective enforcement of Regulation (EC) No 726/2004 would be ensured by an appropriate management of the resources available at Community and national level.

(4)

As a result of the system of parallel powers in relation to supervision and enforcement by the Community and the Member States with regard to marketing authorisations granted in accordance with Regulation (EC) No 726/2004, the provisions of this Regulation can be effectively enforced only in a framework of close cooperation, in accordance with Article 10 of the Treaty, between the Member States, the Agency and the Commission. For that purpose it is necessary to set up arrangements for consultation and cooperation between them.

(5)

It is appropriate that, for the purposes of the initiation and conduct of the infringement procedure and the quantification of financial penalties, the Agency and the Commission should take into account any procedure by a Member State against the same marketing authorisation holder and based on the same legal grounds and the same facts.

(6)

In order to ensure the effective conduct of the inquiry stage of alleged infringements, the Agency and the Commission should have recourse to the competent authorities of the Member States, designated as the supervisory authorities of medicinal products authorised through the centralised procedure by Regulation (EC) No 726/2004, to carry out the necessary measures of inquiry and to obtain information relating to infringements falling within the scope of this Regulation. To that end, it is appropriate that the supervisory authorities conduct the inspection and surveillance activities for which they are competent in accordance with the provisions of Regulation (EC) No 726/2004, Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products (2) and Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (3) and their implementing provisions.

(7)

The obligations connected with marketing authorisations granted in accordance with Regulation (EC) No 726/2004 falling within the scope of this Regulation should be enforceable by means of two types of financial penalties: fines and periodic penalty payments. Maximum amounts for both categories should be established.

(8)

The decision to initiate an infringement procedure under this Regulation should be taken by the Agency, which should first inform the Commission and the Member States. In the course of an inquiry, the Agency should be empowered to require such information to be supplied as is necessary to detect any infringement. It should also be able to rely on the cooperation of national competent authorities. Any supervisory powers entrusted to the Agency by Community law as regards marketing authorisations for medicinal products granted in accordance with Regulation (EC) No 726/2004 may be used by it in the course of the investigation of an infringement.

(9)

The decisions by the Commission imposing penalties should be based on the inquiry by the Agency, the observations of the marketing authorisation holder subject to the infringement procedure and, where appropriate, other information submitted to it. Any supervisory powers entrusted to the Commission by Community law as regards marketing authorisations for medicinal products granted in accordance with Regulation (EC) No 726/2004 may be used by it in the course of the decision-making stage of an infringement procedure.

(10)	It is appropriate that decisions imposing penalties be based exclusively on objections on which the marketing authorisation holder concerned has been able to comment.

(11)	The penalties imposed should be effective, proportionate and dissuasive, having regard to the circumstances of the specific case.

(12)	It appears appropriate to provide for a specific procedure in cases where the Commission intends to impose a fine for failure by a marketing authorisation holder subject to an infringement procedure to comply with a request for information from the Agency or the Commission.

(13)

When carrying out an infringement procedure, the Agency and the Commission must ensure the respect of the rights of defence and of the principle of confidentiality in accordance with the general principles of law, and the case-law of the Court of Justice of the European Communities. In particular, the marketing authorisation holder subject to the infringement procedure should have the right to be heard by the Agency during the inquiry stage and by the Commission once it has been notified a statement of objections, as well as to access the file compiled by the Agency and the Commission. While the Commission should be entitled to compel marketing authorisation holders to provide the necessary information and documents relating to a presumed infringement, the right to silence in situations where the holder would be compelled to provide answers which may involve an admission on its part of the existence of an infringement, as developed by the Court of Justice, should also be respected.

(14)	For the purposes of ensuring legal certainty in the conduct of the infringement procedure, it is necessary to lay down detailed rules for the computation of time-limits and limitation periods for the imposition and enforcement of penalties.

(15)	Decisions imposing penalties are to be enforced in accordance with Article 256 of the Treaty and are subject to review by the Court of Justice.

(16)	This Regulation respects the fundamental rights and observes the principles recognised in particular by the Charter of Fundamental Rights of the European Union.

(17)	The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee for Medicinal Products for Human Use and the Standing Committee for Veterinary Medicinal Products,

HAS ADOPTED THIS REGULATION:

CHAPTER I

GENERAL PROVISIONS

Article 1

Subject-matter and scope

This Regulation lays down rules concerning the application of financial penalties to the holders of marketing authorisations, granted under Regulation (EC) No 726/2004, in respect of infringements of the following obligations, in cases where the infringement concerned may have significant public health implications in the Community, or where it has a Community dimension by taking place or having its effects in more than one Member State, or where interests of the Community are involved:

1.

the completeness and the accuracy of the particulars and documents contained in an application for marketing authorisation under Regulation (EC) No 726/2004, or of any other documents and data submitted to the European Medicines Agency established by that Regulation, hereinafter ‘the Agency’, in response to obligations laid down in that Regulation;

2.	conditions or restrictions included in the market authorisation and concerning the supply or use of the medicinal product, as referred to in Article 9(4)(b), the second subparagraph of Article 10(1), Article 34(4)(c) and the second subparagraph of Article 35(1) of Regulation (EC) No 726/2004;

3.	conditions or restrictions included in the marketing authorisation with regard to the safe and effective use of the medicinal product, as referred to in Article 9(4)(c), Article 10(1), Article 34(4)(d) and Article 35(1) of Regulation (EC) No 726/2004;

4.

the introduction of any necessary variations to the terms of the marketing authorisation to take account of technical and scientific progress and enable the medicinal products to be manufactured and checked by means of generally accepted scientific methods, as referred to in Article 16(1) and Article 41(1) of Regulation (EC) No 726/2004;

5.

the supply of any new information which may entail a variation to the terms of the marketing authorisation, the notification of any prohibition or restriction imposed by the competent authorities of any country in which the medicinal product is marketed, or the supply of any information that may influence the evaluation of the risks and benefits of the product, as referred to in Article 16(2) and Article 41(4) of Regulation (EC) No 726/2004;

6.	the supply at the request of the Agency of any data demonstrating that the risk-benefit balance remains favourable, as referred to in Article 16(2) and Article 41(4) of Regulation (EC) No 726/2004;

7.	the detection of residues in the case of veterinary medicinal products, as referred to in Article 41(2) and (3) of Regulation (EC) No 726/2004;

8.	placing on the market in accordance with the content of the summary of the product characteristics and the labelling and package leaflet as contained in the marketing authorisation;

9.	the specific obligations referred to in Article 14(7) of Regulation (EC) No 726/2004 or in any other provisions adopted pursuant thereto;

10.	the specific procedures referred to in Article 14(8) and Article 39(7) of Regulation (EC) No 726/2004;

11.

notification to the Agency of the dates of actual marketing and of the date when the product ceases to be on the market, and provision to the Agency of data relating to the volume of sales and the volume of prescriptions of the product, as referred to in Article 13(4) and Article 38(4) of Regulation (EC) No 726/2004;

12.	the appropriately qualified person responsible for pharmacovigilance, as referred to in Article 23 and Article 48 of Regulation (EC) No 726/2004;

13.	recording and reporting of suspected serious adverse reactions and, in the case of veterinary medicinal products, human adverse reactions, as referred to in Article 24(1) and Article 49(1) of Regulation (EC) No 726/2004;

14.	reporting of suspected serious unexpected adverse reactions, suspected transmission of infectious agents and, in the case of veterinary medicinal products, human adverse reactions, as referred to in Article 24(2) and Article 49(2) of Regulation (EC) No 726/2004;

15.	detailed recording of all suspected adverse reactions and submission of such records in the form of periodic safety update reports, as referred to in Article 24(3) and Article 49(3) of Regulation (EC) No 726/2004;

16.	communication of information relating to pharmacovigilance concerns to the general public, as referred to in Article 24(5) and Article 49(5) of Regulation (EC) No 726/2004;

17.	collation and assessment of specific pharmacovigilance data, as referred to in the fourth paragraph of Article 26 and the fourth paragraph of Article 51 of Regulation (EC) No 726/2004.

Article 2

Complementarity of procedures

For the purposes of the initiation and conduct of the infringement procedure provided for in Chapter II, the Agency and the Commission shall take into account any infringement procedure by a Member State against the same marketing authorisation holder and based on the same legal grounds and the same facts.

Article 3

Cooperation by the competent authorities of the Member States

1.   The competent authorities of the Member States shall cooperate with the Agency and the Commission to enable them to carry out their duties under this Regulation.

2.   Information provided by the national competent authorities in response to a request from the Agency or the Commission under this Regulation shall be used by the Agency and the Commission only for the following purposes:

(a)	as evidence for the purposes of applying this Regulation;

(b)	for carrying out the tasks entrusted to them for the authorisation and supervision of medicinal products under Regulation (EC) No 726/2004.

Article 4

Burden of proof

In any infringement procedure under this Regulation, the burden of proving an infringement shall rest on the Commission.

CHAPTER II

INFRINGEMENT PROCEDURE

SECTION 1

Inquiry

Subsection 1

Initiation of procedure

Article 5

Initiation of the infringement procedure

1.   The Agency may initiate the infringement procedure on its own initiative or following a request from the Commission or a Member State.

The Agency shall inform the Commission that it intends to initiate the infringement procedure.

2.   The Agency shall initiate the infringement procedure only after informing the Member States.

Article 6

Request for information

Prior to initiating an infringement procedure, the Agency may request from the marketing authorisation holder concerned any information relating to the alleged infringement.

The Agency shall state the purpose of the request and the fact that it is made under this Regulation, and indicate a time-limit for the submission of the reply by the marketing authorisation holder, which shall be at least four weeks.

Where the request is in response to a request from a Member State under Article 5(1), that Member State shall be informed by the Agency.

Article 7

Notification

The Agency shall send written notification of the initiation of an infringement procedure to the marketing authorisation holder concerned, to the Member States and to the Commission.

The notification shall set out the allegations against the marketing authorisation holder, specifying the provision allegedly infringed, and the evidence on which those allegations are founded.

It shall give notice to the marketing authorisation holder that fines or periodic penalty payments may be imposed.

Subsection 2

Measures of inquiry

Article 8

Requests by the Agency

1.   The Agency may request the marketing authorisation holder to provide written or oral explanations, or particulars or documents.

Requests shall be addressed in writing to the marketing authorisation holder. The Agency shall state the legal basis and the purpose of the request, fix a time-limit by which the information is to be provided, which shall be at least four weeks, and inform the marketing authorisation holder of the fines provided for in Article 19(1)(a) and (b) for failing to comply with the request or for supplying incorrect or misleading information.

2.   The Agency may request national competent authorities to cooperate in the investigation in the following ways:

(a)	by performing any of the tasks entrusted to the supervisory authorities by Articles 19(1) and 44(1) of Regulation (EC) No 726/2004;

(b)	by performing inspections or other supervisory measures in accordance with Articles 111 to 115 of Directive 2001/83/EC and Articles 80, 81 and 82 of Directive 2001/82/EC.

Requests shall be addressed in writing and shall state the legal basis and the purpose of the request. The time-limit for the submission of the reply or the conduct of the measure of inquiry shall be determined by agreement between the Agency and the national competent authority to which the request is addressed, having regard to the specific circumstances of the case.

3.   The Agency may ask any natural or legal persons to provide information relating to the alleged infringement.

Requests shall be addressed in writing and shall state the legal basis and the purpose of the request, and shall fix a time-limit by which the information should be provided, which shall be at least four weeks.

Article 9

Right to be heard

Before adoption of the report provided for in Article 10, the Agency shall invite the marketing authorisation holder to submit written observations.

It shall do so in writing, indicating a time-limit for the submission of those observations, which shall be at least four weeks.

Subsection 3

Report

Article 10

Content and time-limits

1.   The Agency shall provide the Commission, the Member States and the marketing authorisation holder with a report summarising its findings in the light of the inquiry carried out in accordance with this Section.

2.   Where the Agency considers that the marketing authorisation holder has committed an infringement as referred to in Article 1, the report shall also include an assessment of the circumstances of the specific case in accordance with the criteria set out in Article 18(2) and a request to the Commission for application of financial penalties.

3.   The Agency shall adopt its report no later than 18 months after notification of initiation of the procedure in accordance with Article 7 or one year after notification by the Commission of the return of the file in accordance with Article 15.

SECTION 2

Decision-making stage

Subsection 1

Procedure

Article 11

Statement of objections

1.   Where, following a request from the Agency pursuant to Article 10(2), the Commission decides to continue with the infringement procedure, it shall notify in writing to the marketing authorisation holder a statement of objections containing the following:

(a)	the allegations against the marketing authorisation holder, including a precise indication of which provision has allegedly been infringed, and the evidence on which those allegations are founded;

(b)	notice that fines or periodic penalty payments may be imposed.

2.   Where, within 18 months of receiving the request from the Agency, the Commission has not notified a statement of objections, it shall provide the marketing authorisation holder with an explanatory statement.

Article 12

Right to reply

1.   When notifying the statement of objections, the Commission shall set a time-limit within which the marketing authorisation holder may submit to the Commission his written observations on the statement of objections.

That time-limit shall be at least four weeks.

The Commission shall not be obliged to take into account written observations received after the expiry of that time-limit.

2.   The marketing authorisation holder may annex to his written observations, statements from other persons who may corroborate any aspect of those written observations.

Article 13

Oral hearing

1.   Where the marketing authorisation holder so requests in his written observations, the Commission shall give him an opportunity to develop his arguments at an oral hearing.

The date for the oral hearing shall be set by the Commission.

2.   Where necessary, the Commission may invite the national competent authorities or any other persons to take part in the oral hearing.

3.   The oral hearing shall not be public. Each person may be heard separately or in the presence of other persons invited to attend, having regard to the legitimate interest of marketing authorisation holders and other persons in the protection of their business secrets and other confidential information.

Article 14

Requests for information

1.   After receipt of a request from the Agency pursuant to Article 10(2) and before adoption of the decision referred to in Article 16, the Commission may at any time request the marketing authorisation holder to provide written or oral explanations, or particulars or documents, relating to the alleged infringement.

Requests shall be addressed in writing to the marketing authorisation holder. The Commission shall state the legal basis and the purpose of the request, fix a time-limit by which the information is to be provided, which shall be at least four weeks, and inform the marketing authorisation holder of the fines provided for in Article 19(1)(c) and (d) for failing to comply with the request or supplying incorrect or misleading information.

2.   The Commission may request the Agency, the national competent authorities or any other natural or legal persons to provide information relating to the alleged infringement.

Requests shall be addressed in writing and shall state the legal basis and the purpose of the request. Where the request is addressed to the Agency or a national competent authority, the time-limit by which the information is to be provided shall be determined by the Commission after consultation of the Agency or the national competent authority to which the request is addressed, having regard to the specific circumstances of the case. Where the request is addressed to other natural or legal persons, it shall fix a time-limit by which the information is to be provided, which shall be at least four weeks.

Article 15

New period of inquiry

1.   Where, having regard to the report of the Agency, the observations of the marketing authorisation holder and, as the case may be, other information submitted to it, the Commission considers that additional information is needed in order to continue the procedure, it may return the case-file to the Agency for a new period of inquiry.

The Commission shall clearly indicate to the Agency the points of fact which it should further examine and, if appropriate, suggest possible measures of inquiry to that effect.

2.   Subsections 2 and 3 of Section 1 shall apply to the conduct of the new period of inquiry.

Subsection 2

Decision and financial penalties

Article 16

Forms of financial penalty and maximum amounts

1.   Where, following the procedure provided for in Subsection 1, the Commission finds that the marketing authorisation holder has committed, intentionally or negligently, an infringement as referred to in Article 1, it may adopt a decision imposing a fine not exceeding 5 % of the holder’s Community turnover in the preceding business year.

2.   Where the marketing authorisation holder has not terminated the infringement, the Commission may, in the decision referred to in paragraph 1, impose periodic penalty payments per day not exceeding 2,5 % of the holder’s average daily Community turnover in the preceding business year.

Periodic penalty payments may be imposed for a period running from the date of notification of that decision until the infringement has been brought to an end.

3.   For the purposes of paragraphs 1 and 2, the preceding business year refers to the business year preceding the date of the decision referred to in paragraph 1.

Article 17

Decision

1.   The decision provided for in Article 16 shall be based exclusively on grounds on which the marketing authorisation holder has been able to comment.

2.   The Commission shall inform the marketing authorisation holder of the judicial remedies available.

3.   The Commission shall communicate the adoption of the decision to the Agency and to the Member States.

4.   When publishing details of its decision in accordance with the second subparagraph of Article 84(3) of Regulation (EC) No 726/2004, the Commission shall have regard to the legitimate interest of marketing authorisation holders and other persons in the protection of their business secrets.

Article 18

Principles governing the application and quantification of financial penalties

1.   In determining whether to impose a financial penalty and in determining the appropriate financial penalty, the Commission shall be guided by the principles of effectiveness, proportionality and dissuasiveness.

2.   In each case, the Commission shall take into consideration, where relevant, the following circumstances:

(a)

the seriousness and the effects of the infringement, and, in particular, the following: (i) the way in which the infringement adversely affects the rights, safety or well-being of patients; (ii) its effects on animal health and welfare and the impact on animal owners; (iii) whether it poses or could pose a risk to public health, animal health or the environment; (iv) the gravity of the infringement in relation to public health, animal health and the environment;

(b)

on the one hand, the good faith of the marketing authorisation holder in the interpretation and fulfilment of the obligations connected with marketing authorisations granted in accordance with Regulation (EC) No 726/2004 or, on the other hand, any evidence of wilful deceit on the part of the marketing authorisation holder;

(c)

on the one hand, the degree of diligence and cooperation shown by the marketing authorisation holder in the detection of the infringement and the application of corrective action, or during the course of the infringement procedure or, on the other hand, any obstruction by the marketing authorisation holder of the detection of an infringement and the conduct of an infringement procedure, or any non-compliance by the marketing authorisation holder with requests made by the Agency, the Commission or a national competent authority in application of this Regulation;

(d)	the turnover of the medicinal product concerned;

(e)	the need to adopt provisional measures by the Commission or urgent action by a Member State in accordance with Articles 20 or 45 of Regulation (EC) No 726/2004 as a result of an infringement;

(f)	the repetition, frequency or duration of the infringement by that marketing authorisation holder;

(g)	prior sanctions, including penalties, imposed on the same marketing authorisation holder.

3.   In determining the amount of the financial penalty, the Commission shall take into account any penalties already imposed on the marketing authorisation holder at national level on the basis of the same legal grounds and the same facts.

SECTION 3

Non-cooperation

Article 19

Financial penalties

1.   The Commission may by decision impose on marketing authorisation holders fines not exceeding 0,5 % of their Community turnover in the preceding business year where, intentionally or negligently:

(a)	they do not comply with a measure of inquiry adopted pursuant to Article 8(1);

(b)	they supply incorrect or misleading information in response to a measure of inquiry adopted pursuant to Article 8(1);

(c)	they do not comply with a request for information pursuant to Article 14;

(d)	they supply incorrect or misleading information in response to a request for information pursuant to Article 14.

2.   Where the non-cooperation of the marketing authorisation holder continues, the Commission may, in the decision referred to in paragraph 1, impose periodic penalty payments per day not exceeding 0,5 % of the holder’s average daily Community turnover in the preceding business year.

Periodic penalty payments may be imposed for a period running from the date of notification of that decision until the non-cooperation has ceased.

3.   For the purposes of paragraphs 1 and 2, the preceding business year refers to the business year preceding the date of the decision referred to in paragraph 1.

Article 20

Procedure

When the Commission intends to adopt a decision as referred to in Article 19(1), it shall first notify in writing the marketing authorisation holder, setting a time-limit within which the marketing authorisation holder may submit to the Commission his written observations. That time-limit shall be at least four weeks.

The Commission shall not be obliged to take into account written observations received after the expiry of that time-limit.

CHAPTER III

ACCESS TO THE FILE, REPRESENTATION, CONFIDENTIALITY AND TEMPORAL PROVISIONS

Article 21

Access to the file

Following notification under Article 7, the marketing authorisation holder shall have the right, on request, to access the documents and other materials compiled by the Agency and the Commission which serve as evidence of an alleged infringement.

Documents obtained through access to the file shall be used only for the purposes of judicial or administrative proceedings for the application of this Regulation.

Article 22

Legal representation

The marketing authorisation holder shall have the right to legal representation during the infringement procedure.

Article 23

Confidentiality and professional secrecy

1.   Without prejudice to the exchange and to the use of information foreseen in Article 3, an infringement procedure shall be carried out subject to the principles of confidentiality and of professional secrecy. The Agency and the Commission, their officials, servants and other persons working under their supervision shall not disclose information acquired or exchanged by them pursuant to this Regulation and of the kind covered by the obligation of professional secrecy and confidentiality.

2.   Without prejudice to the right to access the case-file, the marketing authorisation holder shall not have access to business secrets, confidential information or internal documents held by the Agency, the Commission or a Member State.

3.   Any person who submits information or observations pursuant to Articles 8, 9, 12 or 14 shall clearly identify any material considered to be confidential, giving reasons, and provide a separate non-confidential version by the date set by the Agency or the Commission.

4.   Without prejudice to paragraph 3, the Agency and the Commission may require persons who submit information or observations pursuant to this Regulation to identify the documents or parts of documents which they consider to contain business secrets or other confidential information belonging to them.

The Agency and the Commission may also require marketing authorisation holders and other persons to identify any part of a report by the Agency, of a statement of objections or of a decision adopted by the Commission which in their view contains business secrets.

The Agency and Commission may set a time-limit within which the marketing authorisation holder and other persons are to:

(a)	substantiate their claim for confidentiality with regard to each individual document or part of document;

(b)	provide the Commission with a non-confidential version of the documents, in which the confidential passages are deleted;

(c)	provide a concise description of each piece of deleted information.

The time-limit referred to in the third subparagraph shall be at least two weeks.

5.   If the marketing authorisation holder or other persons fail to comply with paragraphs 3 and 4, the Commission may assume that the information or observations concerned do not contain confidential information.

Article 24

Application of time-limits

1.   The time-limits laid down in this Regulation shall run from the day following receipt of a communication or delivery thereof by hand.

In the case of a communication from the marketing authorisation holder, it shall be sufficient for the purposes of the relevant time-limits for the communication to have been dispatched by registered post before the relevant time-limit has expired.

2.   Where the time-limit falls to expire on a Saturday, Sunday or public holiday, it shall be extended up to the end of the following working day.

3.   In setting the time-limits provided for in Articles 6, 8(1), 12(1) and 14(1), the Agency and the Commission, as the case may be, shall have regard both to the time required for preparation of the submission and to the urgency of the case.

4.   Where appropriate and upon reasoned request made before the expiry of the original time-limit, time-limits may be extended.

Article 25

Limitation periods for the imposition of financial penalties

1.   The right of the Commission to adopt a decision imposing a financial penalty pursuant to Article 16 shall expire after five years.

In the case of the financial penalties provided for in Article 19, the right of the Commission to adopt a decision imposing such a penalty shall expire after three years.

Time shall begin to run on the day on which the infringement is committed. However, in the case of continuing or repeated infringements, time shall begin to run on the day on which the infringement ceases.

2.   Any action taken by the Agency or the Commission for the purpose of the investigation or infringement procedure shall interrupt the limitation periods laid down in paragraph 1. The limitation period shall be interrupted with effect from the date on which the action is notified to the marketing authorisation holder.

3.   Each interruption shall start time running afresh. However, the limitation period shall expire at the latest on the day on which a period equal to twice the limitation period has elapsed without the Commission having imposed a financial penalty. The period shall be extended by the time during which limitation is suspended pursuant to paragraph 4.

4.   The limitation period for the imposition of financial penalties shall be suspended for as long as the decision of the Commission is the subject of proceedings pending before the Court of Justice of the European Communities.

Article 26

Limitation periods for the collection of financial penalties

1.   The right to start a recovery procedure shall expire one year after the decision pursuant to Article 16 or Article 19 has become final.

2.   The limitation period for the recovery of financial penalties shall be interrupted by any action of the Commission or of a Member State, acting at the request of the Commission, designed to enforce payment of the penalty.

3.   Each interruption shall start time running afresh.

4.   The limitation period for the recovery of financial penalties shall be suspended for so long as:

(a)	time to pay is allowed;

(b)	enforcement of payment is suspended pursuant to a decision of the Court of Justice of the European Communities.

CHAPTER IV

FINAL PROVISIONS

Article 27

Transitional provision

In the case of infringements which began before its entry into force, this Regulation shall apply to the part of the infringement which takes place after that date.

Article 28

Entry into force

This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union.

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(1)  OJ L 136, 30.4.2004, p. 1. Regulation as amended by Regulation (EC) No 1901/2006 (OJ L 378, 27.12.2006, p. 1).

(2)  OJ L 311, 28.11.2001, p. 1. Directive as amended by Directive 2004/28/EC (OJ L 136, 30.4.2004, p. 58).

(3)  OJ L 311, 28.11.2001, p. 67. Directive as last amended by Regulation (EC) No 1901/2006.

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15.6.2007

EN

Official Journal of the European Union

L 155/20

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COMMISSION REGULATION (EC) No 659/2007

of 14 June 2007

opening and providing for the administration of import tariff quotas for bulls, cows and heifers other than for slaughter of certain Alpine and mountain breeds

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Council Regulation (EC) No 1254/1999 of 17 May 1999 on the common organisation of the market in beef and veal (1), and in particular the first subparagraph of Article 32(1) thereof,

Whereas,

(1)	In the framework of the World Trade Organisation, the Community has undertaken to open annual import tariff quotas for bulls, cows and heifers other than for slaughter of certain Alpine and mountain breeds.

(2)	It is necessary to lay down detailed rules for the opening and administration of these import tariff quotas every year for the period from 1 July to 30 June of the following year.

(3)

Pursuant to Article 29(1) of Regulation (EC) No 1254/1999, imports into the Community should be subject to import licences. However, it is appropriate to manage these import tariff quotas by attributing import rights as a first step and issuing import licences as a second, as provided for in Article 6(3) of Commission Regulation (EC) No 1301/2006 of 31 August 2006 laying down common rules for the administration of import tariff quotas for agricultural products managed by a system of import licences (2). In this way, operators that have obtained import rights should be able to decide, during the course of the import tariff quota period, the moment when they wish to apply for import licences, taking into account their actual trade flows. In any case, Regulation (EC) No 1301/2006 limits the period of validity of licences to the last day of the import tariff quota period.

(4)

Rules should be laid down on the submission of applications and the information to be given in the applications and licences, where necessary in addition to or by way of derogation from certain provisions of Commission Regulation (EC) No 1445/95 of 26 June 1995 on rules of application for import and export licences in the beef and veal sector and repealing Regulation (EEC) No 2377/80 (3) and Commission Regulation (EC) No 1291/2000 of 9 June 2000 laying down common detailed rules for the application of the system of import and export licences and advance fixing certificates for agricultural products (4).

(5)

Regulation (EC) No 1301/2006 lays down in particular detailed provisions on the applications for import rights, the status of applicants and the issue of import licences. The provisions of that Regulation should apply, from 1 July 2007, to import licences issued pursuant to this Regulation, without prejudice to additional conditions laid down in this Regulation.

(6)

In order to prevent speculation, the quantities available within the import tariff quotas should be made accessible to operators which are able to show that they are genuinely engaged in import on a significant scale from third countries. Therefore, in order to ensure efficient management, the traders concerned should be required to have imported a minimum of 25 animals during each of the two reference periods referred to in Article 5 of Regulation (EC) No 1301/2006, provided that a consignment of 25 animals may be considered to be a commercially viable consignment. Moreover, for administrative reasons, Member States should be allowed to accept certified copies of the documents proving the existence of trade with third countries.

(7)	In addition, a security should be fixed for import rights. Import licences should not be transferable and licences should be issued to traders solely for the quantities for which they have been allocated import rights.

(8)

In order to oblige operators to apply for import licences for all import rights allocated, submission of the licence application for the quantities allocated should constitute, with regard to the import rights security, a primary requirement within the meaning of Commission Regulation (EEC) No 2220/85 of 22 July 1985 laying down common detailed rules for the application of the system of securities for agricultural products (5).

(9)

Article 82 of Council Regulation (EEC) No 2913/92 of 12 October 1992 establishing the Community Customs Code (6) provides for customs supervision of goods released for free circulation at a reduced rate of duty on account of their end-use. The animals imported under the import tariff quotas provided for in this Regulation should be monitored for a certain period in order to ensure that they are not slaughtered during that period.

(10)	To this end, a security should be lodged, the amount of which should cover the difference between the Common Customs Tariff duty and the reduced duty applicable on the date of release for free circulation of animals in question.

(11)

For the sake of clarity, Commission Regulation (EC) No 1081/1999 of 26 May 1999 opening and providing for the administration of tariff quotas for imports of bulls, cows and heifers other than for slaughter of certain Alpine and mountain breeds, repealing Regulation (EC) No 1012/98 and amending Regulation (EC) No 1143/98 (7), should therefore be repealed and replaced by a new Regulation as of 1 July 2007.

(12)	The measures provided for in this Regulation are in accordance with the opinion of the Management Committee for Beef and Veal,

HAS ADOPTED THIS REGULATION:

Article 1

The import tariff quotas for bulls, cows and heifers other than for slaughter of certain Alpine and mountain breeds referred to in Annex I are hereby opened every year for the period from 1 July to 30 June of the following year (import tariff quota periods).

The tariff quotas shall have order numbers 09.4196 and 09.4197.

Article 2

1.   For the purposes of this Regulation, animals as referred to in Article 1 shall be other than for slaughter where they are not slaughtered within four months of the date of acceptance of the declaration of release for free circulation.

Derogations may be granted in duly proven cases of force majeure.

2.   To qualify under the import tariff quota covered by order number 09.4197, the following documents must be presented:

(a)	for bulls: a pedigree certificate,

(b)	for cows and heifers: a pedigree certificate or a certificate of registration in a herdbook certifying the purity of the breed.

Article 3

1.   The import tariff quotas referred to in Annex I shall be managed by attributing import rights as a first step and issuing import licences as a second.

2.   Regulations (EC) No 1445/95, (EC) No 1291/2000 and (EC) No 1301/2006 shall apply, save as otherwise provided for in this Regulation.

Article 4

1.   For the purposes of application of Article 5 of Regulation (EC) No 1301/2006, applicants shall demonstrate that they have imported at least 25 animals covered by CN code 0102 90 during each of the two reference periods referred to in that Article.

Member States may accept as proof of trade with third countries copies of the documents referred to in the second paragraph of Article 5 of Regulation (EC) No 1301/2006, duly certified by the issuing authority.

2.   A company formed by the merger of companies each having reference imports complying with the minimum quantity referred to in paragraph 1 of this Article may use those reference imports as proof of trade.

Article 5

1.   Applications for imports rights shall be submitted no later than 13:00, Brussels time, on 20 June preceding yearly import tariff quota period.

2.   A security of EUR 3 per head relating to the import rights shall be lodged with the competent authority together with the application for import rights.

3.   No later than 16:00, Brussels time, on the fifth working day following the end of the period for the submission of applications referred to in paragraph 1, Member States shall notify the Commission of the total quantities applied for each order number.

Article 6

1.   Import rights shall be awarded starting from the seventh and no later than the sixteenth working day following the end of the period for the notifications referred to in Article 5(3).

2.   If application of the allocation coefficient referred to in Article 7(2) of Regulation (EC) No 1301/2006 results in fewer import rights to be allocated than had been applied for, the security lodged in accordance with Article 5(2) of this Regulation shall be released proportionally without delay.

Article 7

1.   The release for free circulation of the quantities awarded under the quotas referred to in Annex I is subject to the presentation of an import licence.

2.   Import licence applications shall cover the total quantity allocated. This obligation shall constitute a primary requirement within the meaning of Article 20(2) of Regulation (EEC) No 2220/85.

Article 8

1.   Import licence applications shall be submitted solely in the Member State where the applicant has applied and obtained import rights under the quotas referred to in Annex I.

Each issue of an import licence shall result in a corresponding reduction of the import rights obtained and the security lodged in accordance with Article 5(2) shall be released proportionally without delay.

2.   Import licences shall be issued in the name of the operator who has obtained the import rights.

3.   Import licence applications and import licences shall contain the following:

(a)	in box 8, the country of origin;

(b)	in box 16, one or several of the CN codes listed in Annex I;

(c)	in box 20, the order number of the quota and one of the entries provided for in Annex II.

Article 9

By way of derogation from Article 9(1) of Regulation (EC) No 1291/2000, rights deriving from import licences issued pursuant to this Regulation shall not be transferable.

Article 10

1.   Imported animals shall be monitored in accordance with Article 82 of Regulation (EEC) No 2913/92 to ensure that they are not slaughtered within four months of their release for free circulation.

2.   In order to ensure that the obligation not to slaughter imported animals referred to in paragraph 1 is fulfilled and that unpaid duties are collected where that obligation is not complied with, importers shall lodge a security with the competent customs authorities. The security shall be equal to the difference between the customs duties laid down in the Common Customs Tariff and the duties referred to in Annex I applicable on the date of release for free circulation of the animals in question.

3.   The securities provided for in paragraph 2 shall be released immediately where proof is presented to the customs authorities concerned that the animals:

(a)	have not been slaughtered within the four months following the date of their release for free circulation; or

(b)	they have been slaughtered within that period for reasons of force majeure or for health reasons or have died of disease or as a result of an accident.

Article 11

Regulation (EC) No 1081/1999 is repealed.

Article 12

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

However, Article 11 shall apply from 1 July 2007.

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(1)  OJ L 160, 26.6.1999, p. 21. Regulation as last amended by Regulation (EC) No 1913/2005 (OJ L 307, 25.11.2005, p. 2).

(2)  OJ L 238, 1.9.2006, p. 13. Regulation as amended by Regulation (EC) No 289/2007 (OJ L 78, 17.3.2007, p. 17).

(3)  OJ L 143, 27.6.1995, p. 35. Regulation as last amended by Regulation (EC) No 586/2007 (OJ L 139, 31.5.2007, p. 5).

(4)  OJ L 152, 24.6.2000, p. 1. Regulation as last amended by Regulation (EC) No 1913/2006 (OJ L 365, 21.12.2006, p. 52).

(5)  OJ L 205, 3.8.1985, p. 5. Regulation as last amended by Regulation (EC) No 1913/2006.

(6)  OJ L 302, 19.10.1992, p. 1. Regulation as last amended by Regulation (EC) No 1791/2006 (OJ L 363, 20.12.2006, p. 1).

(7)  OJ L 131, 27.5.1999, p. 15. Regulation as last amended by Regulation (EC) No 1965/2006 (OJ L 408, 30.12.2006, p. 26, corrected by OJ L 47, 16.2.2007, p. 21).

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15.6.2007

EN

Official Journal of the European Union

L 155/26

---

COMMISSION REGULATION (EC) No 660/2007

of 14 June 2007

fixing the export refunds on milk and milk products

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Council Regulation (EC) No 1255/1999 of 17 May 1999 on the common organisation of the market in milk and milk products (1), and in particular Article 31(3) thereof,

Whereas:

(1)	Article 31(1) of Regulation (EC) No 1255/1999 provides that the difference between prices on the world market for the products listed in Article 1 of that Regulation and prices for those products on the Community market may be covered by an export refund.

(2)	Given the present situation on the market in milk and milk products, no export refunds should therefore be fixed.

(3)	The Management Committee for Milk and Milk Products has not delivered an opinion within the time limit set by its chairman,

HAS ADOPTED THIS REGULATION:

Article 1

No export refunds as provided for in Article 31 of Regulation (EC) No 1255/1999 shall be granted on the products set out in the Annex to this Regulation.

Article 2

This Regulation shall enter into force on 15 June 2007.

---

(1)  OJ L 160, 26.6.1999, p. 48. Regulation as last amended by Regulation (EC) No 1913/2005 (OJ L 307, 25.11.2005, p. 2).

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15.6.2007

EN

Official Journal of the European Union

L 155/30

---

COMMISSION REGULATION (EC) No 661/2007

of 14 June 2007

granting no export refund for butter in the framework of the standing invitation to tender provided for in Regulation (EC) No 581/2004

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Council Regulation (EC) No 1255/1999 of 17 May 1999 on the common organisation of the market in milk and milk products (1), and in particular the third subparagraph of Article 31(3) thereof,

Whereas:

(1)	Commission Regulation (EC) No 581/2004 of 26 March 2004 opening a standing invitation to tender for export refunds concerning certain types of butter (2) provides for a permanent tender.

(2)

Pursuant to Article 5 of Commission Regulation (EC) No 580/2004 of 26 March 2004 establishing a tender procedure concerning export refunds for certain milk products (3) and following an examination of the tenders submitted in response to the invitation to tender, it is appropriate not to grant any refund for the tendering period ending on 12 June 2007.

(3)	The Management Committee for Milk and Milk Products has not delivered an opinion within the time limit set by its chairman,

HAS ADOPTED THIS REGULATION:

Article 1

For the permanent tender opened by Regulation (EC) No 581/2004, for the tendering period ending on 12 June 2007 no export refund shall be granted for the products and destinations referred to in Article 1(1) of that Regulation.

Article 2

This Regulation shall enter into force on 15 June 2007.

---

(1)  OJ L 160, 26.6.1999, p. 48. Regulation as last amended by Commission Regulation (EC) No 1913/2005 (OJ L 307, 25.11.2005, p. 2).

(2)  OJ L 90, 27.3.2004, p. 64. Regulation as last amended by Regulation (EC) No 276/2007 (OJ L 76, 16.3.2007, p. 16).

(3)  OJ L 90, 27.3.2004, p. 58. Regulation as last amended by Regulation (EC) No 128/2007 (OJ L 41, 13.2.2007, p. 6).

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15.6.2007

EN

Official Journal of the European Union

L 155/31

---

COMMISSION REGULATION (EC) No 662/2007

of 14 June 2007

fixing the export refunds on white and raw sugar exported without further processing

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Council Regulation (EC) No 318/2006 of 20 February 2006 on the common organisation of the market in the sugar sector (1), and in particular the second subparagraph of Article 33(2) thereof,

Whereas:

(1)	Article 32 of Regulation (EC) No 318/2006 provides that the difference between prices on the world market for the products listed in Article 1(1)(b) of that Regulation and prices for those products on the Community market may be covered by an export refund.

(2)	Given the present situation on the sugar market, export refunds should therefore be fixed in accordance with the rules and certain criteria provided for in Articles 32 and 33 of Regulation (EC) No 318/2006.

(3)	The first subparagraph of Article 33(2) of Regulation (EC) No 318/2006 provides that the world market situation or the specific requirements of certain markets may make it necessary to vary the refund according to destination.

(4)	Refunds should be granted only on products that are allowed to move freely in the Community and that comply with the requirements of Regulation (EC) No 318/2006.

(5)	The measures provided for in this Regulation are in accordance with the opinion of the Management Committee for Sugar,

HAS ADOPTED THIS REGULATION:

Article 1

Export refunds as provided for in Article 32 of Regulation (EC) No 318/2006 shall be granted on the products and for the amounts set out in the Annex to this Regulation.

Article 2

This Regulation shall enter into force on 15 June 2007.

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(1)  OJ L 58, 28.2.2006, p. 1. Regulation as last amended by Commission Regulation (EC) No 247/2007 (OJ L 69, 9.3.2007, p. 3).

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15.6.2007

EN

Official Journal of the European Union

L 155/33

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COMMISSION REGULATION (EC) No 663/2007

of 14 June 2007

fixing the maximum export refund for white sugar in the framework of the standing invitation to tender provided for in Regulation (EC) No 958/2006

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Council Regulation (EC) No 318/2006 of 20 February 2006 on the common organisation of the markets in the sugar sector (1), and in particular the second subparagraph and point (b) of the third subparagraph of Article 33(2) thereof,

Whereas:

(1)	Commission Regulation (EC) No 958/2006 of 28 June 2006 on a standing invitation to tender to determine refunds on exports of white sugar for the 2006/2007 marketing year (2) requires the issuing of partial invitations to tender.

(2)	Pursuant to Article 8(1) of Regulation (EC) No 958/2006 and following an examination of the tenders submitted in response to the partial invitation to tender ending on 14 June 2007, it is appropriate to fix a maximum export refund for that partial invitation to tender.

(3)	The measures provided for in this Regulation are in accordance with the opinion of the Management Committee for Sugar,

HAS ADOPTED THIS REGULATION:

Article 1

For the partial invitation to tender ending on 14 June 2007, the maximum export refund for the product referred to in Article 1(1) of Regulation (EC) No 958/2006 shall be 38,778 EUR/100 kg.

Article 2

This Regulation shall enter into force on 15 June 2007.

---

(1)  OJ L 58, 28.2.2006, p. 1. Regulation as last amended by Commission Regulation (EC) No 247/2007 (OJ L 69, 9.3.2007, p. 3).

(2)  OJ L 175, 29.6.2006, p. 49. Regulation as amended by Regulation (EC) No 203/2007 (OJ L 61, 28.2.2007, p. 3).

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15.6.2007

EN

Official Journal of the European Union

L 155/34

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COMMISSION REGULATION (EC) No 664/2007

of 14 June 2007

fixing the maximum export refund for white sugar in the framework of the standing invitation to tender provided for in Regulation (EC) No 38/2007

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Council Regulation (EC) No 318/2006 of 20 February 2006 on the common organisation of the markets in the sugar sector (1), and in particular the second subparagraph and point (b) of the third subparagraph of Article 33(2) thereof,

Whereas:

(1)

Commission Regulation (EC) No 38/2007 of 17 January 2007 opening a standing invitation to tender for the resale for export of sugar held by the intervention agencies of Belgium, the Czech Republic, Spain, Ireland, Italy, Hungary, Poland, Slovakia and Sweden (2) requires the issuing of partial invitations to tender.

(2)	Pursuant to Article 4(1) of Regulation (EC) No 38/2007 and following an examination of the tenders submitted in response to the partial invitation to tender ending on 13 June 2007, it is appropriate to fix a maximum export refund for that partial invitation to tender.

(3)	The measures provided for in this Regulation are in accordance with the opinion of the Management Committee for Sugar,

HAS ADOPTED THIS REGULATION:

Article 1

For the partial invitation to tender ending on 13 June 2007, the maximum export refund for the product referred to in Article 1(1) of Regulation (EC) No 38/2007 shall be 435,00 EUR/tonne.

Article 2

This Regulation shall enter into force on 15 June 2007.

---

(1)  OJ L 58, 28.2.2006, p. 1. Regulation as last amended by Commission Regulation (EC) No 247/2007 (OJ L 69, 9.3.2007, p. 3).

(2)  OJ L 11, 18.1.2007, p. 4. Regulation as amended by Regulation (EC) No 203/2007 (OJ L 61, 28.2.2006, p. 3).

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15.6.2007

EN

Official Journal of the European Union

L 155/35

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COMMISSION REGULATION (EC) No 665/2007

of 14 June 2007

amending the rates of the refunds applicable to certain milk products exported in the form of goods not covered by Annex I to the Treaty

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Council Regulation (EC) No 1255/1999 of 17 May 1999 on the common organisation of the markets in the milk and milk products sector (1), and in particular Article 31(3) thereof,

Whereas:

(1)	The rates of the refunds applicable from 25 May 2007 to the products listed in the Annex, exported in the form of goods not covered by Annex I to the Treaty, were fixed by Commission Regulation (EC) No 570/2007 (2).

(2)	It follows from applying the rules and criteria contained in Regulation (EC) No 570/2007 to the information at present available to the Commission that the export refunds at present applicable should be altered as shown in the Annex hereto,

HAS ADOPTED THIS REGULATION:

Article 1

The rates of refund fixed by Regulation (EC) No 570/2007 are hereby altered as shown in the Annex hereto.

Article 2

This Regulation shall enter into force on 15 June 2007.

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(1)  OJ L 160, 26.6.1999, p. 48. Regulation as last amended by Regulation (EC) No 1913/2005 (OJ L 307, 25.11.2005, p. 2).

(2)  OJ L 133, 25.5.2007, p. 18.

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15.6.2007

EN

Official Journal of the European Union

L 155/37

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COMMISSION REGULATION (EC) No 666/2007

of 14 June 2007

amending the rates of refunds applicable to certain products from the sugar sector exported in the form of goods not covered by Annex I to the Treaty

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Council Regulation (EC) No 318/2006 of 20 February 2006 on the common organisation of the market in the sugar sector (1), and in particular Article 33(2)(a) and (4) thereof,

Whereas:

(1)	The rates of the refunds applicable from 25 May 2007 to the products listed in the Annex, exported in the form of goods not covered by Annex I to the Treaty, were fixed by Commission Regulation (EC) No 571/2007 (2).

(2)	It follows from applying the rules and criteria contained in Regulation (EC) No 571/2007 to the information at present available to the Commission that the export refunds at present applicable should be altered as shown in the Annex hereto,

HAS ADOPTED THIS REGULATION:

Article 1

The rates of refund fixed by Regulation (EC) No 571/2007 are hereby altered as shown in the Annex hereto.

Article 2

This Regulation shall enter into force on 15 June 2007.

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(1)  OJ L 58, 28.2.2006, p. 1. Regulation as last amended by Commission Regulation (EC) No 247/2007 (OJ L 69, 9.3.2007, p. 3).

(2)  OJ L 133, 25.5.2007, p. 21.

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15.6.2007

EN

Official Journal of the European Union

L 155/39

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COMMISSION REGULATION (EC) No 667/2007

of 14 June 2007

fixing the rates of the refunds applicable to certain cereal and rice products exported in the form of goods not covered by Annex I to the Treaty

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Council Regulation (EC) No 1784/2003 of 29 September 2003 on the common organisation of the market in cereals (1), and in particular Article 13(3) thereof,

Having regard to Council Regulation (EC) No 1785/2003 of 29 September 2003 on the common organisation of the market in rice (2), and in particular Article 14(3) thereof,

Whereas:

(1)

Article 13(1) of Regulation (EC) No 1784/2003 and Article 14(1) of Regulation (EC) No 1785/2003 provide that the difference between quotations or prices on the world market for the products listed in Article 1 of each of those Regulations and the prices within the Community may be covered by an export refund.

(2)

Commission Regulation (EC) No 1043/2005 of 30 June 2005 implementing Council Regulation (EC) No 3448/93 as regards the system of granting export refunds on certain agricultural products exported in the form of goods not covered by Annex I to the Treaty, and the criteria for fixing the amount of such refunds (3), specifies the products for which a rate of refund is to be fixed, to be applied where these products are exported in the form of goods listed in Annex III to Regulation (EC) No 1784/2003 or in Annex IV to Regulation (EC) No 1785/2003 as appropriate.

(3)	In accordance with the first paragraph of Article 14 of Regulation (EC) No 1043/2005, the rate of the refund per 100 kilograms for each of the basic products in question is to be fixed each month.

(4)

The commitments entered into with regard to refunds which may be granted for the export of agricultural products contained in goods not covered by Annex I to the Treaty may be jeopardised by the fixing in advance of high refund rates. It is therefore necessary to take precautionary measures in such situations without, however, preventing the conclusion of long-term contracts. The fixing of a specific refund rate for the advance fixing of refunds is a measure which enables these various objectives to be met.

(5)

Taking into account the settlement between the European Community and the United States of America on Community exports of pasta products to the United States, approved by Council Decision 87/482/EEC (4), it is necessary to differentiate the refund on goods falling within CN codes 1902 11 00 and 1902 19 according to their destination.

(6)

Pursuant to Article 15(2) and (3) of Regulation (EC) No 1043/2005, a reduced rate of export refund has to be fixed, taking account of the amount of the production refund applicable, pursuant to Commission Regulation (EEC) No 1722/93 (5), for the basic product in question, used during the assumed period of manufacture of the goods.

(7)

Spirituous beverages are considered less sensitive to the price of the cereals used in their manufacture. However, Protocol 19 of the Act of Accession of the United Kingdom, Ireland and Denmark provides that the necessary measures must be decided to facilitate the use of Community cereals in the manufacture of spirituous beverages obtained from cereals. Accordingly, it is necessary to adapt the refund rate applying to cereals exported in the form of spirituous beverages.

(8)	The Management Committee for Cereals has not delivered an opinion within the time limit set by its chairman,

HAS ADOPTED THIS REGULATION:

Article 1

The rates of the refunds applicable to the basic products listed in Annex I to Regulation (EC) No 1043/2005 and in Article 1 of Regulation (EC) No 1784/2003 or in Article 1 of Regulation (EC) No 1785/2003, and exported in the form of goods listed in Annex III to Regulation (EC) No 1784/2003 or in Annex IV to Regulation (EC) No 1785/2003 respectively, shall be fixed as set out in the Annex to this Regulation.

Article 2

This Regulation shall enter into force on 15 June 2007.

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(1)  OJ L 270, 21.10.2003, p. 78. Regulation as amended by Commission Regulation (EC) No 1154/2005 (OJ L 187, 19.7.2005, p. 11).

(2)  OJ L 270, 21.10.2003, p. 96. Regulation as last amended by Commission Regulation (EC) No 797/2006 (OJ L 144, 31.5.2006, p. 1).

(3)  OJ L 172, 5.7.2005, p. 24. Regulation as last amended by Regulation (EC) No 447/2007 (OJ L 106, 24.4.2007, p. 31).

(4)  OJ L 275, 29.9.1987, p. 36.

(5)  OJ L 159, 1.7.1993, p. 112. Regulation as last amended by Regulation (EC) No 1584/2004 (OJ L 280, 31.8.2004, p. 11).

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15.6.2007

EN

Official Journal of the European Union

L 155/43

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COMMISSION REGULATION (EC) No 668/2007

of 14 June 2007

fixing the export refunds on syrups and certain other sugar products exported without further processing

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Council Regulation (EC) No 318/2006 of 20 February 2006 on the common organisation of the market in the sugar sector (1), and in particular the second subparagraph of Article 33(2) thereof,

Whereas:

(1)	Article 32 of Regulation (EC) No 318/2006 provides that the difference between prices on the world market for the products listed in Article 1(1)(c), (d) and (g) of that Regulation and prices for those products on the Community market may be covered by an export refund.

(2)	Given the present situation on the sugar market, export refunds should therefore be fixed in accordance with the rules and certain criteria provided for in Articles 32 and 33 of Regulation (EC) No 318/2006.

(3)	The first subparagraph of Article 33(2) of Regulation (EC) No 318/2006 provides that the world market situation or the specific requirements of certain markets may make it necessary to vary the refund according to destination.

(4)

Refunds should be granted only on products that are allowed to move freely in the Community and that comply with the requirements of Commission Regulation (EC) No 951/2006 of 30 June 2006 laying down detailed rules for the implementation of Regulation (EC) No 318/2006 as regards trade with third countries in the sugar sector (2).

(5)

Export refunds may be set to cover the competitive gap between Community and third country's exports. Community exports to certain close destinations and to third countries granting Community products a preferential import treatment are currently in a particular favourable competitive position. Therefore, refunds for exports to those destinations should be abolished.

(6)	The measures provided for in this Regulation are in accordance with the opinion of the Management Committee for Sugar,

HAS ADOPTED THIS REGULATION:

Article 1

1.   Export refunds as provided for in Article 32 of Regulation (EC) No 318/2006 shall be granted on the products and for the amounts set out in the Annex to this Regulation subject to the conditions provided for in paragraph 2 of this Article.

2.   To be eligible for a refund under paragraph 1 products must meet the relevant requirements laid down in Articles 3 and 4 of Regulation (EC) No 951/2006.

Article 2

This Regulation shall enter into force on 15 June 2007.

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(1)  OJ L 58, 28.2.2006, p. 1. Regulation as last amended by Commission Regulation (EC) No 247/2007 (OJ L 69, 9.3.2007, p. 3).

(2)  OJ L 178, 1.7.2006, p. 24. Regulation as amended by Regulation (EC) No 2031/2006 (OJ L 414, 30.12.2006, p. 43).

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15.6.2007

EN

Official Journal of the European Union

L 155/45

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COMMISSION REGULATION (EC) No 669/2007

of 14 June 2007

amending Regulation (EC) No 195/2007 opening the buying-in of butter in certain Member States for the period 1 March to 31 August 2007

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Council Regulation (EC) No 1255/1999 of 17 May 1999 on the common organisation of the market in milk and milk products (1),

Having regard to Commission Regulation (EC) No 2771/1999 of 16 December 1999 laying down detailed rules for the application of Council Regulation (EC) No 1255/1999 as regards intervention on the market in butter and cream (2), and in particular Article 2 thereof,

Whereas:

(1)	Commission Regulation (EC) No 195/2007 (3) establishes the list of Member States in which buying-in for butter is open, as provided for in Article 6(1) of Regulation (EC) No 1255/1999.

(2)

On the basis of most recent communications by Portugal, the Commission has observed that butter market prices have been equal or superior to 92 % of the intervention price for two consecutive weeks. Intervention buying-in should therefore be suspended in that Member State. Portugal should therefore be withdrawn from the list established in Regulation (EC) No 195/2007.

(3)	Regulation (EC) No 195/2007 should therefore be amended accordingly,

HAS ADOPTED THIS REGULATION:

Article 1

Article 1 of Regulation (EC) No 195/2007 is replaced by the following text:

Article 2

This Regulation shall enter into force on 15 June 2007.

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(1)  OJ L 160, 26.6.1999, p. 48. Regulation as last amended by Regulation (EC) No 1913/2005 (OJ L 307, 25.11.2005, p. 2).

(2)  OJ L 333, 24.12.1999, p. 11. Regulation as last amended by Regulation (EC) No 2107/2005 (OJ L 337, 22.12.2005, p. 20).

(3)  OJ L 59, 27.2.2007, p. 62. Regulation as last amended by Regulation (EC) No 354/2007 (OJ L 90, 30.3.2007, p. 47).

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15.6.2007

EN

Official Journal of the European Union

L 155/46

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COMMISSION REGULATION (EC) Νo 670/2007

of 14 June 2007

fixing the export refunds on products processed from cereals and rice

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Council Regulation (EC) No 1784/2003 of 29 September 2003 on the common organisation of the market in cereals (1), and in particular Article 13(3) thereof,

Having regard to Council Regulation (EC) No 1785/2003 of 29 September 2003 on the common organisation of the market in rice (2), and in particular Article 14(3) thereof,

Whereas:

(1)

Article 13 of Regulation (EC) No 1784/2003 and Article 14 of Regulation (EC) No 1785/2003 provide that the difference between quotations or prices on the world market for the products listed in Article 1 of those Regulations and prices for those products within the Community may be covered by an export refund.

(2)

Article 14 of Regulation (EC) No 1785/2003 provides that when refunds are being fixed account must be taken of the existing situation and the future trend with regard to prices and availabilities of cereals, rice and broken rice on the Community market on the one hand and prices for cereals, rice, broken rice and cereal products on the world market on the other. The same Articles provide that it is also important to ensure equilibrium and the natural development of prices and trade on the markets in cereals and rice and, furthermore, to take into account the economic aspect of the proposed exports, and the need to avoid disturbances on the Community market.

(3)	Article 2 of Commission Regulation (EC) No 1518/95 (3) on the import and export system for products processed from cereals and from rice defines the specific criteria to be taken into account when the refund on these products is being calculated.

(4)

The refund to be granted in respect of certain processed products should be graduated on the basis of the ash, crude fibre, tegument, protein, fat and starch content of the individual product concerned, this content being a particularly good indicator of the quantity of basic product actually incorporated in the processed product.

(5)

There is no need at present to fix an export refund for manioc, other tropical roots and tubers or flours obtained therefrom, given the economic aspect of potential exports and in particular the nature and origin of these products. For certain products processed from cereals, the insignificance of Community participation in world trade makes it unnecessary to fix an export refund at the present time.

(6)	The world market situation or the specific requirements of certain markets may make it necessary to vary the refund for certain products according to destination.

(7)	The refund must be fixed once a month. It may be altered in the intervening period.

(8)	Certain processed maize products may undergo a heat treatment following which a refund might be granted that does not correspond to the quality of the product; whereas it should therefore be specified that on these products, containing pregelatinised starch, no export refund is to be granted.

(9)	The Management Committee for Cereals has not delivered an opinion within the time limit set by its chairman,

HAS ADOPTED THIS REGULATION:

Article 1

The export refunds on the products listed in Article 1 of Regulation (EC) No 1518/95 are hereby fixed as shown in the Annex to this Regulation.

Article 2

This Regulation shall enter into force on 15 June 2007.

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(1)  OJ L 270, 21.10.2003, p. 78. Regulation as amended by Commission Regulation (EC) No 1154/2005 (OJ L 187, 19.7.2005, p. 11).

(2)  OJ L 270, 21.10.2003, p. 96. Regulation as last amended by Commission Regulation (EC) No 1549/2004 (OJ L 280, 31.8.2004, p. 13).

(3)  OJ L 147, 30.6.1995, p. 55. Regulation as last amended by Regulation (EC) No 2993/95 (OJ L 312, 23.12.1995, p. 25).

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15.6.2007

EN

Official Journal of the European Union

L 155/49

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COMMISSION DIRECTIVE 2007/34/EC

of 14 June 2007

amending, for the purposes of its adaptation to technical progress, Council Directive 70/157/EEC concerning the permissible sound level and the exhaust system of motor vehicles

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Council Directive 70/156/EEC of 6 February 1970 on the approximation of the laws of the Member States relating to the type-approval of motor vehicles and their trailers (1), and in particular the second indent of Article 13(2) thereof,

Having regard to Council Directive 70/157/EEC relating to the permissible sound level and the exhaust system of motor vehicles (2), and in particular Article 3 thereof,

Whereas:

(1)	Directive 70/157/EEC is one of the separate Directives in the context of the Community type-approval procedure laid down in Directive 70/156/EEC. The provisions of Directive 70/156/EEC relating to systems, components and separate technical units for vehicles therefore apply to Directive 70/157/EEC.

(2)

Since the entry into force of Directive 70/157/EEC of 6 February 1970, the noise limits for motor vehicles have been reduced several times, most recently in 1995. The last reduction did not have the expected effects and subsequent studies have shown that the measurement method no longer reflects the real life driving behaviour. It is therefore necessary to introduce a new test cycle and bring the driving conditions for carrying out the noise test closer into line with real life driving operations. The new test cycle is contained in UN/ECE Regulation No 51, 02 series of amendments (3).

(3)

During a transitional period, the current test as well as the new test should be carried out for type-approval and the results of both tests should be reported to the Commission. This would enable the Commission to obtain the necessary data for establishing appropriate limit values for the new measurement method which would replace the existing test protocol. The current method should continue to be required in order to receive type-approval and the new method should be used for monitoring purposes. After the transitional period, the test protocol as adapted to the new test should become the only measurement required in order to receive type-approval.

(4)

In order to take into account the most recent amendments to UN/ECE Regulations Nos 51 and 59, to which the Community has already acceded, it is appropriate to adapt Directive 70/157/EEC to technical progress by aligning it with the technical requirements of those regulations. This is important, in particular, in order to take over the mandatory monitoring procedure of the motor vehicle noise emissions laid down in the UN/ECE Regulation No 51 for the purposes of EC type-approval. Otherwise, the Directive would fall behind the Regulation with regard to technical advancement.

(5)

Pursuant to Article 3 of Directive 70/157/EEC, the measures provided for by this Directive do not modify the requirements set out in points 5.2.2.1 and 5.2.2.5 of Annex I to Directive 70/157/EEC. With regard to the new structure of the Annexes, it is necessary to adapt the numbering and references specified in those points. In order to ensure the link to other provisions of Community legislation, it is also appropriate to provide for a correlation between the current and the new numbering.

(6)	The measures provided for in this Directive are in accordance with the opinion of the Committee for Adaptation to Technical Progress,

HAS ADOPTED THIS DIRECTIVE:

Article 1

1.   Directive 70/157/EEC is amended as follows:

(a)	Annex I is replaced by the text set out in Annex I to this Directive;

(b)	Annex II is replaced by the text set out in Annex II to this Directive;

(c)	Annex III is replaced by the text set out in Annex III to this Directive;

(d)	Annex IV is deleted.

2.   References to points 5.2.2.1 and 5.2.2.5 of Annex I to Directive 70/157/EEC shall be construed as references to points 2.1 and 2.2 of Annex I, as replaced by this Directive.

Article 2

With effect from 6 July 2008 and until 6 July 2010, the vehicle to be type-approved shall be subject to the test laid down in Annex 10 of UN/ECE Regulation No 51 for monitoring purposes only. The results of that test shall be added to the documents set out in Appendices 1 and 2 of Annex I to Directive 70/157/EEC as amended by this Directive, in conformity with Annex 9 of UN/ECE Regulation No 51. The Member State concerned shall send such information documents to the Commission. These obligations do not affect cases of extension of existing approvals according to this Directive. For the purpose of this monitoring procedure a vehicle is not considered to be a new type if the vehicle differs only in respect to paragraphs 2.2.1 and 2.2.2 of UN/ECE Regulation No 51.

Article 3

1.   Member States shall adopt and publish, by 5 July 2008 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.

They shall apply those provisions from 6 July 2008.

When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.

2.   Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.

Article 4

This Directive shall enter into force on the 20th day following that of its publication in the Official Journal of the European Union.

Article 5

This Directive is addressed to the Member States.

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(1)  OJ L 42, 23.2.1970, p. 1. Directive as last amended by Directive 2006/96/EC (OJ L 363, 20.12.2006, p. 81).

(2)  OJ L 42, 23.2.1970, p. 16. Directive as last amended by Directive 2006/96/EC.

(3)  OJ L 137, 30.5.2007, p. 68.

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