4.7.2009   

EN

Official Journal of the European Union

L 175/1

4.7.2009   

EN

Official Journal of the European Union

L 175/3

(1)

All pharmacologically active substances used in the Community in veterinary medicinal products intended for food-producing animals should be evaluated in accordance with Regulation (EEC) No 2377/90.

(2)

The substance gamithromycin is included in Annex III to Regulation (EEC) No 2377/90 for bovine species, applicable to fat, liver and kidney, excluding animals producing milk for human consumption. The provisional maximum residue limits (hereinafter MRLs) for that substance set out in that Annex will expire on 1 July 2009. Additional data were provided and assessed leading the Committee for Medicinal Products for Veterinary Use to recommend that the provisional MRLs for gamithromycin should be set as definitive and consequently included in Annex I to Regulation (EEC) No 2377/90 for bovine species, applicable to fat, liver and kidney, excluding animals producing milk for human consumption.

(3)

Regulation (EEC) No 2377/90 should therefore be amended accordingly.

(4)

It is necessary to provide for an adequate period before this Regulation becomes applicable, in order to enable the Member States to make any necessary adjustments with respect to the existing authorisations to place the veterinary medicinal products concerned which have been granted in accordance with 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) on the market.

(5)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Veterinary Medicinal Products,

4.7.2009   

EN

Official Journal of the European Union

L 175/5

(1)

All pharmacologically active substances used in the Community in veterinary medicinal products intended for food-producing animals should be evaluated in accordance with Regulation (EEC) No 2377/90.

(2)

The substance diclofenac is included in Annex I to Regulation (EEC) No 2377/90 for bovine species, as regards muscle, fat, liver and kidney tissues, excluding animals producing milk for human consumption. A request has been made to the Committee for Medicinal Products for Veterinary Use to consider whether the existing entry for diclofenac, for bovine species in that Annex should be extended to include maximum residue limits applicable to milk. Following examination of the request, it is considered appropriate to amend the existing entry for diclofenac in Annex I for bovine species to include the established maximum residue limits applicable to milk.

(3)

Regulation (EEC) No 2377/90 should therefore be amended accordingly.

(4)

It is necessary to provide for an adequate period before this Regulation becomes applicable, in order to enable the Member States to make any necessary adjustments with respect to the existing authorisations to place the veterinary medicinal products concerned which have been granted in accordance with 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) on the market.

(5)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Veterinary Medicinal Products,

4.7.2009   

EN

Official Journal of the European Union

L 175/7

(1)

In accordance with Article 6(2) and pursuant to Article 17(2) of Regulation (EC) No 510/2006, Italy’s application to register the name ‘Aceto Balsamico di Modena’ was published in the Official Journal of the European Union  (2).

(2)

Germany, Greece and France submitted objections to the registration under Article 7(1) of Regulation (EC) No 510/2006. These objections were deemed admissible under points (a) to (d) of the first subparagraph of Article 7(3) of that Regulation.

(3)

Germany’s objection referred in particular to the concern that the registration of ‘Aceto Balsamico di Modena’ as a protected geographical indication would adversely affect other products that have been placed lawfully on the market for at least five years and sold as Balsamessig/Aceto balsamico, as well as to the alleged generic character of these terms. Germany also pointed to the lack of clarity regarding the stages of production which must take place in the area of origin.

(4)

France’s objection concerned the fact that ‘Aceto Balsamico di Modena’ does not have its own reputation that is distinct from that of ‘Aceto balsamico tradizionale di Modena’, which has already been registered as a protected designation of origin under Council Regulation (EC) No 813/2000 (3). France claims that consumers could be misled as to the nature and origin of the product in question.

(5)

Greece stressed the importance of balsamic vinegar production in Greece, which is marketed under names such as ‘balsamico’ or ‘balsamon’ and the negative impact that registration of the name ‘Aceto Balsamico di Modena’ would have on these products, which have been placed lawfully on the market for at least five years. Greece also maintains that the terms ‘aceto balsamico’, ‘balsamic’, etc. are generic.

(6)

By letters dated 4 March 2008, the Commission asked the Member States concerned to seek agreement among themselves in accordance with their internal procedures.

(7)

Given that no agreement was reached between France, Germany, Greece and Italy within the designated timeframe, the Commission must adopt a decision in accordance with the procedure outlined in Article 15(2) of Regulation (EC) No 510/2006.

(8)

The Commission has requested the opinion of the scientific committee for designations of origin, geographical indications and certificates of specific character established under Decision 93/53/EC (4) as to whether the conditions for registration were met. The committee stated in its unanimous opinion submitted on 6 March 2006 that the name ‘Aceto Balsamico di Modena’ has an undeniable reputation on the national and international market, as demonstrated by its frequent use in numerous recipes in many Member States, and the many references to it on the Internet, in the press and other media. ‘Aceto Balsamico di Modena’ therefore meets the inherent condition for the product having a specific reputation linked to that name. The committee noted the fact that these products have co-existed on the market for hundreds of years. It also noted that ‘Aceto Balsamico di Modena’ and ‘Aceto balsamico tradizionale di Modena’ are different as regards their characteristics, customer base, usage, method of distribution, presentation and price, thereby ensuring the fair treatment of the producers in question and not misleading consumers. The Commission fully concurs with these points.

(9)

In order to further distinguish between these products, it has been pointed out that numerical qualifiers were included in the general ban on using terms other than those expressly provided for in the technical specifications. Moreover, a number of minor changes have been made to the technical specifications for the term ‘Aceto Balsamico di Modena’ aimed at removing any ambiguities.

(10)

It appears that Germany and Greece did not refer to the entire name, i.e. ‘Aceto Balsamico di Modena’ in their objections regarding the generic nature of the name proposed for registration, but only to some elements of it, namely the words ‘aceto’, ‘balsamico’ and ‘aceto balsamico’, or to translations thereof. However, protection is granted to the term ‘Aceto Balsamico di Modena’ as a whole. Individual non-geographical components of that term may be used, even jointly and also in translation, throughout the Community, provided the principles and rules applicable in the Community’s legal order are respected.

(11)

In the light of the above, the name ‘Aceto Balsamico di Modena’ should be entered in the register of protected designations of origin and protected geographical indications.

(12)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Protected Geographical Indications and Protected Designations of Origin,

4.7.2009   

EN

Official Journal of the European Union

L 175/12

(1)

The Council, in the conclusions of its meeting on economic and financial affairs of 28 November 2006, has agreed to establish an Anti-tax fraud strategy implemented at Community level, especially for tax fraud in the field of indirect taxation, in order to complement national efforts.

(2)

Certain measures which have been discussed in that context require an amendment of Directive 2006/112/EC (3).

(3)

The importation of goods is exempt from value added tax (VAT) if followed by a supply or transfer of those goods to a taxable person in another Member State. The conditions under which that exemption is granted are laid down by Member States. Experience, however, shows that divergences in application are exploited by traders to avoid payment of VAT on goods imported under those circumstances.

(4)

In order to prevent that exploitation it is necessary to specify, for particular transactions, at Community level, a set of minimum conditions under which this exemption applies.

(5)

Since, for those reasons, the objective of this Directive, namely to address the problem of VAT evasion, cannot be sufficiently achieved by the Member States themselves and can therefore be better achieved at Community level, the Community may adopt measures in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve that objective.

(6)

In accordance with point 34 of the Interinstitutional Agreement on better law-making (4), Member States are encouraged to draw up, for themselves and in the interests of the Community, their own tables illustrating, as far as possible, the correlation between this Directive and the transposition measures, and to make them public.

(7)

Directive 2006/112/EC should therefore be amended accordingly,

1.

Article 22 shall be replaced by the following:

‘Article 22

The application by the armed forces of a State party to the North Atlantic Treaty, for their use or for the use of the civilian staff accompanying them, of goods which they have not purchased subject to the general rules governing taxation on the domestic market of a Member State shall be treated as an intra-Community acquisition of goods for consideration, where the importation of those goods would not be eligible for the exemption provided for in Article 143(1)(h).’;

2.

in Article 140, point (b) shall be replaced by the following:

3.

Article 143 shall be amended as follows:

4.7.2009   

EN

Official Journal of the European Union

L 175/14

(1)

The Governing Board of the Clean Sky Joint Undertaking has approved and submitted a draft amendment replacing in Article 23(4) of Annex I to Regulation (EC) No 71/2008 with a different text to allow defining access rights not only for research use but also for commercial use in the grant agreement.

(2)

Whereas this amendment, which does not affect the essential elements of the Clean Sky Statutes is justified, as pursuant to Article 15 of Regulation (EC) No 71/2008, the intellectual rights policy of the Clean Sky Joint Undertaking should be based on the principles of Regulation (EC) No 1906/2006 of the European Parliament and of the Council (2) where access rights for use include for commercial exploitation and should promote not only the creation but also the exploitation of knowledge (ref. Recital 29 and Article 23(2) of Annex I to Regulation (EC) No 71/2008),

Clean Sky Joint Undertaking

c/o Liam Breslin

European Commission — DG RTD

Clean Sky Joint Undertaking Interim Executive Director

CDMA 04/166

1049 Brussels

BELGIUM

4.7.2009   

EN

Official Journal of the European Union

L 175/16

(1)

The first subparagraph of Article 16(2) of Directive 98/8/EC (hereinafter referred to as the Directive) provides that the Commission shall commence a 10-year work programme for the systematic examination of all active substances already on the market on 14 May 2000 (hereinafter referred to as the review programme).

(2)

Malathion (EC No 204-497-7; CAS No 121-75-5) was identified as available on the market before 14 May 2000 as an active substance of biocidal products for purposes other than those referred to in Article 2(2)(c) and (d) of the Directive.

(3)

As no complete dossier was submitted in support of the inclusion of malathion in Annex I, IA or IB of the Directive within the deadline prescribed in part B of Annex V to Commission Regulation (EC) No 2032/2003 (2), the Commission decided, by Commission Decision 2007/565/EC (3), that malathion shall not be included in Annexes I, IA or IB to the Directive. In accordance with Article 4(1) of Commission Regulation (EC) No 1451/2007 (4), biocidal products containing malathion shall no longer be placed on the market.

(4)

Article 15(1) of the Directive lays down the conditions under which Member States may authorise temporarily for a period not exceeding 120 days the placing on the market of biocidal products not complying with the provisions of the Directive. Such temporary authorisation may only be granted for a limited and controlled use if such a measure appears necessary because of an unforeseen danger which cannot be contained by other means. In this case, the Member State concerned shall immediately inform the other Member States and the Commission of its action and the justification for it. The temporary measure may be extended by a decision taken in accordance with the management procedure referred to in Article 28(2) of the Directive.

(5)

France has informed the Commission and the other Member States about its decision of 27 February 2009 to temporarily authorise the placing on the market of biocidal products containing malathion for product type 18 as defined in Annex V of Directive 98/8/EC (insecticides, acaricides and products to control other arthropods). The authorisation was granted for a period of 120 days starting on 3 March 2009 and was only valid for vector disease control carried out by public operators in the Department of French Guiana. According to the information provided by France, the temporary authorisation of biocidal products containing malathion was necessary in view of the rapidly developing epidemic of dengue in French Guiana. The local authorities did not have other effective insecticidal products available for large-scale use against adult mosquitoes.

(6)

On 28 April 2009, France requested the Commission to decide that the action may be extended or repeated in accordance with Article 15(1) of Directive 98/8/EC. The request was made based on the risk that there would still not be any appropriate alternative products for vector mosquito control available in French Guiana on 1 July 2009 when the initial authorisation expires.

(7)

With regard to the importance of the dengue epidemic in the French overseas department of Guiana, the current unavailability of insecticidal products other than malathion in the said department, and the risk that alternatives will not be available when the temporary authorisation granted by France expires, it is appropriate to allow France to extend the temporary authorisation until alternative insecticidal products are available but at the latest until 1 November 2009.

(8)

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

(a)

such biocidal products shall be used only under the control of public authorities;

(b)

such biocidal products shall be used only until appropriate alternative biocidal products complying with the provisions of Directive 98/8/EC are available in the Department of French Guiana.

4.7.2009   

EN

Official Journal of the European Union

L 175/18

(1)

In accordance with Article 18.1 of the Statute of the ESCB, national central banks of Member States that have adopted the euro (hereinafter the ‘NCBs’) and the European Central Bank (ECB) (hereinafter jointly the ‘Eurosystem central banks’) may operate in the financial markets by, among other things, buying and selling outright marketable instruments.

(2)

On 7 May 2009 and subsequently on 4 June 2009 the Governing Council decided that in view of the current exceptional circumstances prevailing in the market a programme (hereinafter the ‘covered bo nd purchase programme’ or the ‘programme’) should be initiated under which the NCBs and exceptionally the ECB in direct contact with counterparties may according to their allocated share purchase outright eligible covered bonds. The Eurosystem central banks intend to implement the covered bond purchase programme gradually, taking into account market conditions and the Eurosystem’s monetary policy needs. The objectives of these purchases are to contribute to: (a) promoting the ongoing decline in money market term rates; (b) easing funding conditions for credit institutions and enterprises; (c) encouraging credit institutions to maintain and expand their lending to clients; and (d) improving market liquidity in important segments of the private debt securities market.

(3)

As part of the single monetary policy, the outright purchase of eligible covered bonds by Eurosystem central banks under the programme should be implemented in a uniform manner, in accordance with the terms of this Decision,

1.

They shall be either (i) covered bonds issued in accordance with the criteria set out in Article 22(4) of the UCITS Directive (2) (hereinafter the ‘UCITS-compliant covered bonds’), or (ii) structured covered bonds that a Eurosystem central bank at its sole discretion considers as offering safeguards similar to UCITS-compliant covered bonds.

2.

Each covered bond issue shall, as a rule, have a minimum issue size of EUR 500 million. In special cases, a Eurosystem central bank may decide to purchase outright covered bonds with an issue size of below EUR 500 million, provided that the issue size is not below EUR 100 million, when this Eurosystem central bank decides at its sole discretion that specific market circumstances or risk management considerations require such purchase.

3.

The covered bond issue shall, as a rule, have a minimum rating of ‘AA’ or equivalent, awarded by at least one of the major rating agencies.

4.

If the issuer of the covered bond is an entity (other than a credit institution) incorporated in the euro area, the conditions shall be that (i) such an entity only issues covered bonds, and (ii) the covered bonds are guaranteed in a manner satisfactory to the relevant Eurosystem central bank by a credit institution incorporated in the euro area, or, alternatively, have safeguards of a similar nature that satisfy the requirements of the relevant Eurosystem central bank.

5.

The covered bonds shall be issued pursuant to legislation governing covered bonds that is in force in a euro area Member State. In the case of structured covered bonds, the law governing the documentation of the covered bonds shall be the law of a euro area Member State.