23.4.2010   

EN

Official Journal of the European Union

L 102/1

(1)

Regulation No 19/65/EEC empowers the Commission to apply Article 101(3) of the Treaty on the Functioning of the European Union (2) by regulation to certain categories of vertical agreements and corresponding concerted practices falling within Article 101(1) of the Treaty.

(2)

Commission Regulation (EC) No 2790/1999 of 22 December 1999 on the application of Article 81(3) of the Treaty to categories of vertical agreements and concerted practices (3) defines a category of vertical agreements which the Commission regarded as normally satisfying the conditions laid down in Article 101(3) of the Treaty. In view of the overall positive experience with the application of that Regulation, which expires on 31 May 2010, and taking into account further experience acquired since its adoption, it is appropriate to adopt a new block exemption regulation.

(3)

The category of agreements which can be regarded as normally satisfying the conditions laid down in Article 101(3) of the Treaty includes vertical agreements for the purchase or sale of goods or services where those agreements are concluded between non-competing undertakings, between certain competitors or by certain associations of retailers of goods. It also includes vertical agreements containing ancillary provisions on the assignment or use of intellectual property rights. The term ‘vertical agreements’ should include the corresponding concerted practices.

(4)

For the application of Article 101(3) of the Treaty by regulation, it is not necessary to define those vertical agreements which are capable of falling within Article 101(1) of the Treaty. In the individual assessment of agreements under Article 101(1) of the Treaty, account has to be taken of several factors, and in particular the market structure on the supply and purchase side.

(5)

The benefit of the block exemption established by this Regulation should be limited to vertical agreements for which it can be assumed with sufficient certainty that they satisfy the conditions of Article 101(3) of the Treaty.

(6)

Certain types of vertical agreements can improve economic efficiency within a chain of production or distribution by facilitating better coordination between the participating undertakings. In particular, they can lead to a reduction in the transaction and distribution costs of the parties and to an optimisation of their sales and investment levels.

(7)

The likelihood that such efficiency-enhancing effects will outweigh any anti-competitive effects due to restrictions contained in vertical agreements depends on the degree of market power of the parties to the agreement and, therefore, on the extent to which those undertakings face competition from other suppliers of goods or services regarded by their customers as interchangeable or substitutable for one another, by reason of the products' characteristics, their prices and their intended use.

(8)

It can be presumed that, where the market share held by each of the undertakings party to the agreement on the relevant market does not exceed 30 %, vertical agreements which do not contain certain types of severe restrictions of competition generally lead to an improvement in production or distribution and allow consumers a fair share of the resulting benefits.

(9)

Above the market share threshold of 30 %, there can be no presumption that vertical agreements falling within the scope of Article 101(1) of the Treaty will usually give rise to objective advantages of such a character and size as to compensate for the disadvantages which they create for competition. At the same time, there is no presumption that those vertical agreements are either caught by Article 101(1) of the Treaty or that they fail to satisfy the conditions of Article 101(3) of the Treaty.

(10)

This Regulation should not exempt vertical agreements containing restrictions which are likely to restrict competition and harm consumers or which are not indispensable to the attainment of the efficiency-enhancing effects. In particular, vertical agreements containing certain types of severe restrictions of competition such as minimum and fixed resale-prices, as well as certain types of territorial protection, should be excluded from the benefit of the block exemption established by this Regulation irrespective of the market share of the undertakings concerned.

(11)

In order to ensure access to or to prevent collusion on the relevant market, certain conditions should be attached to the block exemption. To this end, the exemption of non-compete obligations should be limited to obligations which do not exceed a defined duration. For the same reasons, any direct or indirect obligation causing the members of a selective distribution system not to sell the brands of particular competing suppliers should be excluded from the benefit of this Regulation.

(12)

The market-share limitation, the non-exemption of certain vertical agreements and the conditions provided for in this Regulation normally ensure that the agreements to which the block exemption applies do not enable the participating undertakings to eliminate competition in respect of a substantial part of the products in question.

(13)

The Commission may withdraw the benefit of this Regulation, pursuant to Article 29(1) of Council Regulation (EC) No 1/2003 of 16 December 2002 on the implementation of the rules on competition laid down in Articles 81 and 82 of the Treaty (4), where it finds in a particular case that an agreement to which the exemption provided for in this Regulation applies nevertheless has effects which are incompatible with Article 101(3) of the Treaty.

(14)

The competition authority of a Member State may withdraw the benefit of this Regulation pursuant to Article 29(2) of Regulation (EC) No 1/2003 in respect of the territory of that Member State, or a part thereof where, in a particular case, an agreement to which the exemption provided for in this Regulation applies nevertheless has effects which are incompatible with Article 101(3) of the Treaty in the territory of that Member State, or in a part thereof, and where such territory has all the characteristics of a distinct geographic market.

(15)

In determining whether the benefit of this Regulation should be withdrawn pursuant to Article 29 of Regulation (EC) No 1/2003, the anti-competitive effects that may derive from the existence of parallel networks of vertical agreements that have similar effects which significantly restrict access to a relevant market or competition therein are of particular importance. Such cumulative effects may for example arise in the case of selective distribution or non compete obligations.

(16)

In order to strengthen supervision of parallel networks of vertical agreements which have similar anti-competitive effects and which cover more than 50 % of a given market, the Commission may by regulation declare this Regulation inapplicable to vertical agreements containing specific restraints relating to the market concerned, thereby restoring the full application of Article 101 of the Treaty to such agreements,

(a)

‘vertical agreement’ means an agreement or concerted practice entered into between two or more undertakings each of which operates, for the purposes of the agreement or the concerted practice, at a different level of the production or distribution chain, and relating to the conditions under which the parties may purchase, sell or resell certain goods or services;

(b)

‘vertical restraint’ means a restriction of competition in a vertical agreement falling within the scope of Article 101(1) of the Treaty;

(c)

‘competing undertaking’ means an actual or potential competitor; ‘actual competitor’ means an undertaking that is active on the same relevant market; ‘potential competitor’ means an undertaking that, in the absence of the vertical agreement, would, on realistic grounds and not just as a mere theoretical possibility, in case of a small but permanent increase in relative prices be likely to undertake, within a short period of time, the necessary additional investments or other necessary switching costs to enter the relevant market;

(d)

‘non-compete obligation’ means any direct or indirect obligation causing the buyer not to manufacture, purchase, sell or resell goods or services which compete with the contract goods or services, or any direct or indirect obligation on the buyer to purchase from the supplier or from another undertaking designated by the supplier more than 80 % of the buyer's total purchases of the contract goods or services and their substitutes on the relevant market, calculated on the basis of the value or, where such is standard industry practice, the volume of its purchases in the preceding calendar year;

(e)

‘selective distribution system’ means a distribution system where the supplier undertakes to sell the contract goods or services, either directly or indirectly, only to distributors selected on the basis of specified criteria and where these distributors undertake not to sell such goods or services to unauthorised distributors within the territory reserved by the supplier to operate that system;

(f)

‘intellectual property rights’ includes industrial property rights, know how, copyright and neighbouring rights;

(g)

‘know-how’ means a package of non-patented practical information, resulting from experience and testing by the supplier, which is secret, substantial and identified: in this context, ‘secret’ means that the know-how is not generally known or easily accessible; ‘substantial’ means that the know-how is significant and useful to the buyer for the use, sale or resale of the contract goods or services; ‘identified’ means that the know-how is described in a sufficiently comprehensive manner so as to make it possible to verify that it fulfils the criteria of secrecy and substantiality;

(h)

‘buyer’ includes an undertaking which, under an agreement falling within Article 101(1) of the Treaty, sells goods or services on behalf of another undertaking;

(i)

‘customer of the buyer’ means an undertaking not party to the agreement which purchases the contract goods or services from a buyer which is party to the agreement.

(a)

undertakings in which a party to the agreement, directly or indirectly:

(b)

undertakings which directly or indirectly have, over a party to the agreement, the rights or powers listed in point (a);

(c)

undertakings in which an undertaking referred to in point (b) has, directly or indirectly, the rights or powers listed in point (a);

(d)

undertakings in which a party to the agreement together with one or more of the undertakings referred to in points (a), (b) or (c), or in which two or more of the latter undertakings, jointly have the rights or powers listed in point (a);

(e)

undertakings in which the rights or the powers listed in point (a) are jointly held by:

(a)

the supplier is a manufacturer and a distributor of goods, while the buyer is a distributor and not a competing undertaking at the manufacturing level; or

(b)

the supplier is a provider of services at several levels of trade, while the buyer provides its goods or services at the retail level and is not a competing undertaking at the level of trade where it purchases the contract services.

(a)

the restriction of the buyer's ability to determine its sale price, without prejudice to the possibility of the supplier to impose a maximum sale price or recommend a sale price, provided that they do not amount to a fixed or minimum sale price as a result of pressure from, or incentives offered by, any of the parties;

(b)

the restriction of the territory into which, or of the customers to whom, a buyer party to the agreement, without prejudice to a restriction on its place of establishment, may sell the contract goods or services, except:

(c)

the restriction of active or passive sales to end users by members of a selective distribution system operating at the retail level of trade, without prejudice to the possibility of prohibiting a member of the system from operating out of an unauthorised place of establishment;

(d)

the restriction of cross-supplies between distributors within a selective distribution system, including between distributors operating at different level of trade;

(e)

the restriction, agreed between a supplier of components and a buyer who incorporates those components, of the supplier’s ability to sell the components as spare parts to end-users or to repairers or other service providers not entrusted by the buyer with the repair or servicing of its goods.

(a)

any direct or indirect non-compete obligation, the duration of which is indefinite or exceeds five years;

(b)

any direct or indirect obligation causing the buyer, after termination of the agreement, not to manufacture, purchase, sell or resell goods or services;

(c)

any direct or indirect obligation causing the members of a selective distribution system not to sell the brands of particular competing suppliers.

(a)

the obligation relates to goods or services which compete with the contract goods or services;

(b)

the obligation is limited to the premises and land from which the buyer has operated during the contract period;

(c)

the obligation is indispensable to protect know-how transferred by the supplier to the buyer;

(d)

the duration of the obligation is limited to a period of one year after termination of the agreement.

(a)

the market share of the supplier shall be calculated on the basis of market sales value data and the market share of the buyer shall be calculated on the basis of market purchase value data. If market sales value or market purchase value data are not available, estimates based on other reliable market information, including market sales and purchase volumes, may be used to establish the market share of the undertaking concerned;

(b)

the market shares shall be calculated on the basis of data relating to the preceding calendar year;

(c)

the market share of the supplier shall include any goods or services supplied to vertically integrated distributors for the purposes of sale;

(d)

if a market share is initially not more than 30 % but subsequently rises above that level without exceeding 35 %, the exemption provided for in Article 2 shall continue to apply for a period of two consecutive calendar years following the year in which the 30 % market share threshold was first exceeded;

(e)

if a market share is initially not more than 30 % but subsequently rises above 35 %, the exemption provided for in Article 2 shall continue to apply for one calendar year following the year in which the level of 35 % was first exceeded;

(f)

the benefit of points (d) and (e) may not be combined so as to exceed a period of two calendar years;

(g)

the market share held by the undertakings referred to in point (e) of the second subparagraph of Article 1(2) shall be apportioned equally to each undertaking having the rights or the powers listed in point (a) of the second subparagraph of Article 1(2).

23.4.2010   

EN

Official Journal of the European Union

L 102/8

(1)

Commission Regulation (EC) No 1580/2007 of 21 December 2007 laying down implementing rules of Council Regulations (EC) No 2200/96, (EC) No 2201/96 and (EC) No 1182/2007 in the fruit and vegetable sector (2) provides for surveillance of imports of the products listed in Annex XVII thereto. That surveillance is to be carried out in accordance with the rules laid down in Article 308d of Commission Regulation (EEC) No 2454/93 of 2 July 1993 laying down provisions for the implementation of Council Regulation (EEC) No 2913/92 establishing the Community Customs Code (3).

(2)

For the purposes of applying Article 5(4) of the Agreement on Agriculture (4) concluded as part of the Uruguay Round of multilateral trade negotiations and in the light of the latest data available for 2007, 2008 and 2009, the trigger levels for additional duties on cucumbers and cherries, other than sour cherries, should be adjusted.

(3)

Regulation (EC) No 1580/2007 should therefore be amended accordingly.

(4)

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

23.4.2010   

EN

Official Journal of the European Union

L 102/10

(1)

Directive 2002/99/EC lays down the general animal health rules governing all stages of the production, processing and distribution within the Union and the introduction from third countries of products of animal origin and products obtained therefrom intended for human consumption. That Directive provides that special import conditions are to be established for each third country or group of third countries, having regard to their animal health situation.

(2)

Directive 2009/158/EC lays down the animal health conditions governing trade within the Union and imports from third countries of poultry and hatching eggs. That Directive provides that poultry is to come from third countries free of avian influenza or which, although they are not free from that disease, apply measures to control it which are at least equivalent to those laid down by the relevant Union legislation.

(3)

Commission Regulation (EC) No 798/2008 of 8 August 2008 laying down a list of third countries, territories, zones or compartments from which poultry and poultry products may be imported into and transit through the Community and the veterinary certification requirements (3) provides that the commodities covered by it are only to be imported into and transited through the Union from the third countries, territories, zones or compartments listed in the table in Part 1 of Annex I thereto.

(4)

Pursuant to that Regulation, where an outbreak of highly pathogenic avian influenza (HPAI) occurs in a third country, territory, zone or compartment previously free of that disease, that third country, territory, zone or compartment is to again be considered as free of HPAI, provided that certain conditions are met; said conditions concern the implementation of a stamping out policy to control the disease, including adequate cleansing and disinfection carried out on all previously infected establishments. In addition, avian influenza surveillance must have been carried out in accordance with Part II of Annex IV to that Regulation during a three-month period following completion of the stamping out policy and cleansing and disinfection.

(5)

Israel is currently listed in Part 1 of Annex I to Regulation (EC) No 798/2008 as a third country free from highly pathogenic avian influenza. Imports of poultry commodities to which that Regulation applies are therefore authorised from the whole territory of that third country.

(6)

Israel has notified to the Commission an outbreak of highly pathogenic avian influenza of the H5N1 subtype on its territory.

(7)

Due to the confirmed outbreak of HPAI, the territory of Israel may no longer be considered as free from that disease and the veterinary authorities of Israel have suspended issuing veterinary certificates for consignments of certain poultry commodities accordingly. Israel has also implemented a stamping out policy in order to control the disease and limit its spread.

(8)

The information on the control measures taken has been submitted to the Commission. That information and the epidemiological situation in Israel have been evaluated by the Commission.

(9)

The prompt and decisive action taken by Israel to confine the disease and the positive outcome of the evaluation of the epidemiological situation allows limiting the restrictions on imports into the Union for certain poultry commodities to the zones affected by the disease, which the veterinary authorities of Israel have placed under restrictions due to the outbreak of highly pathogenic avian influenza.

(10)

In addition, Israel is carrying out surveillance activities for avian influenza which appear to meet the requirements laid down in Part II of Annex IV to Regulation (EC) No 798/2008.

(11)

Taking into account the favourable development of the epidemiological situation and related surveillance activities for avian influenza in resolving the outbreak, it is appropriate to limit the time period during which the authorisation for imports into the Union is suspended until 1 May 2010.

(12)

Annex I to Regulation (EC) No 798/2008 should therefore be amended accordingly.

(13)

In order to implement the zoning requirements and thereby allowing trade to resume as soon as possible this Regulation should enter into force the day after publication.

(14)

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

23.4.2010   

EN

Official Journal of the European Union

L 102/19

(1)

Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such authorisation.

(2)

In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of the preparation set out in the Annex to this Regulation. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

(3)

The application concerns the authorisation of a new use of the preparation of Bacillus subtilis C-3102 (DSM 15544) as a feed additive for weaned piglets, to be classified in the additive category ‘zootechnical additives’.

(4)

The use of that micro-organism preparation has been authorised for chickens for fattening by Commission Regulation (EC) No 1444/2006 (2).

(5)

New data were submitted in support of the application for authorisation for weaned piglets. The European Food Safety Authority (the Authority) concluded in its opinion of 9 December 2009 (3) that Bacillus subtilis C-3102 (DSM 15544) does not have an adverse effect on animal health, human health or the environment and that the use of that preparation can improve the performance of the animals. The Authority does not consider that there is a need for specific requirements of post market monitoring. It also verified the report on the method of analysis of the feed additive in feed submitted by the Community Reference Laboratory set up by Regulation (EC) No 1831/2003.

(6)

The assessment of Bacillus subtilis C-3102 (DSM 15544) shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of that preparation should be authorised, as specified in the Annex to this Regulation.

(7)

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

23.4.2010   

EN

Official Journal of the European Union

L 102/21

(1)

Commission Regulation (EC) No 721/2008 (2) authorises a preparation of red carotenoid-rich bacterium Paracoccus carotinifaciens as a feed additive for salmon and trout until 15 August 2018. That feed additive is classified in the category ‘sensory additives’, functional group ‘a (ii). Colourants; substances which when fed to animals add colours to food of animal origin’.

(2)

The Commission received an application requesting a modification of the conditions of the authorisation as regards the composition of the feed additive. That application was accompanied by the relevant supporting data. The Commission forwarded that application to the European Food Safety Authority (the Authority).

(3)

The Authority concluded in its opinion of January 2010 that the requested modification would not affect the safety and efficacy of the product (3).

(4)

The assessment of the modified preparation shows that it satisfies the conditions for authorisation, provided for in Article 5 of Regulation (EC) No 1831/2003.

(5)

Regulation (EC) No 721/2008 should therefore be amended accordingly.

(6)

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

the words

are replaced by the words

23.4.2010   

EN

Official Journal of the European Union

L 102/22

(1)

Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such authorisation.

(2)

In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of the preparation set out in the Annex to this Regulation. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

(3)

The application concerns the authorisation of zinc chelate of hydroxy analogue of methionine as a feed additive for all animal species, to be classified in the additive category ‘nutritional additives’.

(4)

From the opinion of the European Food Safety Authority (‘the Authority’) adopted on 11 November 2009 (2), read in combination with those of 16 April 2008 (3) and 2 April 2009 (4) it results that zinc chelate of hydroxy analogue of methionine does not have an adverse effect on animal health, human health or the environment. According to the opinion of 16 April 2008, the use of that preparation may be considered as a source of available zinc and fulfils the criteria of a nutritional additive for all animal species. The Authority recommends appropriate measures for user safety. It does not consider that there is a need for specific requirements of post market monitoring. It also verified the report on the method of analysis of the feed additive in feed submitted by the Community Reference Laboratory set up by Regulation (EC) No 1831/2003.

(5)

The assessment of that preparation shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of that preparation should be authorised, as specified in the Annex to this Regulation.

(6)

By Commission Regulation (EC) No 888/2009 of 25 September 2009 concerning the authorisation of Zinc chelate of hydroxy analogue of methionine as a feed additive for chickens for fattening (5) that preparation was already authorised as a feed additive for chickens for fattening. That Regulation should be repealed.

(7)

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

23.4.2010   

EN

Official Journal of the European Union

L 102/25

(1)

In order to ensure uniform application of the Combined Nomenclature annexed to Regulation (EEC) No 2658/87, it is necessary to adopt measures concerning the classification of the goods referred to in the Annex to this Regulation.

(2)

Regulation (EEC) No 2658/87 has laid down the general rules for the interpretation of the Combined Nomenclature. Those rules apply also to any other nomenclature which is wholly or partly based on it or which adds any additional subdivision to it and which is established by specific provisions of the Union, with a view to the application of tariff and other measures relating to trade in goods.

(3)

Pursuant to those general rules, the goods described in column 1 of the table set out in the Annex should be classified under the CN codes indicated in column 2, by virtue of the reasons set out in column 3 of that table.

(4)

It is appropriate to provide that binding tariff information which has been issued by the customs authorities of Member States in respect of the classification of goods in the Combined Nomenclature but which is not in accordance with this Regulation can, for a period of three months, continue to be invoked by the holder, under Article 12(6) of Council Regulation (EEC) No 2913/92 of 12 October 1992 establishing the Community Customs Code (2).

(5)

The measures provided for in this Regulation are in accordance with the opinion of the Customs Code Committee,

23.4.2010   

EN

Official Journal of the European Union

L 102/27

23.4.2010   

EN

Official Journal of the European Union

L 102/29

(1)

Article 162(1) of Regulation (EC) No 1234/2007 provides that the difference between prices on the world market for the products listed in Part XV of Annex I to 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 beef and veal, export refunds should therefore be set in accordance with the rules and criteria provided for in Articles 162 to 164 and 167 to 170 of Regulation (EC) No 1234/2007.

(3)

Article 164(1) of Regulation (EC) No 1234/2007 provides that the refund may vary according to destination, especially where the world market situation, the specific requirements of certain markets, or obligations resulting from agreements concluded in accordance with Article 300 of the Treaty make this necessary.

(4)

Refunds should be granted only on products that are allowed to move freely in the Community and that bear the health mark as provided for in Article 5(1)(a) of Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific hygiene rules for food of animal origin (2). Those products must also satisfy the requirements laid down in Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs (3) and Regulation (EC) No 854/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific rules for the organisation of official controls on products of animal origin intended for human consumption (4).

(5)

The conditions laid down in the third subparagraph of Article 7(2) of Commission Regulation (EC) No 1359/2007 of 21 November 2007 laying down the conditions for granting special export refunds on certain cuts of boned meat of bovine animals (5) provide for a reduction of the special refund if the quantity of cuts of boned meat to be exported amounts to less than 95 %, but not less than 85 %, of the total weight of cuts produced by boning.

(6)

Commission Regulation (EC) No 62/2010 (6) should therefore be repealed and replaced by a new regulation.

(7)

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

23.4.2010   

EN

Official Journal of the European Union

L 102/33

(1)

Commission Regulation (EC) No 619/2008 of 27 June 2008 opening a standing invitation to tender for export refunds concerning certain milk products (2) provides for a permanent tender.

(2)

Pursuant to Article 6 of Commission Regulation (EC) No 1454/2007 of 10 December 2007 laying down common rules for establishing a tender procedure for fixing export refunds for certain agricultural 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 20 April 2010.

(3)

The Management Committee for the Common Organisation of Agricultural Markets has not delivered an opinion within the time limit set by its Chair,

23.4.2010   

EN

Official Journal of the European Union

L 102/34

(1)

Commission Regulation (EC) No 619/2008 of 27 June 2008 opening a standing invitation to tender for export refunds concerning certain milk products (2) provides for a standing invitation to tender procedure.

(2)

Pursuant to Article 6 of Commission Regulation (EC) No 1454/2007 of 10 December 2007 laying down common rules for establishing a tender procedure for fixing export refunds for certain agricultural 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 20 April 2010.

(3)

The Management Committee for the Common Organisation of Agricultural Markets has not delivered an opinion within the time limit set by its Chair,

23.4.2010   

EN

Official Journal of the European Union

L 102/35

(1)

Article 162(1) of Regulation (EC) No 1234/2007 provides that the difference between prices on the world market for the products referred to in Part XIX of Annex I to that Regulation and prices in the Community for those products may be covered by an export refund.

(2)

In view of the current situation on the market in eggs, export refunds should be fixed in accordance with the rules and certain criteria provided for in Articles 162 to 164, 167, 169 and 170 of Regulation (EC) No 1234/2007.

(3)

Article 164(1) of Regulation (EC) No 1234/2007 provides that refunds may vary according to destination, especially where the world market situation, the specific requirements of certain markets, or obligations resulting from agreements concluded in accordance with Article 300 of the Treaty make this necessary.

(4)

Refunds should be granted only on products which are authorised to move freely within the Community and comply with requirements under Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs (2) and of Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific hygiene rules for food of animal origin (3), as well as marking requirements under point A of Annex XIV to Regulation (EC) No 1234/2007.

(5)

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

23.4.2010   

EN

Official Journal of the European Union

L 102/37

(1)

Article 162(1) of Regulation (EC) No 1234/2007 provides that the difference between prices on the world market for the products referred to in Part XX of Annex I to that Regulation and prices in the Community for those products may be covered by an export refund.

(2)

In view of the current situation on the market in poultrymeat, export refunds should be fixed in accordance with the rules and criteria provided for in Articles 162 to 164, 167, 169 and 170 of Regulation (EC) No 1234/2007.

(3)

Article 164(1) of Regulation (EC) No 1234/2007 provides that refunds may vary according to destination, especially where the world market situation, the specific requirements of certain markets, or obligations resulting from agreements concluded in accordance with Article 300 of the Treaty make this necessary.

(4)

Refunds should be granted only on products which are authorised to move freely in the Community and bear the identification mark provided for in Article 5(1)(b) of Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific hygiene rules for food of animal origin (2). Those products should also comply with the requirements of Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs (3).

(5)

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

23.4.2010   

EN

Official Journal of the European Union

L 102/39

(1)

Article 162(1) of Regulation (EC) No 1234/2007 provides that the difference between prices on the world market for the products listed in Part XVII of Annex I to 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 pigmeat, export refunds should therefore be fixed in accordance with the rules and criteria provided for in Articles 162 to 164, 167, 169 and 170 of Regulation (EC) No 1234/2007.

(3)

Article 164(1) of Regulation (EC) No 1234/2007 provides that the refund may vary according to destination, especially where the world market situation, the specific requirements of certain markets, or obligations resulting from agreements concluded in accordance with Article 300 of the Treaty make this necessary.

(4)

Refunds should be granted only on products that are allowed to move freely in the Community and that bear the health mark as provided for in Article 5(1)(a) of Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific hygiene rules for food of animal origin (2). Those products must also satisfy the requirements laid down in Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs (3) and Regulation (EC) No 854/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific rules for the organisation of official controls on products of animal origin intended for human consumption (4).

(5)

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

23.4.2010   

EN

Official Journal of the European Union

L 102/41

(1)

Commission Regulation (EC) No 1484/95 (3) lays down detailed rules for implementing the system of additional import duties and fixes representative prices for poultrymeat and egg products and for egg albumin.

(2)

Regular monitoring of the data used to determine representative prices for poultrymeat and egg products and for egg albumin shows that the representative import prices for certain products should be amended to take account of variations in price according to origin. The representative prices should therefore be published.

(3)

In view of the situation on the market, this amendment should be applied as soon as possible.

(4)

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

23.4.2010   

EN

Official Journal of the European Union

L 102/43

(1)

Article 162(1)b of Regulation (EC) No 1234/2007 provides that the difference between prices in international trade for the products referred to in Article 1(1)(s) and listed in Part XIX of Annex 1 to of that Regulation and prices within the Community may be covered by an export refund where these goods are exported in the form of goods listed Part V of the Annex XX to that Regulation.

(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 (2), 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 Part V of Annex XX to Regulation (EC) No 1234/2007.

(3)

In accordance with paragraph 2(b) 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 for a period of the same duration as that for which refunds are fixed for the same products exported unprocessed.

(4)

Article 11 of the Agreement on Agriculture concluded under the Uruguay Round lays down that the export refund for a product contained in a good may not exceed the refund applicable to that product when exported without further processing.

(5)

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

23.4.2010   

EN

Official Journal of the European Union

L 102/45

(1)

Directives 90/385/EEC, 93/42/EEC and 98/79/EC contain provisions on a European databank for medical devices which require the establishment of that databank.

(2)

The aim of the European databank for medical devices is to strengthen market surveillance by providing competent authorities with fast access to information on manufacturers and authorised representatives, devices and certificates and to vigilance data, to share information on clinical investigation data, as well as to contribute to a uniform application of those Directives, in particular in relation to registration requirements.

(3)

The databank should therefore contain the data required by Directives 90/385/EEC, 93/42/EEC and 98/79/EC, in particular on registration of manufacturers and devices, data relating to certificates issued or renewed, modified, supplemented, suspended, withdrawn or refused, data obtained in accordance with the vigilance procedure and data on clinical investigations.

(4)

Such a databank has been developed by the European Commission in cooperation with the Member States under the name ‘European Databank for Medical Devices (Eudamed)’ and is being used by numerous Member States on a voluntary basis.

(5)

The data should be entered into the databank using prescribed data transfer methods.

(6)

It is appropriate to use an internationally recognised nomenclature for medical devices when entering data into Eudamed in order to allow a uniform description of the devices concerned and efficient use of that databank. Given that data can be entered in all official languages of the Community, a numeric code should be used so that devices can be easily searched.

(7)

The Global Medical Device Nomenclature that has been developed based on EN ISO 15225:2000 Nomenclature — Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange is such an internationally recognised nomenclature. The need to establish and maintain Eudamed and to start implementing the Global Medical Device Nomenclature as a basis for that databank was recalled in the Council Conclusions of 2 December 2003 on Medical Devices (4).

(8)

An appropriate transitional period is necessary to allow Member States to prepare for the mandatory use of Eudamed and to take account of the changes introduced by Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market (5).

(9)

Member States should only be required to enter data existing before 1 May 2011 to the extent required for the future functioning of Eudamed. It is necessary for the completeness of Eudamed to enter data existing before 1 May 2011 on the manufacturer, the authorised representative and on device registration, which are required by Directives 93/42/EEC and 98/79/EC, in the form in which such data are available at national level.

(10)

The measures provided for in this Decision are in accordance with the opinion of the Committee on Medical Devices,

23.4.2010   

EN

Official Journal of the European Union

L 102/49