(1)

Directive 2000/75/EC lays down control rules and measures to combat and eradicate bluetongue, including rules on the establishment of protection and surveillance zones, the implementation of vaccination programmes, and an exit ban on animals leaving those zones.

(2)

Commission Regulation (EC) No 1266/2007 (2) lays down rules for the control, monitoring, surveillance and restrictions on movements of animals, in relation to bluetongue, in and from a protection and surveillance zone (restricted zone).

(3)

Annex III to that Regulation establishes the conditions for exemptions from the exit ban applicable to movements of susceptible animals, their semen, ova and embryos provided for in Directive 2000/75/EC.

(4)

According to the opinion of the Scientific Panel on animal health and welfare of the EFSA on vectors and vaccines (3), adopted on 27 April 2007, vaccination is a suitable tool for the control of bluetongue and for avoiding clinical outbreaks and therefore to limit the losses of farmers.

(5)

The vaccination of animals against bluetongue represents a major change of the immune status of the susceptible population. The proof of the absence of general or specific bluetongue virus serotype or serotypes circulation in a part of the restricted zone should be made by the Member States by means of the results of the bluetongue monitoring programmes in place pursuant to Regulation (EC) No 1266/2007. Such monitoring programmes should include passive clinical surveillance and active laboratory-based surveillance by means of at least monitoring with sentinel animals.

(6)

Laboratory-based surveillance by means sentinel animals should not be restricted only to serological test but it may also be carried out by other diagnostic methods, namely agent identification tests.

(7)

Vaccination in the absence of virus circulation should not be discouraged and preventive vaccination in restricted zones without virus circulation should not be impeded. However, pursuant to Directive 2000/75/EC, vaccination against bluetongue is only permitted within the protection zone. Article 7(1) of Regulation (EC) No 1266/2007 provides that movements of animals within the same restricted zone where the same bluetongue virus serotype or serotypes are circulating are to be allowed by the competent authority provided that the animals to be moved do not show any clinical signs of bluetongue on the day of transport, assuming that these animals do not pose an additional risk to animal health.

(8)

Areas where vaccination has been applied and where there is no circulation of specific bluetongue virus serotype or serotypes present a lower risk than the other areas which are part of the restricted zone where there is virus circulation. Therefore, Member States should be permitted to demarcate, within the protection zone areas where vaccination has been applied and where there is no circulation of specific bluetongue virus serotype or serotypes. The intention to demarcate these areas should be notified to the Commission, together with all information demonstrating that it is justified. The other Member States should be also informed of such demarcation.

(9)

Article 7(2) of that Regulation permits movements of animals from a protection zone to a surveillance zone, subject to certain conditions. Movements of animals within the same restricted zone, from a part of that zone with virus circulation to a part with vaccination and without virus circulation should be permitted under conditions similar to those required for movements of animals from a protection zone to a surveillance zone within the same restricted zone to limit the risk of virus spread into the part of the restricted zone with vaccination and without virus circulation. Therefore, the current rules for movements of animals within the same restricted zone where the same bluetongue virus serotype or serotypes are circulating should be amended.

(10)

Movements of animals from a part of a restricted zone with vaccination and without virus circulation to an area outside the restricted zone are currently permitted subject to the same conditions as those applied when animals are moved from a restricted zone with virus circulation to an area outside the restricted zone. However, taking into account the relative low level of risk of movements of animals from a part of a restricted zone with vaccination and without virus circulation, it is appropriate to permit such movements under less strict conditions as regards the virus identification test that is required for certain categories of vaccinated animals. Annex III to Regulation (EC) No 1266/2007 should therefore be amended accordingly.

(11)

Regulation (EC) No 1266/2007 should therefore be amended accordingly.

(12)

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

1.

Article 7 is amended as follows:

2.

in Annex I, point 1.1.2.1. is replaced by the following:

1.1.2.1.   Monitoring with sentinel animals:

(*1)  It has been estimated that 20 % is the normal annual rate of seroconversion in an infected zone. However, in the Community, virus circulation mainly takes place in a period of around six months (end of spring/mid-autumn). Therefore 2 % is a conservative estimation of the expected monthly rate of seroconversion.’ "

3.

in Annex III, Section A is amended as follows:

(1)

Coccidiostats and histomonostats are substances intended to kill or inhibit protozoa, which may, inter alia, be authorised for use as feed additives in accordance with Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (2). Authorisations of coccidiostats and histomonostats as feed additives lay down specific conditions for use such as the target animal species or categories for which the additives are intended.

(2)

Feed business operators may produce within one establishment a broad range of feeds and different types of products may have to be manufactured after each other in the same production line. It may happen that unavoidable traces of a product remain in the production line and end up in the beginning of the production of another feed product. This transfer from one production lot to another is called ‘carry-over’ or ‘cross-contamination’ and may occur for instance when coccidiostats or histomonostats are used as authorised feed additives. This may result in the contamination of feed produced subsequently by the presence of technically unavoidable traces of those substances in ‘non-target feed’, i.e. in feed for which the use of coccidiostats or histomonostats are not authorised, such as feed intended for animal species or categories not provided for in the additive authorisation. This unavoidable cross-contamination may occur at all stages of production and processing of feed but also during storage and transport of feed.

(3)

In order to prevent the adoption by Member States of national rules addressing the issue of unavoidable carry-over of authorised coccidiostats or histomonostats in non-target feed and their resulting presence in derived foodstuffs, which would hinder the functioning of the internal market, it is necessary to adopt harmonised Community rules in this matter.

(4)

The unavoidable carry-over in non-target feed of active substances contained in authorised coccidiostats and histomonostats are considered as undesirable substances in animal feed within the meaning of Directive 2002/32/EC of the European Parliament and of the Council (3) and their presence should not endanger animal health, human health or the environment. Therefore, maximum levels for these substances in animal feed are established by Commission Directive 2009/8/EC (4) amending Annex I to Directive 2002/32/EC.

(5)

The occurrence of unavoidable carry-over of coccidiostats and histomonostats in non-target feed, even below maximum levels set under Directive 2002/32/EC, may result in the presence of residues of these substances in food products of animal origin. Therefore, in order to protect public health, and insofar there is no maximum residue limit (MRL) yet fixed for the specific food concerned in the frame of Council Regulation (EEC) No 2377/90 of 26 June 1990 laying down a Community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin (5) or in the frame of Regulation (EC) No 1831/2003, maximum tolerances for the presence of active substances contained in coccidiostats and histomonostats should be established in food of animal origin originating from the non-target feed concerned, in the context of Regulation (EEC) No 315/93 laying down Community procedures for contaminants in food.

(6)

On a request from the Commission, the European Food Safety Authority (‘the Authority’) adopted several opinions (6) on the risks involved for animal health and public health as the consequence of unavoidable carry-over of coccidiostats or histomonostats authorised as feed additives into non-target feed. For each coccidiostat or histomonostat authorised as feed additive, the Authority's assessment took into account hypothetical carry-over rates of 2 %, 5 % and 10 % from feed produced with the highest authorised dose of the coccidiostats or histomonostats into the afterwards produced non-target feed.

(7)

Considering the conclusions of the individual scientific opinions, it can be stated that generally the Authority concluded that the presence of the coccidiostats or histomonostats authorised as feed additives, in non-target feed at levels resulting from an unavoidable carry-over, and taking into account all prevention measures, is unlikely to result in adverse animal health effects and that the risk to consumers' health from the ingestion of residues in products from animals exposed to cross-contaminated feed is negligible.

(8)

Taking into account the Authority's opinions and the currently different approaches applied in the Member States to address the unavoidable cross-contamination, it is proposed to set maximum levels for food as laid down in the Annexes to this Regulation, in order to ensure a proper functioning of the internal market and to protect public health. The provisions provided in Annex should be reviewed by 1 July 2011 at the latest to take account of developments in scientific and technical knowledge.

(9)

The maximum levels set in the Annex to this Regulation should be continuously adapted to changes of maximum residue levels (MRL) established for the specific food concerned in the frame of Regulation (EEC) No 2377/90 laying down a Community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin or in the frame of Regulation (EC) No 1831/2003. In view of the occurrence of a possible time gap between these amendments and the consequent adaptation to the maximum levels laid down in the Annex to this Regulation, the latter should be considered as without prejudice to the maximum residue levels of coccidiostats or histomonostats established in the frame of Regulation (EEC) No 2377/90 or in the frame of Regulation (EC) No 1831/2003.

(10)

Due to the fact that the unavoidable carry-over of coccidiostats or histomonostats into non-target feed may result in the presence of these substances as contaminants in derived food, it is appropriate to take a comprehensive and integrated approach to address the issue through the simultaneous adoption and application of this Regulation and the Directive 2009/8/EC setting maximum levels for the unavoidable carry-over of coccidiostats or histomonostats into non-target feed.

(11)

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

(1)

Directive 2000/29/EC lists organisms which are harmful to plants or plant products and provides for certain measures against their introduction into Member States from other Member States or third countries.

(2)

On the basis of information supplied by Member States and an examination of Annexes I, II, IV and V to Directive 2000/29/EC by experts, it is appropriate to amend the lists of harmful organisms in Annexes I and II to improve protection against the introduction of such organisms into the Community. All changes are based on technical and scientific evidence.

(3)

Taking into account increased international trade in plants and plant products, a phytosanitary protection of the Community is needed against the introduction of the following harmful organisms which are so far not known to be present in the Community: Dendrolimus sibiricus Tschetverikov; Rhynchophorus palmarum (L.); Agrilus planipennis Fairmaire on plants of Fraxinus L., Juglans mandshurica Maxim., Ulmus davidiana Planch., Ulmus parvifolia Jacq., and Pterocarya rhoifolia Siebold & Zucc., and only known to be present in Canada, China, Japan, Mongolia, Republic of Korea, Russia, Taiwan and the United States; Chrysanthemum stem necrosis virus on plants of Dendranthema (DC.) Des Moul. and Lycopersicon lycopersicum (L.) Karsten ex Farw.; Scrobipalpopsis solanivora (Povolny) on tubers of Solanum tuberosum L. and Stegophora ulmea (Schweinitz : Fries) Sydow & Sydow on plants of Ulmus L. and Zelkova L., intended for planting, other than seeds. In addition, the further spread of Paysandisia archon (Burmeister), found in some areas in the Community on 11 genera of Palmae and under official control, needs to be limited for the same reasons.

(4)

The names of Saissetia nigra (Nietm.) and Diabrotica virgifera Le Conte should be amended in line with the revised scientific denominations of those organisms. Saissetia nigra (Nietm.) has become Parasaissetia nigra (Nietner). Diabrotica virgifera Le Conte has been split into two subspecies, namely Diabrotica virgifera virgifera Le Conte, regionally present in the Community, and Diabrotica virgifera zeae Krysan & Smith, not present in the Community.

(5)

The listing of those organisms in Annexes I and II to Directive 2000/29/EC needs therefore to be amended.

(6)

Consequently, the relevant requirements in Annexes IV and V to Directive 2000/29/EC for the import or movement of host plants of harmful organisms referred to in Annexes I and II need to be amended to take account of the amended listing in Annexes I and II.

(7)

The CN code for wood of Acer saccharum Marsh. needs to be updated in Annex V, Part B to complete the list of CN codes for wood subject to import control.

(8)

Annexes I, II, IV and V to Directive 2000/29/EC should therefore be amended accordingly.

(9)

The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Plant Health,

(1)

Coccidiostats and histomonostats are substances intended to kill or inhibit protozoa, which may, inter alia, be authorised for use as feed additives in accordance with Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (2). Authorisations of coccidiostats and histomonostats as feed additives lay down specific conditions for use such as the target animal species or categories for which the additives are intended.

(2)

Feed business operators may produce within one establishment a broad range of feeds and different types of products may have to be manufactured after each other in the same production line. It may happen that unavoidable traces of a product remain in the production line and end up in the beginning of the production of another feed product. This transfer from one production lot to another is called ‘carry-over’ or ‘cross-contamination’ and may occur for instance when coccidiostats or histomonostats are used as authorised feed additives. This may result in the contamination of feed produced subsequently by the presence of technically unavoidable traces of those substances in ‘non-target feed’, i.e. in feed for which the use of coccidiostats or histomonostats are not authorised, such as feed intended for animal species or categories not provided for in the additive authorisation. This unavoidable cross-contamination may occur at all stages of production and processing of feed but also during storage and transport of feed.

(3)

Regulation (EC) No 183/2005 of the European Parliament and of the Council of 12 January 2005 laying down requirements for feed hygiene (3) provides for specific requirements for feed businesses using coccidiostats and histomonostats in the production of feed. In particular, the operators concerned have to take all appropriate measures concerning facilities and equipment, production, storage and transport in order to avoid any cross-contamination, and this in accordance with the obligations provided for in Articles 4 and 5 of the above mentioned Regulation. The establishment of maximum levels of unavoidable carry-over of coccidiostats and histomonostats in non-target feed in accordance with Directive 2002/32/EC should not interfere with the primary obligation of operators to apply good manufacturing practices aiming at avoiding this cross-contamination. Continued effort is therefore still needed by the operators concerned in order to avoid the presence of such undesirable substances in animal feed.

(4)

Taking into account the application of good manufacturing practices, the maximum levels of unavoidable carry-over of coccidiostats or histomonostats in non-target feed should be established following the ALARA (As Low As Reasonably Achievable) principle. For the purpose of enabling the feed manufacturer to manage the above mentioned unavoidable carry-over, a carry-over rate of approximately 3 % compared to the authorised maximum content should be considered as regards feed for less sensitive non-target animal species, while a carry-over rate of approximately 1 % compared to the authorised maximum content should be retained for feed intended to sensitive non-target animal species and ‘withdrawal feed’, i.e. feed used for the period before slaughter. The carry-over rate of 1 % should also be considered for cross-contamination of other feed for target species to which no coccidiostats or histomonostats are added, and as regards non-target feed for ‘continuous food-producing animals’, such as dairy cows or laying hens, where there is evidence of transfer from feed to food of animal origin. If feed materials are fed directly to the animals or if complementary feedingstuffs are used, their use in a daily ration should not lead to the animal being exposed to a higher levels of an coccidiostat or histomonostat than the corresponding maximum levels of exposure where only complete feedingstuffs are used in a daily ration.

(5)

In order to prevent the adoption by Member States of national rules addressing the issue of unavoidable carry-over of authorised coccidiostats or histomonostats in non-target feed and their resulting presence in derived foodstuffs, which would hinder the functioning of the internal market, it is necessary to adopt harmonised Community rules in this matter.

(6)

The unavoidable carry-over in non-target feed of active substances contained in authorised coccidiostats and histomonostats should be considered as undesirable substances in animal feed within the meaning of Directive 2002/32/EC and their presence should not endanger animal health, human health or the environment. Therefore, maximum levels for these substances in animal feed should be established within Annex I of the said Directive in order to prevent undesirable and harmful effects.

(7)

Where MRLs have been laid down in the frame of Council Regulation (EEC) No 2377/90 of 26 June 1990 laying down a Community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin (4) or in the frame of Regulation (EC) No 1831/2003, compliance with those provisions should be ensured when establishing maximum levels of unavoidable carry-over of coccidiostats or histomonostats in non-target feed.

(8)

The occurrence of unavoidable carry-over of coccidiostats and histomonostats in non-target feed, even below maximum levels that should be set under Directive 2002/32/EC, may result in the presence of residues of these substances in food products of animal origin. Therefore, in order to protect public health, and insofar there is no maximum residue limit (MRL) yet fixed for the specific food concerned, maximum tolerances for the presence of active substances contained in coccidiostats and histomonostats have been established by Commission Regulation (EC) No 124/2009 of 10 February 2009 setting maximum levels for the presence of coccidiostats or histomonostats in food resulting from the unavoidable carry-over of these substances in non-target feed (5), in the context of Council Regulation (EEC) No 315/93 of 8 February 1993 laying down Community procedures for contaminants in food (6).

(9)

On a request from the Commission, the European Food Safety Authority (the Authority) adopted several opinions (7) on the risks involved for animal health and public health as the consequence of unavoidable carry-over of coccidiostats or histomonostats authorised as feed additives into non-target feed. For each coccidiostat or histomonostat authorised as feed additive, the Authority’s assessment took into account hypothetical carry-over rates of 2 %, 5 % and 10 % from feed produced with the highest authorised dose of the coccidiostats or histomonostats into the afterwards produced non-target feed.

(10)

Considering the conclusions of the individual scientific opinions, it can be stated that generally the Authority concluded that the presence of the coccidiostats or histomonostats authorised as feed additives, in non-target feed at levels resulting from an unavoidable carry-over, and taking into account all prevention measures, is unlikely to result in adverse animal health effects and that the risk to consumers, health from the ingestion of residues in products from animals exposed to cross-contaminated feed is negligible.

(11)

Taking into account the Authority’s opinions and the currently different approaches applied in the Member States to address the unavoidable cross-contamination, it is proposed to set maximum levels for feed as laid down in the Annexes to this Directive, in order to ensure a proper functioning of the internal market and to protect animal and public health.

(12)

The establishment of maximum levels of undesirable substances in animal feed should take place through an adaptation of Annex I of Directive 2002/32/EC, as provided for in Article 8(1) of that Directive. When adapting the technical provisions in Annex I of Directive 2002/32/EC, developments in scientific and technical knowledge have been taken into account through the consideration of scientific opinions of the Authority and of the development of analytical methods in feed. The provisions provided in Annex should be reviewed by 1 July 2011 at the latest to take account of developments in scientific and technical knowledge.

(13)

The maximum levels set in the Annex to this Directive should be continuously adapted to the conditions of use provided for in the authorisations of coccidiostats and histomonostats as feed additives. In view of the occurrence of a possible time gap between the authorisation – or modification, suspension or revocation of the authorisation – of a coccidiostat or histomonostat as feed additive and the consequent amendment to the maximum levels laid down in the Annexes to this Directive, the latter should be considered as without prejudice to the levels of coccidiostats or histomonostats authorised as feed additives in the frame of Regulation (EC) No 1831/2003.

(14)

Due to the fact that the unavoidable carry-over of coccidiostats or histomonostats into non-target feed may result in the presence of these substances as contaminants in derived food, it is appropriate to take a comprehensive and integrated approach to address the issue through the simultaneous adoption and application of this Directive setting maximum levels for the unavoidable carry-over of coccidiostats or histomonostats into non-target feed and the Commission Regulation setting maximum levels for the resulting presence of these substances in food.

(15)

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

(1)

Traditional knowledge of farmers combined with recent results from research indicate that some species of Leguminosae and Plantago lanceolata not listed in Council Directives 66/401/EEC, 66/402/EEC (2), 2002/55/EC (3) or 2002/57/EC (4) (hereinafter the existing legislation), in particular when used in mixtures with species covered by the existing legislation, are interesting for fodder production permitting a balanced feeding of animals throughout the year while at the same time contributing to the rehabilitation of soils in non-arable or marginal cropping lands. It is the case for Biserrula pelecinus, Lotus glaber, Lotus uliginosus, Medicago italica, Medicago littoralis, Medicago murex, Medicago polymorpha, Medicago rugosa, Medicago scutelatta, Medicago truncatula, Ornithopus compressus, Ornithopus sativus, Plantago lanceolata, Trifolium fragiferum, Trifolium glanduliferum, Trifolium hirtum, Trifolium michelianum, Trifolium squarrosum, Trifolium subterraneum, Trifolium vesiculosum, and Vicia benghalensis (hereinafter species referred to in recital 1).

(2)

In accordance with the second indent of Article 13(1) of Directive 66/401/EEC only seeds of plant species listed in the existing legislation, with the exception of the varieties mentioned in Article 4(2) of Council Directive 2002/53/EC (5), may be marketed throughout the Community in seed mixtures intended for use as fodder plants. In the absence of the possibility to market mixtures containing seed of the species referred to in recital 1, farmers wishing to make use of those species, have to transport and sow them as individual species, or in certain cases, prepare mixtures themselves at the farm, involving additional cost and work. In addition, there is an increased risk that the different species included in the mixture will be unevenly distributed on the field since the mixtures are not prepared by professionals.

(3)

To allow the species referred to in recital 1 to be marketed in such mixtures it would be necessary to amend Article 2(1)(A) of Directive 66/401/EEC by including those species in that provision.

(4)

In order to decide about such an amendment to Article 2(1)(A) of Directive 66/401/EEC, it is necessary to gather information on the marketing of mixtures containing the species referred to in recital 1. In particular it needs to be verified, whether, where those species are used in mixtures, it is possible to confirm by official post-control that the percentage of seed of each component indicated on the label of the package corresponds to the composition of the mixture and whether mixtures of the same lot are homogeneous in all packages marketed. In the absence of that information, it would be impossible to guarantee to users that the seed of mixtures containing species referred to in recital 1 will provide high-quality results.

(5)

It is therefore appropriate to organise a temporary experiment to verify whether the species referred to in recital 1 fulfil the requirements for being included in Article 2(1)(A) of Directive 66/401/EEC.

(6)

Member States participating in the experiment should be released from the obligations set out in the second indent of Article 13(1) of Directive 66/401/EEC with respect to the species referred to in recital 1. They should allow the placing on the market of mixtures containing those species under certain conditions.

(7)

It is appropriate to provide for specific requirements for the certification of the species referred to in recital 1 in order to ensure that the seed of these species fulfils the same requirements in all participating Member States. These requirements should be based on the conditions set out in OECD Certification Schemes for the Varietal Certification or the Control of Seed Moving in International Trade (hereinafter: OECD Schemes) or in the national standards of the Member State in which the seed is produced.

(8)

In addition to the general conditions provided for in Commission Decision 2004/371/EC of 20 April 2004 on conditions for the placing on the market of seed mixtures intended for use as fodder plants (6), specific conditions should be set out for the marketing of mixtures under the experiment. Those conditions should ensure the collection of sufficient information for the assessment of the experiment. It is, therefore, necessary to provide for rules on labelling, monitoring and reporting.

(9)

Given the experimental nature of the measure provided for by this Decision, a maximum quantity for the marketing of seed mixtures should be fixed, taking into account the need to test different mixtures using existing facilities.

(10)

To allow Member States to verify that the maximum quantity is not exceeded, firms intending to produce such seed mixtures should communicate to the Member States concerned the quantities they intend to produce. Member States should have the possibility to prohibit the marketing of seed mixtures where they consider this necessary in view of the need to test different mixtures without exceeding the maximum quantity.

(11)

In order to allow suppliers to produce and market a sufficient quantity of seed and to permit the competent authorities to inspect that material and collect sufficient and comparable information to be used for the preparation of the report, the experiment should take place over a period of at least five marketing seasons.

(12)

The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on Seeds and Propagating Material for Agriculture, Horticulture and Forestry,

(a)

it belongs to a variety listed in a national catalogue of a Member State or in the OECD List of Varieties Eligible for the Seed Certification;

(b)

it is certified in accordance with Annex I;

(c)

it fulfils the conditions set out in point 1 of Annex II.

(1)

Newcastle disease is an infectious viral disease which causes high mortality in poultry.

(2)

In the event of an outbreak of Newcastle disease, there is a risk that the disease agent might spread to other poultry holdings within that Member State, but also to other Member States and to third countries through trade in live poultry or their products.

(3)

An outbreak of that disease can therefore quickly take on epidemic proportions liable to reduce sharply the profitability of poultry farming.

(4)

Council Directive 92/66/EEC of 14 July 1992 introducing Community measures for the control of Newcastle disease (2) sets out measures which in the event of an outbreak have to be immediately implemented by Member States as a matter of urgency to prevent further spread of the virus.

(5)

Decision 90/424/EEC lays down the procedures governing the Community’s financial contribution towards specific veterinary measures, including emergency measures. Pursuant to Article 4(2) of that Decision, Member States shall obtain a financial contribution towards the costs of certain measures to eradicate Newcastle disease.

(6)

Articles 3(5) and 4(2) of Decision 90/424/EEC lay down rules on the percentage of the costs incurred by the Member State that may be covered by the Community’s financial contribution.

(7)

The payment of a Community financial contribution towards emergency measures to eradicate Newcastle disease is subject to the rules laid down in Commission Regulation (EC) No 349/2005 of 28 February 2005 laying down rules on the Community financing of emergency measures and of the campaign to combat certain animal diseases under Council Decision 90/424/EEC (3).

(8)

Outbreaks of Newcastle disease occurred in Germany in 2008. Germany took measures, in accordance with Directive 92/66/EEC and Article 3(2) of Decision 90/424/EEC, to combat those outbreaks.

(9)

Germany has fully complied with its technical and administrative obligations as set out in Article 3(3) of Decision 90/424/EEC and Article 6 of Regulation (EC) No 349/2005.

(10)

On 18 June 2008 and 17 July 2008, Germany submitted an estimate of the costs incurred in taking measures to eradicate Newcastle disease.

(11)

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

(1)

Directive 97/23/EC provides that pressure equipment and assemblies may be placed on the market and put into service only if, when properly installed and maintained and used for their intended purpose, they do not endanger the health and safety of persons and, where appropriate, domestic animals and property.

(2)

Pressure equipment and assemblies are presumed to meet the essential requirements referred to in Article 3 of Directive 97/23/EC if they conform to the national standards transposing the harmonised standards the reference numbers of which have been published in the Official Journal of the European Union.

(3)

Pursuant to Article 6 of Directive 97/23/EC, Sweden lodged a formal objection in respect of standard EN 3-8:2006 adopted by the European Committee for Standardisation (CEN) on 2 November 2006 the references of which have not yet been published in the Official Journal of the European Union.

(4)

In its formal objection Sweden notes that Section 5 of standard EN 3-8:2006 does not specify the types of materials to be used and does therefore not satisfy the essential requirements of point 4 of Annex I to Directive 97/23/EC.

(5)

Since Section 5 of standard EN 3-8:2006 provides for a case by case material appraisal by the notified body (particular material appraisal approach), the specification of the types of materials to be used is not necessarily required. Furthermore, in the absence of concrete technical specifications, Section 5 of standard EN 3-8:2006 cannot confer the presumption of conformity to the requirements of point 4 of Annex I to Directive 97/23/EC.

(6)

In addition Sweden considers that in Section 6 of standard EN 3-8:2006, important information necessary to meet the requirements of point 2.2.4 of Annex I to Directive 97/23/EC is missing, due to the lack of specification of materials in Section 5 of that standard.

(7)

Directive 97/23/EC describes in Section 2.2 of Annex I the methods to ensure adequate strength of the pressure equipment, including a calculation method or experimental design method without calculation. The experimental design method is based on a test programme as defined in point 2.2.4 (a) and (b), that includes a pressure strength test.

(8)

Section 6 of standard EN 3-8:2006 provides for the experimental design method without calculation. As required by point 2.2.4 of Annex I to Directive 97/23/EC, it provides for a test programme with several tests. Directive 97/23/EC does not exclude the particular material appraisal approach as a method to prove compliance of the materials used with the material specifications in point 4 of Annex I, when the manufacturer applies the experimental design method. As Section 5 of EN 3-8:2006 does not contain specific material requirements, the equipment manufacturer must ensure that the materials used comply with the requirements of point 4 of Annex I to the Directive. On the basis of this, the material characteristics would be used as a parameter of the pressure test in the framework of the experimental design method test program, under the control of the notified body responsible for the conformity assessment of the equipment.

(9)

Sweden further notes that Section 7.2.2 on welding procedures of EN 3-8:2006 does not comply with point 3.1.2 of Annex I to Directive 97/23/EC, as, in addition to the standards listed, it contains an open reference to other recognised welding EN standards.

(10)

Directive 97/23/EC stipulates in point 3.1.2 of Annex I the requirements on permanent joining. The reference in Section 7.2.2 of standard EN 3-8:2006 that ‘other standards are acceptable’ is not an adequate and sufficiently concrete wording of a standard intended to confer the presumption of conformity to the requirements of Directive 97/23/EC. A harmonised standard conferring the presumption of conformity to the requirements of the Directive must provide concrete technical specifications on the design, manufacture and testing, in order to help manufacturers and enable pressure equipment to be presumed to meet the relevant essential requirements. However, Section 7.2.2 of EN 3-8:2006 contains a series of concrete references to standards which contain welding specifications. Therefore, although section 7.2.2 should be improved, it would not be proportionate to refrain from publishing the references of the standard on this ground.

(11)

Finally, Sweden considers that Section 7.3.1 of standard EN 3-8:2006, on the traceability of materials used in the various parts of pressure equipment is imprecise, does not provide for specific technical solutions and therefore, it can not confer the presumption of conformity to the requirements of point 3.1.5 of Annex I to Directive 97/23/EC.

(12)

Directive 97/23/EC requires in point 3.1.5 of Annex I (traceability) the application of suitable procedures in order to identify, by suitable means, the material making up of the components which contribute to the pressure resistance of the equipment, from their receipt and production, up to the final test of the manufactured pressure equipment. The objective of this requirement is to avoid any doubt about the material specifications used for the equipment. Manufacturers may apply different procedures, according to the characteristics and methods of manufacture. The notified body that performs the conformity assessment procedure of the equipment must assess, on a case by case basis, whether these procedures meet the requirement of point 3.1.5 of Annex I to the Directive. However, although Section 7.3.1 should be improved, it would not be proportionate not to publish the reference numbers of the standard on this ground.

(13)

For this purpose, the Commission will request CEN to present within three years a revised version of standard EN 3-8:2006 in order to better reflect compliance with the essential requirements of Directive 97/23/EC. Following the implementation of this mandate and depending on its results, possible further decisions concerning the current version of the standard could be envisaged.

(14)

The references of standard EN 3-8:2006 should therefore be published in the Official Journal of the European Union,

(1)

Pursuant to Article 32(3) of the Internal Agreement, the discharge for the financial management of the Seventh EDF is to be given to the Commission by the European Parliament on the recommendation of the Council.

(2)

The overall implementation by the Commission of the operations of the Seventh EDF during the financial year 2007 has been satisfactory,

(1)

Pursuant to Article 33(3) of the Internal Agreement, the discharge for the financial management of the Eighth EDF is to be given to the Commission by the European Parliament on the recommendation of the Council.

(2)

The overall implementation by the Commission of the operations of the Eighth EDF during the financial year 2007 has been satisfactory,

(1)

Pursuant to Article 32(3) of the Internal Agreement, the discharge for the financial management of the Ninth EDF is to be given to the Commission by the European Parliament on the recommendation of the Council.

(2)

The overall implementation by the Commission of the operations of the Ninth EDF during the financial year 2007 has been satisfactory,

(1)

On 10 February 2004, the Council adopted Common Position 2004/133/CFSP on restrictive measures against extremists in the former Yugoslav Republic of Macedonia (FYROM) (1).

(2)

Common Position 2004/133/CFSP was extended until 10 February 2009 by Common Position 2008/104/CFSP (2).

(3)

Following a review of Common Position 2004/133/CFSP, it is considered appropriate to extend its application for a further period of five months, as well as to remove certain persons from the list in the Annex thereto,