31.5.2008   

EN

Official Journal of the European Union

L 141/1

(1)

The Protocol setting out, for the period from 18 January 2005 to 17 January 2011, the fishing opportunities and the financial contribution provided for by the Agreement between the European Economic Community and the Republic of Seychelles on fishing off Seychelles was adopted by Council Regulation (EC) No 115/2006 on 23 January 2006 (2).

(2)

Under Article 9 of the Agreement, the European Community and Seychelles have held a meeting of the Joint Committee.

(3)

Following this meeting of the Joint Committee, amendments have been made to the Protocol setting out, for the period from 18 January 2005 to 17 January 2011, the fishing opportunities and the financial contribution provided for by the Fisheries Partnership Agreement initialled on 23 September 2004 and adopted by Regulation (EC) No 115/2006 on 23 January 2006.

(4)

It is in the Community’s interest to approve these amendments to the Protocol,

31.5.2008   

EN

Official Journal of the European Union

L 141/3

(1)

Regulation (EC) No 1580/2007 lays down, pursuant to the outcome of the Uruguay Round multilateral trade negotiations, the criteria whereby the Commission fixes the standard values for imports from third countries, in respect of the products and periods stipulated in the Annex thereto.

(2)

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

31.5.2008   

EN

Official Journal of the European Union

L 141/5

(1)

Pursuant to Regulation (EC) No 550/2004, the Commission is required to identify and adopt the relevant provisions of the Eurocontrol Safety Regulatory Requirements (ESARRs), taking into account existing Community legislation. ESARR 6 entitled ‘Software in ATM systems’ provides a set of safety regulatory requirements for the implementation of a software safety assurance system.

(2)

Commission Regulation (EC) No 2096/2005 of 20 December 2005 laying down common requirements for the provision of air navigation services (2) states in the last sentence of Recital 12 that ‘The relevant provisions of ESARR 1 on safety oversight in ATM, and of ESARR 6 on software in ATM systems, should be identified and adopted by way of separate Community acts.’

(3)

Annex II to Regulation (EC) No 2096/2005 requires providers of air traffic services to implement a safety management system as well as safety requirements for risk assessment and mitigation with regard to changes. Within the framework of its safety management system, and as part of its risk assessment and mitigation activities with regard to changes, a provider of air traffic services should define and implement a software safety assurance system to deal specifically with software related aspects.

(4)

The prime software safety objective to be met for functional systems that contain software is to ensure that the risks associated with the use of software in the European Air Traffic Management network systems (EATMN software) have been reduced to a tolerable level.

(5)

This Regulation should not cover military operations and training as referred to in Article 1(2) of Regulation (EC) No 549/2004 of the European Parliament and of the Council of 10 March 2004 laying down the framework for the creation of the single European sky (the framework Regulation) (3).

(6)

Annex II to Regulation (EC) No 2096/2005 should therefore be amended accordingly.

(7)

The measures provided for in this Regulation are in accordance with the opinion of the Single Sky Committee,

1.

‘software’ means computer programmes and corresponding configuration data, including non-developmental software, but excluding electronic items, namely application specific integrated circuits, programmable gate arrays or solid-state logic controllers;

2.

‘configuration data’ means data that configures a generic software system to a particular instance of its use;

3.

‘non-developmental software’ means a software not developed for the current contract;

4.

‘safety assurance’ means all planned and systematic actions necessary to provide adequate confidence that a product, a service, an organisation or a functional system achieves acceptable or tolerable safety;

5.

‘organisation’ means either an ATS provider, a CNS provider or an entity providing ATFM or ASM;

6.

‘functional system’ means a combination of systems, procedures and human resources organised to perform a function within the context of ATM;

7.

‘risk’ means the combination of the overall probability, or frequency of occurrence of a harmful effect induced by a hazard and the severity of that effect;

8.

‘hazard’ means any condition, event, or circumstance which could induce an accident;

9.

‘new software’ means a software that has been ordered or for which binding contracts have been signed after the entry into force of this Regulation;

10.

‘safety objective’ means a qualitative or quantitative statement that defines the maximum frequency or probability at which a hazard can be expected to occur;

11.

‘safety requirement’ means a risk-mitigation means, defined from the risk-mitigation strategy that achieves a particular safety objective, including organisational, operational, procedural, functional, performance, and interoperability requirements or environment characteristics;

12.

‘cutover or hot swapping’ means the approach of replacing European air traffic management network (EATMN) system components or software while the system is operational;

13.

‘software safety requirement’ means a description of what is to be produced by the software given the inputs and constraints, and if met, ensures that EATMN software performs safely and according to operational need;

14.

‘EATMN software’ means software used in the EATMN systems referred to in Article 1;

15.

‘requirements validity’ means the confirmation by examination and provision of objective evidence that the particular requirements for a specific use are as intended;

16.

‘achieved with independence’ means, for software verification process activities, that the verification process activities are performed by a person(s) other than the developer of the item being verified;

17.

‘software malfunction’ means the inability of a programme to perform a required function correctly;

18.

‘software failure’ means the inability of a programme to perform a required function;

19.

‘COTS’ means a commercial available application sold by vendors through public catalogue listings and not intended to be customised or enhanced;

20.

‘software components’ means a building block that can be fitted or connected together with other reusable blocks of software to combine and create a custom software application;

21.

‘independent software components’ means those software components which are not rendered inoperative by the same failure condition that causes the hazard;

22.

‘software timing performances’ means the time allowed for the software to respond to given inputs or to periodic events, and/or the performance of the software in terms of transactions or messages handled per unit time;

23.

‘software capacity’ means the ability of the software to handle a given amount of data flow;

24.

‘accuracy’ means the required precision of the computed results;

25.

‘software resource usage’ means the amount of resources within the computer system that can be used by the application software;

26.

‘software robustness’ means the behaviour of the software in the event of unexpected inputs, hardware faults and power supply interruptions, either in the computer system itself or in connected devices;

27.

‘overload tolerance’ means the behaviour of the system in the event of, and in particular its tolerance to, inputs occurring at a greater rate than expected during normal operation of the system;

28.

‘correct and complete EATMN software verification’ means all software safety requirements which correctly state what is required of the software component by the risk assessment and mitigation process and their implementation is demonstrated to the level required by the software assurance level;

29.

‘software life cycle data’ means the data that is produced during the software life cycle to plan, direct, explain, define, record, or provide evidence of activities; this data enables the software life cycle processes, system or equipment approval and post-approval modification of the software product;

30.

‘software life cycle’ means:

31.

‘system safety requirement’ means a safety requirement derived for a functional system.

(a)

the software safety requirements correctly state what is required by the software, in order to meet safety objectives and requirements, as identified by the risk assessment and mitigation process;

(b)

traceability is addressed in respect of all software safety requirements;

(c)

the software implementation contains no functions which adversely affect safety;

(d)

the EATMN software satisfies its requirements with a level of confidence which is consistent with the criticality of the software;

(e)

assurances are provided confirming that the general safety requirements set out in points (a) to (d) are satisfied, and the arguments that demonstrate the required assurances are at all times derived from:

1.

is documented, specifically as part of the overall risk assessment and mitigation documentation;

2.

allocates software assurance levels to all operational EATMN software in compliance with the requirements set out in Annex I;

3.

includes assurances of:

4.

determines the rigour to which the assurances are established; the rigour must be defined for each software assurance level, and increase as the software increases in criticality; for that purpose:

5.

uses feedback of EATMN software experience to confirm that the software safety assurance system and the assignment of assurance levels are appropriate. For that purpose, the effects from a software malfunction or failure reported according to the relevant requirements on reporting and assessment of safety occurrences shall be assessed in comparison with the effects identified for the system concerned as per the severity classification scheme established in Section 3.2.4 of Annex II to Regulation (EC) No 2096/2005.

31.5.2008   

EN

Official Journal of the European Union

L 141/11

(1)

Pursuant to the first subparagraph of Article 6(2) of Regulation (EC) No 510/2006 and in accordance with Article 17(2) thereof, Poland’s application to register the name ‘Miód wrzosowy z Borów Dolnośląskich’, Greece’s application to register the name ‘Σταφίδα Ζακύνθου’ (Stafida Zakynthou) and the Czech Republic’s application to register the name ‘Chodské pivo’ were published in the Official Journal of the European Union  (2).

(2)

As no objections within the meaning of Article 7 of Regulation (EC) No 510/2006 were received by the Commission, these names should be entered in the Register,

31.5.2008   

EN

Official Journal of the European Union

L 141/13

(1)

Article 10(2) of Regulation (EC) No 1784/2003 states that the import duty on products falling within CN codes 1001 10 00, 1001 90 91, ex 1001 90 99 (high quality common wheat), 1002, ex 1005 other than hybrid seed, and ex 1007 other than hybrids for sowing, is to be equal to the intervention price valid for such products on importation and increased by 55 %, minus the cif import price applicable to the consignment in question. However, that duty may not exceed the rate of duty in the Common Customs Tariff.

(2)

Article 10(3) of Regulation (EC) No 1784/2003 lays down that, for the purposes of calculating the import duty referred to in paragraph 2 of that Article, representative cif import prices are to be established on a regular basis for the products in question.

(3)

Under Article 2(2) of Regulation (EC) No 1249/96, the price to be used for the calculation of the import duty on products of CN codes 1001 10 00, 1001 90 91, ex 1001 90 99 (high quality common wheat), 1002 00, 1005 10 90, 1005 90 00 and 1007 00 90 is the daily cif representative import price determined as specified in Article 4 of that Regulation.

(4)

Import duties should be fixed for the period from 1 June 2008, and should apply until new import duties are fixed and enter into force.

(5)

However, in accordance with Council Regulation (EC) No 1/2008 of 20 December 2007 temporarily suspending customs duties on imports of certain cereals for the 2007/08 marketing year (3), the application of certain duties set by this Regulation is suspended,

31.5.2008   

EN

Official Journal of the European Union

L 141/16

(1)

Directive 64/432/EEC provides that a Member State or part of a Member State may be declared officially free of bovine tuberculosis and enzootic bovine leukosis as regards bovine herds subject to compliance with certain conditions set out in that Directive.

(2)

The lists of regions of Member States declared free of bovine tuberculosis and enzootic bovine leukosis are set out in Commission Decision 2003/467/EC of 23 June 2003 establishing the official tuberculosis, brucellosis and enzootic-bovine-leukosis-free status of certain Member States and regions of Member States as regards bovine herds (2).

(3)

Italy has submitted to the Commission documentation demonstrating compliance with the appropriate conditions provided for in Directive 64/432/EEC as regards all the provinces of the Region of Veneto in order that that region may be considered an officially bovine tuberculosis-free region of Italy.

(4)

Following the evaluation of that documentation, that region of Italy should be recognised as an officially bovine-tuberculosis-free region of that Member State.

(5)

Poland has also submitted to the Commission documentation demonstrating compliance with the appropriate conditions provided for in Directive 64/432/EEC as regards two administrative regions (powiaty) within the superior administrative unit (Voivodship) of Małopolskie, in order that those regions may be considered officially enzootic-bovine-leukosis-free regions of Poland.

(6)

Following the evaluation of that documentation, those regions (powiaty) of Poland should be recognised as officially enzootic-bovine-leukosis-free regions of that Member State.

(7)

Decision 2003/467/EC should therefore be amended accordingly.

(8)

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

31.5.2008   

EN

Official Journal of the European Union

L 141/20

(1)

In the framework of Regulation (EEC) No 793/93 the following substances have been identified as priority substances for evaluation in accordance with Commission Regulation (EC) No 2364/2000 of 25 October 2000 concerning the fourth list of priority substances as foreseen under Council Regulation (EEC) No 793/93 (2):

(2)

The rapporteur Member State designated pursuant to those Regulations has completed the risk evaluation activities with regard to man and the environment for those substances in accordance with Commission Regulation (EC) No 1488/94 of 28 June 1994 laying down the principles for the assessment of risks to man and the environment of existing substances in accordance with Council Regulation (EEC) No 793/93 (3) and has suggested a strategy for limiting the risks.

(3)

The Scientific Committee on Health and Environmental Risks (SCHER) has been consulted and has issued opinions with respect to the risk evaluations carried out by the rapporteur. The opinions have been published on the website of the Scientific Committee.

(4)

The results of the risk evaluation and further results of the strategies for limiting the risks are set out in the corresponding Commission Communication (4).

(5)

It is appropriate, on the basis of that evaluation, to recommend certain risk reduction measures for certain substances. For the substances which are not specifically listed, there are no recommendations for the addressees of this Recommendation.

(6)

The risk reduction measures recommended for workers should be considered within the framework of the legislation for workers protection, which is considered to provide an adequate framework to limit the risks of the relevant substances to the extent needed.

(7)

The risk reduction measures provided for in this recommendation are in accordance with the opinion of the Committee set up pursuant to Article 15(1) of Regulation (EEC) No 793/93,

1.

Competent authorities in the Member States concerned should lay down, in the permits issued under Directive 2008/1/EC of the European Parliament and of the Commission (5), conditions, emission limit values or equivalent parameters or technical measures regarding 2,4-dinitrotoluene in order to operate according to the Best Available Techniques (BAT) taking into account the technical characteristic of the installations concerned, their geographical location and the local environmental conditions.

2.

Member States should carefully monitor the implementation of BAT regarding 2,4-dinitrotoluene and report any important developments to the Commission in the framework of the exchange of information on BAT.

3.

Local emissions to the aquatic environment and via air emissions of 2,4-DNT should, where necessary, be controlled by national rules to ensure that no risk for the environment is expected.

4.

This Recommendation is addressed to all sectors importing, producing, transporting, storing, formulating into a preparation or other processing, using, disposing or recovering the substances and to the Member States.

31.5.2008   

EN

Official Journal of the European Union

L 141/22

‘(c)

it was placed on the market in the Community, or in the countries acceding to the European Union on 1 January 1995, on 1 May 2004 or on 1 January 2007, before entry into force of this Regulation by the manufacturer or importer and was considered as having been notified in accordance with the first indent of Article 8(1) of Directive 67/548/EEC but does not meet the definition of a polymer as set out in this Regulation, provided the manufacturer or importer has documentary evidence of this;’,

‘(c)

it was placed on the market in the Community, or in the countries acceding to the European Union on 1 January 1995, on 1 May 2004 or on 1 January 2007, by the manufacturer or importer at any time between 18 September 1981 and 31 October 1993 inclusive, and before the entry into force of this Regulation it was considered as having been notified in accordance with the first indent of Article 8(1) of Directive 67/548/EEC in the version of Article 8(1) resulting from the amendment effected by Directive 79/831/EEC, but it does not meet the definition of a polymer as set out in this Regulation, provided the manufacturer or importer has documentary evidence of this;’.

31.5.2008   

EN

Official Journal of the European Union

L 141/22