title: Council Directive 2009/71/Euratom of 25 June 2009 establishing a Community framework for the nuclear safety of nuclear installations

text:
               2.7.2009

               EN

               Official Journal of the European Union

               L 172/18

      COUNCIL DIRECTIVE 2009/71/EURATOM

   of 25 June 2009
   establishing a Community framework for the nuclear safety of nuclear installations
   THE COUNCIL OF THE EUROPEAN UNION,
   Having regard to the Treaty establishing the European Atomic Energy Community, and in particular Articles 31 and 32 thereof,
   Having regard to the proposal from the Commission, drawn up after obtaining the opinion of a group of persons appointed by the Scientific and Technical Committee from among scientific experts in the Member States, and after having consulted the European Economic and Social Committee (1),
   Having regard to the opinion of the European Parliament (2),
   Whereas:

               (1)

               Article 2(b) of the Treaty provides for the establishment of uniform safety standards to protect the health of workers and of the general public.

               (2)

               Article 30 of the Treaty provides for the establishment of basic standards within the Community for the protection of the health of workers and the general public against the dangers arising from ionizing radiations.

               (3)

               Council Directive 96/29/Euratom of 13 May 1996 laying down basic safety standards for the protection of the health of workers and the general public against the dangers arising from ionizing radiation (3) establishes the basic safety standards. The provisions of that Directive have been supplemented by more specific legislation.

               (4)

               As recognised by ‘the Court of Justice’ of the European Communities (hereinafter referred to as the Court of Justice) in its case-law (4), the Community shares competences, together with its Member States, in fields covered by the Convention on Nuclear Safety (5).

               (5)

               As recognised by the Court of Justice in its case-law, the provisions of Chapter 3 of the Treaty, related to health and safety, form a coherent whole conferring upon the Commission powers of some considerable scope in order to protect the population and the environment against risks of nuclear contamination.

               (6)

               As recognised by the Court of Justice in its case-law, the tasks imposed on the Community by Article 2(b) of the Treaty to lay down uniform safety standards to protect the health of the population and of workers does not mean that, once such standards have been defined, a Member State may not provide for more stringent measures of protection.

               (7)

               Council Decision 87/600/Euratom of 14 December 1987 on Community arrangements for the early exchange of information in the event of a radiological emergency (6) established a framework for notification and provision of information to be used by the Member States in order to protect the general public in case of a radiological emergency. Council Directive 89/618/Euratom of 27 November 1989 on informing the general public about health protection measures to be applied and steps to be taken in the event of a radiological emergency (7) imposed obligations on the Member States to inform the general public in the event of a radiological emergency.

               (8)

               National responsibility of Member States for the nuclear safety of nuclear installations is the fundamental principle on which nuclear safety regulation has been developed at the international level, as endorsed by the Convention on Nuclear Safety. That principle of national responsibility, as well as the principle of prime responsibility of the licence holder for the nuclear safety of a nuclear installation under the supervision of its national competent regulatory authority, should be enhanced and the role and independence of the competent regulatory authorities should be reinforced by this Directive.

               (9)

               Each Member State may decide on its energy mix in accordance with relevant national policies.

               (10)

               When developing the appropriate national framework under this Directive, national circumstances will be taken into account.

               (11)

               The Member States have already implemented measures enabling them to achieve a high level of nuclear safety within the Community.

               (12)

               While this Directive concerns principally the nuclear safety of nuclear installations, it is also important to ensure the safe management of spent fuel and radioactive waste, including at storage and disposal facilities.

               (13)

               Member States should assess, where appropriate, the relevant fundamental safety principles set by the International Atomic Energy Agency (8) which should constitute a framework of practices that Member States should have regard to when implementing this Directive.

               (14)

               It is useful to build on the process where the national safety authorities of the Member States having nuclear power plants on their territory have been working together in the context of Western European Nuclear Regulators′ Association (WENRA) and have defined many safety reference levels for power reactors.

               (15)

               Following the Council’s invitation to set up a High Level Group at EU level, as recorded in its Conclusions of 8 May 2007 on nuclear safety and safe management of spent nuclear fuel and radioactive waste, the European Nuclear Safety Regulators Group (ENSREG) was established by Commission Decision 2007/530/Euratom of 17 July 2007 on establishing the European High Level Group on Nuclear Safety and Waste Management (9) to contribute to the achievement of the Community objectives in the field of nuclear safety.

               (16)

               It is useful to establish a unified structure for reports of Member States to the Commission on the implementation of this Directive. Given its members′ wide experience ENSREG could make a valuable contribution in this respect, thereby facilitating consultation and cooperation of national regulatory authorities.

               (17)

               On 15 October 2008 at its fifth meeting ENSREG adopted 10 principles to be used when drafting a nuclear safety Directive, as noted in its minutes dated 20 November 2008.

               (18)

               Advances in nuclear technology, lessons learnt from operating experience and safety research and improvements in regulatory frameworks could have the potential to further improve safety. In keeping with the commitment to maintain and improve safety, Member States should take those factors into account when extending their nuclear power programme or deciding to use nuclear power for the first time.

               (19)

               The establishment of a strong safety culture within a nuclear installation is one of the fundamental safety management principles necessary for achieving its safe operation.

               (20)

               Maintenance and further development of expertise and skills in nuclear safety should be based, inter alia, on a process of learning from past operating experience and employing developments in methodology and science, as appropriate.

               (21)

               In the past, self-assessments have been carried out in Member States in close connection with international peer reviews under the auspices of the IAEA as International Regulatory Review Team or Integrated Regulatory Review Service missions. These self-assessments were carried out and these missions were invited by Member States on a voluntary basis in the spirit of openness and transparency. Self-assessments and accompanying peer reviews of the legislative, regulatory and organisational infrastructure should be aimed at strengthening and enhancing the national framework of Member States, whilst recognising their competencies in ensuring nuclear safety of nuclear installations on their territory. The self-assessments followed by international peer reviews are neither an inspection nor an audit, but a mutual learning mechanism that accepts different approaches to the organisation and practices of a competent regulatory authority, while considering regulatory, technical and policy issues of a Member State that contribute to ensuring a strong nuclear safety regime. The international peer reviews should be regarded as an opportunity to exchange professional experience and to share lessons learned and good practices in an open and cooperative spirit through advice by peers rather than control or judgement. Recognising a need for flexibility and appropriateness in regard to different existing systems in Member States, a Member State should be free to determine the segments of its system being subject to the specific peer review invited, with the aim of continuously improving nuclear safety.

               (22)

               In accordance with point 34 of the Interinstitutional Agreement on better law-making (10), Member States are encouraged to draw up, for themselves and in the interests of the Community, their own tables illustrating, as far as possible, the correlation between this Directive and the transposition measures and to make them public,

         HAS ADOPTED THIS DIRECTIVE:
   CHAPTER 1

      OBJECTIVES, DEFINITIONS AND SCOPE OF APPLICATION

   Article 1
   Objectives
   The objectives of this Directive are:

               (a)

               to establish a Community framework in order to maintain and promote the continuous improvement of nuclear safety and its regulation;

               (b)

               to ensure that Member States shall provide for appropriate national arrangements for a high level of nuclear safety to protect workers and the general public against the dangers arising from ionizing radiations from nuclear installations.

         Article 2
   Scope
   1.   This Directive shall apply to any civilian nuclear installation operating under a licence as defined in Article 3(4) at all stages covered by this licence.
   2.   This Directive does not prevent Member States from taking more stringent safety measures in the subject-matter covered by this Directive, in compliance with Community law.
   3.   This Directive supplements the basic standards referred to in Article 30 of the Treaty as regards the nuclear safety of nuclear installations and is without prejudice to Directive 96/29/Euratom.
   Article 3
   Definitions
   For the purposes of this Directive the following definitions shall apply:

               1.

               ‘nuclear installation’ means:

                           (a)

                           an enrichment plant, nuclear fuel fabrication plant, nuclear power plant, reprocessing plant, research reactor facility, spent fuel storage facility; and

                           (b)

                           storage facilities for radioactive waste that are on the same site and are directly related to nuclear installations listed under point (a);

               2.

               ‘nuclear safety’ means the achievement of proper operating conditions, prevention of accidents and mitigation of accident consequences, resulting in protection of workers and the general public from dangers arising from ionizing radiations from nuclear installations;

               3.

               ‘competent regulatory authority’ means an authority or a system of authorities designated in a Member State in the field of regulation of nuclear safety of nuclear installations as referred to in Article 5;

               4.

               ‘licence’ means any legal document granted under the jurisdiction of a Member State to confer responsibility for the siting, design, construction, commissioning and operation or decommissioning of a nuclear installation;

               5.

               ‘licence holder’ means a legal or natural person having overall responsibility for a nuclear installation as specified in a licence.

         CHAPTER 2

      OBLIGATIONS

   Article 4
   Legislative, regulatory and organisational framework
   1.   Member States shall establish and maintain a national legislative, regulatory and organisational framework (hereinafter referred to as the ‘national framework’) for nuclear safety of nuclear installations that allocates responsibilities and provides for coordination between relevant state bodies. The national framework shall establish responsibilities for:

               (a)

               the adoption of national nuclear safety requirements. The determination on how they are adopted and through which instrument they are applied rests with the competence of the Member States;

               (b)

               the provision of a system of licensing and prohibition of operation of nuclear installations without a licence;

               (c)

               the provision of a system of nuclear safety supervision;

               (d)

               enforcement actions, including suspension of operation and modification or revocation of a licence.

         2.   Member States shall ensure that the national framework is maintained and improved when appropriate, taking into account operating experience, insights gained from safety analyses for operating nuclear installations, development of technology and results of safety research, when available and relevant.
   Article 5
   Competent regulatory authority
   1.   Member States shall establish and maintain a competent regulatory authority in the field of nuclear safety of nuclear installations.
   2.   Member States shall ensure that the competent regulatory authority is functionally separate from any other body or organisation concerned with the promotion, or utilisation of nuclear energy, including electricity production, in order to ensure effective independence from undue influence in its regulatory decision making.
   3.   Member States shall ensure that the competent regulatory authority is given the legal powers and human and financial resources necessary to fulfil its obligations in connection with the national framework described in Article 4(1) with due priority to safety. This includes the powers and resources to:

               (a)

               require the licence holder to comply with national nuclear safety requirements and the terms of the relevant licence;

               (b)

               require demonstration of this compliance, including the requirements under paragraphs 2 to 5 of Article 6;

               (c)

               verify this compliance through regulatory assessments and inspections; and

               (d)

               carry out regulatory enforcement actions, including suspending the operation of nuclear installation in accordance with conditions defined by the national framework referred to in Article 4(1).

         Article 6
   Licence holders
   1.   Member States shall ensure that the prime responsibility for nuclear safety of a nuclear installation rests with the licence holder. This responsibility cannot be delegated.
   2.   Member States shall ensure that the national framework in place requires licence holders, under the supervision of the competent regulatory authority, to regularly assess and verify, and continuously improve, as far as reasonably achievable, the nuclear safety of their nuclear installations in a systematic and verifiable manner.
   3.   The assessments referred to in paragraph 2 shall include verification that measures are in place for prevention of accidents and mitigation of consequences of accidents, including verification of the physical barriers and licence holder’s administrative procedures of protection that would have to fail before workers and the general public would be significantly affected by ionizing radiations.
   4.   Member States shall ensure that the national framework in place requires licence holders to establish and implement management systems which give due priority to nuclear safety and are regularly verified by the competent regulatory authority.
   5.   Member States shall ensure that the national framework in place requires licence holders to provide for and maintain adequate financial and human resources to fulfil their obligations with respect to nuclear safety of a nuclear installation, laid down in paragraphs 1 to 4.
   Article 7
   Expertise and skills in nuclear safety
   Member States shall ensure that the national framework in place requires arrangements for education and training to be made by all parties for their staff having responsibilities relating to the nuclear safety of nuclear installations in order to maintain and to further develop expertise and skills in nuclear safety.
   Article 8
   Information to the public
   Member States shall ensure that information in relation to the regulation of nuclear safety is made available to the workers and the general public. This obligation includes ensuring that the competent regulatory authority informs the public in the fields of its competence. Information shall be made available to the public in accordance with national legislation and international obligations, provided that this does not jeopardise other interests such as, inter alia, security, recognised in national legislation or international obligations.
   Article 9
   Reporting
   1.   Member States shall submit a report to the Commission on the implementation of this Directive for the first time by 22 July 2014, and every three years thereafter, taking advantage of the review and reporting cycles under the Convention on Nuclear Safety.
   2.   On the basis of the Member States′ reports, the Commission shall submit a report to the Council and the European Parliament on progress made with the implementation of this Directive.
   3.   Member States shall at least every 10 years arrange for periodic self-assessments of their national framework and competent regulatory authorities and invite an international peer review of relevant segments of their national framework and/or authorities with the aim of continuously improving nuclear safety. Outcomes of any peer review shall be reported to the Member States and the Commission, when available.
   CHAPTER 3

      FINAL PROVISIONS

   Article 10
   Transposition
   1.   Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 22 July 2011. They shall forthwith inform the Commission thereof.
   When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States.
   2.   Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive and of any subsequent amendments to those provisions.
   Article 11
   Entry into force
   This Directive shall enter into force on the twentieth day following its publication in the Official Journal of the European Union.
   Article 12
   Addressees
   This Directive is addressed to the Member States.

      Done at Luxembourg, 25 June 2009.

            For the Council

            The President

         L. MIKO

      (1)  Opinion of 10 June 2009 (not yet published in the Official Journal).

      (2)  Opinion of the European Parliament of 22 April 2009 (not yet published in the Official Journal).

      (3)  OJ L 159, 29.6.1996, p. 1.

      (4)  C-187/87 (1988 ECR p. 5013), C-376/90 (1992 ECR I-6153) and C-29/99 (2002 ECR I-11221).

      (5)  OJ L 318, 11.12.1999, p. 21.

      (6)  OJ L 371, 30.12.1987, p. 76.

      (7)  OJ L 357, 7.12.1989, p. 31.

      (8)  IAEA Safety Fundamentals: Fundamental safety principles, IAEA Safety Standard Series No SF-1 (2006).

      (9)  OJ L 195, 27.7.2007, p. 44.

      (10)  OJ C 321, 31.12.2003, p. 1.


title: Commission Directive 2010/37/EU of 17 June 2010 amending Directive 2008/60/EC laying down specific purity criteria on sweeteners  (Text with EEA relevance )

text:
               18.6.2010

               EN

               Official Journal of the European Union

               L 152/12

         COMMISSION DIRECTIVE 2010/37/EU
   of 17 June 2010
   amending Directive 2008/60/EC laying down specific purity criteria on sweeteners
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives (1) and in particular Article 30(5) thereof,
   After consulting the European Food Safety Authority (EFSA),
   Whereas:

               (1)

               Commission Directive 2008/60/EC (2) laying down specific purity criteria on sweeteners sets out the purity criteria for the sweeteners for use in foodstuffs listed in European Parliament and Council Directive 94/35/EC of 30 June 1994 on sweeteners for use in Foodstuffs (3).

               (2)

               The European Food Safety Authority (EFSA) assessed the information on the safety in use of neotame as a sweetener and flavour enhancer and expressed its opinion of 27 September 2007 (4). On the basis of the proposed uses, it has been considered appropriate to permit the use of this food additive. It is therefore necessary to adopt specifications for this food additive which is allocated E 961 as E number.

               (3)

               It is necessary to take into account the specifications and analytical techniques for additives as set out in the Codex Alimentarius drafted by the Joint Expert Committee on Food Additives (JECFA). In particular, the specific purity criteria need to be adapted to reflect the limits for individual heavy metals of interest, where appropriate.

               (4)

               Directive 2008/60/EC should therefore be amended accordingly.

               (5)

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

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Annex I to Directive 2008/60/EC is amended in accordance with the Annex to this Directive.
   Article 2
   1.   Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 31 March 2011 at the latest. They shall forthwith communicate to the Commission the text of those provisions.
   When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
   2.   Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
   Article 3
   This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
   Article 4
   This Directive is addressed to the Member States.

      Done at Brussels, 17 June 2010.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 354, 31.12.2008, p. 16.

      (2)  OJ L 158, 18.6.2008, p. 17.

      (3)  OJ L 237, 10.9.1994, p. 3.

      (4)  Scientific opinion of the Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food on a request from the European Commission on neotame as a sweetener and flavour enhancer. The EFSA Journal (2007) 581, 1-43.

      ANNEX
      In Annex I to Directive 2008/60/EC the following entry E 961 is inserted after the entry E 959:

                     ‘E 961 —   NEOTAME

                        Synonyms

                     N-[N-(3,3-dimethylbutyl)-L-α-aspartyl]-L-phenylalanine 1-methyl ester,
                     N(3,3-dimethylbutyl)-L-aspartyl-L-phenylalanine methyl ester

                        Definition

                     Neotame is manufactured by reaction under hydrogen pressure of aspartame with 3,3,-dimethylbutyraldehyde in methanol in presence of a palladium/carbon catalyst. It is isolated and purified by filtration, where diatomaceous earth may be used. After solvent removal via distillation, neotame is washed with water, isolated by centrifugation and finally vacuum dried

                     CAS No

                     165450-17-9

                     Chemical name

                     N-[N-(3,3-dimethylbutyl)-L-α-aspartyl]-L-phenylalanine 1-methyl ester

                     Chemical formula

                     C20H30N2O5

                     Molecular weight

                     378,47

                        Description

                     white to off-white powder

                     Assay

                     Not less than 97,0 % on the dried basis

                        Identification

                     Solubility

                     4,75 % (w/w) at 60 °C in water, soluble in ethanol and ethyl acetate

                        Purity

                     Water content

                     Not more than 5 % (Karl Fischer, sample size 25 ± 5 mg)

                     pH

                     5,0 – 7,0 (0,5 % aqueous solution)

                     Melting range

                     81 °C to 84 °C

                     N-[(3,3-dimethylbutyl)-L-α-aspartyl]-L-phenylalanine

                     Not more than 1,5 %

                     Lead

                     Not more than 1 mg/kg’


Avis juridique important

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31976L0371

First Commission Directive 76/371/EEC of 1 March 1976 establishing Community methods of sampling for the official control of feedingstuffs

Official Journal L 102 , 15/04/1976 P. 0001 - 0007 Finnish special edition: Chapter 3 Volume 7 P. 0041  Greek special edition: Chapter 03 Volume 15 P. 0025  Swedish special edition: Chapter 3 Volume 7 P. 0041  Spanish special edition: Chapter 03 Volume 10 P. 0037  Portuguese special edition Chapter 03 Volume 10 P. 0037

FIRST COMMISSION DIRECTIVE  of 1 March 1976  establishing Community methods of sampling for the official control of feedingstuffs  (76/371/EEC)  THE COMMISSION OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community,  Having regard to the Council Directive of 20 July 1970 on the introduction of Community methods of sampling and analysis for the official control of feedingstuffs (1), as last amended by the Act of Accession (2), and in particular Article 2 thereof,  Whereas that Directive requires that official control of feedingstuffs be carried out using Community methods of sampling and analysis for the purpose of checking compliance with requirements arising under the provisions laid down by law, regulation or administrative action concerning the quality and composition of feedingstuffs;  Whereas, as a first stage, methods of sampling should be laid down for the control of the constituents of feedingstuffs and their additives and for the control of undesirable substances and products, with the exception of residues of pesticides and micro-organisms, which these feedingstuffs may contain;  Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee for Feedingstuffs,  HAS ADOPTED THIS DIRECTIVE:    Article 1 The Member States shall require that sampling for the official control of feedingstuffs, as regards the determination of constituents, additives and undesirable substances and products, with the exception of residues of pesticides and micro-organisms, be carried out in accordance with the methods described in the Annex to this Directive.   Article 2 The Member States shall, not later than 1 January 1977, bring into force the laws, regulations or administrative provisions necessary to comply with this Directive. They shall forthwith notify the Commission thereof.   Article 3 This Directive is addressed to the Member States.     Done at Brussels, 1 March 1976.  For the Commission  P.J. LARDINOIS  Member of the Commission  (1)OJ No L 170, 3.8.1970, p. 2. (2)OJ No L 73, 27.3.1972, p. 14.       ANNEX METHODS OF SAMPLING    1. PURPOSE AND SCOPE  Samples intended for the official control of feedingstuffs, for quality and composition, shall be taken according to the methods described below. Samples thus obtained shall be considered as representative of the sampled portions.       2. SAMPLING OFFICERS  The samples shall be taken by officers authorized for that purpose by the Member States.       3. DEFINITIONS  Sampled portion : A quantity of product constituting a unit, and having characteristics presumed to be uniform.  Incremental sample : A quantity taken from one point in the sampled portion.  Aggregate sample : An aggregate of incremental samples taken from the same sampled portion.  Reduced sample : A representative part of the aggregate sample, obtained from the latter by a process of reduction.  Final sample : A part of the reduced sample or of the homogenized aggregate sample.       4. APPARATUS      4.1. The sampling apparatus must be made of materials which cannot contaminate the products to be sampled. Such apparatus may be officially approved by the Member States.           4.2. Apparatus recommended for the sampling of solid feedingstuffs      4.2.1. Manual sampling        4.2.1.1. Flat-bottomed shovel with vertical sides.               4.2.1.2. Sampling spear with a long split or compartments. The dimensions of the sampling spear must be appropriate to the characteristics of the sampled portion (depth of container, dimensions of sack, etc.) and to the particle size of the feedingstuff.                          4.2.2. Mechanical sampling  Approved mechanical apparatus may be used for the sampling of moving feedingstuffs.           4.2.3. Divider  Apparatus designed to divide the sample into approximately equal parts may be used for taking incremental samples and for the preparation of reduced and final samples.     5. QUANTITATIVE REQUIREMENTS  5.A. In relation to the control of substances or products uniformly distributed throughout the feedingstuff    >PIC FILE= "T0009121">    >PIC FILE= "T0009122">    >PIC FILE= "T0009123">        6. INSTRUCTIONS FOR TAKING, PREPARING AND PACKAGING THE SAMPLES      6.1. General  The samples must be taken and prepared as quickly as possible bearing in mind the precautions necessary to ensure that the product is neither changed nor contaminated. Instruments and also surfaces and containers intended to receive samples must be clean and dry.           6.2. Incremental samples  6.2.A. In relation to the control of substances or products uniformly distributed throughout the feedingstuff  Incremental samples must be taken at random throughout the whole sampled portion and they must be of approximately equal sizes.  6.2.A.1. Loose feedingstuffs  An imaginary division shall be made of the sampled portion into a number of approximately equal parts. A number of parts corresponding to the number of incremental samples required in accordance with 5.A.2 shall be selected at random and at least one sample taken from each of these parts.  Where appropriate, sampling may be carried out when the sampled portion is being moved (loading or unloading).  6.2.A.2. Packaged feedingstuffs  Having selected the required number of packages for sampling as indicated in 5.A.2, part of the contents of each package shall be removed using a spear or shovel. Where necessary, the samples shall be taken after emptying the packages separately.  6.2.A.3. Homogeneous or homogenizable liquid or semi-liquid feedingstuffs  Having selected the required number of containers for sampling as indicated in 5.A.2, the contents shall be homogenized if necessary and an amount taken from each container.  The incremental samples may be taken when the contents are being discharged.   6.2.A.4. Non-homogenizable, liquid or semi-liquid feedingstuffs  Having selected the required number of containers for sampling as indicated in 5.A.2, samples shall be taken from different levels.  Samples may also be taken when the contents are being discharged but the first fractions should be discarded:  In either case the total volume taken must not be less than 10 litres.  6.2.A.5. Feed blocks and mineral licks  Having selected the required number of blocks or licks for sampling as indicated in 5.A.2, a part of each block or lick shall be taken.    6.2.B. In relation to the control of undesirable substances or products likely to be distributed non-uniformly throughout the feedingstuff, such as aflatoxins, rye ergot, castor-oil plant and crotalaria in straight feedingstuffs  An imaginary division shall be made of the sampled portion into a number of approximately equal parts, corresponding to the number of aggregate samples provided for in 5.B.3. If this number is greater than one, the total number of incremental samples provided for in 5.B.2 shall be distributed approximately equally over the different parts. Then take samples of approximately equal sizes (d) and such that the total amount in the samples from each part is not less than the minimum 4 kg quantity required for each aggregate sample. Incremental samples taken from different parts shall not be aggregated.    6.3. Preparation of aggregate samples  6.3.A. in relation to the control of substances of products distributed uniformly throughout the feedingstuff  The incremental samples shall be mixed to form a single aggregate sample.  6.3.B. In relation to the control of undesirable substances or products likely to be distributed non-uniformly throughout the feedingstuff, such as aflatoxins, rye ergot, castor-oil plant and crotalaria in straight feedingstuffs  The incremental samples from each part of the sampled portion shall be mixed and the number of aggregate samples provided for in 5. B. 3, made up taking care to note the origin of each aggregate sample.    6.4. Preparation of final samples  The material in each aggregate sample shall be carefully mixed to obtain an homogenized sample (e). If necessary the aggregate sample should first be reduced to at least 2 kg or two litres (reduced sample) either by using a mechanical divider or by the quartering method.  At least three final samples shall then be prepared, of approximately the same amount and conforming to the quantitative requirements of 5.A.4 or 5.B.4. Each sample shall be put into an appropriate container. All necessary precautions shall be taken to avoid any change of composition of the sample, contamination or adulteration which might arise during transportation or storage.       (d) For packaged feedingstuffs, a part of the contents of the packages to be sampled shall be removed, using a spear or shovel, after having, if necessary, emptied the packages separately.   (e) Any lumps shall be broken up (if necessary by separating them out and returning them to the sample) in each aggregate sample separately.       6.5. Packaging of final samples  The containers of packages shall be sealed and labelled (the total label must be incorporated in the seal) in such a manner that they cannot be opened without damaging the seal.       7. SAMPLING RECORD  A record must be kept of each sampling, permitting each sampled portion to be identified unambiguously.       8. DESTINATION OF SAMPLES  For each aggregate sample, at least one final sample shall be sent as quickly as possible to the authorized analytical laboratory, together with the information necessary for the analyst.


Avis juridique important

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31977L0796

Council Directive 77/796/EEC of 12 December 1977 aiming at the mutual recognition of diplomas, certificates and other evidence of formal qualifications for goods haulage operators and road passenger transport operators, including measures intended to encourage these operators effectively to exercise their right to freedom of establishment

Official Journal L 334 , 24/12/1977 P. 0037 - 0039 Greek special edition: Chapter 06 Volume 2 P. 0011  Spanish special edition: Chapter 07 Volume 2 P. 0089  Portuguese special edition Chapter 07 Volume 2 P. 0089

COUNCIL DIRECTIVE  of 12 December 1977  aiming at the mutual recognition of diplomas, certificates and other evidence of formal qualifications for goods haulage operators and road passenger transport operators, including measures intended to encourage these operators effectively to exercise their right to freedom of establishment  (77/796/EEC)  THE COUNCIL OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community, and in particular Articles 49, 57 and 235 thereof,  Having regard to the proposal from the Commission,  Having regard to the opinion of the European Parliament (1),  Having regard to the opinion of the Economic and Social Committee (2),  Whereas, in its Directives 74/561/EEC (3) and 74/562/EEC (4), the Council imposed certain conditions for admission to the occupation of goods haulage operator and road passenger transport operator in national and international transport and whereas it is appropriate to ensure the mutual recognition of diplomas, certificates and other evidence of formal qualifications in respect of the activities covered by these Directives ; whereas this Directive does not concern those undertakings referred to in the abovementioned Directives unless they are companies or firms within the meaning of Article 58 of the Treaty;  Whereas, in respect of good repute and financial standing, it would be appropriate to acknowledge [relevant] documents issued by a competent authority in the transport operator's country of origin or the country whence he comes as sufficient proof for admission to the activities concerned in a host Member State;  Whereas, in respect of professional competence, the certificates issued pursuant to the Community provisions on admission to the occupation of transport operator, must be recognized as sufficient proof by the host Member State;  Whereas to the extent that Member States also make admission to, or the carrying out of, the activities covered by this Directive by employees subject to the possession of skills and professional competence, this Directive must also apply to that category of person ; whereas it would therefore also be appropriate to apply to employees the provisions on proof of good repute and of no previous bankruptcy,  HAS ADOPTED THIS DIRECTIVE:    Article 1 1. Member States shall, in respect of the activities referred to in Article 2, take the measures defined in this Directive concerning the establishment in their territories of the natural persons and undertakings referred to in Title I of the General Programme for the abolition of restrictions on freedom of establishment.  2. This Directive shall also apply to nationals of Member States who, pursuant to Council Regulation (EEC) No 1612/68 of 15 October 1968 on freedom of movement for workers within the Community (5), carry on the activities referred to in Article 2 in the capacity of employees.   Article 2 This Directive shall apply to activities covered by Council Directives 74/561/EEC and 74/562/EEC.   Article 3 1. Without prejudice to paragraphs 2 and 3 below, a host Member State shall, for the purpose of admission to any of the activities referred to in Article 2, accept as  (1)OJ No C 125, 8.6.1976, p. 54. (2)OJ No C 197, 23.8.1976, p. 35. (3)OJ No L 308, 19.11.1974, p. 18. (4)OJ No L 308, 19.11.1974, p. 23. (5)OJ No L 257, 19.10.1968, p. 2.   sufficient proof of good repute or of no previous bankruptcy an extract from a judicial record or, failing that, an equivalent document issued by a competent judicial or administrative authority in the transport operator's country of origin or the country whence he comes, showing that these requirements have been met.  2. Where the host Member State imposes on its own nationals certain requirements as to good repute and proof that such requirements are satisfied cannot be obtained from the document referred to in paragraph 1, that State shall accept as sufficient evidence in respect of nationals of other Member States a certificate issued by a competent judicial or administrative authority in the country of origin or in the country whence the foreign national comes stating that the requirements in question have been met. Such certificates shall relate to the specific facts regarded as relevant by the host country.  3. Where the country of origin or country whence the foreign national comes does not issue the document required in accordance with paragraphs 1 and 2, such document may be replaced by a declaration on oath or by a solemn declaration - made by the person concerned before a competent judicial or administrative authority or, where appropriate, a notary in that person's country of origin or the country whence he comes ; such authority or notary shall issue a certificate attesting the authenticity of the declaration on oath or solemn declaration. The declaration in respect of no previous bankrupty may also be made before a competent professional body in the same country.  4. Documents issued in accordance with paragraphs 1 and 2 shall not be accepted if produced more than three months after their date of issue. This condition shall apply also to declarations made in accordance with paragraph 3.   Article 4 1. Where in a host Member State a certificate is required as proof of financial standing, that State shall regard corresponding certificates issued by banks in the country of origin or in the country whence the foreign national comes or by other financial bodies designated by that country, as equivalent to certificates issued in its own territory.  2. Where a Member State imposes on its own nationals certain requirements as to financial standing and where proof that such requirements are satisfied cannot be obtained from the document referred to in paragraph 1, that State shall accept as sufficient evidence, in respect of nationals of other Member States, a certificate issued by a competent administrative authority in the country of origin or in the country whence the foreign national comes, stating that the requirements in question have been met. Such certificate shall relate to the specific facts regarded as relevant by the host country.   Article 5 1. Member States shall recognize the certificates referred to in the second subparagraph of Article 3 (4) of Directive 74/561/EEC and the second subparagraph of Article 2 (4) of Directive 74/562/EEC and issued by another Member State as sufficient proof of professional competence if they are based on an examination passed by the applicant or on three years' practical experience.  2. With regard to natural persons and undertakings authorized, before 1 January 1975, under national regulations in a Member State to engage in the occupation of goods haulage operator or passenger transport operator in national and/or international road transport and in so far as the undertakings concerned are companies or firms within the meaning of Article 58 of the Treaty, Member States shall accept as sufficient proof of professional competence certificates stating that the activity concerned has actually been carried on in a Member State for a period of three years. This activity must not have ceased more than five years before the date of submission of the certificate.  In the case of an undertaking, the certificate stating that the activity has actually been carried on shall be issued in respect of one of the natural persons actually in charge of the transport activities of the undertaking.   Article 6 Member States shall, within the time limit laid down in Article 7, designate the authorities and bodies competent to issue the documents referred to in Articles 3 and 4 and the certificate referred to in Article 5 (2). They shall immediately inform the other Member States and the Commission thereof.   Article 7 1. Member States shall bring into force the measures necessary to comply with this Directive before 1 January 1979 and shall immediately inform the Commission thereof.   2. Member States shall forward to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.   Article 8 This Directive is addressed to the Member States.     Done at Brussels, 12 December 1977.  For the Council  The President  L. DHOORE


title: Commission Directive 2011/78/EU of 20 September 2011 amending Directive 98/8/EC of the European Parliament and of the Council to include Bacillus thuringiensis subsp. israelensis Serotype H14, Strain AM65-52 as an active substance in Annex I thereto  Text with EEA relevance

text:
               21.9.2011

               EN

               Official Journal of the European Union

               L 243/7

         COMMISSION DIRECTIVE 2011/78/EU
   of 20 September 2011
   amending Directive 98/8/EC of the European Parliament and of the Council to include Bacillus thuringiensis subsp. israelensis Serotype H14, Strain AM65-52 as an active substance in Annex I thereto
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (1), and in particular the second subparagraph of Article 16(2) thereof,
   Whereas:

               (1)

               Commission Regulation (EC) No 1451/2007 of 4 December 2007 on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market (2) establishes a list of active substances to be assessed, with a view to their possible inclusion in Annex I, IA or IB to Directive 98/8/EC. That list includes Bacillus thuringiensis subsp. israelensis Serotype H14.

               (2)

               Pursuant to Regulation (EC) No 1451/2007, Strain AM65-52 of Bacillus thuringiensis subsp. israelensis Serotype H14, has been evaluated in accordance with Article 11(2) of Directive 98/8/EC for use in product-type 18, insecticides, acaricides and products to control other arthropods, as defined in Annex V to that Directive. Strain SA3A of Bacillus thuringiensis subsp. israelensis Serotype H14 is still under evaluation for use in that product-type.

               (3)

               Italy was designated as Rapporteur Member State and submitted the competent authority report, together with a recommendation, to the Commission on 11 July 2008 in accordance with Article 14(4) and (6) of Regulation (EC) No 1451/2007.

               (4)

               The competent authority report was reviewed by the Member States and the Commission. In accordance with Article 15(4) of Regulation (EC) No 1451/2007, the findings of the review were incorporated, within the Standing Committee on Biocidal Products on 6 May 2011, in an assessment report.

               (5)

               It appears from the evaluations that biocidal products used as insecticides, acaricides and products to control other arthropods and containing Bacillus thuringiensis subsp. israelensis Serotype H14, Strain AM65-52, may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC. It is therefore appropriate to include Bacillus thuringiensis subsp. israelensis Serotype H14, Strain AM65-52 in Annex I to that Directive.

               (6)

               Not all potential uses have been evaluated at Union level. It is therefore appropriate that Member States assess those uses or exposure scenarios and those risks to human populations and to environmental compartments that have not been representatively addressed in the Union level risk assessment and, when granting product authorisations, ensure that appropriate measures are taken or specific conditions imposed in order to reduce the identified risks to acceptable levels.

               (7)

               In the light of the potential risks identified for professional use without personal protective equipment, it is appropriate to require that product authorisations for professional use are granted only for use with appropriate personal protective equipment, unless it can be demonstrated in the application for product authorisation that risks to professional users can be reduced to an acceptable level by others means.

               (8)

               In the light of the possible indirect human exposure via consumption of food as a result of those uses represented in the assessment, it is appropriate to require, where relevant, verification of the need to set new or to amend existing maximum residue levels according to Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council (3) or Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC (4). Measures should be adopted ensuring that the applicable maximum residue levels are not exceeded.

               (9)

               The provisions of this Directive should be applied at the same time in all Member States in order to ensure equal treatment on the Union market of biocidal products containing the active substance Bacillus thuringiensis subsp. israelensis Serotype H14, Strain AM65-52 and also to facilitate the proper operation of the market for biocidal products in general.

               (10)

               A reasonable period should be allowed to elapse before an active substance is included in Annex I to Directive 98/8/EC, in order to permit Member States and interested parties to prepare themselves to meet the new requirements entailed and to ensure that applicants who have prepared dossiers can benefit fully from the 10-year period of data protection, which, in accordance with Article 12(1)(c)(ii) of Directive 98/8/EC, starts from the date of inclusion.

               (11)

               After inclusion, Member States should be allowed a reasonable period to implement Article 16(3) of Directive 98/8/EC.

               (12)

               Directive 98/8/EC should therefore be amended accordingly.

               (13)

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

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Annex I to Directive 98/8/EC is amended in accordance with the Annex to this Directive.
   Article 2
   1.   Member States shall adopt and publish, by 30 September 2012 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive.
   They shall apply those provisions from 1 October 2013.
   When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
   2.   Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
   Article 3
   This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
   Article 4
   This Directive is addressed to the Member States.

      Done at Brussels, 20 September 2011.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 123, 24.4.1998, p. 1.

      (2)  OJ L 325, 11.12.2007, p. 3.

      (3)  OJ L 152, 16.6.2009, p. 11.

      (4)  OJ L 70, 16.3.2005, p. 1.

      ANNEX
      In Annex I to Directive 98/8/EC, the following entry is added:

                     No

                     Common Name

                     IUPAC Name
                     Identification Numbers

                     Minimum purity of the active substance in the biocidal product as placed on the market

                     Date of inclusion

                     Deadline for compliance with Article 16(3) (except for products containing more than one active substance, for which the deadline to comply with Article 16(3) shall be the one set out in the last of the inclusion decisions relating to its active substances)

                     Expiry date of inclusion

                     Product-type

                     Specific provisions (1)

                     ‘46

                        Bacillus thuringiensis subsp. israelensis Serotype H14, Strain AM65-52

                     Not applicable

                     No relevant impurities

                     1 October 2013

                     30 September 2015

                     30 September 2023

                     18

                     When assessing the application for authorisation of a product in accordance with Article 5 and Annex VI, Member States shall assess, where relevant for the particular product, those uses or exposure scenarios and those risks to human populations and to environmental compartments that have not been representatively addressed in the Union level risk assessment.
                     Products authorised for professional use shall be used with appropriate personal protective equipment, unless it can be demonstrated in the application for product authorisation that risks to professional users can be reduced to an acceptable level by other means.
                     For products containing Bacillus thuringiensis subsp. israelensis Serotype H14, Strain AM65-52 that may lead to residues in food or feed, Member States shall verify the need to set new or to amend existing maximum residue levels (MRLs) according to Regulation (EC) No 470/2009 or Regulation (EC) No 396/2005, and take any appropriate risk mitigation measures ensuring that the applicable MRLs are not exceeded.’

         (1)  For the implementation of the common principles of Annex VI, the content and conclusions of assessment reports are available on the Commission website: http://ec.europa.eu/comm/environment/biocides/index.htm


title: Council Directive 2008/117/EC of 16 December 2008 amending Directive 2006/112/EC on the common system of value added tax to combat tax evasion connected with intra-Community transactions

text:
               20.1.2009

               EN

               Official Journal of the European Union

               L 14/7

      COUNCIL DIRECTIVE 2008/117/EC
   of 16 December 2008
   amending Directive 2006/112/EC on the common system of value added tax to combat tax evasion connected with intra-Community transactions
   THE COUNCIL OF THE EUROPEAN UNION,
   Having regard to the Treaty establishing the European Community, and in particular Article 93 thereof,
   Having regard to the proposal from the Commission,
   Having regard to the opinion of the European Parliament (1),
   Having regard to the opinion of the European Economic and Social Committee (2),
   Whereas:

               (1)

               The evasion of value added tax (VAT) has a significant impact on the Member States’ tax revenue and distorts economic activity in the single market by creating unjustified flows of goods and by placing goods on the market at abnormally low prices.

               (2)

               The shortcomings of the intra-Community VAT arrangements, and in particular the system for the exchange of information on supplies of goods within the Community, as laid down by Council Directive 2006/112/EC (3), are one of the causes of this tax evasion. In particular, the time that elapses between a transaction and the corresponding exchange of information under the VAT information exchange system is an obstacle to the effective use of that information to tackle fraud.

               (3)

               In order to combat VAT evasion effectively, it is necessary for the administration of the Member State in which the VAT is chargeable to receive information on intra-Community supplies of goods within a deadline not exceeding one month.

               (4)

               In order for the cross-checking of information to be useful for combating fraud, intra-Community transactions should be declared for the same tax period by both the supplier and the purchaser or customer.

               (5)

               In view of changes in the business environment and operative tools, it is desirable to ensure that these declarations can be made by simple electronic procedures in order to reduce the administrative burden to a minimum.

               (6)

               In order to preserve the balance between the Community’s objectives in combating tax evasion and reducing the administrative burden on economic operators, Member States should be allowed to authorise operators to submit on a quarterly basis the recapitulative statements concerning intra-Community supplies of goods where their amount is not significant. It is appropriate that Member States wishing to organise a progressive entry into application of this proposal could, on a transitory basis, set this amount at a higher level. Likewise, Member States should be allowed to authorise operators to submit the information on intra-Community supplies of services on a quarterly basis.

               (7)

               The impact of the speeding-up of the exchange of information on Member States’ ability to combat VAT fraud as well as the option mechanisms should be assessed by the Commission after one year of application of the new measures, in particular with a view to determine whether these option mechanisms should be maintained.

               (8)

               Since the objectives of the proposed action to tackle VAT evasion cannot be sufficiently achieved by the Member States, whose action in the matter depends on information collected by the other Member States, and can therefore, by reason of the need to involve all Member States, be better achieved at Community level, the Community may adopt measures in accordance with the principle of subsidiarity, as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve those objectives.

               (9)

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

               (10)

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

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Directive 2006/112/EC is hereby amended as follows:

               1.

               Article 64(2) shall be replaced by the following:
               ‘2.   Supplies of services for which VAT is payable by the customer pursuant to Article 196, which are supplied continuously over a period of more than one year and which do not give rise to statements of account or payments during that period shall be regarded as being completed on expiry of each calendar year until such time as the supply of services comes to an end.
               Member States may provide that, in certain cases other than those referred to in the previous paragraph, the continuous supply of goods or services over a period of time is to be regarded as being completed at least at intervals of one year.’;

               2.

               in Article 66, the following subparagraph shall be added:
               ‘The derogation provided for in the first paragraph shall not, however, apply to supplies of services in respect of which VAT is payable by the customer pursuant to Article 196.’;

               3.

               Article 263 shall be replaced by the following:
               ‘Article 263
               1.   The recapitulative statement shall be drawn up for each calendar month within a period not exceeding one month and in accordance with procedures to be determined by the Member States.
               1a.   However, Member States, in accordance with the conditions and limits which they may lay down, may allow taxable persons to submit the recapitulative statement for each calendar quarter within a time limit not exceeding one month from the end of the quarter, where the total quarterly amount, excluding VAT, of the supplies of goods as referred to in Articles 264(1)(d) and 265(1)(c) does not exceed either in respect of the quarter concerned or in respect of any of the previous four quarters the sum of EUR 50 000 or its equivalent in national currency.
               The option provided for in the first subparagraph shall cease to be applicable after the end of the month during which the total value, excluding VAT, of the supplies of goods as referred to in Article 264(1)(d) and 265(1)(c) exceeds, in respect of the current quarter, the sum of EUR 50 000 or its equivalent in national currency. In this case, a recapitulative statement shall be drawn up for the month(s) which has (have) elapsed since the beginning of the quarter, within a time limit not exceeding one month.
               1b.   Until 31 December 2011, Member States are allowed to set the sum mentioned in paragraph 1a at EUR 100 000 or its equivalent in national currency.
               1c.   In the case of supplies of services as referred to in Article 264(1)(d), Member States, in accordance with the conditions and limits which they may lay down, may allow taxable persons to submit the recapitulative statement for each calendar quarter within a time limit not exceeding one month from the end of the quarter.
               Member States may, in particular, require the taxable persons who carry out supplies of both goods and services as referred to in Article 264(1)(d) to submit the recapitulative statement in accordance with the deadline resulting from paragraphs 1 to 1b.
               2.   Member States shall allow, and may require, the recapitulative statement referred to in paragraph 1 to be submitted by electronic file transfer, in accordance with conditions which they lay down.’;

               4.

               Article 264(2) shall be replaced by the following:
               ‘2.   The value referred to in paragraph 1(d) shall be declared for the period of submission established in accordance with Article 263(1) to (1c) during which VAT became chargeable.
               The amounts referred to in paragraph 1(f) shall be declared for the period of submission established in accordance with Article 263(1) to (1c) during which the person acquiring the goods was notified of the adjustment.’;

               5.

               Article 265(2) shall be replaced by the following:
               ‘2.   The value referred to in paragraph 1(c) shall be declared for the period of submission established in accordance with Article 263(1) to (1b) during which VAT became chargeable.’.

         Article 2
   On the basis of information provided by the Member States, the Commission shall present, no later than 30 June 2011, a report assessing the impact of Article 263(1) of Directive 2006/112/EC on Member States’ ability to fight against VAT fraud connected with intra-Community supplies of goods and services as well as the usefulness of the options provided for in Article 263(1a) to (1c), as well as, depending on the conclusions of the report, the appropriate proposals.
   Article 3
   1.   Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive with effect from 1 January 2010. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.
   When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
   2.   Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
   Article 4
   This Directive shall enter into force on the day following its publication in the Official Journal of the European Union.
   Article 5
   This Directive is addressed to the Member States.

      Done at Brussels, 16 December 2008.

            For the Council

            The President

         R. BACHELOT-NARQUIN

      (1)  Opinion of 4.12.2008 (not yet published in the Official Journal).

      (2)  Opinion of 22.10.2008 (not yet published in the Official Journal).

      (3)  OJ L 347, 11.12.2006, p. 1.

      (4)  OJ C 321, 31.12.2003, p. 1.