title: Directive 2005/33/EC of the European Parliament and of the Council of 6 July 2005 amending Directive 1999/32/EC

text:
               22.7.2005

               EN

               Official Journal of the European Union

               L 191/59

      DIRECTIVE 2005/33/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

   of 6 July 2005
   amending Directive 1999/32/EC
   as regards the sulphur content of marine fuels
   THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
   Having regard to the Treaty establishing the European Community, and in particular Article 175(1) thereof,
   Having regard to the proposal from the Commission (1),
   Having regard to the opinion of the European Economic and Social Committee (2),
   After consulting the Committee of the Regions,
   Acting in accordance with the procedure laid down in Article 251 of the Treaty (3),
   Whereas:

               (1)

               The Community's environmental policy, as set out in the action programmes on the environment and, in particular, in the Sixth Community Environment Action Programme adopted by Decision No 1600/2002/EC of the European Parliament and of the Council (4), on the basis of Article 174 of the Treaty, aims to achieve levels of air quality that do not give rise to unacceptable impacts on, and risks to, human health and the environment.

               (2)

               Council Directive 1999/32/EC of 26 April 1999 relating to a reduction in the sulphur content of certain liquid fuels (5) lays down the maximum permitted sulphur content of heavy fuel oil, gas oil and marine gas oil used in the Community.

               (3)

               Directive 1999/32/EC requires the Commission to consider what measures could be taken to reduce the contribution to acidification of the combustion of marine fuels other than marine gas oils and, if appropriate, make a proposal.

               (4)

               Emissions from shipping due to the combustion of marine fuels with high sulphur content contribute to air pollution in the form of sulphur dioxide and particulate matter, harming human health, damaging the environment, public and private property and cultural heritage and contributing to acidification.

               (5)

               Human beings and the natural environment in coastal areas and in the vicinity of ports are particularly affected by pollution from ships with high sulphur fuels. Specific measures are therefore required in this regard.

               (6)

               The measures in this Directive complement Member States' national measures to comply with emission ceilings for atmospheric pollutants set out in Directive 2001/81/EC of the European Parliament and of the Council (6).

               (7)

               Reducing the sulphur content of fuels has certain advantages for ships, in terms of operating efficiency and maintenance costs, and facilitates the effective use of certain emission abatement technologies such as selective catalytic reduction.

               (8)

               The Treaty requires consideration to be given to the special characteristics of the outermost regions of the Community, namely the French overseas departments, the Azores, Madeira and the Canary Islands.

               (9)

               In 1997, a diplomatic conference adopted a Protocol to amend the International Convention for the Prevention of Pollution from Ships, 1973, as modified by the Protocol of 1978 relating thereto (hereinafter MARPOL). This Protocol adds a new Annex VI to MARPOL, containing regulations for the prevention of air pollution from ships. The 1997 Protocol, and consequently Annex VI to MARPOL, entered into force on 19 May 2005.

               (10)

               Annex VI to MARPOL makes provision for certain areas to be designated as Sulphur Oxide Emission Control Areas (hereinafter SOx Emission Control Areas). It already designates the Baltic Sea as such an area. Discussions within the International Maritime Organisation (IMO) have resulted in agreement on the principle of the designation of the North Sea, including the English Channel, as a SOx Emission Control Area following the entry into force of Annex VI.

               (11)

               Given the global nature of maritime shipping, every effort should be made to find international solutions. Both the Commission and the Member States should endeavour to secure within the IMO a worldwide reduction in the maximum authorised sulphur content of marine fuels, including by examining the merits of designating new sea areas as SOx Emission Control Areas in accordance with Annex VI to MARPOL.

               (12)

               Enforcement of the obligations with regard to the sulphur content of marine fuels is necessary to achieve the aims of this Directive. Effective sampling and dissuasive penalties throughout the Community are necessary to ensure credible implementation of this Directive. Member States should take enforcement action with respect to vessels flying their flag and to vessels of all flags while in their ports. It is also appropriate for Member States to cooperate closely to take additional enforcement action with respect to other vessels in accordance with international maritime law.

               (13)

               To allow sufficient time for the maritime industry to bring about technical adaptation to a maximum limit of 0,1 % sulphur by weight for marine fuels used by inland waterway vessels and ships at berth in Community ports, the date on which this requirement is to be applied should be 1 January 2010. Since this deadline might present Greece with technical problems, a temporary derogation is appropriate for some specific vessels operating within the territory of the Hellenic Republic.

               (14)

               This Directive should be seen as the first step in an ongoing process to reduce marine emissions, offering prospects for further emission reductions through lower fuel sulphur limits and abatement technologies, and for economic instruments to be developed as an incentive to achieve significant reductions.

               (15)

               It is essential to reinforce Member States' positions in IMO negotiations, in particular to promote, in the revision phase of Annex VI to MARPOL, the consideration of more ambitious measures as regards tighter sulphur limits for heavy fuel oils used by ships and the use of equivalent alternative emission abatement measures.

               (16)

               In its resolution A.926(22), the IMO Assembly invited Governments, particularly those in regions where SOx Emission Control Areas have been designated, to ensure the availability of low sulphur bunker fuel oil in areas within their jurisdiction and to call on the oil and shipping industries to facilitate the availability and use of low sulphur bunker fuel oil. Member States should take action as appropriate to ensure that local marine fuel suppliers make compliant fuel available, in sufficient quantities to meet demand.

               (17)

               The IMO has adopted guidelines for the sampling of fuel oil for determining compliance with Annex VI to MARPOL, and is due to develop guidelines on exhaust gas cleaning systems and other technological methods to limit SOx emissions in SOx Emission Control Areas.

               (18)

               Directive 2001/80/EC of the European Parliament and of the Council of 23 October 2001 on the limitation of emissions of certain pollutants into the air from large combustion plants (7) recasts Council Directive 88/609/EEC (8) . Directive 1999/32/EC should be revised accordingly, as provided for in Article 3(4) thereof.

               (19)

               It is appropriate for the existing Committee on Safe Seas and the Prevention of Pollution from Ships established by Regulation (EC) No 2099/2002 of the European Parliament and of the Council (9) to assist the Commission in the context of the approval of emission abatement technologies.

               (20)

               Emission abatement technologies, provided they have no adverse effect on ecosystems and are developed subject to appropriate approval and control mechanisms, can provide emission reductions at least equivalent to, or even greater than, those achievable using low sulphur fuel. It is essential that the correct conditions exist to promote the emergence of new emission abatement technologies.

               (21)

               The European Maritime Safety Agency should provide assistance to the Commission and Member States, as appropriate, in monitoring the implementation of this Directive.

               (22)

               The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (10).

               (23)

               Directive 1999/32/EC should therefore be amended accordingly,

         HAVE ADOPTED THIS DIRECTIVE:
   Article 1
   Directive 1999/32/EC is amended as follows:

               1.

               Article 1(2) shall be replaced by the following:

                           ‘2.

                           Reductions in emissions of sulphur dioxide resulting from the combustion of certain petroleum-derived liquid fuels shall be achieved by imposing limits on the sulphur content of such fuels as a condition for their use within Member States' territory, territorial seas and exclusive economic zones or pollution control zones.’The limitations on the sulphur content of certain petroleum-derived liquid fuels as laid down in this Directive shall not, however, apply to:
                                       (a)

                                       fuels intended for the purposes of research and testing;

                                       (b)

                                       fuels intended for processing prior to final combustion;

                                       (c)

                                       fuels to be processed in the refining industry;

                                       (d)

                                       fuels used and placed on the market in the outermost regions of the Community provided that the relevant Member States ensure that, in those regions:

                                                   —

                                                   air quality standards are respected,

                                                   —

                                                   heavy fuel oils are not used if their sulphur content exceeds 3 % by mass;

                                       (e)

                                       fuels used by warships and other vessels on military service. However, each Member State shall endeavour to ensure, by the adoption of appropriate measures not impairing the operations or operational capability of such ships, that these ships act in a manner consistent, so far as is reasonable and practical, with this Directive;

                                       (f)

                                       any use of fuels in a vessel necessary for the specific purpose of securing the safety of a ship or saving life at sea;

                                       (g)

                                       any use of fuels in a ship necessitated by damage sustained to it or its equipment, provided that all reasonable measures are taken after the occurrence of the damage to prevent or minimise excess emissions and that measures are taken as soon as possible to repair the damage. This shall not apply if the owner or master acted either with intent to cause damage, or recklessly;

                                       (h)

                                       fuels used on board vessels employing approved emission abatement technologies in accordance with Article 4c.';

               2.

               Article 2 shall be amended as follows:

                           (a)

                           the first indent in point 1 shall be replaced by the following:

                                       ‘-

                                       any petroleum-derived liquid fuel, excluding marine fuel, falling within CN code 2710 19 51 to 2710 19 69, or’;

                           (b)

                           the first subparagraph of point 2 shall be replaced by the following:
                           ‘gas oil means:

                                       —

                                       any petroleum-derived liquid fuel, excluding marine fuel, falling within CN code 2710 19 25, 2710 19 29, 2710 19 45 or 2710 19 49, or

                                       —

                                       any petroleum-derived liquid fuel, excluding marine fuel, of which less than 65 % by volume (including losses) distils at 250 oC and of which at least 85 % by volume (including losses) distils at 350 oC by the ASTM D86 method.’;

                           (c)

                           point 3 shall be replaced by the following:

                                       ‘3.

                                          marine fuel means any petroleum-derived liquid fuel intended for use or in use on board a vessel, including those fuels defined in ISO 8217;’

                           (d)

                           the following points shall be inserted:

                                       ‘3a.

                                          marine diesel oil means any marine fuel which has a viscosity or density falling within the ranges of viscosity or density defined for DMB and DMC grades in Table I of ISO 8217;

                                       3b.

                                          marine gas oil means any marine fuel which has a viscosity or density falling within the ranges of viscosity or density defined for DMX and DMA grades in Table I of ISO 8217;

                                       3c.

                                          MARPOL means the International Convention for the Prevention of Pollution from Ships, 1973, as modified by the Protocol of 1978 relating thereto;

                                       3d.

                                          Annex VI to MARPOL means the annex, entitled “Regulations for the Prevention of Air Pollution from Ships”, that the Protocol of 1997 adds to MARPOL;

                                       3e.

                                          Ox Emission Control Areas means sea areas defined as such by the IMO under Annex VI to MARPOL;

                                       3f.

                                          passenger ships means ships that carry more than 12 passengers, where a passenger is every person other than:

                                                   (i)

                                                   the master and the members of the crew or other person employed or engaged in any capacity on board a ship on the business of that ship, and

                                                   (ii)

                                                   a child under one year of age;

                                       3g.

                                          regular services means a series of passenger ship crossings operated so as to serve traffic between the same two or more ports, or a series of voyages from and to the same port without intermediate calls, either:

                                                   (i)

                                                   according to a published timetable, or

                                                   (ii)

                                                   with crossings so regular or frequent that they constitute a recognisable schedule;

                                       3h.

                                          warship means a ship belonging to the armed forces of a State bearing the external marks distinguishing such ships of its nationality, under the command of an officer duly commissioned by the government of the State and whose name appears in the appropriate service list or its equivalent, and manned by a crew which is under regular armed forces discipline;

                                       3i.

                                          ships at berth means ships which are securely moored or anchored in a Community port while they are loading, unloading or hotelling, including the time spent when not engaged in cargo operations;

                                       3j.

                                          inland waterway vessel means a vessel particularly intended for use on an inland waterway as defined in Council Directive 82/714/EEC of 4 October 1982 laying down technical requirements for inland waterway vessels (11) , including all vessels which carry:

                                                   (i)

                                                   a Community inland navigation certificate, as defined in Directive 82/714/EEC,

                                                   (ii)

                                                   a certificate issued pursuant to Article 22 of the Revised Convention for the Navigation of the Rhine;

                                       3k.

                                          placing on the market means supplying or making available to third persons, against payment or free of charge, anywhere within Member States' jurisdictions, marine fuels for on-board combustion. It excludes supplying or making available marine fuels for export in ships' cargo tanks;

                                       3l.

                                          outermost regions means the French overseas departments, the Azores, Madeira and the Canary Islands, as set out in Article 299 of the Treaty;

                                       3m.

                                          emission abatement technology means an exhaust gas cleaning system, or any other technological method that is verifiable and enforceable;’

                           (e)

                           point 6 shall be deleted;

               3.

               Article 3 shall be replaced by the following:
               ‘Article 3
               Maximum sulphur content of heavy fuel oil
               1.   Member States shall take all necessary steps to ensure that, as from 1 January 2003, heavy fuel oils are not used within their territory if their sulphur content exceeds 1 % by mass.

                           2.

                                       (i)

                                       Subject to appropriate monitoring of emissions by competent authorities this requirement shall not apply to heavy fuel oils used:

                                                   (a)

                                                   in combustion plants which fall within the scope of Directive 2001/80/EC of the European Parliament and of the Council of 23 October 2001 on the limitation of emissions of certain pollutants into the air from large combustion plants (12), which are considered new in accordance with the definition given in Article 2(9) thereof and which comply with the sulphur dioxide emission limits for such plants set out in Annex IV to that Directive and applied in accordance with Article 4 thereof;

                                                   (b)

                                                   in combustion plants which fall within the scope of Directive 2001/80/EC, which are considered existing in accordance with the definition given in Article 2(10) thereof, where the sulphur dioxide emissions from these combustion plants are equal to or less than 1 700 mg/Nm3 at an oxygen content in the flue gas of 3 % by volume on a dry basis, and where, from 1 January 2008, the emissions of sulphur dioxide from combustion plants subject to Article 4(3)(a) of Directive 2001/80/EC are equal to or less than those resulting from compliance with the emission limit values for new plants contained in Part A of Annex IV to that Directive and where appropriate applying Articles 5, 7 and 8 thereof;

                                                   (c)

                                                   in other combustion plants which do not fall under (a) or (b), where the sulphur dioxide emissions from those combustion plants do not exceed 1 700 mg/Nm3 at an oxygen content in the flue gas of 3 % by volume on a dry basis;

                                                   (d)

                                                   for combustion in refineries, where the monthly average of emissions of sulphur dioxide averaged over all plants in the refinery, irrespective of the type of fuel or fuel combination used, is within a limit to be set by each Member State, which shall not exceed 1 700 mg/Nm3. This shall not apply to combustion plants which fall under (a) or, from 1 January 2008, to those which fall under (b).

                                       (ii)

                                       Member States shall take the necessary measures to ensure that any combustion plant using heavy fuel oil with a sulphur concentration greater than that referred to in paragraph 1 is not operated without a permit issued by a competent authority, which specifies the emission limits.

                     3.   The provisions of paragraph 2 shall be reviewed and, if appropriate, amended in the light of any future amendment of Directive 2001/80/EC.’

               4.

               Article 4 shall be amended as follows:

                           (a)

                           with effect from 1 January 2010:

                                       (i)

                                       in paragraph 1, the words ‘including marine gas oils’ shall be deleted;

                                       (ii)

                                       paragraph 2 shall be deleted;

                           (b)

                           with effect from 11 August 2005, paragraphs 3 and 4 shall be deleted;

               5.

               The following Articles shall be inserted:
               ‘Article 4a
               Maximum sulphur content of marine fuels used in SOx Emission Control Areas and by passenger ships operating on regular services to or from Community ports
               1.   Member States shall take all necessary measures to ensure that marine fuels are not used in the areas of their territorial seas, exclusive economic zones and pollution control zones falling within SOx Emission Control Areas if the sulphur content of those fuels exceeds 1,5 % by mass. This shall apply to all vessels of all flags, including vessels whose journey began outside the Community.
               2.   The application dates for paragraph 1 shall be as follows:

                           (a)

                           for the Baltic Sea area referred to in regulation 14(3)(a) of Annex VI to MARPOL, 11 August 2006;

                           (b)

                           for the North Sea:

                                       —

                                       12 months after entry into force of the IMO designation, according to established procedures, or

                                       —

                                       11 August 2007,

                                 whichever is the earlier;

                           (c)

                           for any other sea areas, including ports, that the IMO subsequently designates as SOx Emission Control Areas in accordance with regulation 14(3)(b) of Annex VI to MARPOL: 12 months after the date of entry into force of the designation.

                     3.   Member States shall be responsible for the enforcement of paragraph 1 at least in respect of:

                           —

                           vessels flying their flag, and

                           —

                           in the case of Member States bordering SOx Emission Control Areas, vessels of all flags while in their ports.

                     Member States may also take additional enforcement action in respect of other vessels in accordance with international maritime law.
               4.   From the date referred to in paragraph 2(a), Member States shall take all necessary measures to ensure that marine fuels are not used in their territorial seas, exclusive economic zones and pollution control zones by passenger ships operating on regular services to or from any Community port if the sulphur content of those fuels exceeds 1,5 % by mass. Member States shall be responsible for the enforcement of this requirement at least in respect of vessels flying their flag and vessels of all flags while in their ports.
               5.   From the date referred to in paragraph 2(a), Member States shall require the correct completion of ships' logbooks, including fuel-changeover operations, as a condition of ships' entry into Community ports.
               6.   From the date referred to in paragraph 2(a), and in accordance with Regulation 18 of Annex VI to MARPOL, Member States shall:

                           —

                           maintain a register of local suppliers of marine fuel,

                           —

                           ensure that the sulphur content of all marine fuels sold in their territory is documented by the supplier on a bunker delivery note, accompanied by a sealed sample signed by the representative of the receiving ship,

                           —

                           take action as appropriate against marine fuel suppliers that have been found to deliver fuel that does not comply with the specification stated on the bunker delivery note,

                           —

                           ensure that remedial action as appropriate is taken to bring any non-compliant marine fuel discovered into compliance.

                     7.   From the date referred to in paragraph 2(a), Member States shall ensure that marine diesel oils are not placed on the market in their territory if the sulphur content of those marine diesel oils exceeds 1,5 % by mass.
               8   The Commission shall notify Member States of the application dates mentioned in paragraph 2(b) and publish them in the Official Journal of the European Union.

               Article 4b
               Maximum sulphur content of marine fuels used by inland waterway vessels and ships at berth in Community ports
               1.   With effect from 1 January 2010, Member States shall take all necessary measures to ensure that the following vessels do not use marine fuels with a sulphur content exceeding 0,1 % by mass:

                           (a)

                           inland waterway vessels; and

                           (b)

                           ships at berth in Community ports, allowing sufficient time for the crew to complete any necessary fuel-changeover operation as soon as possible after arrival at berth and as late as possible before departure.
                           Member States shall require the time of any fuel-changeover operation to be recorded in ships' logbooks.

                     2.   Paragraph 1 shall not apply:

                           (a)

                           whenever, according to published timetables, ships are due to be at berth for less than two hours;

                           (b)

                           to inland waterway vessels that carry a certificate proving conformity with the International Convention for the Safety of Life at Sea, 1974, as amended, while those vessels are at sea;

                           (c)

                           until 1 January 2012 for the vessels listed in the Annex and operating exclusively within the territory of the Hellenic Republic;

                           (d)

                           to ships which switch off all engines and use shore-side electricity while at berth in ports.

                     3.   With effect from 1 January 2010, Member States shall ensure that marine gas oils are not placed on the market in their territory if the sulphur content of those marine gas oils exceeds 0,1 % by mass.
               Article 4c
               Trials and use of new emission abatement technologies
               1.   Member States may, in cooperation with other Member States, as appropriate, approve trials of ship emission abatement technologies on vessels flying their flag, or in sea areas within their jurisdiction. During these trials the use of marine fuels meeting the requirements of Articles 4a and 4b shall not be mandatory, provided that:

                           —

                           the Commission and any port State concerned are notified in writing at least six months before trials begin,

                           —

                           permits for trials do not exceed 18 months in duration,

                           —

                           all ships involved install tamper-proof equipment for the continuous monitoring of funnel gas emissions and use it throughout the trial period,

                           —

                           all ships involved achieve emission reductions which are at least equivalent to those which would be achieved through the limits on sulphur in fuel specified in this Directive,

                           —

                           there are proper waste management systems in place for any waste generated by the emission abatement technologies throughout the trial period,

                           —

                           there is an assessment of impacts on the marine environment, particularly ecosystems in enclosed ports, harbours and estuaries throughout the trial period, and

                           —

                           full results are provided to the Commission, and made publicly available, within six months of the end of the trials.

                     2.   Emission abatement technologies for ships flying the flag of a Member State shall be approved in accordance with the procedure referred to in Article 3(2) of Regulation (EC) No 2099/2002 of the European Parliament and of the Council of 5 November 2002 establishing a Committee on Safe Seas and the Prevention of Pollution from Ships (COSS) (13), taking into account:

                           —

                           guidelines to be developed by the IMO,

                           —

                           results of any trials conducted under paragraph 1,

                           —

                           effects on the environment, including achievable emission reductions, and impacts on ecosystems in enclosed ports, harbours and estuaries,

                           —

                           feasibility of monitoring and verification.

                     3.   Criteria shall be established for the use of emission abatement technologies by ships of all flags in enclosed ports, harbours and estuaries in the Community in accordance with the procedure referred to in Article 9(2). The Commission shall communicate these criteria to the IMO.
               4.   As an alternative to using low sulphur marine fuels meeting the requirements of Articles 4a and 4b, Member States may allow ships to use an approved emission abatement technology, provided that these ships:

                           —

                           continuously achieve emission reductions which are at least equivalent to those which would be achieved through the limits on sulphur in fuel specified in this Directive,

                           —

                           are fitted with continuous emission monitoring equipment, and

                           —

                           document thoroughly that any waste streams discharged into enclosed ports, harbours and estuaries have no impact on ecosystems, based on criteria communicated by the authorities of port States to the IMO.’

               6.

               Article 6 shall be amended as follows:

                           (a)

                           the following paragraph shall be inserted:

                                       ‘1a.

                                       Member States shall take the necessary measures to ensure that the sulphur content of marine fuels complies with the relevant provisions of Articles 4a and 4b.

                                 Each of the following means of sampling, analysis and inspection shall be used as appropriate:

                                       —

                                       sampling of the marine fuel for on-board combustion while being delivered to ships, following IMO guidelines, and analysis of its sulphur content;

                                       —

                                       sampling and analysis of the sulphur content of marine fuel for on-board combustion contained in tanks, where feasible, and in sealed bunker samples on board ships;

                                       —

                                       inspection of ships' log books and bunker delivery notes.

                                 Sampling shall commence on the date on which the relevant limit for maximum sulphur content in the fuel comes into force. It shall be carried out with sufficient frequency, in sufficient quantities, and in such a way that the samples are representative of the fuel examined, and of the fuel being used by ships while in relevant sea areas, ports and inland waterways.
                           Member States shall also take reasonable measures, as appropriate, to monitor the sulphur content of marine fuels other than those to which Articles 4a and 4b apply.’;

                           (b)

                           in paragraph 2, point (a) shall be replaced by the following:

                                       ‘(a)

                                       ISO method 8754 (1992) and PrEN ISO 14596 for heavy fuel oil and marine fuels;’

               7.

               Article 7 shall be replaced by the following:
               ‘Article 7
               Reporting and review
               1.   On the basis of the results of the sampling, analysis and inspections carried out in accordance with Article 6, Member States shall by 30 June of each year provide the Commission with a short report on the sulphur content of the liquid fuels falling within the scope of this Directive and used within their territory during the preceding calendar year. That report shall include a record of the total number of samples tested by fuel type and shall indicate the corresponding quantity of fuel used, and the calculated average sulphur content. Member States shall also report the number of inspections made on board ships, and record the average sulphur content of marine fuels used in their territory which do not fall within the scope of this Directive on 11 August 2005.
               2.   On the basis, inter alia, of:

                           (a)

                           annual reports submitted in accordance with paragraph 1;

                           (b)

                           observed trends in air quality, acidification, fuel costs and modal shift;

                           (c)

                           progress in reducing emissions of sulphur oxides from ships through IMO mechanisms following Community initiatives in this regard;

                           (d)

                           a new cost-effectiveness analysis, including direct and indirect environmental benefits, of measures contained in Article 4a(4) and of possible further emission reduction measures; and

                           (e)

                           the implementation of Article 4c,

                     the Commission shall, by 2008, submit a report to the European Parliament and to the Council.
               The Commission may submit with its report proposals for amending this Directive, in particular as regards:

                           —

                           a second stage of sulphur limit values laid down for each fuel category, and

                           —

                           taking account of work within the IMO, the sea areas where low sulphur marine fuels are to be used.

                     The Commission shall give particular consideration to proposals for:

                           (a)

                           the designation of additional SOx Emission Control Areas;

                           (b)

                           the reduction of sulphur limits for marine fuel used in SOx Emission Control Areas possibly down to 0,5 %;

                           (c)

                           alternative or complementary measures.

                     3.   By 31 December 2005, the Commission shall report to the European Parliament and to the Council on the possible use of economic instruments, including mechanisms such as differentiated dues and kilometre charges, tradable emission permits and offsetting.
               The Commission may consider submitting proposals on economic instruments as alternative or complementary measures in the context of the 2008 review, provided that environmental and health benefits can be clearly demonstrated.
               4.   Any amendments necessary to make technical adaptations to Article 2, points 1, 2, 3, 3a, 3b and 4 or Article 6(2) in the light of scientific and technical progress shall be adopted in accordance with the procedure referred to in Article 9(2). Such adaptations shall not result in any direct changes to the scope of this Directive or to limits on sulphur in fuel specified in this Directive.’;

               8.

               Article 9 shall be replaced by the following:
               ‘Article 9
               Committee procedure
               1.   The Commission shall be assisted by a committee.
               2.   Where reference is made to this paragraph, Articles 5 and 7 of Council Decision 1999/468/EC (14) shall apply, having regard to the provisions of Article 8 thereof.
               The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.
               3.   The Committee shall adopt its Rules of Procedure.’

               9.

               The text set out in the Annex to this Directive shall be added.

         Article 2
   Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 11 August 2006. 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 a reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States.
   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 Strasbourg, 6 July 2005.

            For the European Parliament

            The President

         J. BORRELL FONTELLES

            For the Council

            The President

         J. STRAW

      (1)  OJ C 45 E, 25.2.2003, p. 277.

      (2)  OJ C 208, 3.9.2003, p. 27.

      (3)  Opinion of the European Parliament of 4 June 2003 (OJ C 68 E, 18.3.2004, p. 311), Council Common Position of 9 December 2004 (OJ C 63 E, 15.3.2005, p. 26), Position of the European Parliament of 13 April 2005 (not yet published in the Official Journal) and Council Decision of 23 May 2005.

      (4)  OJ L 242, 10.9.2002, p. 1.

      (5)  OJ L 121, 11.5.1999, p. 13. Directive as amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council (OJ L 284, 31.10.2003, p. 1).

      (6)  OJ L 309, 27.11.2001, p. 22. Directive as amended by the 2003 Act of Accession.

      (7)  OJ L 309, 27.11.2001, p. 1. Directive as amended by the 2003 Act of Accession.

      (8)  OJ L 336, 7.12.1988, p. 1.

      (9)  OL L 324, 29.11.2002, p. 1. Regulation as amended by Commission Regulation (EC) No 415/2004 (OJ L 68, 6.3.2004, p. 10).

      (10)  OJ L 184, 17.7.1999, p. 23.

      (11)  OJ L 301, 28.10.1982, p. 1. Directive as last amended by the 2003 Act of Accession.

      (12)  OJ L 309, 27.11.2001, p. 1. Directive as amended by the 2003 Act of Accession.

      (13)  OJ L 324, 29.11.2002, p. 1. Regulation as amended by Commission Regulation (EC) No 415/2004 (OJ L 68, 6.3.2004, p. 10).

      (14)  OJ L 184, 17.7.1999, p. 23

      ANNEX

            ‘ANNEX
            GREEK VESSELS

                        VESSEL'S NAME

                        DELIVERY YEAR

                        IMO No

                        ARIADNEPALACE

                        2002

                        9221310

                        IKARUSPALACE

                        1997

                        9144811

                        KNOSSOSPALACE

                        2001

                        9204063

                        OLYMPIAPALACE

                        2001

                        9220330

                        PASIPHAEPALACE

                        1997

                        9161948

                        FESTOSPALACE

                        2001

                        9204568

                        EUROPAPALACE

                        2002

                        9220342

                        BLUESTAR I

                        2000

                        9197105

                        BLUESTAR II

                        2000

                        9207584

                        BLUE STAR ITHAKI

                        1999

                        9203916

                        BLUE STAR NAXOS

                        2002

                        9241786

                        BLUE STAR PAROS

                        2002

                        9241774

                        HELLENIC SPIRIT

                        2001

                        9216030

                        OLYMPIC CHAMPION

                        2000

                        9216028

                        LEFKAORI

                        1991

                        9035876

                        SOPHOKLISVENIZELOS

                        1990

                        8916607’


Avis juridique important

|

31986L0469

Council Directive 86/469/EEC of 16 September 1986 concerning the examination of animals and fresh meat for the presence of residues

Official Journal L 275 , 26/09/1986 P. 0036 - 0045 Finnish special edition: Chapter 3 Volume 21 P. 0280  Swedish special edition: Chapter 3 Volume 21 P. 0280

*****COUNCIL  DIRECTIVE  of 16 September 1986  concerning the examination of animals and fresh meat for the presence of residues  (86/469/EEC)  THE COUNCIL OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community, and in particular Article 43 thereof,  Having regard to Council Directive 64/433/EEC of 26 June 1964 on health problems affecting intra-Community trade in fresh meat (1), as last amended by Regulation (EEC) No 3768/85 (2), and in particular Article 4 thereof,  Having regard to Council Directive 81/602/EEC of 31 July 1981 concerning the prohibition of certain substances having a hormonal action and of any substance having a thyrostatic action (3),  Having regard to the proposals from the Commission (4),  Having regard to the opinions of the European Parliament (5),  Having regard to the opinions of the Economic and Social Committee (6),  Whereas Article 4 (2) of Directive 64/433/EEC lays down as regards examination of animals or meat for residues that the Council shall adopt:  - the detailed arrangements for controls,  - the tolerances for the substances referred to in the second subparagraph of Article 4 (1) (b) of that Directive,  - the frequency of sampling;  Whereas, on 16 July 1985, the Council, by Directive 85/358/EEC supplementing Directive 81/602/EEC concerning the prohibition of certain substances having a hormonal action and of any substances having a thyrostatic action (7), adopted certain rules of control with a view to guaranteeing the uniform application of Directive 81/602/EEC; whereas supplementary measures would appear to be appropriate;  Whereas the detailed arrangements for controls of animals and fresh meat for residues, for the frequency of sampling of animals or meat, for examination for residues, and for the establishment of maximum permitted limits of residues of substances having a pharmacological action and of the conversion products thereof and other substances transmitted to meat are regulated in a differing fashion in the Member States; whereas the consequences of such residues for human health are assessed differently in such regulations; whereas these differences lead to major obstacles in intra-Community trade and to a distortion in the conditions of competition between products that are the subject of common organizations of the market;  Whereas it is therefore necessary to adopt a general solution concerning controls in the Community of farm animals and meat and meat products obtained therefrom for the presence of residues, whether these products are intended for the national market of Member States or intra-Community trade;  Whereas it is desirable that Member States should draw up plans which take account of their situation; whereas these plans must be approved and, if necessary, amended or amplified by means of a Community procedure;  Whereas it is appropriate to provide that sampling be carried out officially in the Member States in accordance with common criteria for the different groups of substances of concern; whereas it is appropriate that samples are subject to examination at officially authorized laboratories;  Whereas it is appropriate that the national reference laboratories designated in accordance with Article 4 (1) (b) of Directive 64/433/EEC should coordinate the standards and methods of analysis used in their respective territories; whereas it is appropriate that for each residue or group of residues of concern a Community laboratory should be designated for liaison with the national reference laboratories;  Whereas further details of the criteria of operation of laboratories should be established later;  Whereas, when an examination reveals the presence of residues, it is necessary that common control measures are taken to ascertain and eliminate the cause of the residue, and which ensure that meat showing residues which exceed the permitted level is excluded from consumption;  Whereas, in order to make it easier to implement the provisions envisaged, provision should be made for a procedure which establishes close cooperation between the Member States and the Commission within the Standing Veterinary Committee set up by Decision 68/361/EEC (1);  Whereas it is necessary to keep under review the details of the controls carried out in particular in terms of the results which are found;  Whereas it is necessary to provide for the amendment and, where necessary, supplementation of technical provisions concerning controls and frequency of sampling to take account of new knowledge and scientific and technical developments;  Whereas it is desirable that Community control measures be introduced to guarantee uniform application in all Member States of the provisions of this Directive;  Whereas provision should be made for a procedure designed to settle any conflict which might arise between Member States on the efficiency of the controls provided for by this Directive;  Whereas the adoption of a harmonized set of rules in the Community leads to the setting-up of arrangements for imports from third countries, offering equivalent guarantees; whereas, in this connection, Council Directive 72/462/EEC of 12 December 1972 on health and veterinary inspection problems upon importation of bovine animals and swine and fresh meat from third countries (2) should be amended;  Whereas the decisions necessary to set up the arrangements for imports from third countries must be adopted both in the framework of Directive 72/462/EEC and that established by this Directive;  Whereas it is desirable to entrust the Commission with the task of taking certain measures for the application of this Directive; whereas, with this in mind, provision should be made for a procedure which establishes close and efficient cooperation between the Commission and the Member States within the Standing Veterinary Committee,  HAS ADOPTED THIS DIRECTIVE:  Article 1  Member States shall ensure that examination of animals, their excrement and body fluids and of tissues and fresh meat for the presence of residues is carried out in accordance with the requirements of this Directive or provisions to be added at a later date, in particular those which will be adopted in accordance with Article 16.  Article 2  The definitions given in Article 2 of Directive 64/433/EEC and, where necessary, those given in Article 1 of Directive 85/649/EEC (3) shall apply for the purposes of this Directive.  In addition:  (a) 'official sample' means a sample, taken by the competent authority, which bears, for the examination of the residue concerned, a reference to the species, the type, the amount and the method of collection and the identification of the origin of the animal and the meat; this sample is to be taken without prior warning;  (b) 'approved laboratory' means a laboratory approved by the competent authorities of a Member State to make an examination of an official sample in order to detect the presence of residues;  (c) 'residue' means residue of substances having a pharmacological action and of conversion products thereof and other substances transmitted to meat and which are likely to be dangerous to human health.  Article 3  Member States shall assign a central department or body to coordinate implementation of the inspections provided for in this Directive. In particular, that department or body shall be responsible for:  - drawing up the plans provided for in Article 4 enabling the competent departments to carry out the required inspections,  - coordinating the activities of regional departments responsible for carrying out inspections for different residues,  - collecting the results of those inspections and the data which must be sent to the Commission.  Article 4  1. Member States shall submit to the Commission:  - by 31 May 1987, a plan setting out the national measures to be taken to achieve the stated objective of this Directive in respect of the substances referred to in Annex I, Group A, I and II,  - by 31 May 1988, a plan stating the measures relating to the examination for residues in substances from the other groups.  Both of these plans will have to take into account the specific situation of each Member State and specify inter alia:  - legislation on the use of substances, and in particular on their prohibition or authorization, distribution, placing on the market and rules for administration,  - the infrastructure of the services (in particular giving details of the authorities associated with the implementation of the plans, and the type and size of the bodies involved in such implementation),  - a list of approved laboratories indicating their capacity for processing samples,  - whether there is a total or partial ban on using the substances referred to in Annex I, Group A, in particular in the absence of Community regulations,  - a list of the substances investigated, the methods of analysis and standards for interpreting the findings,  - the number of official samples to be taken in conjunction with the number of animals slaughtered with regard to the species concerned during preceding years,  - a list of the substances referred to in Annex I, Group B, indicating the number of samples and the reasons for this number,  - details of the rules observed when official samples are collected, in particular the rules permitting the indication of the details specified in point (a) of the second paragraph of Article 2,  - the type of measures laid down by the competent authorities with regard to products in which the presence of residues has been detected.  2. The Commission shall examine the plans communicated in accordance with paragraph 1, in order to determine whether they conform to the provisions laid down in this Directive.  3. In accordance with the procedure provided for in Article 15, the Commission shall approve the plans referred to in paragraph 1. In accordance with the same procedure, the Commission may decide that the Member State concerned must amend or supplement the plan which it has submitted. The abovementioned decisions must be adopted by 30 September 1987 for plans relating to inspection for the substances referred to in Annex I, Group A, I and II and by 30 September 1988 for plans relating to inspection for the other residues.  4. At the request of the Member State concerned, and in order to take account of developments in the situation in that Member State or in one of its regions, the Commission may decide, in accordance with the procedure provided for in Article 14, to approve any amendment or addition to a plan previously approved pursuant to paragraph 3.  5. In accordance with the procedure provided for in Article 14, the Commission may decide that a Member State must amend or supplement a plan previously approved pursuant to paragraph 3 in order to take account of the developments in the situation in that State or of findings established under Articles 5, 11 and 12.  Article 5  1. Veterinary experts from the Commission may, in cooperation with the competent authorities of the Member States, make on-the-spot checks in so far as that is indispensable for ensuring uniform application of this Directive.  A Member State within whose territory a check is being carried out shall give all necessary assistance to the experts in carrying out their duties. The Commission shall inform the Member State concerned of the results of the investigation.  The Member State concerned shall take any measures which may prove necessary to take account of the results of the investigation. If the Member State does not take those measures, the Commission may, after the situation has been examined by the Standing Veterinary Committee, have recourse to the provisions of Article 4 (5).  2. The general provisions for implementing this Article, especially as regards the frequency and method of carrying out the checks referred to in the first subparagraph of paragraph 1, shall be laid down in accordance with the procedure set out in Article 15.  Article 6  Member States shall ensure that during examination for the presence of residues:  - the minimum frequencies for inspections, as laid down in Annex II, are complied with.  However:  (i) Luxembourg shall be authorized to inspect 0,01 and 0,2 % of animals instead of a random statistical frequency of 300 and 700 official samples respectively.  (ii) In the case of the substances referred to in Annex I, Group A, I and II:  - for the initial stage Denmark shall be authorized to carry out inspections using 750 official samples, - until the total ban on the use of anabolic substances in production for the national market is extended, the United Kingdom shall be authorized to inspect only 0,15 % of animals slaughtered in slaughterhouses approved and inspected in accordance with Articles 8 (1) and 9 of Directive 64/433/EEC, the rest of the bovine population being officially sampled annually at a frequency which gives 99,9 % assurance that in the absence of positive findings, the proportion of the bovine fattening population liable to contain residues will be less than 1 %,  - the inspections are applied in accordance with the procedures to be specified in the plan which will be approved, amended or supplemented pursuant to Article 4.  Article 7  1. The following shall be inserted in Article 3 (2) of Directive 72/462/EEC:  '(f ) that country's legislation on the use of substances, in particular legislation concerning the prohibition or authorization of substances, their distribution, release on to the market and their rules covering administration and inspection;'.  2. Admission to, or retention on, the list referred to in Article 3 of Directive 72/462/EEC shall be subject to the submission, by the third country concerned, of a plan giving details of the guarantees afforded by the said country for the checking of residues.  The effect of these guarantees must be at least equivalent to that resulting from the guarantees provided for by this Directive.  In accordance with the procedure provided for in Article 14, the Commission shall approve the plans in question. Likewise in accordance with this procedure, guarantees alternative to these resulting from the application of this Directive may be allowed.  Decisions to be taken in this context must be adopted:  (i) not later than 31 December 1987 as regards the substances referred to in Annex I, Group A, I and II;  (ii) not later than 31 December 1988 as regards the substances referred to in Annex I, Group A, III and Group B, I and II.  3. Where no decision within the meaning of paragraph 2 is taken with regard to a given third country by the said dates, entry of that country on the list referred to in Article 3 of Directive 72/462/EEC shall be suspended in accordance with the procedure provided for in Article 14.  4. Compliance by the competent authorities of third countries with the execution of the plans shall be verified when the inspections referred to in Article 5 of Directive 72/462/EEC are carried out.  Article 8  1. Member States shall seek to ensure, when implementing this Directive, that:  (a) official samples are taken from animals, their excrement and body fluids and from tissues and fresh meat for examination at approved laboratories for residues in accordance with Annex II;  (b) the national reference laboratories designated in accordance with Article 4 (1) (b) of Directive 64/433/EEC coordinate standards and methods of analysis for each residue or group of residues concerned, including the arrangement of periodic comparative tests of split samples by approved laboratories, and compliance with the limits laid down.  2. The Council, acting by a qualified majority on a proposal from the Commission, shall designate for each residue or group of residues a Community reference laboratory which shall be responsible for coordinating inspections, to be selected from among the various national reference laboratories, and shall determine, according to the needs of this Directive, the powers and conditions of operation of those reference laboratories.  3. The analysis of samples referred to in paragraph 1 must be carried out in accordance with methods which are applied by the Member States and have been submitted to the Commission under their inspection plans.  All positive findings must, if challenged, be confirmed by a laboratory officially approved for that purpose by the competent authorities, using the reference methods established pursuant to Article 4 (1) (b) of Directive 64/433/EEC.  Article 9  1. Where an examination of an official sample taken in accordance with Annex II reveals the presence of residues of prohibited substances or quantities of authorized substances exceeding the levels set by Community law or, in their absence, national levels permitted on 16 September 1986 the competent authorities shall seek to ensure that it obtains without delay:  (a) all information, to be established according to the procedure laid down in Article 15, needed to identify the animal and the farm of origin;  (b) the result of the examination.  Where the results of the controls carried out in one Member State indicate the need for investigation or action in one or more other Member States or in one or more third countries, the Member State concerned shall inform the other Member States and the Commission thereof.  Member States in which an investigation or action proves to be necessary shall take the appropriate measures. 2. The competent authorities shall thereupon ensure that:  (a) an investigation is carried out at the farm of origin to determine the reasons for the presence of residues;  (b) an investigation of the source or sources of the substances concerned is carried out as necessary at the levels of manufacture, handling, storage, transport, administration, distribution or sale.  3. The competent authorities shall also ensure that:  (a) the herd or animals at the farm of origin and herds which, as a result of the investigations referred to in paragraph 2 may be regarded as containing the residues in question, bear an official marking and are subjected to appropriate examinations;  (b) if the examination reveals the presence of prohibited substances, the animals may not be placed on the market for human or animal consumption;  (c) if the conditions of use of an authorized substance have not been respected and, in particular, if the examination reveals the presence of residues of authorized substances above the permitted levels referred to in paragraph 1, the slaughter of animals for human consumption is prohibited until it can be ensured that the amount of residue no longer exceeds the permissible levels. This period may under no circumstances be shorter than the waiting period prescribed for the substances in question;  (d) during the period of examination, the animals are disposed of to other persons only subject to the control of the official veterinarian.  4. By way of derogation from paragraph 3 (c), animals whose slaughter is prohibited may be slaughtered before the end of the prohibition period if the competent authority has been informed before the envisaged slaughter date, and the place of slaughter has been indicated to it. The officially marked animals must be accompanied to the place of slaughter by an official veterinary certificate containing the information required under paragraph 1 (a).  The meat of each animal whose slaughter is notified pursuant to the first subparagraph shall be officially sampled for the residue concerned and shall be detained until the result of the examination is known.  Meat in which the presence of residues is confirmed must be excluded from human consumption.  5. The competent authorities shall also ensure that the production establishment or animal holdings in the same region or locality supplying the establishment are subject to additional monitoring for the substance concerned.  6. For the effective application of this Directive, a Member State may require that, within its own territory, a register be kept, in particular, on the farm, at the slaughterhouse or at markets.  Article 10  Without prejudice to Article 4, the competent authority may - where there is suspicion that residues are present - subject the animals of the species concerned or the fresh meat in question to examinations to establish the presence of such residues in its national production.  Article 11  1. Where a Member State considers that, in another Member State, the checks provided for in this Directive are not being, or have ceased to be, carried out, it shall inform the competent central authority of that State accordingly. Following an investigation in accordance with Article 9 (2), that authority shall take all necessary measures and shall, at the earliest opportunity, notify the competent central authority of the first Member State of the decisions taken and the reasons for such decisions.  If the first Member State fears that such measures are not being taken or are inadequate, it shall, together with the Member State which has been challenged, seek ways and means of remedying the situation; if appropriate, this may involve a visit.  Member States shall inform the Commission of disputes and of solutions arrived at.  If the Member States involved are unable to reach agreement, one of them shall bring the matter to the notice of the Commission within a reasonable period of time and the latter shall entrust one or more experts with delivering an opinion.  Pending the experts' conclusions, the Member States of destination may carry out checks on products coming from the establishment or establishments or from a holding or holdings challenged by the dispute and, if the result is positive, take measures similar to those provided for in Article 10 (4) of Directive 64/433/EEC.  In the light of the experts' opinion, appropriate measures may be taken in accordance with the procedure provided for in Article 15.  These measures may be reviewed in accordance with the same procedure should the experts deliver a new opinion within a period of 15 days.  2. The general rules for the application of this Article shall be adopted in accordance with the procedure set out in Article 15.  Article 12  Every year the Member States shall inform the Commission and the other Member States of the implementation of the plans approved in accordance with Article 4. In the light of that information, Article 4 (5) may be invoked.  Within the Standing Veterinary Committee the Commission will inform the Member States periodically - and at all events whenever it sees fit on public health grounds - of the development of the situation in the various regions of the Community. Article 13  The Annexes may be amended or supplemented by the Council acting by a qualified majority on a proposal from the Commission.  Article 14  1. Where the procedure laid down in this Article is to be followed, matters shall without delay be referred to the Standing Veterinary Committee set up by the Council Decision of 15 October 1968 (hereinafter referred to as 'the Committee') by its chairman, either on his own initiative or at the request of a Member State.  2. Within the Committee, the votes of the Member States shall be weighted as provided in Article 148 (2) of the Treaty. The chairman shall not vote.  3. The Commission representative shall submit a draft of the measures to be taken. The Committee shall deliver its opinion on those measures within two days. Opinions shall be delivered by a majority of 54 votes.  4. The Commission shall adopt the measures and implement them immediately where they are in accordance with the opinion of the Committee. If they are not in accordance with the opinion of the Committee, or if no opinion is delivered, the Commission shall forthwith submit to the Council a proposal concerning the measures to be taken. The Council shall adopt the measures by a qualified majority.  If, 15 days after the proposal was submitted to it, the Council has not adopted any measures, the Commission shall adopt the measures proposed and implement them immediately unless the Council has rejected those measures by a simple majority.  Article 15  1. Where the procedure laid down in this Article is to be followed, matters shall without delay be referred to the Committee by its chairman, either on his own initiative or at the request of a Member State.  2. Within the Committee the votes of the Member States shall be weighted as provided for in Article 148 (2) of the Treaty. The chairman shall not vote.  3. The Commission representative shall submit a draft of the measures to be taken. The Committee shall deliver its opinion on those measures within a time limit which the chairman may set according to the urgency of the matter submitted. Opinions shall be delivered by a majority of 54 votes.  4. The Commission shall adopt the measures and implement them immediately where they are in accordance with the opinion of the Committee. If they are not in accordance with the opinion of the Committee, or if no opinion is delivered, the Commission shall forthwith submit a proposal to the Council concerning the measures to be taken. The Council shall adopt the measures by a qualified majority.  If, three months after the proposals were submitted to it, the Council has not adopted any measures, the Commission shall adopt the measures proposed and implement them immediately unless the Council has rejected those measures by a simple majority.  Article 16  Acting on a proposal from the Commission, to be submitted before 1 January 1989, the Council shall, as a first stage, lay down the measures to be taken for the examination of residues in poultry and poultrymeat and, subsequently, the measures for fish-farming products.  Article 17  In accordance with the procedure laid down in Article 14, possible transitional measures may be decided on for a maximum duration of one year.  Article 18  Member States shall bring into force the laws, regulations and administrative provisions necessary to comply:  (a) with the provisions of Articles 3 and 4 not later than 1 April 1987;  (b) with the provisions of Articles 5, 11 and 12 not later than 31 December 1987;  (c) with the remaining provisions  (i) not later than 31 December 1987 as regards the substances referred to in Annex I, Group A, I and II;  (ii) not later than 31 December 1988 as regards the substances referred to in Annex I, Group A, III and Group B, I and II.  Article 19  This Directive is addressed to the Member States.  Done at Brussels, 16 September 1986.  For the Council  The President  M. JOPLING  (1) OJ No 121, 29. 7. 1964, p. 2012/64.  (2) OJ No L 362, 31. 12. 1985, p. 8.  (3) OJ No L 222, 7. 8. 1981, p. 32.  (4) OJ No C 251, 1. 10. 1981, p. 7 and OJ No C 132, 31. 5. 1985, p. 5.  (5) OJ No C 267, 11. 10. 1982, p. 59 and OJ No C 120, 20. 5. 1986, p. 176.  (6) OJ No C 112, 3. 5. 1982, p. 5 and OJ No C 75, 3. 4. 1986, p. 1.  (7) OJ No L 191, 23. 7. 1985, p. 46.  (1) OJ No L 255, 18. 10. 1968, p. 23.  (2) OJ No L 302, 31. 12. 1972, p. 28.  (3) OJ No L 382, 31. 12. 1985, p. 228.  ANNEX I  RESIDUE GROUPS  A. GROUPS COMMON TO ALL MEMBER STATES  Group I  (a) Stilbenes, stilbene derivatives, their salts and esters.  (b) Thyrostatic substances.  (c) Other substances with oestrogenic, androgenic or gestagenic action, with the exception of substances in Group II.  Group II  Substances authorized in accordance with Article 4 of Directive 81/602/EEC, and Article 2 of Directive 85/649/EEC.  Group III  (a) Inhibitors  Antibiotics, sulphonamides and similar antimicrobial substances.  (b) Chloramphenicol  B. SPECIFIC GROUPS  Group I: Other medicines  (a) Endo- and ectoparasitic substances.  (b) Tranquillizers and beta-blockers.  (c) Other veterinary medicines.  Group II: Other residues  (a) Contaminants present in feedingstuffs.  (b) Contaminants present in the environment.  (c) Other substances.  CHAPTER I  RESIDUE SAMPLING  A. SAMPLING CONDITIONS AND RANDOMIZATION  (a) Member States shall ensure that official samples are taken in accordance with the appropriate sampling system and the following variable criteria.  (b) Variable criteria  Account shall be taken of:  (i) legislation in force regarding the use of the substances referred to in the residue groups (in particular the prohibition of use or authorization of use);  (ii) factors liable to encourage fraud or misuse;  (iii) the animal population concerned as regards:  - total size of population,  - homogenity of population groups,  - age of animals, in particular in respect of Group B, I and II, substances,  - sex of animals in particular as regards Group A, I and II, substances;  (iv) the environment of farms as regards:  - regional differences,  - the relation to industrial activity, in particular for Group B, I and II, substances,  - relation to arable farming in particular for Group B, II (a) and (b) substances;  (v) farm production systems including:  - intensive farming units,  - fattening systems, in particular as regards Group A substances,  - husbandry systems, in particular feeding regimes and animal health care measures;  (vi) problems liable to arise, in the light of known precedents and other information;  (vii) the required degree of consumer protection, according to the nature and toxicity of the substance in question.  B. SAMPLING SYSTEM  Member States shall apply, for each group of substances, and according to the health-protection level and variable criteria appropriate to their territory, a sampling and examination system in accordance with the provisions of Chapter II.  CHAPTER II  SAMPLING LEVELS AND FREQUENCY  I. FOR RESIDUES REFERRED TO IN ANNEX I, A, I AND II  During the first year following the implementation of this Directive, Member States shall comply with at least the following frequencies:  A. Group A, I  1. In the case of young bovine animals for fattening (less than two years old):  (a) initial inspection on at least 0,15 % of those bovine animals of which at least 0,10 % are slaughtered animals and the rest - i. e. at least 0,05 % - are inspected at the farm; (b) if, over a six-month period, one positive finding for 1 000 samples (1) is officially confirmed during the above sampling operations, Member States shall measure the quantity of possible residues by application of an intensive sampling frequency on a minimum of 0,25 % of those bovine animals of which at least 0,1 % are inspected at the farm.  This intensification of inspections may be restricted to the category of animals and the substance which was the subject of the positive finding.  Furthermore, it may be confined to the production region in which the positive finding was confirmed.  The regions will be determined at the time the plans referred to in Article 4 are approved;  (c) If, after one year's application of the sampling frequency indicated in paragraph (a), no positive findings are officially confirmed during the following year, Member States may apply the sampling corresponding to the routine stage, viz. 300 samples per year.  These samples must be taken in such a way as to give at least a 95 % assurance that there will be residue in less than 1 % of the bovine fattening population if no positive findings are made.  If, following the sampling mentioned above, one positive finding is officially confirmed, Member States shall measure the quantity of possible residues by application of the sampling frequency for the initial stage referred to in (a) above.  2. Culled cows:  - initial stage: 700 samples,  - intensive stage: 0,25 % of slaughtered cows,  - routine stage: 300 samples  3. Pigs, sheep and goats and solipeds:  - initial stage: 700 samples,  - routine stage: 300 samples,  - intensive stage: for the species concerned, double the inspection carried out in the routine stage, with a minimum of 0,1 % of animals slaughtered.  The criteria for the transition between stages of inspections specified in point 1 apply by analogy to Groups 2 and 3.  B. Group A, II  - initial stage: 700 samples,  - intensive stage: 0,25 % of cows slaughtered,  - routine stage: 300 samples.  The general criteria for the transition between stages of inspections specified in point A (1) above apply to this group by analogy.  During the initial stage the samples must be taken in such a way as to give at least a 99,9 % assurance that there will be residue in less than 1 % of the animals if no positive findings are made.  II. FOR GROUP A, III (a)  1. Member States shall carry out inspections on 0,10 % of animals slaughtered. For these inspections Member States shall be authorized to:  - adapt their inspection measures to take account of marketing authorization and conditions for such marketing,  - carry out inspections on groups of substances,  - restrict the inspections to regions producing the species likely to be affected by these substances.  2. In the event of a positive finding at the slaughterhouse, Article 9 shall apply.  III. FOR GROUP A, III (b)  1. Member States which prohibit the use of this substance - including thereapeutic treatment - for animals intended for human consumption shall take at least 300 samples per year.  2. The other Member States shall inspect at least 0,01 % of slaughtered animals of the species concerned, up to a maximum of 300 samples of each species.  If a positive finding is confirmed at the slaughterhouse, Article 9 shall apply.If, during a one-year period, no positive findings are confirmed, inspections shall be carried out on at least 300 samples per year.  These samples must be taken in such a way as to give at least a 95 % assurance that, if no positive findings are made, there will be residue in less than 1 % of the animals.  3. For each positive case found in a Member State, Article 9 shall apply, with an increase in the inspections to 0,05 % of slaughtered animals of the species concerned in the administrative region where the positive case has been detected.  IV. FOR THE SUBSTANCES SPECIFIED IN GROUP B  Minimum annual sampling frequency: 700 samples.  Inspection procedures will be specified in the plans which the Member States will submit pursuant to Article 4.  The frequency of inspections must comply with the following criteria:  - the application of inspections may be regionalized (regions of a size such that the national result is not distorted) and confined to certain species representative of production in those regions,  - monitoring of substances may be carried out using pools of substances in which each substance or group of substances will have to be subject to a minimum inspection, with the possibility of staggered inspections.  (1) For Luxembourg and Greece: one positive finding per six-month period.


title: Commission Directive (EU) 2016/1214 of 25 July 2016 amending Directive 2005/62/EC as regards quality system standards and specifications for blood establishments (Text with EEA relevance)

text:
                  26.7.2016

                  EN

                  Official Journal of the European Union

                  L 199/14

            COMMISSION DIRECTIVE (EU) 2016/1214
      of 25 July 2016
      amending Directive 2005/62/EC as regards quality system standards and specifications for blood establishments
      (Text with EEA relevance)
      THE EUROPEAN COMMISSION,
      Having regard to the Treaty on the Functioning of the European Union,
      Having regard to Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage, and distribution of human blood and blood components and amending Directive 2001/83/EC (1), and in particular point (h) of the second paragraph of Article 29 thereof,
      Whereas:

                  (1)

                  Article 2 of Commission Directive 2005/62/EC (2) requires Member States to ensure that the quality system in place in all blood establishments complies with the standards and specifications set out in the Annex to that Directive.

                  (2)

                  Article 2 of Directive 2005/62/EC also requires the Commission to develop good practice guidelines for the interpretation of the standards and specifications referred to in that Article.

                  (3)

                  Good Practice Guidelines (the ‘GPG’) have been jointly developed by the Commission and the European Directorate for the Quality of Medicines and Healthcare of the Council of Europe and published by the Council of Europe (3).

                  (4)

                  The GPG have been developed and are updated taking into account scientific and technical expertise. The GPG fully reflect the detailed principles and guidelines of good manufacturing practice established under Article 47 of Directive 2001/83/EC (4) which are relevant for blood establishments and their quality systems, and are already successfully used in blood establishments in the Union. Accordingly, they should be taken into account when implementing the standards and specifications set out in the Annex to Directive 2005/62/EC. Paragraph 2 of Article 2 of that Directive should therefore be amended accordingly.

                  (5)

                  The Commission, which actively participates in the process leading to amendments of the GPG together with experts from the Member States, should inform the competent authorities designated by the Member States of any significant changes to the GPG, which should also be taken into account.

                  (6)

                  The measures provided for in this Directive are in accordance with the opinion of the Committee set up by Directive 2002/98/EC,

            HAS ADOPTED THIS DIRECTIVE:
      Article 1
      In Article 2 of Directive 2005/62/EC, paragraph 2 is replaced by the following:

         ‘2.   Member States shall ensure that, in order to implement the standards and specifications set out in the Annex to this Directive, there are good practice guidelines available to and used by all blood establishments, in their quality system, good practice guidelines which take fully into account, where relevant for blood establishments, the detailed principles and guidelines of good manufacturing practice, as referred to in the first subparagraph of Article 47 of Directive 2001/83/EC. In doing so, Member States shall take into account the Good Practice Guidelines jointly developed by the Commission and the European Directorate for the Quality of Medicines and Healthcare of the Council of Europe and published by the Council of Europe (*).

      Article 2
      1.   Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 15 February 2018 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 twentieth day following that of its publication in the Official Journal of the European Union.
      Article 4
      This Directive is addressed to the Member States.

         Done at Brussels, 25 July 2016.

               For the Commission

               The President

            Jean-Claude JUNCKER

         (1)  OJ L 33, 8.2.2003, p. 30.

         (2)  Commission Directive 2005/62/EC of 30 September 2005 implementing Directive 2002/98/EC of the European Parliament and of the Council as regards Community standards and specifications relating to a quality system for blood establishments (OJ L 256, 1.10.2005, p. 41).

         (3)  Good Practice Guidelines, included in the Guide to the preparation, use and quality assurance of blood components, Appendix to Recommendation No. R (95) 15 of the Committee of Minsters on the preparation, use and quality assurance of blood components adopted on 12 October 1995.

         (4)  Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p. 67).