Avis juridique important

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31989L0428

Council Directive 89/428/EEC of 21 June 1989 on procedures for harmonizing the programmes for the reduction and eventual elimination of pollution caused by waste from the titanium dioxide industry

Official Journal L 201 , 14/07/1989 P. 0056 - 0060 Finnish special edition: Chapter 15 Volume 9 P. 0076  Swedish special edition: Chapter 15 Volume 9 P. 0076

*****COUNCIL  DIRECTIVE  of 21 June 1989  on procedures for harmonizing the programmes for the reduction and eventual elimination of pollution caused by waste from the titanium dioxide industry  (89/428/EEC)  THE COUNCIL OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community, and in particular Article 130s thereof,  Having regard to the proposal from the Commission (1),  Having regard to the opinion of the European Parliament (2),  Having regard to the opinion of the Economic and Social Committee (3),  Whereas Council Directive 78/176/EEC of 20 February 1978 on waste from the titanium dioxide industry (4), as last amended by Directive 83/29/EEC (5), and in particular Article 9 thereof, requires the Member States to draw up programmes for the progressive reduction and eventual elimination of pollution caused by waste from industrial establishments in existence on 20 February 1978;  Whereas these programmes set general targets for the reduction of pollution caused by liquid, solid and gaseous wastes to be achieved by 1 July 1987; whereas these programmes were to be submitted to the Commission so that it could present suitable proposals to the Council for their harmonization with regard to the reduction and eventual elimination of this pollution and the improvement of the conditions of competition in the titanium dioxide industry;  Whereas, in order to protect the aquatic environment, dumping of waste and discharges of certain wastes, in particular of solid and strong acid wastes, should be prohibited and discharges of other wastes, in particular of weak acid and neutralized wastes, should be progressively reduced;  Whereas existing industrial establishments should employ the appropriate systems for treating the wastes in order to meet the requisite targets by the set dates;  Whereas installation of those systems can give rise to major technico-economic difficulties; whereas Member States should therefore be able to defer application of the various provisions, on condition that a programme of effective reduction of pollution is drawn up and submitted to the Commission; whereas where Member States experience particular difficulties with regard to programmes for the elimination of discharges, the Commission should be able to extend the relevant time limits;  Whereas, in respect of discharges of certain wastes, Member States should be able to make use of quality objectives in such a way that the results are equivalent in all respects to those obtained through limit values; whereas such equivalence should be demonstrated in a programme to be presented to the Commission;  Whereas, without prejudice to the obligations placed on Member States by Council Directive 80/779/EEC of 15 July 1980 on air quality limit values and guide values for sulphur dioxide and suspended particulates (6), as last amended by Directive 89/427/EEC (7), and Council Directive 84/360/EEC of 28 June 1984 on the combating of air pollution from industrial plants (8), it is expedient to protect the quality of the air by fixing appropriate emission standards in respect of gaseous discharges from the titanium dioxide industry;  Whereas, in order to verify the effective application of the measures, Member States should undertake monitoring in relation to the actual production of each establishment;  Whereas all waste from the titanium dioxide industry should be avoided or re-used where technically and economically feasible and whereas such waste should be re-used or disposed of without endangering human health or the environment,  HAS ADOPTED THIS DIRECTIVE:  Article 1  This Directive lays down, as required by Article 9 (3) of Directive 78/176/EEC, procedures for harmonizing the programmes for the reduction and eventual elimination of pollution from existing industrial establishments and is intended to improve the conditions of competition in the titanium dioxide industry.  Article 2  1. For the purpose of this Directive:  (a) where the sulphate process is used:  - 'solid waste' shall mean:  - insoluble ore residues not broken down by sulphuric acid during the manufacturing process,  - copperas, i.e. crystalline ferrous sulphate (FeSO4.7H2.O),  - 'strong acid waste' shall mean:  the mother liquors arising from the filtration phase following hydrolysis of the titanyl sulphate solution. If these mother liquors are associated with weak acid wastes which overall contain more than 0,5 % free sulphuric acid and various heavy metals (1), the liquors and waste taken together shall be considered strong acid waste,  - 'treatment waste' shall mean:  filtration salts, sludges and liquid waste arising from the treatment (concentration or neutralization) of strong acid waste and containing various heavy metals, but not including neutralized and filtered or decanted waste containing only traces of heavy metals and which, before any dilution, has a pH value above 5,5,  - 'weak acid waste' shall mean:  wash waters, cooling waters, condensates and other sludges and liquid wastes, other than those included in the above definitions, containing 0,5 % or less free sulphuric acid,  - 'neutralized waste' shall mean:  any liquid which has a pH value over 5,5, contains only traces of heavy metals, and is obtained directly by filtration or decantation from strong or weak acid waste after its treatment to reduce its acidity and its heavy metals' content,  - 'dust' shall mean:  all kinds of dust from production plants and in particular ore and pigment dust;  - 'SOx' shall mean:  gaseous sulphur dioxide trioxide released in the various stages of the manufacturing and internal waste treatment processes, including acid droplets;  (b) where the chloride process is used:  - 'solid waste' shall mean:  - insoluble ore residues not broken down by the chlorine during the manufacturing process,  - metal chlorides and metal hydroxides (filtration substances) arising in solid form from the manufacture of titanium tetrachloride,  - coke residues arising from the manufacture of titanium tetrachloride,  - 'strong acid waste' shall mean:  waste containing more than 0,5 % free hydrochloric acid and various heavy metals (1),  - 'treatment waste' shall mean:  filtration salts, sludges and liquid waste arising from the treatment (concentration or neutralization) of strong acid waste and containing various heavy metals, but not including neutralized and filtered or decanted waste containing only traces of heavy metals and which, before any dilution, has a pH value over 5,5,  - 'weak acid waste' shall mean:  wash waters, cooling waters, condensated and other sludges and liquid wastes, other than those included in the above definitions, containing 0,5 % or less free hydrochloric acid,  - 'neutralized waste' shall mean:  any liquid which a pH value over 5,5, contains only traces of heavy metals, and is obtained directly by filtration or decantation from strong or weak acid waste after its treatment to reduce its acidity and its heavy metals content;  - 'dust' shall mean:  all kinds of dust from production plants and in particular ore, pigment and coke dust,  - 'chlorine' shall mean:  gaseous chlorine released in the various stages of the manufacturing process;  (c) where the sulphate process or the chlorine process is used:  - 'dumping' shall mean:  any deliberate disposal into inland surface waters, internal coastal waters, territorial waters or the high seas of substances and materials by or from ships or aircraft (2), of any type whatsoever, and from fixed and floating platforms.  2. The terms defined in Directive 78/176/EEC shall have the same meaning in this Directive.  Article 3  The dumping of any solid waste, strong acid waste, treatment waste, weak acid waste, or neutralized waste, as referred to in Article 2 shall be prohibited with effect from 31 December 1989.  Article 4  Member States shall take the necessary measures to ensure that discharges of waste into inland surface waters, internal coastal waters, territorial waters and the high sea are prohibited:  (a) as regards solid waste, strong acid waste and treatment waste from existing industrial establishments using the sulphate process:  - by 31 December 1989 in all the abovementioned waters;  (b) as regards solid waste and strong acid waste from existing industrial establishments using the chloride process;  - by 31 December 1989 in all the abovementioned waters.  Article 5  1. Member States may defer the date of application referred to in Articles 3 and 4 until 31 December 1992 at the latest, if serious techno-economic difficulties so require and provided that a programme of effective reduction of dumping and discharge of wastes referred to in Articles 3 and 4 resulting in their final prohibition by 1992 at the latest is submitted to the Commission by 31 December 1989. Three months at the latest following adoption of this Directive, the Commission shall be informed (1) of such cases, which shall be the subject of consultation with the Commission. The Commission shall inform the other Member States.  2. In the case of Member States which avail themselves of the option provided for in paragraph 1 but which are unable to fulfil the requirements laid down in Article 4 by 31 December 1992 the Commission may grant an extension of six months. The Commission may also grant an extension of six months for the submission of programmes referred to in paragraph 1, at the request of any Member State which experiences difficulties in connection with its own authorization procedures.  Article 6  Member States shall take the necessary measures to ensure that discharges of waste are reduced in accordance with the following provisions:  (a) from existing industrial establishments using the sulphate process:  - weak acid waste and neutralized waste shall be reduced by 31 December 1992 in all waters to a value of not more than 800 kg of total suphate per tonne of titanium dioxide produced (i.e. corresponding to the SO4 ions contained in the free sulphuric acid and in the metallic sulphates);  (b) from existing industrial establishments using the chloride process:  - weak acid waste, treatment waste, and neutralized waste shall be reduced by 31 December 1989 in all waters to the following values of total chloride per tonne of titanium dioxide produced (i.e. corresponding to the C1 ions contained in the free hydrochloric acid and in the metallic chlorides):  130 kg using natural rutile,  228 kg using synthetic rutile,  450 kg using slag.  In the case of an establishment using more than one type of ore, the values shall apply in proportion to the quantity of these ores used.  Article 7  1. Except where inland surface waters are concerned, Member States may defer the date of application referred to in point (a) of Article 6 until 31 December 1994 at the latest if serious technico-economic difficulties so require and provided that a programme of effective reduction of discharges of such waste is submitted to the Commission by 31 December 1989. Such a programme shall enable the following limit values per tonne of titanium dioxide produced to be reached by the dates shown:  - weak acid waste and neutralized waste: 1 200 kg - 31 December 1992,  - weak acid waste and neutralized waste: 800 kg - 31 December 1994.  Three months at the latest following adoption of this Directive the Commission shall be informed (1) of such cases, which shall be the subject of consultation with the Commission. The Commission shall inform the other Member States.  2. Member States may defer the date of application referred to in point (b) of Article 6 until 31 December 1992 at the latest if major technico-economic difficulties so require and provided that a programme of effective reduction of discharge of such waste enabling the limit value set in point (b) of Article 6 to be reached by 1992 at  the latest is submitted to the Commission by 31 December 1989. Three months at the latest following adoption of this Directive the Commission shall be informed (1) of such cases, which shall be the subject of consultation with the Commission. The Commission shall inform the other Member States.  Article 8  1. As regards the requirements of Article 6, Member States may choose to make use of quality objectives applied in such a way that the effects in terms of protecting the environment and avoiding distortions of competition are equivalent to that of the limit values.  2. If a Member State chooses to make use of quality objectives, it shall present to the Commission a programme (1), demonstrating that the measures achieve an effect which, in terms of protecting the environment and avoiding distortion of competition, is equivalent to that of the limit values by the dates when these limit values are applied in accordance with Article 6.  This programme shall be submitted to the Commission at least six months before the Member State proposes to apply the quality objectives.  This programme shall be assessed by the Commission in accordance with the procedures laid down in Article 10 of Directive 78/176/EEC.  The Commission shall inform the other Member States.  Article 9  1. Member States shall take the necessary measures to ensure that discharges into the atmosphere are reduced in accordance with the following provisions:  (a) in the case of existing industrial establishments using the sulphate process:  (i) as regards dust, discharges shall be reduced by 31 December 1990 to a value of not more than 50 mg/nm3 (2) from major sources and not more than 150 mg/nm3 (2) from any other source (3);  (ii) as regards SOx, discharges arising from digestion and calcination steps in the manufacture of titanium dioxide shall be reduced by 1 January 1995 to a value of not more than 10 kg of SO2 equivalent per tonne of titanium dioxide produced;  (iii) Member States shall require means to be installed for preventing the emission of acid droplets;  (iv) plants for the concentration of waste acid shall not discharge more than 500 mg/nm3 SOx calculated as SO2 equivalent (4);  (v) plants for the roasting of salts generated by the treatment of waste shall be equipped with the best available technology not entailing excessive costs in order to reduce SOx emissions;  (b) in the case of existing industrial establishments using the chloride process:  (i) as regards dust, discharges shall be reduced by 31 December 1989 to a value of not more than 50 mg/nm3 (2) from major sources and not more than 150 mg/nm3 (2) from any other source (3);  (ii) as regards chlorine, discharges shall be reduced by 31 December 1989 to a daily average concentration of not more than 5 mg/nm3 (5) and not more than 40 mg/nm3 at any time.  2. This Directive shall not prejudice Directive 80/779/EEC.  3. The procedure for monitoring the reference measurements for discharges of SOx into the atmosphere is set out in the Annex.  Article 10  Member States shall monitor the values and reductions specified in Articles 6, 8 and 9 in relation to the actual production of each establishment.  Article 11  Member States shall take the measures necessary to ensure that all waste from the titanium dioxide industry, and in particular waste subject to prohibition on discharge or dumping into water or on discharge into the atmosphere is:  - avoided or re-used where technically and economically feasible,  - re-used or disposed of without endangering human health or harming the environment.  The same shall apply to waste arising from the re-use or treatment of the abovementioned waste.  Article 12  1. Member States shall take the measures necessary to comply with this Directive not later than 31 December 1989. They shall forthwith inform the Commission thereof.  2. Member States shall communicate to the Commission the provisions of national law which they adopt in the field governed by this Directive.  Article 13  This Directive is addressed to the Member States.  Done at Luxembourg, 21 June 1989.  For the Council  The President  C. ARANZADI  (1) OJ No C 138, 26. 5. 1983, p. 5,  and OJ No C 167, 27. 6. 1984, p. 9.  (2) OJ No C 127, 14. 5. 1984, p. 29, and  OJ No C 158, 26. 6. 1989.  (3) OJ No C 358, 31. 12. 1983, p. 40.  (4) OJ No L 54, 25. 2. 1978, p. 19.  (5) OJ No L 32, 3. 2. 1983, p. 28.  (6) OJ No L 229, 30. 8. 1980, p. 30.  (7) See page 53 of this Official Journal.  (8) OJ No L 188, 16. 7. 1984, p. 20.  (1) Strong acid waste which has been diluted until it contains 0,5 % or less free sulphuric acid shall also be covered by this definition.  (2) 'Ships and aircraft' shall mean sea-going vessels and airborne craft of any type whatsoever. This expression shall include air-cushion craft, floating craft, whether self-propelled or not and fixed or floating platforms.  (1) Such information shall be provided under Article 14 of Directive 78/176/EEC or separately should circumstances so require.  (1) Such information shall be provided under Article 14 of Directive 78/176/EEC or separately should circumstances so require.  (2) Cubic metre at a temperature of 273 K and pressure of 101,3 kPa.  (3) Member States shall inform the Commission of those minor sources not included in their measurement.  (4) For new concentration processes the Commission can agree to a different value if the Member States can demonstrate the non-availability of techniques to achieve this standard.  (5) It is considered that these values correspond to a maximum of 6 grams per tonne of titanium dioxide produced.  ANNEX  Procedure for monitoring the reference measurements for gaseous SOx emissions  For the purposes of calculating the quantities of SO2 and SO3 and acid droplets expressed as SO2 equivalent, discharged by specific installations, account mut be taken of the volume of gas discharged over the duration of the specific operations in question and of the average SO2/SO3 content measured over the same period. The SO2/SO3 flow rate and content must be determined under the same temperture and humidity conditions.


Avis juridique important

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32002L0098

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

Official Journal L 033 , 08/02/2003 P. 0030 - 0040

Directive 2002/98/EC of the European Parliament and of the Councilof 27 January 2003setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/ECTHE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,Having regard to the Treaty establishing the European Community, and in particular Article 152(4)(a) thereof,Having regard to the proposal from the Commission(1),Having regard to the opinion of the Economic and Social Committee(2),Having regard to the opinion of the Committee of the Regions(3),Acting in accordance with the procedure laid down in Article 251 of the Treaty(4), in the light of the joint text approved by the Conciliation Committee on 4 November 2002,Whereas:(1) The extent to which human blood is used therapeutically demands that the quality and safety of whole blood and blood components be ensured in order to prevent in particular the transmission of diseases.(2) The availability of blood and blood components used for therapeutic purposes is dependent largely on Community citizens who are prepared to donate. In order to safeguard public health and to prevent the transmission of infectious diseases, all precautionary measures during their collection, processing, distribution and use need to be taken making appropriate use of scientific progress in the detection and inactivation and elimination of transfusion transmissible pathogenic agents.(3) The quality, safety, and efficacy requirements of proprietary industrially-prepared medicinal products derived from human blood or plasma were ensured through 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(5). The specific exclusion of whole blood, plasma and blood cells of human origin from that Directive, however, has led to a situation whereby their quality and safety, in so far as they are intended for transfusion and not processed as such, are not subject to any binding Community legislation. It is essential, therefore, that whatever the intended purpose, Community provisions should ensure that blood and its components are of comparable quality and safety throughout the blood transfusion chain in all Member States, bearing in mind the freedom of movement of citizens within Community territory. The establishment of high standards of quality and safety, therefore, will help to reassure the public that human blood and blood components which are derived from donations in another Member State nonetheless meet the same requirements as those in their own country.(4) In respect of blood or blood components as a starting material for the manufacture of proprietary medicinal products, Directive 2001/83/EC refers to measures to be taken by Member States to prevent the transmission of infectious diseases, comprising the application of the monographs of the European Pharmacopoeia and the recommendations of the Council of Europe and the World Health Organisation (WHO) as regards in particular the selection and testing of blood and plasma donors. Furthermore, Member States should take measures to promote Community self-sufficiency in human blood or blood components and to encourage voluntary unpaid donations of blood and blood components.(5) In order to ensure that there is an equivalent level of safety and quality of blood components, whatever their intended purpose, technical requirements for the collection and testing of all blood and blood components including starting materials for medicinal products should be established by this Directive. Directive 2001/83/EC should be amended accordingly.(6) The Commission's Communication of 21 December 1994 on Blood Safety and Self-sufficiency in the European Community identified the need for a blood strategy in order to reinforce confidence in the safety of the blood transfusion chain and promote Community self-sufficiency.(7) In its Resolution of 2 June 1995, on blood safety and self-sufficiency in the Community(6), the Council invited the Commission to submit appropriate proposals in the framework of the development of a blood strategy.(8) In its Resolution of 12 November 1996 on a strategy towards blood safety and self-sufficiency in the European Community(7), the Council invited the Commission to submit proposals as a matter of urgency with a view to encouraging the development of a coordinated approach to the safety of blood and blood products.(9) In its Resolutions of 14 September 1993(8), 18 November 1993(9), 14 July 1995(10), and 17 April 1996(11) on blood safety and self-sufficiency through voluntary unpaid donations in the European Community, the European Parliament stressed the importance of ensuring the highest level of blood safety and has reiterated its continued support for the objective of Community self-sufficiency.(10) In elaborating the provisions of this Directive account has been taken of the opinion of the Scientific Committee for Medicinal Products and Medical Devices as well as international experience in this field.(11) The nature of autologous transfusion necessitates a specific consideration in respect of how and when to apply the different provisions of this Directive.(12) Hospital blood banks are hospital units which perform a limited number of activities, storage, distribution, and compatibility tests. In order to ensure that the quality and safety of blood and blood components are preserved during the whole transfusion chain, while taking account of the specific nature and functions of hospital blood banks, only provisions relevant to these activities should apply to hospital blood banks.(13) Member States should ensure that an appropriate mechanism for designating, authorising, accrediting or licensing exists to ensure that the activities of blood establishments are performed in accordance with the requirements of this Directive.(14) Member States should organise inspection and control measures, to be carried out by officials representing the competent authority, to ensure the compliance of the blood establishment with the provisions of this Directive.(15) Personnel directly involved in the collection, testing, processing, storage and distribution of blood and blood components need to be appropriately qualified and provided with timely and relevant training, without prejudice to existing Community legislation on the recognition of professional qualifications and on the protection of workers.(16) Blood establishments should establish and maintain quality systems involving all activities that determine the quality policy objectives and responsibilities and implement them by such means as quality planning, quality control, quality assurance, and quality improvement within the quality system, taking into account the principles of good manufacturing practice as well as the EC conformity assessment system.(17) An adequate system to ensure traceability of whole blood and blood components should be established. Traceability should be enforced through accurate donor, patient, and laboratory identification procedures, through record maintenance, and through an appropriate identification and labelling system. It is desirable that a system is developed in order to enable the unique and unmistakable identification of donations of blood and blood components in the Community. In the case of blood and blood components imported from third countries, it is important that an equivalent level of traceability be ensured by the blood establishments in the stages preceding importation into the Community. The same requirements of traceability which apply to blood and blood components collected in the Community should be ensured in the stages following importation.(18) It is important to introduce a set of organised surveillance procedures to collect and evaluate information on the adverse or unexpected events or reactions resulting from the collection of blood or blood components in order to prevent similar or equivalent events or reactions from occurring thereby improving the security of transfusion by adequate measures. To this end a common system of notification of serious adverse events and reactions linked to the collection, processing, testing, storage, and distribution of blood and blood components should be established in Member States.(19) It is important that when abnormal findings are reported to the donor, relevant counselling is also provided.(20) Modern blood-transfusion practice has been founded on the principles of voluntary donor services, anonymity of both donor and recipient, benevolence of the donor, and absence of profit on the part of the establishments involved in blood transfusion services.(21) All necessary measures need to be taken in order to provide prospective donors of blood or blood components with assurances regarding the confidentiality of any health-related information provided to the authorised personnel, the results of the tests on their donations as well as any future traceability of their donation.(22) According to Article 152(5) of the Treaty, the provisions of this Directive cannot affect national provisions on the donations of blood. Article 152(4)(a) of the Treaty states that Member States cannot be prevented from maintaining or introducing more stringent protective measures as regards standards of quality and safety of blood and blood components.(23) Voluntary and unpaid blood donations are a factor which can contribute to high safety standards for blood and blood components and therefore to the protection of human health. The efforts of the Council of Europe in this area should be supported and all necessary measures should be taken to encourage voluntary and unpaid donations through appropriate measures and initiatives and through ensuring that donors gain greater public recognition, thereby also increasing self-sufficiency. The definition of voluntary and unpaid donation of the Council of Europe should be taken into account.(24) Blood and blood components used for therapeutic purposes or for use in medical devices should be obtained from individuals whose health status is such that no detrimental effects will ensue as a result of the donation and that any risk of transmission of infectious diseases is minimised; each and every blood donation should be tested in accordance with rules which provide assurances that all necessary measures have been taken to safeguard the health of individuals who are the recipients of blood and blood components.(25) Directive 95/46/EC of the European Parliament and the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and the free movement of such data(12) requires that data related to the health of an individual be subject to reinforced protection. However, it covers only personal data and not that rendered anonymous. This Directive should therefore introduce additional safeguards to prevent any unauthorised changes to donation registries, or processing records, or the unauthorised disclosure of information.(26) The Commission should be empowered to establish technical requirements and adopt any necessary changes thereto and to the Annexes in order to take into account scientific and technical progress.(27) Setting of technical requirements and adaptation to progress should take into account the Council recommendation of 29 June 1998 on the suitability of blood and plasma donors and the screening of donated blood in the EC(13), relevant recommendations of the Council of Europe and the WHO as well as indications of relevant European institutions and organisations such as the monographs of the European Pharmacopoeia.(28) It is necessary that the best possible scientific advice is available to the Community in relation to the safety of blood and blood components, in particular as regards adapting the provisions of this Directive to scientific and technical progress.(29) Tests should be carried out in conformity with the latest scientific and technical procedures that reflect current best practice as defined by, and regularly reviewed and updated through, an appropriate expert consultation process. This review process should also take due account of scientific advances in the detection, inactivation and elimination of pathogens which can be transmitted via transfusion.(30) 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(14).(31) In order to increase the effective implementation of the provisions adopted under this Directive it is appropriate to provide for penalties to be applied by Member States.(32) Since the objectives of this Directive, namely to contribute to general confidence both in the quality of donated blood and blood components and in the health protection of donors, to attain self-sufficiency at a Community level and to enhance confidence in the safety of the transfusion chain among the Member States, cannot be sufficiently achieved by the Member States and can therefore by reason of its scale and effects 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.(33) Responsibility for the organisation of health services and the provision of medical care should remain the responsibility of each Member State,HAVE ADOPTED THIS DIRECTIVE:CHAPTER IGENERAL PROVISIONSArticle 1ObjectivesThis Directive lays down standards of quality and safety of human blood and of blood components, in order to ensure a high level of human health protection.Article 2Scope1. This Directive shall apply to the collection and testing of human blood and blood components, whatever their intended purpose, and to their processing, storage, and distribution when intended for transfusion.2. Where blood and blood components are collected and tested for the sole purpose and exclusive use in autologous transfusion and are clearly identified as such, the requirements to be complied with in respect thereof shall be in accordance with those referred to in Article 29(g).3. This Directive shall apply without prejudice to Directives 93/42/EEC(15), 95/46/EC or 98/79/EC(16).4. This Directive does not apply to blood stem cells.Article 3DefinitionsFor the purposes of this Directive:(a) "blood" shall mean whole blood collected from a donor and processed either for transfusion or for further manufacturing;(b) "blood component" shall mean a therapeutic constituent of blood (red cells, white cells, platelets, plasma) that can be prepared by various methods;(c) "blood product" shall mean any therapeutic product derived from human blood or plasma;(d) "autologous transfusion" shall mean transfusion in which the donor and the recipient are the same person and in which pre-deposited blood and blood components are used;(e) "blood establishment" shall mean any structure or body that is responsible for any aspect of the collection and testing of human blood or blood components, whatever their intended purpose, and their processing, storage, and distribution when intended for transfusion. This does not include hospital blood banks;(f) "hospital blood bank" shall mean a hospital unit which stores and distributes and may perform compatibility tests on blood and blood components exclusively for use within hospital facilities, including hospital based transfusion activities;(g) "serious adverse event" shall mean any untoward occurrence associated with the collection, testing, processing, storage and distribution, of blood and blood components that might lead to death or life-threatening, disabling or incapacitating conditions for patients or which results in, or prolongs, hospitalisation or morbidity;(h) "serious adverse reaction" shall mean an unintended response in donor or in patient associated with the collection or transfusion of blood or blood components that is fatal, life-threatening, disabling, incapacitating, or which results in, or prolongs, hospitalisation or morbidity;(i) "blood component release" shall mean a process which enables a blood component to be released from a quarantine status by the use of systems and procedures to ensure that the finished product meets its release specification;(j) "deferral" shall mean suspension of the eligibility of an individual to donate blood or blood components such suspension being either permanent or temporary;(k) "distribution" shall mean the act of delivery of blood and blood components to other blood establishments, hospital blood banks and manufacturers of blood and plasma derived products. It does not include the issuing of blood or blood components for transfusion.(l) "haemovigilance" shall mean a set of organised surveillance procedures relating to serious adverse or unexpected events or reactions in donors or recipients, and the epidemiological follow-up of donors;(m) "inspection" shall mean formal and objective control according to adopted standards to assess compliance with this Directive and other relevant legislation and to identify problems.Article 4Implementation1. Member States shall designate the competent authority or authorities responsible for implementing the requirements of this Directive.2. This Directive shall not prevent a Member State from maintaining or introducing in its territory more stringent protective measures which comply with the provisions of the Treaty.In particular, a Member State may introduce requirements for voluntary and unpaid donations, which include the prohibition or restriction of imports of blood and blood components, to ensure a high level of health protection and to achieve the objective set out in Article 20(1), provided that the conditions of the Treaty are met.3. In carrying out the activities covered by this Directive the Commission may have recourse to technical and/or administrative assistance to the mutual benefit of the Commission and of the beneficiaries, relating to identification, preparation, management, monitoring, audit and control, as well as to support expenditure.CHAPTER IIOBLIGATIONS ON MEMBER STATES AUTHORITIESArticle 5Designation, authorisation, accreditation or licensing of blood establishments1. Member States shall ensure that activities relating to the collection and testing of human blood and blood components, whatever their intended purpose, and to their preparation, storage, and distribution when intended for transfusion, are undertaken only by the blood establishments which have been designated, authorised, accredited or licensed by the competent authority for that purpose.2. For the purpose of paragraph 1, the blood establishment shall submit the information listed in Annex I to the competent authority.3. The competent authority, having verified whether the blood establishment complies with the requirements set out in this Directive, shall indicate to the blood establishment which activities it may undertake and which conditions apply.4. No substantial change in activities shall be undertaken by the blood establishment without prior written approval by the competent authority.5. The competent authority may suspend or revoke the designation, authorisation, accreditation or licence of a blood establishment if inspection or control measures demonstrate that the blood establishment does not comply with the requirements of this Directive.Article 6Hospital blood banksArticles 7, 10, 11(1), 12(1), 14, 15, 22 and 24 shall apply to hospital blood banks.Article 7Provisions for existing establishmentsMember States may decide to maintain national provisions for nine months after the date laid down in Article 32 so as to enable blood establishments operating under their legislation to comply with the requirements of this Directive.Article 8Inspection and control measures1. Member States shall ensure that the competent authority organise inspections and appropriate control measures in blood establishments to ensure that the requirements of this Directive are complied with.2. Inspection and control measures shall be organised by the competent authority on a regular basis. The interval between two inspections and control measures shall not exceed two years.3. Such inspection and control measures shall be carried out by officials representing the competent authority who must be empowered to:(a) inspect blood establishments as well as facilities of any third parties on its own territory entrusted by the holder of the designation, authorisation, accreditation or licence referred to in Article 5 with the task of carrying out evaluation and testing procedures pursuant to Article 18;(b) take samples for examination and analysis;(c) examine any documents relating to the object of the inspection, subject to the provisions in force in the Member States at the time of the entry into force of this Directive and which place restrictions on these powers with regard to the descriptions of the method of preparation.4. The competent authority shall organise inspection and other control measures as appropriate in the event of any serious adverse event or reaction or suspicion thereof in accordance with Article 15.CHAPTER IIIPROVISIONS FOR BLOOD ESTABLISHMENTSArticle 9Responsible person1. Blood establishments shall designate a person (responsible person), responsible for:- ensuring that every unit of blood or blood components has been collected and tested, whatever its intended purpose, and processed, stored, and distributed, when intended for transfusion, in compliance with the laws in force in the Member State,- providing information to the competent authority in the designation, authorisation, accreditation or licensing procedures as required in Article 5,- the implementation of the requirements of Articles 10, 11, 12, 13, 14 and 15 in the blood establishment.2. The responsible person shall fulfil the following minimum conditions of qualification:(a) he/she shall possess a diploma, certificate or other evidence of formal qualifications in the field of medical or biological sciences awarded on completion of a university course of study or a course recognised as equivalent by the Member State concerned;(b) he/she shall have practical post-graduate experience in relevant areas for at least two years, in one or more establishments which are authorised to undertake activities related to collection and/or testing of human blood and blood components, or to their preparation, storage, and distribution.3. The tasks specified in paragraph 1 may be delegated to other persons who shall be qualified by training and experience to perform such tasks.4. Blood establishments shall notify the competent authority of the name of the responsible person referred to in paragraph 1 and other persons referred to in paragraph 3 together with information on the specific tasks for which they are responsible.5. Where the responsible person or such other persons referred to in paragraph 3 are permanently or temporarily replaced, the blood establishment shall provide immediately the name of the new responsible person and his or her date of commencement to the competent authority.Article 10PersonnelPersonnel directly involved in collection, testing, processing, storage, and distribution of human blood and blood components shall be qualified to perform those tasks and be provided with timely, relevant and regularly updated training.CHAPTER IVQUALITY MANAGEMENTArticle 11Quality system for blood establishments1. Member States shall take all necessary measures to ensure that each blood establishment establishes and maintains a quality system for blood establishments based on the principles of good practice.2. The Commission shall establish the Community standards and specifications referred to in Article 29(h) for the activities relating to a quality system to be carried out by a blood establishment.Article 12Documentation1. Member States shall take all necessary measures in order to ensure that blood establishments maintain documentation on operational procedures, guidelines, training and reference manuals, and reporting forms.2. Member States shall take all necessary measures in order to ensure that access is provided to these documents for officials entrusted with inspection and control measures referred to in Article 8.Article 13Record keeping1. Member States shall take all necessary measures to ensure that blood establishments maintain records of the information required in Annexes II and IV and under Article 29(b), (c) and (d). The records shall be kept for a minimum of 15 years.2. The competent authority shall keep records of the data received from the blood establishments according to Articles 5, 7, 8, 9 and 15.CHAPTER VHAEMOVIGILANCEArticle 14Traceability1. Member States shall take all necessary measures in order to ensure that blood and blood components collected, tested, processed, stored, released and/or distributed on their territory can be traced from donor to recipient and vice versa.To this end, Member States shall ensure that blood establishments implement a system for identification of each single blood donation and each single blood unit and components thereof enabling full traceability to the donor as well as to the transfusion and the recipient thereof. The system must unmistakably identify each unique donation and type of blood component. This system shall be established in accordance with the requirements referred to in Article 29(a).With regard to blood and blood components imported from third countries, Member States shall ensure that the donor identification system to be implemented by blood establishments permits an equivalent level of traceability.2. Member States shall take all necessary measures in order to ensure that the system used for the labelling of blood and blood components collected, tested, processed, stored, released and/or distributed on their territory complies with the identification system referred to in paragraph 1 and the labelling requirements listed in Annex III.3. Data needed for full traceability in accordance with this Article shall be kept for at least 30 years.Article 15Notification of serious adverse events and reactions1. Member States shall ensure that:- any serious adverse events (accidents and errors) related to the collection, testing, processing, storage and distribution of blood and blood components which may have an influence on their quality and safety, as well as any serious adverse reactions observed during or after transfusion which may be attributed to the quality and the safety of blood and blood components are notified to the competent authority,- blood establishments have in place a procedure accurately, efficiently and verifiably to withdraw from distribution blood or blood components associated with the notification referred to above.2. These serious adverse events and reactions shall be notified in accordance with the procedure and notification format referred to in Article 29(i).CHAPTER VIPROVISIONS FOR THE QUALITY AND SAFETY OF BLOOD AND BLOOD COMPONENTSArticle 16Provision of information to prospective donorsMember States shall ensure that all prospective donors of blood or blood components in the Community are provided with information referred to in Article 29(b).Article 17Information required from donorsMember States shall take all necessary measures to ensure that, upon agreement of a willingness to commence the donation of blood or blood components, all donors in the Community provide the information referred to in Article 29(c) to the blood establishment.Article 18Eligibility of donors1. Blood establishments shall ensure that there are evaluation procedures in place for all donors of blood and blood components and that the criteria for donation referred to in Article 29(d) are met.2. The results of the donor evaluation and testing procedures shall be documented and any relevant abnormal findings shall be reported to the donor.Article 19Examination of donorsAn examination of the donor, including an interview, shall be carried out before any donation of blood or blood components. A qualified health professional shall be responsible, in particular, for giving to and gathering from donors the information which is necessary to assess their eligibility to donate and shall, on the basis thereof, assess the eligibility of donors.Article 20Voluntary and unpaid blood donation1. Member States shall take the necessary measures to encourage voluntary and unpaid blood donations with a view to ensuring that blood and blood components are in so far as possible provided from such donations.2. Member States shall submit reports to the Commission on these measures two years after the entry into force of this Directive, and thereafter every three years. On the basis of these reports the Commission shall inform the European Parliament and the Council of any necessary further measure it intends to take at Community level.Article 21Testing of donationsBlood establishments shall ensure that each donation of blood and blood components is tested in conformity with requirements listed in Annex IV.Member States shall ensure that blood and blood components imported into the Community are tested in conformity with requirements listed in Annex IV.Article 22Storage, transport and distribution conditionsBlood establishments shall ensure that the storage, transport and distribution conditions of blood and blood components comply with the requirements referred to in Article 29(e).Article 23Quality and safety requirements for blood and blood componentsBlood establishments shall ensure that quality and safety requirements for blood and blood components meet the high standards in compliance with the requirements referred to in Article 29(f).CHAPTER VIIDATA PROTECTIONArticle 24Data protection and confidentialityMember States shall take all necessary measures to ensure that all data, including genetic information, collated within the scope of this Directive to which third parties have access have been rendered anonymous so that the donor is no longer identifiable.For that purpose, they shall ensure:(a) that data security measures are in place as well as safeguards against unauthorised data additions, deletions or modifications to donor files or deferral records, and transfer of information;(b) that procedures are in place to resolve data discrepancies;(c) that no unauthorised disclosure of such information occurs, whilst guaranteeing the traceability of donations.CHAPTER VIIIEXCHANGE OF INFORMATION, REPORTS AND PENALTIESArticle 25Information exchangeThe Commission shall hold regular meetings with the competent authorities designated by the Member States, delegations of experts from blood establishments and other relevant parties to exchange information on the experience acquired with regard to the implementation of this Directive.Article 26Reports1. Member States shall send to the Commission, commencing on 31 December 2003 and every three years thereafter, a report on the activities undertaken in relation to the provisions of this Directive, including an account of the measures taken in relation to inspection and control.2. The Commission shall transmit to the European Parliament, the Council, the Economic and Social Committee and the Committee of the Regions, the reports submitted by the Member States on the experience gained in implementing this Directive.3. The Commission shall transmit to the European Parliament, the Council, the Economic and Social Committee and the Committee of the Regions, commencing on 1 July 2004 and every three years thereafter, a report on the implementation of the requirements in this Directive, and in particular those relating to inspection and control.Article 27PenaltiesMember States shall lay down the rules on penalties applicable to infringements of the national provisions adopted pursuant to this Directive and shall take all measures necessary to ensure that they are implemented. The penalties provided for must be effective, proportionate, and dissuasive. Member States shall notify those provisions to the Commission by the date specified in Article 32 at the latest and shall notify it without delay of any subsequent amendments affecting them.CHAPTER IXCOMMITTEESArticle 28Regulatory procedure1. The Commission shall be assisted by a Committee.2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.The period referred to in Article 5(6) of Decision 1999/468/EC shall be set at three months.3. The Committee shall adopt its rules of procedure.Article 29Technical requirements and their adaptation to technical and scientific progressThe adaptation of the technical requirements set out in Annexes I to IV to technical and scientific progress shall be decided in accordance with the procedure referred to in Article 28(2).The following technical requirements and their adaptation to technical and scientific progress shall be decided in accordance with the procedure referred to in Article 28(2):(a) traceability requirements;(b) information to be provided to donors;(c) information to be obtained from donors including the identification, health history, and the signature of the donor;(d) requirements concerning the suitability of blood and plasma donors and the screening of donated blood including- permanent deferral criteria and possible exemption thereto- temporary deferral criteria;(e) storage, transport and distribution requirements;(f) quality and safety requirements for blood and blood components;(g) requirements applicable to autologous transfusions;(h) Community standards and specifications relating to a quality system for blood establishments;(i) Community procedure for notifying serious adverse reactions and events and notification format.Article 30Consultation of scientific committee(s)The Commission may consult the relevant scientific committee(s) when establishing the technical requirements referred to in Article 29 and when adapting the technical requirements set out in Annexes I to IV to scientific and technical progress, in particular with a view to ensuring an equivalent level of quality and safety of blood and blood components used for transfusion and blood and blood components used as a starting material for the manufacture of medicinal products.CHAPTER XFINAL PROVISIONSArticle 31Amendment of Directive 2001/83/ECArticle 109 of Directive 2001/83/EC shall be replaced by the following:"Article 109For the collection and testing of human blood and human plasma, 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(17) shall apply."Article 32Transposition1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 8 February 2005. They shall forthwith inform the Commission thereof.When Member States adopt those provisions, they shall contain a reference to this Directive or shall be accompanied by such 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 texts of the provisions of national law that they have already adopted or which they adopt in the field governed by this Directive.Article 33Entry into forceThis Directive shall enter into force on the day of its publication in the Official Journal of the European Union.Article 34AddresseesThis Directive is addressed to the Member States.Done at Brussels, 27 January 2003.For the European ParliamentThe PresidentP. CoxFor the CouncilThe PresidentG. Drys(1) OJ C 154 E, 29.5.2001, p. 141 andOJ C 75 E, 26.3.2002, p. 104.(2) OJ C 221, 7.8.2001, p. 106.(3) OJ C 19, 22.1.2002, p. 6.(4) Opinion of the European Parliament of 6 September 2001 (OJ C 72 E, 21.3.2002, p. 289), Council Common Position of 14 February 2002 (OJ C 113 E, 14.5.2002, p. 93) and Decision of the European Parliament of 12 June 2002 (not yet published in the Official Journal). Decision of the European Parliament of 18 December 2002 and Decision of the Council of 16 December 2002.(5) OJ L 311, 28.11.2001, p. 67.(6) OJ C 164, 30.6.1995, p. 1.(7) OJ C 374, 11.12.1996, p. 1.(8) OJ C 268, 4.10.1993, p. 29.(9) OJ C 329, 6.12.1993, p. 268.(10) OJ C 249, 25.9.1995, p. 231.(11) OJ C 141, 13.5.1996, p. 131.(12) OJ L 281, 23.11.1995, p. 31.(13) OJ L 203, 21.7.1998, p. 14.(14) OJ L 184, 17.7.1999, p. 23.(15) Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (OJ L 169, 12.7.1993, p. 1). Directive as last amended by Directive 2001/104/EC of the European Parliament and of the Council (OJ L 6, 10.1.2002, p. 50).(16) Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices (OJ L 331, 7.12.1998, p. 1).(17) OJ L 33, 8.2.2003, p. 30.ANNEX IINFORMATION TO BE PROVIDED BY BLOOD ESTABLISHMENT TO THE COMPETENT AUTHORITY FOR THE PURPOSES OF DESIGNATION, AUTHORISATION, ACCREDITATION OR LICENSING IN ACCORDANCE WITH ARTICLE 5(2)Part A: General information:- identification of the blood establishment- name, qualification and contact details of responsible persons- a list of hospital blood banks which it supplies.Part B: A description of the quality system, to include:- documentation, such as an organisation chart, including responsibilities of responsible persons and reporting relationships- documentation such as site master file or quality manual describing the quality system in accordance with Article 11(1)- number and qualifications of personnel- hygiene provisions- premises and equipment- list of standard operating procedures for recruitment, retention and assessment of donors, for processing and testing, distribution and recall of blood and blood components and for the reporting and recording of serious adverse reactions and events.ANNEX IIREPORT OF THE BLOOD ESTABLISHMENT'S PRECEDING YEAR'S ACTIVITYThis annual report will include:- total number of donors who give blood and blood components- total number of donations- an updated list of the hospital blood banks which it supplies- total number of whole donations not used- number of each component produced and distributed- incidence and prevalence of transfusion transmissible infectious markers in donors of blood and blood components- number of product recalls- number of serious adverse events and reactions reported.ANNEX IIILABELLING REQUIREMENTSThe label on the component must contain the following information:- the official name of the component- the volume or weight or number of cells in the component (as appropriate)- the unique numeric or alphanumeric donation identification- the name of producing blood establishment- the ABO Group (not required for plasma intended only for fractionation)- the Rh D Group, either Rh D positive or Rh D negative (not required for plasma intended only for fractionation)- the date or time of expiry (as appropriate)- the temperature of storage- the name, composition and volume of anticoagulant and/or additive solution (if any).ANNEX IVBASIC TESTING REQUIREMENTS FOR WHOLE BLOOD AND PLASMA DONATIONSThe following tests must be performed for whole blood and apheresis donations, including autologous predeposit donations:- ABO Group (not required for plasma intended only for fractionation)- Rh D Group (not required for plasma intended only for fractionation)- testing for the following infections in the donors:- Hepatitis B (HBs-Ag)- Hepatitis C (Anti-HCV)- HIV 1/2 (Anti-HIV 1/2)Additional tests may be required for specific components or donors or epidemiological situations.


title: Council Directive 2005/15/EC of 28 February 2005 amending Annex IV to Directive 2000/29/EC on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community

text:
               2.3.2005

               EN

               Official Journal of the European Union

               L 56/12

         COUNCIL DIRECTIVE 2005/15/EC
   of 28 February 2005
   amending Annex IV to Directive 2000/29/EC on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community
   THE COUNCIL OF THE EUROPEAN UNION,
   Having regard to the Treaty establishing the European Community,
   Having regard to Council Directive 2000/29/EC of 8 May 2000 on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community (1), and in particular point (d) of the second paragraph of Article 14 thereof,
   Having regard to the proposal of the Commission,
   Whereas:

               (1)

               Directive 2004/102/EC (2) amends Annexes II, III, IV and V to Directive 2000/29/EC and is to be implemented by the Member States by 1 March 2005.

               (2)

               Directive 2004/102/EC contains provisions related to wood and wood products. The measures related to pallets, boxes and dunnage align Community measures with the FAO International Standard for Phytosanitary Measures (ISPM) No 15 on ‘Guidelines for regulating wood packaging material in international trade’ which was adopted in March 2002 by the Fourth Interim Commission on Phytosanitary Measures (ICPM).

               (3)

               Standard No 15 describes that wood packaging (including dunnage) made of coniferous and non-coniferous raw wood, should be subjected to approved measures such as heat treatment (56 °C for a minimum of 30 minutes) or fumigation with Methyl Bromide. Moreover the wood should display a specified mark to certify that the wood has been subjected to an approved measure.

               (4)

               The Standard also provides that countries may require that imported wood packaging material subjected to an approved measure be made from debarked wood and display a mark subject to ‘technical justification’.

               (5)

               Third countries have requested that the Community consider alternative methods of achieving the same goal. To this end, research is under way on technical aspects of debarking wood, in particular the efficiency of ‘pest risk reduction’ of debarking in addition to treatment measures.

               (6)

               While awaiting the results of that research, it is appropriate to postpone for debarked wood, the application of the requirement to be used.

               (7)

               Directive 2000/29/EC should therefore be amended accordingly.

               (8)

               The Standing Committee on Plant Health has not delivered an opinion within the time limit set by its Chairman,

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Directive 2000/29/EC is amended as follows:

               1.

               In Annex IV, Part A, section I, point 2, the following paragraph shall be added at the end of the right hand column:
               ‘The first indent, requiring wood packaging material to be made from debarked round wood, shall only apply from 1 March 2006.’

               2.

               In Annex IV, Part A, section I, point 8, the following paragraph shall be added at the end of the right hand column:
               ‘The first line of point (a), requiring wood packaging material to be made from debarked round wood, shall only apply from 1 March 2006.’

         Article 2
   1.   Member States shall adopt and publish, not later than 28 February 2005, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between these provisions and this Directive.
   They shall apply these provisions from 1 March 2005.
   When Member States adopt these provisions, 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 the 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.
   Article 3
   This Directive shall enter into force on the third 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, 28 February 2005.

            For the Council

            The President

         F. BODEN

      (1)  OJ L 169, 10.7.2000, p. 1. Directive as last amended by Commission Directive 2004/102/EC (OJ L 309, 6.10.2004, p. 9).

      (2)  OJ L 309, 6.10.2004, p. 9.