Avis juridique important

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31992L0013

Council Directive 92/13/EEC of 25 February 1992 coordinating the laws, regulations and administrative provisions relating to the application of Community rules on the procurement procedures of entities operating in the water, energy, transport and telecommunications sectors

Official Journal L 076 , 23/03/1992 P. 0014 - 0020 Finnish special edition: Chapter 6 Volume 3 P. 0127  Swedish special edition: Chapter 6 Volume 3 P. 0127

COUNCIL DIRECTIVE 92/13/EEC of 25 February 1992 coordinating the laws, regulations and administrative provisions relating to the application of Community rules on the procurement procedures of entities operating in the water, energy, transport and  telecommunications sectorsTHE COUNCIL OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community, and in particular Article 100a thereof,  Having regard to the proposal from the Commission(1) ,  In cooperation with the European Parliament(2) ,  Having regard to the opinion of the Economic and Social Committee(3) ,  Whereas Council Directive 90/531/EEC of 17 September 1990 on the procurement procedures of entities operating in the water, energy, transport and telecommunications sectors(4)  lays down rules for procurement procedures to ensure that potential  suppliers and contractors have a fair opportunity to secure the award of contracts, but does not contain any specific provisions ensuring its effective application;  Whereas the existing arrangements at both national and Community levels for ensuring its application are not always adequate;  Whereas the absence of effective remedies or the inadequacy of existing remedies could deter Community undertakings from submitting tenders; whereas, therefore, the Member States must remedy this situation;  Whereas Council Directive 89/665/EEC of 21 December 1989 on the coordination of the laws, regulations and administrative provisions relating to the application of review procedures to the award of public supply and public works contracts(5)  is limited  to contract award procedures within the scope of Council Directive 71/305/EEC of 26 July 1971 concerning the coordination of procedures for the award of public works contracts(6) , as last amended by Directive 90/531/EEC, and Council Directive 77/62/EEC  of 21 December 1976 coordinating procedures for the award of public supply contracts(7) , as last amended by Directive 90/531/EEC;  Whereas the opening-up of procurement in the sectors concerned to Community competition implies that provisions must be adopted to ensure that appropriate review procedures are made available to suppliers or contractors in the event of infringement of  the relevant Community law or national rules implementing that law;  Whereas it is necessary to provide for a substantial increase in the guarantees of transparency and non-discrimination and whereas, for it to have tangible effects, effective and rapid remedies must be available;  Whereas account must be taken of the specific nature of certain legal orders by authorizing the Member States to choose between the introduction of different powers for the review bodies which have equivalent effects;  Whereas one of these options includes the power to intervene directly in the contracting entities' procurement procedures such as by suspending them, or by setting aside decisions or discriminatory clauses in documents or publications;  Whereas the other option provides for the power to exert effective indirect pressure on the contracting entities in order to make them correct any infringements or prevent them from committing infringements, and to prevent injury from occurring;  Whereas claims for damages must always be possible;  Whereas, where a claim is made for damages representing the costs of preparing a bid or of participating in an award procedure, the person making the claim is not be required, in order to obtain the reimbursement of his costs, to prove that the contract  would have been awarded to him in the absence of such infringement;  Whereas the contracting entities which comply with the procurement rules may make this known through appropriate means; whereas this requires an examination, by independent persons, of procurement procedures and practices applied by those entities;  Whereas for this purpose an attestation system, allowing for a declaration on the correct application of the procurement rules, to be made in notices published in the Official Journal of the European Communities, is appropriate;  Whereas the contracting entities should have the opportunity of having recourse to the attestation system if they so wish; whereas the Member States must offer them the possibility of doing so; whereas they can do so either by setting up the system  themselves or by allowing the contracting entities to have recourse to the attestation system established by another Member State; whereas they may confer the task of carrying out the examination under the attestation system to persons, professions or  staff of institutions;  Whereas the necessary flexibility in the introduction of such a system is guaranteed by laying down the essential requirements for it in this Directive; whereas operational details should be provided in European Standards to which this Directive refers;   Whereas the Member States may need to determine operational details prior to, or in addition to, the rules contained in European Standards;  Whereas, when undertakings do not seek review, certain infringements may not be corrected unless a specific mechanism is put in place;  Whereas, accordingly, the Commission, when it considers that a clear and manifest infringement has been committed during a contract award procedure, should be able to bring it to the attention of the competent authorities of the Member State and of the  contracting entity concerned so that appropriate steps are taken for the rapid correction of that infringement;  Whereas it is necessary to provide for the possibility of conciliation at Community level to enable disputes to be settled amicably;  Whereas the application in practice of this Directive should be reviewed at the same time as that of Directive 90/531/EEC on the basis of information to be supplied by the Member States concerning the functioning of the national review procedures;  Whereas this Directive must be brought into effect at the same time as Directive 90/531/EEC;  Whereas it is appropriate that the Kingdom of Spain, the Hellenic Republic and the Portuguese Republic are granted adequate additional periods to transpose this Directive, taking account of the dates of application of Directive 90/531/EEC in those  countries,  HAS ADOPTED THIS DIRECTIVE:  CHAPTER I Remedies at national level   Article 1  1.  The Member States shall take the measures necessary to ensure that decisions taken by contracting entities may be reviewed effectively and, in particular, as rapidly as possible in accordance with the conditions set out in the following  Articles and, in particular, Article 2 (8), on the grounds that such decisions have infringed Community law in the field or procurement or national rules implementing that law as regards:  (a) contract award procedures falling within the scope of Council Directive 90/531/EEC; and (b) compliance with Article 3 (2) (a) of that Directive in the case of the contracting entities to which that provision applies.  2.  Member States shall ensure that there is no discrimination between undertakings likely to make a claim for injury in the context of a procedure for the award of a contract as a result of the distinction made by this Directive between national rules  implementing Community law and other national rules.  3.  The Member States shall ensure that the review procedures are available, under detailed rules which the Member States may establish, at least to any person having or having had an interest in obtaining a particular contract and who has been or risks  being harmed by an alleged infringement. In particular, the Member States may require that the person seeking the review must have previously notified the contracting entity of the alleged infringement and of his intention to seek review.  Article 2  1.  The Member States shall ensure that the measures taken concerning the review procedures specified in Article 1 include provision for the powers:  either (a) to take, at the earliest opportunity and by way of interlocutory procedure, interim measures with the aim of correcting the alleged infringement or preventing further injury to the interests concerned, including measures to suspend or to ensure the  suspension of the procedure for the award of a contract or the implementation of any decision taken by the contracting entity; and (b) to set aside or ensure the setting aside of decisions taken unlawfully, including the removal of discriminatory technical, economic or financial specifications in the notice of contract, the periodic indicative notice, the notice on the existence of  a system of qualification, the invitation to tender, the contract documents or in any other document relating to the contract award procedure in question;  or (c) to take, at the earliest opportunity, if possible by way of interlocutory procedures and if necessary by a final procedure on the substance, measures other than those provided for in points (a) and (b) with the aim of correcting any identified  infringement and preventing injury to the interests concerned; in particular, making an order for the payment of a particular sum, in cases where the infringement has not been corrected or prevented.  Member States may take this choice either for all contracting entities or for categories of entities defined on the basis of objective criteria, in any event preserving the effectiveness of the measures laid down in order to prevent injury being caused  to the interests concerned;  (d) and, in both the above cases, to award damages to persons injured by the infringement.  Where damages are claimed on the grounds that a decision has been taken unlawfully, Member States may, where their system of internal law so requires and provides bodies having the necessary powers for that purpose, provide that the contested decision  must first be set aside or declared illegal.  2.  The powers referred to in paragraph 1 may be conferred on separate bodies responsible for different aspects of the review procedure.  3.  Review procedures need not in themselves have an automatic suspensive effect on the contract award procedures to which they relate.  4.  The Member States may provide that, when considering whether to order interim measures, the body responsible may take into account the probable consequences of the measures for all interests likely to be harmed, as well as the public interest, and  may decide not to grant such measures where their negative consequences could exceed their benefits. A decision no to grant interim measures shall not prejudice any other claim of the person seeking these measures.  5.  The sum to be paid in accordance with paragraph 1 (c) must be set at a level high enough to dissuade the contracting entity from committing or persisting in an infringement. The payment of that sum may be made to depend upon a final decision that  the infringement has in fact taken place.  6.  The effects of the exercise of the powers referred to in paragraph 1 on a contract concluded subsequent to its award shall be determined by national law. Furthermore, except where a decision must be set aside prior to the award of damages, a Member  State may provide that, after the conclusion of a contract following its award, the powers of the body responsible for the review procedures shall be limited to awarding damages to any person harmed by an infringement.  7.  Where a claim is made for damages representing the costs of preparing a bid or of participating in an award procedure, the person making the claim shall be required only to prove an infringement of Community law in the field of procurement or  national rules implementing that law and that he would have had a real chance of winning the contract and that, as a consequence of that infringement, that chance was adversely affected.  8.  The Member States shall ensure that decisions taken by bodies responsible for review procedures can be effectively enforced.  9.  Whereas bodies responsible for review procedures are not judicial in character, written reasons for their decisions shall always be given. Furthermore, in such a case, provision must be made to guarantee procedures whereby any allegedly illegal  measures taken by the review body or any alleged defect in the exercise of the powers conferred on it can be the subject of judicial review or review by another body which is a court or tribunal within the meaning of Article 177 of the Treaty and  independent of both the contracting entity and the review body.  The members of the independent body referred to in the first paragraph shall be appointed and leave office under the same conditions as members of the judiciary as regards the authority responsible for their appointment, their period of office, and  their removal. At least the President of this independent body shall have the same legal and professional qualifications as members of the judiciary. The independent body shall take its decisions following a procedure in which both sides are heard, and  these decisions shall, by means determined by each Member State, be legally binding.  CHAPTER 2 Attestation   Article 3  The Member States shall give contracting entities the possibility of having recourse to an attestation system in accordance with Articles 4 to 7.  Article 4  Contracting entities may have their contract award procedures and practices which fall within the scope of Directive 90/531/EEC examined periodically with a view to obtaining an attestation that, at that time, those procedures and practices  are in conformity with Community law concerning the award of contracts and the national rules implementing the law.  Article 5  1.  Attestors shall report to the contracting entity, in writing, on the results of their examination. They shall satisfy themselves, before delivering to the contracting entity the attestation referred to in Article 4, that any  irregularities identified in the contracting entity's award procedures and practices have been corrected and measures have been taken to ensure that those irregularities are not repeated.  2.  Contracting entities having obtained that attestation may include the following statement in notice published in the Official Journal of the European Communities pursuant to Articles 16 to 18 of Directive 90/531/EEC:  'The contracting entity has obtained an attestation in accordance with Council Directive 92/13/EEC that, on ................., its contract award procedures and practices were in conformity with Community law and the national rules implementing that  law.' Article 6  1.  Attestors shall be independent of the contracting entities and must be completely objective in carrying out their duties. They shall offer appropriate guarantees of relevant professional qualifications and experience.  2.  Member States may identify any persons, professions or institutions whose staff, called upon the act as attestors, they regard as fulfilling the requirements of paragraph 1. For these purposes, Member States may require professional qualifications,  at least at the level of a higher education diploma within the meaning of Directive 89/48/EEC(8) , which they regard as relevant, or provide that particular examinations of professional competence organized or recognized by the State offer such  guarantees.  Article 7  The provisions of Articles 4, 5 and 6 shall be considered as essential requirements for the development of European standards on attestation.  CHAPTER 3 Corrective mechanism   Article 8  1.  The Commission may invoke the procedures for which this Article provides when, prior to a contract being concluded, it considers that a clear and manifest infringement of Community provisions in the field of procurement has been committed  during a contract award procedure fallig within the scope of Directive 90/531/EEC or in relation to Article 3 (2) (a) of that Directive in the case of the contracting entities to which that provision applies.  2.  The Commission shall notify the Member States and the contracting entity concerned of the reasons which have led it to conclude that a clear and manifest infringement has been committed and request its correction by appropriate means.  3.  Within 30 days of receipt of the notification referred to in paragraph 2, the Member States concerned shall communicate to the Commission:  (a) its confirmation that the infringement has been corrected; or (b) a reasoned submission as to why no correction has been made; or (c) a notice to the effect that the contract award procedure has been suspended either by the contracting entity on its own initiative or on the basis of the powers specified in Article 2 (1) (a).  4.  A reasoned submission in accordance with paragraph 3 (b) may rely among other matters on the fact that the alleged infringement is already the subject of judicial review proceedings or of a review as referred to in Article 2 (9). In such a case, the  Member State shall inform the Commission of the result of those proceedings as soon as it becomes known.  5.  Where notice has been given that a contract award procedure has been suspended in accordance with paragraph 3 (c), the Member State concerned shall notify the Commission when the suspension is lifted or another contract procedure relating in whole  or in part to the same subject matter is begun. That new notification shall confirm that the alleged infringement has been corrected or include an reasoned submission as to why no correction has been made.  CHAPTER 4 Conciliation   Article 9  1.  Any person having or having had an interest in obtaining a particular contract falling within the scope of Directive 90/531/EEC and who, in relation to the procedure for the award of that contract, considers that he has been or risks  being harmed by an alleged infringement of Community law in the field of procurement or national rules impelementing that law may request the application of the conciliation procedure provided for in Articles 10 and 11.  2.  The request referred to in paragraph 1 shall be addressed in writing to the Commission or to the national authorities listed in the Annex. These authorities shall forward requests to the Commission as quickly as possible.  Article 10  1.  Where the Commission considers, on the basis of the request referred to in Article 9, that the dispute concerns the correct application of Community law, it shall ask the contracting entity to state whether it is willing to take part in  the conciliation procedure. If the contracting entity declines to take part, the Commission shall inform the person who made the request that the procedure cannot be initiated. If the contracting entity agrees, paragraphs 2 to 7 shall apply.  2.  The Commission shall propose, as quickly as possible, a conciliator drawn from a list of independent persons accredited for this purpose. This list shall be drawn up by the Commission, following consultation of the Advisory Committee for Public  Contracts or, in the case of contracting entities the activities of which are defined in Article 2 (2) (d) of Directive 90/531/EEC, following consultation of the Advisory Committee on Telecommunications Procurement.  Each party to the conciliation procedure shall declare whether it accepts the conciliator, and shall designate an additional conciliator. The conciliators may invite not more than two other persons as experts to advices them in their work. The parties  to the conciliation procedure and the Commission may reject any expert invited by the conciliators.  3.  The conciliators shall give the person requesting the application of the conciliation procedure, the contracting entity and any other candidate or tenderer participating in the relevant contract award procedure the opportunity to make  representations on the matter either orally or in writing.  4.  The conciliators shall endeavour as quickly as possible to reach an agreement between the parties which is in accordance with Community law.  5.  The conciliators shall report to the Commission on their findings and on any result achieved.  6.  The person requesting the application of the concilation procedure and the contracting entity shall have the right to terminate the procedure at any time.  7.  Unless the parties decide otherwise, the person requesting the application of the conciliation procedure and the contracting entity shall be responsible for their own costs. In addition, they shall each bear half of the costs of the procedure,  excluding the costs of intervening parties.  Article 11  1.  Where, in relation to a particular contract award procedure, an interested person within the meaning of Article 9, other than the person requesting the conciliation procedure, is pursuing judicial review proceedings or other proceedings  for review within the meaning of this Directive, the contracting entity shall inform the conciliators. These shall inform that person that a request has been made to apply the conciliation procedure and shall invite that person to indicate within a  given time limit whether he agrees to participate in that procedure. If that person refuses to participate, the conciliators may decide, acting if necessary by a majority, to terminate the conciliation procedure if they consider that the participation  of this person is necessary to resolve the dispute. They shall notify their decision to the Committee and give the reasons for it.  2.  Action taken pursuant to this Chapter shall be without prejudice to:  (a) any action that the Commission or any Member State might take pursuant ot Articles 169 or 170 of the Treaty or pursuant to Chapter 3 of this Directive;  (b) the rights of the persons requesting the conciliation procedure, of the contracting entity or of any other person.  CHAPTER 5 Final provisions   Article 12  1.  Not later than four years after the application of this Directive, the Commission, in consultation with the Advisory Committee for Public Contracts, shall review the manner in which the provisions of this Directive have been implemented  and, in particular, the use of the European Standards and, if necessary, make proposals for amendments.  2.  Before 1 March each year the Member States shall communicate to the Commission information on the operation of their national review procedures during the preceding calendar year. The nature of the information shall be determined by the Commission  in consultation with the Advisory Committee for Public Contracts.  3.  In the case of matters relating to contracting entities the activities of which are defined in Article 2 (2) (d) of Directive 90/531/EEC, the Commission shall also consult the Advisory Committee on Telecommunications Procurement.  Article 13  1.  Member States shall take, before 1 January 1993, the measures necessary to comply with this Directive. The Kingdom of Spain shall take these measures not later than 30 June 1995. The Hellenic Republic and the Portuguese Republic shall  take these measures not later than 30 June 1997. They shall forthwith inform the Commission thereof.  When Member States adopt these measures, they shall contain an reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member  States.  2.  Member States shall bring into force the measures referred to in paragraph 1 on the same dates as those (laid down in Directive 90/531/EEC).  3.  Member States shall communicate to the Commission the texts of the main provisions of domestic law which they adopt in the field governed by this Directive.  Article 14  This Directive is addressed to the Member States.  Done at Brussels, 25 February 1992.  For the CouncilThe PresidentVitor MARTINS    (1) OJ No C 216, 31. 8. 1990, p. 8; and OJ No C 179, 10. 7. 1991, p. 18.  (2) OJ No C 106, 22. 4. 1991, p. 82 and OJ No C 39, 17. 2. 1992.  (3) OJ No C 60, 8. 3. 1991, p. 16.  (4) OJ No L 297, 29. 10. 1990, p. 1.  (5) OJ No L 395, 30. 12. 1989, p. 33.  (6) OJ No L 185, 16. 8. 1971, p. 5.  (7) OJ No L 13, 15. 1. 1977, p. 1.  (8) OJ No L 19, 24. 1. 1989, p. 16.    ANNEX   National authorities to which requests for application of the conciliation procedure referred to in Article 9 may be addressed   Belgium  Services du Premier Ministre Diensten Van de Eerste Minister Ministère des Affaires économiques Ministerie van Economische Zaken Denmark  Industri- og Handelsstyrelsen (supply contracts) Boligsministeriet (works contracts) Germany  Bundesministerium fuer Wirtschaft Greece  Ypoyrgeio Viomichanias, Energeias kai Technologias Ypoyrgeio Emporioy Ypoyrgeio Perivallontos, Chorotaxias kai Dimosion Ergon Spain  Ministerio de Economía y Hacienda France  Commission centrale des marchés Ireland  Department of Finance Italy  Presidenza del Consiglio dei Ministri Politiche Comunitarie Luxembourg  Ministère des travaux publics Netherlands  Ministerie van Economische Zaken Portugal  Conselho de mercados de obras publicas e particulares United Kingdom  HM Treasury


Avis juridique important

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32004L0033

Commission Directive 2004/33/EC of 22 March 2004 implementing Directive 2002/98/EC of the European Parliament and of the Council as regards certain technical requirements for blood and blood components (Text with EEA relevance)

Official Journal L 091 , 30/03/2004 P. 0025 - 0039

Commission Directive 2004/33/ECof 22 March 2004implementing Directive 2002/98/EC of the European Parliament and of the Council as regards certain technical requirements for blood and blood components(Text with EEA relevance)THE COMMISSION OF THE EUROPEAN COMMUNITIES,Having regard to the Treaty establishing the European Community,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 points (b) to (g) of the second paragraph of Article 29 thereof,Whereas:(1) Directive 2002/98/EC lays down standards of quality and safety for the collection and testing of human blood and blood components, whatever their intended purpose, and for their processing, storage and distribution when intended for transfusion so as to ensure a high level of human health protection.(2) In order to prevent the transmission of diseases by blood and blood components and to ensure an equivalent level of quality and safety, Directive 2002/98/EC calls for the establishment of specific technical requirements.(3) This Directive lays down those technical requirements, which take account of Council Recommendation 98/463/EC of 29 June 1998 on the suitability of blood and plasma donors and the screening of donated blood in the European Community(2), certain recommendations of the Council of Europe, the opinion of the Scientific Committee for Medicinal Products and Medical Devices, the monographs of the European Pharmacopoeia, particularly in respect of blood or blood components as a starting material for the manufacture of proprietary medicinal products and recommendations of the World Health Organisation (WHO), as well as international experience in this field.(4) Blood and blood components imported from third countries, including those used as starting material/raw material for the manufacture of medicinal products derived from human blood and human plasma, should meet the quality and safety requirements set out in this Directive.(5) With regard to blood and blood components collected for the sole purpose of, and exclusive use in, autologous transfusion (autologous donation), specific technical requirements should be laid down, as required by Article 2(2) of Directive 2002/98/EC. Such donations should be clearly identified and kept separate from other donations to ensure that they are not used for transfusion to other patients.(6) It is necessary to determine common definitions for technical terminology in order to ensure the consistent implementation of Directive 2002/98/EC.(7) 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 1DefinitionsFor the purposes of this Directive, the definitions set out in Annex I shall apply.Article 2Provision of information to prospective donorsMember States shall ensure that blood establishments provide prospective donors of blood or blood components with the information set out in Part A of Annex II.Article 3Information required from donorsMember States shall ensure that upon agreement of willingness to commence the donation of blood or blood components, donors provide the information set out in Part B of Annex II to the blood establishment.Article 4Eligibility of donorsBlood establishments shall ensure that donors of whole blood and blood components comply with the eligibility criteria set out in Annex III.Article 5Storage, transport and distribution conditions for blood and blood componentsBlood establishments shall ensure that the storage, transport and distribution conditions for blood and blood components comply with the requirements set out in Annex IV.Article 6Quality and safety requirements for blood and blood componentsBlood establishments shall ensure that the quality and safety requirements for blood and blood components comply with the requirements set out in Annex V.Article 7Autologous donations1. Blood establishments shall ensure that autologous donations comply with the requirements set out in Directive 2002/98/EC and the specific requirements set out in this Directive.2. Autologous donations shall be clearly identified as such and shall be kept separate from allogeneic donations.Article 8ValidationMember States shall ensure that all testing and processes referred to in Annexes II to V are validated.Article 9Transposition1. Without prejudice to Article 7 of Directive 2002/98/EC, Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 8 February 2005 at the latest. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.Article 10Entry into forceThis Directive shall enter into force on the 20th day following that of its publication in the Official Journal of the European Union.Article 11AddresseesThis Directive is addressed to the Member States.Done at Brussels, 22 March 2004.For the CommissionDavid ByrneMember of the Commission(1) OJ L 33, 8.2.2003, p. 30.(2) OJ L 203, 21.7.1998, p. 14.ANNEX IDEFINITIONS(as referred to in Article 1)1. "Autologous donation" means blood and blood components collected from an individual and intended solely for subsequent autologous transfusion or other human application to that same individual.2. "Allogeneic donation" means blood and blood components collected from an individual and intended for transfusion to another individual, for use in medical devices or as starting material/raw material for manufacturing into medicinal products.3. "Validation" means the establishment of documented and objective evidence that the particular requirements for a specific intended use can be consistently fulfilled.4. "Whole blood" means a single blood donation.5. "Cryopreservation" means prolongation of the storage life of blood components by freezing.6. "Plasma" means the liquid portion of the blood in which the cells are suspended. Plasma may be separated from the cellular portion of a whole blood collection for therapeutic use as fresh-frozen plasma or further processed to cryoprecipitate and cryoprecipitate-depleted plasma for transfusion. It may be used for the manufacture of medicinal products derived from human blood and human plasma or used in the preparation of pooled platelets, or pooled, leucocyte-depleted platelets. It may also be used for re-suspension of red cell preparations for exchange transfusion or perinatal transfusion.7. "Cryoprecipitate" means a plasma component prepared from plasma, fresh-frozen, by freeze-thaw precipitation of proteins and subsequent concentration and re-suspension of the precipitated proteins in a small volume of the plasma.8. "Washed" means a process of removing plasma or storage medium from cellular products by centrifugation, decanting of the supernatant liquid from the cells and addition of an isotonic suspension fluid, which in turn is generally removed and replaced following further centrifugation of the suspension. The centrifugation, decanting, replacing process may be repeated several times.9. "Red cells" means the red cells from a single whole blood donation, with a large proportion of the plasma from the donation removed.10. "Red cells, buffy coat removed" means the red cells from a single whole blood donation, with a large proportion of the plasma from the donation removed. The buffy coat, containing a large proportion of the platelets and leucocytes in the donated unit, is removed.11. "Red cells, leucocyte-depleted" means the red cells from a single whole blood donation, with a large proportion of the plasma from the donation removed, and from which leucocytes are removed.12. "Red cells in additive solution" means the red cells from a single whole blood donation, with a large proportion of the plasma from the donation removed. A nutrient/preservative solution is added.13. "Additive solution" means a solution specifically formulated to maintain beneficial properties of cellular components during storage.14. "Red cells, buffy coat removed, in additive solution" means the red cells from a single whole blood donation, with a large proportion of the plasma from the donation removed. The buffy coat, containing a large proportion of the platelets and leucocytes in the donated unit, is removed. A nutrient/preservative solution is added.15. "Buffy coat" means a blood component prepared by centrifugation of a unit of whole blood, and which contains a considerable proportion of the leucocytes and platelets.16. "Red cells, leucocyte-depleted, in additive solution" means the red cells from a single whole blood donation, with a large proportion of the plasma from the donation removed, and from which leucocytes are removed. A nutrient/preservative solution is added.17. "Red cells, apheresis" means the red cells from an apheresis red cell donation.18. "Apheresis" means a method of obtaining one or more blood components by machine processing of whole blood in which the residual components of the blood are returned to the donor during or at the end of the process.19. "Platelets, apheresis" means a concentrated suspension of blood platelets obtained by apheresis.20. "Platelets, apheresis, leucocyte-depleted" means a concentrated suspension of blood platelets, obtained by apheresis, and from which leucocytes are removed.21. "Platelets, recovered, pooled" means a concentrated suspension of blood platelets, obtained by processing of whole blood units and pooling the platelets from the units during or after separation.22. "Platelets, recovered, pooled, leucocyte-depleted" means a concentrated suspension of blood platelets, obtained by processing of whole blood units and pooling the platelets from the units during or after separation, and from which leucocytes are removed.23. "Platelets, recovered, single unit" means a concentrated suspension of blood platelets, obtained by processing of a single unit of whole blood.24. "Platelets, recovered, single unit, leucocyte-depleted" means a concentrated suspension of blood platelets, obtained by processing of a single whole blood unit from which leucocytes are removed.25. "Plasma, fresh-frozen" means the supernatant plasma separated from a whole blood donation or plasma collected by apheresis, frozen and stored.26. "Plasma, cryoprecipitate-depleted for transfusion" means a plasma component prepared from a unit of plasma, fresh-frozen. It comprises the residual portion after the cryoprecipitate has been removed.27. "Granulocytes, apheresis" means a concentrated suspension of granulocytes obtained by apheresis.28. "Statistical process control" means a method of quality control of a product or a process that relies on a system of analysis of an adequate sample size without the need to measure every product of the process.ANNEX IIINFORMATION REQUIREMENTS(as referred to in Articles 2 and 3)PART AInformation to be provided to prospective donors of blood or blood components1. Accurate educational materials, which are understandable for members of the general public, about the essential nature of blood, the blood donation procedure, the components derived from whole blood and apheresis donations, and the important benefits to patients.2. For both allogeneic and autologous donations, the reasons for requiring an examination, health and medical history, and the testing of donations and the significance of "informed consent".For allogeneic donations, self-deferral, and temporary and permanent deferral, and the reasons why individuals are not to donate blood or blood components if there could be a risk for the recipient.For autologous donations, the possibility of deferral and the reasons why the donation procedure would not take place in the presence of a health risk to the individual whether as donor or recipient of the autologous blood or blood components.3. Information on the protection of personal data: no unauthorised disclosure of the identity of the donor, of information concerning the donor's health, and of the results of the tests performed.4. The reasons why individuals are not to make donations which may be detrimental to their health.5. Specific information on the nature of the procedures involved either in the allogeneic or autologous donation process and their respective associated risks. For autologous donations, the possibility that the autologous blood and blood components may not suffice for the intended transfusion requirements.6. Information on the option for donors to change their mind about donating prior to proceeding further, or the possibility of withdrawing or self-deferring at any time during the donation process, without any undue embarrassment or discomfort.7. The reasons why it is important that donors inform the blood establishment of any subsequent event that may render any prior donation unsuitable for transfusion.8. Information on the responsibility of the blood establishment to inform the donor, through an appropriate mechanism, if test results show any abnormality of significance to the donor's health.9. Information why unused autologous blood and blood components will be discarded and not transfused to other patients.10. Information that test results detecting markers for viruses, such as HIV, HBV, HCV or other relevant blood transmissible microbiologic agents, will result in donor deferral and destruction of the collected unit.11. Information on the opportunity for donors to ask questions at any time.PART BInformation to be obtained from donors by blood establishments at every donation1. Identification of the donorPersonal data uniquely, and without any risk of mistaken identity, distinguishing the donor, as well as contact details.2. Health and medical history of the donorHealth and medical history, provided on a questionnaire and through a personal interview performed by a qualified healthcare professional, that includes relevant factors that may assist in identifying and screening out persons whose donation could present a health risk to others, such as the possibility of transmitting diseases, or health risks to themselves.3. Signature of the donorSignature of the donor, on the donor questionnaire, countersigned by the health care staff member responsible for obtaining the health history confirming that the donor has:(a) read and understood the educational materials provided;(b) had an opportunity to ask questions;(c) been provided with satisfactory responses to any questions asked;(d) given informed consent to proceed with the donation process;(e) been informed, in the case of autologous donations, that the donated blood and blood components may not be sufficient for the intended transfusion requirements; and(f) acknowledged that all the information provided by the donor is true to the best of his/her knowledge.ANNEX IIIELIGIBILITY CRITERIA FOR DONORS OF WHOLE BLOOD AND BLOOD COMPONENTS(as referred to in Article 4)1. ACCEPTANCE CRITERIA FOR DONORS OF WHOLE BLOOD AND BLOOD COMPONENTSUnder exceptional circumstances, individual donations from donors who do not comply with the following criteria may be authorised by a qualified healthcare professional in the blood establishment. All such cases must be clearly documented and subject to the quality management provisions in Articles 11, 12, and 13 of Directive 2002/98/EC.The following criteria do not apply to autologous donations.1.1. Age and body weight of donors>TABLE>1.2. Haemoglobin levels in donor's blood>TABLE>1.3. Protein levels in donor's blood>TABLE>1.4. Platelet levels in donor's blood>TABLE>2. DEFERRAL CRITERIA FOR DONORS OF WHOLE BLOOD AND BLOOD COMPONENTSThe tests and deferral periods indicated by an asterisk (*) are not required when the donation is used exclusively for plasma for fractionation.2.1. Permanent deferral criteria for donors of allogeneic donations>TABLE>2.2. Temporary deferral criteria for donors of allogeneic donations2.2.1. InfectionsDuration of deferral periodAfter an infectious illness, prospective donors shall be deferred for at least two weeks following the date of full clinical recovery.However, the following deferral periods shall apply for the infections listed in the table:>TABLE>2.2.2. Exposure to risk of acquiring a transfusion-transmissible infection>TABLE>2.2.3. Vaccination>TABLE>2.2.4. Other temporary deferrals>TABLE>2.3. Deferral for particular epidemiological situations>TABLE>2.4. Deferral criteria for donors of autologous donations>TABLE>ANNEX IVSTORAGE, TRANSPORT AND DISTRIBUTION CONDITIONS FOR BLOOD AND BLOOD COMPONENTS(as referred to in Article 5)1. STORAGE1.1. Liquid storage>TABLE>1.2. Cryopreservation>TABLE>2. TRANSPORT AND DISTRIBUTIONTransport and distribution of blood and blood components at all stages of the transfusion chain must be under conditions that maintain the integrity of the product.3. ADDITIONAL REQUIREMENTS FOR AUTOLOGOUS DONATIONS3.1. Autologous blood and blood components must be clearly identified as such and stored, transported and distributed separately from allogeneic blood and blood components.3.2. Autologous blood and blood components must be labelled as required by Directive 2002/98/EC and in addition the label must include the identification of the donor and the warning "FOR AUTOLOGOUS TRANSFUSION ONLY".ANNEX VQUALITY AND SAFETY REQUIREMENTS FOR BLOOD AND BLOOD COMPONENTS(as referred to in Article 6)1. THE BLOOD COMPONENTS>TABLE>2. QUALITY CONTROL REQUIREMENTS FOR BLOOD AND BLOOD COMPONENTS2.1. Blood and blood components must comply with the following technical quality measurements and meet the acceptable results.2.2. Appropriate bacteriological control of the collection and manufacturing process must be performed.2.3. Member States must take all necessary measures to ensure that all imports of blood and blood components from third countries, including those used as starting material/raw material for the manufacture of medicinal products derived from human blood or human plasma, shall meet equivalent standards of quality and safety to the ones laid down in this Directive.2.4. For autologous donations, the measures marked with an asterisk (*) are recommendations only.>TABLE>


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31990L0629

Commission Directive 90/629/EEC of 30 October 1990 adapting to technical progress Council Directive 76/115/EEC on the approximation of the laws of the Member States relating to anchorages for motor vehicle safety belts

Official Journal L 341 , 06/12/1990 P. 0014 - 0019 Finnish special edition: Chapter 13 Volume 20 P. 0016  Swedish special edition: Chapter 13 Volume 20 P. 0016

COMMISSION DIRECTIVEof 30 October 1990adapting  to technical progress Council Directive 76/115/EEC on the approximation of the laws of the Member  States relating to anchorages for motor vehicle safety belts(90/629/EEC)THE  COMMISSION OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Economic Community, Having regard to Council Directive 76/115/EEC of 18 December 1975 on the approximation of the laws  of the Member States relating to anchorages for motor-vehicle safety belts (1), as last amended by  Commission Directive 82/318/EEC (2), and in particular Article 6 thereof, Whereas practical experience and technological development show that it is possible to improve road  safety by applying similar requirements to those existing already to vehicle categories M2 with a  permissible maximum mass exceeding 3 500 kilograms and M3 (buses) which were not covered hitherto  and to generally extend the requirements toseating positions, not covered hitherto, of other  vehicle categories; Whereas that experience shows that some existing definitions and requirements have to be adjusted  slightly; Whereas the protection against "submarining'' should be improved, which could be provided by  modified positioning of the anchorages for safety belts and/or modifications tothe seat  construction; whereas a test procedure must be developed which enables the improvement in the level  of protection to be shown; Whereas the provisions of this Directive are in accordance with the opinion of the Committee on the  Adaptation to Technical Progress of the Directives on the removal of technical barriers to trade in  motor vehicles, HAS ADOPTED THIS DIRECTIVE: Article 1Annex I to Directive 76/115/EEC, is hereby amended in accordance with  the Annex to this Directive. Article 21.  With effect from 1 May 1991 no Member State may, on grounds relating to anchorages  for safety belts: - refuse, in respect of a type of vehicle, to grant EEC type-approval, or to issue the copy of the  certificate provided for in the last indent of Article 10 (1) of Directive 70/156/EEC (3), or to  grant national type-approval, or- prohibit the entry into service of vehiclesif the anchorages  in this type of vehicle or in these vehicles comply with the requirements of Directive 76/115/EEC,  as amended by this Directive. 2.  With effect from 1 July 1992 Member States: - shall no longer issue the copy of the certificate provided for in the last indent of Article 10  (1) of Directive 70/156/EEC in respect of a type of vehicle, - may refuse to grant national type-approval in respect of a type of vehiclein which the  anchorages do not comply with the requirements of Directive 76/115/EEC, as amended by this  Directive. 3.  With effect from 1 July 1997 Member States may prohibit the entry into service of vehicles in  which the anchorages do not comply with the requirements of Directive 76/115/EEC, as amended by  this Directive. Article 3The Commission shall, not later than 31 December 1992, proceed to a further review of  the provisions of Directive 76/115/EEC and notably Annex I, item 4.4.3 thereof, in order to improve the protection against the riskof submarining, which amendment might include  new measures and related dynamic test methods. Article 4Member States shall implement the provisions necessary in order to comply with this  Directive before 1 May 1991. They shall forthwith inform the Commission thereof. When Member States adopt these provisions, these shall contain a reference to this Directive or  shall be accompanied by such reference at the time of their official publication. The procedure for  such reference shall be adopted by Member States. Article 5This Directive is addressed to the Member States. Done at Brussels, 30 October 1990. For the CommissionMartin BANGEMANNVice-President(1) OJ N° L 24, 30. 1. 1976,  p. 6. (2) OJ N° L 139, 19. 5. 1982, p. 9. (3) OJ N° L 42, 23. 2. 1970, p. 1.  ANNEX Annex I is amended as follows: After item 1.6, a new item 1.6.1 is added: '1.6.1. a "front passenger seat'` means any seat where the "foremost H-point'' of the seat in question is  in or in front of the vertical tranverse plane through the drivers R-point.'Item 4.2.1.1, amend to  read: 'incorporate retractors. This provision shall not apply to vehicles for which, according to item  4.3, lap belts only for front outboard seating positions are allowed. If anchorages . . .`. (Remainder unchanged)Item 4.3 is replaced by the following: '4.3. Minimum number of belt anchorages to be provided (see Appendix 1). 4.3.1. Any vehicle in categories M and N (except those vehicles which include places specially designed  for standing passengers in categories M2 over 3,5 tonnes and M3) must be equipped with safety belt  anchorages which satisfy the requirements of this Directive. 4.3.2. The minimum number of safety belt anchorages for each forward directed seating position shall be as  specified in Appendix 1. 4.3.3. However, for outboard seating positions - other than front - of vehicles of the category M1, shown  in Appendix 1 and marked with the symbol oe, two lower anchorages are allowed, where there exists a  passage between a seat and the nearest side wall of the vehicle intended to permit access of  passengers to other parts of the vehicle. A space between a seat and the side wall is considered as  a passage, if the distance between that side wall, with all doors closed, and a vertical  longitudinal plane passing through the centreline of the seat concerned - measured at the R-point  position and perpendicularly to the median longitudinal plane of the vehicle - is more than 500  mm. 4.3.4. For the front centre seating positions shown in Appendix 1 and marked with the symbol *, two lower  anchorages shall be considered adequate where the windscreen is located outside the reference zone  defined in Annex II to Directive 74/60/EEC; if located inside this reference zone, three anchorages  are required. As regards belt anchorages, the windscreen is considered as part of the reference zone when it is  capable of entering into static contact with the test apparatus according to the method described  in Annex II to Directive 74/60/EEC. 4.3.5. For all seating positions shown in Appendix 1 and marked with the symbol ll=, each exposed seating  position, as defined in item 4.3.6, must be equipped with two lower anchorages. 4.3.6. An "exposed seating position'` is one where there is no "protective screen'' in front of the seat  within the following defined space: - between two horizontal planes, one through the H-point and the other 400 mm above it, - between two vertical longitudinal planes which are symmetrical in relation to the H-point and are  400 mm apart, - behind a transverse vertical plane 1,30 m from the H-point. For the purposes of this requirement "protective screen'' means a surface of suitable strength and  showing no discontinuities such that, if a sphere of 165 mm diameter is geometrically projected in  a longitudinal horizontal direction through any point of the space defined above and through the  centre of the sphere, nowhere in the protective screen is there any aperture through which the  geometrical projection of the sphere could be passed. A seat is considered to be an "exposed seating position'', if the protective screens within the  space defined above have a combined surface area of less than 800 cm$. 4.3.7. For all folding seats, as well as all the seats of any vehicle which are not covered in items 4.3.1  to 4.3.5, no belt anchorages are required. However, if the vehicle is fitted with anchorages for  such seats, these anchorages must comply with the provisions of this Directive. In this case, two lower anchorages shall be sufficient.'Item 4.4.3 reads as follows: '4.4.3. Location of the effective lower belt anchorages (see Apendix 2)4.4.3.1. Front seats, vehicle-category M1In motor vehicles of category M1 the angle  á1 (other than buckle  side) shall be within the range of 30 to 80g and the angle á2 (buckle side) shall be within the  range of 45 to 80g. Both angle-requirements shall be valid for all normal travelling positions of  the front seats. Where atleast one of the angles á1 and á2 is constant in all normal positions of  use, its value shall be60 p 10g. In case of adjustable seats with an adjusting device as described in item 1.12, with a seatback  inclination angle of less than 20g (see Annex III, figure 1), the angle á1 may be below the minimum  value (30g) stipulated above, provided it is not less than 20g in any normal position of use. 4.4.3.2. Rear seats, vehicle category M1In motor vehicles of category M1 the angles á1 and á2 shall be  within the range of 30 to 80g for all rear seats. If rear seats are adjustable the above angles  shall be valid for all normal travelling positions. 4.4.3.3. Front seats, vehicle categories other than M1In motor vehicles of categories other than M1 the  angles á1 and á2 must be between 30 to 80g for all normal travelling positions of the front seats.  Where in the case of front seats of vehicles with a maximum vehicle mass not exceeding 3,5 tonnes  at least one of the angles á1 and á2 is constant in all normal positions of use, its value shall be  60 p 10g. 4.4.3.4. Rear seats and special front or rear seats, vehicle categories other than M1In vehicles of  categories other than M1, in the case of: - bench seats, - adjustable seats (front and rear) with an adjusting device as described in item 1.12 with a  seatback angle of less than 20g (see Annex III, figure 1), and- other rear seats, angles á1 and á2 may be between 20 and 80g in any normal position of use. Where in the case of  front seats of vehicles with a maximum vehicle mass not exceeding 3,5 tonnes at least one of the  angles á1 and á2 is constant in all normal positions of use, its value shall be 60 p 10g.`Old item  4.4.3.3 becomes 4.4.3.5. Add at the end of 4.4.4.1: 'Where a two-door configuration is used to provide access to both the front and rear seats and the  upper anchorage is fitted to the "B'` post, the system must be designed so as not to impede access  to or egress from the vehicle.'After item 5.2.3, a new item 5.2.4 is added: '5.2.4. If a test method other than that prescribed in items 5.2.1 to 5.2.3 of this Directive is used,  evidence must be furnished that it is equivalent.`Item 5.3.5.3 reads as follows: '5.3.5.3. When a manufacturer supplies his vehicle with safety belts, the corresponding belt anchorages may,  at the request of the manufacturer, be submitted only to a test in which the loads are transmitted  to them by means of a device reproducing the geometry of the type of belts to be attached to these  anchorages.`Item 5.3.6 reads as follows: '5.3.6. If no upper belt anchorages are provided for the outboard seats and the centre seats, the lower  belt anchorages shall be submitted to the test prescribed in 5.4.3, in which the loads are  transmitted to these anchorages by means of a device reproducing the geometry of a lap belt.`Item  5.4.1.2 reads as follows: '5.4.1.2. For vehicles in categories M1 and N1, a test load of 1 350 p 20 daN shall be applied by a traction  device (see Annex IV, figure 2) attached to the belt anchorages of the same belt by means of a  device reproducing the geometry of the upper torso strap of such a safety belt. For vehicles in categories M2 and N2, the test load shall be 675 p 20 daN. For vehicles in categories M3 and N3, the test load shall be 450 p 20 daN.`Item 5.4.1.3 reads as  follows: '5.4.1.3. For vehicles in categories M1 and N1, at the same time a tractive force of 1 350 p 20 daN shall be  applied to a traction device (see Annex IV, figure 1) attached to the two lower belt anchorages. For vehicles in categories M2 and N2, this test load shall be 675 p 20 daN. For vehicles in categories M3 and N3, this test load shall be 450 p 20 daN.`Item 5.4.2.1 reads as  follows: '5.4.2.1. For vehicles in categories M1 and N1, a test load of 1 350 p 20 daN shall be applied to a traction  device (see Annex IV, figure 2) attached to the belt upper anchorage and to the opposite lower belt  anchorage of the same belt, using, if supplied by the manufacturer, a retractor fixed at the upper  belt anchorage. For vehicles in categories M2 and N2, this test load shall be 675 p 20 daN. For vehicles in categories M3 and N3, this test load shall be 450 p 20 daN.`Item 5.4.2.2 reads as  follows: '5.4.2.2. For vehicles in categories M1 and N1, at the same time a tractive force of 1 350 p 20 daN shall be  applied to a traction device (see Annex IV, figure 1) attached to the lower belt anchorages. For vehicles in categories M2 and N2, this test load shall be 675 p 20 daN. For vehicles in categories M3 and N3, this test load shall be 450 p 20 daN.`Item 5.4.3 reads as  follows: '5.4.3. Test in configuration of a lap belt. For vehicles in categories M1 and N1, a test load of 2 225 p 20 daN shall be applied to a traction  device (see Annex IV, figure 1) attached to the two lower belt anchorages. For vehicles in categories M2 and N2, this test load shall be 1 110 p 20 daN. For vehicles in categories M3 and N3, this test load shall be 740 p 20 daN.`Item 5.4.4.2, amend  the sentence which was added with Directive 82/318/EEC to read: 'In the case of vehicles in categories M2 and N2, this force must be equal to 10 times the weight  of the complete seat; for categories M3 and N3 it must be equal to 6,6 times the weight of the  complete seat.`Replace old items 5.4.5.2 and 5.4.5.3 by the following new 5.4.5.2: '5.4.5.2. For vehicles in categories M1 and N1, at the same time, a tractive force of 1 350 p 20 daN shall be  applied to a traction device (see Annex IV, figure 3) attached to the two lower belt anchorages. For vehicles in categories M2 and N2, this test load shall be 675 p 20 daN. For vehicles in categories M3 and N3, this test load shall be 450 p 20 daN.`*oell=Add new  Appendices 1 and 2 to Annex I as follows: Appendix 1MINIMUM NUMBER OF ANCHORAGE POINTS>TABLE>Appendix 2LOCATION OF LOWER  ANCHORAGES, ANGLE REQUIREMENTS ONLY: á (0)Discarding a TABLE >TABLE>- buckle side30 8030 80 45 80 (*)30 80- other than buckle side30 8030 80  30 80 (*)30 80- angle constant50 7030 80 50 70 (*)50 70- bench: 30 8020 80  - buckle side 45 80 (*)20 80  - other than buckle side 30 80 (*)20 80-  adjustable seat with seat back angle <  20°20 8020 80 20 80 (*) 45 80 (*)20 80Rear (outboard  and centre)20 8020 80 30 80 (*)20 80Folding seatN° belt anchorage required. If anchorage is  fitted: see angle requirements Front andRear. (*) ''other than buckle side'` (á 1): 20 80°''buckle side'` (á 2): 45 80°(both: if angle is not  constant: see item 4.4.3.1).'


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31989L0396

Council Directive 89/396/EEC of 14 June 1989 on indications or marks identifying the lot to which a foodstuff belongs

Official Journal L 186 , 30/06/1989 P. 0021 - 0022 Finnish special edition: Chapter 15 Volume 9 P. 0071  Swedish special edition: Chapter 15 Volume 9 P. 0071

COUNCIL DIRECTIVE of 14 June 1989 on indications or marks identifying the lot to which a foodstuff belongs (89/396/EEC) THE COUNCIL OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community, and in particular Article 100a thereof,  Having regard to the proposal from the Commission (1),  In cooperation with the European Parliament (2),  Having regard to the opinion of the Economic and Social Committee (3),  Whereas it is necessary to adopt measures with the aim of progressively establishing the internal market over the period expiring on 31 December 1992; whereas the internal market comprises an area without internal frontiers in which the free movement of  goods, persons, services and capital is ensured;  Whereas trade in foodstuffs occupies a very important place in the internal market;  Whereas indication of the lot to which a foodstuff belongs meets the need for better information on the identity of products; whereas it is therefore a useful source of information when foodstuffs are the subject of dispute or constitute a health hazard  for consumers;  Whereas Council Directive 79/112/EEC of 18 December 1978 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs (4), as last amended by Directive 89/395/EEC (5), contains no provisions on indication of lot identification; whereas some Member States have meanwhile adopted national measures requiring such indication;  Whereas at international level there is now a general obligation to provide a reference to the manufacturing or packaging lot of prepackaged foodstuffs; whereas it is the Community's duty to contribute to the development of international trade;  Whereas it is therefore advisable to adopt rules of a general and horizontal nature in order to establish a common lot identification system;   Whereas the efficiency of this system depends on its application at the various marketing stages; whereas it is nevertheless desirable to exclude certain products and operations in particular those taking place at the start of the distribution network  for agricultural products;  Whereas the concept of a lot implies that several sales units of a foodstuff have almost identical production, manufacture or packaging characteristics; whereas that concept therefore could not apply to bulk products or products which, owing to their  individual specificity or heterogeneous nature, could not be considered as forming a homogeneous batch;  Whereas, in view of the variety of identification methods used, it is up to the trader to determine the lot and to affix the corresponding indication or mark;  Whereas, in order to satisfy the information requirements for which it is intended, this indication must be clearly distinguishable and recognizable as such;  Whereas the date of minimum durability or 'use by' date, may, in conformity with Directive 79/112/EEC, serve as the lot identification, provided it is indicated precisely,  HAS ADOPTED THIS DIRECTIVE:    Article 1 1.  This Directive concerns the indication which allows identification of the lot to which a foodstuff belongs.  2.  For the purposes of this Directive, 'lot' means a batch of sales units of a foodstuff produced, manufactured or packaged under practically the same conditions.  Article 2 1.  A foodstuff may not be marketed unless it is accompanied by an indication as referred to in Article 1 (1).  2.  However, paragraph 1 shall not apply:  (a)  to agricultural products which, on leaving the holding are:  - sold or delivered to temporary storage, preparation or packaging stations,  - transported to producers' organizations, or - collected for immediate integration into an operational preparation or processing system;  (b)  when, at the point of sale to the ultimate consumer, the foodstuffs are not prepackaged, are packaged at the request of the purchaser or are prepackaged for immediate sale;  (c)  to packagings or containers, the largest side of which has an area of less than 10 cm$.  3.  Member States may, until 31 December 1996, refrain from requiring the indication referred to in Article 1 (1) to be mentioned in the case of the glass bottles intended for re-use which are indelibly marked and which therefore bear no label, ring or  collar.  Article 3 The lot shall be determined in each case by the producer, manufacturer or packager of the foodstuff in question, or the first seller established within the Community.  The indication referred to in Article 1 (1) shall be determined and affixed under the responsibility of one or other of those operators. It shall be preceded by the letter 'L' except in cases where it is clearly distinguishable from the other  indications on the label.  Article 4 When the foodstuffs are prepackaged, the indication referred to in Article 1 (1) and, where appropriate, the letter 'L' shall appear on the prepackaging or on a label attached thereto.  When the foodstuffs are not prepackaged, the indication referred to in Article 1 (1) and, where appropriate, the letter 'L' shall appear on the packaging or on the container or, failing that, on the relevant commercial documents.  It shall in all cases appear in such a way as to be easily visible, clearly legible and indelible.  Article 5 When the date of minimum durability or 'use by' date appears on the label, the indication referred to in Article 1 (1) need not appear on the foodstuff, provided that the date consists at least of the uncoded indication of the day and the  month in that order.  Article 6 This Directive shall apply without prejudice to the indications laid down by specific Community provisions.  The Commission shall publish and keep up to date a list of the provisions in question.  Article 7 Member States shall, where necessary, amend their laws, regulations or administrative provisions so as to:  - authorize trade in products complying with this Directive by not later than 20 June 1990,  - prohibit trade in products not complying with this Directive with effect from 20 June 1991, however, trade in products placed on the market or labelled before that date and not conforming with this Directive may continue until stocks run out.  They shall forthwith inform the Commission thereof.  Article 8 This Directive is addressed to the Member States.   Done at Luxembourg, 14 June 1989.  For the Council The President P. SOLBES  (1) OJ No C 310, 20. 11. 1987, p. 2. (2) OJ No C 167, 27. 6. 1988, p. 425, and OJ No C 120, 16. 5. 1989. (3) OJ No C 95, 11. 4. 1988, p. 1. (4) OJ No L 33, 8. 2. 1979, p. 1. (5) See page 17 of this Official Journal.


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32002L0016

Commission Directive 2002/16/EC of 20 February 2002 on the use of certain epoxy derivatives in materials and articles intended to come into contact with foodstuffs (Text with EEA relevance)

Official Journal L 051 , 22/02/2002 P. 0027 - 0031

Commission Directive 2002/16/ECof 20 February 2002on the use of certain epoxy derivatives in materials and articles intended to come into contact with foodstuffs(Text with EEA relevance)THE COMMISSION OF THE EUROPEAN COMMUNITIES,Having regard to the Treaty establishing the European Community,Having regard to Council Directive 89/109/EEC of 21 December 1988 on the approximation of the laws of the Member States relating to materials and articles intended to come into contact with foodstuffs(1), and in particular Article 3 thereof,After consulting the Scientific Committee on Food,Whereas:(1) The use and/or presence of 2,2-bis(4-hydroxyphenyl)propane bis(2,3-epoxypropyl) ether ("BADGE"), bis(hydroxyphenyl)methane bis(2,3-epoxypropyl)ethers ("BFDGE") and novolac glycidyl ethers ("NOGE") in materials and articles intended to come into contact with foodstuffs has led to questions about their safety, mainly when they are used as an additive.(2) Test results have shown significant levels of these substances and certain derivatives thereof in some foodstuffs.(3) The Scientific Committee on Food has given an opinion that the specific migration limit for BADGE and some of its derivatives can be extended for another three years pending the submission of further toxicological data for evaluation.(4) Acceptance of the use and/or presence of BADGE may therefore be provisionally extended.(5) The Scientific Committee on Food has examined the data available on BFDGE, which are very similar to the corresponding data obtained for BADGE.(6) Acceptance of the use and/or presence of BFDGE and some of its derivatives may therefore also be continued pending the submission and evaluation of further toxicological data, under certain conditions.(7) The Scientific Committee on Food has stated that, in the absence of information about the potential exposure and toxicological profile of NOGE components with more than two aromatic rings and their derivatives, it is not in a position to evaluate the safety of use and/or the presence of corresponding products. The Committee is therefore of the opinion that at present, it is not appropriate to use NOGE as an additive in materials and articles intended to come into contact with foodstuffs due to its tendency to migrate in this application.(8) The use and/or presence of NOGE components with more than two aromatic rings and their derivatives in plastic materials and articles, surface coatings and adhesives intended to come into contact with foodstuffs should be regulated through the establishment of a strict limit, which should, in practice, provisionally rule out their use as additives. This provisional limit should apply pending the submission of adequate data for a more complete scientific risk assessment, in accordance with Article 5(7) of the World Trade Organisation Agreement on the Application of Sanitary and Phytosanitary Measures, and the development of adequate methods for the determination of their levels in foodstuffs.(9) The use and/or presence of NOGE and BFDGE as starting substances for the preparation of special coatings used to cover the surfaces of very big containers should provisionally be allowed to continue, pending the submission of further technical data. The large volume/surface area ratio of these containers, their repeated use over their long lifetime which reduces migration, and their contact with foodstuffs at ambient temperature in the majority of the applications suggest that it is not necessary to set a migration limit for NOGE and BFDGE in such containers.(10) Member States which have not yet authorised the use and/or the presence of BADGE and/or BFDGE and/or NOGE in materials and articles intended to come into contact with foodstuffs should be able to maintain their prohibition.(11) The use and/or presence of BADGE, BFDGE and NOGE in plastic materials and articles, surface coatings such as varnishes, lacquers and paints, as well as adhesives, should be regulated at Community level to avoid risks to human health and barriers to the free movement of goods.(12) Errors due to the presence of other chemical substances may occur during analysis. Validated methods of analysis are, therefore, necessary for correct verification of compliance with the restrictions set out in the Directive.(13) A transitional period should be provided for in respect of materials and articles which are brought into contact with foodstuffs before the deadline for implementation of this Directive.(14) This transitional period should also take into account the requirements of Directive 2000/13/EC of the European Parliament and of the Council of 20 March 2000 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs(2), as amended by Commission Directive 2001/101/EC(3).(15) In view of the new technical requirements, Commission Directive 2001/61/EC of 8 August 2001 on the use of certain epoxy derivatives in materials and articles intended to come into contact with foodstuffs(4) should be repealed for reasons of clarity.(16) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Foodstuffs,HAS ADOPTED THIS DIRECTIVE:Article 11. This Directive shall apply to materials and articles which, in the finished product state, are intended to come into contact or are brought into contact with foodstuffs and are intended for that purpose and which are manufactured with or contain one or more of the following substances:(a) 2,2-bis(4-hydroxyphenyl)propane bis(2,3-epoxypropyl) ether (hereinafter "BADGE"), and some of its derivatives;(b) bis(hydroxyphenyl)methane bis(2,3-epoxypropyl)ethers (hereinafter "BFDGE"), and some of their derivatives;(c) other novolac glycidyl ethers (hereinafter "NOGE"), and some of their derivatives.For the purposes of this Directive, "materials and articles" are:(a) materials and articles made of any type of plastics;(b) materials and articles covered by surface coatings;(c) adhesives.2. This Directive shall not apply to containers or storage tanks having a capacity greater than 10000 litres or to pipelines belonging to or connected with them, covered by special coatings called "heavy-duty coatings".Article 2The materials and articles referred to in Article 1(1) shall not release the substances listed in Annex I in a quantity exceeding the limit laid down in that Annex.The use and/or presence of BADGE in the manufacture of those materials and articles may only be continued until 31 December 2004.Article 3The materials and articles referred to in Article 1(1) shall not release the substances listed in Annex II in a quantity which, when added, to the sum of BADGE and its derivatives listed in Annex I, exceeds the limit laid down in Annex II.The use and/or presence of BFDGE in the manufacture of those materials and articles may only be continued until 31 December 2004.Article 4As from 1 March 2003, the quantity of NOGE components with more than two aromatic rings and at least one epoxy group as well as their derivatives containing chlorohydrin functions and having a molecular mass less than 1000 daltons shall not be detectable in the materials and articles referred to in Article 1(1) at the detection limit of 0,2 mg/6 dm2, including analytical tolerance.For the purpose of this Directive, the detection limit specified in the first paragraph should be verified by a validated method of analysis. If such a method does not exist, an analytical method with appropriate performance characteristics may be used, pending the development of a validated method.The use and/or presence of NOGE in the manufacture of those materials and articles may only be continued until 31 December 2004.Article 5The requirements of this Directive shall not apply to materials and articles covered by surface coatings, and adhesives, referred to in points (b) and (c) of the second subparagraph of Article 1(1), which are brought into contact with foodstuffs before 1 March 2003. These materials and articles may continue to be placed on the market provided that the date of filling appears on the materials and articles, taking into account the requirements of Directive 2000/13/EC.Article 6Directive 2001/61/EC is hereby repealed.References to the repealed Directive shall be construed as references to this Directive and be read in accordance with the correlation table set out in Annex III.Article 7Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 28 February 2003 at latest. They shall forthwith inform the Commission thereof.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.Article 8This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Communities.Article 9This Directive is addressed to the Member States.Done at Brussels, 20 February 2002.For the CommissionDavid ByrneMember of the Commission(1) OJ L 40, 11.2.1989, p. 38.(2) OJ L 109, 6.5.2000, p. 29.(3) OJ L 310, 28.11.2001, p. 19.(4) OJ L 215, 9.8.2001, p. 26.ANNEX ISpecific migration limit for BADGE and certain of its derivatives1. The sum of the migration levels of the following substances:(a) BADGE (= 2,2-bis(4-hydroxyphenyl)propane bis(2,3-epoxypropyl) ether;(b) BADGE.H2O;(c) BADGE.HCl;(d) BADGE.2HCl;(e) BADGE.H2O.HClshall not exceed the following limits:- 1 mg/kg in foodstuffs or in food simulants (analytical tolerance excluded), or- 1 mg/6 dm2 in accordance with the cases provided by Article 4 of Commission Directive 90/128/EEC(1).2. The migration testing shall be carried out in accordance to the rules established in Council Directive 82/711/EEC(2), as well as in Directive 90/128/EEC. However in aqueous food simulants, this value should also include BADGE.2H2O unless the material or article is labelled for use in contact only with those foods and/or beverages for which it has been demonstrated that the sum of the migration levels of the five substances listed in paragraph 1(a), (b), (c), (d) and (e) cannot exceed the limits provided in paragraph 1.3. For the purpose of this Directive, the specific migration of the substances listed in paragraph 1(a), (b), (c), (d) and (e) should be determined by a validated method of analysis. If such a method does not exist, an analytical method with appropriate performance characteristics may be used, pending the development of a validated method.(1) OJ L 75, 21.3.1990, p. 19.(2) OJ L 297, 23.10.1982, p. 26.ANNEX IISpecific migration limit for BFDGE and certain of its derivatives1. The sum of the migration levels of the following substances:(a) BFDGE (= bis(hydroxyphenyl)methane bis(2,3-epoxypropyl)ethers);(b) BFDGE.H2O;(c) BFDGE.HCl;(d) BFDGE.2HCl;(e) BFDGE.H2O.HCladded to the sum of those listed in Annex I, shall not exceed the following limits:- 1 mg/kg in foodstuffs or in food simulants (analytical tolerance excluded), or- 1 mg/6 dm2 in accordance with the cases provided by Article 4 of Directive 90/128/EEC.2. The migration testing shall be carried out in accordance to the rules established in Directive 82/711/EEC, as well as in Directive 90/128/EEC. However in aqueous food simulants, this value should also include BFDGE.2H2O unless the material or article is labelled for use in contact only with those foods and/or beverages for which it has been demonstrated that the sum of the migration levels of the five substances listed in paragraph 1(a), (b), (c), (d) and (e), added to those listed in Annex I, cannot exceed the limits provided in paragraph 1.3. For the purpose of this Directive, the specific migration of the substances listed in paragraph 1(a), (b), (c), (d) and (e) should be determined by a validated method of analysis. If such a method does not exist, an analytical method with appropriate performance characteristics may be used, pending the development of a validated method.ANNEX IIICorrelation table>TABLE>


Avis juridique important

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31985L0408

Commission Directive 85/408/EEC of 11 July 1985 adapting to technical progress Council Directive 84/536/EEC on the approximation of the laws of the Member States relating to the permissible sound power level of power generators

Official Journal L 233 , 30/08/1985 P. 0018 - 0019 Spanish special edition: Chapter 15 Volume 6 P. 0080  Portuguese special edition Chapter 15 Volume 6 P. 0080  Finnish special edition: Chapter 15 Volume 7 P. 0057  Swedish special edition: Chapter 15 Volume 7 P. 0057

COMMISSION DIRECTIVEof 11 July  1985adapting to technical progress Council Directive 84/536/EEC on the approximation of the laws  of the Member States relating to the permissible sound power level of power  generators(88/408/EEC)THE COMMISSION OF THE EUROPEAN COMMUNITIES,Having regard to  the Treaty establishing the European Economic Community,Having regard to Council Directive  84/536/EEC of 17 September 1984 on the approximation of the laws of the Member States relating to  the permissible sound power level of power generators (1) and in particular Article 7  thereof,Whereas, in view of experience gained and of the state of the art, it is now necessary to  match the requirements of Annex I of Directive 84/536/EEC to the actual test conditions;Whereas the  measures provided for in this Directive are in accordance with the opinion of the Committee on the  Adaptation to Technical Progress of the Directive on the Determination of the Noise Emission of  Construction Plant and Equipment, HAS ADOPTED THIS DIRECTIVE:Article 1Annex I to Directive 84/536/EEC is hereby  amended in accordance with the Annex to this Directive.Article 2The Member States shall, by 26  March 1986, adopt and publish the provisions required to comply with this Directive and shall  forthwith inform the Commission thereof.Article 3This Directive is addressed to the Member  States.Done at Brussels, 11 July 1985.For the CommissionStanley CLINTON  DAVISMember of the Commission(1) OJ N° L 300, 19. 11. 1984, p. 149.  ANNEXAMENDMENTS TO ANNEX I TO DIRECTIVE 84/536/EEC6.3.Measuring sitePoint 6.3 shall be  reworded as follows:The measuring site must be flat and horizontal. This site, up to and including  the vertical projection of the microphone positions, shall be of concrete or non-porous asphalt.  Skid-mounted power generators shallbe placed on supports 0,40 m high, unless otherwise required by  the manufacturer's conditions of installation.6.4.1.Measuring surface, measuring distancePoint  6.4.1 shall be reworded as follows:The measuring surface to be used for the test shall be a  hemisphere.The radius shall be:4 m, where the greatest dimension of the power generator to be  tested is not more than 1,5 m,10 m, where the greatest dimension of the power generator to be  tested is more than 1,5 m but not more than 4 m,16 m, where the greatest dimension of the power  generator to be tested is more than 4 m.6.4.2.1.GeneralPoint 6.4.2.1 shall be reworded as  follows:For measurements there shall be six measuring points, i.e. points 2, 4, 6, 8, 10 and 12,  arranged as defined in section 6.4.2.2 of Annex I to Directive 79/113/EEC.For testing the power  generator, the geometric centre of the power generator shall be positioned vertically above the  centre of the hemisphere.The x axis of the set of coordinates, in relation to which the positions  of the measuring points are fixed, shall be parallel to the main axis of the power generator.