ANNEX VIII_REFERRED TO IN ARTICLE 8.21

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2011 elv_amendment_annex_II

DIRECTIVESCOMMISSION DIRECTIVE 2011/37/EUof 30 March 2011amending Annex II to Directive 2000/53/EC of the European Parliament and of the Council onend-of-life vehicles(Text with EEA relevance)THE EUROPEAN COMMISSION,Having regard to the Treaty on the Functioning of the EuropeanUnion,Having regard to Directive 2000/53/EC of the European Parliament and of the Council of 18 September 2000 onend-of-life vehicles ( 1 ), and in particular Article 4(2)(b) thereof,Whereas:(1) Directive 2000/53/EC prohibits the use of lead, mercury,cadmium or hexavalent chromium in materials andcomponents of vehicles put on the market after 1 July 2003, other than in cases listed in Annex II to that Directive and under the conditions specified therein. Pursuant to Article 4(2)(b) of Directive 2000/53/EC, Annex II to that Directive should be adapted to scientific and technical progress by the Commission on a regular basis.(2) Annex II to Directive 2000/53/EC lists vehicle materialsand components exempted from the prohibition set outin Article 4(2)(a) thereof. Vehicles put on the market before the expiry date of a given exemption may contain lead, mercury, cadmium or hexavalent chromium in materials and components listed in Annex II to Directive 2000/53/EC.(3) Certain materials and components containing lead,mercury, cadmium or hexavalent chromium shouldcontinue to be exempted from the prohibition set out in Article 4(2)(a) of Directive 2000/53/EC, since the use of such substances in those specific materials and components is still technically or scientifically unavoidable. It is therefore appropriate to prolong the expiry date of those exemptions until the use of the prohibited substances becomes avoidable.(4) The use of lead in automotive thermoelectric materials inapplications reducing CO 2 emissions by recuperation of exhaust heat is currently technically and scientifically unavoidable. Those materials should therefore be temporarily exempted from the prohibition set out in Article 4(2)(a) of Directive 2000/53/EC.(5) Certainmaterials and components containing lead, mercury, cadmium or hexavalent chromium shouldcontinue to be exempted from the prohibition set out in Article 4(2)(a) of Directive 2000/53/EC without an expiry date, since the use of such substances in the specific materials and components listed in Annex II to that Directive is still technically or scientifically unavoidable.(6) AnnexII to Directive 2000/53/EC provides that spare parts put on the market after 1 July 2003 which areused for vehicles put on the market before 1 July 2003 are exempted from the provisions of Article 4(2)(a) of that Directive. The exemption allows for the repair of vehicles put on the market before the entry into force of the prohibition set out in that Article with spare parts meeting the same quality and safety requirements as the parts with which they were originally equipped.(7) Spareparts for vehicles put on the market after 1 July 2003 but before the expiry date of a given exemption of Annex II to Directive 2000/53/EC are not covered by that exemption. Hence, spare parts for those vehicles should be heavy metal free, even if they are used to replace parts which originally contained heavy metals.(8) Incertain cases it is technically impossible to repair vehicles with spare parts other than original ones as this would require changes in dimensional and functional properties of entire vehicle systems. Such spare parts cannot fit into the vehicle systems originally manu factured with parts containing heavy metals and these vehicles cannot be repaired and may need to be prematurely disposed of. Annex II to Directive 2000/53/EC should therefore be amended to enable the repair of such vehicles.( 1 ) OJ L 269, 21.10.2000, p. 34.(9) Directive 2000/53/EC should therefore be amendedaccordingly.(10) The measures provided for in this Directive are inaccordance with the opinion of the Committee established under Article 18(1) of Directive 2006/12/EC ofthe European Parliament and of the Council of 5 April2006 on waste (1),HAS ADOPTED THIS DIRECTIVE:Article 1Annex II to Directive 2000/53/EC is replaced by the text set outin the Annex to this Directive.Article 2Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 31 December 2011 at the latest.Article 3This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union.Article 4This Directive is addressed to the Member States.Done at Brussels, 30 March 2011.For the CommissionThe PresidentJosé Manuel BARROSO(1) OJ L 114, 27.4.2006, p. 9.ANNEX‘ANNEX IIMaterials and components exempt from Article 4(2)(a)Lead as an alloying elementLead and lead compounds in componentsHexavalent chromiumMercuryCadmium( 1) Dismantling if, in correlation with entry 10(a), an average threshold of 60 grams per vehicle is exceeded. For the application of this clause electronic devices not installed by the manufacturer on the production line shall not be taken into account. ( 2 ) This exemption shall be reviewed in 2015. ( 3 ) This exemption shall be reviewed in 2014. ( 4 ) This exemption shall be reviewed before 1 January 2012. ( 5) Dismantling if, in correlation with entries 8(a) to 8(j), an average threshold of 60 grams per vehicle is exceeded. For the application of this clause electronic devices not installed by the manufacturer on the production line shall not be taken into account.Notes:— A maximum concentration value up to 0,1 % by weight and in homogeneous material, for lead, hexavalent chromium and mercury and up to 0,01 % by weight in homogeneous material for cadmium shall be tolerated,— The re-use of parts of vehicles which were already on the market at the date of expiry of an exemption shall be allowed without limitation since it is not covered by Article 4(2)(a),— Spare parts put on the market after 1 July 2003 which are used for vehicles put on the market before 1 July 2003 shall be exempted from the provisions of Article 4(2)(a) (*). motors and brake linings.’。

IEC-61854架空线.隔离层的要求和检验

NORMEINTERNATIONALECEI IEC INTERNATIONALSTANDARD 61854Première éditionFirst edition1998-09Lignes aériennes –Exigences et essais applicables aux entretoisesOverhead lines –Requirements and tests for spacersCommission Electrotechnique InternationaleInternational Electrotechnical Commission Pour prix, voir catalogue en vigueurFor price, see current catalogue© IEC 1998 Droits de reproduction réservés Copyright - all rights reservedAucune partie de cette publication ne peut être reproduite niutilisée sous quelque forme que ce soit et par aucunprocédé, électronique ou mécanique, y compris la photo-copie et les microfilms, sans l'accord écrit de l'éditeur.No part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical,including photocopying and microfilm, without permission in writing from the publisher.International Electrotechnical Commission 3, rue de Varembé Geneva, SwitzerlandTelefax: +41 22 919 0300e-mail: inmail@iec.ch IEC web site http: //www.iec.chCODE PRIX PRICE CODE X– 2 –61854 © CEI:1998SOMMAIREPages AVANT-PROPOS (6)Articles1Domaine d'application (8)2Références normatives (8)3Définitions (12)4Exigences générales (12)4.1Conception (12)4.2Matériaux (14)4.2.1Généralités (14)4.2.2Matériaux non métalliques (14)4.3Masse, dimensions et tolérances (14)4.4Protection contre la corrosion (14)4.5Aspect et finition de fabrication (14)4.6Marquage (14)4.7Consignes d'installation (14)5Assurance de la qualité (16)6Classification des essais (16)6.1Essais de type (16)6.1.1Généralités (16)6.1.2Application (16)6.2Essais sur échantillon (16)6.2.1Généralités (16)6.2.2Application (16)6.2.3Echantillonnage et critères de réception (18)6.3Essais individuels de série (18)6.3.1Généralités (18)6.3.2Application et critères de réception (18)6.4Tableau des essais à effectuer (18)7Méthodes d'essai (22)7.1Contrôle visuel (22)7.2Vérification des dimensions, des matériaux et de la masse (22)7.3Essai de protection contre la corrosion (22)7.3.1Composants revêtus par galvanisation à chaud (autres queles fils d'acier galvanisés toronnés) (22)7.3.2Produits en fer protégés contre la corrosion par des méthodes autresque la galvanisation à chaud (24)7.3.3Fils d'acier galvanisé toronnés (24)7.3.4Corrosion causée par des composants non métalliques (24)7.4Essais non destructifs (24)61854 © IEC:1998– 3 –CONTENTSPage FOREWORD (7)Clause1Scope (9)2Normative references (9)3Definitions (13)4General requirements (13)4.1Design (13)4.2Materials (15)4.2.1General (15)4.2.2Non-metallic materials (15)4.3Mass, dimensions and tolerances (15)4.4Protection against corrosion (15)4.5Manufacturing appearance and finish (15)4.6Marking (15)4.7Installation instructions (15)5Quality assurance (17)6Classification of tests (17)6.1Type tests (17)6.1.1General (17)6.1.2Application (17)6.2Sample tests (17)6.2.1General (17)6.2.2Application (17)6.2.3Sampling and acceptance criteria (19)6.3Routine tests (19)6.3.1General (19)6.3.2Application and acceptance criteria (19)6.4Table of tests to be applied (19)7Test methods (23)7.1Visual examination (23)7.2Verification of dimensions, materials and mass (23)7.3Corrosion protection test (23)7.3.1Hot dip galvanized components (other than stranded galvanizedsteel wires) (23)7.3.2Ferrous components protected from corrosion by methods other thanhot dip galvanizing (25)7.3.3Stranded galvanized steel wires (25)7.3.4Corrosion caused by non-metallic components (25)7.4Non-destructive tests (25)– 4 –61854 © CEI:1998 Articles Pages7.5Essais mécaniques (26)7.5.1Essais de glissement des pinces (26)7.5.1.1Essai de glissement longitudinal (26)7.5.1.2Essai de glissement en torsion (28)7.5.2Essai de boulon fusible (28)7.5.3Essai de serrage des boulons de pince (30)7.5.4Essais de courant de court-circuit simulé et essais de compressionet de traction (30)7.5.4.1Essai de courant de court-circuit simulé (30)7.5.4.2Essai de compression et de traction (32)7.5.5Caractérisation des propriétés élastiques et d'amortissement (32)7.5.6Essais de flexibilité (38)7.5.7Essais de fatigue (38)7.5.7.1Généralités (38)7.5.7.2Oscillation de sous-portée (40)7.5.7.3Vibrations éoliennes (40)7.6Essais de caractérisation des élastomères (42)7.6.1Généralités (42)7.6.2Essais (42)7.6.3Essai de résistance à l'ozone (46)7.7Essais électriques (46)7.7.1Essais d'effet couronne et de tension de perturbations radioélectriques..467.7.2Essai de résistance électrique (46)7.8Vérification du comportement vibratoire du système faisceau/entretoise (48)Annexe A (normative) Informations techniques minimales à convenirentre acheteur et fournisseur (64)Annexe B (informative) Forces de compression dans l'essai de courantde court-circuit simulé (66)Annexe C (informative) Caractérisation des propriétés élastiques et d'amortissementMéthode de détermination de la rigidité et de l'amortissement (70)Annexe D (informative) Contrôle du comportement vibratoire du systèmefaisceau/entretoise (74)Bibliographie (80)Figures (50)Tableau 1 – Essais sur les entretoises (20)Tableau 2 – Essais sur les élastomères (44)61854 © IEC:1998– 5 –Clause Page7.5Mechanical tests (27)7.5.1Clamp slip tests (27)7.5.1.1Longitudinal slip test (27)7.5.1.2Torsional slip test (29)7.5.2Breakaway bolt test (29)7.5.3Clamp bolt tightening test (31)7.5.4Simulated short-circuit current test and compression and tension tests (31)7.5.4.1Simulated short-circuit current test (31)7.5.4.2Compression and tension test (33)7.5.5Characterisation of the elastic and damping properties (33)7.5.6Flexibility tests (39)7.5.7Fatigue tests (39)7.5.7.1General (39)7.5.7.2Subspan oscillation (41)7.5.7.3Aeolian vibration (41)7.6Tests to characterise elastomers (43)7.6.1General (43)7.6.2Tests (43)7.6.3Ozone resistance test (47)7.7Electrical tests (47)7.7.1Corona and radio interference voltage (RIV) tests (47)7.7.2Electrical resistance test (47)7.8Verification of vibration behaviour of the bundle-spacer system (49)Annex A (normative) Minimum technical details to be agreed betweenpurchaser and supplier (65)Annex B (informative) Compressive forces in the simulated short-circuit current test (67)Annex C (informative) Characterisation of the elastic and damping propertiesStiffness-Damping Method (71)Annex D (informative) Verification of vibration behaviour of the bundle/spacer system (75)Bibliography (81)Figures (51)Table 1 – Tests on spacers (21)Table 2 – Tests on elastomers (45)– 6 –61854 © CEI:1998 COMMISSION ÉLECTROTECHNIQUE INTERNATIONALE––––––––––LIGNES AÉRIENNES –EXIGENCES ET ESSAIS APPLICABLES AUX ENTRETOISESAVANT-PROPOS1)La CEI (Commission Electrotechnique Internationale) est une organisation mondiale de normalisation composéede l'ensemble des comités électrotechniques nationaux (Comités nationaux de la CEI). La CEI a pour objet de favoriser la coopération internationale pour toutes les questions de normalisation dans les domaines de l'électricité et de l'électronique. A cet effet, la CEI, entre autres activités, publie des Normes internationales.Leur élaboration est confiée à des comités d'études, aux travaux desquels tout Comité national intéressé par le sujet traité peut participer. Les organisations internationales, gouvernementales et non gouvernementales, en liaison avec la CEI, participent également aux travaux. La CEI collabore étroitement avec l'Organisation Internationale de Normalisation (ISO), selon des conditions fixées par accord entre les deux organisations.2)Les décisions ou accords officiels de la CEI concernant les questions techniques représentent, dans la mesuredu possible un accord international sur les sujets étudiés, étant donné que les Comités nationaux intéressés sont représentés dans chaque comité d’études.3)Les documents produits se présentent sous la forme de recommandations internationales. Ils sont publiéscomme normes, rapports techniques ou guides et agréés comme tels par les Comités nationaux.4)Dans le but d'encourager l'unification internationale, les Comités nationaux de la CEI s'engagent à appliquer defaçon transparente, dans toute la mesure possible, les Normes internationales de la CEI dans leurs normes nationales et régionales. Toute divergence entre la norme de la CEI et la norme nationale ou régionale correspondante doit être indiquée en termes clairs dans cette dernière.5)La CEI n’a fixé aucune procédure concernant le marquage comme indication d’approbation et sa responsabilitén’est pas engagée quand un matériel est déclaré conforme à l’une de ses normes.6) L’attention est attirée sur le fait que certains des éléments de la présente Norme internationale peuvent fairel’objet de droits de propriété intellectuelle ou de droits analogues. La CEI ne saurait être tenue pour responsable de ne pas avoir identifié de tels droits de propriété et de ne pas avoir signalé leur existence.La Norme internationale CEI 61854 a été établie par le comité d'études 11 de la CEI: Lignes aériennes.Le texte de cette norme est issu des documents suivants:FDIS Rapport de vote11/141/FDIS11/143/RVDLe rapport de vote indiqué dans le tableau ci-dessus donne toute information sur le vote ayant abouti à l'approbation de cette norme.L’annexe A fait partie intégrante de cette norme.Les annexes B, C et D sont données uniquement à titre d’information.61854 © IEC:1998– 7 –INTERNATIONAL ELECTROTECHNICAL COMMISSION––––––––––OVERHEAD LINES –REQUIREMENTS AND TESTS FOR SPACERSFOREWORD1)The IEC (International Electrotechnical Commission) is a worldwide organization for standardization comprisingall national electrotechnical committees (IEC National Committees). The object of the IEC is to promote international co-operation on all questions concerning standardization in the electrical and electronic fields. To this end and in addition to other activities, the IEC publishes International Standards. Their preparation is entrusted to technical committees; any IEC National Committee interested in the subject dealt with may participate in this preparatory work. International, governmental and non-governmental organizations liaising with the IEC also participate in this preparation. The IEC collaborates closely with the International Organization for Standardization (ISO) in accordance with conditions determined by agreement between the two organizations.2)The formal decisions or agreements of the IEC on technical matters express, as nearly as possible, aninternational consensus of opinion on the relevant subjects since each technical committee has representation from all interested National Committees.3)The documents produced have the form of recommendations for international use and are published in the formof standards, technical reports or guides and they are accepted by the National Committees in that sense.4)In order to promote international unification, IEC National Committees undertake to apply IEC InternationalStandards transparently to the maximum extent possible in their national and regional standards. Any divergence between the IEC Standard and the corresponding national or regional standard shall be clearly indicated in the latter.5)The IEC provides no marking procedure to indicate its approval and cannot be rendered responsible for anyequipment declared to be in conformity with one of its standards.6) Attention is drawn to the possibility that some of the elements of this International Standard may be the subjectof patent rights. The IEC shall not be held responsible for identifying any or all such patent rights. International Standard IEC 61854 has been prepared by IEC technical committee 11: Overhead lines.The text of this standard is based on the following documents:FDIS Report on voting11/141/FDIS11/143/RVDFull information on the voting for the approval of this standard can be found in the report on voting indicated in the above table.Annex A forms an integral part of this standard.Annexes B, C and D are for information only.– 8 –61854 © CEI:1998LIGNES AÉRIENNES –EXIGENCES ET ESSAIS APPLICABLES AUX ENTRETOISES1 Domaine d'applicationLa présente Norme internationale s'applique aux entretoises destinées aux faisceaux de conducteurs de lignes aériennes. Elle recouvre les entretoises rigides, les entretoises flexibles et les entretoises amortissantes.Elle ne s'applique pas aux espaceurs, aux écarteurs à anneaux et aux entretoises de mise à la terre.NOTE – La présente norme est applicable aux pratiques de conception de lignes et aux entretoises les plus couramment utilisées au moment de sa rédaction. Il peut exister d'autres entretoises auxquelles les essais spécifiques décrits dans la présente norme ne s'appliquent pas.Dans de nombreux cas, les procédures d'essai et les valeurs d'essai sont convenues entre l'acheteur et le fournisseur et sont énoncées dans le contrat d'approvisionnement. L'acheteur est le mieux à même d'évaluer les conditions de service prévues, qu'il convient d'utiliser comme base à la définition de la sévérité des essais.La liste des informations techniques minimales à convenir entre acheteur et fournisseur est fournie en annexe A.2 Références normativesLes documents normatifs suivants contiennent des dispositions qui, par suite de la référence qui y est faite, constituent des dispositions valables pour la présente Norme internationale. Au moment de la publication, les éditions indiquées étaient en vigueur. Tout document normatif est sujet à révision et les parties prenantes aux accords fondés sur la présente Norme internationale sont invitées à rechercher la possibilité d'appliquer les éditions les plus récentes des documents normatifs indiqués ci-après. Les membres de la CEI et de l'ISO possèdent le registre des Normes internationales en vigueur.CEI 60050(466):1990, Vocabulaire Electrotechnique International (VEI) – Chapitre 466: Lignes aériennesCEI 61284:1997, Lignes aériennes – Exigences et essais pour le matériel d'équipementCEI 60888:1987, Fils en acier zingué pour conducteurs câblésISO 34-1:1994, Caoutchouc vulcanisé ou thermoplastique – Détermination de la résistance au déchirement – Partie 1: Eprouvettes pantalon, angulaire et croissantISO 34-2:1996, Caoutchouc vulcanisé ou thermoplastique – Détermination de la résistance au déchirement – Partie 2: Petites éprouvettes (éprouvettes de Delft)ISO 37:1994, Caoutchouc vulcanisé ou thermoplastique – Détermination des caractéristiques de contrainte-déformation en traction61854 © IEC:1998– 9 –OVERHEAD LINES –REQUIREMENTS AND TESTS FOR SPACERS1 ScopeThis International Standard applies to spacers for conductor bundles of overhead lines. It covers rigid spacers, flexible spacers and spacer dampers.It does not apply to interphase spacers, hoop spacers and bonding spacers.NOTE – This standard is written to cover the line design practices and spacers most commonly used at the time of writing. There may be other spacers available for which the specific tests reported in this standard may not be applicable.In many cases, test procedures and test values are left to agreement between purchaser and supplier and are stated in the procurement contract. The purchaser is best able to evaluate the intended service conditions, which should be the basis for establishing the test severity.In annex A, the minimum technical details to be agreed between purchaser and supplier are listed.2 Normative referencesThe following normative documents contain provisions which, through reference in this text, constitute provisions of this International Standard. At the time of publication of this standard, the editions indicated were valid. All normative documents are subject to revision, and parties to agreements based on this International Standard are encouraged to investigate the possibility of applying the most recent editions of the normative documents indicated below. Members of IEC and ISO maintain registers of currently valid International Standards.IEC 60050(466):1990, International Electrotechnical vocabulary (IEV) – Chapter 466: Overhead linesIEC 61284:1997, Overhead lines – Requirements and tests for fittingsIEC 60888:1987, Zinc-coated steel wires for stranded conductorsISO 34-1:1994, Rubber, vulcanized or thermoplastic – Determination of tear strength – Part 1: Trouser, angle and crescent test piecesISO 34-2:1996, Rubber, vulcanized or thermoplastic – Determination of tear strength – Part 2: Small (Delft) test piecesISO 37:1994, Rubber, vulcanized or thermoplastic – Determination of tensile stress-strain properties– 10 –61854 © CEI:1998 ISO 188:1982, Caoutchouc vulcanisé – Essais de résistance au vieillissement accéléré ou à la chaleurISO 812:1991, Caoutchouc vulcanisé – Détermination de la fragilité à basse températureISO 815:1991, Caoutchouc vulcanisé ou thermoplastique – Détermination de la déformation rémanente après compression aux températures ambiantes, élevées ou bassesISO 868:1985, Plastiques et ébonite – Détermination de la dureté par pénétration au moyen d'un duromètre (dureté Shore)ISO 1183:1987, Plastiques – Méthodes pour déterminer la masse volumique et la densitérelative des plastiques non alvéolairesISO 1431-1:1989, Caoutchouc vulcanisé ou thermoplastique – Résistance au craquelage par l'ozone – Partie 1: Essai sous allongement statiqueISO 1461,— Revêtements de galvanisation à chaud sur produits finis ferreux – Spécifications1) ISO 1817:1985, Caoutchouc vulcanisé – Détermination de l'action des liquidesISO 2781:1988, Caoutchouc vulcanisé – Détermination de la masse volumiqueISO 2859-1:1989, Règles d'échantillonnage pour les contrôles par attributs – Partie 1: Plans d'échantillonnage pour les contrôles lot par lot, indexés d'après le niveau de qualité acceptable (NQA)ISO 2859-2:1985, Règles d'échantillonnage pour les contrôles par attributs – Partie 2: Plans d'échantillonnage pour les contrôles de lots isolés, indexés d'après la qualité limite (QL)ISO 2921:1982, Caoutchouc vulcanisé – Détermination des caractéristiques à basse température – Méthode température-retrait (essai TR)ISO 3417:1991, Caoutchouc – Détermination des caractéristiques de vulcanisation à l'aide du rhéomètre à disque oscillantISO 3951:1989, Règles et tables d'échantillonnage pour les contrôles par mesures des pourcentages de non conformesISO 4649:1985, Caoutchouc – Détermination de la résistance à l'abrasion à l'aide d'un dispositif à tambour tournantISO 4662:1986, Caoutchouc – Détermination de la résilience de rebondissement des vulcanisats––––––––––1) A publierThis is a preview - click here to buy the full publication61854 © IEC:1998– 11 –ISO 188:1982, Rubber, vulcanized – Accelerated ageing or heat-resistance testsISO 812:1991, Rubber, vulcanized – Determination of low temperature brittlenessISO 815:1991, Rubber, vulcanized or thermoplastic – Determination of compression set at ambient, elevated or low temperaturesISO 868:1985, Plastics and ebonite – Determination of indentation hardness by means of a durometer (Shore hardness)ISO 1183:1987, Plastics – Methods for determining the density and relative density of non-cellular plasticsISO 1431-1:1989, Rubber, vulcanized or thermoplastic – Resistance to ozone cracking –Part 1: static strain testISO 1461, — Hot dip galvanized coatings on fabricated ferrous products – Specifications1)ISO 1817:1985, Rubber, vulcanized – Determination of the effect of liquidsISO 2781:1988, Rubber, vulcanized – Determination of densityISO 2859-1:1989, Sampling procedures for inspection by attributes – Part 1: Sampling plans indexed by acceptable quality level (AQL) for lot-by-lot inspectionISO 2859-2:1985, Sampling procedures for inspection by attributes – Part 2: Sampling plans indexed by limiting quality level (LQ) for isolated lot inspectionISO 2921:1982, Rubber, vulcanized – Determination of low temperature characteristics –Temperature-retraction procedure (TR test)ISO 3417:1991, Rubber – Measurement of vulcanization characteristics with the oscillating disc curemeterISO 3951:1989, Sampling procedures and charts for inspection by variables for percent nonconformingISO 4649:1985, Rubber – Determination of abrasion resistance using a rotating cylindrical drum deviceISO 4662:1986, Rubber – Determination of rebound resilience of vulcanizates–––––––––1) To be published.。

Annex B

BS EN 1041:2008EN 1041:2008 (E)Annex B 附件B(informative)Guidance on alternative labelling for instructions for use (IFU)选择性商标使用指导指南Directives 93/42/EEC and 90/385/EEC foresee the possibility that, in the light of technicalprogress, the information laid down in Annex I, Section 13.1 of the Directive 93/42/EEC andAnnex I, Section 15 of the Directive 90/385/EEC may be provided by alternative means in thefuture. In such circumstances, approval is necessary as described in the regulatory procedurereferred to in Article 7(2a) of the Directive 93/42/EEC or Article 9 (10) of the Directive90/385/EEC.指示预见，根据技术过程，附件1的信息，指示93/42/EEC和附件1的13.1部分，指示90/385/EEC的15部分，未来可能由选择性方法提供。

在此情况下，如调整程序中涉及指示93/42/EEC条款2和指示90/385/EEC条款9中的正式批准是必要的，If alternative labelling is approved, manufacturers should consider the following:如果选择性商标获批，厂商必须考虑以下内容：The information provided with a medical device is intended to permit the device to be usedsafely and for the purposes intended by the manufacturer. This information comprises thedetails on the label and the data in the instructions for use (IFU). When appropriate for aparticular device, e.g., for professional users, the IFU can be provided by alternative means.Examples of ways of delivering alternative labelling include, but are not limited to, physicalelectronic media such as CD/DVD-ROMs packaged with the device, "help" systems providedwith the device, and information delivered over the Internet.医疗器械的信息旨在允许设备安全使用以及为了厂商的目的。

List of Amendments Annex XVII -

REACHREACH RestrictionsREACH foresees a restriction process to regulate the manufacture, placing on the market or use of certain substances, either on their own or in mixtures or articles, within the EU territory if they pose an unacceptable risk to health or the environment. Such activities may be limited or even banned, if necessary. The restriction is designed to manage risks that are not addressed by the other REACH processes or by other Union legislation.From 1 June 2009, Annex XVII of the REACH Regulation replaced Directive 76/769/EEC on the approximation of the laws, regulations and administrative provisions of the Member States, relating to restrictions on the marketing and use of certain dangerous substances and mixtures.Regulations amending Annex XVII of REACHCommission Regulation (EU) 2021/2204 of 13 December 2021 amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), as regards carcinogenic, mutagenic or reproductive toxicant (CMR) substancesCommission Regulation (EU) 2021/2030 of 19 November 2021 amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regardsN,N-dimethylformamideCommission Regulation (EU) 2021/1297 of 4 August 2021 amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council as regards perfluorocarboxylic acids containing 9 to 14 carbon atoms in the chain (C9-C14 PFCAs), their salts and C9-C14 PFCA-related substancesCorrigendum to Commission Regulation (EU) 2021/1297 of 4 August 2021 amending AnnexXVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council asregards perfluorocarboxylic acids containing 9 to 14 carbon atoms in the chain (C9-C14PFCAs), their salts and C9-C14 PFCA-related substances (Official Journal of the EuropeanUnion L 282 of 5 August 2021)Corrigendum: In Latvian language version only, OJ L 89, page 11, 17.03.2022Commission Regulation (EU) 2021/1199 of 20 July 2021 amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council as regards polycyclic-aromatic hydrocarbons (PAHs) in granules or mulches used as infill material in synthetic turf pitches or in loose form on playgrounds or in sport applicationsCommission Regulation (EU) 2021/57 of 25 January 2021 amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards lead in gunshot in or around wetlandsREACHCommission Regulation (EU) 2020/2096 of 15 December 2020 amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), as regards carcinogenic, mutagenic or reproductive toxicant (CMR) substances, devices covered by Regulation (EU) 2017/745 of the European Parliament and of the Council, persistent organic pollutants, certain liquid substances or mixtures, nonylphenol and testing methods for azocolourants (Text with EEA relevance)Commission Regulation (EU) 2020/2081 of 14 December 2020 amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards substances in tattoo inks or permanent make-up (Text with EEA relevance)Commission Regulation (EU) 2020/1149 of 3 August 2020 amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards diisocyanates (Text with EEA relevance)Regulation (EU) 2019/1148 of the European Parliament and of the Council of 20 June 2019 on the marketing and use of explosives precursors, amending Regulation (EC) No 1907/2006 and repealing Regulation (EU) No 98/2013Commission Regulation (EU) 2019/957 of 11 June 2019 amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards (3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl) silanetriol and TDFAs (Text with EEA relevance.) Commission Regulation (EU) 2018/2005 of 17 December 2018 amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regardsbis(2-ethylhexyl) phthalate (DEHP), dibutyl phthalate (DBP), benzyl butyl phthalate (BBP) and diisobutyl phthalate (DIBP) (Text with EEA relevance.)Commission Regulation (EU) 2018/1513 of 10 October 2018 amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards certain substances classified as carcinogenic, mutagenic or toxic for reproduction (CMR), category 1A or 1B (Text with EEA relevance)Commission Regulation (EU) 2018/675 of 2 May 2018 amending the Appendices to Annex XVII to Regulation EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards CMR substances (Text with EEA relevance)Commission Regulation (EU) 2018/589 of 18 April 2018 amending Annex XVII to Regulation EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards methanol (Text with EEA relevance)Corrigendum to Commission Regulation (EU) 2018/589 of 18 April 2018 amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerningthe Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards methanolREACHCommission Regulation (EU) 2018/588 of 18 April 2018 amending Annex XVII to Regulation EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards 1-methyl-2-pyrrolidone (Text with EEA relevance)Commission Regulation (EU) 2018/35 of 10 January 2018 amending Annex XVII to Regulation EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards octamethylcyclotetrasiloxane ('D4') and decamethylcyclopentasiloxane ('D5') (Text with EEA relevance)Commission Regulation (EU) 2017/1510 of 30 August 2017 amending the Appendices to Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards CMR substances (Text with EEA relevance)Commission Regulation (EU) 2017/1000 of 13 June 2017 amending Annex XVII to Regulation EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards perfluorooctanoic acid (PFOA), its salts and PFOA-related substanceCommission Regulation (EU)2017/227 of 9 February 2017 amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regardsbis(pentabromophenyl)ether –Link to Eur-LexCorrigendum to Commission Regulation (EU) 2017/227 of 9 February 2017 amending AnnexXVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Councilconcerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards bis(pentabromophenyl)etherCommission Regulation (EU) 2016/2235of 12 December 2016 amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards bisphenol A –Link to Eur-LexCommission Regulation (EU) 2016/1017ED of 23 June 2016 amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards inorganic ammonium saltsCommission Regulation (EU) 2016/1005ED of 22 June 2016 amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards asbestos fibres (chrysotile)Commission Regulation (EU) 2016/217 ED of 16 February 2016 amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards cadmium.REACHCommission Regulation (EU) 2016/26of 13 January 2016 amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards nonylphenol ethoxylates.Commission Regulation (EU) 2015/1494 of 4 September 2015 amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards benzene.Commission Regulation (EU) 2015/628of 22 April 2015 amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Regist ration, Evaluation, Authorisation and Restriction of Chemicals (‘REACH’) as regards lead and its compounds.Commission Regulation (EU) 2015/326of 2 March 2015 amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards polycyclic aromatic hydrocarbons and phthalates.Commission Regulation (EU) No 474/2014 of 8 May 2014 amending Annex XVII toRegulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (‘REACH’) as regards 1,4-dichlorobenzene.Commission Regulation (EU) No 317/2014 of 27 March 2014 amending Regulation(EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards Annex XVII (CMR substances).Commission Regulation (EU) No 301/2014 of 25 March 2014 amending Annex XVII toRegulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards chromium VI compounds.Commission Regulation (EU) No 1272/2013of 6 December 2013 amending Annex XVII to Regulation (EC) No1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards polycyclic aromatic hydrocarbons. Corrigendum: In German language version only, OJ L 109, page 49, 12.4.2014Commission Regulation (EU) No 126/2013of 13 February 2013 amending Annex XVII to Regulation (EC) No1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). This Regulation corrects several entries in the Annex XVII to REACH in terms of terminology and recent update of CEN methods.Commission Regulation (EU) No 848/2012of 19 September 2012 amending Annex XVII to Regulation (EC) No1907/2006 of the European Parliament and of the Council on the Registration, Evaluation,REACHAuthorisation and Restriction of Chemicals (REACH) as regards phenylmercury compounds, prohibits the manufacture, placing on the market and use of 5 phenylmercury compounds as well as placing on the market of articles containing any of those substances at a concentration level of 0.01% or more.Commission Regulation (EU) No 847/2012of 19 September 2012 amending Annex XVII to Regulation (EC) No1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards mercury, extends the scope of entry 18a to mercury measuring devices used in industrial and professional applications.Commission Regulation (EU) No 836/2012of 18 September 2012 amending Annex XVII to Regulation (EC) No1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards lead, prohibits the placing on the market and the use of lead in jewellery articles at a concentration level of 0.05% or above.Commission Regulation (EU) No 835/2012of 18 September 2012 amending Regulation (EC) No 1907/2006 ofthe European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards Annex XVII (Cadmium), in particular the use in a list of plastic materials.Commission Regulation (EU) No 412/2012of 15 May 2012 amending Annex XVII to Regulation (EC) No1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) in order to prohibit the use of dimethylfumarate (DMF) in articles or parts thereof, in concentrations greater than 0.1 mg/kg, as well as the placing on the market of articles or parts thereof containing DMF in concentrations greater than 0.1 mg/kg. It makes permanent an existing temporary prohibition adopted under Directive 2001/95/EC on general product safety.Commission Regulation (EU) No 109/2012of 9 February 2012 amending Regulation (EC) No 1907/2006 of theEuropean Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards Annex XVII (CMR substances) amended Annex XVII of REACH in order to include a number of newly classified CMR substances in Appendices 1 to 6 so that they are aligned to the entries concerning CMR substances in Regulation (EC) No 790/2009 amending Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures.Commission Regulation (EU) No 494/2011of 20 May 2011 amending Regulation (EC) No 1907/2006 of theEuropean Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards Annex XVII (Cadmium), and, related Corrigendum OJ L 136/105of 24 May 2011. More on RestrictionsREACHCommission Regulation (EU) No 366/2011of 14 April 2011 amending Regulation (EC) No 1907/2006 of theEuropean Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards Annex XVII (Acrylamide). More on RestrictionsCommission Regulation (EU) No 207/2011adopted on 2 March 2011 deleted Entry 44 concerningpentabromodiphenyl ether and Entry 53 concerning PFOS from Annex XVII as these substances are now regulated under Regulation (EC) No 2004/850 on Persistent organic pollutants as amended by Commission Regulation (EU) No 757/2010of 24 August 2010.Commission Regulation (EU) 276/2010adopted on 31 March 2010 amended Annex XVII of REACH in order toinclude the last restrictions adopted in 2009 under Directive 76/769/EEC that is to say the modification of the restrictions concerning lamp oils and grill lighter fluids (entry 3) and organostannic compounds (entry 20) and the new restriction concerning dichloromethane (entry 59).Commission Regulation (EC) No 552/2009of 22 June 2009 amending Regulation (EC) No 1907/2006 of theEuropean Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards Annex XVII.。

2010-26-EU-欧盟新排放指令

DIRECTIVESCOMMISSION DIRECTIVE 2010/26/EUof 31 March 2010amending Directive 97/68/EC of the European Parliament and of the Council on the approximation of the laws of the Member States relating to measures against the emission of gaseous and particulate pollutants from internal combustion engines to be installed in non-road mobile machinery(Text with EEA relevance)THE EUROPEAN COMMISSION, Having regard to the Treaty on the Functioning of the European Union,Having regard to Directive 97/68/EC of 16 December 1997 of the European Parliament and of the Council on the approxi mation of the laws of the Member States relating to measures against the emission of gaseous and particulate pollutants from internal combustion engines to be installed in non-road mobile machinery ( 1 ), and in particular Articles 14 and 14a thereof, Whereas:(1) Article 14a of Directive 97/68/EC sets out the criteria and the procedure for extending the period referred to in Article 9a(7) of that Directive. Studies carried out in accordance with Article 14a of Directive 97/68/EC show that there are substantial technical difficulties to comply with stage II requirements for professional use, multi- positional, hand-held mobile machinery in which engines of classes SH:2 and SH:3 are installed. It is therefore necessary to extend the period referred to in Article 9a(7) until 31 July 2013. (2) Since the amendment of Directive 97/68/EC in 2004, technical progress has been made in the design of diesel engines with a view to make them compliant with the exhaust emission limits for stages IIIB and IV. Electronically controlled engines, largely replacing me- chanically controlled fuel injection and control systems, have been developed. Therefore, the current general type- approval requirements in Annex I to Directive 97/68/EC should be adapted accordingly and general type-approval requirements for stages IIIB and IV should be introduced. (3) Annex II to Directive 97/68/EC specifies the technical details of the information documents that need to be submitted by the manufacturer to the type-approval authority with the application for engine type-approval. The details specified regarding the additional anti- pollution devices are generic and should be adapted to the specific after-treatment systems that need to be used to ensure that engines comply with exhaust emission limit stages IIIB and IV. More detailed information on the after-treatment devices installed on the engines should be submitted to enable type-approval authorities to assess the engine’s capability to comply with stages IIIB and IV.(4) Annex III to Directive 97/68/EC sets out the methodtesting the engines and determining their level of emissions of gaseous and particulate pollutants. The type-approval testing procedure of engines to demon strate compliance with the exhaust emission limits of stage IIIB and IV should ensure that the simultaneous compliance with the gaseous (carbon monoxide, hydro carbons, oxides of nitrogen) and the particulate emission limits is demonstrated. The non-road steady cycle (NRSC) and non-road transient cycle (NRTC) should be adapted accordingly. (5) Point 1.3.2 of Annex III to Directive 97/68/EC foreseesthe modification of the symbols (section 2.18 of Annex I), the test sequence (Annex III) and calculation equations (Appendix III to Annex III), prior to the introduction of the cold/hot composite test sequence. The type approval procedure to demonstrate compliance with the exhaust emission limits of stage IIIB and IV requires the intro duction of a detailed description of the cold start cycle. (6) Section 3.7.1 of Annex III to Directive 97/68/EC sets out the test cycle for the different equipment specifications. The test cycle under point 3.7.1.1 (specification A) needs to be adapted to clarify which engine speed needs to be used in the type approval calculation method. It is also necessary to adapt the reference to the updated version of the international testing standard ISO 8178-4:2007.( 1 ) OJ L 59, 27.2.1998, p. 1.(7) Section 4.5 of Annex III to Directive 97/68/EC outlines the emissions test run. This section needs to be adapted to take account of the cold start cycle. (8) Appendix 3 of Annex III to Directive 97/68/EC sets out the criteria for the data evaluation and calculation of the gaseous emissions and the particulate emissions, for both the NRSC test and the NRTC test set out in Annex III. The type approval of engines in accordance with stage IIIB and IV requires the adaptation of the calculation method for the NRTC test. (9) Annex XIII to Directive 97/68/EC sets out the provisions for engines placed on the market under a ‘flexible scheme’. To ensure a smooth implementation of stage IIIB, an increased use of this flexibility scheme may be needed. Therefore, the adaptation to technical progress to enable the introduction of stage IIIB compliant engines needs to be accompanied by measures to avoid that the use of the flexibility scheme may be hampered by notifi cation requirements which are no longer adapted to the introduction of such engines. The measures should aim at simplifying the notification requirements and the reporting obligations, and at making them more focused and tailored to the need for market surveillance authorities to respond to the increased use of the flexi bility scheme that will result from the introduction of stage IIIB. (10) Since Directive 97/68/EC provides for the type-approval of stage IIIB engines (category L) as from 1 January 2010 it is necessary to provide for the possibility to grant type approval from that date. (11) For reasons of legal certainty this Directive should enter into force as a matter of urgency. (12) The measures provided for in this Directive are in accordance with the opinion of the Committee estab lished in Article 15(1) of Directive 97/68/EC, HAS ADOPTED THIS DIRECTIVE: Article 1 Amendments to Directive 97/68/EC Directive 97/68/EC is amended as follows: 1. in Article 9a(7), the following subparagraph is added: ‘Notwithstanding the first subparagraph, an extension of the derogation period is granted until 31 July 2013, within the category of top handle machines, for professional use, multi- positional, hand-held hedge trimmers and top handle tree service chainsaws in which engines of classes SH:2 and SH:3 are installed.’;2. Annex I is amended in accordance with Annex I to this Directive;3. Annex II is amended in accordance with Annex II to this Directive;4. Annex III is amended in accordance with Annex III to this Directive;5. Annex V is amended in accordance to Annex IV to this Directive;6. Annex XIII is amended in accordance with Annex V to this Directive.Article 2Transitional provisionWith effect from the day following the publication of this Directive in the Official Journal, Member States may grant type-approval in respect of electronically controlled engines which comply with the requirements laid down in Annexes I, II, III, V and XIII to Directive 97/68/EC, as amended by this Directive.Article 3Transposition1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with the Directive within 12 months after the publication of the Directive. They shall forthwith communicate to the Commission the text of those provisions.They shall apply those provisions from 31 March 2011.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 4Entry into forceThis Directive shall enter into force on the day following its publication in the Official Journal of the European Union .Article 5AddresseesThis Directive is addressed to the Member States. Done at Brussels, 31 March 2010. For the Commission The President José Manuel BARROSOANNEX IThe following section 8 is added to Annex I to Directive 97/68/EC:IIIBIVSTAGESANDFOR‘8. TYPEAPPROVALREQUIREMENTS8.1. This section shall apply to the type-approval of electronically controlled engines, which uses electronic control todetermine both the quantity and timing of injecting fuel (hereafter “engine”). This section shall apply irrespective of the technology applied to such engines to comply with the emission limit values set out in sections 4.1.2.5 and 4.1.2.6 of this Annex.8.2. DefinitionsFor the purpose of this section, the following definitions shall apply:8.2.1. “emission control strategy” means a combination of an emission control system with one base emission controlstrategy and with one set of auxiliary emission control strategies, incorporated into the overall design of an engine or non-road mobile machinery into which the engine is installed.8.2.2. “reagent” means any consumable or non-recoverable medium required and used for the effective operation of theexhaust after-treatment system.8.3. Generalrequirements8.3.1. Requirements for base emission control strategy8.3.1.1. The base emission control strategy, activated throughout the speed and torque operating range of the engine,shall be designed as to enable the engine to comply with the provisions of this Directive8.3.1.2. Any base emission control strategy that can distinguish engine operation between a standardised type approvaltest and other operating conditions and subsequently reduce the level of emission control when not operating under conditions substantially included in the type approval procedure is prohibited.8.3.2. Requirements for auxiliary emission control strategy8.3.2.1. An auxiliary emission control strategy may be used by an engine or a non-road mobile machine, provided thatthe auxiliary emission control strategy, when activated, modifies the base emission control strategy in response toa specific set of ambient and/or operating conditions but does not permanently reduce the effectiveness of theemission control system:(a) where the auxiliary emission control strategy is activated during the type approval test, sections 8.3.2.2 and8.3.2.3 shall not apply;(b) where the auxiliary emission control strategy is not activated during the type approval test, it must bedemonstrated that the auxiliary emission control strategy is active only for as long as required for thepurposes identified in section 8.3.2.3.8.3.2.2. The control conditions applicable to this section are all of the following:(a) an altitude not exceeding 1 000 metres (or equivalent atmospheric pressure of 90 kPa);(b) an ambient temperature within the range 275 K to 303 K (2 °C to 30 °C);(c) the engine coolant temperature above 343 K (70 °C).Where the auxiliary emission control strategy is activated when the engine is operating within the control conditions set out in points (a), (b) and (c), the strategy shall only be activated exceptionally.8.3.2.3. An auxiliary emission control strategy may be activated in particular for the following purposes:(a) by onboard signals, for protecting the engine (including air-handling device protection) and/or non-roadmobile machine into which the engine is installed from damage;(b) for operational safety and strategies;(c) for prevention of excessive emissions, during cold start or warming-up, during shut-down;(d) if used to trade-off the control of one regulated pollutant under specific ambient or operating conditions, formaintaining control of all other regulated pollutants, within the emission limit values that are appropriate forthe engine concerned. The purpose is to compensate for naturally occurring phenomena in a manner thatprovides acceptable control of all emission constituents.8.3.2.4. The manufacturer shall demonstrate to the technical service at the time of the type-approval test that theoperation of any auxiliary emission strategy complies with the provisions of section 8.3.2. The demonstration shall consist of an evaluation of the documentation referred to in section 8.3.3.8.3.2.5. Any operation of an auxiliary emission control strategy not compliant with section 8.3.2 is prohibited.8.3.3. Documentation requirements8.3.3.1. The manufacturer shall provide an information folder accompanying the application for type-approval at thetime of submission to the technical service, which ensures access to any element of design and emission control strategy and the means by which the auxiliary strategy directly or indirectly controls the output variables. The information folder shall be made available in two parts:(a) the documentation package, annexed to the application for type-approval, shall include a full overview of theemission control strategy. Evidence shall be provided that all outputs permitted by a matrix, obtained fromthe range of control of the individual unit inputs, have been identified. This evidence shall be attached to theinformation folder as referred to in Annex II;(b) the additional material, presented to the technical service but not annexed to the application for type-approval, shall include all the modified parameters by any auxiliary emission control strategy and theboundary conditions under which this strategy operates and in particular:(i) a description of the control logic and of timing strategies and switch points, during all modes ofoperation for the fuel and other essential systems, resulting in effective emissions control (such asexhaust gas recirculation system (EGR) or reagent dosing);(ii) a justification for the use of any auxiliary emission control strategy applied to the engine, accompanied by material and test data, demonstrating the effect on exhaust emissions. This justification may be basedon test data, sound engineering analysis, or a combination of both;(iii) a detailed description of algorithms or sensors (where applicable) used for identifying, analysing, or diagnosing incorrect operation of the NO x control system;(iv) the tolerance used to satisfy the requirements in section 8.4.7.2, regardless of the used means.8.3.3.2. The additional material referred to in point (b) of section 8.3.3.1 shall be treated as strictly confidential. It shallbe made available to the type-approval authority on request. The type-approval authority shall treat this material as confidential.ofoperationNO x control measures8.4. Requirementstoensurecorrect8.4.1. The manufacturer shall provide information that fully describes the functional operational characteristics of theNO x control measures using the documents set out in section 2 of Appendix 1 to Annex II and in section 2 of Appendix 3 to Annex II.8.4.2. If the emission control system requires a reagent, the characteristics of that reagent, including the type of reagent,information on concentration when the reagent is in solution, operational temperature conditions and reference to international standards for composition and quality must be specified by the manufacturer, in section 2.2.1.13 of Appendix 1 and in section 2.2.1.13 of Appendix 3 to Annex II.8.4.3. The engine emission control strategy shall be operational under all environmental conditions regularly pertainingin the territory of the Community, especially at low ambient temperatures.8.4.4. The manufacturer shall demonstrate that the emission of ammonia during the applicable emission test cycle ofthe type approval procedure, when a reagent is used, does not exceed a mean value of 25 ppm.8.4.5. If separate reagent containers are installed on or connected to a non-road mobile machine, means for taking asample of the reagent inside the containers must be included. The sampling point must be easily accessible without requiring the use of any specialised tool or device.8.4.6. Use and maintenance requirements8.4.6.1. The type approval shall be made conditional, in accordance with Article 4(3), upon providing to each operator ofnon-road mobile machinery written instructions comprising the following:(a) detailed warnings, explaining possible malfunctions generated by incorrect operation, use or maintenance ofthe installed engine, accompanied by respective rectification measures;(b) detailed warnings on the incorrect use of the machine resulting in possible malfunctions of the engine,accompanied by respective rectification measures;(c) information on the correct use of the reagent, accompanied by an instruction on refilling the reagentbetween normal maintenance intervals;(d) a clear warning, that the type-approval certificate, issued for the type of engine concerned, is valid only whenall of the following conditions are met:(i) the engine is operated, used and maintained in accordance with the instructions provided;(ii) prompt action has been taken for rectifying incorrect operation, use or maintenance in accordance with the rectification measures indicated by the warnings referred to in point (a) and (b);(iii) no deliberate misuse of the engine has taken place, in particular deactivating or not maintaining an EGR or reagent dosing system.The instructions shall be written in a clear and non-technical manner using the same language as is used in the operator’s manual on non-road mobile machinery or engine.8.4.7. Reagent control (where applicable)8.4.7.1. The type approval shall be made conditional, in accordance with the provisions of section 3 of Article 4, uponproviding indicators or other appropriate means, according to the configuration of the non-road mobile machinery, informing the operator on:(a) the amount of reagent remaining in the reagent storage container and by an additional specific signal, whenthe remaining reagent is less than 10 % of the full container’s capacity;(b) when the reagent container becomes empty, or almost empty;(c) when the reagent in the storage tank does not comply with the characteristics declared and recorded insection 2.2.1.13 of Appendix 1 and section 2.2.1.13 of Appendix 3 to Annex II, according to the installedmeans of assessment.(d) when the dosing activity of the reagent is interrupted, in cases other than those executed by the engine ECUor the dosing controller, reacting to engine operating conditions where the dosing is not required, providedthat these operating conditions are made available to the type approval authority.8.4.7.2. By the choice of the manufacturer the requirements of reagent compliance with the declared characteristics andthe associated NO x emission tolerance shall be satisfied by one of the following means:(a) direct means, such as the use of a reagent quality sensor.(b) indirect means, such as the use of a NO x sensor in the exhaust to evaluate reagent effectiveness.(c) any other means, provided that its efficacy is at least equal to the one resulting by the use of the means ofpoints (a) or (b) and the main requirements of this section are maintained.’ANNEX IIAnnex II to Directive 97/68/EC is amended as follows:1. Section 2 of Appendix 1 is replaced by the following:POLLUTIONAIRAGAINSTTAKEN‘2. MEASURESyes/no(*)............................................................................................................gases:recyclingcrankcase2.1. Deviceforcoverednotbyheading)ifanother(ifanti-pollutiondevices2.2. Additionalandany,(*)yes/noconverter:2.2.1. Catalytic.......................................................................................................................................................................................2.2.1.1. Make(s):........................................................................................................................................................................................2.2.1.2. Type(s):converterselements................................................................................................................andcatalytic2.2.1.3. Numberofconverter(s):...............................................................................................thecatalyticofandvolume2.2.1.4. Dimensions-........................................................................................................................................................action:ofcatalytic2.2.1.5. Typeprecious........................................................................................................................................metals:of2.2.1.6. Totalchargeconcentration:...........................................................................................................................................................2.2.1.7. Relative.....................................................................................................................................material):and2.2.1.8. Substrate(structure...............................................................................................................................................................................2.2.1.9. Celldensity:2.2.1.10. Type of casing for the catalytic converter(s): .................................................................................................................2.2.1.11. Location of the catalytic converter(s) (place(s) and maximum/minimum distance(s) from engine): ............2.2.1.12. Normal operating range (K): ................................................................................................................................................2.2.1.13. Consumable reagent (where appropriate): .......................................................................................................................2.2.1.13.1. Type and concentration of reagent needed for catalytic action: .............................................................................2.2.1.13.2. Normal operational temperature range of reagent: ......................................................................................................2.2.1.13.3. International standard (where appropriate): ....................................................................................................................2.2.1.14. NO x sensor: yes/no (*)(*)yes/nosensor:2.2.2. Oxygen.......................................................................................................................................................................................2.2.2.1. Make(s):............................................................................................................................................................................................2.2.2.2. Type:.....................................................................................................................................................................................2.2.2.3. Location:(*)yes/noinjection:2.2.3. Airetc.):.........................................................................................................................................pump,2.2.3.1. Type(pulseair,air(*)yes/no2.2.4. EGR:etc.):pressure,........................................................................2.2.4.1. Characteristicspressure/low(cooled/uncooled,high(*)yes/no2.2.5. Particulatetrap:particulate.........................................................................................................thetrap:capacityof2.2.5.1. Dimensionsandparticulatetrap:.........................................................................................................................theandof2.2.5.2. Typedesignengine):..................................................................fromdistance(s)2.2.5.3. Locationand(place(s)maximum/minimumdescriptionand/ordrawing:regeneration,............................................................................ofor2.2.5.4. Methodsystempressure(kPa)and..................................................................................range:2.2.5.5. Normal(K)operatingtemperature(*)yes/nosystems:2.2.6. Otheroperation:...................................................................................................................................................and2.2.6.1. Description___________(*) Strike out what does not apply.’2. Section 2 of Appendix 3 is replaced by the following:POLLUTIONAGAINSTAIRTAKEN‘2. MEASURESyes/no(*)............................................................................................................gases:crankcase2.1. Deviceforrecyclingcoverednotbyheading)ifanotherany,anti-pollutiondevices(ifand2.2. Additional(*)yes/noconverter:2.2.1. Catalytic.......................................................................................................................................................................................2.2.1.1. Make(s):........................................................................................................................................................................................2.2.1.2. Type(s):and................................................................................................................converterselementscatalyticof2.2.1.3. Numberconverter(s):...............................................................................................thecatalyticofandvolume2.2.1.4. Dimensions-........................................................................................................................................................action:ofcatalytic2.2.1.5. Typeprecious........................................................................................................................................metals:of2.2.1.6. Totalchargeconcentration:...........................................................................................................................................................2.2.1.7. Relative.....................................................................................................................................material):and2.2.1.8. Substrate(structure...............................................................................................................................................................................2.2.1.9. Celldensity:2.2.1.10. Type of casing for the catalytic converter(s): .................................................................................................................2.2.1.11. Location of the catalytic converter(s) (place(s) and maximum/minimum distance(s) from engine): ............2.2.1.12. Normal operating range (K) .................................................................................................................................................2.2.1.13. Consumable reagent (where appropriate): .......................................................................................................................2.2.1.13.1. Type and concentration of reagent needed for catalytic action: .............................................................................2.2.1.13.2. Normal operational temperature range of reagent: ......................................................................................................2.2.1.13.3. International standard (where appropriate): ....................................................................................................................2.2.1.14. NO x sensor: yes/no (*)yes/no(*)sensor:2.2.2. Oxygen.......................................................................................................................................................................................2.2.2.1. Make(s):............................................................................................................................................................................................2.2.2.2. Type:.....................................................................................................................................................................................2.2.2.3. Location:(*)yes/noinjection:2.2.3. Airetc.):.........................................................................................................................................pump,2.2.3.1. Type(pulseair,air(*)yes/no2.2.4. EGR:etc.):pressure,........................................................................2.2.4.1. Characteristicspressure/low(cooled/uncooled,high(*)yes/no2.2.5. Particulatetrap:particulate.........................................................................................................thetrap:capacityof2.2.5.1. Dimensionsandparticulatetrap:.........................................................................................................................theandof2.2.5.2. Typedesignengine):..................................................................fromdistance(s)2.2.5.3. Locationand(place(s)maximum/minimumdescriptionand/ordrawing:regeneration,............................................................................ofor2.2.5.4. Methodsystempressure(kPa)and..................................................................................range:2.2.5.5. Normal(K)operatingtemperature(*)yes/nosystems:2.2.6. Otheroperation:...................................................................................................................................................and2.2.6.1. Description___________(*) Strike out what does not apply.’。

EN 2002-61-EC AZO

DIRECTIVE2002/61/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCILof19July2002amending for the nineteenth time Council Directive76/769/EEC relating to restrictions on the marketing and use of certain dangerous substances and preparations(azocolourants)THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,Having regard to the Treaty establishing the European Commu-nity,and in particular Article95thereof,Having regard to the proposals from the Commission(1),Having regard to the opinion of the Economic and Social Committee(2),Acting in accordance with the procedure laid down in Article 251of the Treaty(3),Whereas:(1)Work on the internal market should gradually improvethe quality of life,health protection and consumer safety.The measures provided for in this Directive ensure ahigh level of health and consumer protection.(2)Textile and leather articles containing certain azodyeshave the capacity to release certain arylamines,whichmay pose cancer risks.(3)Limitations already adopted or planned by certainMember States on the use of azodyed textile and leatherarticles concern the completion and functioning of theinternal market.It is therefore necessary to approximatethe laws of the Member States in this field and,conse-quently,to amend Annex I to Council Directive76/769/EEC of27July1976on the approximation of the laws,regulations and administrative provisions of the MemberStates relating to restrictions on the marketing and useof certain dangerous substances and preparations(4).(4)The Scientific Committee on Toxicity,Ecotoxicity andthe Environment(CSTEE),after being consulted by theCommission,has confirmed that cancer risks posed bytextile and leather goods coloured by certain azodyes,give cause for concern.(5)In order to protect human health,the use of dangerousazodyes and the placing on the market of some articlescoloured with such dyes should be prohibited.(6)For textile articles made of recycled fibres,a maximumconcentration of70ppm for the amines listed in point43in the appendix to Directive76/769/EEC should beapplied.This should be the case for a transitional perioduntil1January2005if the amines are released by theresidues deriving from the previous dyeing of the samefibres.This will allow for the recycling of textiles,whichhas overall benefits for the environment.(7)Harmonised testing methods are necessary for the appli-cation of this Directive.The Commission,in accordancewith Article2a of Directive76/769/EEC,should establishsuch methods.The testing methods should preferably bedeveloped at European level,if appropriate by theEuropean Committee for Standardisation(CEN).(8)In the light of new scientific knowledge,testing methodsshould be reviewed,including testing methods foranalysing4-amino azobenzene.(9)In the light of new scientific knowledge,the provisionson certain azocolourants should be reviewed,in parti-cular with regard to the need to include other materialsnot covered by this Directive,as well as other aromaticamines.Special attention should be paid to possible risksto children.(10)This Directive applies without prejudice to Communitylegislation laying down minimum requirements for theprotection of workers contained in Council Directive89/391/EEC(5)and in individual directives based thereon,inparticular Council Directive90/394/EEC(6)and Directive98/24/EC of the European Parliament and of theCouncil(7),HAVE ADOPTED THIS DIRECTIVE:Article1Annex I to Directive76/769/EEC is hereby amended as set out in the Annex to this Directive.Article2Testing methods for the application of point43of Annex I to Directive76/769/EEC shall be adopted by the Commission in accordance with the procedure laid down in Article2a of that Directive.1p.67andOJ C96E,27.3.2001,p.269.(2)OJ C204,18.7.2000,p.90.(3)Opinion of the European Parliament of7September2000(OJ C135,7.5.2001,p.257),Council Common Position of18February2002(OJ C119E,22.5.2002,p.7)and Decision of the European Parliament of11June2002(not yet published in the Official Journal).(4)OJ L262,27.9.1976,p.201.Directive as last amended by Commis-sion Directive2001/91/EC(OJ L286,30.10.2001,p.27).(5)OJ L183,29.6.1989,p.1.(6)OJ L196,26.7.1990,p.1.Directive as last amended by Directive1999/38/EC(OJ L138,1.6.1999,p.66).(7)OJ L131,5.5.1998,p.11.Article31.Member States shall adopt and publish,not later than11September2003,the laws,regulations and administrative provisions necessary to comply with this Directive.They shall forthwith inform the Commis-sion thereof.They shall apply these provisions from11September2003.2.When Member States adopt these measures,they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication.The methods of making such reference shall be laid down by Member States.Article4This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities.Article5This Directive is addressed to the Member States.Done at Brussels,19July2002.For the European ParliamentThe PresidentP.COX For the council The President T.PEDERSENANNEXAnnex I to Directive76/769/EEC is amended as follows:1.The following point shall be added:‘43.Azocolourants 1.Azodyes which,by reductive cleavage of one or more azo groups,may release one ormore of the aromatic amines listed in the Appendix,in detectable concentrations,i.e.above30ppm in the finished articles or in the dyed parts thereof,according to thetesting method established in accordance with Article2a of this Directive,may not beused in textile and leather articles which may come into direct and prolonged contactwith the human skin or oral cavity,such as:—clothing,bedding,towels,hairpieces,wigs,hats,nappies and other sanitary items,sleeping bags,—footwear,gloves,wristwatch straps,handbags,purses/wallets,briefcases,chaircovers,purses worn round the neck,—textile or leather toys and toys which include textile or leather garments,—yarn and fabrics intended for use by the final consumer.2.Furthermore,the textile and leather Articles referred to in point1above may not beplaced on the market unless they conform to the requirements set out in that point.By way of derogation,until1January2005,this provision shall not apply to textilearticles made of recycled fibres if the amines are released by residues deriving fromprevious dyeing of the same fibres and if the listed amines are released in concentra-tions below70ppm.3.Not later than11September2005,the Commission shall,in the light of new scientificknowledge,review the provisions on azocolourants.’2.The following point shall be added to the Appendix:‘Point43—AzocolourantsList of aromatic aminesCAS number Index number EC number Substances 192-67-1612-072-00-6202-177-1biphenyl-4-ylamine4-aminobiphenylxenylamine292-87-5612-042-00-2202-199-1benzidine395-69-2202-441-64-chloro-o-toluidine491-59-8612-022-00-3202-080-42-naphthylamine597-56-3611-006-00-3202-591-2o-aminoazotoluene4-amino-2',3-dimethylazobenzene4-o-tolylazo-o-toluidine 699-55-8202-765-85-nitro-o-toluidine7106-47-8612-137-00-9203-401-04-chloroaniline8615-05-4210-406-14-methoxy-m-phenylenediamine 9101-77-9612-051-00-1202-974-44,4'-methylenedianiline4,4'-diaminodiphenylmethaneCAS number Index number EC number Substances1091-94-1612-068-00-4202-109-03,3'-dichlorobenzidine3,3'-dichlorobiphenyl-4,4'-ylenedia-mine11119-90-4612-036-00-X204-355-43,3'-dimethoxybenzidine o-dianisi-dine12119-93-7612-041-00-7204-358-03,3'-dimethylbenzidine4,4'-bi-o-toluidine13838-88-0612-085-00-7212-658-84,4'-methylenedi-o-toluidine14120-71-8204-419-16-methoxy-m-toluidine p-cresidine 15101-14-4612-078-00-9202-918-94,4'-methylene-bis-(2-chloro-aniline)2,2'-dichloro-4,4'-methylene-dianiline 16101-80-4202-977-04,4'-oxydianiline17139-65-1205-370-94,4'-thiodianiline1895-53-4612-091-00-X202-429-0o-toluidine2-aminotoluene1995-80-7612-099-00-3202-453-14-methyl-m-phenylenediamine 20137-17-7205-282-02,4,5-trimethylaniline2190-04-0612-035-00-4201-963-1o-anisidine2-methoxyaniline2260-09-3611-008-00-4200-453-64-amino azobenzene’。

附录翻译

目錄LIST OF ANNEXES附錄一物質評估和化學安全報告準備總則ANNEX I GENERAL PROVISIONS FOR ASSESSING SUBSTANCES AND PREPARING CHEMICAL SAFETY REPORTS附錄二安全資料表(SDS)編寫指南ANNEX II GUIDE TO THE COMPILATION OF SAFETY DATA SHEETS附錄三總量 1 到 10 噸的物質註冊標準ANNEX III CRITERIA FOR SUBSTANCES REGISTERED IN QUANTITIES BETWEEN 1 AND 10TONNES.附錄四依據條款第2條第7項a款豁免註冊義務之物質ANNEX IV EXEMPTIONS FROM THE OBLIGATION TO REGISTER IN ACCORDANCE WITH ARTICLE2(7)(a)附錄五依據條款第2條第7項b款豁免註冊義務之物質ANNEX V EXEMPTIONS FROM THE OBLIGATION TO REGISTER IN ACCORDANCE WITH ARTICLE2(7)(b)附錄六第 10 條條款規定必須提交的資訊ANNEX VI INFORMATION REQUIREMENTS REFERRED TO IN ARTICLE 10附錄七製造或進口1公噸(含)以上物質之標準資訊要求ANNEX VII STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED OR IMPORTED IN QUANTITIES OF ONE TONNE OR MORE附錄八每年製造或進口量為10公噸(含)以上之物質之標準資訊要求1ANNEX VIII STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED ORIMPORTED IN QUANTITIES OF 10 TONNES OR MORE附錄九每年製造和進口量為100公噸(含)以上之物質之標準資訊要求ANNEX IX STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCESMANUFACTURED ORIMPORTED IN QUANTITIES OF 100 TONNES OR MORE附錄十每年製造和進口量為 1000 公噸(含)以上之物質之標準資訊要求ANNEX X STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED ORIMPORTED IN QUANTITIES OF 1 000 TONNES OR MORE附錄十一附錄七到附錄十內所定標準檢驗規範修訂之規定ANNEX XI GENERAL RULES FOR ADAPTATION OF THE STANDARD TESTING REGIME SET OUT IN ANNEXES VII TO X.附錄十二下游使用者評估物質和準備化學安全性報告總則ANNEX XII GENERAL PROVISIONS FOR DOWNSTREAM USERS TO ASSESS SUBSTANCES AND PREPARE CHEMICAL SAFETY REPORTS.附錄十三持久性、生物蓄積性及毒性物質，和高持久性及高生物蓄積性之物質判定標準ANNEX XIII CRITERIA FOR THE IDENTIFICATION OF PERSISTENT, BIOACCUMULATIVE AND TOXIC SUBSTANCES, AND VERY PERSISTENT AND VERY BIOACCUMULATIVE SUBSTANCES.附錄十四授權物質主題清單ANNEX XIV LIST OF SUBSTANCES SUBJECT TO AUTHORISATION(尚未有資料，歐盟將於2009.6.1前訂出建議案)附錄十五檔案ANNEX XV DOSSIERS附錄十六社會經濟分析ANNEX XVI SOCIO-ECONOMIC ANALYSIS附錄十七危險物質、混合物與成品產製與置於市場之限制ANNEX XVII RESTRICTIONS ON THE MANUFACTURE, PLACING ON THE MARKET AND USE OF CERTAIN DANGEROUS SUBSTANCES, PREPARATIONS AND ARTICLES附錄一物質評估和化學安全報告準備總則0. 前言0.1. 本附錄旨在規範製造商和進口商如何評估並紀錄衍生於其製造、輸入物質之風險已受到妥善管制，以及供應鏈下游其他的使用人亦可妥善管制其風險。

Annex 7

Annex 7i2010D IGITAL L IBRARIES C OPYRIGHT S UBGROUP’S R ECOMMENCED K EY P RINCIPLES FOR R IGHTS C LEARANCE C ENTRES AND D ATABASES FOR O UT-OF-P RINT W ORKS PREFACEThe European Commission has made digital libraries a key aspect of i2010 as expressed inter alia in its Communication i2010: Digital Libraries of 30 September 2005. The Commission’s Recommen-dation of 24 August, approved by the Council in November 2006 focuses on digital preservation, orphan works and out-of-print works. Text-based, visual, musical and audiovisual materials include works which the pertinent rightholder (author or publisher/producer) may no longer wish to comer-cialise. Digitisation and online accessibility to such works could be facilitated.A High Level Expert Group (HLG) was appointed to advise the Commission on implementation issues regarding the European Digital Libraries initiative. To develop solutions on key copyright is-sues, the HLG established a Copyright Subgroup which worked out a set of High Level Principles1 that were endorsed by the HLG at its meeting 17 October, 2006.As a part of the solution on copyright issues, the Copyright Subgroup recommended rights clear-ance centres and dedicated databases concerning information on out-of-print works taking into ac-count that any mechanism intended to facilitate the European Digital Libraries (EDL) should in principle be established or promoted on a voluntary basis. The High Level Principles are fundamen-tal for the establishment of Rights Clearance Centres (RCC) and Databases (DB) in relation to the i2010 European Digital Libraries.Moreover, co-ordination should take place among the various initiatives at national levels and across the European Union, to avoid unnecessary duplication among different initiatives. National RCCs could act as portals and centralised access points for the clearance of rights and be accessible across borders, supported by DBs and registries. Interlinking national databases would establish a European centralised access point and a European wide solution. It should take account of the vari-ety of existing and future information resources available. Aiming to facilitate the digitisation and making available out-of-print works the Copyright Subgroup developed a Model Licence. It was endorsed by the HLG at its meeting 18 April, 2007 and is available on the European Commission’s web page2.OUT-OF-PRINT WORKS - RIGHTS AND PROCEDURESThere are various reasons why a work is declared to be no longer commercially available/out of print3. Preamble G of the out-of-print works Model Licence2 recognises that the rightholder may at his/her sole discretion decides whether a work is to be considered in or out of print. At the time of a request by a cultural institution to digitise a work in copyright it may already have been declared by the right holder as being no longer commercially available and “out-of-print”, or it may be declared as such as a consequence of the request.Rights in an out-of-print work depend on the legislation as well as contractual arrangements between the creator and publisher/producer. The legislation of some countries decides that the rights to works which are no longer commercialised or in print revert to the author of the work. Rights may also re-vert to the author by contract, sometimes depending on the number of copies available or other conditions. Often also publishers/producers hold rights in an out of print/commerce works.1 Report on Digital Preservation, Orphan works and Out-of-Print works. Selected Implementation Issues, page 2/32 http://ec.europa.eu/information_society/newsroom/cf/itemlongdetail.cfm?item_id=33663 For audiovisual works « out of commerce », see e.g. Commission Recommendation of 24 August 2006 on the digitisation, and online accessibility of cultural material and digital preservation, Whereas 10 and Recommendation 6bA work that is declared by the rightholder to be out of print/no longer commercially available may already exist in (an) electronic format(s)4. Where this is not the case, the rightholder may wish to digitise the work her/himself. Moreover, the rightholder may also wish to authorise directly her/himself the digitisation and/or making available of the out-of-print/commerce work and adminis-ter all or some rights in such works directly her/himself or through (an) agent(s). Rightholders or the agent(s) may also on a voluntary basis choose to co-operate in the establishing of a centralised clear-ance centre and/or make use of an already established one, e.g. a Reproduction Rights Organisation (RRO) for the licensing of the digitisation, making available or the accessing of a work that has been declared as being no longer commercially available/out-of-print.HIGH LEVEL PURPOSE OF RIGHTS CLEARANCE CENTRES AND DATABASESThe main purpose of Rights Clearance Centres (RCCs) and the Databases (DBs) for out-of-print works is to create nationally convenient, albeit not compulsory centralised access points for the clearance of rights to digitise and make available works that the pertinent rightholders have declared to be no longer commercialised/out of print. These instruments would facilitate the realisation of the European Commission i2010 Digital Libraries initiative. They are therefore intended for use by rightholders and cultural institution for the clearance of rights in respect of such works and represent a part of the out-of-print work solution proposed by the Copyright Subgroup endorsed by the HLG as an alternative to individual licensing directly by rightholders,. When a mandate has been granted by the rightholder to the RCC, this may imply that it is authorised to license the digitisation and/or making available of the out-of-print work or to redirect the request to the rightholder.The RCCs and DBs represent a combined solution that shall:1.enable cultural institutions such as libraries, archives and museums to conduct an online searchin order to discover whethera.the work has been declared out-of-print and is already registered as available digitally, e.g.from another library which has already sought and obtained permission to digitise the workb.the work has been declared out-of-print and no permission has been granted to make itavailable online2. enable cultural institutions such as libraries, archives and museums to proceed from discovery of digitisation status toa.seek permission to digitise the work, either directly from the rightholder(s) or through theprocedures established by the centralised Rights Clearance Centre (RCC).b.digitise the work subject to the relevant terms and conditions established, and, when applica-ble, subsequently make the digitisation accessible to its users on the conditions established in the licensing agreement; orc.seek access to a work that has been digitised and made available digitally from anothersource, e.g. another national or foreign library, archive or museum, or another authorised userDEFINITIONSDatabase means a network of databases (libraries; publishers; industry sources; Reproduction Rights Organisations (RROs); other authorities (both national and international)) of metadata accessed via national portals.Rights Clearance Centre (RCC) means a nationally established centralised access point to a network of clearance centres made up of that of the RCC and those of individual authors or publishers and their representatives such as RROs4 In the case of an electronic version the rightholder may decide to offer it on demand or declare not to commercialise it.Metadata is a relationship that someone claims to exist between two entities, one of which is the referent. (Definition used by Indecs)GOVERNING PRINCIPLES OF THE DATABASES AND RIGHTS CLEARANCE CENTRES FOR OUT-OF-PRINT WORKSFor rightholders the governing principles are:- Respect for copyright and related rights, including moral rights of creators and perform-ers of copyrighted works;- Digitisation and use within the premises of libraries should take place with rightholders’ consent or be based on statutory exception;- Online availability should take place with rightholders’ consent;- Rightholders’ consent means in principle rights clearance, which should be based on individual or collective licensing or a combination thereof.For libraries, archives and museums the governing principles are:- Respect for copyright and related rights, including moral rights of creators and perform-ers of copyrighted works;- Legal certainty in their activities;- Making works available to their users, which means access either within the premises of libraries, archives and museums or online availability;- Digitisation of copyright works requires getting permissions to digitise and access the work.R IGHTS C LEARANCE C ENTRE (RCC).K EY P RINCIPLES1.PolicyThe RCC shall be based on voluntary participation by the rightholdersThe use of the RCC shall be voluntary by cultural institutionsRights clearance can be carried out directly from the RCC or as a redirection to the rightholder’s own database or other sources authorised by the rightholder to license the digitisation and/or making available of the work, depending on the mandate from the rightholder to the RCC.2.The MandateSubject to the mandate from the rightholder, the RCC licenses the digitisation, making available and use of a work on the principle of a voluntary mandateThe rightholder shall be at liberty to register metadata on the work with a RCC and, if so, with one or more RCCs3.LicensingThe RCC shall establish a request handling policy which shall includei.Direct licensing including a register of works which the RCC has been authorised to li-cenceii.Redirecting to individual rightholdersiii.Redirecting to rightholder representatives including Collective Management Organisations (CMOs)iv. a list of works for which the RCC has been authorised to redirectThe Licensing policies and criteria shall be worked out in co-operation with the pertinent rightholder associations and the collective management organisations in the relevant fields The RCC shall establish and publicise its licensing policy and criteria, including the policy for using the RCC outside its national territoryThe licensing policy must enable cultural institutions to apply for a licence to digitise and make available an out-of-print work.4.Licensing ConditionsSubject to national legislation, the RCC shall allow rightholders to establish licensing condi-tions individuallyThe RCC shall establish a set of default conditions which shall apply in the absence of condi-tions set by the rightholderThe default licences shall include stipulations on the moral rights to be observedThe default licence shall include the terms on the monitoring and enforcement of the licence conditionsThe default conditions for out-of-print works shall be based on the Model Licence for out-of-print works developed by the Copyright Subgroup of the i2010 Digital Libraries initiative.5.RemunerationThe RCC pays out to the rightholder all such fees it collects on his/her behalf through such channels as are agreedThe RCC will ensure shortest possible period from collection to distribution of remuneration to rightholders6.InteroperabilityThe RCC shall work out and publicise its policy on integration with individual rights clearance mechanismsThe RCC shall establish and publicise a policy on interlinking with other RCCs outside its bor-ders7.TransparencyThe RCC will define and publicise “relevant information” to participating rightholders, cul-tural institions and other potential licenseesWhat is “relevant information” shall be worked out in co-operation with the pertinent national rightholder associations and the CMOs in the relevant sectors consulting also representatives from the cultural institutions, and include administrative costsThe RCC shall ensure that “relevant information” is easy accessible to participating righthold-ers and cultural institutionsThe RCC shall keep and make publicly available a register of works on which metadata is available for out-of-print worksD ATA B ASES (DB).K EY P RINCIPLES1.PolicyThe DB shall contain metadata on out-of-print works, not the content/work itselfThe DB owner may at its sole discretion establish its policy for collecting, storing and making available metadata in the DBThe DB owner shall publicise its criteria foro linking to other national DBs on metadatao storing and/or linking to metadata DBs on out-of-print works outside its national territoriesDuplication of existing databases/catalogues shall be avoided as far as possible2.DatabaseThe DB shall include metadata, and only metadata on worksThe DB shall enable the storage of metadata on works on the basis of different types of contractual arrangementsSubject to the principles established in this document, especially at 5, the DB owner shall at its own discretion establish technical and other standards as well as the policy for the use of the DB, taking into account that it must facilitate interoperability with other databasesThe principles for building, including the structuring of the DB, shall start from existing DBs (both private and public)The DB must allow redirection to other relevant DBs both in- and outside its territoryThe DB shall include the registration of all data relevant to the Model licence on out-of-print works as devised by the i2010 Digital Libraries Copyright subgroup3.MetadataThe DB shall apply a definition of metadata and their values as devised by the Copyright Sub-group in the context of the i2010 Digital Libraries initiativeAs a minimum the DB shall include metadata describing:worksrightsmanifestation of worksmeta-metadata (who is declaring what, and when)The DB owner shall establish and publicisecriteria for quality controlcriteria for enriching and updating of metadatacriteria for accessing metadata4.StandardsThe DB shall use existing standards.The DB shall contribute to the further development of existing international standards rather than looking for own proprietary solutionsStandards are required forIdentification of works, manifestation of works, parties, and possibly rights, i.e. ISO TC-46, SC-9 for content (in text based: ISBN, ISSN, ISTC, ISAN, ISMN, DOI, ISNI are directly relevant)Metadata and metadata interoperability modelsMessaging and accessing metadataStandards are referred to:Content (at work and at manifestation of work (publication) level)Rights and right termsPartiesThe metadata standards will likely be based on the ONIX family of standards5.InteroperabilityThe DB owner shall make such information available on the structure etc. that is necessary to ensure interoperability with other DBs for out-of-print worksThe DB must provide a register for out-of-prints for which permission has been granted26 November, 2007- END of Documents -。

IMO Circular 207(81)

ANNEX 7RESOLUTION MSC.207(81)(adopted on 18 May 2006)ADOPTION OF AMENDMENTS TO THEINTERNATIONAL LIFE-SAVING APPLIANCE (LSA) CODETHE MARITIME SAFETY COMMITTEE,RECALLING Article 28(b) of the Convention on the International Maritime Organization concerning the functions of the Committee,NOTING resolution MSC.48(66), by which it adopted the International Life-Saving Appliance Code (hereinafter referred to as “the LSA Code”), which has become mandatory under chapter III of the International Convention for the Safety of Life at Sea, 1974 (hereinafter referred to as “the Convention”),NOTING ALSO article VIII(b) and regulation III/3.10 of the Convention concerning the procedure for amending the LSA Code,HAVING CONSIDERED, at its eighty-first session, amendments to the LSA Code, proposed and circulated in accordance with article VIII(b)(i) of the Convention,1. ADOPTS, in accordance with article VIII(b)(iv) of the Convention, amendments to the LSA Code, the text of which is set out in the Annex to the present resolution;2. DETERMINES, in accordance with article VIII(b)(vi)(2)(bb) of the Convention, that the amendments shall be deemed to have been accepted on 1 January 2010, unless, prior to that date, more than one third of the Contracting Governments to the Convention or Contracting Governments the combined merchant fleets of which constitute not less than 50% of the gross tonnage of the world’s merchant fleet, have notified their objections to the amendments;3. INVITES Contracting Governments to note that, in accordance with article VIII(b)(vii)(2) of the Convention, the amendments shall enter into force on 1 July 2010 upon their acceptance in accordance with paragraph 2 above;4. REQUESTS the Secretary-General, in conformity with article VIII(b)(v) of the Convention, to transmit certified copies of the present resolution and the text of the amendments contained in the Annex to all Contracting Governments to the Convention;5. FURTHER REQUESTS the Secretary-General to transmit copies of this resolution and its Annex to Members of the Organization, which are not Contracting Governments to the Convention.ANNEXAMENDMENTS TOTHE INTERNATIONAL LIFE-SAVING APPLIANCE (LSA) CODECHAPTER IGENERAL1 The existing subparagraph .2 of paragraph 1.2.2 is replaced by the following:“.2 not be damaged in stowage throughout the air temperature range -30°C to +65°C and, in the case of personal life-saving appliances, unless otherwise specified,remain operational throughout the air temperature range -15°C to +40°C;”2 The existing subparagraph .6 of paragraph 1.2.2 is replaced by the following:“.6 be of international or vivid reddish orange, or a comparably highly visible colour on all parts where this will assist detection at sea;”CHAPTER IIPERSONAL LIFE-SAVING APPLIANCES3 The words “sufficient to operate the quick-release arrangement” in paragraph 2.1.1.7 are replaced by the words “of not less than4 kg”.4 In paragraph 2.1.3, the word “and” is moved from the end of subparagraph .4 to the end of subparagraph .5, and the following new subparagraph .6 is added:“.6 be provided with a quick-release arrangement that will automatically release and activate the signal and associated self-igniting light connected to a lifebuoy havinga mass of not more than 4 kg.”5 The existing section 2.2 is replaced by the following:“2.2 Lifejackets2.2.1 General requirements for lifejackets2.2.1.1 A lifejacket shall not sustain burning or continue melting after being totallyenveloped in a fire for a period of 2 s.2.2.1.2Lifejackets shall be provided in three sizes in accordance with table 2.1. If alifejacket fully complies with the requirements of two adjacent size ranges, it may be marked with both size ranges, but the specified ranges shall not be divided. Lifejackets shall be marked by either weight or height, or by both weight and height, according to table 2.1.Table 2.1 – Lifejacket sizing criteriaLifejacket marking Infant Child Adult User’s size:Weight (kg) Height (cm) less than 15less than 10015 or more butless than 43100 or more butless than 15543 or more155 or more2.2.1.3 If an adult lifejacket is not designed to fit persons weighing up to 140 kg and witha chest girth of up to 1,750 mm, suitable accessories shall be available to allow it to besecured to such persons.2.2.1.4The in-water performance of a lifejacket shall be evaluated by comparison to theperformance of a suitable size standard reference lifejacket, i.e. reference test device (RTD) complying with the recommendations of the Organization.*2.2.1.5 An adult lifejacket shall be so constructed that:.1 at least 75% of persons who are completely unfamiliar with the lifejacket can correctly don it within a period of 1 min without assistance, guidanceor prior demonstration;.2 after demonstration, all persons can correctly don it within a period of 1 min without assistance;.3 it is clearly capable of being worn in only one way or inside-out and, if donned incorrectly, it is not injurious to the wearer;.4 the method of securing the lifejacket to the wearer has quick and positive means of closure that do not require tying of knots;.5 it is comfortable to wear; and.6 it allows the wearer to jump into the water from a height of at least 4.5 m while holding on to the lifejacket, and from a height of at least 1m witharms held overhead, without injury and without dislodging or damagingthe lifejacket or its attachments.2.2.1.6When tested according to the recommendations of the Organization on atleast 12 persons, adult lifejackets shall have sufficient buoyancy and stability in calm fresh water to:*Refer to the Revised Recommendation on testing of life-saving appliances (resolution MSC.81(70)), as amended..1 lift the mouth of exhausted or unconscious persons by an average height of not less than the average provided by the adult RTD;.2 turn the body of unconscious, face-down persons in the water to a position where the mouth is clear of the water in an average time not exceeding thatof the RTD, with the number of persons not turned by the lifejacket nogreater than that of the RTD;.3 incline the body backwards from the vertical position for an average torso angle of not less than that of the RTD minus 5°;.4 lift the head above horizontal for an average faceplane angle of not less than that of the RTD minus 5°; and.5 return the wearer to a stable face-up position after being destabilized when floating in the flexed foetal position.*2.2.1.7An adult lifejacket shall allow the person wearing it to swim a short distance andto board a survival craft.2.2.1.8An infant or child lifejacket shall perform the same as an adult lifejacket exceptas follows:.1 donning assistance is permitted for small children and infants;.2 the appropriate child or infant RTD shall be used in place of the adult RTD; and.3 assistance may be given to board a survival craft, but wearer mobility shall not be reduced to any greater extent than by the appropriate size RTD.2.2.1.9With the exception of freeboard and self-righting performance, the requirementsfor infant lifejackets may be relaxed, if necessary, in order to:.1 facilitate the rescue of the infant by a caretaker;.2 allow the infant to be fastened to a caretaker and contribute to keeping the infant close to the caretaker;.3 keep the infant dry, with free respiratory passages;.4 protect the infant against bumps and jolts during evacuation; and.5 allow a caretaker to monitor and control heat loss by the infant.2.2.1.10In addition to the markings required by paragraph 1.2.2.9, an infant or childlifejacket shall be marked with:* Refer to the illustration on page 11 of the IMO Pocket Guide to Cold Water Survival and to the Revised Recommendation on testing of life-saving appliances (resolution MSC.81(70)), as amended..1 the size range in accordance with paragraph 2.2.1.2; and.2 an “infant” or “child” symbol as shown in the “infant’s lifejacket” or “child’s lifejacket” symbol adopted by the Organization.*2.2.1.11A lifejacket shall have buoyancy which is not reduced by more than 5% after24 h submersion in fresh water.2.2.1.12The buoyancy of a lifejacket shall not depend on the use of loose granulatedmaterials.2.2.1.13Each lifejacket shall be provided with means of securing a lifejacket light asspecified in paragraph 2.2.3 such that it shall be capable of complying with paragraphs 2.2.1.5.6 and 2.2.3.1.3.2.2.1.14 Each lifejacket shall be fitted with a whistle firmly secured by a lanyard.2.2.1.15Lifejacket lights and whistles shall be selected and secured to the lifejacket insuch a way that their performance in combination is not degraded.2.2.1.16A lifejacket shall be provided with a releasable buoyant line or other means tosecure it to a lifejacket worn by another person in the water.2.2.1.17 A lifejacket shall be provided with a suitable means to allow a rescuer to lift thewearer from the water into a survival craft or rescue boat.2.2.2 Inflatable lifejacketsA lifejacket which depends on inflation for buoyancy shall have not less than twoseparate compartments, shall comply with the requirements of paragraph 2.2.1 and shall: .1 inflate automatically upon immersion, be provided with a device to permit inflation by a single manual motion and be capable of having eachchamber inflated by mouth;.2 in the event of loss of buoyancy in any one compartment be capable of complying with the requirements of paragraphs 2.2.1.5, 2.2.1.6 and2.2.1.7; and.3 comply with the requirements of paragraph 2.2.1.11 after inflation by means of the automatic mechanism.* Refer to Symbols related to life-saving appliances and arrangements, adopted by the Organization by resolution A.760(18), as amended.2.2.3Lifejacket lights2.2.3.1 Each lifejacket light shall:.1 have a luminous intensity of not less than 0.75 cd in all directions of the upper hemisphere;.2 have a source of energy capable of providing a luminous intensity of 0.75 cd for a period of at least 8 h;.3 be visible over as great a segment of the upper hemisphere as is practicable when attached to a lifejacket; and.4 be of white colour.2.2.3.2If the light referred to in paragraph 2.2.3.1 is a flashing light, it shall, in addition:.1 be provided with a manually operated switch; and.2 flash at a rate of not less than 50 flashes and not more than 70 flashes per minute with an effective luminous intensity of at least 0.75 cd.”6 The word “The” in the beginning of paragraph 2.3.1.1 is replaced by the word “An”.7 The existing subparagraph .1 of paragraph 2.3.1.1 is replaced by the following:“.1 it can be unpacked and donned without assistance within 2 min, taking into account donning of any associated clothing*, donning of a lifejacket if theimmersion suit must be worn in conjunction with a lifejacket to meet therequirements of paragraph 2.3.1.2, and inflation of orally inflatable chambers iffitted;”8 The existing subparagraph .3 of paragraph 2.3.1.1 is replaced by the following:“.3 it will cover the whole body with the exception of the face, except that covering for the hands may be provided by separate gloves which shall be permanentlyattached to the suit;”9 The existing paragraph 2.3.1.2 is replaced by the following:“2.3.1.2 An immersion suit on its own, or worn in conjunction with a lifejacket if necessary, shall have sufficient buoyancy and stability in calm fresh water to:.1 lift the mouth of an exhausted or unconscious person clear of the water by not less than 120 mm; and*Refer to paragraph 3.1.3 of the Recommendation on testing of life-saving appliances, adopted by the Maritime Safety Committee of the Organization by resolution MSC.81(70), as amended..2 allow the wearer to turn from a face-down to a face-up position in not more than 5 s.”10 In paragraph 2.3.1.3.3, the words “or its attachments,” are inserted between the words “the immersion suit” and “or being injured”.11 In paragraph 2.3.1.4, the number “2.2.1.8” is replaced by “2.2.1.14”.12 The following new paragraphs 2.3.1.5 and 2.3.1.6 are inserted after the existing paragraph 2.3.1.4:“2.3.1.5 An immersion suit which has buoyancy and is designed to be worn without a lifejacket shall be provided with a releasable buoyant line or other means to secure it to a suit worn by another person in the water.2.3.1.6An immersion suit which has buoyancy and is designed to be worn without alifejacket shall be provided with a suitable means to allow a rescuer to lift the wearer from the water into a survival craft or rescue boat.”13 The existing paragraph 2.3.1.5 is replaced by the following:“2.3.1.7 If an immersion suit is to be worn in conjunction with a lifejacket, the lifejacket shall be worn over the immersion suit. Persons wearing such an immersion suit shall be able to don a lifejacket without assistance. The immersion suit shall be marked to indicate that it must be worn in conjunction with a compatible lifejacket.”14 The following new paragraph 2.3.1.8 is added:“2.3.1.8 An immersion suit shall have buoyancy which is not reduced by more than 5% after 24 h submersion in fresh water and does not depend on the use of loose granulated materials.”15 The existing paragraph 2.3.3 is deleted.16 The word “The” in the beginning of paragraph 2.4.1.1 is replaced by the word “An”.17 The existing subparagraph .3 of paragraph 2.4.1.1 is replaced by the following:“.3 covers the whole body except, where the Administration so permits, the feet;covering for the hands and head may be provided by separate gloves and a hood,both of which shall be permanently attached to the suit;”18 The existing paragraph 2.4.1.2 is deleted and paragraphs 2.4.1.3 and 2.4.1.4 are renumbered as paragraphs 2.4.1.2 and 2.4.1.3 respectively.19 The words “or its attachments,” are inserted between the words “the suit” and “or being injured” in subparagraph .2 of the renumbered paragraph 2.4.1.2.20 The renumbered paragraph 2.4.1.3 is replaced by the following:“2.4.1.3An anti-exposure suit shall be fitted with a light complying with the requirements of paragraph 2.2.3 such that it shall be capable of complying with paragraphs 2.2.3.1.3 and 2.4.1.2.2, and the whistle prescribed by paragraph 2.2.1.14.”21 The existing subparagraph .2 of paragraph 2.4.2.1 is replaced by the following:“.2 be so constructed that, when worn as marked and following one jump into the water which totally submerges the wearer, the suit continues to provide sufficientthermal protection to ensure that when it is worn in calm circulating water at atemperature of 5°C, the wearer’s body core temperature does not fall at a rate ofmore than 1.5°C per hour, after the first 0.5 h.”***。

IS 2008

DRAFT MSC RESOLUTION ADOPTION OF THE INTERNATIONAL CODE ON INTACT STABILITY, 2008 (2008 IS CODE)
THE MARITIME SAFETY COMMITTEE, RECALLING Article 28(b) of the Convention on the International Maritime Organization concerning the functions of the Committee, RECALLING ALSO resolution A.749(18) entitled “Code on Intact Stability for All Types of Ships Covered by IMO Instruments”, as amended by resolution MSC.75(69), RECOGNIZING the need to update the aforementioned Code and the importance of establishing mandatory international intact stability requirements, NOTING resolution MSC…[(85)], by which it adopted, inter alia, amendments to the International Convention for the Safety of Life at Sea, 1974, as amended (1974 SOLAS Convention) and to the Protocol of 1988 relating to the International Convention on Load Lines, 1966, (1988 LL Protocol) to make the introduction and the provisions of part A of the International Code on Intact Stability, 2008 mandatory under the Convention and the Protocol, HAVING CONSIDERED, at its [eighty-fifth] session, the text of the proposed International Code on Intact Stability, 2008, 1. ADOPTS the International Code on Intact Stability, 2008 (2008 IS Code), the text of which is set out in the Annex to the present resolution; 2. INVITES Contracting Governments to the 1974 SOLAS Convention and Parties to the 1988 LL Protocol to note that the 2008 IS Code will take effect on [1 July 2010] upon the entry into force of the respective amendments to the 1974 SOLAS Convention and 1988 LL Protocol; 3. REQUESTS the Secretary-General to transmit certified copies of the present resolution and the text of the 2008 IS Code contained in the Annex to all Contracting Governments to the 1974 SOLAS Convention and Parties to the 1988 LL Protocol; 4. FURTHER REQUESTS the Secretary-General to transmit copies of this resolution and the Annex to all Members of the Organization which are not Contracting Governments to the 1974 SOLAS Convention and Parties to the 1988 LL Protocol; 5. RECOMMENDS Governments concerned to use the recommendatory provisions contained in part B of the 2008 IS Code as a basis for relevant safety standards, unless their national stability requirements provide at least an equivalent degree of safety.

2007／47／EC欧盟新版医疗器械指令

DIRECTIVE2007/47/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCILof5September2007amending Council Directive90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices,Council Directive93/42/EEC concerning medical devices and Directive98/8/EC concerning the placing of biocidal products on the market(Text with EEA relevance)THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,Having regard to the Treaty establishing the European Commu-nity,and in particular Article95thereof,Having regard to the proposal from the Commission,Having regard to the opinion of the European Economic and Social Committee(1),Acting in accordance with the procedure laid down in Article251 of the Treaty(2),Whereas:(1)Council Directive93/42/EEC(3)requires the Commissionto submit a report to the Council,no later than five years from the date of implementation of that Directive, concerning:(i)information on incidents occurring follow-ing the placing of devices on the market,(ii)clinical investigation carried out in accordance with the procedure set out in Annex VIII to Directive93/42/EEC,and(iii) design examination and EC type examination of medical devices that incorporate,as an integral part,a substance which,if used separately,may be considered to be a medicinal product as defined in Directive2001/83/EC of the European Parliament and of the Council of6November 2001on the Community code relating to medicinal products for human use(4)and which is liable to act upon the body with action ancillary to that of the device.(2)The Commission brought forward the conclusions of thatreport in its Communication to the Council and the European Parliament on medical devices which,at the request of the Member States,was expanded to cover all aspects of the Community regulatory framework for medical devices.(3)This Communication was welcomed by the Council in itsConclusions on medical devices of2December2003(5).Itwas also discussed by the European Parliament which on 3June2003adopted a resolution on the health implications of Directive93/42/EEC(6).(4)Following from the conclusions drawn in that Commu-nication it is necessary and appropriate to amend Council Directive90/385/EEC(7),Directive93/42/EEC and Direc-tive98/8/EC of the European Parliament and of the Council(8).(5)To ensure consistency of interpretation and implementationbetween Directives93/42/EEC and90/385/EEC the legal framework related to issues such as authorised representa-tive,the European databank,health protection measures, and the application of Directive93/42/EEC as regards medical devices incorporating stable derivates of human blood or human plasma,as introduced by Directive2000/ 70/EC(9),should be extended to Directive90/385/EEC.The application of the provisions on medical devices incorpor-ating stable derivates of human blood or human plasma includes application of Directive2002/98/EC of the European Parliament and of the Council of27January 2003setting standards of quality and safety for the collection,testing,processing,storage and distribution of human blood and blood components and amending Directive2001/83/EC(10).(6)It is necessary to clarify that software in its own right,whenspecifically intended by the manufacturer to be used for one or more of the medical purposes set out in the definition ofa medical device,is a medical device.Software for generalpurposes when used in a healthcare setting is not a medical device.(7)Particular care should be taken to ensure that thereprocessing of medical devices does not endanger patients’safety or health.It is therefore necessary to provide clarification on the definition of the term‘single use’,as well as to make provision for uniform labelling and(1)OJ C195,18.8.2006,p.14.(2)Opinion of the European Parliament of29March2007(not yetpublished in the Official Journal)and Council Decision of23July 2007.(3)OJ L169,12.7.1993,p.1.Directive as last amended by Regulation(EC)No1882/2003of the European Parliament and of the Council (OJ L284,31.10.2003,p.1).(4)OJ L311,28.11.2001,p.67.Directive as last amended byRegulation(EC)No1901/2006of the European Parliament and of the Council(OJ L378,27.12.2006,p.1).(5)OJ C20,24.1.2004,p.1.(6)OJ C68E,18.3.2004,p.85.(7)OJ L189,20.7.1990,p.17.Directive as last amended by Regulation(EC)No1882/2003.(8)OJ L123,24.4.1998,p.1.Directive as last amended by CommissionDirective2007/20/EC(OJ L94,4.4.2007,p.23).(9)Directive2000/70/EC of the European Parliament and of theCouncil of16November2000amending Council Directive93/42/ EEC as regards medical devices incorporating stable derivates of human blood or human plasma(OJ L313,13.12.2000,p.22). (10)OJ L33,8.2.2003,p.30.instructions for use.Moreover,the Commission should engage in further analysis in order to see if additional measures are appropriate to ensure a high level of protection for patients.(8)In the light of technical innovation and the development ofinitiatives at the international level it is necessary to enhance the provisions on clinical evaluation,including clarification that clinical data is generally required for all devices regardless of classification and the possibility to centralise data on clinical investigations in the European databank.(9)In order to provide clearer evidence of the compliance ofcustom-made device manufacturers,an explicit requirement for a post market production review system involving incident reporting to authorities should be introduced,as is already in place for other devices,and to enhance patient information,a requirement should be introduced that the ‘Statement’under Annex VIII to Directive93/42/EEC should be available to the patient and that it should contain the name of the manufacturer.(10)In the light of technical progress in information technologyand medical devices,a process should be provided to allow information supplied by the manufacturer to be available by other means.(11)Manufacturers of Class I sterile and/or measuring medicaldevices should be given the option of using the full quality assurance conformity assessment module in order to provide them with more flexibility in the choice of compliance modules.(12)In order to support market surveillance activities byMember States it is necessary and appropriate,in the case of implantable devices,to increase the time period for the retention of documents for administrative purposes to at least15years.(13)For the appropriate and efficient functioning of Directive93/42/EEC as regards regulatory advice on classification issues arising at national level,in particular on whether or not a product falls under the definition of a medical device, it is in the interest of national market surveillance and the health and safety of humans to establish a procedure for decisions on whether or not a product falls under the medical device definition.(14)To ensure that,where a manufacturer does not have aregistered place of business in the Community,authorities have a single individual person authorised by the manufacturer whom they can address in matters relating to the compliance of the devices with the Directives it is necessary to introduce an obligation for such manufacturers to designate an authorised representative for a device.This designation should be effective at least for all devices of the same model.(15)To further ensure public health and safety it is necessary toprovide for a more consistent application of the provisions on health protection measures.Particular care should be taken to ensure that,when in use,the products do not endanger patients’health or safety.(16)In support of transparency in Community legislation,certain information related to medical devices and their conformity with Directive93/42/EEC,in particular infor-mation on registration,on vigilance reports and on certificates,should be available to any interested party and the general public.(17)To better coordinate the application and efficiency ofnational resources when applied to issues related to Directive93/42/EEC,the Member States should cooperate with each other and at international level.(18)As design for patient safety initiatives play an increasingrole in public health policy,it is necessary to expressly set out the need to consider ergonomic design in the essential requirements.In addition the level of training and knowl-edge of the user,such as in the case of a lay user,should be further emphasised within the essential requirements.The manufacturer should place particular emphasis on the consequences of misuse of the product and its adverse effects on the human body.(19)In the light of experience gained regarding activities of boththe notified bodies and the authorities in the assessment of devices which require intervention of the appropriate authorities for medicines and human blood derivatives their duties and tasks should be clarified.(20)Taking account of the growing importance of software inthe field of medical devices,be it as stand alone or as software incorporated in a device,validation of software in accordance with the state of the art should be an essential requirement.(21)In the light of the increased use of third Parties to carry outthe design and manufacture of devices on behalf of the manufacturer,it is important that the manufacturer demonstrates that he applies adequate controls to the third party to continue to ensure the efficient operating of the quality system.(22)The classification rules are based on the vulnerability of thehuman body taking account of the potential risks associated with the technical design and manufacture of the devices.Explicit prior authorisation with regard to conformity,including an assessment of the design documentation,is required for Class III devices to be placed on the market.In performing its duties under the quality assurance and verification conformity assessment modules for all other classes of devices,it is essential and necessary for a notified body,in order to be assured of thecompliance of the manufacturer with Directive93/42/EEC, to review the design documentation for the medical device.The depth and extent of this review should be commensu-rate with the classification of the device,the novelty of the intended treatment,the degree of intervention,the novelty of the technology or construction materials,and the complexity of the design and/or technology.This review can be achieved by taking a representative example of design documentation of one or more type(s)of devices from those being manufactured.Further review(s),and in particular the assessment of changes to the design that could affect conformity with the essential requirements, should be part of the surveillance activities of the notified body.(23)It is necessary to remove the incoherence in theclassification rules as a result of which invasive devices with respect to body orifices intended for connection to an active Class I medical device were not classified.(24)The measures necessary for the implementation ofDirective90/385/EEC and Directive93/42/EEC should be adopted in accordance with Council Decision1999/468/EC of28June1999laying down the procedures for the exercise of implementing powers conferred on the Commission(1).(25)In particular,power should be conferred on the Commis-sion to adapt classification rules for medical devices,to adapt the means by which the information needed to use medical devices safely and properly may be set out,to determine conditions for making certain information publicly available,to adapt the provisions on clinical investigations set out in certain Annexes,to adopt particular requirements for placing certain medical devices on the market or putting them into service,and to take decisions to withdraw such devices from the market for reasons of protection of health or safety.Since those measures are of general scope and are designed to amend or supplement Directive90/385/EEC and Directive93/42/EEC by the modification or addition of non-essential elements, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article5a of Decision1999/468/EC.(26)When,on imperative grounds of urgency,the normal timelimits for the regulatory procedure with scrutiny cannot be complied with,the Commission should be able to use the urgency procedure provided for in Article5a(6)of Decision 1999/468/EC for taking decisions on withdrawal of certain medical devices from the market and for the adoption of particular requirements for placing such devices on the market or putting them into service for reasons of protection of health or safety.(27)The Commission should give a mandate to CEN and/orCenelec to specify technical requirements and a suitable specific label for phthalate-containing devices within12 months after entry into force of this Directive.(28)Many Member States have established recommendationswith the aim of reducing or limiting the use of medical devices containing critical phthalates on children,pregnant and nursing women and other patients at risk.To enable medical professionals to avoid such risks,devices which possibly release phthalates to the body of the patient should be labelled accordingly.(29)In accordance with the essential requirements on the designand manufacture of medical devices,manufacturers should avoid the use of substances that may possibly compromise the health of patients,in particular of substances which are carcinogenic,mutagenic or toxic to reproduction,and should,as appropriate,strive to develop alternative substances or products with a lower risk potential.(30)It should be clarified that alongside Directives90/385/EECand93/42/EEC,in vitro diagnostic medical devices,which are the subject of Directive98/79/EC of the European Parliament and of the Council of27October1998on in vitro diagnostic medical devices(2),should also be excluded from the scope of Directive98/8/EC.(31)In accordance with point34of the Interinstitutionalagreement on better law-making(3),Member States are encouraged to draw up,for themselves and in the interests of the Community,their own tables illustrating,as far as possible,the correlation between this Directive and the transposition measures,and to make them public.(32)Directives90/385/EEC,93/42/EEC and98/8/EC shouldtherefore be amended accordingly,HAVE ADOPTED THIS DIRECTIVE:Article1Directive90/385/EEC is hereby amended as follows:1.Article1shall be amended as follows:(a)paragraph2shall be amended as follows:(i)point(a)shall be replaced by the following:‘(a)“medical device”means any instrument,apparatus,appliance,software,material orother article,whether used alone or incombination,together with any accessories,including the software intended by its(1)OJ L184,17.7.1999,p.23.Decision as amended by Decision2006/512/EC(OJ L200,22.7.2006,p.11).(2)OJ L331,7.12.1998,p.1.Directive as last amended by Regulation(EC)No1882/2003.(3)OJ C321,31.12.2003,p.1.manufacturer to be used specifically fordiagnostic and/or therapeutic purposes andnecessary for its proper application,intended by the manufacturer to be usedfor human beings for the purpose of:—diagnosis,prevention,monitoring,treatment or alleviation of disease,—diagnosis,monitoring,treatment,alle-viation of or compensation for aninjury or handicap,—investigation,replacement or modifi-cation of the anatomy or of aphysiological process,—control of conception,and which does not achieve its principalintended action in or on the human bodyby pharmacological,immunological ormetabolic means,but which may beassisted in its function by such means;’(ii)points(d),(e)and(f)shall be replaced by the following:‘(d)“custom-made device”means any device specifically made in accordance with a dulyqualified medical practitioner's written pre-scription which gives,under his responsi-bility,specific design characteristics and isintended for the sole use of a particularpatient.Mass-produced devices which needto be adapted to meet the specific require-ments of the medical practitioner or anyother professional user shall not be con-sidered to be custom-made devices;(e)“device intended for clinical investigation”means any device intended for use by aduly qualified medical practitioner whenconducting clinical investigations asreferred to in Section2.1of Annex7inan adequate human clinical environment.For the purpose of conducting clinicalinvestigation,any other person who,byvirtue of his professional qualifications,isauthorised to carry out such investigationshall be accepted as equivalent to a dulyqualified medical practitioner;(f)“intended purpose”means the use forwhich the device is intended according tothe data supplied by the manufacturer onthe labelling,in the instructions and/or inpromotional material;’(iii)the following points shall be added:‘(j)“authorised representative”means any nat-ural or legal person established in theCommunity who,explicitly designated bythe manufacturer,acts and may beaddressed by authorities and bodies in theCommunity instead of the manufacturerwith regard to the latter's obligations underthis Directive;(k)“clinical data”means the safety and/orperformance information that is generatedfrom the use of a device.Clinical data aresourced from:—clinical investigation(s)of the deviceconcerned,or—clinical investigation(s)or other stu-dies reported in the scientific litera-ture,of a similar device for whichequivalence to the device in questioncan be demonstrated,or—published and/or unpublished reportson other clinical experience of eitherthe device in question or a similardevice for which equivalence to thedevice in question can be demon-strated.’;(b)paragraph3shall be replaced by the following:‘3.Where an active implantable medical device is intended to administer a substance defined as a medicinal product within the meaning of Article1of Directive2001/83/EC(*),that device shall be gov-erned by this Directive,without prejudice to the provisions of Directive2001/83/EC with regard to the medicinal product.(*)OJ L311,28.11.2001,p.67.Directive as last amended by Regulation(EC)No1901/2006(OJL378,27.12.2006,p.1)’(c)paragraph4shall be replaced by the following:‘4.Where an active implantable medical device incorporates,as an integral part,a substance which, if used separately,may be considered to be a medicinal product within the meaning of Article1of Directive 2001/83/EC and which is liable to act upon thehuman body with action that is ancillary to that of the device,that device shall be evaluated and authorised in accordance with this Directive.’;(d)the following paragraph shall be inserted:‘4a.Where a device incorporates,as an integral part,a substance which,if used separately,may beconsidered to be a medicinal product constituent ora medicinal product derived from human blood orhuman plasma within the meaning of Article1of Directive2001/83/EC and which is liable to act upon the human body with action that is ancillary to that of the device,hereinafter referred to as a“human blood derivative”,that device shall be assessed and authorised in accordance with this Directive.’;(e)paragraph5shall be replaced by the following:‘5.This Directive constitutes a specific Directive within the meaning of Article1(4)of Directive2004/ 108/EC(*).(*)Directive2004/108/EC of the European Parlia-ment and of the Council of15December2004on the approximation of the laws of the MemberStates relating to electromagnetic compatibility(OJ L390,31.12.2004,p.24).’;(f)the following paragraph shall be added:‘6.This Directive shall not apply to:(a)medicinal products covered by Directive2001/83/EC.In deciding whether a product falls underthat Directive or this Directive,particularaccount shall be taken of the principal modeof action of the product;(b)human blood,blood products,plasma or bloodcells of human origin or to devices whichincorporate at the time of placing on the marketsuch blood products,plasma or cells with theexception of devices referred to in paragraph4a;(c)transplants or tissues or cells of human origin orto products incorporating or derived fromtissues or cells of human origin,with theexception of devices referred to in paragraph4a;(d)transplants or tissues or cells of animal origin,unless a device is manufactured utilising animaltissue which is rendered non-viable or non-viable products derived from animal tissue.’;2.Article2shall be replaced by the following:‘A rticle2Member States shall take all necessary steps to ensure that the devices may be placed on the market and/or put into service only if they comply with the requirements laid down in this Directive when duly supplied,properly implanted and/or properly installed,maintained and used in accordance with their intended purposes.’;3.Article3shall be replaced by the following:‘A rticle3The active implantable medical devices referred to in Article1(2)(c),(d)and(e),hereinafter referred to as “devices”,shall satisfy the essential requirements set out inAnnex1which apply to them,account being taken of the intended purpose of the devices concerned.Where a relevant hazard exists,devices which are also machinery within the meaning of Article2(a)of Directive 2006/42/EC of the European Parliament and of the Council of17May2006on machinery(*)shall also meet the essential health and safety requirements set out in Annex I to that Directive to the extent to which those essential health and safety requirements are more specific than the essential requirements set out in Annex1to this Directive.(*)OJ L157,9.6.2006,p.24.’;4.in Article4,paragraphs1,2and3shall be replaced by thefollowing:‘1.Member States shall not create any obstacle to the placing on the market or the putting into service within their territory of devices complying with the provisions of this Directive and bearing the CE marking provided for in Article12,which indicates that they have been the subject of an assessment of their conformity in accordance with Article9.2.Member States shall not create any obstacles to:—devices intended for clinical investigations being made available to duly qualified medical practitioners orauthorised persons for that purpose if they satisfy theconditions laid down in Article10and in Annex6,—custom-made devices being placed on the market and put into service if they satisfy the conditions laiddown in Annex6and are accompanied by thestatement,which shall be available to the particularidentified patient,referred to in that Annex.These devices shall not bear the CE marking.3.At trade fairs,exhibitions,demonstrations,etc.,Member States shall not create any obstacle to the showing of devices which do not conform to this Directive,provided that a visible sign clearly indicates that such devices do not conform and cannot be marketed or put into service until they have been made to comply by the manufacturer or his authorised representative.’;5.Article5shall be replaced by the following:‘A rticle51.Member States shall presume compliance with theessential requirements referred to in Article3in respect of devices which are in conformity with the relevant national standards adopted pursuant to the harmonised standards the references of which have been published in the Official Journal of the European Union;Member States shall publish the references of such national standards.2.For the purposes of this Directive,reference toharmonised standards also includes the monographs of the European Pharmacopoeia notably on interaction between medicinal products and materials used in devices containing such medicinal products,the references of which have been published in the Official Journal of the European Union.’;6.Article6shall be amended as follows:(a)in paragraph1the reference‘83/189/EEC’shall bereplaced by the reference‘98/34/EC(*)(*)Directive98/34/EC of the European Parliament and of the Council of22June1998laying downa procedure for the provision of information inthe field of technical standards and regulationsand of rules on Information Society services(OJL204,21.7.1998,p.37).Directive as lastamended by the2003Act of Accession.’;(b)paragraph2shall be replaced by the following:‘2.The Commission shall be assisted by a standingcommittee(hereinafter referred to as the Committee).3.Where reference is made to this paragraph,Articles5and7of Decision1999/468/EC shallapply,having regard to the provisions of Article8thereof.The period laid down in Article5(6)of Decision1999/468/EC shall be set at three months.4.Where reference is made to this paragraph,Article5a(1)to(4)and Article7of Decision1999/468/EC shall apply,having regard to the provisions ofArticle8thereof.5.Where reference is made to this paragraph,Article5a(1),(2),(4)and(6),and Article7ofDecision1999/468/EC shall apply,having regard tothe provisions of Article8thereof.’;7.Article8shall be replaced by the following:‘A rticle81.Member States shall take the necessary steps to ensurethat information brought to their knowledge regarding the incidents mentioned below involving a device is recorded and evaluated in a centralised manner:(a)any malfunction of or deterioration in the character-istics and performances of a device,as well as anyinadequacy in the labelling or in the instructions foruse which might lead to or might have led to the deathof a patient or user or to a serious deterioration in hisstate of health;(b)any technical or medical reason in relation to thecharacteristics or performances of a device for thereasons referred to in point(a),leading to systematicrecall of devices of the same type by the manufacturer.2.Where a Member State requires medical practitionersor the medical institutions to inform the competent authorities of any incidents referred to in paragraph1,it shall take the necessary steps to ensure that the manufacturer of the device concerned,or his authorised representative,is also informed of the incident.3.After carrying out an assessment,if possible togetherwith the manufacturer or his authorised representative, Member States shall,without prejudice to Article7, immediately inform the Commission and the other Member States of measures that have been taken or are contemplated to minimise the recurrence of the incidents referred to in paragraph1,including information on the underlying incidents.4.The measures necessary for the implementation of thisArticle shall be adopted in accordance with the regulatory procedure referred to in Article6(3).’;8.Article9shall be amended as follows:(a)paragraph8shall be replaced by the following:‘8.Decisions taken by the notified bodies inaccordance with Annexes2,3and5shall be validfor a maximum of five years and may be extended onapplication,made at a time agreed in the contractsigned by both Parties,for further periods of amaximum length of five years.’;(b)the following paragraph shall be added:‘10.The measures designed to amend non-essentialelements of this Directive,inter alia by supplementingit,relating to the means by which,in the light of。

07_2 Marpol Annex VI

MARPOL Annex VI Air PollutionMARPOL Annex VIEntry-into-force, background, application & ratification status Survey and certificatsion Scope of air pollution prevention requirements • Ozone depleting substances – (Regulation 12) • NOx – (Regulation 13) • SOx & SECA’s – (Regulation 14) • VOC – (Regulation 15) • Incineration – (Regulation 16) • FO quality – (Regulation 18) Survey and Port state Inspections Regional requirements in the EU, USA and Norway Revision of Annex VI & Future developmentsVersion 27 October 2010 Slide 21Regulation 12,Ozone Depleting SubstancesProhibits deliberate emissions, to be delivered to reception facilities Halons and CFC’s prohibited in new installations. HCFC’s (e.g. R22) accepted in new installations until 1. January 2020.Version27 October 2010Slide 3Regulation 12 ,Ozone-Depleting SubstancesWhat are they (but not limited to): - Halon 1211 - Halon 1301 - Halon 2402 - CFC-R11 - CFC-R12 - CFC-R13 - CFC-R113 - CFC-R114 - CFC-R115 - HCFC-R22HFCs are not ozone depleting and is not regulated by Annex VI Commonly used HFCs:R134a, R152a R404a, R407cVersion27 October 2010Slide 42Regulation 13: NOx Emission limitsEntry into force 1 July 2010NOx limit for fuel oilTier I Tier II Tier IIIRequirement 17.0 g/kWh (= today) 14.4 g/kWh 3.4 g/kWhEnforcement 1-JanShips constructed 1-Jan2000 1-Janto 1-Jan-2011 1Ships constructed after 1JanJan-2011 1Ships constructed after 1JanJan-2016 and operating in ECAsShips (>5MW) constructed 1-Jan-90 to 1-Jan-00 to comply with Tier I, provided approved method for NOx reduction is available and cost effectiveVersion27 October 2010Slide 5NOx Emission limitsShip Constructed (≥ 1 January) ≥ 1990 to 2000 Retroactive to existing engines 2000 ≤ x <2011 2011 ≤ x <2016 ≥ 2016 Application of Requirements Engine size > 5000 kW and ≥ 90 liters Emission Limits Compliance at engine’s delivery except as below 1st IAPP Renewal Survey ≥ 12 months after IMO advised by Party of availability (physical and cost) of “upgrade kit” * ---Tier II Tier III Operation outside of ECA Operation within ECA Relative NO2 Reduction from Tier I Current 15.5% - 21.8% 80%Slide 6Tier I> 130 kW Ships ≥ 24m L or total propulsion power ≥ 750kWTotal Weight of NO2 Emission (g/kWh) RPM Tier I Tier II Tier IIIVersion< 130 17.0 14.4 3.4130 ≤ n < 2000 45.0*n(-0.2) 44.0*n(-0.23) 9*n(-0.2)27 October 2010≥ 2000 9.8 7.7 2.03Regulation 13 - NOx CertificationRequired for diesel engine with output greater than 130 kW on ships keel laid on or after 1 January 2000 or major conversions of engines after this date Certification of engines according to the NOx Technical Code - EIAPP Certificate18 16 14 12 10 8 6 4 2 0 0 200 400 600 800 1000 1200 1400 1600 1800 2000 2200 Rated engine speed (rpm)Not for: - emergency diesels - life boat engines - boilersVersion 27 October 2010g r a m N O X /k W hSlide 7Regulation 13 – NOx Verification MethodsParameter check methodVerify that the following documentation is onboard:EIAPP Certificate and Technical file for each engine Record book of engine parameters for recording all of the changes made to engines NOx influencing components and settings spare parts as per specification in technical file need be used.Simplified Measurement Method test cycle in technical file-Verification tests during periodical and intermediate surveys according toPerformed more or less like the parent testing on testbed Full load running of the engine for about 20 minutes 10% deviation from the applicable NOx limit is allowedDirect measurement and monitoring methodDirect measurement of the NOx emissions during the engine operationSpot checks logged with other operating data on a regular basis Continuous monitoring and data storage Data must be taken within the last 30 days and must follow technical code Monitoring records to be kept onboard for at least three months any system or procedure utilised to monitor engine NOx emissions by the direct measurement method shall meet the requirements of MEPC Resolution 103(49)Version27 October 2010Slide 84Regulation 13 – installed engine, major conversion and exempted enginesInstalled engine: “installed” relates to an engine that is permanently secured or connected to the ship’s structure, fuel / coolant / exhaust systems or power systems (IACS UI MPC 16) Major modification:The engine is replaced by a new engine built on or after 1 January 2000, A substantial modification (changing camshaft, fuel injection system, or any nox setting or component), The maximum continuous rating of the engine is increased by more than 10%Exempted engines: In addition to lifeboat engines and emergency enginesReg. 19 (2) d) ”Emission from diesel engines that are solely dedicated to the exploration, exploitation and associated offshore processing of sea-bed mineral resources” are consistent with article 2(3)b(ii) of the Convention , exempt from the provisions of this annexVersion 27 October 2010 Slide 9Latest MARPOL Annex VI revisionUpdate - IMO MEPC58 - Adopted 9 October 2008 – Enter into force 1 July 2010Sulphur limit for fuel oilGlobalSulphur content 4.50% 3.50% 0.50% 1.50% 1.00% 0.10%Enforcement [Prior to 1 January 2012] [1 January 2012] [1 January 2020]* [Prior to 1 July 2010] [1 July 2010] [1 January 2015]ECA (SECA)*Subject to a review of fuel availability in 2018, with the option to delay the 0.5% sulphur global cap by five yearsAbatement technology (ex Scrubbers) is an "equivalent measure". This means that an Administration may allow abatement technologies, but the Administration (and not the ship) have to acknowledge that: They have equivalent efficiency in terms of SOx, PM and NOx emissions. That they operate within the requirements of the IMO guidelines That they do not harm the environment.Version27 October 2010Slide 105Possible new SECAsVersion27 October 2010Slide 11Next ECA – USA + CanadaAnnex VI entered into force for the U.S. on January 8, 2009 (Canada has yet to ratify Annex VI)Annex VI entered into force ECA application from US and Canada submitted in March 2009. U.S. on January 8, 2009for theEarliest possible approval date is at the MEPC 60 meeting, which is anticipated to take place in March 2010. If approved, it is expected to enter ECA application from US and it will require all ships within 200 into force as early as August 2012 and Canada submitted Annex VI 2009. nautical miles to use low sulphur fuel according to Marpolin MarchECA limitsEarliest possible approval date is at the MEPC 60 meeting, which is anticipated to take place in March 2010. If approved, it is expected to enter into force as early as August 2012 and it will require all ships within 200 nautical miles to use low sulphur fuel according to Marpol g3 Annex VI ECA limits200 nautical milesVersion27 October 2010Slide 126Slide 12 g3gkje, 2009-04-07***Until 01 July 2010******Until 01 Jan 2012***Version27 October 2010Slide 13EU Directive – from January 01, 2010Vessels have 2 hours to change over completely to 0,1% S fuel after arrival/berthing according to some European ports If the Main Engine is not operating during the time spent at berth, it can be shut down and started up on a fuel exceeding the 0.1% sulphur limit (i.e. Heavy fuel Oil). O.1% limit will be interpreted as 0.10% by some European Ports and 0.14% by others. Sulphur results according to ISO 8217 are reported with two significant figures.Version27 October 2010Slide 147Californian regulations - CARBFuel requirements apply to ocean-going vessel main (propulsion) diesel engines, auxiliary diesel engines, and auxiliary boilers when operating within the 24 nautical mile regulatory zone off the California Coastline.Effective date July 1, 2009 January 1, 2012Fuel*Phase I Fuel requirement Marine gas oil (DMA) at or below 1.5% sulfur; or Marine diesel oil (DMB) at or below 0.5% sulfur Phase II Fuel requirement Marine gas oil (DMA) or marine diesel oil (DMB) at or below 0.1% sulfur*DMA and DMB are marine grades of fuel as defined in Table I of International Standard ISO 8217:2005Version27 October 2010Slide 15California RequirementsCARB- Max 0.5% MDO (DMB) or 1.5% MGO (DMA) within 24 nm zone in aux. engines - 0.1% MGO as of 2010 - Abatement technology Non compliance feesPort visit 1st port visitDE Vessel $32,500Other Vessels $13,000 $26,000 $39,000 $52,000 $65,0002nd port visit $65,000 3rd port visit 4th port visit 5 or more visitsVersion$97,500 $130,000 $162,00027 October 2010Slide 168Operating in SECAsOperation on LSFO all the time Changeover to LSFO Scrubbing Any other technological methodVersion27 October 2010Slide 17LSFO Change-OverVersion27 October 2010Slide 189Slide 19Upon completion of change-over the Volume LSFO per tank onboard.It is strongly recommended to SloptkSloptkP RoomH.F.O .H.F.O .H.F.O .H.F.O .H.F.O.Service Tank no.1 & 2H.F.O.Settling Tank no.1H.F.O.settl. tank no 2The tank can possibly be divided on the middle by welding a bulkhead to fit the existing tank service tank, facing the engine The new LSHFO tank needs to be fitted with following piping:often have a viscosity that is lower than that of Most marine equipment designed for the use of MGO or MDO requires aSlide 23are produced, they are more likely to have poor ignition and/or combustion propertiesSlide 27Data collected by DNV Petroleum Services show that, with the progress in oil refining technologies, the content of catalytic fines (cat-fines) in fuels the fuel oil after refining. When not removed, these particles, typically Will lead to e.g. increased cylinder-,Class requirementsClass requirements as to the modification of machinery, systems and components for the use of low sulphur and lowThe installation shall be subject to survey by the Society in accordanceProvided applicable documentation as described in Appendix A is submitted for approval, DNV will upon request from the owner issue aDNV has developed a new voluntary class notation ECA (SOx)Sets a new standard for design of fuel oil systems as well as required modifications for machinery components to enable consumption of lowVersion Slide 3727 October 2010 Can achieve up to 98% reduction of SOx, 80% reduction of PM and 20% reduction of NOxMay require very high seawater flow rate / or additional chemical additivesScrubber allows for use of cheap HSFO inside and outside SECAsNeeds to be type approved according to IMO resolution MEPC.130(53) or fitted with continuous emissions monitoring systemNeeds to be designed of very corrosion resistant materials Requires wash water treatment system (HC, ash vanadium etc)Requires large space onboardHigh investment cost: 80 –300 Euros / kW Seawater scrubbingVersion Slide 3827 October 2010Regulation18 -Fuel Oil QualityDelivered from authorised supplier-Free from inorganic acids-Not include chemical waste-Within NOx and SOx limitsBunker delivery notes to be kept on board for 3 yearsSample to be kept until substantially consumed and not less than 12 months27 October 201027 October 2010Version Slide 40Version Slide 4227 October 2010Updating of text in Annex VI and NOx Technical code。

WHO药品生产技术转移指南Annex7

285©World Health OrganizationWHO Technical Report Series, No. 961, 2011Annex 7WHO guidelines on transfer of technologyin pharmaceutical manufacturing1. Intr o duct i on2. Sc o pe3. Gl o ssary4. Organ i zat i on and management5. Pr o duct i on: transfer (process i ng, packag i ng and clean i ng)6. Qual i ty control: analyt i cal method transfer7. Prem i ses and equ i pment8. D o cumentat i on9. Qual i ﬁ cat i on and val i dat i on References1. IntroductionThese gu i d i ng pr i nc i ples on transfer of technology are i ntended to serve asa framework wh i ch can be appl i ed i n a ﬂ ex i ble manner rather than as str i ctr i g i d gu i dance. Focus has been placed on the qual i ty aspects, i n l i ne w i th WHO’s mandate.1.1 Transfer of processes to an alternat i ve s i te occurs at some stage i n thel i fe-cycle of most products, from development, scale-up, manufactur i ng, product i on and launch, to the post-approval phase.1.2 Transfer of technology i s deﬁ ned as “a log i cal procedure that controlsthe transfer of any process together w i th i ts documentat i on and profess i onal expert i se between development and manufacture or between manufacture s i tes”. It i s a systemat i c procedure that i s followed i n order to pass the documented knowledge and exper i ence ga i ned dur i ng development and or commerc i al i zat i on to an appropr i ate, respons i ble and author i zed party.Technology transfer embod i es both the transfer of documentat i on and the demonstrated ab i l i ty of the rece i v i ng un i t (RU) to effect i vely perform the cr i t i cal elements of the transferred technology, to the sat i sfact i on of all part i es and any appl i cable regulatory bod i es.1.3 L i terature searches revealed l i ttle i nformat i on on the sub j ect or i g i nat i ngfrom nat i onal or reg i onal regulatory b od i es. Gu i dance on i ntracompany transfers was prepared b y the Internat i onal Soc i ety for Pharmaceut i cal Eng i neer i ng (ISPE) (1).1.4 The ever chang i ng bus i ness strateg i es of pharmaceut i cal compan i esi ncreas i ngly i nvolve i ntra- and i ntercompany transfers of technology forreasons such as the need for add i t i onal capac i ty, relocat i on of operat i ons or consol i dat i ons and mergers. The WHO Expert Comm i ttee on Spec iﬁ cat i ons for Pharmaceut i cal Preparat i ons, therefore, recommended i n i ts forty-second report that WHO address th i s i ssue through preparat i on of WHO gu i del i nes on th i s matter (2).1.5Transfer of technology requ i res a documented, planned approach us i ngtra i ned and knowledgeable personnel work i ng w i th i n a qual i ty system, w i th documentat i on of data cover i ng all aspects of development, product i on and qual i ty control. Usually there i s a send i ng un i t (SU), a rece i v i ng un i t and the un i t manag i ng the process, wh i ch may or may not be a separate ent i ty. For “contract manufactur i ng” please see good manufactur i ng pract i ces (GMP) (3).1.6 For the transfer to be successful, the follow i ng general pr i nc i ples andrequ i rements should be met:•the pro j ect plan should encompass the qual i ty aspects of the pro j ect and be based upon the pr i nc i ples of qual i ty r i sk management;286•the capab i l i t i es of the SU and at the RU should b e s i m i lar, b ut not necessar i ly i dent i cal, and fac i l i t i es and equ i pment should operate accord i ng to s i m i lar operat i ng pr i nc i ples;• a comprehens i ve techn i cal gap analys i s between the SU and RU i nclud i ngtechn i cal r i sk assessment and potent i al regulatory gaps, should b e performed as needed;•adequately tra i ned staff should be ava i lable or should be tra i ned at the RU:—regulatory requ i rements i n the countr i es of the SU and the RU, andi n any countr i es where the product i s i ntended to be suppl i ed, shouldb e taken i nto account and i nterpreted cons i stently throughout anytransfer programme pro j ect; and—there should be effect i ve process and product knowledge transfer.1.7Technology transfer can be cons i dered successful i f there i s documentedev i dence that the RU can rout i nely reproduce the transferred product, process or method aga i nst a predeﬁ ned set of spec iﬁ cat i ons as agreed w i th the SU.1.8 In the event that the RU i dent iﬁ es part i cular problems w i th the processdur i ng the transfer, the RU should commun i cate them back to the SU to ensure cont i nu i ng knowledge management.1.9 Technology transfer pro j ects, part i cularly those b etween d i fferentcompan i es, have legal and econom i c i mpl i cat i ons. If such i ssues, wh i ch may i nclude i ntellectual property r i ghts, royalt i es, pr i c i ng, conﬂi ct ofi nterest and conﬁ dent i al i ty, are expected to i mpact on open commun i cat i onof techn i cal matters i n any way, they should be addressed before and dur i ng plann i ng and execut i on of the transfer.1.10 Any lack of transparency may lead to i neffect i ve transfer oftechnology.1.11 Some of the pr i nc i ples outl i ned i n th i s document may also b eappl i cab le to manufactur i ng i nvest i gat i onal pharmaceut i cal products for cl i n i cal tr i als as part of research and development, but th i s i s not the ma i n focus of th i s gu i dance and has been excluded due to the complex i ty of the processes.1.12 Some of the respons i b i l i t i es outl i ned i n th i s document for the SUmay also be cons i dered to be part of the management un i t respons i b i l i t i es.2. ScopeNote: Th i s sect i on spec iﬁ cally prov i des for transfer of qual i ty control (QC) methods where a techn i cal agreement ex i sts (SU manufacturer to RU manufacturer or SU manufacturer to RU QC laboratory). Where no such techn i cal agreements ex i st (e.g. test i ng by nat i onal laborator i es or test i ng287for procurement agenc i es) a number of the po i nts l i sted i n sect i on 2.4 may not be workable, and alternat i ve approaches may be requ i red.2.1 Th i s document g i ves gu i dance i n pr i nc i ple and prov i des generalrecommendat i ons on the act i v i t i es necessary to conduct a successful i ntra- or i nters i te transfer of technology as descr i bed i n the Introduct i on to these gu i del i nes. The i ntent i on i s to address the bas i c cons i derat i ons needed fora successful transfer i n order to sat i sfy the regulatory author i ty deﬁ ned forthe transfer process.2.2 The gu i del i nes w i ll be appl i ed to manufactur i ng act i ve pharmaceut i cali ngred i ents (APIs), manufactur i ng and packag i ng of b ulk mater i als,manufactur i ng and packag i ng of ﬁ n i shed pharmaceut i cal products (FPPs) and/or perform i ng analyt i cal test i ng.2.3 The recommendat i ons prov i ded i n these gu i del i nes apply to all dosageforms but need to be ad j usted on a case-by-case bas i s (e.g. by us i ng r i sk management pr i nc i ples). Part i cularly close control of certa i n aspects w i ll be requ i red for certa i n formulat i ons such as ster i le products, and metered-dose aerosols. WHO gu i dance on manufacture of spec iﬁ c pharmaceut i cal products(4,5) w i ll be useful i n th i s regard.2.4 The gu i del i nes address the follow i ng areas at the SU and the RU:—transfer of development and product i on (process i ng, packag i ng and clean i ng);—transfer of analyt i cal methods for qual i ty assurance and qual i ty control;—sk i lls assessment and tra i n i ng;—organ i zat i on and management of the transfer;—assessment of prem i ses and equ i pment;—documentat i on; and—qual iﬁ cat i on and val i dat i on.2.5Because each transfer pro j ect i s un i que, the prov i s i on of a comprehens i veset of gu i del i nes i s beyond the scope of th i s document.2.6 These gu i del i nes do not prov i de gu i dance on any legal, ﬁ nanc i al orcommerc i al cons i derat i ons assoc i ated w i th technology transfer pro j ects. 3. GlossaryThe deﬁ n i t i ons g i ven below apply to the terms used i n these gu i del i nes.They may have d i fferent mean i ngs i n other contexts.acceptance criteriaMeasurable terms under wh i ch a test result w i ll be cons i dered acceptable. 288active pharmaceutical ingredient (API)Any sub stance or m i xture of sub stances i ntended to b e used i n the manufacture of a pharmaceut i cal dosage form and that, when so used, b ecomes an act i ve i ngred i ent of that pharmaceut i cal dosage form. Such substances are i ntended to furn i sh pharmacolog i cal act i v i ty or other d i rect effect i n the d i agnos i s, cure, m i t i gat i on, treatment, or prevent i on of d i sease or to affect the structure and funct i on of the body.bracketingAn exper i mental des i gn to test only the extremes of, for example, dosage strength. The des i gn assumes that the extremes w i ll be representat i ve of all the samples between the extremes.change control (C/C)A formal system b y wh i ch qual iﬁ ed representat i ves of appropr i ate d i sc i pl i nes rev i ew proposed or actual changes that m i ght affect a val i dated status. The i ntent i s to determ i ne the need for act i on that would ensure that the system i s ma i nta i ned i n a val i dated state.commissioningThe sett i ng up, ad j ustment and test i ng of equ i pment or a system to ensure that i t meets all the requ i rements, as spec iﬁ ed i n the user requ i rement spec iﬁ cat i on, and capac i t i es as spec iﬁed b y the des i gner or developer. Comm i ss i on i ng i s carr i ed out before qual iﬁ cat i on and val i dat i on.control strategyA planned set of controls, der i ved from current product and process understand i ng, that assures process performance and product qual i ty. The controls can i nclude parameters and attr i b utes related tomater i als and components related to drug sub stances and drug product mater i als and components, fac i l i ty and equ i pment operat i ng cond i t i ons, i n-process controls, ﬁ n i shed product spec iﬁ cat i ons, and the assoc i ated methods and frequency of mon i tor i ng and control (6).corrective action (C/A)Any act i on to be taken when the results of mon i tor i ng at a cr i t i cal control po i nt i nd i cate a loss of control.criticalHav i ng the potent i al to i mpact on product qual i ty or performance i n a s i gn iﬁ cant way.critical control point (CCP)A step at wh i ch control can be appl i ed and i s essent i al to prevent or el i m i nate a pharmaceut i cal qual i ty hazard or to reduce i t to an acceptable level.289design qualiﬁ cation (DQ)Documented ev i dence that the prem i ses, support i ng systems, ut i l i t i es, equ i pment and processes have b een des i gned i n accordance w i th the requ i rements of good manufactur i ng pract i ces (GMP).design spaceThe mult i d i mens i onal comb i nat i on and i nteract i on of i nput var i ables (e.g.mater i al attr i butes) and process parameters that have been demonstrated to prov i de assurance of qual i ty (7).drug master ﬁ le (DMF)Deta i led i nformat i on concern i ng a spec iﬁ c fac i l i ty, process or product subm i tted to the med i c i nes regulatory author i ty, i ntended for i ncorporat i oni nto the appl i cat i on for market i ng author i zat i on.ﬁ nished pharmaceutical product (FPP)A product that has undergone all stages of product i on, i nclud i ng packag i ngi n i ts ﬁ nal conta i ner and labell i ng. An FPP may conta i n one or more APIs.gap analysisIdent iﬁ cat i on of cr i t i cal elements of a process wh i ch are ava i lable at the SU but are m i ss i ng from the RU.good manufacturing practices (GMP)That part of qual i ty assurance wh i ch ensures that pharmaceut i cal products are cons i stently produced and controlled to the qual i ty standards appropr i ate to the i r i ntended use and as requ i red by the market i ng author i zat i on (3).in-process control (IPC)Checks performed dur i ng product i on i n order to mon i tor and, i f necessary, to ad j ust the process to ensure that the product conforms to i ts spec iﬁ cat i ons.The control of the env i ronment or equ i pment may also be regarded as a part of i n-process control.installation qualiﬁ cation (IQ)The performance of tests to ensure that the i nstallat i ons (such as mach i nes, measur i ng dev i ces, ut i l i t i es and manufactur i ng areas) used i na manufactur i ng process are appropr i ately selected and correctly i nstalledand operate i n accordance w i th establ i shed spec iﬁ cat i ons.intercompany transferA transfer of technology between s i tes of d i fferent compan i es.intracompany transferA transfer of technology between s i tes of the same group of compan i es.290operational qualiﬁ cation (OQ)Documented ver iﬁ cat i on that the system or subsystem performs as i ntended over all ant i c i pated operat i ng ranges.performance qualiﬁ cation (PQ)Documented ver iﬁ cat i on that the equ i pment or system operates cons i stently and g i ves reproduc i b i l i ty w i th i n deﬁ ned spec iﬁ cat i ons and parameters for prolonged per i ods. (In the context of systems, the term “process val i dat i on”may also be used.)process validationDocumented ev i dence wh i ch prov i des a h i gh degree of assurance that a spec iﬁc process w i ll cons i stently result i n a product that meets i ts predeterm i ned spec iﬁ cat i ons and qual i ty character i st i cs.qualiﬁ cationAct i on of prov i ng and document i ng that any prem i ses, systems and equ i pment are properly i nstalled, and/or work correctly and lead to the expected results. Qual iﬁ cat i on i s often a part (the i n i t i al stage) of val i dat i on, but the i nd i v i dual qual iﬁ cat i on steps alone do not const i tute process val i dat i on.qualiﬁ cation batchesThose batches produced by the RU to demonstrate i ts ab i l i ty to reproduce the product (1).quality assurance (QA)Qual i ty assurance i s a w i de-rang i ng concept cover i ng all matters that i nd i v i dually or collect i vely i nﬂuence the qual i ty of a product.It i s the total i ty of the arrangements made w i th the ob j ect i ve of ensur i ng that pharmaceut i cal products are of the qual i ty requ i red for the i r i ntended use. quality control (QC)Qual i ty control covers all measures taken, i nclud i ng the sett i ng of spec iﬁ cat i ons, sampl i ng, test i ng and analyt i cal clearance, to ensure that start i ng mater i als, i ntermed i ates, packag i ng mater i als and ﬁ n i shed pharmaceut i cal products conform w i th establ i shed spec iﬁ cat i ons for i dent i ty, strength, pur i ty and other character i st i cs.quality planningPart of qual i ty management focused on sett i ng qual i ty ob j ect i ves and spec i fy i ng necessary operat i onal processes and related resources to fulﬁ l the qual i ty ob j ect i ves (6).quality policyOverall i ntent i ons and d i rect i on of an organ i zat i on related to qual i ty as formally expressed by sen i or management (6).291quality risk management (QRM)Qual i ty r i sk management i s a systemat i c process for the assessment, control, commun i cat i on and rev i ew of r i sks to the qual i ty of the pharmaceut i cal product throughout the product l i fe-cycle.receiving unit (RU)The i nvolved d i sc i pl i nes at an organ i zat i on where a des i gnated product, process or method i s expected to be transferred.sending unit (SU)The i nvolved d i sc i pl i nes at an organ i zat i on from where a des i gnated product, process or method i s expected to be transferred.spikingThe add i t i on of a known amount of a compound to a standard, sample or placeb o, typ i cally for the purpose of conﬁ rm i ng the performance of an analyt i cal procedure.standard operating procedure (SOP)An author i zed wr i tten procedure g i v i ng i nstruct i ons for perform i ng operat i ons not necessar i ly spec iﬁ c to a g i ven product or mater i al (e.g.equ i pment operat i on, ma i ntenance and clean i ng, val i dat i on, clean i ng of prem i ses and env i ronmental control, sampl i ng and i nspect i on). Certa i n SOPs may b e used to supplement product-spec iﬁc master and b atch product i on documentat i on.technology transfer reportA documented summary of a spec iﬁ c technology transfer pro j ect l i st i ngprocedures, acceptance cr i ter i a, results ach i eved and conclus i ons. Any dev i at i on should be d i scussed and j ust iﬁ ed.validationAct i on of prov i ng and document i ng that any process, procedure or method actually and cons i stently leads to the expected results.validation master plan (VMP)A h i gh-level document that establ i shes an umbrella val i dat i on plan for theent i re pro j ect and summar i zes the manufacturer’s overall ph i losophy and approach, to be used for establ i sh i ng performance adequacy. It prov i desi nformat i on on the manufacturer’s val i dat i on work programme anddeﬁ nes deta i ls of and t i mescales for the val i dat i on work to be performed,i nclud i ng a statement of the respons i b i l i t i es of those i mplement i ng theplan.292validation protocol (or plan) (VP)A document descr i b i ng the act i v i t i es to b e performed i n a val i dat i on,i nclud i ng the acceptance cr i ter i a for the approval of a manufactur i ngprocess — or a part thereof — for rout i ne use.validation report (VR)A document i n wh i ch the records, results and evaluat i on of a completedval i dat i on programme are assembled and summar i zed. It may also conta i n proposals for the i mprovement of processes and or equ i pment.n and management4. Organizatio4.1 Transfer compr i ses an SU and an RU. In some c i rcumstances theremay be an add i t i onal un i t wh i ch w i ll be respons i ble for d i rect i ng, manag i ng and approv i ng the transfer.4.2 There i s a formal agreement between the part i es, wh i ch spec iﬁ es therespons i b i l i t i es before, dur i ng and after transfer.4.3 Organ i zat i on and management of a successful technology transferneed to ensure that the ma i n steps have been executed and documented as descr i bed i n sect i on 1.6.4.4There should b e a pro j ect management plan wh i ch i dent iﬁ esand controls all the necessary act i v i t i es i dent iﬁed at the start of the undertak i ng.4.5 The transfer protocol should l i st the i ntended sequent i al stages of thetransfer. The protocol should i nclude:—ob j ect i ve;—scope;—key personnel and the i r respons i b i l i t i es;—a parallel compar i son of mater i als, methods and equ i pment;—the transfer stages w i th documented ev i dence that each cr i t i cal stage has been sat i sfactor i ly accompl i shed before the next commences;—i dent iﬁ cat i on of cr i t i cal control po i nts;—exper i mental des i gn and acceptance cr i ter i a for analyt i cal methods;—i nformat i on on tr i al product i on b atches, qual iﬁ cat i on b atches and process val i dat i on;—change control for any process dev i at i ons encountered;—assessment of end-product;—arrangements for keep i ng retent i on samples of act i ve i ngred i ents,i ntermed i ates and ﬁ n i shed products, and i nformat i on on referencesubstances where appl i cable; and—conclus i on, i nclud i ng s i gned-off approval by pro j ect manager.2934.6 The SU should prov i de the necessary val i dat i on documentat i on forthe process and i ts support funct i ons. Usually, an estab l i shed process i s transferred, and such documentat i on i s already ava i lable.4.7 The SU should prov i de cr i ter i a and i nformat i on on hazards andcr i t i cal steps assoc i ated w i th the product, process or method to b e transferred, to serve as a b as i s for a qual i ty r i sk management (QRM) exerc i se at the RU (7–10).4.8 The SU or th i rd party should assess the su i tab i l i ty and degree ofpreparedness of the RU before transfer, w i th regard to prem i ses, equ i pment and support serv i ces (e.g. purchas i ng and i nventory control mechan i sms, qual i ty control (QC) procedures, documentat i on, computer val i dat i on, s i te val i dat i on, equ i pment qual iﬁ cat i on, water for pharmaceut i cal product i on and waste management).4.9The SU and the RU should j o i ntly ver i fy that the follow i ng,sat i sfactor i ly completed, val i dat i on protocols are ava i lable:•i nstallat i on qual iﬁ cat i on (IQ) and operat i onal qual iﬁ cat i on (OQ) data formanufactur i ng and packag i ng equ i pment at the RU s i te and analyt i calequ i pment; and•qual iﬁ cat i on of the rooms for both manufacture and packag i ng at the RUs i te.4.10The SU and the RU should j o i ntly i mplement any tra i n i ngprogrammes that may b e requ i red spec iﬁc to the product, process or method to be transferred, e.g. on analyt i cal methods or equ i pment usage, and assess tra i n i ng outcomes.4.11 The SU and the RU should j o i ntly execute the transfer protocolaccord i ng to a checkl i st and or ﬂ ow d i agram show i ng the sequence of steps to be carr i ed out to effect an efﬁ c i ent transfer.4.12 Any changes and adaptat i ons made dur i ng the course of thetechnology transfer should be fully documented.4.13 The SU and the RU should j o i ntly document the execut i on of thetransfer protocol i n a transfer of technology summary i n a report.teamProject4.14 Any transfer pro j ect w i ll be managed by a team compr i s i ng membersw i th clearly deﬁ ned key respons i b i l i t i es. The team should be drawn from members of relevant d i sc i pl i nes from both the SU and RU s i tes.4.15 The team memb ers should have the necessary qual iﬁ cat i ons andexper i ence to manage the i r part i cular aspect of the transfer.2945.Production: transfer (processing, packagingand cleaning)5.1 The RU should b e ab le to accommodate the i ntended product i oncapac i ty. If poss i ble, i t should b e estab l i shed at the outset whether thei ntent i on i s to perform s i ngle-batch manufacture, cont i nuous product i on orcampa i gns.5.2 Cons i derat i on should be g i ven to the level and depth of deta i l to betransferred to support product i on and any further process development and opt i m i zat i on at the RU as i ntended under the transfer pro j ect plan.5.3 Cons i derat i on should b e g i ven to the techn i cal expert i se, s i tetechnology and s i te capab i l i t i es for the RU. It should be i dent iﬁ ed upfront by the SU of any process robustness i ssues so that plans may be put i n place at the RU.5.4 The SU and the RU should j o i ntly develop a protocol for the transferof relevant i nformat i on related to the process under cons i derat i on from the SU to the RU, as well as the development of a comparable process at the RU.materialsStarting5.5 The spec iﬁ cat i ons and relevant funct i onal character i st i cs of thestart i ng mater i als (APIs and exc i p i ents) (11,12) to be used at the RU should be cons i stent w i th mater i als used at the SU. Any propert i es wh i ch are l i kely to i nﬂ uence the process or product should be i dent iﬁ ed and character i zed.Active pharmaceutical ingredients (API)5.6 The SU should prov i de the RU w i th the open (appl i cant’s) partof the API master ﬁle (APIMF or drug master ﬁle (DMF) or act i ve substance master ﬁ le (ASMF)), or equ i valent i nformat i on and any relevant add i t i onal i nformat i on on the API of i mportance for the manufacture of the pharmaceut i cal product. The follow i ng are examples of the i nformat i on wh i ch may typ i cally be prov i ded; however the i nformat i on needed i n each spec iﬁ c case should be assessed us i ng the pr i nc i ples of QRM:•manufacturer and assoc i ated supply cha i n;•step of the API to be transferred;•ﬂ ow chart of synthes i s pathway, outl i n i ng the process, i nclud i ng entry po i nts for raw mater i als, cr i t i cal steps, process controls and i ntermed i ates;•where relevant, deﬁ n i t i ve phys i cal form of the API (i nclud i ngphotom i crographs and other relevant data) and any polymorph i c and solvate forms;•solub i l i ty proﬁ le;295•i f relevant, pH i n solut i on;•part i t i on coefﬁ c i ent, i nclud i ng the method of determ i nat i on;•i ntr i ns i c d i ssolut i on rate, i nclud i ng the method of determ i nat i on;•part i cle s i ze and d i str i but i on, i nclud i ng the method of determ i nat i on;•bulk phys i cal propert i es, i nclud i ng data on bulk and tap dens i ty, surfacearea and poros i ty as appropr i ate;•water content and determ i nat i on of hygroscop i c i ty, i nclud i ng water act i v i ty data and spec i al handl i ng requ i rements;•m i crob i olog i cal cons i derat i ons (i nclud i ng ster i l i ty, bacter i al endotox i nsand b i ob urden levels where the API supports m i crob i olog i cal growth)i n accordance w i th nat i onal, reg i onal or i nternat i onal pharmacopoe i alrequ i rements;•spec iﬁ cat i ons and j ust iﬁ cat i on for release and end-of-l i fe l i m i ts;•summary of stab i l i ty stud i es conducted i n conform i ty w i th current gu i del i nes, i nclud i ng conclus i ons and recommendat i ons on retest date;•l i st of potent i al and observed synthet i c i mpur i t i es, w i th data to supportproposed spec iﬁ cat i ons and typ i cally observed levels;•i nformat i on on degradants, w i th a l i st of potent i al and ob served degradat i on products and data to support proposed spec iﬁ cat i ons andtyp i cally observed levels;•potency factor, i nd i cat i ng ob served pur i ty and j ust iﬁ cat i on for any recommended ad j ustment to the i nput quant i ty of API for product manufactur i ng, prov i d i ng example calculat i ons; and•spec i al cons i derat i ons w i th i mpl i cat i ons for storage and or handl i ng,i nclud i ng b ut not l i m i ted to safety and env i ronmental factors (e.g. asspec iﬁ ed i n mater i al safety data sheets) and sens i t i v i ty to heat, l i ght ormo i sture.Excipients5.7 The exc i p i ents (11) to be used have a potent i al i mpact on the ﬁ nalproduct. The i r spec iﬁ cat i ons and relevant funct i onal character i st i cs should, therefore, b e made ava i lab le b y the SU for transfer to the RU s i te. The follow i ng are examples of the i nformat i on wh i ch may typ i cally be prov i ded;however, the i nformat i on needed i n each spec iﬁ c case should be assessed us i ng the pr i nc i ples of QRM:•manufacturer and assoc i ated supply cha i n;•descr i pt i on of funct i onal i ty, w i th j ust iﬁ cat i on for i nclus i on of any ant i ox i dant, preservat i ve or any exc i p i ent;•deﬁ n i t i ve form (part i cularly for sol i d and i nhaled dosage forms);•solub i l i ty proﬁ le (part i cularly for i nhaled and transdermal dosage forms);•part i t i on coefﬁ c i ent, i nclud i ng the method of determ i nat i on (for transdermal dosage forms);296•i ntr i ns i c d i ssolut i on rate, i nclud i ng the method of determ i nat i on (for transdermal dosage forms);•part i cle s i ze and d i str i but i on, i nclud i ng the method of determ i nat i on (for sol i d, i nhaled and transdermal dosage forms);•bulk phys i cal propert i es, i nclud i ng data on bulk and tap dens i ty, surface area and poros i ty as appropr i ate (for sol i d and i nhaled dosage forms);•compact i on propert i es (for sol i d dosage forms);•melt i ng po i nt range (for sem i-sol i d or top i cal dosage forms);•pH range (for parenteral, sem i-sol i d or top i cal, l i qu i d and transdermal dosage forms);•i on i c strength (for parenteral dosage forms);•spec iﬁ c dens i ty or grav i ty (for parenteral, sem i-sol i d or top i cal, l i qu i d and transdermal dosage forms);•v i scos i ty and or v i scoelast i c i ty (for parenteral, sem i-sol i d or top i cal, l i qu i d and transdermal dosage forms);•osmolar i ty (for parenteral dosage forms);•water content and determ i nat i on of hygroscop i c i ty, i nclud i ng water act i v i ty data and spec i al handl i ng requ i rements (for sol i d and i nhaled dosage forms);•mo i sture content range (for parenteral, sem i sol i d or top i cal, l i qu i d and transdermal dosage forms);•m i crob i olog i cal cons i derat i ons (i nclud i ng ster i l i ty, bacter i al endotox i ns and b i ob urden levels where the exc i p i ent supports m i crob i olog i cal growth) i n accordance w i th nat i onal, reg i onal or i nternat i onal pharmacopoe i al requ i rements, as appl i cable (for general and spec iﬁ c monographs);•spec iﬁ cat i ons and j ust iﬁ cat i on for release and end-of-l i fe l i m i ts;•i nformat i on on adhes i ves support i ng compl i ance w i th peel, sheer and adhes i on des i gn cr i ter i a (for transdermal dosage forms);•spec i al cons i derat i ons w i th i mpl i cat i ons for storage and or handl i ng, i nclud i ng b ut not l i m i ted to safety and env i ronmental factors (e.g. as spec iﬁ ed i n mater i al safety data sheets (MSDS)) and sens i t i v i ty to heat, l i ght or mo i sture; and•regulatory cons i derat i ons, e.g. documentat i on to support compl i ance w i th transm i ss i le an i mal spong i form encephalopathy cert iﬁ cat i on requ i rements (where appl i cable).Information on process and ﬁ nished pharmaceuticalproducts information5.8 The SU should prov i de a deta i led character i zat i on of the product,i nclud i ng i ts qual i tat i ve and quant i tat i ve compos i t i on, phys i cal descr i pt i on, method of manufacture, i n-process controls, control method and spec iﬁ cat i ons, packag i ng components and conﬁ gurat i ons, and any safety and handl i ng cons i derat i ons.297。

(EC)NO.244-2009 非定向灯EUP指令

COMMISSION REGULATION(EC)No244/2009of18March2009implementing Directive2005/32/EC of the European Parliament and of the Council with regard to ecodesign requirements for non-directional household lamps(Text with EEA relevance)THE COMMISSION OF THE EUROPEAN COMMUNITIES,Having regard to the Treaty establishing the European Community,Having regard to Directive2005/32/EC of the European Parliament and of the Council of6July2005establishing a framework for the setting of ecodesign requirements for energy-using products and amending Council Directive92/42/EEC and Directives96/57/EC and2000/55/EC of the European Parliament and of the Council(1)and in particular Article15(1)thereof,After consulting the Ecodesign Consultation Forum,Whereas:(1)Under Directive2005/32/EC ecodesign requirementsshall be set by the Commission for energy usingproducts representing significant volumes of sales andtrades,having significant environmental impact andpresenting significant potential for improvement interms of their environmental impact without entailingexcessive costs.(2)Article16(2)first indent of Directive2005/32/ECprovides that in accordance with the procedure referredto in Article19(3)and the criteria set out inArticle15(2),and after consulting the Ecodesign Consultation Forum,the Commission shall as appropriateintroduce an implementing measure on domesticlighting products.(3)The Commission has carried out a preparatory studywhich analysed the technical,environmental andeconomic aspects of lighting products typically used inhouseholds.The study has been developed together withstakeholders and interested parties from the Communityand third countries,and the results have been madepublicly available on the EUROPA website of theCommission.(4)Mandatory ecodesign requirements apply to productsplaced on the Community market wherever they areinstalled or used,therefore such requirements cannotbe made dependent on the application in which theproduct is used(such as for domestic lighting).(5)Products subject to this Regulation are designed essentially for the full or partial illumination of a householdroom,by replacing or complementing natural light withartificial light,in order to enhance visibility within thatspace.Special purpose lamps designed essentially forother types of applications(such as traffic signals,terrarium lighting,or household appliances)and clearlyindicated as such on accompanying product informationshould not be subject to the ecodesign requirements setout in this Regulation.(6)New technologies emerging on the market such as lightemitting diodes should be subject to this Regulation.(7)The environmental aspects of the products covered thatare identified as significant for the purposes of this Regulation are energy in the use phase as well as mercurycontent and mercury emissions.(8)The annual electricity consumption related to productssubject to this Regulation in the Community has beenestimated to be112TWh in2007,corresponding to45Mt CO2emissions.Without taking specificmeasures,the consumption is predicted to increase to135TWh in2020.The preparatory studies showedthat electricity consumption of products subject to thisRegulation can be significantly reduced.(9)Mercury emitted in the different life cycle phases of thelamps,including from use-phase electricity generationand from the80%of compact fluorescent lampscontaining mercury which are presumed not to berecycled at the end of life,has been estimated to be2,9tonnes in2007from the installed stock of lamps.Without taking specific measures,the mercury emissionsof the installed lamp stock is predicted to increase to3,1tonnes in2020while it has been demonstrated that itcan be significantly reduced.(1)OJ L191,22.7.2005,p.29.Although the mercury content of compact fluorescentlamps is considered to be a significant environmentalaspect,it is appropriate to regulate it under Directive2002/95/EC of the European Parliament and of theCouncil of27January2003on the restriction of theuse of certain hazardous substances in electrical and electronic equipment(1).The setting of energy efficiency requirements for lampssubject to this Regulation will lead to a decrease of theoverall mercury emissions.(10)Article10(1)(d)of the Directive2002/96/EC of theEuropean Parliament and of the Council of27January2003on Waste Electrical and Electronic Equipment(2)should be fully implemented to ensure minimising thepotential risks for the environment and for human healthin case of accidental breakage of compact fluorescentlamps or at their end of life.(11)Improvements of electricity consumption of productssubject to this Regulation should be achieved byapplying existing non-proprietary cost effective technologies,which lead to a reduction of the combinedexpenses for purchasing and operating the equipment.(12)Ecodesign requirements for products subject to thisRegulation should be set with a view to improving theenvironmental performance of the products affected,contributing to the functioning of the internal marketand to the Community objective of reducing energyconsumption by20%in2020compared with theassumed energy consumption in that year if nomeasures are implemented.(13)This Regulation should increase the market penetrationof energy efficient products subject to this Regulation,leading to estimated energy savings of39TWh in2020,compared with the assumed energy consumptionin that year if no Ecodesign measure is implemented.(14)The ecodesign requirements should not affect functionality from the user’s perspective and should not negatively affect health,safety or the environment.Inparticular,the benefits of reducing the electricityconsumption during the use phase should over-compensate potential,if any,additional environmentalimpacts during the production phase of productssubject to this Regulation.(15)A staged entry into force of the ecodesign requirementsshould provide a sufficient timeframe for manufacturersto re-design products subject to this Regulation as appropriate.The timing of the stages should be set in such away that negative impacts related to functionalities ofequipment on the market are avoided,and cost impactsfor end-users and manufacturers,in particular small andmedium enterprises,are taken into account,whileensuring timely achievement of the objectives of thisRegulation.(16)Measurements of the relevant product parameters shouldbe performed taking into account the generallyrecognised state of the art measurement methods;manufacturers may apply harmonised standards set up inaccordance with Article10of Directive2005/32/EC assoon as they are made available and published for thatpurpose in the Official Journal of the European Union.(17)In accordance with Article8of Directive2005/32/EC,this Regulation should specify the applicable conformityassessment procedures.(18)In order to facilitate compliance checks,manufacturersshould provide information in the technical documentation referred to in Annexes V and VI to Directive2005/32/EC in so far as this information relates to therequirements laid down in this Regulation.(19)In addition to the legally binding requirements,the identification of indicative benchmarks for best available technologies for products subject to this Regulation shouldcontribute to ensuring wide availability and to facilitatingaccess to information.This can further facilitate the integration of best design technologies for improving the lifecycle environmental performance of products subject tothis Regulation.(20)A review of this measure should take particular note ofthe evolution of sales of special purpose lamp types so asto verify that they are not used for general lightingpurposes,of the development of new technologies suchas LEDs and of the feasibility of establishing energy efficiency requirements at the‘A’class level as defined inCommision Directive98/11/EC of27January1998implementing Council Directive92/75with regard toenergy labeling of household lamps(3).(21)The requirements contained in this measure allowhalogen lamps of socket G9and R7s to remain on themarket for a limited period of time,recognising the needto service the existing luminaire stock,to prevent unduecosts on consumers and to give time to manufacturers todevelop luminaires dedicated to more efficient lightingtechnologies.(22)The measures provided for in this Regulation are inaccordance with the opinion of the Committee established by Article19(1)of Directive2005/32/EC,(1)OJ L37,13.2.2003,p.19.(2)OJ L37,13.2.2003,p.24.(3)OJ L71,10.3.1998,p.1.HAS ADOPTED THIS REGULATION:Article1Subject matter and scopeThis Regulation establishes ecodesign requirements for the placing on the market of non-directional household lamps, including when they are marketed for non-household use or when they are integrated into other products.It also establishes product information requirements for special purpose lamps.The requirements set out in this Regulation shall not apply to the following household and special purpose lamps:(a)lamps having the following chromaticity coordinatesx and y:—x<0,200or x>0,600—y<–2,3172x2+2,3653x–0,2800ory>–2,3172x2+2,3653x–0,1000;(b)directional lamps;(c)lamps having a luminous flux below60lumens or above12000lumens;(d)lamps having:—6%or more of total radiation of the range250-780nm in the range of250-400nm,—the peak of the radiation between315-400nm(UVA) or280-315nm(UVB);(e)fluorescent lamps without integrated ballast;(f)high-intensity discharge lamps;(g)incandescent lamps with E14/E27/B22/B15caps,with avoltage equal to or below60volts and without integrated transformer in Stages1-5according to Article3.Article2DefinitionsFor the purposes of this Regulation,the definitions set out in Directive2005/32/EC shall apply.The following definitions shall also apply:1.‘household room illumination’means the full or partialillumination of a household room,by replacing or complementing natural light with artificial light,in order to enhance visibility within that space;2.‘lamp’means a source made in order to produce an opticalradiation,usually visible,including any additional components necessary for starting,power supply or stable operation of the lamp or for the distribution, filtering or transformation of the optical radiation,in case those components cannot be removed without permanently damaging the unit;3.‘household lamp’means a lamp intended for householdroom illumination;it does not include special purpose lamps;4.‘special purpose lamp’means a lamp not intended forhousehold room illumination because of its technical parameters or because the related product information indicates that it is unsuitable for household room illumination;5.‘directional lamp’means a lamp having at least80%lightoutput within a solid angle ofπsr(corresponding to a cone with angle of120°);6.‘non-directional lamp’means a lamp that is not a directional lamp;7.‘filament lamp’means a lamp in which light is produced bymeans of a threadlike conductor which is heated to incandescence by the passage of an electric current.The lamp may or may not contain gases influencing the process of incandescence;8.‘incandescent lamp’means a filament lamp in which thefilament operates in an evacuated bulb or is surrounded by inert gas;9.‘tungsten halogen lamp’means a filament lamp in whichthe filament is made of tungsten and is surrounded by gas containing halogens or halogen compounds.Tungsten halogen lamps are supplied either with or without integrated power supply;10.‘discharge lamp’means a lamp in which the light isproduced,directly or indirectly,by an electric discharge through a gas,a metal vapour or a mixture of several gases and vapours;11.‘fluorescent lamp’means a discharge lamp of the lowpressure mercury type in which most of the light is emitted by one or several layers of phosphors excited by the ultraviolet radiation from the discharge.Fluorescent lamps are supplied either with or without integrated ballasts;12.‘ballast’means a device which serves to limit the current ofthe lamp(s)to the required value in case it is connected between the supply and one or more discharge lamps.It may also include means for transforming the supply voltage,dimming the lamp,correcting the power factor and,either alone or in combination with a starting device,providing the necessary conditions for starting the lamp(s).It can be integrated or external to the lamp;13.‘power supply’means a device which is designed to convertalternating current(AC)power input from the mains power source input into direct current(DC)or another AC output;14.‘compact fluorescent lamp’means a unit which cannot bedismantled without being permanently damaged,provided with a lamp cap and incorporating a fluorescent lamp and any additional components necessary for starting and stable operation of the lamp;15.‘fluorescent lamp without integrated ballast’means a singleand double capped fluorescent lamp without integrated ballast;16.‘high intensity discharge lamp’means an electric dischargelamp in which the light producing arc is stabilized by wall temperature and the arc has a bulb wall loading in excess of3watts per square centimetre;17.‘light emitting diode’or‘LED’means a solid state deviceembodying a p-n junction,emitting optical radiation when excited by an electric current;18.‘LED lamp’means a lamp incorporating one or several LED.For the purposes of Annexes II to IV,the definitions set out in Annex I shall also apply.Article3Ecodesign requirements1.Non-directional household lamps shall meet the ecodesign requirements set out in Annex II.Each ecodesign requirement shall apply in accordance with the following stages:Stage1:1September2009,Stage2:1September2010,Stage3:1September2011,Stage4:1September2012,Stage5:1September2013,Stage6:1September2016.Unless a requirement is superseded or this is otherwise specified, it shall continue to apply together with the other requirements introduced at later stages.2.Starting from1September2009:For special purpose lamps,the following information shall be clearly and prominently indicated on their packaging and in all forms of product information accompanying the lamp when it is placed on the market:(a)their intended purpose;and(b)that they are not suitable for household room illumination.The technical documentation file drawn up for the purposes of conformity assessment pursuant to Article8of Directive 2005/32/EC shall list the technical parameters(if any)that make the lamp design specific for the special purpose indicated on the packaging.Article4Conformity assessment1.The conformity assessment procedure referred to in Article8of Directive2005/32/EC shall be the internal design control system set out in Annex IV to that Directive or the management system set out in Annex V to that Directive.2.For the purposes of conformity assessment pursuant to Article8of Directive2005/32/EC,the technical documentation file shall contain a copy of the product information provided in accordance with Annex II,part3,to this Regulation.Article5Verification procedure for market surveillance purposes When performing the market surveillance checks referred to in Article3(2)of Directive2005/32/EC,the authorities of the Member States shall apply the verification procedure described in Annex III to this Regulation for the requirements set out in Annex II to this Regulation.Article6Indicative benchmarksThe indicative benchmarks for best-performing products and technology available on the market at the time of adopting this Regulation are identified in Annex IV.Article7RevisionThe Commission shall review this Regulation in light of technological progress no later than five years after the entry into force and present the result of this review to the Consultation Forum.Entry into forceThis Regulation shall enter into force on the20th day following its publication in the Official Journal of the European Union.This Regulation shall be binding in its entirety and directly applicable in all Member States.Done at Brussels,18March2009.For the CommissionAndris PIEBALGSMember of the CommissionTechnical parameters covered and definitions for the purposes of Annexes II to IV1.TECHNICAL PARAMETERS FOR ECODESIGN REQUIREMENTSFor the purposes of compliance and verification of compliance with the requirements of this Regulation,the parameters below shall be established by reliable,accurate and reproducible measurement procedures,which take into account the generally recognised state of the art measurement methods.(a)‘Lamp efficacy’(ηlamp),which is the quotient of the luminous flux emitted(Ф)by the power consumed by thelamp(P lamp):ηlamp=Ф/P lamp(unit:lm/W).The power dissipated by non-integrated auxiliary equipment,such as ballasts,transformers or power supplies,is not included in the power consumed by the lamp;(b)‘Lamp lumen maintenance factor’(LLMF),which is the ratio of the luminous flux emitted by the lamp at a giventime in its life to the initial(100hour)luminous flux;(c)‘Lamp survival factor’(LSF),which is the defined fraction of the total number of lamps that continue to operate ata given time under defined conditions and switching frequency;(d)‘Lamp lifetime’,which is the period of operation time after which the fraction of the total number of lamps whichcontinue to operate corresponds to the lamp survival factor of the lamp,under defined conditions and switching frequency;(e)‘Chromaticity’,which is the property of a colour stimulus defined by its chromaticity coordinates,or by itsdominant or complementary wavelength and purity taken together;(f)‘Luminous flux’(Φ),which is a quantity derived from radiant flux(radiant power)by evaluating the radiationaccording to the spectral sensitivity of the human eye,measured after100hours of lamp running time;(g)‘Correlated colour temperature’(Tc[K]),which is temperature of a Planckian(black body)radiator whoseperceived colour most closely resembles that of a given stimulus at the same brightness and under specified viewing conditions;(h)‘Colour rendering’(Ra),which is the effect of an illuminant on the colour appearance of objects by conscious orsubconscious comparison with their colour appearance under a reference illuminant;(i)‘Specific effective radiant ultraviolet power’,which is the effective power of the ultraviolet radiation of a lampweighted according to the spectral correction factors and related to its luminous flux(unit:mW/klm);(j)‘Lamp start time’,the time needed,after the supply voltage is switched on,for the lamp to start fully and remain alight;(k)‘Lamp warm-up time’,which is the time needed for the lamp after start-up to emit a defined proportion of its stabilized luminous flux;(l)‘Power factor’,which is the ratio of the absolute value of the active power to the apparent power under periodic conditions;(m)‘Luminance’,which is the amount of light,per unit of apparent surface,that is emitted by or reflected by a particular area within a given solid angle(unit:cd/m2);(n)‘Lamp mercury content’,which is the mercury contained in the lamp and is measured according to the Annex to Commission Decision2002/747/EC(1).(1)OJ L242,10.9.2002,p.44.2.DEFINITIONS(a)a‘rated value’is the value of a quantity used for specification purposes,established for a specified set of operatingconditions of a product.Unless stated otherwise,all requirements are set in rated values;(b)a‘nominal value’is the value of a quantity used to designate and identify a product;(c)‘Second lamp envelope’is a second outer lamp envelope which is not required for the production of light,such asan external sleeve for preventing mercury and glass release into the environment in case of lamp breakage,for protecting from ultraviolet radiation or for serving as a light diffuser;(d)‘Clear lamp’is a lamp(excluding compact fluorescent lamps)with a luminance above25000cd/m2for lampshaving a luminous flux below2000lm and above100000cd/m2for lamps having more luminous flux, equipped with only transparent envelopes in which the light producing filament,LED or discharge tube is clearly visible;(e)‘Non-clear lamp’is a lamp that does not comply with the specifications under point(d),including compactfluorescent lamps;(f)‘Switching cycle’is the sequence of switching on and switching off the lamp with defined intervals;(g)‘Premature failure’is when a lamp reaches its end of life after a period in operation which is less than the rated lifetime stated in the technical documentation;(h)‘Lamp cap’means that part of a lamp which provides connection to the electrical supply by means of a socket orlamp connector and,in most cases,also serves to retain the lamp in the socket;(i)‘Lamp holder’or‘socket’means a device which holds the lamp in position,usually by having the cap inserted in it,in which case it also provides the means of connecting the lamp to the electric supply.ANNEX IIEcodesign requirements for non-directional household lampsMP EFFICACY REQUIREMENTSIncandescent lamps with S14,S15or S19caps shall be exempted from the efficacy requirements of Stages1to4as defined in Article3of this Regulation,but not from Stages5and6.The maximum rated power(P max)for a given rated luminous flux(Φ)is provided in Table1.The exceptions to these requirements are listed in Table2and the correction factors applicable to the maximum rated power are in Table3.Table1Table2ExceptionsThe correction factors in Table3are cumulative where appropriate and also applicable to the products covered by the exceptions of Table2.Table3Correction factorsMP FUNCTIONALITY REQUIREMENTSThe lamp functionality requirements are set out in Table4for compact fluorescent lamps and in Table5for lamps excluding compact fluorescent lamps and LED lamps.Where the rated lamp lifetime is higher than2000h,the Stage1requirements for the parameters‘Rated lamp lifetime’,‘Lamp Survival Factor’and‘Lumen maintenance’in Tables4and5are only applicable as from Stage2.For the purposes of testing the number of times the lamp can be switched on and off before failure,the switching cycle shall consist of periods comprising1minute on and3minutes off,while the other test conditions are defined according to Annex III.For the purposes of testing lamp lifetime,lamp survival factor,lumen maintenance and premature failure,the standard switching cycle according to Annex III shall be used.Table4Functionality requirements for compact fluorescent lampsTable5Functionality requirements for lamps excluding compact fluorescent lamps and LED lamps3.PRODUCT INFORMATION REQUIREMENTS ON LAMPSFor non-directional household lamps,the following information shall be provided as from Stage2,except where otherwise stipulated.rmation to be visibly displayed prior to purchase to end-users on the packaging and on free accesswebsitesThe information does not need to be specified using the exact wording of the list below.It may be displayed using graphs,figures or symbols rather than text.These information requirements do not apply to filament lamps not fulfilling the efficacy requirements of Stage4.(a)When the nominal lamp power is displayed outside the energy label in accordance with Directive98/11/EC,thenominal luminous flux of the lamp shall also be separately displayed in a font at least twice as large as the nominal lamp power display outside the label;(b)Nominal life time of the lamp in hours(not higher than the rated life time);(c)Number of switching cycles before premature lamp failure;(d)Colour temperature(also expressed as a value in Kelvins);(e)Warm-up time up to60%of the full light output(may be indicated as‘instant full light’if less than1second);(f)A warning if the lamp cannot be dimmed or can be dimmed only on specific dimmers;(g)If designed for optimal use in non-standard conditions(such as ambient temperature Ta≠25°C),informationon those conditions;(h)Lamp dimensions in millimeters(length and diameter);(i)If equivalence with an incandescent lamp is claimed on the packaging,the claimed equivalent incandescent lamppower(rounded to1W)shall be that corresponding in Table6to the luminous flux of the lamp contained in the packaging.The intermediate values of both the luminous flux and the claimed incandescent lamp power(rounded to1W) shall be calculated by linear interpolation between the two adjacent values.Table6(j)The term‘energy saving lamp’or any similar product related promotional statement about lamp efficacy may only be used if the lamp complies with the efficacy requirements applicable to non-clear lamps in Stage1 according to Tables1,2and3.If the lamp contains mercury(k)Lamp mercury content as X,X mg;(l)Indication which website to consult in case of accidental lamp breakage to find instructions on how to clean up the lamp debris.rmation to be made publicly available on free-access websitesAs a minimum,the following information shall be expressed at least as values.(a)The information specified in point3.1;(b)Rated wattage(0,1W precision);(c)Rated luminous flux;(d)Rated lamp life time;(e)Lamp power factor;(f)Lumen maintenance factor at the end of the nominal life;(g)Starting time(as X,X seconds);(h)Colour rendering.If the lamp contains mercury(i)Instructions on how to clean up the lamp debris in case of accidental lamp breakage;(j)Recommendations on how to dispose of the lamp at its end of life.ANNEX IIIVerification procedure for market surveillance purposesMember State authorities shall test a sample batch of minimum20lamps of the same model from the same manufacturer randomly selected.The batch shall be considered to comply with the provisions set out in Annex II as applicable,of this Regulation if the average results of the batch do not vary from the limit,threshold or declared values by more than10%.Otherwise,the model shall be considered not to comply.For the purposes of checking conformity with the requirements,the authorities of the Member States shall use accurate and reliable state-of-the-art measurement methods which deliver reproducible results,including:—where available,harmonised standards the reference numbers of which have been published for that purpose in the Official Journal of the European Union in accordance with Articles9and10of Directive2005/32/EC,—otherwise,the methods set out in the following documents:(1)Cenelec:rue de Stassart/De Stassartstraat35,B-1050Brussels,tel.(32-2)5196871,fax(32-2)5196919().International Commission on Illumination:CIE Central Bureau Kegelgasse27A-1030Vienna AUSTRIA tel:+43171431870 fax:+431714318718(http://www.cie.co.at/).。

MEPC.347(78)

ANNEX 9RESOLUTION MEPC.347(78)(adopted on 10 June 2022)GUIDELINES FOR THE VERIFICATION AND COMPANY AUDITS BY THE ADMINISTRATION OF PART III OF THE SHIP ENERGY EFFICIENCY MANAGEMENTPLAN (SEEMP)THE MARINE ENVIRONMENT PROTECTION COMMITTEE,RECALLING Article 38(a) of the Convention on the International Maritime Organization concerning the functions of the Marine Environment Protection Committee (the Committee) conferred upon it by international conventions for the prevention and control of marine pollution from ships,NOTING that the Committee adopted, at its seventy-sixth session, by resolution MEPC.328(76), the 2021 Revised MARPOL Annex VI which will enter into force on 1 November 2022,NOTING IN PARTICULAR that the 2021 Revised MARPOL Annex VI (MARPOL Annex VI) contains amendments concerning mandatory goal-based technical and operational measures to reduce carbon intensity of international shipping,NOTING FURTHER that regulation 26 of MARPOL Annex VI requires each ship to keep on board a Ship Energy Efficiency Management Plan (SEEMP), to be developed and reviewed, taking into account the guidelines adopted by the Organization,RECOGNIZING that the aforementioned amendments to MARPOL Annex VI require relevant guidelines for uniform and effective implementation of the regulations and to provide sufficient lead time for industry to prepare,HAVING CONSIDERED, at its seventy-eighth session, draft Guidelines for the verification and company audits by the Administration of part III of the Ship Energy Efficiency Management Plan (SEEMP),1 ADOPTS the Guidelines for the verification and company audits by the Administration of part III of the Ship Energy Efficiency Management Plan (SEEMP), as set out in the annex to the present resolution;2 INVITES Administrations to take the annexed Guidelines into account when developing and enacting national laws which give force to and implement requirements set forth in regulation 26 of MARPOL Annex VI;3 REQUESTS the Parties to MARPOL Annex VI and other Member Governments to bring the annexed Guidelines to the attention of masters, seafarers, shipowners, ship operators and any other interested parties;4 AGREES to keep the Guidelines under review in light of experience gained with their implementation, also taking into consideration that, in accordance with regulations 25.3 and 28.11 of MARPOL Annex VI, a review of the technical and operational measures to reduce carbon intensity of international shipping shall be completed by 1 January 2026.ANNEXGUIDELINES FOR THE VERIFICATION AND COMPANY AUDITS BY THE ADMINISTRATION OF PART III OF THE SHIP ENERGY EFFICIENCY MANAGEMENTPLAN (SEEMP)CONTENTS1 INTRODUCTION2 DEFINITIONS3 RESPONSIBILITIES4 VERIFICATION OF THE SEEMP AND DOCUMENTATION5 INITIAL, PERIODICAL, ADDITIONAL VERIFICATIONS AND COMPANY AUDITS6 ELEMENTS OF VERIFICATION7 COMBINATION WITH ISMANNEX – SAMPLE FORMAT FOR CONFIRMATION OF COMPLIANCE1 INTRODUCTION1.1 The Guidelines for the verification and company audits by the Administration of part III of the Ship Energy Efficiency Management Plan (SEEMP) have been developed to assist Administrations with carrying out the verifications and company audits required by regulation 26.3.3 of MARPOL Annex VI.1.2 The aim of these Guidelines is to:.1 provide guidance to Administrations to effectively and efficiently carry out verifications of, and company audits related to, the Ship Energy EfficiencyManagement Plan (SEEMP) to ensure compliance with regulation 26.3 andwith regulation 28 of MARPOL Annex VI; and.2 ensure that the SEEMP includes the relevant elements in accordance with regulation 26.3 of MARPOL Annex VI, as applicable, and that the SEEMP isreliable, while minimizing the costs and associated burdens to the ship andthe Administration.1.3 The verification of and the company audits related to the SEEMP may be carried out by the Administration or an organization recognized by it.11.4 It should be noted that the Organization has adopted separate 2022Guidelines for Administration verification of ship fuel oil consumption data and operational carbon intensity (resolution MEPC.348(78), adopted 10 June 2022).2 DEFINITIONSFor the purpose of these Guidelines, the definitions in MARPOL Annex VI apply.3 RESPONSIBILITIES3.1 The responsibilities of Administrations and ships are set out in MARPOL Annex VI. These Guidelines do not change those responsibilities or create any new obligations.3.2 An Administration may authorize an organization to carry out verifications of, and company audits related to, the SEEMP, and issue the Confirmation of Compliance, submit the data to the Organization and perform other actions authorized by the Administration. In every case, the Administration assumes full responsibility for all tasks conducted by the Administration, or any organization duly authorized by it (hereinafter referred to as "the Administration").3.3 Verification of, and company audits related to, the SEEMP do not relieve the company, management, those undertaking delegated SEEMP tasks, officers or seafarers of their obligations as to compliance with those requirements in regulation 28 of MARPOL Annex VI.3.4 The company is responsible for:.1 informing relevant personnel and those undertaking the delegated SEEMP tasks about the content of the SEEMP;1Refer to the Code for Recognized Organizations (RO Code), as adopted by the Organization by resolution MEPC.237(65), as may be amended by the Organization..2 appointing responsible members of staff to accompany the verifier; and.3 providing access and evidential materials as requested by the verifier.4 VERIFICATION OF THE SEEMP AND DOCUMENTATION4.1 To facilitate the verification, the Administration should indicate what documentation, if any, the company should submit along with its SEEMP.5 INITIAL, PERIODICAL, ADDITIONAL VERIFICATIONS AND COMPANY AUDITS 5.1 The verification and audit process for the SEEMP according to regulation 26.3.3 of MARPOL Annex VI should normally involve the following:.1 initial verification;.2 periodical verifications;.3 additional verifications; and.4 company audits.5.2 The initial, periodical, additional verifications and company audits should be based on documentary evidence.Initial verification (regulation 5.4.6 of MARPOL Annex VI)5.3 The Administration should perform an initial verification to ensure that for each ship to which regulation 26.3 of MARPOL Annex VI applies, the SEEMP complies with regulation 26.3.1 of MARPOL Annex VI. In accordance with regulation 5.4.6 of MARPOL Annex VI, this process must be done prior to 1 January 2023 for existing ships or before a new ship is put in service.5.4 On satisfactory assessment of the SEEMP part III, the Administration can issue the Confirmation of Compliance (sample format in the annex to this document).Periodical verification (regulation 5.4.6 of MARPOL Annex VI)5.5 If any of the elements in regulation 26.3.1 is updated, and in any case every three years, the Administration should perform a periodical verification to ensure the SEEMP complies with regulation 26.3.1 of MARPOL Annex VI in accordance with regulation 5.4.6 of MARPOL Annex VI.5.6 On satisfactory assessment of SEEMP part III, the Administration should issue the Confirmation of Compliance (sample format in the annex to this document).Additional verifications (regulation 6.8 of MARPOL Annex VI)5.7 The Administration should, in the case of a ship rated as D for three consecutive years or a ship rated as E, perform an additional verification to ensure that a plan of corrective actions has been established in accordance with regulations 28.7 and 28.8.5.8 On satisfactory verification of the plan of corrective actions, the Administration can issue the Statement of Compliance according to regulation6.8.Company audits5.9 The Administration should, in accordance with regulation 26.3.3, perform periodical company audits to:.1 verify that the SEEMP for which the Confirmation of Compliance has previously been issued complies with regulation 26.3.1 and, in the case ofnon-compliance, require remedial action;.2 confirm that the ship is being operated in accordance with SEEMP part III, regardless of its rating;.3 verify the progress made in the (corrective) actions to be taken in the execution of the three-year implementation plan and the plan of correctiveactions;.4 verify self-assessment and improvement of actions taken; and.5 verify the assignment of responsibilities related to the implementation and monitoring of measures.5.10 The periodical company audits may include annual audits of the company (company audits) and verifications on board the ship (shipboard audits).5.11 These additional shipboard verifications and company audits, if undertaken, should be six months after the issuance of the Statement of Compliance at the latest.6 ELEMENTS OF VERIFICATION6.1 Verification could consist of, but not be limited to, the following elements:.1 verification of the method of calculations of the CII and that there is a proper description of the method to report ship data to the Administration;.2 assessment of the effectiveness (of the combination) of measures, so that when implemented the ship will with reasonable assurance achieve therequired annual operational CII, including the goal as set in accordance withparagraph 4.1.7 and 9.7 of the SEEMP Guidelines; and.3 robustness of the three-year implementation plan and, where applicable, the plan of corrective actions, including whether realistic timelines forimplementation of actions have been included.7 COMBINATION WITH ISM AUDITS7.1 Verification of implementation aspects of the SEEMP on board (monitoring, self-evaluation and improvements, etc.) could be combined with the ISM audits.7.2 The verifications may be carried out in accordance with guidelines on implementation of the ISM Code referred to in Chapter 15 of the ISM Code.ANNEXSAMPLE FORMAT FOR CONFIRMATION OF COMPLIANCECONFIRMATION OF COMPLIANCE – SEEMP PART IIIIssued under the provisions of the Protocol of 1997, as amended, to amend the International Convention for the Prevention of Pollution from Ships, 1973, as modified by the Protocol of 1978 related thereto (hereinafter referred to as "the Convention") under the authority of the Government of:. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .(full designation of the Country)by . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (full designation of the competent person or organization authorized under the provisions ofthe Convention)Particulars of ship*Name of ship . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Distinctive number or letters. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . .IMO number†. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. .Port of registry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Gross tonnage. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .SEEMP part III date of revision, as applicable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . THIS IS TO CONFIRM:Taking into account the 2022 Guidelines for the development of a Ship Energy Efficiency Management Plan (SEEMP)adopted by resolution MEPC.346(78), the ship's SEEMP has been developed and complies with regulation 26.3.1 of Annex VI of the Convention.Issued at: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .(place of issue of the Confirmation)Date (dd/mm/yyyy) . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . .. .(date of issue) (signature of duly authorized officialissuing the Confirmation)(seal or stamp of the authority, as appropriate)*Alternatively, the particulars of the ship may be placed horizontally in boxes.†In accordance with the IMO Ship Identification Number Scheme, adopted by the Organization by resolution A.1117(30).***。

MARPOL Annex VI(ABS解说)

Understanding
MARPOL
Annex VI
A Guide for Ship Owners
our MISSION The mission of the American Bureau of Shipping is to serve the public interest as well as the needs of our clients by promoting the security of life, property and the natural environment primarily through the development and verification of standards for the design, construction and operational maintenance of marine-related facilities.
quality & environmental
POLICY
It is the policy of the American Bureau of Shipping to be responsive to the individual and collective needs of our clients as well as those of the public at large, to provide quality services in support of our mission, and to provide our services consistent with international standards developed to avoid, reduce or control pollution to the environment.

3MARPOL公约78年议定书

not less than 15 States, the combined merchant fleets of which constitute not less than 50 % of the gross tonnage of the world’s merchant shipping.
3. Protocol of 1978
3. Protocol of 1978
3.3.7 Denunciation 1 The present Protocol may be denounced by
any Party at any time after the expiry of five years from the date on which the Protocol enters into force for that Party. 2 It shall be effected by deposit of an instrument of denunciation. 3 Effectiveness/12 months/after denunciation.
modifications and additions set out in the present Protocol.
3. Protocol of 1978
3.3.1 General Obligations (Article I) 2 The provisions of the Convention and the present Protocol shall be read and interpreted together as one single instrument. 3 Every reference to the present Protocol constitutes at the same time a reference to the Annex hereto.

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