New Machinery Directive 2006/42/EC TÜV Rheinland Taiwan Ltd. Taichung Branch In cooperation with TAMI Seminar 27.02.2009 Taichung Werner Feuker Andy Wen Page 1
Machinery Directive 2006/42/EC Topics: 1. General introduction of European Directives 機械指令簡介 2. Reasons of amendment and milestones for Machinery Directive 修訂的理由及機械指令的沿革 3. Comparison MSD 2006/42/EC MSD 98/37/EC with essential differences in the content 新舊機械指令 2006/42/EC 與 98/37/EC 的比較 4. Major differences in the Annexes of the New Machinery Directive 2006/42/EC 新機械指令 2006/42/EC 附件中之主要差異 5. Summery 結論 6. FAQ Frequently asked questions 問與答 Page 2
1. General introduction of European Directives Page 3
27 Member States of the European Union In 2008 492.8Mio Residents 23 Official Languages Main Currency: EURO Legislative: European Parliament Page 4
General introduction of European Directives History of European standardization 1957 1985 1987 Treaties of Rome Market without borders and customs Harmonization of all technical standards New Approach Harmonization of all technical standards Directives with fundamental requirements Treaties of Rome became European Act Article 100a(95) and 118a(137) important for machinery Page 5
European Act Article 100a(95) and 118a(137) important for machinery Article 100a(95) Article118a(137) Quality and safety requirements Directives with fundamental requirements to the design, construct and equipment of machines For example: MSD and LVD Operating industrial safety regulation Minimum requirements to safety and health care at the workplace For example: Directive 650 EWG Page 6
European Directives Important EC Directives for machinery: - Machinery Directive - Low Voltage Directive - EMC Directive - ATEX Directive - Acoustic Noise Directive - Emission Directive - and other Directives See: http://www.newapproach.org/directivelist.asp Page 7
Directive, Standard EU Directive Harmonized EN Standards National or international standards if no EN available National or company requirements Page 8
2. Reasons of amendment and milestones for Machinery Directive Page 9
Main purpose of Machinery Directive (2) The social cost of large number of accidents caused directly by the use of machinery can be reduced by inherently safe design and construction of machinery and proper installation and maintenance (3) Member States are responsible for ensuring the health and safety on their territory Page 10
Why the EU need a new Machinery Directive? Meaning of the Directive : Freedom of movement of persons, services, capital and goods in the European Union Therefore it is necessary to have harmonized directives valid for each member state of the EU (like LVD, TOY, PD, PPE...) Commission got the task of revision of MSD Functionality, Practice Suitability, Effectiveness For that reason so called: Molitor-Report Page 11
Molitor Report Recommendations Clarification of scope Differentiation to Low Voltage Directive and Lifting Directive Application on partly completed machinery Modification of procedures for assessing the conformity; Additional law simplifications; Page 12
Course of Proceedings of new MSD 17.May 2006 Formal postulation 09. June 2006 Published in the Official Journal of the European Union 29. June 2006 Entry into force of MSD 2006/42/EC 29. June 2008 Member States adopt and publish the provisions 29. December 2009 Implementation of MSD No transition period Page 13
National Implementation - Germany Implementation by 9. Decree to GPSGV Time: June 29, 2008 Application from Dec. 29, 2009 (No transition period ) ZLS will do the designation for all applicants of Notified Body at the same time Page 14
3. Comparison MSD 2006/42/EC MSD 98/37/EC with essential differences in the content Page 15
What is new, what was until now 2006/42 98/37 Instruction part Art 1 29 條文說明條款 1-29 Instruction part Art 1-16 條文說明條款 1-16 Annex I Essential requirements 附件一基本健康與安全要求 Annex I Essential requirements 附件一基本健康與安全要求 Annex II Declarations 附件一宣告書 Annex III CE Marking 附件三 CE 宣示 Annex II Declarations 附件一宣告書 Annex III CE Conformity Mark. 附件三 CE 符合標示 Page 16
Annex IV:Categories of M. 附件四 : 機械種類 Annex V:List of safety components 附件五 : 安全零組件 Annex IV:Types of M. 附件四 : 機械種類 Annex V: EC Declaration of Conformity 附件五 : 安全零組件 Annex VI:Assembly instructi. partly completed Machinery 附件六 : 組裝說明書 Annex.VI: EC Type Examination 附件六 : 型式驗證 Annex VII: Technical file 附件七 : 技術文件 Annex VIII:Assessment of conformity-manufacture 附件捌 : 機械製造商藉由內檢所做之服符合性評估 Annex VII: Minim. criteria NB 附件七 : 驗證單位最低準則 Void 空白 Annex IX:EC Type Examinat. 附件九 : EC 型式驗證 Annex X: Full quality assurance 附件十 : 全面品質保證 Annex IX: Correlation table 附件九 : 相關表格 Annex XI: Minim. Criteria: NB 附件十一 : 會員國據以考量認可驗證機構之準則 Annex XII: Correlation table 附件十二 : 相關表格 Page 17
Essential improvements new MSD Clear description of scope; 清楚說明範圍 Differentiation against other Directives 其它指令的差異 Procedures for assessing the conformity 評估符合性程序 Procedures for partly completed machinery 半成品機械的程序 Essential requirements adjusted to state of the art 超出於最新技術 Page 18
Strengthening of market surveillance Art.4 Market surveillance (appointment of authorities; predictable misuse) 條款四 : 指定權責單位 Art.9 Specific measures for hazardous machinery 條款九 : 相調和機械的特殊評估 Art.10 Challenging a harmonized standard 條款十 : 調和標準的質疑 Art.11 Safeguard clause ( withdraw from the market, restrict, prohibit ) 條款十一 : 安全防護條款 Art.18 Confidentiality (confidential treatment of warnings) 條款十八 : 保密性 Art.19 Cooperation between Member States 條款十九 : 會員國之間的合作 Page 19
http://ec.europa.eu/consumers/dyna/rapex/rapex_archives_en.cfm Page 20
Modifications in Detail Art.1, Scope Machinery 機械 Interchangeable equipment 可更換設備 Safety components 安全零組件 Lifting accessories 昇降配件 New Chains, ropes and webbing 鍊條. 繩索及帶子 New Removable mechanical transmission device 可移動機械傳動裝置 Partly completed machinery 半成品機械 New Page 21
An assembly, consisting of linked parts or components at least one of which moves; 相關零組件或零組件組合而成至少會有一項移動 Joined together for a specific application; 組合是為了特殊用途 Fitted with or intended to be fitted with a drive system; 安裝組驅動系統 Even missing the connection to source of energy 未連接動力 Even the function is ready for use after it is mounted on a means of transport, or installed in a building or a structure 安裝在一個搬運設備建築物或結構上方可使用 Even if part 1 and part 2 = machine 一項 + 二項方可使用 Even if part 1 and part 2 = partly completed machine 一項 + 二項 = 部分完整機械 Page 22