2017年12月29日歐盟發(fā)布的附錄1草案的第4章，與2007年附錄1中的“人員”部分相比，有較大的變化。新修改的條款在大部分都是根據(jù)行業(yè)先進的實踐做法，很大程度上改進了2007版附錄中不明確的條款。
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附錄1第四章人員章節(jié)，與前一版本的主要變化分類解讀的摘譯如下：
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Chapter 4 contains 16 clauses, compared with 10 from the 2007 version. Only 4 clauses are brand new, with others previously located in different sections of Annex.
新的附錄1第四章有16條，2007版只有10條。這16條中有4條是全新的。
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以下為本文中的術語解釋：
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Brand New–clauses which do not have any?significant correlation to an existing clause from the 2007 version of Annex 1. Each clause is categorized for potential impact individually.
全新的——與附件1的2007版本中的現(xiàn)有條款沒有任何相關性的條款。每個條款分別針對潛在的影響進行分類。
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Negligible Change–clauses that will not, or are unlikely to, require action to ensure compliance. These may be exact or near copies of previous clauses, or they may be reworded clauses where the intent has not changed.
輕微的變化——可能不需要采取行動來確保合規(guī)的條款。可能是和前一版本條款的同樣的條款，或是意思沒有改變但重新進行描述的條款。
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Minor Change–clauses which are likely only to affect a small number of manufacturers and require only a relatively small effort to become compliant.
微小變化——可能只影響少數(shù)提供企業(yè)的條款，只需要相對較小的努力就可以符合規(guī)定。
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Moderate Change–Still a relatively small number of affected manufacturers, but requiring greater effort for compliance.
中等變化——只有相對較少的提供企業(yè)受到影響，需要很多的努力以達到合規(guī)。
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Significant Change?- Even with the significant?changes, there will be some manufacturers whose practices already align with the new clauses. These changes will be significant because the number of manufacturers currently non-compliant is notably higher than for other?changes, and/or the effort to ddress compliance is likely to be?substantial compared with other changes.
重大變化——即使有重大變化，也會有一些提供企業(yè)的做法已經(jīng)與新的條款保持一致。這些變化將是非常重要的，因為目前不合規(guī)的提供企業(yè)數(shù)量明顯高于其他的變化，并且/或者與其他變化相比，需要達到合規(guī)的難度更大。
Brand New Clauses in Chapter 4
第四章中全新的條款
Clauses with Negligible Change in Chapter 4
第四章中輕微改變
Clauses with Minor Change in Chapter 4
第四章中的微小改變
Clauses with Moderate Change in Chapter 4
第四章中的中等改變
Clauses with Significant Change in Chapter 4
第四章中的重大改變
