Document?32010D0087
最近歐盟取消口罩CE認證的事情傳的紛紛揚揚，歐盟到底是不是真的取消了對口罩等防護類產品的CE要求？其實事情是這樣的：一、醫療器械類的口罩（EN14683標準）：◆如果市場監督機構確定產品符合醫療器械的基本安全和性能要求，即使其符合性評價還未完成，市場監督機構可以允許其在一定的時間內進行銷售，同時該產品必須繼續完成其符合性評價過程。◆成員國主管當局也可在疫情期間評估和組織采購沒有CE標記的醫療器械，該產品僅可提供給醫療工作者使用，不能在市場上流通銷售。同時市場抽查將會重點抽查防疫相關醫療器械，以防止不合格產品導致嚴重風險。二、個人防護用品（PPE）類的口罩（EN149標準）：◆涉及的產品包括拋棄式和可重復使用的口罩、可重復使用的工作服、手套和眼罩等（主要是預防病毒和有害物質的產品）。需要具有PPE法規授權資格的公告機構進行符合性評價。◆應急審批產品如果不采用PPE法規協調標準作為產品技術要求而采用其它技術要求，比如WHO的推薦要求，須確保采用的技術要求與PPE法規基本健康與安全要求同等防護水平。公告機構對這類采用其它技術要求的PPE產品進行發證時，需要立即通知主管當局和其它PPE法規的公告機構。◆如果市場監督機構確定產品符合PPE法規的基本健康和安全要求，即使其符合性評價還未完成，市場監督機構可以允許其在一定的時間內進行銷售，同時該產品必須繼續完成其符合性評價過程。◆成員國主管當局也可在疫情期間評估和組織采購沒有CE標記的PPE產品，該產品僅可提供給醫療工作者使用，不能在市場上流通銷售。同時市場抽查將會重點抽查防疫相關PPE產品，以防止不合格產品導致嚴重風險。也就是說，只要處于正在進行符合性評估的過程中，就可以在沒有CE標志的情況下先行進入歐盟市場。由市場監督部門進行抽查，發現問題再進行處罰。重點如下：◆成員國可采購安全有效，但沒有CE標記的醫療產品；◆緊急物資專供醫療人員使用，不可在市場上流通；◆僅疫情期間有效。考慮到《歐洲聯盟運作條約》，特別是其第292條，在當前的COVID-19全球爆發以及病毒在歐盟各個地區的快速傳播的背景下，對個人防護設備（以下稱“PPE”）的需求，例如口罩，手套，防護工作服或眼鏡防護以及用于外科口罩，探查手套和某些禮服等醫療設備的數量呈指數增長。特別是，由于通過現有渠道以及通過新渠道的需求呈指數增長，某些類型的PPE（例如一次性口罩）的供應鏈承受著巨大的壓力。此外，此類產品的全球供應鏈也遭受了嚴重破壞，這也引起了歐盟市場的反響。牢記歐盟公民的健康和安全是重中之重，因此，確保向最需要的人迅速提供最適當的個人防護設備和醫療設備，以確保提供足夠的保護，這一點至關重要。活躍于整個歐盟的經濟運營商正在不懈努力，以提高各自的制造和分銷能力。為了減輕各種破壞性因素的影響，經濟運營商正在通過啟動新的生產線和/或使其供應商基礎多樣化來重新設計其供應鏈。如果供應增加而沒有任何不適當的延誤，則工業利益相關者的這些努力將無法發揮全部作用。有關個人防護設備的設計，制造和投放市場的要求，由歐洲議會和理事會于2016年3月9日頒布的第（EU）2016/425號條例（關于個人防護設備）以及廢除理事會第89/686號指令規定/EEC（1）。1993年6月14日關于醫療器械的理事會指令93/42/EEC對醫療器械的設計，制造和投放市場提出了要求（2）。歐洲議會和2017年4月5日關于醫療器械的理事會（EU）2017/745條例，該指令2001/83/EC，條例（EC）178/2002和條例（EC）的修訂已廢除該指令1223/2009和廢除理事會指令90/385/EEC和93/42/EEC（3），自2020年5月26日起生效。一次性和可重復使用的口罩，可防止顆粒物危害，一次性和可重復使用的工作服，手套和眼鏡防護，用于預防和防止有害生物制劑（如病毒）屬于本法規范圍內的產品（歐盟）2016/425。外科口罩，檢查手套和某些長袍類型的產品屬于93/42/EEC指令和2017/745法規（EU）的范圍。在發生COVID-19威脅的情況下，此類PPE和醫療設備對于參與遏制病毒并避免其進一步傳播的醫護人員，急救人員和其他人員至關重要。（EU）2016/425法規充分協調了PPE的設計，制造和投放市場的規則，并根據PPE的類別（取決于其所面臨的風險）對PPE提出了一些基本的健康和安全要求旨在保護用戶。因此，根據法規（EU）2016/425制造的PPE物品可以在整個內部市場自由流通，成員國不得對此類產品的制造和投放市場引入額外的和不同的要求。93/42/EEC指令和（EU）2017/745法規充分協調了醫療器械聯盟市場的設計，制造和銷售規則，并根據以下內容建立了一些基本要求以及一般安全和性能要求根據受器械預期用途支配的特定規則對醫療器械進行分類。因此，根據理事會指令93/42/EEC和法規（EU）2017/745制造的設備可以在整個內部市場自由流通，成員國不得對此類設備的制造和投放市場引入額外的和不同的要求產品。PPE旨在防止有害生物制劑，如病毒在法規附件I（EU）四百二十五分之二千零十六為III類，其中包括完全可能導致的風險上市“非常嚴重的后果，如死亡或不可逆的損害健康”。根據（EU）2016/425號法規第8條，為了將PPE產品投放市場，制造商應執行適用的合格評定程序，并在符合條件的情況下證明符合適用的基本健康和安全要求按照適當的程序，貼上CE標志。根據指令93/42/EEC的第11條和（EU）2017/745法規的第52條，一旦后者適用，為了將醫療設備投放市場，制造商應執行適用的合格評定程序并且，如果通過適當的程序證明符合適用的基本要求或一般安全和性能要求，請貼上CE標志。會員國可應正當理由要求批準從合格評定程序中減損，以便在有關會員國領土內投放市場并在使用中保護受保護的單個設備健康。法規（EU）2016/425在技術上是中立的，沒有為PPE產品的設計規定任何特定的強制性技術解決方案。相反，法規（EU）2016/425的附件II規定了基本的健康和安全要求，PPE應該滿足這些基本要求，以便能夠投放市場并在整個歐盟市場上自由流通。93/42/EEC指令和法規（EU）2017/745在技術上是中立的，沒有為醫療設備的設計規定任何特定的強制性技術解決方案。相反，指令93/42/EEC的附件I設置了基本要求，法規（EU）2017/745的附件I設置了一般安全性和性能要求，醫療設備應滿足這些要求才能將其放置在市場，并在整個歐盟市場上自由流通。（EU）2016/425號法規第14條為制造商提供了依賴特定技術解決方案的可能性，這些解決方案在統一標準或其部分中進行了詳細說明，其參考文獻已在《歐盟官方雜志》上發表。根據本條，如果制造商選擇采用這樣的技術解決方案，則假定個人防護設備符合上述統一標準或其部分所涵蓋的基本健康和安全要求。但是，并非必須遵守協調標準。制造商可以自由選擇其他技術解決方案，前提是保留的特定解決方案可確保PPE符合適用的基本健康和安全要求。指令93/42/EEC的第5條和法規（EU）2017/745的第8條為制造商提供了依賴特定技術解決方案的可能性，這些解決方案在統一標準或其部分中作了詳細說明，其參考文獻已在歐盟官方雜志。根據本條，如果制造商選擇采用這種技術解決方案，則假定醫療器械符合上述協調標準或其部分所涵蓋的要求。但是，并非必須遵守協調標準。制造商可以自由選擇其他技術解決方案，前提是保留的特定解決方案可確保醫療設備符合適用的基本健康和安全要求。（EU）2016/425號法規第19條規定了具體的合格評定程序，該程序適用于不同類別的PPE。根據本條，第三類個人防護裝備的項目，例如旨在防止有害生物制劑的項目，應進行合格評定程序的特定組合，分別在同一法規的附件V，VII和VIII中進行描述。可能使用的每種不同的合格評定程序都需要第三方合格評定機構的強制參與。93/42/EEC指令的第11條和法規（EU）2017/745的第52條一旦適用，就制定適用于不同類別醫療設備的特定合格評定程序。根據這些條款，屬于第一類的醫療設備（定制或研究用設備除外）應接受EC合格聲明的合格評定程序，而無需第三方合格評定機構的參與。公告機構是成員國指定的合格評定機構，并有權執行法規（EU）2016/425中的第三方合格評定任務。根據第（EU）2016/425號法規第26條第4款和附件V第7點（F）的規定，指定機構必須評估PPE產品是否符合適用的基本健康和安全要求。認證機構不僅需要在制造商采用統一標準的地方進行評估，還需要在制造商遵循其他技術解決方案的情況下進行評估。交付合格評定證書時，指定機構必須通知其通知當局，也可能需要將其簽發的證書通知其他指定機構，因此，公告機構應評估根據其他技術解決方案生產的產品（例如，世衛組織關于適當選擇個人防護裝備的建議中所包含的產品）是否也符合適用的基本健康和安全要求。考慮到確保個人防護裝備供應鏈中所有利益相關者之間有效信息交換的重要性，公告機構得出結論認為，遵循另一項特定標準或技術解決方案的個人防護裝備符合適用于其的基本健康和安全要求，這些信息將有助于快速評估根據同一特定標準或技術解決方案生產的其他產品。為此，此外，根據法規（EU）2016/425中的相關市場監督程序，尤其是其中的第38（1）和（2）條，如果市場監督機構遇到非CE標志的PPE產品，則需要對其進行評估它。市場評估機構在評估過程中發現個人防護設備不符合本規章的要求時，應要求經濟經營者采取糾正措施以使個人防護設備符合要求或召回或撤回它，與風險的性質相稱。他們還應將評估結果以及他們要求經濟經營者采取的行動告知委員會和其他成員國。因此，為了解決在COVID-19爆發時（非CE標志的PPE打算進入歐盟市場）所必需的PPE短缺的問題，相關的市場監督機構應對產品進行評估，如果發現這些產品屬于符合相關法規所規定的基本健康與安全要求的人員，應采取措施，在有限的時間內或在與指定機構進行合格評定程序的同時，將此類PPE投放到歐盟市場。為了確保可以在其他會員國提供此類產品，并考慮到確保有效交換信息以及對對公民健康和安全的所有威脅作出協調反應的重要性，考慮到在COVID-19爆發中使用的某些類型的PPE或醫療設備也可能用于其他目的，有必要使會員國采取一切適當措施，以確保不攜帶PPE或醫療設備的醫療設備。根據本建議書第8段可以在歐盟市場上投放的CE標記僅提供給醫護人員，1.為了確保在COVID-19爆發中提供個人防護設備和醫療設備以提供適當的保護，委員會邀請整個供應鏈中的所有經濟運營商以及指定機構和市場監督機構在其部署中采取所有措施處置以支持旨在確保整個歐盟市場的個人防護設備和醫療設備的供應與不斷增長的需求相匹配的工作。但是，此類措施不應對整體健康和安全水平產生不利影響，所有相關利益相關方應確保投放到歐盟市場的任何個人防護設備或醫療設備繼續為用戶提供足夠的保護水平'健康和安全。根據（EU）2016/425號條例的指定機構，應優先考慮并迅速進行PPE經濟運營商在保護COVID-19時應保護的PPE經濟運營商所有新提交的要求中的合格評定活動。對于遵循非統一標準的技術解決方案生產的PPE產品，只要這些技術解決方案確保足夠的保護水平，WHO關于適當選擇PPE的建議可以用作此類技術解決方案的潛在參考來源。符合法規（EU）2016/425規定的適用基本健康與安全要求。向遵循統一標準以外的其他技術解決方案生產的PPE產品頒發證書的認證機構，應立即將其頒發的證書和遵循的具體技術解決方案通知相關的通報機構以及根據（EU）2016/425條的其他認證機構。公告機構應通過根據法規（EU）2016/425第36條成立的公告機構小組的協調來交換此類信息。就醫療器械而言，根據指令93/42/EEC第11（13）條和法規（EU）2017/745的第59條，還應考慮成員國授權從合格評定程序中減損的可能性。后者在不需要指定機構介入的情況下也適用。成員國的相關市場監督機構應優先關注不合規的個人防護設備或醫療設備，這些設備會對其預期用戶的健康和安全造成嚴重風險。市場監督機構發現PPE或醫療設備可確保根據（EU）2016/425法規或93/42/EEC指令或2017（EU）法規的基本要求確保足夠的健康和安全水平/745，即使尚未按照協調規則完全完成包括CE標志在內的合格評定程序，它們仍可以授權在限定的時間內在歐盟市場上提供這些產品程序正在執行中。不帶CE標志的PPE或醫療設備也可以進行評估，并由相關成員國當局組織購買的一部分，前提是要確保此類產品僅在當前健康危機期間可供醫護人員使用，并確保它們沒有進入常規分銷渠道，并可供其他用戶使用。市場監督機構應立即將其授予特定PPE或醫療設備的任何臨時安排告知委員會和其他成員國。對于個人防護設備，應通過用于市場監視的信息和通信系統（ICSMS）來完成。
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2010/87/: Commission Decision of 5 February 2010 on standard contractual clauses for the transfer of personal data to processors established in third countries under Directive 95/46/EC of the European Parliament and of the Council (notified under document C(2010) 593) (Text with EEA relevance)
2010/87/: Commission Decision of 5 February 2010 on standard contractual clauses for the transfer of personal data to processors established in third countries under Directive 95/46/EC of the European Parliament and of the Council (notified under document C(2010) 593) (Text with EEA relevance)
2010/87/: Commission Decision of 5 February 2010 on standard contractual clauses for the transfer of personal data to processors established in third countries under Directive 95/46/EC of the European Parliament and of the Council (notified under document C(2010) 593) (Text with EEA relevance)
OJ L 39, 12.2.2010, p. 5–18 (BG, ES, CS, DA, DE, ET, EL, EN, FR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
Special edition in Croatian: Chapter 13 Volume 052 P. 250 - 263
In force: This act has been changed. Latest consolidated version: 17/12/2016
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12.2.2010??? |
EN |
Official Journal of the European Union |
L 39/5 |
COMMISSION DECISION
of 5 February 2010
on standard contractual clauses for the transfer of personal data to processors established in third countries under Directive 95/46/EC of the European Parliament and of the Council
(notified under document C(2010) 593)
(Text with EEA relevance)
(2010/87/EU)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data?(1), and in particular Article 26(4) thereof,
After consulting the European Data Protection Supervisor,
Whereas:
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(1) |
Pursuant to Directive 95/46/EC Member States are required to provide that a transfer of personal data to a third country may only take place if the third country in question ensures an adequate level of data protection and the Member States’ laws, which comply with the other provisions of the Directive, are respected prior to the transfer. |
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(2) |
However, Article 26(2) of Directive 95/46/EC provides that Member States may authorise, subject to certain safeguards, a transfer or a set of transfers of personal data to third countries which do not ensure an adequate level of protection. Such safeguards may in particular result from appropriate contractual clauses. |
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(3) |
Pursuant to Directive 95/46/EC the level of data protection should be assessed in the light of all the circumstances surrounding the data transfer operation or set of data transfer operations. The Working Party on the protection of individuals with regard to the processing of personal data established under that Directive has issued guidelines to aid with the assessment. |
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(4) |
Standard contractual clauses should relate only to data protection. Therefore, the data exporter and the data importer are free to include any other clauses on business related issues which they consider as being pertinent for the contract as long as they do not contradict the standard contractual clauses. |
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(5) |
This Decision should be without prejudice to national authorisations Member States may grant in accordance with national provisions implementing Article 26(2) of Directive 95/46/EC. This Decision should only have the effect of requiring the Member States not to refuse to recognise, as providing adequate safeguards, the standard contractual clauses set out in it and should not therefore have any effect on other contractual clauses. |
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(6) |
Commission Decision 2002/16/EC of 27 December 2001 on standard contractual clauses for the transfer of personal data to processors established in third countries, under Directive 95/46/EC?(2) was adopted in order to facilitate the transfer of personal data from a data controller established in the European Union to a processor established in a third country which does not offer adequate level of protection. |
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(7) |
Much experience has been gained since the adoption of Decision 2002/16/EC. In addition, the report on the implementation of Decisions on standard contractual clauses for the transfers of personal data to third countries?(3) has shown that there is an increasing interest in promoting the use of the standard contractual clauses for international transfers of personal data to third countries not providing an adequate level of protection. In addition, stakeholders have submitted proposals with a view to updating the standard contractual clauses set out in Decision 2002/16/EC in order to take account of the rapidly expanding scope of data-processing activities in the world and to address some issues that were not covered by that Decision?(4). |
|
(8) |
The scope of this Decision should be limited to establishing that the clauses which it sets out may be used by a data controller established in the European Union in order to adduce adequate safeguards within the meaning of Article 26(2) of Directive 95/46/EC for the transfer of personal data to a processor established in a third country. |
|
(9) |
This Decision should not apply to the transfer of personal data by controllers established in the European Union to controllers established outside the European Union which fall within the scope of Commission Decision 2001/497/EC of 15 June 2001 on standard contractual clauses for the transfer of personal data to third countries, under Directive 95/46/EC?(5). |
|
(10) |
This Decision should implement the obligation provided for in Article 17(3) of Directive 95/46/EC and should not prejudice the content of the contracts or legal acts established pursuant to that provision. However, some of the standard contractual clauses, in particular as regards the data exporter’s obligations, should be included in order to increase clarity as to the provisions which may be contained in a contract between a controller and a processor. |
|
(11) |
Supervisory authorities of the Member States play a key role in this contractual mechanism in ensuring that personal data are adequately protected after the transfer. In exceptional cases where data exporters refuse or are unable to instruct the data importer properly, with an imminent risk of grave harm to the data subjects, the standard contractual clauses should allow the supervisory authorities to audit data importers and sub-processors and, where appropriate, take decisions which are binding on data importers and sub-processors. The supervisory authorities should have the power to prohibit or suspend a data transfer or a set of transfers based on the standard contractual clauses in those exceptional cases where it is established that a transfer on contractual basis is likely to have a substantial adverse effect on the warranties and obligations providing adequate protection for the data subject. |
|
(12) |
Standard contractual clauses should provide for the technical and organisational security measures to be applied by data processors established in a third country not providing adequate protection, in order to ensure a level of security appropriate to the risks represented by the processing and the nature of the data to be protected. Parties should make provision in the contract for those technical and organisational measures which, having regard to applicable data protection law, the state of the art and the cost of their implementation, are necessary in order to protect personal data against accidental or unlawful destruction or accidental loss, alteration, unauthorised disclosure or access or any other unlawful forms of processing. |
|
(13) |
In order to facilitate data flows from the European Union, it is desirable for processors providing data-processing services to several data controllers in the European Union to be allowed to apply the same technical and organisational security measures irrespective of the Member State from which the data transfer originates, in particular in those cases where the data importer receives data for further processing from different establishments of the data exporter in the European Union, in which case the law of the designated Member State of establishment should apply. |
|
(14) |
It is appropriate to lay down the minimum information that the parties should specify in the contract dealing with the transfer. Member States should retain the power to particularise the information the parties are required to provide. The operation of this Decision should be reviewed in the light of experience. |
|
(15) |
The data importer should process the transferred personal data only on behalf of the data exporter and in accordance with his instructions and the obligations contained in the clauses. In particular the data importer should not disclose the personal data to a third party without the prior written consent of the data exporter. The data exporter should instruct the data importer throughout the duration of the data-processing services to process the data in accordance with his instructions, the applicable data protection laws and the obligations contained in the clauses. |
|
(16) |
The report on the implementation of Decisions on standard contractual clauses for the transfers of personal data to third countries recommended the establishment of appropriate standard contractual clauses on subsequent onwards transfers from a data processor established in a third country to another data processor (sub-processing), in order to take account of business trends and practices for more and more globalised processing activity. |
|
(17) |
This Decision should contain specific standard contractual clauses on the sub-processing by a data processor established in a third country (the data importer) of his processing services to other processors (sub-processors) established in third countries. In addition, this Decision should set out the conditions that the sub-processing should fulfil to ensure that the personal data being transferred continue to be protected notwithstanding the subsequent transfer to a sub-processor. |
|
(18) |
In addition, the sub-processing should only consist of the operations agreed in the contract between the data exporter and the data importer incorporating the standard contractual clauses provided for in this Decision and should not refer to different processing operations or purposes so that the purpose limitation principle set out by Directive 95/46/EC is respected. Moreover, where the sub-processor fails to fulfil his own data-processing obligations under the contract, the data importer should remain liable toward the data exporter. The transfer of personal data to processors established outside the European Union should not prejudice the fact that the processing activities should be governed by the applicable data protection law. |
|
(19) |
Standard contractual clauses should be enforceable not only by the organisations which are parties to the contract, but also by the data subjects, in particular where the data subjects suffer damage as a consequence of a breach of the contract. |
|
(20) |
The data subject should be entitled to take action and, where appropriate, receive compensation from the data exporter who is the data controller of the personal data transferred. Exceptionally, the data subject should also be entitled to take action, and, where appropriate, receive compensation from the data importer in those cases, arising out of a breach by the data importer or any sub-processor under it of any of its obligations referred to in the paragraph 2 of Clause 3, where the data exporter has factually disappeared or has ceased to exist in law or has become insolvent. Exceptionally, the data subject should be also entitled to take action, and, where appropriate, receive compensation from a sub-processor in those situations where both the data exporter and the data importer have factually disappeared or ceased to exist in law or have become insolvent. Such third-party liability of the sub-processor should be limited to its own processing operations under the contractual clauses. |
|
(21) |
In the event of a dispute between a data subject, who invokes the third-party beneficiary clause, and the data importer, which is not amicably resolved, the data importer should offer the data subject a choice between mediation or litigation. The extent to which the data subject will have an effective choice will depend on the availability of reliable and recognised systems of mediation. Mediation by the data protection supervisory authorities of the Member State in which the data exporter is established should be an option where they provide such a service. |
|
(22) |
The contract should be governed by the law of the Member State in which the data exporter is established enabling a third-party beneficiary to enforce a contract. Data subjects should be allowed to be represented by associations or other bodies if they so wish and if authorised by national law. The same law should also govern the provisions on data protection of any contract with a sub-processor for the sub-processing of the processing activities of the personal data transferred by the data exporter to the data importer under the contractual clauses. |
|
(23) |
Since this Decision applies only to subcontracting by a data processor established in a third country of his processing services to a sub-processor established in a third country, it should not apply to the situation by which a processor established in the European Union and performing the processing of personal data on behalf of a controller established in the European Union subcontracts his processing operations to a sub-processor established in a third country. In such situations, Member States are free whether to take account of the fact that the principles and safeguards of the standard contractual clauses set out in this Decision have been used to subcontract to a sub-processor established in a third country with the intention of providing adequate protection for the rights of data subjects whose personal data are being transferred for sub-processing operations. |
|
(24) |
The Working Party on the protection of individuals with regard to the processing of personal data established under Article 29 of Directive 95/46/EC has delivered an opinion on the level of protection provided under the standard contractual clauses annexed to this Decision, which has been taken into account in the preparation of this Decision. |
|
(25) |
Decision 2002/16/EC should be repealed. |
|
(26) |
The measures provided for in this Decision are in accordance with the opinion of the Committee established under Article 31 of Directive 95/46/EC, |
HAS ADOPTED THIS DECISION:
Article 1
The standard contractual clauses set out in the Annex are considered as offering adequate safeguards with respect to the protection of the privacy and fundamental rights and freedoms of individuals and as regards the exercise of the corresponding rights as required by Article 26(2) of Directive 95/46/EC.
Article 2
This Decision concerns only the adequacy of protection provided by the standard contractual clauses set out in the Annex for the transfer of personal data to processors. It does not affect the application of other national provisions implementing Directive 95/46/EC that pertain to the processing of personal data within the Member States.
This Decision shall apply to the transfer of personal data by controllers established in the European Union to recipients established outside the territory of the European Union who act only as processors.
Article 3
For the purposes of this Decision the following definitions shall apply:
|
(a) |
‘special categories of data’ means the data referred to in Article 8 of Directive 95/46/EC; |
|
(b) |
‘supervisory authority’ means the authority referred to in Article 28 of Directive 95/46/EC; |
|
(c) |
‘data exporter’ means the controller who transfers the personal data; |
|
(d) |
‘data importer’ means the processor established in a third country who agrees to receive from the data exporter personal data intended for processing on the data exporter’s behalf after the transfer in accordance with his instructions and the terms of this Decision and who is not subject to a third country’s system ensuring adequate protection within the meaning of Article 25(1) of Directive 95/46/EC; |
|
(e) |
‘sub-processor’ means any processor engaged by the data importer or by any other sub-processor of the data importer and who agrees to receive from the data importer or from any other sub-processor of the data importer personal data exclusively intended for the processing activities to be carried out on behalf of the data exporter after the transfer in accordance with the data exporter’s instructions, the standard contractual clauses set out in the Annex, and the terms of the written contract for sub-processing; |
|
(f) |
‘applicable data protection law’ means the legislation protecting the fundamental rights and freedoms of individuals and, in particular, their right to privacy with respect to the processing of personal data applicable to a data controller in the Member State in which the data exporter is established; |
|
(g) |
‘technical and organisational security measures’ means those measures aimed at protecting personal data against accidental or unlawful destruction or accidental loss, alteration, unauthorised disclosure or access, in particular where the processing involves the transmission of data over a network, and against all other unlawful forms of processing. |
Article 4
1.???Without prejudice to their powers to take action to ensure compliance with national provisions adopted pursuant to Chapters II, III, V and VI of Directive 95/46/EC, the competent authorities in the Member States may exercise their existing powers to prohibit or suspend data flows to third countries in order to protect individuals with regard to the processing of their personal data in cases where:
|
(a) |
it is established that the law to which the data importer or a sub-processor is subject imposes upon him requirements to derogate from the applicable data protection law which go beyond the restrictions necessary in a democratic society as provided for in Article 13 of Directive 95/46/EC where those requirements are likely to have a substantial adverse effect on the guarantees provided by the applicable data protection law and the standard contractual clauses; |
|
(b) |
a competent authority has established that the data importer or a sub-processor has not respected the standard contractual clauses in the Annex; or |
|
(c) |
there is a substantial likelihood that the standard contractual clauses in the Annex are not being or will not be complied with and the continuing transfer would create an imminent risk of grave harm to the data subjects. |
2.???The prohibition or suspension pursuant to paragraph 1 shall be lifted as soon as the reasons for the suspension or prohibition no longer exist.
3.???When Member States adopt measures pursuant to paragraphs 1 and 2, they shall, without delay, inform the Commission which will forward the information to the other Member States.
Article 5
The Commission shall evaluate the operation of this Decision on the basis of available information three years after its adoption. It shall submit a report on the findings to the Committee established under Article 31 of Directive 95/46/EC. It shall include any evidence that could affect the evaluation concerning the adequacy of the standard contractual clauses in the Annex and any evidence that this Decision is being applied in a discriminatory way.
Article 6
This Decision shall apply from 15 May 2010.
Article 7
1.???Decision 2002/16/EC is repealed with effect from 15 May 2010.
2.???A contract concluded between a data exporter and a data importer pursuant to Decision 2002/16/EC before 15 May 2010 shall remain in force and effect for as long as the transfers and data-processing operations that are the subject matter of the contract remain unchanged and personal data covered by this Decision continue to be transferred between the parties. Where contracting parties decide to make changes in this regard or subcontract the processing operations that are the subject matter of the contract they shall be required to enter into a new contract which shall comply with the standard contractual clauses set out in the Annex.
Article 8
This Decision is addressed to the Member States.
Done at Brussels, 5 February 2010.
For the Commission
Jacques BARROT
Vice-President
(1)??OJ L?281, 23.11.1995, p.?31.
(2)??OJ L?6, 10.1.2002, p.?52.
(3)??SEC(2006) 95, 20.1.2006.
(4)??The International Chamber of Commerce (ICC), Japan Business Council in Europe (JBCE), EU Committee of the American Chamber of Commerce in Belgium (Amcham), and the Federation of European Direct Marketing Associations (FEDMA).
(5)??OJ L?181, 4.7.2001, p.?19.
ANNEX
STANDARD CONTRACTUAL CLAUSES (PROCESSORS)
For the purposes of Article 26(2) of Directive 95/46/EC for the transfer of personal data to processors established in third countries which do not ensure an adequate level of data protection
Name of the data exporting organisation: …
Address: …
Tel. …; fax …; e-mail: …
Other information needed to identify the organisation
…
(the data exporter)
And
Name of the data importing organisation: …
Address: …
Tel. …; fax …; e-mail: …
Other information needed to identify the organisation:
…
(the data importer)
each a ‘party’; together ‘the parties’,
HAVE AGREED on the following Contractual Clauses (the Clauses) in order to adduce adequate safeguards with respect to the protection of privacy and fundamental rights and freedoms of individuals for the transfer by the data exporter to the data importer of the personal data specified in Appendix 1.
Clause 1
Definitions
For the purposes of the Clauses:
|
(a) |
‘personal data’, ‘special categories of data’, ‘process/processing’, ‘controller’, ‘processor’, ‘data subject’ and ‘supervisory authority’ shall have the same meaning as in Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data?(1); |
|
(b) |
‘the data exporter’ means the controller who transfers the personal data; |
|
(c) |
‘the data importer’ means the processor who agrees to receive from the data exporter personal data intended for processing on his behalf after the transfer in accordance with his instructions and the terms of the Clauses and who is not subject to a third country’s system ensuring adequate protection within the meaning of Article 25(1) of Directive 95/46/EC; |
|
(d) |
‘the sub-processor’ means any processor engaged by the data importer or by any other sub-processor of the data importer who agrees to receive from the data importer or from any other sub-processor of the data importer personal data exclusively intended for processing activities to be carried out on behalf of the data exporter after the transfer in accordance with his instructions, the terms of the Clauses and the terms of the written subcontract; |
|
(e) |
‘the applicable data protection law’ means the legislation protecting the fundamental rights and freedoms of individuals and, in particular, their right to privacy with respect to the processing of personal data applicable to a data controller in the Member State in which the data exporter is established; |
|
(f) |
‘technical and organisational security measures’ means those measures aimed at protecting personal data against accidental or unlawful destruction or accidental loss, alteration, unauthorised disclosure or access, in particular where the processing involves the transmission of data over a network, and against all other unlawful forms of processing. |
Clause 2
Details of the transfer
The details of the transfer and in particular the special categories of personal data where applicable are specified in Appendix 1 which forms an integral part of the Clauses.
Clause 3
Third-party beneficiary clause
|
1. |
The data subject can enforce against the data exporter this Clause, Clause 4(b) to (i), Clause 5(a) to (e), and (g) to (j), Clause 6(1) and (2), Clause 7, Clause 8(2), and Clauses 9 to 12 as third-party beneficiary. |
|
2. |
The data subject can enforce against the data importer this Clause, Clause 5(a) to (e) and (g), Clause 6, Clause 7, Clause 8(2), and Clauses 9 to 12, in cases where the data exporter has factually disappeared or has ceased to exist in law unless any successor entity has assumed the entire legal obligations of the data exporter by contract or by operation of law, as a result of which it takes on the rights and obligations of the data exporter, in which case the data subject can enforce them against such entity. |
|
3. |
The data subject can enforce against the sub-processor this Clause, Clause 5(a) to (e) and (g), Clause 6, Clause 7, Clause 8(2), and Clauses 9 to 12, in cases where both the data exporter and the data importer have factually disappeared or ceased to exist in law or have become insolvent, unless any successor entity has assumed the entire legal obligations of the data exporter by contract or by operation of law as a result of which it takes on the rights and obligations of the data exporter, in which case the data subject can enforce them against such entity. Such third-party liability of the sub-processor shall be limited to its own processing operations under the Clauses. |
|
4. |
The parties do not object to a data subject being represented by an association or other body if the data subject so expressly wishes and if permitted by national law. |
Clause 4
Obligations of the data exporter
The data exporter agrees and warrants:
|
(a) |
that the processing, including the transfer itself, of the personal data has been and will continue to be carried out in accordance with the relevant provisions of the applicable data protection law (and, where applicable, has been notified to the relevant authorities of the Member State where the data exporter is established) and does not violate the relevant provisions of that State; |
|
(b) |
that it has instructed and throughout the duration of the personal data-processing services will instruct the data importer to process the personal data transferred only on the data exporter’s behalf and in accordance with the applicable data protection law and the Clauses; |
|
(c) |
that the data importer will provide sufficient guarantees in respect of the technical and organisational security measures specified in Appendix 2 to this contract; |
|
(d) |
that after assessment of the requirements of the applicable data protection law, the security measures are appropriate to protect personal data against accidental or unlawful destruction or accidental loss, alteration, unauthorised disclosure or access, in particular where the processing involves the transmission of data over a network, and against all other unlawful forms of processing, and that these measures ensure a level of security appropriate to the risks presented by the processing and the nature of the data to be protected having regard to the state of the art and the cost of their implementation; |
|
(e) |
that it will ensure compliance with the security measures; |
|
(f) |
that, if the transfer involves special categories of data, the data subject has been informed or will be informed before, or as soon as possible after, the transfer that its data could be transmitted to a third country not providing adequate protection within the meaning of Directive 95/46/EC; |
|
(g) |
to forward any notification received from the data importer or any sub-processor pursuant to Clause 5(b) and Clause 8(3) to the data protection supervisory authority if the data exporter decides to continue the transfer or to lift the suspension; |
|
(h) |
to make available to the data subjects upon request a copy of the Clauses, with the exception of Appendix 2, and a summary description of the security measures, as well as a copy of any contract for sub-processing services which has to be made in accordance with the Clauses, unless the Clauses or the contract contain commercial information, in which case it may remove such commercial information; |
|
(i) |
that, in the event of sub-processing, the processing activity is carried out in accordance with Clause 11 by a sub-processor providing at least the same level of protection for the personal data and the rights of data subject as the data importer under the Clauses; and |
|
(j) |
that it will ensure compliance with Clause 4(a) to (i). |
Clause 5
Obligations of the data importer ?(2)
The data importer agrees and warrants:
|
(a) |
to process the personal data only on behalf of the data exporter and in compliance with its instructions and the Clauses; if it cannot provide such compliance for whatever reasons, it agrees to inform promptly the data exporter of its inability to comply, in which case the data exporter is entitled to suspend the transfer of data and/or terminate the contract; |
|
(b) |
that it has no reason to believe that the legislation applicable to it prevents it from fulfilling the instructions received from the data exporter and its obligations under the contract and that in the event of a change in this legislation which is likely to have a substantial adverse effect on the warranties and obligations provided by the Clauses, it will promptly notify the change to the data exporter as soon as it is aware, in which case the data exporter is entitled to suspend the transfer of data and/or terminate the contract; |
|
(c) |
that it has implemented the technical and organisational security measures specified in Appendix 2 before processing the personal data transferred; |
|
(d) |
that it will promptly notify the data exporter about:
|
|
(e) |
to deal promptly and properly with all inquiries from the data exporter relating to its processing of the personal data subject to the transfer and to abide by the advice of the supervisory authority with regard to the processing of the data transferred; |
|
(f) |
at the request of the data exporter to submit its data-processing facilities for audit of the processing activities covered by the Clauses which shall be carried out by the data exporter or an inspection body composed of independent members and in possession of the required professional qualifications bound by a duty of confidentiality, selected by the data exporter, where applicable, in agreement with the supervisory authority; |
|
(g) |
to make available to the data subject upon request a copy of the Clauses, or any existing contract for sub-processing, unless the Clauses or contract contain commercial information, in which case it may remove such commercial information, with the exception of Appendix 2 which shall be replaced by a summary description of the security measures in those cases where the data subject is unable to obtain a copy from the data exporter; |
|
(h) |
that, in the event of sub-processing, it has previously informed the data exporter and obtained its prior written consent; |
|
(i) |
that the processing services by the sub-processor will be carried out in accordance with Clause 11; |
|
(j) |
to send promptly a copy of any sub-processor agreement it concludes under the Clauses to the data exporter. |
Clause 6
Liability
|
1. |
The parties agree that any data subject, who has suffered damage as a result of any breach of the obligations referred to in Clause 3 or in Clause 11 by any party or sub-processor is entitled to receive compensation from the data exporter for the damage suffered. |
|
2. |
If a data subject is not able to bring a claim for compensation in accordance with paragraph 1 against the data exporter, arising out of a breach by the data importer or his sub-processor of any of their obligations referred to in Clause 3 or in Clause 11, because the data exporter has factually disappeared or ceased to exist in law or has become insolvent, the data importer agrees that the data subject may issue a claim against the data importer as if it were the data exporter, unless any successor entity has assumed the entire legal obligations of the data exporter by contract of by operation of law, in which case the data subject can enforce its rights against such entity. The data importer may not rely on a breach by a sub-processor of its obligations in order to avoid its own liabilities. |
|
3. |
If a data subject is not able to bring a claim against the data exporter or the data importer referred to in paragraphs 1 and 2, arising out of a breach by the sub-processor of any of their obligations referred to in Clause 3 or in Clause 11 because both the data exporter and the data importer have factually disappeared or ceased to exist in law or have become insolvent, the sub-processor agrees that the data subject may issue a claim against the data sub-processor with regard to its own processing operations under the Clauses as if it were the data exporter or the data importer, unless any successor entity has assumed the entire legal obligations of the data exporter or data importer by contract or by operation of law, in which case the data subject can enforce its rights against such entity. The liability of the sub-processor shall be limited to its own processing operations under the Clauses. |
Clause 7
Mediation and jurisdiction
|
1. |
The data importer agrees that if the data subject invokes against it third-party beneficiary rights and/or claims compensation for damages under the Clauses, the data importer will accept the decision of the data subject:
|
|
2. |
The parties agree that the choice made by the data subject will not prejudice its substantive or procedural rights to seek remedies in accordance with other provisions of national or international law. |
Clause 8
Cooperation with supervisory authorities
|
1. |
The data exporter agrees to deposit a copy of this contract with the supervisory authority if it so requests or if such deposit is required under the applicable data protection law. |
|
2. |
The parties agree that the supervisory authority has the right to conduct an audit of the data importer, and of any sub-processor, which has the same scope and is subject to the same conditions as would apply to an audit of the data exporter under the applicable data protection law. |
|
3. |
The data importer shall promptly inform the data exporter about the existence of legislation applicable to it or any sub-processor preventing the conduct of an audit of the data importer, or any sub-processor, pursuant to paragraph 2. In such a case the data exporter shall be entitled to take the measures foreseen in Clause 5(b). |
Clause 9
Governing law
The Clauses shall be governed by the law of the Member State in which the data exporter is established, namely …
Clause 10
Variation of the contract
The parties undertake not to vary or modify the Clauses. This does not preclude the parties from adding clauses on business related issues where required as long as they do not contradict the Clause.
Clause 11
Sub-processing
|
1. |
The data importer shall not subcontract any of its processing operations performed on behalf of the data exporter under the Clauses without the prior written consent of the data exporter. Where the data importer subcontracts its obligations under the Clauses, with the consent of the data exporter, it shall do so only by way of a written agreement with the sub-processor which imposes the same obligations on the sub-processor as are imposed on the data importer under the Clauses?(3). Where the sub-processor fails to fulfil its data protection obligations under such written agreement the data importer shall remain fully liable to the data exporter for the performance of the sub-processor’s obligations under such agreement. |
|
2. |
The prior written contract between the data importer and the sub-processor shall also provide for a third-party beneficiary clause as laid down in Clause 3 for cases where the data subject is not able to bring the claim for compensation referred to in paragraph 1 of Clause 6 against the data exporter or the data importer because they have factually disappeared or have ceased to exist in law or have become insolvent and no successor entity has assumed the entire legal obligations of the data exporter or data importer by contract or by operation of law. Such third-party liability of the sub-processor shall be limited to its own processing operations under the Clauses. |
|
3. |
The provisions relating to data protection aspects for sub-processing of the contract referred to in paragraph 1 shall be governed by the law of the Member State in which the data exporter is established, namely … |
|
4. |
The data exporter shall keep a list of sub-processing agreements concluded under the Clauses and notified by the data importer pursuant to Clause 5(j), which shall be updated at least once a year. The list shall be available to the data exporter’s data protection supervisory authority. |
Clause 12
Obligation after the termination of personal data-processing services
|
1. |
The parties agree that on the termination of the provision of data-processing services, the data importer and the sub-processor shall, at the choice of the data exporter, return all the personal data transferred and the copies thereof to the data exporter or shall destroy all the personal data and certify to the data exporter that it has done so, unless legislation imposed upon the data importer prevents it from returning or destroying all or part of the personal data transferred. In that case, the data importer warrants that it will guarantee the confidentiality of the personal data transferred and will not actively process the personal data transferred anymore. |
|
2. |
The data importer and the sub-processor warrant that upon request of the data exporter and/or of the supervisory authority, it will submit its data-processing facilities for an audit of the measures referred to in paragraph 1. |
On behalf of the data exporter:
Name (written out in full): …
Position: …
Address: …
Other information necessary in order for the contract to be binding (if any):
|
|
Signature … |
On behalf of the data importer:
Name (written out in full): …
Position: …
Address: …
Other information necessary in order for the contract to be binding (if any):
|
|
Signature … |
(1)??Parties may reproduce definitions and meanings contained in Directive 95/46/EC within this Clause if they considered it better for the contract to stand alone.
(2)??Mandatory requirements of the national legislation applicable to the data importer which do not go beyond what is necessary in a democratic society on the basis of one of the interests listed in Article 13(1) of Directive 95/46/EC, that is, if they constitute a necessary measure to safeguard national security, defence, public security, the prevention, investigation, detection and prosecution of criminal offences or of breaches of ethics for the regulated professions, an important economic or financial interest of the State or the protection of the data subject or the rights and freedoms of others, are not in contradiction with the standard contractual clauses. Some examples of such mandatory requirements which do not go beyond what is necessary in a democratic society are, inter alia, internationally recognised sanctions, tax-reporting requirements or anti-money-laundering reporting requirements.
(3)??This requirement may be satisfied by the sub-processor co-signing the contract entered into between the data exporter and the data importer under this Decision.
Appendix 1
to the Standard Contractual Clauses
This Appendix forms part of the Clauses and must be completed and signed by the parties
The Member States may complete or specify, according to their national procedures, any additional necessary information to be contained in this Appendix
Data exporter
The data exporter is (please specify briefly your activities relevant to the transfer):
…
…
…
Data importer
The data importer is (please specify briefly activities relevant to the transfer):
…
…
…
Data subjects
The personal data transferred concern the following categories of data subjects (please specify):
…
…
…
Categories of data
The personal data transferred concern the following categories of data (please specify):
…
…
…
Special categories of data (if appropriate)
The personal data transferred concern the following special categories of data (please specify):
…
…
…
Processing operations
The personal data transferred will be subject to the following basic processing activities (please specify):
…
…
…
|
? |
DATA EXPORTER Name: … Authorised Signature … |
|
? |
DATA IMPORTER Name: … Authorised Signature … |
Appendix 2
to the Standard Contractual Clauses
This Appendix forms part of the Clauses and must be completed and signed by the parties.
Description of the technical and organisational security measures implemented by the data importer in accordance with Clauses 4(d) and 5(c) (or document/legislation attached):
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ILLUSTRATIVE INDEMNIFICATION CLAUSE (OPTIONAL)
Liability
The parties agree that if one party is held liable for a violation of the clauses committed by the other party, the latter will, to the extent to which it is liable, indemnify the first party for any cost, charge, damages, expenses or loss it has incurred.
Indemnification is contingent upon:
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(a) |
the data exporter promptly notifying the data importer of a claim; and |
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(b) |
the data importer being given the possibility to cooperate with the data exporter in the defence and settlement of the claim?(1). |
(1)??Paragraph on liabilities is optional.