EN PPE 2016 425 中英文对照翻译版

REGULATION (EU) 2016/425 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 9 March 2016 on personal protective equipment and repealing Council

Directive 89/686/EEC

(Text with EEA relevance)

欧洲议会和理事会条例(欧盟)2016/425 2016年3月9日关于个人防护装备和废除理事会第89/686/EEC号指令 (与EEA相关的文本)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the

Treaty on the Functioning of the European Union, and in particular Article

114 thereof, Having regard to the proposal from the European Commission, After

transmission of the draft legislative act to the national parliaments, Having

Acting

regard to the opinion of the European Economic and Social Committee (1

),

in accordance with the ordinary legislative procedure (2

),

 Whereas:

欧洲议会和欧盟理事会，考虑到《欧洲联盟运作条约》，特别是其中第114条，考虑到欧洲委员会的建议，将立法草案送交各国议会后，考虑到欧洲经济和社会委员会(1)的意见，按照通常的立法程序行事(2)，而: 

(1)

 Council Directive 89/686/EEC (3

) was adopted in the context of establishing

the internal market, in order to harmonise health and safety requirements

for personal protective equipment (PPE) in all Member States and to remove

obstacles to trade in PPE between Member States.

理事会第89/686/EEC(3)号指令是在建立国内市场的范围内采用的，为了协调所有成员国对个人防护装备(PPE)的健康和安全要求和消除成员国之间个人防护装备贸易的障碍。 

(2)

 Directive 89/686/EEC is based on the ‘new approach’ principles, as set out

in the Council Resolution of 7 May 1985 on a new approach to technical

harmonisation and standards (4

). Thus, it sets only the essential

 requirements applying to PPE, whereas technical details are adopted by the

European Committee for Standardisation (CEN) and the European Committee for

Electrotechnical Standardisation (Cenelec) in accordance with Regulation (EU)

No 1025/2012 of the European Parliament and of the Council (5

). Conformity

with the harmonised standards so set, the reference numbers of which are

published in the Official Journal of the European Union, provides a

presumption of conformity with the requirements of Directive 89/686/EEC.

Experience has shown that those basic principles have worked well in that

sector and should be maintained and even further promoted.

指令89/686/EEC以“新方法”原则为基础，如理事会1985年5月7日关于技术协调和标准的新方法的决议所述(4)。因此，它仅设立了适用于PPE的基本要求,而技术细节是采用欧洲标准化委员会(CEN)和欧洲电工标准化委员会(Cenelec)按照规定(欧盟)没有1025/2012的欧洲议会和理事会(5)。符合如此制定的协调标准，其参考编号发表在欧洲官方杂志上，提供符合89/686/EEC指令要求的推定。经验表明这些基本原则在该部门已取得良好效果，应予以维持，甚至进一步维持提升。 

(3)

 Experience with the application of Directive 89/686/EEC has shown inadequacies

and inconsistencies in the product coverage and conformity assessment

procedures. In order to take account of that experience and to provide

clarification in relation to the framework within which products covered by

this Regulation may be made available on the market, certain aspects of

Directive 89/686/EEC should be revised and enhanced.

使用89/686/EEC指令的经验表明，在产品覆盖范围和合格评估程序方面存在着不足和不一致之处。为了考虑到这一方面并阐明本条例所涉产品可在市场上销售的框架，应修订和加强第89/686/EEC号指令的某些方面。 

(4)

 Since the scope, the essential health and safety requirements and conformity

assessment procedures have to be identical in all the Member States there

is almost no flexibility in transposing a directive based on the new approach

principles into national law. Directive 89/686/EEC should therefore be

replaced by a regulation, which is the appropriate legal instrument for

imposing clear and detailed rules which do not give room for divergent

 transposition by Member States.

由于范围、基本卫生和安全要求以及合格评定程序在所有会员国必须是相同的，因此在将基于新方法原则的指示转到国际法方面几乎没有灵活性。因此，指令89/686/EEC应被一项条例取代，即实施明确和详细规则的适当法律文书，这些规则不给成员国间的不同转位留有空间。 

(5)

 Regulation (EC) No 765/2008 of the European Parliament and of the Council

(6

) lays down rules on the accreditation of conformity assessment bodies,

provides a framework for the market surveillance of products and for controls

on products from third countries, and lays down the general principles of

the CE marking.

监管(EC) 765/2008号的欧洲议会和理事会(6)制定了规则合格评估机构的认证,

为来自第三国的市场监测和控制的产品提供了一个框架,并下达了CE标志的一般原则。

(6) Decision No 768/2008/EC of the European Parliament and of the Council

(1

) lays down common principles and reference provisions intended to apply

across sectoral legislation. In order to ensure consistency with other

 sectoral product legislation, it is appropriate to align certain provisions

of this Regulation to that Decision, in so far as sectoral specificities do

not require a different solution. Therefore, certain definitions, the general

 obligations of economic operators, the presumption of conformity, EU

declaration of conformity, rules on CE marking, requirements for conformity

assessment bodies and notification procedures, the conformity assessment

procedures and the provisions concerning procedures to deal with PPE

presenting a risk should be adapted to that Decision.

欧洲议会和理事会第768/2008/EC号决定(1)规定了旨在适用于所有部门立法的共同原则和参考条款。以确保与他人的一致性部门产品立法，只要部门的具体情况不需要不同的解决办法，就应使本条例的某些规定与该决定相一致。因此，某些定义，一般经济经营者的义务、合格推定、欧盟合格声明、CE标识规则、合格性评估机构要求和通知程序、符合性评估有关处理存在危险的个人防护用品的程序和规定应适用于该决定。 

(7)

 Regulation (EU) No 1025/2012 provides for a procedure for objections to

harmonised standards where those standards do not entirely satisfy the

requirements of this Regulation.

规例(欧洲联盟)第1025/2012号指明了在协调标准不完全符合本规例的规定时，反对该等标准的程序。 

(8)

 This Regulation covers PPE which is new to the Union market when it is placed

on the market; that is to say it is either new PPE made by a manufacturer

established in the Union or PPE, whether new or second-hand, imported from

a third country.

这一规定涵盖了欧盟市场上新推出的个人防护用品;也就是说，它要么是由在欧盟建立的制造商制造的新的个人防护用品，要么是从第三国进口的新的或二手的个人防护用品。 

(9)

 This Regulation should apply to all forms of supply, including distance

selling.

本规定适用于所有形式的供应，包括远程销售。 

(10) Some products on the market that provide a protective function to the

user are excluded from the scope of Directive 89/686/EEC. In order to ensure

as high a level of protection for the user of those products as for the

 user of PPE covered by Directive 89/686/EEC, the scope of this Regulation

should include PPE for private use against heat, in line with similar PPE

for professional use which is already covered by Directive 89/686/EEC.

 Artisanal decorative products do not claim to fulfil a protective function,

are by definition not personal protective equipment and are therefore not

concerned by that inclusion. Clothing intended for private use with

 reflective or fluorescent elements included for reasons of design or

decoration is not personal protective equipment and is therefore not covered

by this Regulation. As for products intended for private use to protect

 against atmospheric conditions that are not of an extreme nature or to protect

against damp and water, including but not limited to seasonal clothing,

umbrellas and dishwashing gloves, those should also fall outside of the

scope of this Regulation. It is also appropriate to clarify the list of excluded

PPE set out in Annex I to Directive 89/686/EEC by adding a reference to products

covered by other legislation and therefore excluded from the scope of this

Regulation.

市场上一些向用户提供保护功能的产品被排除在指令89/686/EEC的范围之外。以确保对这些产品的用户的保护水平与对产品的保护水平一样高指令89/686/EEC所涵盖的个人防护装备，其适用范围应包括个人防暑使用的个人防护装备，与指令89/686/EEC所涵盖的专业使用的类似个人防护装备一致。手工装饰产品并未说明具有保护功能，根据定义，它们不是个人保护设备，因此不予考虑。供私人使用的衣服因设计或装饰原因而包含的反光或荧光元素不属个人防护设备，因此不包括在本规例内。至于供私人使用以保护的产品不受极端天气影响或不受潮湿和水影响的大气条件，包括但不限于季节性服装、雨伞和洗碗手套，这些也不属于本规定适用范围。此外，还应澄清指令89/686/EEC附件一中列出的被排除的个人防护用品清单，增加对其他立法涵盖的产品的引用，从而排除在本条例的范围之外。   

(11) Economic operators should be responsible for the compliance of PPE with

the requirements of this Regulation, in relation to their respective roles

in the supply chain, so as to ensure a high level of protection of public

interests, such as health and safety, and the protection of users, and to

guarantee fair competition on the Union market.

经济运营商应该对PPE的本条例的要求负责,还涉及供应链中他们各自的角,以确保高水平的公共利益的保护,如健康和安全,用户保护,以及保证欧盟市场上公平竞争。 

(12) All economic operators intervening in the supply and distribution chain

should take appropriate measures to ensure that they make available on the

market only PPE which is in conformity with this Regulation. This Regulation

should provide a clear and proportionate distribution of obligations which

correspond to the role of each economic operator in the supply and distribution

chain.

所有干预供应和分销链的经济运营商应采取适当措施，确保只向市场提供符合本条例规定的个人防护用品。这一条例应规定明确且按比例分配的义务，这些义务应符合每个经济运营商在供应和分配链中的作用。 

(13) In order to facilitate communication between economic operators, national

market surveillance authorities and consumers, Member States should encourage

economic operators to include a website address in addition to the postal

address.

为了便利经济运营商、国家市场监测当局和消费者之间的交流，成员国应鼓励经济经营者在邮寄地址之外加上网址。 

(14) The manufacturer, having detailed knowledge of the design and production

process, is best placed to carry out the conformity assessment procedure.

Conformity assessment should therefore remain solely the obligation of the

manufacturer.

制造商对设计和生产过程有详细的了解，最适合执行合格评估程序。因此，符合性评估应仅是合格方的制造商义务。 

(15) It is necessary to ensure that PPE from third countries entering the

Union market complies with the requirements of this Regulation and, in

particular, that appropriate conformity assessment procedures have been

carried out by manufacturers. Provision should therefore be made for importers

to make sure that PPE they place on the market complies with the requirements

of this Regulation and that they do not place on the market PPE which does

not comply with such requirements or which present a risk. Provision should

also be made for importers to make sure that the conformity assessment

procedures have been carried out and that the CE marking and technical

 documentation drawn up by manufacturers are available for inspection by the

competent national authorities.

有必要确保来自第三国的个人防护用品在进入欧盟市场时符合本规定的要求，特别是制造商已实施了适当的合格评估程序。因此，应规定进口商确保其投放市场的个人防护用品符合本规例的规定，而不投放不符合规定或有风险的个人防护用品。还应规定，进口商应确保已执行合格评定程序，并确保CE标志和技术制造商编制的文件可供主管国家当局检查。

(16) The distributor makes PPE available on the market after it has been placed

on the market by the manufacturer or the importer and should act with due

care to ensure that its handling of PPE does not adversely affect the

 compliance of the PPE.

在制造商或进口商将个人防护用品投放市场后，分销商应向市场提供个人防护用品，并应谨慎行事，确保其对个人防护用品的处理不会对PPE的合格性产生不利影响。 

(17) When placing PPE on the market, every importer should indicate on the

PPE his name, registered trade name or registered trade mark and the postal

address at which he can be contacted. Exceptions should be provided for in

 cases where the size or nature of the PPE does not allow it. This includes

cases where the importer would have to open the packaging to put his name

and address on the PPE.

进口商向市场投放个人防护用品时，应在个人防护用品上注明其姓名、注册商品名称或注册商标以及联系地址。在个人防护装备的大小或性质不允许使用的情况下，应规定例外情况。这包括进口商必须打开包装才能在个人防护用品上写上姓名和地址的情况。 

(18) Efforts should be made by economic operators to ensure that all relevant

documentation, such as the user's instructions, whilst ensuring precise and

comprehensible information, are easily understandable, take into account

technological developments and changes to end-user behaviour, and are as up

to date as possible. When PPE is made available on the market in packages

containing multiple units, the instructions and information should accompany

each smallest commercially available unit.

经济运营商应作出努力，确保所有有关文件，例如用户指示，在确保准确和可理解的同时，易于理解，并考虑到技术发展和最终用户行为的变化，并尽可能及时更新。当个人防护用品以包含多个单元的包装在市场上出售时，每个最小的商用单元应附带说明和信息。 

(19) Any economic operator who either places PPE on the market under his own

name or trademark or modifies a product in such a way that compliance with

the requirements of this Regulation may be affected should be

 considered to be the manufacturer and should assume the obligations of the

manufacturer.

任何以个人名义、商标将个人防护装备投放市场，或以可能影响符合本规例规定的方式修改产品的经济经营者，均应被视为制造商应承担的责任。 

(20) Distributors and importers, being close to the market place, should be

involved in market surveillance tasks carried out by the competent national

authorities, and should be prepared to participate actively, providing those

 authorities with all necessary information relating to the PPE concerned.

市场内的经销商和进口商应参与当局执行的市场监测任务，并应积极参与，提供给当局设计个人防护装备的所有必要资料。 

(21) Ensuring traceability of PPE throughout the whole supply chain helps

to make market surveillance simpler and more efficient. An efficient

traceability system facilitates the market surveillance authorities' task

of tracing economic operators who made non-compliant PPE available on the

market. When keeping the information required under this Regulation for the

identification of other economic operators, economic operators should not

 be required to update such information in respect of other economic operators

who have either supplied them with PPE or to whom they have supplied PPE.

确保个人防护用品在整个供应链的可追溯性有助于使市场监督更简单和更有效。一个有效的可追溯系统有助于市场监管机构追踪那些向市场提供不合格个人防护用品的经济经营者。在保存本规例所规定的资料以识辨其他经济经营者时，经济经营者不应就曾提供个人防护装备或曾向其提供个人防护装备的其他经济经营者，要求更新该等资料。 

(22) In order to simplify and adapt certain essential safety requirements

of Directive 89/686/EEC to the current practice, the requirement to label

PPE protecting against harmful noise with a comfort index should be removed

 as experience has shown that it is not possible to measure and establish such

an index. As regards mechanical vibrations, it is appropriate to remove the

requirement not to exceed the limit values set by Union legislation on

 the exposure of workers to vibrations since the use of PPE alone is not able

to achieve this objective. As regards PPE protecting against radiation, it

is no longer necessary to require that the instructions for use supplied by

the manufacturer indicate transmission curves, since the indication of the

protection factor is more useful and is sufficient for the user.

为了简化和适应指令89/686/EEC的某些基本安全要求，并使其适应当前的实践，应该取消对个人防护装备(PPE)进行舒适指数标记以防止有害噪音的要求经验表明，不可能衡量和建立这样一个指数。至于机械振动，它是适当的删除要求不超过限制值的联合立法规定由于只使用个人防护装备，使工人暴露在震动中是不能达到这一目标的。至于防护辐射的个人防护用品不再需要要求制造商提供的使用说明显示传输曲线，因为保护系数的指示对用户来说更有用，也更充分。 

(23) It is necessary to clearly specify the relationship with, and the scope

of this Regulation as regards, the entitlement of Member States to lay down

requirements for the use of PPE at the workplace, in particular pursuant to

in order to avoid any confusion and ambiguity

Council Directive 89/656/EEC (1

),

and hence ensure the free movement of compliant PPE. Article 4 of that Directive

obliges employers to provide PPE which complies with the relevant Union

provisions on design and manufacture with respect to safety and health.

Pursuant to that Article, manufacturers of PPE who provide that PPE to their

employees must ensure that such PPE fulfils the requirements laid down in

this Regulation.

有必要明确指定的关系,和本条例的范围方面,成员国的权利时规定个人防护用品的使用要求在工作场所,特别是根据理事会指令89/656 / EEC(1),为了避免任何混乱和歧义,从而确保兼容PPE的自由流动。该指示第4条规定雇主必须提供符合有关工会关于安全与健康的设计和制造规定的个人防护用品。依据该规定， 向其雇员提供个人防护用品的个人防护用品制造商必须确保此种个人防护用品符合本条例规定的要求。

(24) Market surveillance authorities should have easy access to the EU

declaration of conformity. In order to fulfil that requirement, manufacturers

should ensure that PPE is accompanied either by a copy of the EU declaration

of conformity or by the internet address at which the EU declaration of

conformity can be accessed.

市场监管当局应能方便地获得欧盟的合格性声明。为了满足这一要求，制造商应确保个人防护装备(PPE)随附一份欧盟合格性声明的复印件或可访问欧盟符合性声明的互联网地址。 

(25) To ensure effective access to information for market surveillance

purposes, the information required to identify all applicable Union acts for

PPE should be available in a single EU declaration of conformity. In order

to reduce the administrative burden on economic operators, it should be

possible for that single EU declaration of conformity to be a dossier made

up of relevant individual declarations of conformity.

为确保有效获取用于市场监督目的的信息，确定个人防护用品所有适用的工会行为所需的信息应在单一的欧盟符合性声明中提供。为了减轻经济经营者的行政负担，欧盟单一的符合性声明应该可以成为由相关的个体符合性声明组成的档案。

(26) In order to increase the efficiency of market surveillance, it is

necessary to extend the obligation to draw up complete technical documentation

to all PPE.

为了提高市场监测的效率，有必要拟订完整技术文件将责任扩大到所有个人防护用品。 

(27) In order to ensure that PPE is examined on the basis of the state of the

art, the limit of validity of the EU typeexamination certificate should be

set at a maximum of five years. A process for reviewing the certificate should

be provided for. A minimum content of the certificate should be required in

order to facilitate the work of the market surveillance authorities.

为了确保个人防护装备(PPE)是在现有技术的基础上进行检验的，欧盟类型检验证书的有效期最长应设定为5年。应提供审核证书的流程。为方便市场监管机构的工作，应要求证书的最低限度内容。 

(28) A simplified procedure should be applied in the case of renewal of the

EU type- examination certificate where the manufacturer has not modified the

approved type and the harmonised standards or other technical specifications

 applied by the manufacturer have not been changed and continue to meet the

essential health and safety requirements in the light of the state of the

art. In such cases, additional tests or examinations should not be

 necessary and the administrative burden and related costs should be kept to

a minimum.

如制造商未有更改已获批准的证书类别及协调标准或其他技术规格，即制造商提出的申请并没有改变，并根据目前的技术水平继续满足基本的健康和安全要求，则续办欧盟类型检验证书时，应采用简化程序。在这种情况下，不必进行额外的测试，应尽量减少行政负担和有关费用。 

（29）The CE marking, indicating the conformity of a product, is the visible

consequence of a whole process comprising conformity assessment in a broad

sense. The general principles governing the CE marking are set out in

Regulation (EC) No 765/2008. Rules governing the affixing of the CE marking

on PPE should be laid down in his Regulation.

CE标志，标志着产品的合格性，是一个包含广义符合性评估的整个过程的可见结果。有关CE标志的一般原则载于规例(欧洲共同体)第765/2008号。有关在个人防护装备上加贴CE标志的规则，应在其规例中订明。 

(30) In order to ensure compliance with the essential health and safety

requirements laid down in this Regulation, it is necessary to lay down

appropriate conformity assessment procedures to be followed by the

manufacturer. Directive 89/686/EEC classifies PPE into three categories that

are subject to different conformity assessment procedures. In order to ensure

a consistently high level of safety of all PPE, the range of products subject

to one of the conformity assessment procedures relating to the production

phase should be enlarged. The conformity assessment procedures for each

category of PPE should be set, as far as possible, on the basis of the conformity

 assessment modules laid down in Decision No 768/2008/EC.

为了确保符合本条例规定的基本健康和安全要求，制造商有必要制定适当的符合性评估程序。指令89/686/EEC将个人防护用品分为三类，分别适用于不同的合格评定程序。为了确保所有个人防护用品始终保持高水平的安全性，应扩大受与生产阶段有关的符合性评估程序之一约束的产品范围。应尽可能根据个人防护用品的合格性，制定每一类个人防护用品的符合性评估程序第768/2008/EC号决定所列的评估单元。 

(31) The conformity assessment procedures should be adapted to the specific

conditions of the manufacture of PPE produced in series where each item is

adapted to fit an individual user, and of PPE produced as a single unit to

fit an individual user.

符合性评价程序应适应于生产每一项都适合个别用户的系列防护用品和作为单一单元生产以适合个别用户的防护用品的具体条件。 

(32) It is necessary to ensure a uniformly high level of performance of bodies

performing conformity assessment of PPE throughout the Union, and all such

bodies should perform their functions at the same level and under

 conditions of fair competition. Therefore obligatory requirements should be

set for conformity assessment bodies wishing to be notified in order to provide

conformity assessment services.

有必要确保在整个联盟内对个人防护用品进行符合性评估的机构具有一致的高水平的绩效，所有这些机构应在同一级别和以下履行其职能公平竞争的条件。因此，为了提供合格评定服务，应该对希望得到通知的合格评定机构制定强制性要求。 

（33）If a conformity assessment body demonstrates conformity with the

criteria laid down in harmonised standards, it should be presumed to comply

with the corresponding requirements set out in this Regulation.

如果合格评定机构证明其符合协调标准中规定的标准，则应推定其符合本规例中规定的相应要求。 

(34) In order to ensure a consistent level of quality in the performance of

conformity assessment of PPE, it is also necessary to set requirements for

notifying authorities and other bodies involved in the assessment,

notification and monitoring of notified bodies.

为了确保个人防护用品符合性评估工作的质量水平保持一致，还需要对通知机构和参与对通知机构的评估、通知和监测的其他机构提出要求。 

(35) The system set out in this Regulation should be complemented by the

accreditation system provided for in Regulation (EC) No 765/2008. Since

accreditation is an essential means of verifying the competence of

 conformity assessment bodies, it should also be used for the purposes of

notification.

本规例所载的制度，应由规例(欧洲共同体)第765/2008号所规定的认可制度予以补充。由于认证是核实合格评定机构能力的一种重要手段，因此也应用于通知的目的。

(36) Transparent accreditation as provided for in Regulation (EC) No 765/2008,

ensuring the necessary level of confidence in certificates of conformity,

should be considered by the national public authorities throughout the

 Union as the preferred means of demonstrating the technical competence of

conformity assessment bodies. However, national authorities may consider that

they possess the appropriate means of carrying out that evaluation themselves.

In such cases, in order to ensure the appropriate level of credibility of

evaluations carried out by other national authorities, they should provide

the Commission and the other Member States with the necessary documentary

evidence demonstrating the compliance of the conformity assessment bodies

evaluated with the relevant regulatory requirements.

欧盟委员会第765/2008号规章中规定的透明认证，确保对合格证书的必要信任水平，应由整个欧盟委员会的国家公共当局考虑作为展示合格评定机构技术能力的首选手段。但是，国家当局可以认为它们拥有自行进行这种评价的适当手段。在这种情况下，为了确保其他国家当局进行的评价具有适当程度的可信性，它们应向委员会和其他会员国提供必要的书面证据，证明所评价的合格评定机构符合有关的法规要求。

(38) Since notified bodies may offer their services throughout the Union,

it is appropriate to give the other Member States and the Commission the

opportunity to raise objections concerning a notified body. It is therefore

 important to provide for a period during which any doubts or concerns as to

the competence of conformity assessment bodies can be clarified before they

start operating as notified bodies.

由于公告机构可在整个联盟提供其服务，因此适当的做法是让其他会员国和委员会有机会对公告机构提出异议。因此重要的是，在符合性评估机构开始作为公告机构运作之前，规定一段时间，在此期间可以澄清对其能力的任何怀疑或担忧。

(39) In the interests of competitiveness, it is crucial that notified bodies

apply the conformity assessment procedures without creating unnecessary

burdens for economic operators. For the same reason, and to ensure equal

 treatment of economic operators, consistency in the technical application

of the conformity assessment procedures needs to be ensured. That can best

be achieved through appropriate coordination and cooperation between notified

bodies.

为了提高竞争力，公告机构应用合格评定程序，而不给经济经营者造成不必要的负担是至关重要的。出于同样的原因，为确保经济经营者收到同等待遇、技术应用的一致性、符合性评价程序需要得到保证。这可以通过通知机构之间的适当协调与合作得到最好的实现。

(40) Interested parties should have the right to appeal against the result

of a conformity assessment carried out by a notified body. For that reason,

it is important to ensure that an appeal procedure against decisions taken

by notified bodies is available.

利害关系人有权对公告机构实施的合格评定结果提出上诉。因此，重要的是要确保对公告机构作出的决定有上诉程序。