# EUR-Lex - 52014PC0186 - EN

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# 52014PC0186

**Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on personal protective equipment /* COM/2014/0186 final - 2014/0108 (COD) */**

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EXPLANATORY MEMORANDUM

1.           CONTEXT OF THE PROPOSAL

General context, reasons for and
objectives of this proposal

Directive 89/686/EEC on personal protective
equipment[1]
was adopted on 21 December 1989 and became fully applicable as from 1 July 1995.

Directive 89/686/EEC (PPE Directive) ensures
the free movement of personal protective equipment (PPE). It has contributed
considerably to the completion and operation of the Single Market with regard
to PPE. It permits the free movement of PPE covered by its scope in Europe while ensuring a high level of protection for its user.

The PPE Directive sets out basic
requirements, that PPE must comply with in order to be made available on the EU
market. PPE must be designed and manufactured in compliance with the provisions
of the Directive. Manufacturers must also affix the CE marking and provide users
with instructions for storage, use, cleaning, maintenance, servicing and
disinfection of the PPE.

The PPE Directive is based on Article 114
of the Treaty on the Functioning of the European Union and is one of the first
harmonisation Directives based on the “New Approach” principles, according to
which manufacturers must ensure compliance of their products with the essential
health and safety requirements provided for in the legislative instrument. The
essential requirements are performance based, without imposing specific
technical solutions or specifications.

The PPE Directive applies to PPE that is
defined as “any device or appliance designed to be worn or held by an individual
for protection against one or more health and safety hazards”. It also
covers “interchangeable PPE components which are essential to its
satisfactory functioning and used exclusively for such equipment” and “any
system placed on the market in conjunction with PPE for its connection to
another external, additional device”. Examples of PPE are safety helmets, ear
muffs, safety shoes, life jackets but also bicycle helmets, sunglasses and
high-visibility vests.

Certain types of PPE are excluded from the
scope of the PPE Directive, namely PPE specifically designed and manufactured for
use by armed forces or in the maintenance of law and order, PPE for
self-defence, PPE designed and manufactured for private use against atmospheric
conditions, damp, water and heat, PPE intended for the protection or rescue of
persons on vessels or aircraft, not worn all the time and helmets and visors
intended for users of two- or three-wheeled motor vehicles.

While the directive has successfully
achieved its objectives in creating a single market and ensuring a high level
of protection for users of PPE, certain problems have been encountered in its
implementation. These concern products on the market that do not ensure an
adequate level of protection, diverging approaches of the notified bodies, the
effectiveness of the market surveillance as well as risks related to protective
equipment which is currently not covered by the PPE Directive. Furthermore some
provisions of the PPE Directive should be made clearer and simpler.

This proposal intends to replace Directive 89/686/EEC
on personal protective equipment by a Regulation, in line with the Commission’s
simplification objectives.

The overall objectives of this initiative
are to better protect the health and safety of PPE users, to ensure a level
playing field for PPE economic operators within the internal market and
simplify the European regulatory environment in the field of PPE. The proposal modifies
and clarifies a number of the provisions of the existing Directive and aligns
it with the provisions of Decision No 768/2008/EC[2] establishing a common
framework for the marketing of products (NLF Decision).

More specifically, it is proposed to slightly
enlarge the scope of the current PPE Directive by removing the exclusions of products
for private use providing protection against heat, damp and water. Experience with
the implementation and enforcement of the PPE Directive showed that these exclusions
were no longer justified. In order to improve the health and safety of the users,
the requirements of the PPE Directive and hence of this proposal should apply
to these products. Clarifications were introduced in order to reduce
interpretation, e. g. concerning provisions for made-to-measure and individually
adapted PPE. The list of the products subject to the most stringent conformity
assessment procedure was revised in order to remove inconsistencies.
Documentary requirements were changed in order to improve the work of the
market surveillance authorities and minor changes to three essential health and
safety requirements were introduced in order to remove sources of confusion.

The proposal also intends to align the PPE Directive
to the NLF Decision. Many of the general problems identified at horizontal
level have also been observed in the context of implementing the PPE Directive
(PPE placed on the market that does not ensure an adequate level of protection,
problems with the quality of the services delivered by some notified bodies,
different practices in the Member States as regards the evaluation and
monitoring of notified bodies). A number of manufacturers are also faced with
the problem of the legal framework being complex and sometimes inconsistent. The
alignment of the PPE Directive with the NLF responds to the political commitment
laid down in Article 2 of the NLF Decision.

The NLF Decision sets out a common
framework for EU product harmonisation legislation. This framework consists of
the provisions which are commonly used in EU product legislation (e.g.
definitions, obligations of economic operators, notified bodies, safeguard
mechanisms, etc.). These common provisions have been reinforced to ensure that
the legislation can be applied and enforced more effectively in practice. New elements,
such as obligations of importers, have been introduced, which are crucial for
improving the safety of products on the market.

The Commission has already proposed the
alignment of nine Directives to the NLF Decision within an NLF implementation
package adopted on 21 November 2011.

In view of ensuring consistency across Union harmonisation legislation for industrial products, in accordance with the political
commitment resulting from the adoption of the NLF Decision and the legal
obligation provided for in Article 2 of the NLF Decision, it is necessary that
this proposal is in line with the provisions of the NLF Decision.

The proposal takes into account Regulation
(EU) No 1025/2012 of the European Parliament and of the Council of 25 October
2012 on European standardisation, amending Council Directives 89/686/EEC and
93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC,
2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the European Parliament
and of the Council and repealing Council Decision 87/95/EEC and Decision No 1673/2006/EC
of the European Parliament and of the Council[3].

The proposal also takes into account the
proposal of the Commission of 13 February 2013 for a Regulation on market
surveillance of products[4],
which intends to set out a single legal instrument on the market surveillance
activities in the field of non-food goods, consumer or non-consumer products
and products covered or not by Union harmonisation legislation. The proposal merges
the rules on market surveillance of Directive 2001/95/EC on general product
safety[5],
Regulation (EC) 765/2008 of the European Parliament and of the Council of 9
July 2008 setting out the requirements for accreditation and market
surveillance relating to the marketing of products[6] and of sector-specific
harmonisation legislation in order to increase the effectiveness of market
surveillance activities within the Union. The proposed Regulation on market
surveillance of products contains also the relevant provisions on market
surveillance and safeguard clauses. Therefore, provisions in existing sector
specific harmonisation legislation that relate to market surveillance and
safeguard clauses should be removed from that harmonisation legislation. The
overacting objective of the proposed Regulation is to simplify the Union market
surveillance framework fundamentally so that it works better for its main
users: market surveillance authorities and economic operators. The current PPE
Directive provides for a safeguard clause procedure. In line with the framework
intended to be established by the proposed Regulation on market surveillance of
products, this proposal for a Regulation on PPE does not include the provisions
on market surveillance and safeguard clause procedures for PPE provided for in
the NLF Decision. However, in order to ensure legal clarity, it makes a
reference to the proposed Regulation on market surveillance of products.

Consistency with other policies and
objectives of the Union

This initiative is in
line with the Single Market Act[7], which stressed the need to restore consumer
confidence in the quality of products on the market and the importance of
reinforcing market surveillance.

Furthermore it supports
the Commission’s policy on Better Regulation and simplification of the
regulatory environment.

This proposal does not
change the relationship to the Directive 89/656/EEC[8] of
30 November 1989 on the minimum health and safety requirements for
the use by workers of personal protective equipment at the workplace (third
individual directive within the meaning of Article 16 (1) of Directive
89/391/EEC).

2.           RESULTS OF CONSULTATIONS
WITH THE INTERESTED PARTIES AND IMPACT ASSESSMENTS

Consultation of interested parties

The revision of the PPE Directive has been
discussed with all stakeholders, including Member States, manufacturers' federations,
notified bodies and representatives from standardisation. The consultation
included meetings for a selected group of experts as well as consultation of
the PPE Working Group as well as the PPE AdCo Group of market surveillance
authorities.

While the success of the Directive is
generally recognised a broad consensus exists among the Member States and other stakeholders that some improvements can be made, contributing to an even more
effective protection of the health of the users and to a more efficient
functioning of the PPE legislation including more effective market surveillance.
Most of the proposed improvements result from the day to day experience of
Member States authorities and other stakeholders with the enforcement and
implementation of the PPE legislation and are not directly related to
accidents.

From April to June 2011 a public
consultation collected views and opinions of relevant stakeholders and citizens
on the various issues that the revision of the PPE Directive might address.
Overall 77 responses were received, 74 from the 27 Member States (authorities,
enterprises, notified bodies, trade associations, individual citizens), 2 from
an EFTA country and 1 from overseas. The replies provided the Commission
services with a broader view on the identified policy needs and as such confirmed
the envisaged approaches[9].

In general all stakeholders expressed
support for the initiative. Both authorities and industry consider that the PPE
legislation needs to be simplified and clarified. There is unanimity on the
need to improve market surveillance and the system for assessing and monitoring
notified bodies.

There is also unanimity on the need to
align the PPE Directive to the NLF and thus to improve the existing general
regulatory framework. Authorities fully support the exercise because it will
strengthen the existing system and improve cooperation at EU level. Industry
expects a more level playing field resulting from more effective actions
against products that do not comply with the legislation, as well as a
simplification effect from the alignment of legislation.

Furthermore Member States and stakeholders
expressed their support for:

– 
The extension of the product coverage of the PPE
Directive;

– 
The addition of some types of PPE to the list of
products subject to the most stringent conformity assessment procedure;

– 
The change of three basic health and safety
requirements; and

– 
The change of the requirements to the technical
file, the validity and content of the EC type-examination certificate, and the
EC Declaration of Conformity.

Collection and use of expertise - Impact
assessment

An impact assessment on the revision of the
PPE Directive has been conducted. The impact assessment sets out extensively
the different options of revision of the sector related aspects of the PPE Directive.

With regard to the NLF alignment aspects,
the impact assessment report for the revision of the PPE Directive refers to
the general impact assessment conducted in the framework of the NLF
Implementation package of 21 November 2011[10].

In particular, the modifications due to the
alignment to the NLF Decision and their impacts are expected to be the same as
for the nine product harmonisation Directives included in the Alignment
Package.

The Impact Assessment Report on this Alignment
Package has already examined in depth the different options, which are exactly
the same with regard to the PPE Directive. The Report contained also an
analysis of the impacts resulting from the legislative alignment to the
provisions of the NLF Decision.

Therefore, the Impact Assessment Report on
the revision of the PPE Directive did not examine those aspects and it focussed
on specific issues relating to the PPE Directive as well as on the ways to
address them.

An external study launched and completed in
2010[11]
to complement he results of the consultation .The study
provides an overview of the structure of the PPE market as well as it assesses
the impacts of the proposed measures.

In 2012 another complementary study was
carried out. It focused on analysing the competitiveness impacts of the
envisaged changes[12].

Based on the information collected, the
impact assessment carried out by the Commission examined and compared three
options with regard to problems and issues relating to the PPE Directive.

Option 1 – “Do nothing” - No changes to
the existing situation

This option proposes no changes to the PPE
Directive.

Option 2 – Intervention by
non-legislative measures

Option 2 considers voluntary measures to
resolve the identified issues, e.g., guidance documents containing a commonly
agreed interpretation of the PPE Directive.

Option 3 – Intervention by legislative
measures

This option consists in modifying the PPE Directive.

Option 3 was
found to be the preferred option because:

– 
it is considered more effective than option 2:
due to the lack of enforceability of option 2 it is questionable that the
positive impacts would materialise under that option;

– 
it leads to an improved level of protection of
the health and safety of the users in a framework of legal certainty;

– 
it ensures a more effective work of the market
surveillance authorities and consequently reduces the non-compliant products
and creates a more level playing field;

– 
it does not entail significant costs for
economic operators and notified bodies; for manufacturers of products that are
not yet covered by the PPE Directive the cost will be higher but only affect
those manufacturers that do not meet the basic requirements at the moment;
however, those products are manufactured in mass production resulting in a low
impact on cost per unit;

– 
it will strengthen the competitiveness of
European enterprises as a result of guaranteeing a level playing field for the
economic operators and will lead to a better protection of the users of PPE;

– 
options 1 and 2 do not provide answers to legal
inconsistencies or ambiguities and therefore will not lead to a better
implementation of the PPE Directive.

3.           LEGAL ELEMENTS OF THE
PROPOSAL

3.1.
Scope and definitions

The scope of the proposed Regulation is
enlarged compared to the scope of Directive 89/686/EEC. The exclusions of PPE
designed and manufactured for private use against heat, damp and water, set out
in Annex I of 89/686/EEC, are removed. These products are included in the
scope of the proposed Regulation.

The proposal keeps the other existing
exclusions and clarifies that it does not apply to PPE for head, face or eye
protection, subject to the relevant UNECE Regulation, of users of two- or
three-wheeled motor vehicles.

Two PPE specific definitions have been
added in order to clarify the applicable conformity assessment procedures: “Individually
adapted PPE” and “Made-to-measure PPE”.

Additionally, the general definitions of the
NLF Decision have been inserted.

3.2.
Making available on the market, free movement, obligations of economic
operators, CE marking

The proposal contains the typical
provisions for product-related Union harmonisation legislation and sets out the
obligations of the relevant economic operators (manufacturers, authorised
representatives, importers and distributors), in accordance with the NLF
Decision.

The proposal obliges the manufacturer of
PPE to draw up a technical documentation and to ensure that the PPE is
accompanied by a copy of the EU declaration of conformity or a simplified EU
declaration of conformity.

3.3.
Notified bodies

Proper functioning of notified bodies is
crucial for ensuring a high level of health and safety protection and for the
confidence of all interested parties in the New Approach system.

Therefore, in line with the NLF Decision,
the proposal sets out requirements for national authorities responsible for
conformity assessment bodies (notified bodies). It leaves the ultimate
responsibility for designating and monitoring notified bodies with the
individual Member State.

3.4. Categories
and Conformity assessment

The proposal simplifies the definition of
the categories of PPE. The category only depends on the risk against which the
PPE is intended to protect. The risks belonging to each category are set out in
Annex I. Made-to-measure PPE is defined as category II.

The conformity assessment procedures to be
followed depend on the category of the PPE.

The proposed Regulation changes the
category of a few types of PPE compared to Directive 89/686/EEC. PPE intended
to protect the user against drowning, cuts by hand-held chain-saws,
high-pressure cutting, bullet wounds or knife stabs, and harmful noise is
listed under category III and subject to the most stringent conformity
assessment procedure.

The proposal keeps the applicable conformity
assessment procedures provided for under Directive 89/686/EEC. It however
updates the corresponding modules in line with the NLF Decision.

In module B, EU type-examination,
additional requirements are introduced concerning the minimum content and the length
of validity of the EU type-examination certificates. The module provides for a
procedure for a review of the certificate.

Module B also requires particular steps for
individually adapted PPE and made-to-measure PPE.

3.5.
Essential health and safety requirements

The proposed Regulation changes marginally
three essential health and safety requirements (EHSR) set out in Annex II. EHSR
3.1.3, 3.5, and 3.9.1 are changed in order to remove requirements shown to be
impracticable or that create confusion.

3.6.
Implementing acts

The proposal empowers the Commission to
adopt, where appropriate, implementing acts to ensure the uniform application
of this Regulation in respect of notified bodies that do not meet or no longer
meet the requirements for their notification.

Those implementing acts will be adopted in
accordance with the provisions on implementing acts laid down in Regulation
(EU) No 182/2011 of the European Parliament and of the Council of 16 February
2011 laying down the rules and general principles concerning mechanisms for
control by the Member States of the Commission's exercise of implementing
powers.

3.7. Delegated
acts

The proposal empowers the Commission to
adopt delegated acts in order to modify the category of a specific risk to take
into account the progress of technical knowledge or new scientific evidence.

3.8.
Final provisions

The proposed Regulation will become applicable
two years after its entry into force to allow manufacturers, notified bodies
and Member States time to adapt to the new requirements.

However, the designation of notified bodies
pursuant to the new requirements and process needs to start shortly after the
entry into force of this Regulation. This will ensure that by the date of
application of the proposed Regulation, sufficient notified bodies will have
been designated in accordance with the new rules so as to avoid problems with
production continuity and market supply.

Transitional provisions are foreseen for
products manufactured and the certificates issued by notified bodies under
Directive 89/686/EEC so as to allow stocks to be absorbed and ensure a smooth
transition to the new requirements.

Directive 89/686/EEC will be repealed and
replaced by the proposed Regulation.

3.10.
Union competence, legal basis, subsidiarity principle and legal form

Legal basis

The proposal is based on Article 114 of the
Treaty on the Functioning of the European Union.

Subsidiarity principle

The subsidiarity principle arises in
particular with regard to the newly added provisions aiming at the improvement
of effective enforcement of Directive 89/686/EEC, namely, the economic
operators’ obligations, the traceability provisions, the provisions on the
assessment and notification of conformity assessment bodies.

Experience with the enforcement of the
legislation has shown that measures taken at national level have led to
divergent approaches and to a different treatment of economic operators inside
the EU, which undermines the objectives of Directive 89/686/EEC. If actions are
taken at national level to address the problems, this risks creating obstacles
to the free movement of goods. Furthermore action at national level is limited
to the territorial competence of a Member State. Coordinated action at EU level
can much better achieve the objectives set, and will in particular render
market surveillance more effective. Hence it is more appropriate to take action
at EU level.

Proportionality

In accordance with the principle of
proportionality, the proposed modifications do not go beyond what is necessary
to achieve the objectives set.

The new or modified obligations do not
impose unnecessary burdens and costs on industry - especially on small and
medium sized enterprises - or administrations. Where modifications have been
identified to have negative impacts, the analysis of the impacts of the option
serves to provide the most proportionate response to the problems identified. A
number of modifications concern the improvement of clarity of the existing
Directive without introducing new requirements that entail added cost.

Legislative technique used

The proposal takes the form of a
Regulation.

The proposed change from a Directive to a
Regulation takes into account the Commission’s general objective to simplify
the regulatory environment and the need to ensure a uniform implementation
throughout the Union of the proposed legislation.

The use of a Regulation does not conflict
with the subsidiarity principle. This legislation is based on Article 114 TFEU
with the objective of ensuring the proper functioning of the internal market
for personal protective equipment. To achieve this objective, the PPE Directive
89/686/EEC is a total harmonisation directive. Member States are not allowed to
impose more stringent or additional requirements in their national legislation
for the placing on the market of PPE. In particular, the mandatory essential
health and safety requirements for products and the conformity assessment
procedures to be followed by manufacturers must be identical in all of the
Member States. Given this level of harmonisation, which is necessary to avoid
obstacles to the free movement of PPE, Member States have almost no flexibility
in transposing the Directive into their national law and its content is in many
cases reproduced word for word in the national transposition legislation.

The same applies to the new provisions that
will be integrated into the text following the alignment to the NLF Decision No
768/2008/EC. These provisions lay down requirements, obligations and procedures
for the manufacturers, importers and distributors of PPE and for the notified
bodies that carry out the conformity assessment procedures. All of these
provisions are clear and sufficiently precise to be applied directly by the
actors concerned.

The obligations set by the legislation for
the Member States, such as the obligation to assess, appoint and notify the
conformity assessment bodies are, in any case, not transposed as such into
national law but implemented by the Member States by means of the necessary
regulatory and administrative arrangements. This will not change when the
obligations concerned are set out in a Regulation.

The change from a Directive to a Regulation
will not lead to any change in the regulatory approach. The characteristics of
the New Approach will be fully preserved, in particular the flexibility given
to manufacturers in the choice of the means employed to comply with the
essential requirements (harmonised standards or other technical specifications)
and in the choice of the procedure used to demonstrate compliance from among
the available conformity assessment procedures. The existing mechanisms
supporting the implementation of the legislation (standardisation process,
working groups, market surveillance, administrative cooperation (AdCo), and the
development of guidance documents...) will not be affected by the nature of the
legal instrument and will continue to operate in the same manner under the
Regulation as they currently do under the Directive.

Finally, the use of Regulations in the area
of internal market legislation, in accordance also with the preference
expressed by stakeholders, avoids the risk of ‘gold plating’. It also allows
manufacturers to work directly with the Regulation text instead of needing to
identify and examine 28 transposition laws.

On this basis, it is considered that the
choice of a Regulation is the most appropriate solution for all involved
parties as it will allow a more rapid and coherent application of the proposed
legislation and will establish a clearer regulatory environment for economic
operators.

4.           BUDGETARY IMPLICATION

This proposal does not have any implication
for the EU budget.

5.           OPTIONAL ELEMENTS

Repeal of existing legislation

The adoption of the proposal will lead to
repeal of Directive 89/686/EEC.

European Economic Area

The proposal concerns the EEA and should
therefore be extended to the European Economic Area.

2014/0108 (COD)

Proposal for a

REGULATION OF THE EUROPEAN PARLIAMENT
AND OF THE COUNCIL

on personal protective equipment

(Text with EEA relevance)

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 regard to the opinion of the
European Economic and Social Committee,

Acting in accordance with the ordinary
legislative procedure,

Whereas:

(1)       Council Directive
89/686/EEC[13]
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.

(2)       Directive 89/686/EEC is
based on the New Approach principles, as set out in the Council Resolution on a
new approach to technical harmonisation and standards[14]. Thus, it sets only
the essential safety 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[15]. Conformity with the
harmonised standards so set, the reference number of which is 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 this sector and should be maintained and even
further promoted.

(3)       However, experience with
its application has shown inadequacies and inconsistencies in the product
coverage and conformity assessment procedures. In order to take account of this
experience and to provide clarification in relation to the framework within
which products covered by this Regulation may be marketed, certain aspects of
Directive 89/686/EEC should be revised and enhanced.

(4)       Since the scope, the
essential health and safety requirements and conformity assessment procedures are
to be identical in all the Member States there is almost no flexibility in
transposing Directives 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.

(5)       Regulation (EC) No
765/2008 of the European Parliament and of the Council[16] lays down horizontal
provisions on the accreditation of conformity assessment bodies and on the CE
marking.

(6)       Decision No 768/2008/EC of
the European Parliament and of the Council[17]
provides common principles and reference provisions for the purposes of
legislation based on the New Approach principles. 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
products presenting a risk should be aligned to that Decision.

(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.

(8)       Regulation (EU) No xx/xxxx
of the European Parliament and of the Council [18]
provides detailed rules on market surveillance and on controls of harmonised
products, including PPE, entering the Union from third countries. In accordance
with that Regulation, Member States are to organise and carry out market
surveillance, to appoint market surveillance authorities, to specify their
powers and duties, and to set up general and sector-specific market
surveillance programmes. That Regulation also sets out a safeguard clause
procedure.

(9)       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 level of protection
for the user of those products as for the PPE covered by
Directive 89/686/EEC, the scope of this Regulation should include PPE for
private use against damp, water and heat (e.g. dish-washing gloves, oven
gloves), in line with similar PPE for professional use which is already covered
by Directive 89/686/EEC. Artisanal products, such as handmade gloves, for which
the manufacturer does not explicitly claim a protective function are not
personal protective equipment; they are therefore not concerned by this
inclusion. It is also appropriate to clarify the exclusion list set out in
Annex I to Directive 89/686/EEC by adding a reference to products covered by
other legislation and therefore are excluded from the PPE Regulation.

(10)     In order to facilitate the
understanding and uniform application of this Regulation, new definitions for
“individually adapted PPE” and “made-to-measure PPE” should be introduced and
the conformity assessment procedures for these kinds of PPE should be adapted
to the specific conditions of their manufacture.

(11)     Economic
operators should be responsible for the compliance of products, 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.

(12)     All economic operators
intervening in the supply and distribution chain should take appropriate
measures to ensure that PPE protects the health and safety of persons and that
they make available on the market only products which comply with this
Regulation. This Regulation should provide a clear and proportionate
distribution of obligations which correspond to the role of each operator in
the supply and distribution chain.

(13)     The manufacturer, having
detailed knowledge of the design and production process, is best placed to
carry out the complete conformity assessment procedure. Conformity assessment
should therefore remain the obligation of the manufacturer alone.

(14)     It is necessary to ensure
that PPE entering the Union market complies with this Regulation and, in
particular, that appropriate assessment procedures have been carried out by
manufacturers. Provision should therefore be made for importers to make sure
that the 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 market surveillance
authorities.

(15)     Distributors make 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 their
handling of the PPE does not adversely affect the compliance of the PPE.

(16)     When placing PPE on the
market, importers should indicate on the product their name and the address at
which they can be contacted. Exceptions should be provided for in cases where
the size or nature of the PPE does not allow for such an indication. This
includes cases where the importer would have to open the packaging to put his
name and address on the product.

(17)     Any economic operator that
either places PPE on the market under its 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.

(18)     Distributors and importers,
being close to the market place, should be involved in market surveillance
tasks carried out by competent national authorities, and should be prepared to
participate actively, providing those authorities with all necessary
information relating to the PPE concerned.

(19)     Ensuring traceability of
PPE throughout the 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 product available on the market.

(20)     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.

(21)     It is necessary to clearly
specify the relationship and scope of this Regulation with the entitlement of Member
States to lay down requirements for the use of PPE at workplace, in particular
pursuant to Council Directive 89/656/EEC[19],
in order to avoid any confusion and ambiguity and hence ensure the free
movement of compliant PPE.

(22)     The requirement in other
internal market legislation to supply an EU declaration of conformity with the
equipment has been found to facilitate and to enhance the efficiency of market
surveillance and should therefore also be introduced into this Regulation. It
should be possible to provide a simplified EU declaration of conformity in
order to reduce the burden associated with this requirement without reduction
of its effectiveness. Both possibilities should therefore be provided for in
this Regulation.

(23)     In order to increase the
efficiency of market surveillance it is necessary to extend the obligation to
draw up a complete technical documentation to all PPE.

(24)     In order to ensure that PPE
is examined on the basis of the state of the art the limit of validity of the
EU type-examination certificate should set to 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.

(25)     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 this
Regulation.

(26)     It is crucial to make clear
to manufacturers and users that by affixing the CE marking to the product, the
manufacturer declares that the product is in conformity with this Regulation
and takes full responsibility therefor.

(27)     The CE marking should be
the only marking indicating that PPE is in conformity with Union harmonisation
legislation. However, other markings should be allowed as long as they
contribute to the improvement of consumer protection and are not covered by Union
harmonisation legislation.

(28)     In order to ensure
compliance with the essential safety requirements, 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 for all PPE, the list 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.

(29)     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 under this Regulation.

(30)     In order to ensure a
consistent level of quality in the performance of conformity assessment of PPE,
it is also necessary to set requirements that notifying authorities and other
bodies involved in the assessment, notification and monitoring of notified
bodies must fulfil.

(31)     In order to take into
account the progress of technical knowledge and new scientific evidence, the
power to adopt acts in accordance with Article 290 of the Treaty on the
Functioning of the European Union should be delegated to the Commission to
amend the list of PPE included in each category. It is of particular importance
that the Commission carries out appropriate consultations during its
preparatory work, including at expert level. The Commission, when preparing and
drawing-up delegated acts, should ensure a simultaneous, timely and appropriate
transmission of relevant documents to the European Parliament and Council.

(32)     In order to ensure uniform
conditions for the implementation of this Regulation, implementing
powers should be conferred on the Commission. Those powers should be exercised
in accordance with Regulation (EU) 182/2011 of the European Parliament and of
the Council[20].
The advisory procedure should be used for the adoption of implementing acts requesting
the notifying Member State to take the necessary corrective measures in respect
of notified bodies that do not meet or no longer meet the requirements for
their notification.

(33)     Member States should lay
down rules on penalties applicable to infringements of the provisions of this
Regulation and ensure that they are implemented. Those penalties should be
effective, proportionate and dissuasive.

(34)     In order to allow
manufacturers and other economic operators sufficient time to adapt to the
requirements of this Regulation, it is necessary to provide for a sufficient
transitional period after the entry into force of this Regulation during which
PPE which complies with Directive 89/686/EEC may still be placed on the market.

(35)     Since the objective of this
Regulation, namely to ensure a high level of protection of human health and
safety whilst guaranteeing the functioning of the internal market by setting
harmonised health and safety requirements for PPE and minimum requirements for
market surveillance, cannot be sufficiently achieved by the Member States and
can therefore, by reason of its scale and effects, be better achieved at Union
level, the Union may adopt measures, in accordance with the principle of
subsidiarity set out in Article 5 of the Treaty on European Union. In
accordance with the principle of proportionality, as set out in that Article,
this Regulation does not go beyond what is necessary in order to achieve that
objective.

(36)     Directive 89/686/EEC has
been amended several times. Since further substantial amendments are to be made
and in order to ensure a uniform implementation throughout the Union, Directive
89/686/EEC should be repealed and replaced by a Regulation.

HAVE ADOPTED THIS REGULATION:

CHAPTER
I

GENERAL PROVISIONS

Article
1

Subject Matter

This Regulation lays down requirements for
the design and manufacture of personal protective equipment (PPE) in order to
ensure the health and safety protection of users and rules on its free movement
in the Union.

Article
2

Scope

1.           This Regulation shall
apply to personal protective equipment (PPE), as defined in Article 3.

2.           This Regulation shall not
apply to PPE:

(a) 
specifically designed for use by the armed
forces or for the maintenance of law and order;

(b) 
intended to be used for self-defence;

(c) 
intended for private use to protect against
atmospheric conditions that are not of an extreme nature;

(d) 
for use on seagoing vessels or aircraft that are
subject to the relevant international treaties applicable in Member States;

(e) 
for head, face or eye protection of users,  subject
to the relevant Regulation of the United Nations Economic Commission for Europe
(UNECE), of two- or three-wheeled motor vehicles.

Article
3

Definitions

For the purposes of this Regulation, the
following definitions shall apply:

1.           ‘Personal protective
equipment’ (PPE) means:

(a) 
equipment intended to be worn or held by a
person for protection against one or more risks for his or her health or safety
that is placed on the market separately or combined with personal
non-protective equipment;

(b) 
interchangeable components for equipment referred
to in point (a) which are essential for its protective function;

(c) 
connexion systems for equipment referred to in
point (a) that are not held or worn by a person, that are intended to connect that
equipment to an external device or structure, that are removable and not
intended to be permanently fixed to a structure;

2.           'individually adapted PPE'
means PPE produced in series where each item is manufactured to fit an
individual user;

3.           'made-to-measure PPE'
means PPE produced as a single unit to accommodate the special needs of an
individual user according to a basic model, following the instructions of the
designer of that basic model and respecting the range of permissible
variations;

4.           'making available on the
market' means any supply of PPE for distribution or use on the Union market in
the course of a commercial activity, whether in return for payment or free of
charge;

5.           'placing on the market'
means the first making available of PPE on the Union market;

6.           'manufacturer' means any
natural or legal person who designs or manufactures PPE or has it designed or
manufactured, and markets it under his name or trademark; for the purposes of the
second subparagraph of Article 8(2), the designer of a basic model of
made-to-measure PPE shall be considered as a manufacturer;

7.           'authorised
representative' means any natural or legal person established within the Union
who has received a written mandate from a manufacturer to act on his behalf in
relation to specified tasks;

8.           'importer' means any
natural or legal person established within the Union who places PPE from a
third country on the Union market;

9.           'distributor' means any
natural or legal person in the supply chain, other than the manufacturer or the
importer, who makes PPE available on the market;

10.         'economic operators' means
the manufacturer, the authorised representative, the importer and the
distributor;

11.         ‘technical specification’
means a document that prescribes technical requirements to be fulfilled by PPE;

12.         'harmonised standard' means
harmonised standard as defined in Article 2(1)(c) of Regulation (EU) No
1025/2012;

13.         'accreditation' means
accreditation as defined in Article 2(10) of Regulation (EC) No 765/2008;

14.         'national accreditation
body' means national accreditation body as defined in Article 2(11) of
Regulation (EC) No 765/2008;

15.         'conformity assessment'
means the process demonstrating whether the essential health and safety
requirements of this Regulation relating to PPE have been fulfilled;

16.         'conformity assessment
body' means a body that performs conformity assessment activities including
calibration, testing, certification and inspection;

17.         'recall' means any measure
aimed at achieving the return of PPE that has already been made available to
the end user;

18.         'withdrawal' means any
measure aimed at preventing PPE in the supply chain from being made available
on the market;

19.         'CE marking' means a
marking by which the manufacturer indicates that PPE is in conformity with the
applicable requirements set out in Union harmonisation legislation providing
for its affixing;

20.         'Union harmonisation
legislation' means any Union legislation harmonising the conditions for the
marketing of products.

Article
4

Making available on the market

Member States shall take all appropriate
measures to ensure that PPE is made available on the market only if, where properly
maintained and used for its intended purpose, it complies with this Regulation.

Article
5

Essential health and safety requirements

PPE shall fulfil the applicable essential
health and safety requirements set out in Annex II.

Article
6

Provisions concerning the use of PPE

This Regulation shall not affect Member
States' entitlement, in particular when implementing Directive 89/656/EEC, to
lay down requirements concerning the use of PPE provided that these
requirements do not affect the design of PPE which is placed on the market in
accordance with this Regulation.

Article
7

Free movement

1.           Member States shall not
impede, for the aspects covered by this Regulation, the making available of PPE
which complies with this Regulation in their territory.

2.           At trade fairs,
exhibitions, and demonstrations, Member States shall not prevent the showing of
PPE which does not comply with this Regulation provided that a visible sign
clearly indicates that the PPE does not comply with this Regulation and is not
available on the market until it has been brought into conformity.

During demonstrations, adequate measures shall
be taken to ensure the protection of persons.

CHAPTER
II

OBLIGATIONS
OF ECONOMIC OPERATORS

Article
8

Obligations of manufacturers

1.           When placing PPE on the
market, manufacturers shall ensure that it has been designed and manufactured
in accordance with the applicable essential health and safety requirements set
out in Annex II.

2.           Manufacturers shall draw
up the technical documentation referred to in Annex III and carry out the applicable
conformity assessment procedure(s) referred to in Article 18 or have them
carried out.

The designer of a basic model of
made-to-measure PPE shall draw up the technical documentation referred to in
Annex III and carry out the EU type-examination set out in Annex V or have them
carried out.

Manufacturers of made-to-measure PPE shall
carry out the conformity assessment procedure set out in Annex VI.

Where compliance of PPE with the applicable
essential health and safety requirements has been demonstrated by the
appropriate procedure(s), manufacturers shall draw up an EU declaration of
conformity referred to in Article 15 and affix the CE marking referred to in
Article 16.

3.           Manufacturers shall keep
the technical documentation and the EU declaration of conformity for at least
10 years after the PPE has been placed on the market.

4.           Manufacturers shall ensure
that procedures are in place for series production to remain in conformity with
this Regulation. Changes in the design or characteristics of the PPE and
changes in the harmonised standards or in other technical specifications by
reference to which the conformity of the PPE is declared shall be adequately
taken into account.

5.           Manufacturers shall ensure
that the PPE which they place on the market bears a type, batch or serial
number or other element allowing its identification or, where the size or
nature of the PPE does not allow it, that the required information is provided
on the packaging or a document accompanying the PPE.

6.           Manufacturers shall
indicate, on the PPE, their name, registered trade name or registered trade
mark and the postal address at which they can be contacted or, where that is
not possible, on its packaging or in a document accompanying the PPE. The
address shall indicate a single point at which the manufacturer can be
contacted. The contact details shall be in a language easily understood by
end-users and market surveillance authorities.

7.           Manufacturers shall ensure
that the PPE is accompanied by the instructions set out in point 1.4 of Annex
II in a language which can be easily understood by end-users, as determined by
the Member State concerned.

8.           Manufacturers shall ensure
that the PPE is accompanied by a copy of the EU declaration of conformity
referred to in Article (15)(2). Manufacturers may choose to fulfil this
requirement by accompanying the PPE with the simplified EU declaration of
conformity referred to in Article (15)(3). Where only the simplified EU
declaration of conformity is provided, it shall be immediately followed by the
exact internet address where the full text of the EU declaration of conformity
can be obtained.

9.           Manufacturers who consider
or have reason to believe that PPE which they have placed on the market is not
in conformity with this Regulation shall immediately take the necessary
corrective measures to bring it into conformity, to withdraw it or to recall
it, as appropriate. Furthermore, where the PPE presents a risk, manufacturers
shall immediately inform the market surveillance authorities of the Member
States in which they made the PPE available on the market to that effect,
giving details, in particular, of the non-conformity and of any corrective
measures taken.

10.         Manufacturers shall,
further to a reasoned request from a competent national authority, provide it
with all the information and documentation necessary to demonstrate the conformity
of the PPE, in a language which can be easily understood by that authority.
They shall cooperate with that authority, at its request, on any action taken
to eliminate the risks posed by PPE which they have placed on the market.

Article
9

Authorised representatives

1.           A manufacturer may, by a
written mandate, appoint an authorised representative. The obligations laid
down in Article 8(1) and the obligation to draw up the technical documentation
referred to in Article 8(2) shall not form part of the authorised
representative's mandate.

2.           An authorised
representative shall perform the tasks specified in the mandate received from
the manufacturer. The mandate shall allow the authorised representative to do
at least the following:

(a) 
keep the EU declaration of conformity and the
technical documentation at the disposal of the national market surveillance
authorities for at least 10 years after the PPE has been placed on the market;

(b) 
further to a reasoned request from a national
market surveillance authority, provide that authority with all the information
and documentation necessary to demonstrate the conformity of the PPE;

(c) 
cooperate with the national market surveillance
authorities, at their request, on any action taken to eliminate the risks posed
by PPE covered by the authorised representative's mandate.

Article
10

Obligations of importers

1.           Importers shall place only
compliant PPE on the market.

2.           Before placing PPE on the
market, importers shall ensure that the appropriate conformity assessment
procedure(s) referred to in Article 18 have been carried out by the
manufacturer. They shall ensure that the manufacturer has drawn up the
technical documentation, that the PPE bears the CE marking, is accompanied by the
EU declaration of conformity or a simplified EU declaration of conformity, and
that it is accompanied by the instructions referred to in Article 8(7) and that
the manufacturer has complied with the requirements set out in Article 8(5) and
(6).

Where an importer considers or has reason to
believe that PPE is not in conformity with the applicable essential health and
safety requirements set out in Annex II, he shall not place it on the market
until it has been brought into conformity. Furthermore, where the PPE presents
a risk, the importer shall inform the manufacturer and the market surveillance
authorities to that effect.

3.           Importers shall indicate,
on the PPE, their name, registered trade name or registered trade mark and the
postal address at which they can be contacted, or where that is not possible,
on its packaging or in a document accompanying the PPE. The contact details
shall be in a language easily understood by end-users and market surveillance
authorities.

4.           Importers shall ensure
that the PPE is accompanied by the instructions referred to in point 1.4 of
Annex II in a language which can be easily understood by consumers and other
end-users, as determined by the Member State concerned.

5.           Importers shall ensure
that, while the PPE is under their responsibility, storage or transport
conditions do not jeopardise its conformity with the applicable essential
health and safety requirements set out in Annex II.

6.           Importers who consider or
have reason to believe that PPE which they have placed on the market is not in
conformity with this Regulation shall immediately take the corrective measures
necessary to bring the PPE into conformity, to withdraw it or to recall it, as
appropriate. Furthermore, where the PPE presents a risk, importers shall
immediately inform the market surveillance authorities of the Member States in
which they made the PPE available on the market to that effect, giving details,
in particular, of the non-conformity and of any corrective measures taken.

7.           Importers shall, for at
least 10 years after the PPE has been placed on the market, keep a copy of the
EU declaration of conformity at the disposal of the market surveillance
authorities and ensure that the technical documentation can be made available
to those authorities, upon request.

8.           Importers shall, further
to a reasoned request from a competent national authority, provide it with all
the information and documentation, in paper or electronic form, necessary to
demonstrate the conformity of PPE in a language which can be easily understood
by that authority. They shall cooperate with that authority, at its request, on
any action taken to eliminate the risks posed by PPE which they have placed on
the market.

Article
11

Obligations of distributors

1.           When making PPE available
on the market, distributors shall act with due care in relation to the
requirements of this Regulation.

2.           Before making PPE
available on the market, distributors shall verify that it bears the CE
marking, is accompanied by the EU declaration of conformity or a simplified EU
declaration of conformity, and that it is accompanied by the instructions set
out in point 1.4 of Annex II in a language which can be easily understood by
end-users in the Member State in which PPE is to be made available on the
market and that the manufacturer and the importer have complied with the
requirements set out in Article 8(5) and (6) and Article 10(3).

Where a distributor considers or has reason to
believe that PPE is not in conformity with the applicable essential health and
safety requirements set out in Annex II, he shall not make the PPE available on
the market until it has been brought into conformity. Furthermore, where the
PPE presents a risk, the distributor shall inform the manufacturer or the
importer to that effect as well as the market surveillance authorities.

3.           Distributors shall ensure
that, while PPE is under their responsibility, its storage or transport
conditions do not jeopardise its conformity with the applicable essential
health and safety requirements set out in Annex II.

4.           Distributors who consider
or have reason to believe that PPE which they have made available on the market
is not in conformity with the requirements of this Regulation shall make sure
that the necessary corrective measures are taken to bring it into conformity,
to withdraw it or to recall it, as appropriate. Furthermore, where the PPE
presents a risk, distributors shall immediately inform the market surveillance
authorities of the Member States in which they have made the PPE available on
the market to that effect, giving details, in particular, of the non-conformity
and of any corrective measures taken.

5.           Distributors shall,
further to a reasoned request from a competent national authority, provide it
with all the information and documentation in paper or electronic form
necessary to demonstrate the conformity of the PPE. They shall cooperate with
that authority, at its request, on any action taken to eliminate the risks
posed by PPE which they have made available on the market.

Article
12

Cases in which obligations of manufacturers apply to importers and
distributors

An importer or distributor shall be
considered a manufacturer for the purposes of this Regulation and he shall be
subject to the obligations of the manufacturer set out in Article 8 where he
places PPE on the market under his name or trademark or modifies PPE already
placed on the market in such a way that the conformity with the applicable
essential health and safety requirements set out in Annex II may be affected.

Article
13

Identification of economic operators

Economic operators shall, on request,
identify the following to the market surveillance authorities:

(a) 
any economic operator who has supplied them with
PPE;

(b) 
any economic operator to whom they have supplied
PPE.

Economic operators shall be able to present
the information referred to in the first paragraph for a period of 10 years
after they have been supplied with the PPE and for a period of 10 years
after they have supplied the PPE.

CHAPTER
III

CONFORMITY OF THE PPE

Article
14

Presumption of conformity

PPE which is in conformity with harmonised
standards or parts thereof the references of which have been published in the Official
Journal of the European Union shall be presumed to be in conformity with
the essential health and safety requirements set out in Annex II covered by
those standards or parts thereof.

Article
15

EU declaration of conformity

1.           The EU declaration of
conformity shall state that the fulfilment of the applicable essential health
and safety requirements set out in Annex II has been demonstrated.

2.           The EU declaration of
conformity shall have the structure and shall contain the elements set out in
Annex IX and shall be continuously updated. It shall be translated into the
language or languages required by the Member State in which the PPE is made
available on the market.

3.           A simplified EU
declaration of conformity shall contain the elements set out in Annex X and it shall
be continuously updated. It shall be translated into the language or languages
required by the Member State in which the PPE is made available on the market.
The EU declaration of conformity accessible through internet address shall be
available in the language or languages required by the Member State in which
the PPE is made available on the market.

4.           Where PPE is subject to
more than one Union act requiring an EU declaration of conformity, a single EU
declaration of conformity shall be drawn up in respect of all such Union acts.
That declaration shall contain the identification of the Union acts concerned,
including their publication references.

5.           By drawing up the EU
declaration of conformity, the manufacturer shall assume the full
responsibility for the conformity of the PPE with the requirements of this
Regulation.

Article
16

CE marking

1.           The CE marking shall be
subject to the general principles set out in Article 30 of Regulation (EC) No
765/2008.

2.           The CE marking shall be
affixed visibly, legibly and indelibly to the PPE. Where that is not possible
or not warranted on account of the nature of the PPE, it shall be affixed to
the packaging and to the accompanying documents.

3.           The CE marking shall be
affixed before the PPE is placed on the market. It may be followed by a
pictogram or other marking indicating the risk against which the PPE is
intended to protect.

4.           For category III PPE, the
CE marking shall be followed by the identification number of the notified body
involved in the procedure for ensuring conformity to type based on product
verification or the procedure for ensuring conformity to type based on quality
assurance of the production process.

CHAPTER
IV

CONFORMITY ASSESSMENT

Article
17

Risk categories of PPE

The PPE shall be classified into the risk
categories set out in Annex I.

Article
18

Conformity assessment procedures

The procedures to be followed, for each of
the risk categories set out in Annex I, are as follows:

(a) 
Category I: internal production control (module
A) set out in Annex IV;

(b) 
Category II: EU type-examination (module B) set
out in Annex V that is followed by conformity to type based on internal
production control (module C) set out in Annex VI;

(c) 
Category III: EU type-examination (module B) set
out in Annex V and either of the following:

(1) 
conformity to type based on product verification
(module F) set out in Annex VII;

(2) 
conformity to type based on quality assurance of
the production process (module D) set out in Annex VIII.

CHAPTER
V

NOTIFICATION OF CONFORMITY
ASSESSMENT BODIES

Article
19

Notification

Member States shall notify the Commission
and the other Member States of bodies authorised to carry out third-party
conformity assessment tasks under this Regulation.

Article
20

Notifying authorities

1.           Member States shall
designate a notifying authority that shall be responsible for setting up and
carrying out the necessary procedures for the assessment and notification of
conformity assessment bodies and the monitoring of notified bodies, including
compliance with Article 25.

2.           Member States may decide
that the assessment and monitoring referred to in paragraph 1 shall be carried
out by a national accreditation body within the meaning of and in accordance
with Regulation (EC) No 765/2008.

3.           Where the notifying
authority delegates or otherwise entrusts the assessment, notification or
monitoring referred to in paragraph 1 to a body which is not a governmental
entity, that body shall be a legal entity and shall comply mutatis mutandis
with the requirements laid down in Article 21. In addition that body shall have
arrangements to cover liabilities arising out of its activities.

4.           The notifying authority
shall take full responsibility for the tasks performed by the body referred to
in paragraph 3.

Article
21

Requirements relating to notifying authorities

1.           A notifying authority
shall be established in such a way that no conflict of interest with conformity
assessment bodies occurs.

2.           A notifying authority
shall be organised and operated so as to safeguard the objectivity and
impartiality of its activities.

3.           A notifying authority
shall be organised in such a way that each decision relating to notification of
a conformity assessment body is taken by competent persons different from those
who carried out the assessment.

4.           A notifying authority
shall not offer or provide any activities that conformity assessment bodies
perform or consultancy services on a commercial or competitive basis.

5.           A notifying authority
shall safeguard the confidentiality of the information it obtains.

6.           A notifying authority
shall have a sufficient number of competent personnel at its disposal for the
proper performance of its tasks.

Article
22

Information obligation on notifying authorities

Member States shall inform the Commission
of their procedures for the assessment and notification of conformity
assessment bodies and the monitoring of notified bodies, and of any changes
thereto.

The Commission shall make that information
publicly available.

Article
23

Requirements relating to notified bodies

1.           For the purposes of
notification, a conformity assessment body shall meet the requirements laid
down in paragraphs 2 to 11.

2.           A conformity assessment
body shall be established under national law and have legal personality.

3.           A conformity assessment
body shall be a third-party body independent of the organisation or the PPE it
assesses.

A body belonging to a business association or
professional federation representing undertakings involved in the design,
manufacturing, provision, assembly, use or maintenance of PPE which it
assesses, may, on condition that its independence and the absence of any
conflict of interest are demonstrated, be considered such a body.

4.           A conformity assessment
body, its top level management and the personnel responsible for carrying out
the conformity assessment tasks shall not be the designer, manufacturer,
supplier, purchaser, owner, user or maintainer of the PPE which they assess,
nor the authorised representative of any of those parties. This does not
preclude the use of assessed PPE that are necessary for the operations of the
conformity assessment body or the use of such PPE for personal purposes.

A conformity assessment body, its top level management
and the personnel responsible for carrying out the conformity assessment tasks
shall not be directly or indirectly involved in the design, manufacture, making
available, use or maintenance of PPE, or represent the parties engaged in those
activities. They shall not engage in any activity that may conflict with their
independence of judgement or integrity in relation to conformity assessment
activities for which they are notified. This shall in particular apply to
consultancy services.

Conformity assessment bodies shall ensure that
the activities of their subsidiaries or subcontractors do not affect the
confidentiality, objectivity or impartiality of their conformity assessment
activities.

5.           Conformity assessment
bodies and their personnel shall carry out the conformity assessment activities
with the highest degree of professional integrity and the requisite technical
competence in the specific field and shall be free from all pressures and
inducements, particularly financial, which might influence their judgement or
the results of their conformity assessment activities, especially as regards
persons or groups of persons with an interest in the results of those
activities.

6.           A conformity assessment
body shall be capable of carrying out all the conformity assessment tasks
assigned to it by Annexes V, VII and VIII and in relation to which it has been
notified, whether those tasks are carried out by the conformity assessment body
itself or on its behalf and under its responsibility.

At all times and for each conformity assessment
procedure and each kind of PPE for which it has been notified, a conformity
assessment body shall have at its disposal the necessary:

(a) 
personnel with technical knowledge and
sufficient and appropriate experience to perform the conformity assessment
tasks;

(b) 
descriptions of procedures in accordance with
which conformity assessment is carried out ensuring the transparency and the
ability of reproduction of those procedures. It shall have appropriate policies
and procedures in place that distinguish between tasks it carries out as a
notified body and other activities;

(c) 
procedures for the performance of activities
which take due account of the size of an undertaking, the sector in which it
operates, its structure, the degree of complexity of the PPE technology in
question and the mass or serial nature of the production process.

A conformity assessment body shall have the
means necessary to perform the technical and administrative tasks connected
with the conformity assessment activities in an appropriate manner and shall
have access to all necessary equipment or facilities.

7.           The personnel responsible
for carrying out conformity assessment activities shall have the following:

(a) 
sound technical and vocational training covering
all the conformity assessment tasks for which the conformity assessment body
has been notified;

(b) 
satisfactory knowledge of the requirements of
the assessments they carry out and adequate authority to carry out those
assessments;

(c) 
appropriate knowledge and understanding of the
essential health and safety requirements set out in Annex II, of the
corresponding harmonised standards and of the relevant provisions of Union
harmonisation legislation;

(d) 
the ability to draw up certificates, records and
reports demonstrating that assessments have been carried out.

8.           The impartiality of the
conformity assessment bodies, their management and of the personnel responsible
for carrying out the conformity assessment tasks shall be guaranteed.

The remuneration of the top level management
and personnel responsible for carrying out the conformity assessment tasks of a
conformity assessment body shall not depend on the number of assessments
carried out or on the results of those assessments.

9.           Conformity assessment
bodies shall take out liability insurance unless liability is assumed by the
State in accordance with national law, or the Member State itself is directly
responsible for the conformity assessment.

10.         The personnel of a
conformity assessment body shall observe professional secrecy with regard to
all information obtained in carrying out the tasks under Annexes V, VII and VIII
or any provision of national law giving effect to them, except in relation to
the competent authorities of the Member State in which its activities are
carried out. Proprietary rights shall be protected.

11.         Conformity assessment
bodies shall participate in, or ensure that their personnel responsible for
carrying out the conformity assessment tasks are informed of, the relevant
standardisation activities and the activities of the notified body coordination
group established under this Regulation and shall apply as general guidance the
administrative decisions and documents produced as a result of the work of that
group.

Article
24

Presumption of conformity of notified bodies

Where a conformity assessment body
demonstrates its conformity with the criteria laid down in the relevant
harmonised standards or parts thereof the references of which have been
published in the Official Journal of the European Union, it shall be
presumed to comply with the requirements set out in Article 23 in so far as the
applicable harmonised standards cover those requirements.

Article
25

Subsidiaries of and subcontracting by notified bodies

1.           Where a notified body
subcontracts specific tasks connected with conformity assessment or has
recourse to a subsidiary, it shall ensure that the subcontractor or the
subsidiary meets the requirements set out in Article 23 and shall inform the
notifying authority accordingly.

2.           Notified bodies shall take
full responsibility for the tasks performed by subcontractors or subsidiaries
wherever these are established.

3.           Activities may be
subcontracted or carried out by a subsidiary only with the agreement of the
client.

4.           Notified bodies shall keep
at the disposal of the notifying authority the relevant documents concerning
the assessment of the qualifications of the subcontractor or the subsidiary and
the tasks carried out by them under Annexes V, VII and VIII.

Article
26

Application for notification

1.           A conformity assessment
body shall submit an application for notification to the notifying authority of
the Member State in which it is established.

2.           The application for
notification shall be accompanied by a description of the conformity assessment
activities, the conformity assessment procedure(s) and the kinds of PPE for
which that body claims to be competent, as well as by an accreditation
certificate, where one exists, issued by a national accreditation body
attesting that the conformity assessment body fulfils the requirements laid
down in Article 23.

3.           Where the conformity
assessment body concerned cannot provide an accreditation certificate, it shall
provide the notifying authority with all the documentary evidence necessary for
the verification, recognition and regular monitoring of its compliance with the
requirements laid down in Article 23.

Article
27

Notification procedure

1.           Notifying authorities may
notify only conformity assessment bodies which have satisfied the requirements
laid down in Article 23.

2.           They shall notify the
Commission and the other Member States using the electronic notification tool
developed and managed by the Commission.

3.           The notification shall
include full details of the conformity assessment activities, the conformity
assessment procedure(s) and the kinds of PPE concerned and the relevant
attestation of competence.

4.           Where a notification is
not based on an accreditation certificate referred to in Article 26(2),
the notifying authority shall provide the Commission and the other Member
States with documentary evidence which attests to the conformity assessment
body's competence and the arrangements in place to ensure that that body will
be monitored regularly and will continue to satisfy the requirements laid down
in Article 23.

5.           The body concerned may
perform the activities of a notified body only where no objections are raised
by the Commission or the other Member States within two weeks of a notification
where an accreditation certificate is used or within two months of a
notification where accreditation is not used.

Only such a body shall be considered a notified
body for the purposes of this Regulation.

6.           The notifying authority
shall notify the Commission and the other Member States of any subsequent
relevant changes to the notification.

Article
28

Identification numbers and lists of notified bodies

1.           The Commission shall
assign an identification number to a notified body.

It shall assign a single identification number
even where the body is notified under several Union acts.

2.           The Commission shall make
publicly available the list of the bodies notified under this Regulation,
including the identification numbers that have been assigned to them and the
activities for which they have been notified.

The Commission shall ensure that the list is
kept up to date.

Article
29

Changes to notifications

1.           Where a notifying
authority has ascertained or has been informed that a notified body no longer
meets the requirements laid down in Article 23, or that it is failing to fulfil
its obligations, the notifying authority shall restrict, suspend or withdraw
notification as appropriate, depending on the seriousness of the failure to
meet those requirements or fulfil those obligations. It shall immediately inform
the Commission and the other Member States accordingly.

2.           In the event of
restriction, suspension or withdrawal of notification, or where the notified
body has ceased its activity, the notifying Member State shall take appropriate
steps to ensure that the files of that body are either processed by another
notified body or kept available for the responsible notifying and market
surveillance authorities at their request.

Article
30

Challenge to the competence of notified bodies

1.           The Commission shall
investigate all cases where it doubts, or doubt is brought to its attention
regarding the competence of a notified body or the continued fulfilment by a notified
body of the requirements and responsibilities to which it is subject. The
notifying Member State shall provide the Commission, on request, with all
information relating to the basis for the notification or the maintenance of
the competence of the notified body concerned.

2.           The Commission shall
ensure that all sensitive information obtained in the course of its
investigations is treated confidentially.

3.           Where the Commission ascertains
that a notified body does not meet or no longer meets the requirements for its
notification, it shall adopt an implementing act requesting the notifying
Member State to take the necessary corrective measures, including the
withdrawal of the notification if necessary.

4.           That implementing act
shall be adopted in accordance with the advisory procedure referred to in
Article 38(2).

Article
31

Operational obligations of notified bodies

1.           Notified bodies shall
carry out conformity assessments in accordance with the conformity assessment
procedures provided for in Annexes V, VII and VIII.

2.           Conformity assessments
shall be carried out in a proportionate manner, avoiding unnecessary burdens
for economic operators. Conformity assessment bodies shall perform their
activities taking due account of the size of an undertaking, the sector in
which it operates, its structure, the degree of complexity of the PPE
technology in question and the mass or serial nature of the production process.

In so doing they shall nevertheless respect the
degree of rigour and the level of protection required for the compliance of the
PPE with the requirements of this Regulation.

3.           Where a notified body finds
that the applicable essential health and safety requirements set out in Annex
II or the corresponding harmonised standards or other technical specifications
have not been met by a manufacturer, it shall require the manufacturer to take
appropriate corrective measures and shall not issue a conformity certificate.

4.           Where, in the course of
the monitoring of conformity following the issue of a certificate, a notified
body finds that a PPE no longer complies with the requirements laid down in
this Regulation, it shall require the manufacturer to take appropriate
corrective measures and shall suspend or withdraw the certificate if necessary.

5.           Where corrective measures
are not taken or do not have the required effect, the notified body shall
restrict, suspend or withdraw the certificate, as appropriate.

Article
32

Appeal against decisions of notified bodies

Member States shall ensure that an appeal
procedure against decisions of the notified bodies is available.

Article
33

Information obligation on notified bodies

1.           Notified bodies shall
inform the notifying authority of the following:

(a) 
any refusal, restriction, suspension or
withdrawal of a certificate;

(b) 
any circumstances affecting the scope of and
conditions for notification;

(c) 
any request for information which they have
received from market surveillance authorities regarding conformity assessment
activities;

(d) 
on request, conformity assessment activities
performed within the scope of their notification and any other activity
performed, including cross-border activities and subcontracting.

2.           Notified bodies shall
provide the other bodies notified under this Regulation carrying out similar
conformity assessment activities covering the same kinds of PPE with relevant
information on issues relating to negative and, on request, positive conformity
assessment results.

Article
34

Exchange of experience

The Commission shall provide for the
organisation of exchange of experience between the Member States' national
authorities responsible for notification policy.

Article
35

Coordination of notified bodies

The Commission shall ensure that
appropriate coordination and cooperation between bodies notified under this
Regulation are put in place and properly operated in the form of a sectoral
group of notified bodies.

Member States shall ensure that the bodies
notified by them participate in the work of that group, directly or by means of
designated representatives.

CHAPTER
VI

DELEGATED AND IMPLEMENTING ACTS

Article
36

Delegating power

The Commission shall be empowered to adopt
delegated acts in accordance with Article 37 to amend Annex I with respect to
the category of a specific risk, in response to technical progress and
knowledge or new scientific evidence and by taking into account the conformity
assessment procedure that need to be followed for each category, in accordance
with Article 18.

Article
37

Exercise of the delegation

1.           The power to adopt
delegated acts is conferred on the Commission subject to the conditions laid
down in this Article.

2.           The power to adopt
delegated acts referred to in Article 36 shall be conferred on the Commission
for a period of five years from [the date specified in Article 42(2)].
The Commission shall draw up a report in respect of the delegation of power not
later than nine months before the end of the five-year period. The delegation
of power shall be tacitly extended for periods of an identical duration, unless
the European Parliament or the Council opposes such extension not later than
three months before the end of each period

3.           The delegation of powers
referred to in Article 36 may be revoked at any time by the European Parliament
or by the Council. A decision to revoke shall put an end to the delegation of
the power specified in that decision. It shall take effect the day following
the publication of the decision in the Official Journal of the European
Union or at a later date specified therein. It shall not affect the
validity of any delegated acts already in force.

4.           As soon as it adopts a
delegated act, the Commission shall notify it simultaneously to the European
Parliament and to the Council.

5.           A delegated act adopted
pursuant to Article 36 shall enter into force only if no objection has been
expressed either by the European Parliament or the Council within a period of two
months of notification of that act to the European Parliament and the Council
or if, before the expiry of that period, the European Parliament and the
Council have both informed the Commission that they will not object. That
period shall be extended by two months at the initiative of the European
Parliament or the Council.

Article
38

Committee procedure

1.           The Commission shall be
assisted by a committee. That committee shall be a committee within the meaning
of Regulation (EU) No 182/2011.

2.           Where reference is made to
this paragraph, Article 4 of Regulation (EU) 182/2011 shall apply.

CHAPTER
VII

FINAL AND TRANSITIONAL PROVISIONS

Article
39

Penalties

Member States shall lay down the rules on
penalties applicable to infringements of the provisions of this Regulation and
shall take all measures necessary to ensure that they are implemented. The
penalties provided for must be effective, proportionate and dissuasive. Member
States shall notify those provisions to the Commission by [3 months prior to
the date of application of this Regulation] at the latest and shall notify
it without delay of any subsequent amendment affecting them.

Article
40

Repeal

Directive 89/686/EEC is repealed.

References to the repealed Directive shall
be construed as references to this Regulation and shall be read in accordance
with the correlation table in Annex XI.

Article
41

Transitional period

1.           Without prejudice to
paragraph 2, Member States shall not impede the making available on the market
of products covered by Directive 89/686/EEC which are in conformity with that
Directive and which were placed on the market before [1 year after the date
of application]

2.           EC type-examination
certificates issued under Directive 89/686/EEC shall remain valid until [6
years after the date of application] unless they expire before that date.

Article
42

Entry into force and application

This Regulation shall enter into force on
the twentieth day following its publication in the Official Journal of the
European Union.

It shall apply from [two years after
entry into force].

However, Articles 19 to 35 shall apply from
[six months after entry into force].

This Regulation shall be binding in its
entirety and directly applicable in all Member States.

Done at Brussels,

For the European Parliament                        For the Council

The President                                                 The
President

[1]               OJEU
L 399, 30.12.1989, p.18.

[2]               OJEU L 218, 13.8.2009, p.82.

[3]               OJEU L 316, 14.11.2012, p.12.

[4]               Proposal for a Regulation of the European Parliament
and of the Council on market surveillance of products and amending Council
Directives 89/686/EEC and 93/15/EEC, and Directives 94/9/EC, 94/25/EC,
95/16/EC, 97/23/EC, 1999/5/EC, 2000/9/EC, 2000/14/EC, 2001/95/EC, 2004/108/EC,
2006/42/EC, 2006/95/EC, 2007/23/EC, 2008/57/EC, 2009/48/EC, 2009/105/EC,
2009/142/EC, 2011/65/EU, Regulation (EU) No 305/2011, Regulation (EC) No
764/2008 and Regulation (EC) No 765/2008 of the European Parliament and of the
Council (COM(2013) 75 final).

[5]               OJEU L 11, 15.1.2002, p.4.

[6]               OJEU
L 218, 13.8.2008, p.30.

[7]               Communication from the Commission to the European Parliament,
the Council, the Economic and Social Committee and the Committee of the Regions
(COM(2011) 206 final).

[8]               OJEU L 393, 30.12.1989, p.18.

[9]               A report on the results is available at http://ec.europa.eu/enterprise/sectors/mechanical/files/ppe/pc-report_en.pdf.

[10]             New Legislative Framework (NLF) Alignment Package
(Implementation Goods Package), Commission Staff Working Paper – Impact
Assessment accompanying document to the 10 Proposals to Align Product
Harmonisation Directives to Decision No 768/2008/EC (SEC(2011) 1376 final).

[11]             See http://ec.europa.eu/enterprise/sectors/mechanical/files/ppe/rev-study-assess-part1_en.pdf
(part 1 on market assessment) and http://ec.europa.eu/enterprise/sectors/mechanical/files/ppe/rev-study-assess-part2_en.pdf
(part2 on impact assessment).

[12]             See http://ec.europa.eu/enterprise/sectors/mechanical/files/ppe/rev-study-competitiveness_en.pdf.

[13]             Council Directive 89/686/EEC of 21 December 1989 on the
approximation of the laws of the Member States relating to personal protective
equipment (OJ L 399, 30.12.1989, p. 18).

[14]             Council
Resolution of 7 May 1985 on a new approach to technical harmonisation and
standards (OJ C 136, 4.6.1985, p. 1).

[15]             Regulation (EU) No
1025/2012 of the European Parliament and of the Council of 25 October 2012 on
European standardisation, amending Council Directives 89/686/EEC and 93/15/EEC
and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC,
2007/23/EC, 2009/23/EC and 2009/105/EC of the European Parliament and of the
Council and repealing Council Decision 87/95/EEC and Decision No 1673/2006/EC
of the European Parliament and of the Council (OJ L 316, 14.11.2012, p. 12).

[16]             Regulation
(EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting
out the requirements for accreditation and market surveillance relating to the
marketing of products (OJ L 218, 13.8.2008, p. 30).

[17]             Decision No
768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a
common framework for the marketing of products, and repealing Council Decision
93/465/EEC(OJ L 218, 13.8.2008, p. 82).

[18]             [Regulation (COM/2013/075
final - 2013/0048 (COD))on market surveillance of products and amending
Council Directives 89/686/EEC and 93/15/EEC, and Directives 94/9/EC, 94/25/EC,
95/16/EC, 97/23/EC, 1999/5/EC, 2000/9/EC, 2000/14/EC, 2001/95/EC, 2004/108/EC,
2006/42/EC, 2006/95/EC, 2007/23/EC, 2008/57/EC, 2009/48/EC, 2009/105/EC,
2009/142/EC, 2011/65/EU, Regulation (EU) No 305/2011, Regulation (EC) No
764/2008 and Regulation (EC) No 765/2008 of the European Parliament and of the
Council (OJ L XXXX)].

[19]             Council Directive 89/656/EEC of 30 November 1989 on the
minimum health and safety requirements for the use by workers of personal
protective equipment at the workplace (OJ L 393, 30.12.1989, p. 18).

[20]             Regulation
(EU) 182/2011 of the European Parliament and of the Council of 16 February 2011
laying down the rules and general principles concerning mechanisms for control
by Member States of the Commission's exercise of implementing powers (OJ L 55,
28.2.2011, p. 13).

ANNEX I

Risk
Categories of PPE

Category
I

PPE intended to protect users against
minimal risks. Category I includes exclusively PPE intended to protect users
against the following risks:

(a) 
superficial mechanical injury;

(b) 
contact with water or cleaning materials of weak
action;

(c) 
contact with hot surfaces not exceeding 50°C;

(d) 
damage to the eyes due to exposure to sunlight
(other than during observation of the sun);

(e) 
atmospheric conditions that are not of an
extreme nature.

Category
II

Category II includes:

(a) 
PPE intended to protect users against risks
other than those listed in Categories I and III;

(b) 
made-to-measure PPE except where such PPE is
intended to protect users against risks listed in Category I.

Category
III

PPE intended to protect users against very
serious risks. Category III includes exclusively PPE intended to protect users
against the following risks:

(a) 
inhalation of harmful substances;

(b) 
aggressive chemicals;

(c) 
ionising radiation;

(d) 
high-temperature environments the effects of
which are comparable to those of an air temperature of at least 100°C;

(e) 
low-temperature environments the effects of
which are comparable to those of an air temperature of -50°C or less;

(f) 
falling from a height;

(g) 
electric shock and live working;

(h) 
drowning;

(i) 
cuts by hand-held chain-saws;

(j) 
high-pressure cutting;

(k) 
bullet wounds or knife stabs;

(l) 
harmful noise.

ANNEX II

Essential
health and safety requirements

1.         GENERAL REQUIREMENTS APPLICABLE
TO ALL PPE

PPE must
provide adequate protection against the risks against which it is intended to
protect.

1.1.      Design principles

1.1.1.   Ergonomics

PPE must be designed
and manufactured so that, in the foreseeable conditions of use for which it is
intended, the user can perform the risk-related activity normally whilst
enjoying appropriate protection of the highest level possible.

1.1.2.   Levels and classes of
protection

1.1.2.1.            Optimum level of
protection

The optimum
level of protection to be taken into account in the design is that beyond which
the constraints imposed by the wearing of the PPE would prevent its effective
use during the period of exposure to the risk or the normal performance of the
activity.

1.1.2.2.            Classes of protection
appropriate to different levels of risk

Where
differing foreseeable conditions of use are such that several levels of the same
risk can be distinguished, appropriate classes of protection must be taken into
account in the design of the PPE.

1.2.      Innocuousness of PPE

1.2.1.   Absence of inherent risks and
other nuisance factors

PPE must be
designed and manufactured so as not to create risks or other nuisance factors
under foreseeable conditions of use.

1.2.1.1.            Suitable constituent
materials

The materials
of which the PPE is made, including any of their possible decomposition
products, must not adversely affect the health or safety of users.

1.2.1.2.            Satisfactory surface
condition of all PPE parts in contact with the user

Any part of
the PPE that is in contact or is liable to come into contact with the user when
the PPE is worn must be free of rough surfaces, sharp edges, sharp points and
the like which could cause excessive irritation or injuries.

1.2.1.3.            Maximum permissible
user impediment

PPE shall
hinder as little as possible the actions to be carried out, the postures to be
adopted and sensory perceptions; furthermore, use of the PPE must not engender
actions which might endanger the user or other persons.

1.3.      Comfort and effectiveness

1.3.1.   Adaptation of PPE to user
morphology

PPE must be
designed and manufactured to facilitate its correct positioning on the user and
to remain in place for the foreseeable period of use, bearing in mind ambient
factors, the actions to be carried out and the postures to be adopted. For this
purpose, it must be possible to adapt the PPE to fit the morphology of the user
by all appropriate means such as adequate adjustment and attachment systems or
the provision of an adequate range of sizes.

1.3.2.   Lightness and strength

PPE must be as light as possible without
prejudicing its strength and effectiveness.

As well as the
specific additional requirements which they must satisfy in order to provide
adequate protection against the risks for which they are intended, PPE must be
capable of withstanding environmental factors in the foreseeable conditions of
use.

1.3.3.   Compatibility of types of PPE
intended for simultaneous use

If the same
manufacturer places on the market several models of PPE models of different
types in order to ensure the simultaneous protection of adjacent parts of the
body, they must be compatible.

1.4.      Manufacturer's instructions

In addition to the name and address of the
manufacturer or his authorized representative, or both, the instructions that
must be drawn up by the manufacturer and supplied with the PPE when it is
placed on the market must contain all relevant information on:

(a) 
instructions for storage, use, cleaning,
maintenance, servicing and disinfection. Cleaning, maintenance or disinfectant
products recommended by manufacturers must have no adverse effect on the PPE or
the user when applied in accordance with the relevant instructions;

(b) 
performance as recorded during technical tests
to check the levels or classes of protection provided by the PPE;

(c) 
accessories that may be used with the PPE and
the characteristics of appropriate spare parts;

(d) 
the classes of protection appropriate to
different levels of risk and the corresponding limits of use;

(e) 
the date or period of obsolescence of the PPE or
of certain of its components;

(f) 
the type of packaging suitable for transport;

(g) 
the significance of any markings (see 2.12);

(h) 
where applicable, the references of other Union
harmonisation legislation;

(i) 
the name, address and identification number of
the notified body or bodies involved in the conformity assessment of the PPE.

These
instructions, which must be precise and comprehensible, must be provided at
least in the official language(s) of the Member State of destination.

2.         ADDITIONAL REQUIREMENTS COMMON
TO SEVERAL TYPES OF PPE

2.1.      PPE incorporating adjustment
systems

If PPE
incorporates adjustment systems, the latter must be designed and manufactured
so that, after adjustment, they do no become undone unintentionally in the
foreseeable conditions of use.

2.2.      PPE enclosing the parts of the
body to be protected

As far as
possible, PPE enclosing the parts of the body to be protected must be sufficiently
ventilated to limit perspiration resulting from use; otherwise, it must be
equipped with means of absorbing perspiration.

2.3.      PPE for the face, eyes and
respiratory system

PPE for the face, eyes or respiratory
system shall restrict the user's field of vision and sight as little as
possible.

The screens for these types of PPE must
have a degree of optical neutrality that is compatible with the degree of
precision and the duration of the activities of the user.

If necessary, they must be treated or provided
with means to prevent misting up.

Models of PPE
intended for users requiring sight correction must be compatible with the
wearing of spectacles or contact lenses.

2.4.      PPE subject to ageing

If it is known that the design performance
of new PPE may be significantly affected by ageing, the date of manufacture
and/or, if possible, the date of obsolescence, must be indelibly and
unambiguously marked on each item of PPE or each interchangeable component for
PPE placed on the market and on their packaging.

If the manufacturer is unable to give an
undertaking with regard to the useful life of the PPE, his instructions must
provide all the information necessary to enable the purchaser or user to
establish a reasonable obsolescence date, taking into account the quality level
of the model and the effective conditions of storage, use, cleaning, servicing
and maintenance.

Where
appreciable and rapid deterioration in PPE performance is likely to be caused
by ageing resulting from the periodic use of a cleaning process recommended by
the manufacturer, the latter must, if possible, affix a marking to each item of
PPE placed on the market indicating the maximum number of cleaning operations
that may be carried out before the equipment needs to be inspected or discarded;
failing that, the manufacturer must give this information in his instructions.

2.5.      PPE which may be caught up
during use

Where the
foreseeable conditions of use include in particular the risk of the PPE being
caught up by a moving object thereby creating a danger for the user, the PPE
must possess an appropriate resistance threshold above which a constituent part
will break and eliminate the danger.

2.6.      PPE for use in potentially
explosive atmospheres

PPE intended
for use in potentially explosive atmospheres must be so designed and
manufactured that it cannot be the source of an electric, electrostatic or
impact-induced arc or spark likely to cause an explosive mixture to ignite.

2.7.      PPE intended for rapid
intervention or to be put on or removed rapidly

These types of PPE must be designed and
manufactured to minimize the time required for putting on and removing the
equipment.

Where PPE
comprises fixing systems enabling the PPE to be maintained in the correct
position on the user or removed, it must be possible to operate them quickly
and easily.

2.8.      PPE for intervention in very
dangerous situations

The instructions supplied by the
manufacturer with PPE for intervention in very dangerous situations must
include, in particular, data intended for competent, trained persons who are
qualified to interpret them and ensure their application by the user.

They must also describe the procedure to be
adopted in order to verify that PPE is correctly adjusted and functional when
worn by the user.

Where the PPE
incorporates an alarm which is activated in the absence of the level of
protection normally provided, this must be designed and placed so that it can
be perceived by the user in the foreseeable conditions of use.

2.9.      PPE incorporating components
which can be adjusted or removed by the user

Where PPE
incorporates components which can be adjusted or removed by the user for
replacement purposes, they must be designed and manufactured so that they can
be easily attached and removed without tools.

2.10.    PPE for connection to
complementary equipment external to the PPE

Where PPE
incorporates a connexion system permitting its connection to other,
complementary equipment, the means of attachment must be designed and
manufactured to enable it to be mounted only on appropriate equipment.

2.11.    PPE incorporating a fluid
circulation system

Where PPE
incorporates a fluid circulation system, the latter must be chosen or designed
and placed to permit adequate fluid renewal in the vicinity of the entire part
of the body to be protected, irrespective of the actions, postures or movements
of the user under the foreseeable conditions of use.

2.12.    PPE bearing one or more
identification markings or indicators directly or indirectly relating to health
and safety

The identification markings or indicators
directly or indirectly relating to health and safety affixed to these types of
PPE must, if possible,  take the form of harmonized pictograms or ideograms.
They must be perfectly visible and legible and remain so throughout the
foreseeable useful life of the PPE. In addition, these markings must be
complete, precise and comprehensible so as to prevent any misinterpretation; in
particular, when such markings include words or sentences, the latter must be
written in the official language(s) of the Member State where the equipment is
to be used.

Where the PPE
(or the interchangeable component for PPE) is too small to allow all or part of
the necessary marking to be affixed, the relevant information must be mentioned
on the packaging and in the manufacturer's instructions.

2.13.    PPE capable of signalling the
user's presence visually

PPE intended
for foreseeable conditions of use in which the user's presence must be visibly
and individually signalled must have one (or more) judiciously positioned means
or devices for emitting direct or reflected visible radiation of appropriate
luminous intensity and photometric and colorimetric properties.

2.14.    Multi-risk PPE

PPE intended
to protect the user against several potentially simultaneous risks must be
designed and manufactured to satisfy, in particular, the essential health and
safety requirements specific to each of those risks.

3.         ADDITIONAL REQUIREMENTS SPECIFIC
TO PARTICULAR RISKS

3.1.      Protection against mechanical
impact

3.1.1.   Impact caused by falling or
ejected objects and collisions of parts of the body with an obstacle

PPE intended
for this type of risk must be sufficiently shock-absorbent to prevent injury
resulting, in particular, from the crushing or penetration of the protected
part, at least up to an impact-energy level above which the excessive
dimensions or mass of the means of shock-absorption would preclude effective
use of the PPE for the foreseeable period of wear.

3.1.2.   Falls

3.1.2.1. Prevention of falls due to
slipping

The outsoles
of protective footwear intended to prevent slipping must be designed and
manufactured or equipped with additional means to ensure adequate grip by
friction, studs or spikes, having regard to the nature or state of the ground
surface.

3.1.2.2. Prevention of falls from a height

PPE intended to prevent falls from a height
or their effects must incorporate a body harness and a connexion system which
can be connected to a reliable external anchorage point. It must be designed
and manufactured so that, under the foreseeable conditions of use, the vertical
drop of the user is minimized to prevent collision with obstacles while the
braking force does not attain the threshold value at which physical injury or
the opening or breakage of any PPE component which might cause the user to fall
can be expected to occur.

It must also ensure that, after braking,
the user is maintained in a correct position in which he may await help if
necessary.

The manufacturer's instructions must
specify, in particular, all relevant information relating to:

(a) 
the characteristics required for the reliable
external anchorage point and the necessary minimum clearance below the user;

(b) 
the proper way of putting on the body harness
and of attaching the connexion system to the reliable anchorage point.

3.1.3.   Mechanical vibration

PPE designed
to prevent the effects of mechanical vibrations must be capable of ensuring
adequate attenuation of harmful vibration components for the part of the body
at risk.

3.2.      Protection against static
compression of part of the body

PPE designed
to protect part of the body against static compressive stress must be
sufficiently capable of attenuating its effects to prevent serious injury or
chronic complaints.

3.3.      Protection against mechanical
injuries

PPE
constituent materials and other components designed to protect all or part of
the body against superficial injuries, such as abrasion, perforation, cuts or
bites, must be so chosen or designed and incorporated as to ensure that these
types of PPE provide sufficient resistance to abrasion, perforation and gashing
(see also 3. 1) under the foreseeable conditions of use.

3.4.      Protection in the water

3.4.1.   Prevention of drowning

PPE designed to prevent drowning must be
capable of returning to the surface as quickly as possible, without danger to
his health, a user who may be exhausted or unconscious after falling into a
liquid medium, and of keeping him afloat in a position which permits breathing
while awaiting help.

PPE may be wholly or partially inherently
buoyant or may be inflated by gas which can be manually or automatically
released, or orally.

Under the foreseeable conditions of use:

(a) 
PPE must, without prejudice to its satisfactory
operation, be capable of withstanding the effects of impact with the liquid
medium and the environmental factors inherent in that medium;

(b) 
inflatable PPE must be capable of inflating
rapidly and fully.

Where particular foreseeable conditions of
use so require, certain types of PPE must also satisfy one or more of the
following additional requirements:

(a) 
they must have all the inflation devices
referred to in the second subparagraph, and/or a light or sound-signalling device;

(b) 
they must have a device for hitching and
attaching the body so that the user may be lifted out of the liquid medium;

(c) 
they must be suitable for prolonged use
throughout the period of activity exposing the user, possibly dressed, to the
risk of falling into the liquid medium or requiring his immersion in it.

3.4.2.   Buoyancy aids

Clothing which
will ensure an effective degree of buoyancy, depending on its foreseeable use,
which is safe when worn and which affords positive support in water. In
foreseeable conditions of use, this PPE must not restrict the user's freedom of
movement but must enable him, in particular, to swim or take action to escape
from danger or to rescue other persons.

3.5.      Protection against the harmful
effects of noise

PPE intended to prevent the harmful effects
of noise must be capable of attenuating the latter so that the exposure of the
user does not under any circumstances exceed the limit values laid down by
Directive 2003/10/EC of the European Parliament and of the Council[1].

Each item of
PPE must bear labelling indicating the noise attenuation level provided by the
PPE; should this not be possible, the labelling must be fixed to the packaging.

3.6.      Protection against heat and/or
fire

PPE designed
to protect all or part of the body against the effects of heat and/or fire must
possess thermal insulation capacity and mechanical strength appropriate to the
foreseeable conditions of use.

3.6.1.   PPE constituent materials and
other components

Constituent materials and other components
intended for protection against radiant and convective heat must possess an
appropriate coefficient of transmission of incident heat flux and be
sufficiently incombustible to preclude any risk of spontaneous ignition under
the foreseeable conditions of use.

Where the outside of these materials and
components must be reflective, its reflective power must be appropriate to the
intensity of the heat flux due to radiation in the infra-red range.

Materials and other components of equipment
intended for brief use in high-temperature environments and of PPE which may be
splashed by hot products such as large quantities of molten material must also
possess sufficient thermal capacity to retain most of the stored heat until
after the user has left the danger area and removed his PPE.

PPE materials and other components which
may be splashed by large amounts of hot products must also possess sufficient
mechanical-impact absorbency (see 3.1).

PPE materials
and other components which may accidentally come into contact with flame and
those used in the manufacture of fire-fighting equipment must also possess a
degree of non-flammability corresponding to the risk class associated with the
foreseeable conditions of use. They must not melt when exposed to flames nor
contribute to flame propagation.

3.6.2.   Complete PPE ready for use

Under the foreseeable conditions of use:

(a) 
the quantity of heat transmitted by PPE to the
user must be sufficiently low to prevent the heat accumulated during wear in
the part of the body at risk from attaining, under any circumstances, the pain
or health impairment threshold;

(b) 
the PPE must if necessary prevent liquid or
steam penetration and must not cause burns resulting from contact between its
protective integument and the user.

If PPE incorporates refrigeration devices
for the absorption of incident heat by means of liquid evaporation or solid
sublimation, their design must be such that any volatile substances released
are discharged beyond the outer protective integument and not towards the user.

If PPE incorporates a breathing device, the
latter must adequately fulfil the protective function assigned to it under the
foreseeable conditions of use.

The
manufacturer's instructions accompanying PPE intended for brief use in
high-temperature environments must in particular provide all relevant data for
the determination of the maximum permissible user exposure to the heat
transmitted by the equipment when used in accordance with its intended purpose.

3.7.      Protection against cold

PPE designed
to protect all or part of the body against the effects of cold must possess
thermal insulating capacity and mechanical strength appropriate to the
foreseeable conditions of use for which it is intended.

3.7.1.   PPE constituent materials and
other components

Constituent materials and other components
suitable for protection against cold must possess a coefficient of transmission
of incident thermal flux as low as required under the foreseeable conditions of
use. Flexible materials and other components of PPE intended for use in a
low-temperature environment must retain the degree of flexibility required for
the necessary gestures and postures.

PPE materials
and other components which may be splashed by large amounts of cold products
must also possess sufficient mechanical-impact absorbency (see 3.1).

3.7.2.   Complete PPE ready for use

Under the foreseeable conditions of use the
following requirements apply:

(a) 
the flux transmitted by PPE to the user must be
sufficiently low to prevent the cold accumulated during wear at any point on
the part of the body being protected, including the tips of fingers and toes in
the case of hands or feet, from attaining, under any circumstances, the pain or
health-impairment threshold;

(b) 
PPE must as far as possible prevent the
penetration of such liquids as rain water and must not cause injuries resulting
from contact between its cold protective integument and the user.

If PPE incorporates a breathing device,
this must adequately fulfil the protective function assigned to it under the
foreseeable conditions of use.

The
manufacturer's instructions accompanying PPE intended for brief use in
low-temperature environments must provide all relevant data concerning the
maximum permissible user exposure to the cold transmitted by the equipment.

3.8.      Protection against electric
shock

3.8.1.   Insulating equipment

PPE designed to protect all or part of the
body against the effects of electric current must be sufficiently insulated
against the voltages to which the user is likely to be exposed under the most
unfavourable foreseeable conditions.

To this end, the constituent materials and
other components of these types of PPE must be so chosen or designed and
incorporated as to ensure that the leakage current measured through the
protective integument under test conditions at voltages correlated with those
likely to be encountered in situ is minimized and, at all events, below a
maximum conventional permissible value which correlates with the tolerance
threshold.

Together with their packaging, PPE types
intended exclusively for use during work or activities in electrical
installations which are or may be under tension must bear markings indicating,
in particular, their protection class or corresponding operating voltage, their
serial number and their date of manufacture; a space must also be provided
outside the protective integument of such PPE for the subsequent inscription of
the date of entry into service and those of the periodic tests or inspections
to be conducted.

The
manufacturer's instructions must indicate, in particular, the exclusive use for
which these PPE types are intended and the nature and frequency of the
dielectric tests to which they are to be subjected during their useful life.

3.8.2.   Conductive equipment

Conductive PPE
intended for live working at high voltages shall be designed and manufactured
to ensure that there is no difference of potential between the user and the
installations on which he is intervening.

3.9.      Radiation protection

3.9.1.   Non-ionizing radiation

PPE designed to prevent acute or chronic
eye-damage from sources of non-ionizing radiation must be capable of absorbing
or reflecting the majority of the energy radiated in the harmful wavelengths
without unduly affecting the transmission of the innocuous part of the visible
spectrum, the perception of contrasts and the ability to distinguish colours
where required by the foreseeable conditions of use.

To this end, protective glasses must be so
designed and manufactured as to possess, for each harmful wave length, a
spectral transmission factor such that the radiant-energy illumination density
capable of reaching the user's eye through the filter is minimized and, under
no circumstances, exceeds the maximum permissible exposure value.

Furthermore, the glasses must not
deteriorate or lose their properties as a result of the effects of radiation
emitted under the foreseeable conditions of use and all marketed specimens must
bear the protection-factor number corresponding to the spectral distribution
curve of their transmission factor.

Glasses suitable for radiation sources of
the same type must be classified in the ascending order of their protection
factors and the manufacturer's instructions must indicate, in particular, how
to select the appropriate PPE taking into account the relevant conditions of
use such as the distance from the source and the spectral distribution of the
energy radiated at that distance

The relevant
protection factor number must be marked on all specimens of filtering glasses
by the manufacturer.

3.9.2.   Ionizing radiation

3.9.2.1. Protection against external
radioactive contamination

PPE constituent materials and other
components designed to protect all or part of the body against radioactive
dust, gases, liquids or mixtures thereof must be so chosen or designed and
incorporated as to ensure that this equipment effectively prevents the
penetration of the contaminants under the foreseeable conditions of use.

Depending on the nature or condition of
these contaminants, the necessary leak-tightness can be provided by the
impermeability of the protective integument and/or by any other appropriate
means, such as ventilation and pressurization systems designed to prevent the
back-scattering of these contaminants.

Any
decontamination measures to which PPE is subject must not prejudice its
possible re-use during the foreseeable useful life of these types of equipment.

3.9.2.2. Protection against external irradiation

PPE intended to provide complete user
protection against external irradiation or, failing this, adequate attenuation
thereof, must be designed to counter only weak electron (e. g. beta) or weak
photon (e. g. X, gamma) radiation.

The constituent materials and other
components of these types of PPE must be so chosen or designed and incorporated
as to provide the degree of user protection required by the foreseeable
conditions of use without leading to an increase in exposure time as a result
of the impedance of user gestures, posture or movement (see 1.3.2).

PPE must bear
a mark indicating the type and equivalent thickness of the constituent
material(s) suitable for the foreseeable conditions of use.

3.10.    Protection against dangerous
substances and infectious agents

3.10.1. Respiratory protection

PPE intended for the protection of the
respiratory system must make it possible to supply the user with breathable air
when exposed to a polluted atmosphere and/or an atmosphere having an inadequate
oxygen concentration.

The breathable air supplied to the user by
the PPE must be obtained by appropriate means, for example after filtration of
the polluted air through the protective equipment or by supply from an external
unpolluted source.

The constituent materials and other
components of these types of PPE must be chosen or designed and incorporated to
ensure appropriate user respiration and respiratory hygiene for the period of
wear concerned under the foreseeable conditions of use.

The leak-tightness of the facepiece and the
pressure drop on inspiration and, in the case of the filtering devices,
purification capacity must keep contaminant penetration from a polluted
atmosphere low enough not to be prejudicial to the health or hygiene of the
user.

The PPE must bear the manufacturer's
identification mark and details of the specific characteristics of the
equipment which, in conjunction with the instructions, enable a trained and
qualified user to employ the PPE correctly.

In the case of
filtering equipment, the manufacturer's instructions must also, indicate the
time limit for the storage of new filters kept in their original packaging.

3.10.2. Protection against cutaneous and
ocular contact

PPE intended to prevent the surface contact
of all or part of the body with dangerous substances and infective agents must
be capable of preventing the penetration or permeation of such substances and
agents through the protective integument under the foreseeable conditions of
use for which the PPE is intended.

To this end, the constituent materials and
other components of these types of PPE must be chosen or designed and
incorporated to ensure, as far as possible, complete leak-tightness, which will
allow where necessary prolonged daily use or, failing this, limited
leak-tightness necessitating a restriction of the period of wear.

Where, by
virtue of their nature and the foreseeable conditions of their use, certain
dangerous substances or infectious agents possess high penetrative power which
limits the duration of the protection provided by the PPE in question, the
latter must be subjected to standard tests with a view to their classification
on the basis of their performance. PPE which is considered to be in conformity
with the test specifications must bear a marking indicating, in particular, the
names or, failing this, the codes of the substances used in the tests and the
corresponding standard period of protection. The manufacturer's instructions
must also contain, in particular, an explanation of the codes (if necessary), a
detailed description of the standard tests and all appropriate information for
the determination of the maximum permissible period of wear under the different
foreseeable conditions of use.

3.11.    Diving equipment

The breathing equipment must make it
possible to supply the user with a breathable gaseous mixture, under
foreseeable conditions of use and taking account in particular of the maximum
depth of immersion.

Where the foreseeable conditions of use so
require, the diving equipment must comprise the following:

(a) 
a suit which protects the user against cold (see
3.7);

(b) 
an alarm designed to give the user prompt
warning of an approaching failure in the supply of breathable gaseous mixture
(see 2.8);

(c) 
a life-saving device enabling the user to return
to the surface.

ANNEX III

Technical
documentation for PPE

The technical
documentation shall specify the means used by the manufacturer to ensure the
conformity of the PPE with the applicable essential health and safety
requirements referred to in Article 5 and set out in Annex II.

The technical
documentation shall include at least the following elements:

1. 
a complete description of the PPE and of its
intended use;

2. 
an assessment of the risk(s) against which the
PPE is intended to protect;

3. 
a list of the essential health and safety
requirements that are applicable to the PPE;

4. 
design and manufacturing drawings and schemes of
the PPE and of its components, sub-assemblies, and circuits;

5. 
the descriptions and explanations necessary for
the understanding of the drawings and schemes referred to in point 4 and of the
operation of the PPE;

6. 
the reference(s) of the harmonised standard(s)
referred to in Article 14 that have been applied for the design and
manufacture of the PPE; in the event of partial application of harmonised
standards, the documentation shall specify the parts which have been applied;

7. 
where harmonised standards have not been applied
or only partially applied, descriptions of the other technical specifications
that have been applied in order to satisfy the applicable essential health and
safety requirements;

8. 
the results of the design calculations,
inspections and examinations carried out to verify the conformity of the PPE
with the applicable essential health and safety requirements;

9. 
reports on the tests carried out to verify the
conformity of the PPE with the applicable essential health and safety
requirements and, where appropriate, to establish the relevant protection
class;

10. 
a description of the means used by the
manufacturer during the production of the PPE to ensure the conformity of the
PPE produced with the design specifications;

11. 
a copy of the manufacturer's instructions
referred to in point 1.4 of Annex II;

12. 
for made-to-measure PPE, all the necessary
instructions of the designer of the basic model for manufacturing made-to-measure
PPE on the basis of the approved basic model.

ANNEX IV

Internal
production control

(Module
A)

1. 
Internal production control is the conformity
assessment procedure whereby the manufacturer fulfils the obligations laid down
in points 2, 3 and 4, and ensures and declares on his sole responsibility that
the PPE concerned satisfies the applicable essential health and safety
requirements referred to in Article 5 and set out in Annex II.

2. 
Technical documentation

The manufacturer shall establish the technical
documentation described in Annex III. The documentation shall make it
possible to assess the conformity of the PPE to the applicable requirements,
and shall include an adequate analysis and assessment of the risk(s). The
technical documentation shall specify the applicable requirements and cover, as
far as relevant for the assessment, the design, manufacture and operation of
the PPE.

3. 
Manufacturing

The manufacturer shall take all measures
necessary so that the manufacturing process and its monitoring ensure
compliance of the manufactured PPE with the technical documentation referred to
in point 2 and with the applicable essential health and safety requirements.

4. 
CE marking and EU declaration of conformity

4.1. 
The manufacturer shall affix the CE marking to
each individual PPE that satisfies the applicable essential health and safety
requirements.

4.2. 
The manufacturer shall draw up a written EU
declaration of conformity for a PPE model and keep it together with the
technical documentation at the disposal of the national authorities for 10
years after the PPE has been placed on the market. The EU declaration of
conformity shall identify the PPE for which it has been drawn up.

A copy of the EU declaration of conformity or a
simplified EU declaration of conformity shall accompany every PPE.

5. 
Authorised representative

The manufacturer's obligations set out in point
4 may be fulfilled by his authorised representative, on his behalf and under
his responsibility, provided that they are specified in the mandate.

ANNEX V

EU
type-examination

(Module B)

1. 
EU type-examination is the part of a conformity
assessment procedure in which a notified body examines the technical design of
PPE and verifies and attests that the technical design of the PPE meets the applicable essential health and safety requirements referred to
in Article 5 and set out in Annex II.

2. 
EU type-examination shall be carried out with
the examination of a specimen, representative of the production envisaged, of
the complete PPE (production type).

3. 
Application for EU type-examination

The manufacturer shall lodge an application for
EU type-examination with a single notified body of his choice.

The application shall include:

(a) 
the name and address of the manufacturer and, if
the application is lodged by the authorised representative, his name and address
as well;

(b) 
a written declaration that the same application
has not been lodged with any other notified body;

(c) 
the technical documentation described in Annex
III. The documentation shall make it possible to assess the conformity of the
PPE to the applicable requirements, and shall include an adequate analysis and
assessment of the risk(s). The technical documentation shall specify the
applicable requirements and cover, as far as relevant for the assessment, the
design, manufacture and operation of the PPE;

(d) 
the specimen(s) of the PPE representative of the
production envisaged. The notified body may request further specimens if needed
for carrying out the test programme. For individually adapted PPE, specimens
shall be provided that are representative of the range of different users;

(e) 
for individually adapted PPE, a description of
the measures to be taken by the manufacturer during the fitting and production
process to ensure that each item of PPE complies with the approved type and with
the applicable essential health and safety requirements.

4. 
EU type-examination

The notified body shall:

(a) 
examine the technical documentation to assess
the adequacy of the technical design of the PPE;

(b) 
for individually adapted PPE, examine the
description of the measures referred to in point 3 to assess their adequacy;

(c) 
for made-to-measure PPE, examine the instructions
of the designer of the basic model for manufacturing made-to-measure PPE on the
basis of the approved basic model to assess their adequacy;

(d) 
verify that the specimen(s) have been
manufactured in conformity with the technical documentation, and identify the
elements which have been designed in accordance with the applicable provisions
of the relevant harmonised standards as well as the elements which have been
designed in accordance with other technical specifications;

(e) 
carry out appropriate examinations and tests, or
have them carried out, to check whether, where the manufacturer has chosen to
apply the solutions in the relevant harmonised standards, these have been
applied correctly;

(f) 
carry out appropriate examinations and tests, or
have them carried out, to check whether, where the solutions in the relevant
harmonised standards have not been applied, the solutions adopted by the
manufacturer, including those in other technical specifications applied, meet
the corresponding essential health and safety requirements and have been
applied correctly.

5. 
Evaluation report

The notified body shall draw up an evaluation
report that records the activities undertaken in accordance with point 4 and
their outcomes. Without prejudice to its obligations vis-à vis the notifying
authorities, the notified body shall release the content of that report, in
full or in part, only with the agreement of the manufacturer.

6. 
EU type-examination certificate

6.1. 
Where the type meets the applicable essential
health and safety requirements, the notified body shall issue an EU
type-examination certificate to the manufacturer.

6.2. 
That certificate shall contain at least the
following information:

(a) 
the name and identification number of the
notified body;

(b) 
the name and address of the manufacturer and, if
the application is lodged by the authorised representative, his name and
address;

(c) 
identification of the PPE covered by the
certificate (type, model, manufacturer’s reference);

(d) 
a statement that the PPE complies with the
applicable essential health and safety requirements referred to in Article 5 and
set out in Annex II;

(e) 
where harmonised standards have been fully or
partially applied, the references of those standards or parts thereof;

(f) 
where other technical specifications have been
applied, their references;

(g) 
where applicable, the performance level(s) or
protection class of the PPE;

(h) 
for made-to-measure PPE, the range of
permissible variations of relevant parameters for made-to-measure PPE based on
the approved basic model;

(i) 
the date of issue and, where appropriate, the
date(s) of renewal;

(j) 
the date of expiry (a maximum of five years
after the date of issue or the date of the last renewal);

(k) 
any conditions attached to the issue of the
certificate;

(l) 
for category III PPE, a statement that the
certificate shall only be used in conjunction with one of the conformity
assessment procedures referred to in Article 18.

6.3. 
The EU type-examination certificate may have one
or more annexes attached.

6.4. 
For made-to-measure PPE, if the person to whom
the EU type-examination certificate was issued is not the manufacturer of the
made-to-measure PPE:

(a) 
the manufacturer of the made-to-measure PPE
shall have the written authorisation of the certificate holder to use that
certificate;

(b) 
the certificate holder shall provide the
manufacturer of the made-to-measure PPE with the instructions referred to in point
12 of Annex III.

6.5. 
Where the type does not satisfy the applicable
essential health and safety requirements, the notified body shall refuse to
issue an EU type-examination certificate and shall inform the applicant
accordingly, giving detailed reasons for its refusal.

7. 
Review of the EU type-examination certificate

7.1. 
The notified body shall keep itself apprised of
any changes in the generally acknowledged state of the art which indicate that
the approved type may no longer comply with the applicable essential health and
safety requirements, and shall determine whether such changes require further investigation.
If so, the notified body shall inform the manufacturer accordingly.

7.2. 
The manufacturer shall inform the notified body
that holds the technical documentation relating to the EU type-examination
certificate of all modifications to the approved type that may affect the
conformity of the PPE with the applicable essential health and safety
requirements or the conditions for validity of that certificate. Such
modifications shall require additional approval in the form of an addition to
the original EU type-examination certificate.

7.3. 
The manufacturer shall ensure that the PPE
continues to fulfil the applicable essential health and safety requirements in
light of the state of the art.

7.4. 
The manufacturer shall ask the notified body to
review the EU type-examination certificate:

(a) 
in case of a modification to the PPE referred to
in point 7.2;

(b) 
in case of a change in the state of the art
referred to in point 7.3;

(c) 
at the latest, before the date of expiry of the
certificate.

7.5. 
The notified body shall examine the PPE and carry
out any tests necessary to ensure that the PPE continues to fulfil the
applicable essential health and safety requirements. In that case, it shall
renew the EU type-examination certificate.

7.6. 
If, following the review, the notified body
concludes that the EU type-examination certificate is no longer valid, the body
shall withdraw it and the manufacturer shall cease the placing on the market of
the PPE concerned.

8. 
The notified body shall inform its notifying
authority concerning the EU type-examination certificates and/or any additions
thereto which it has issued or withdrawn, and shall, periodically or upon
request, make available to its notifying authority the list of such
certificates and/or any additions thereto refused, suspended or otherwise
restricted.

The notified body shall inform the other
notified bodies concerning the EU type-examination certificates and/or any
additions thereto which it has refused, withdrawn, suspended or otherwise
restricted, and, upon request, concerning such certificates and/or additions
thereto which it has issued.

The Commission, the Member States and the other notified bodies may, on request, obtain a copy of the EU type-examination
certificates and/or additions thereto. On a reasoned request, the Commission
and the Member States may obtain a copy of the technical documentation and the
results of the examinations carried out by the notified body.

The notified body shall keep a copy of the EU
type-examination certificate, its annexes and additions, as well as the
technical file including the documentation submitted by the manufacturer, until
5 years after the expiry of the validity of that certificate.

9. 
The manufacturer shall keep a copy of the EU
type-examination certificate, its annexes and additions together with the
technical documentation at the disposal of the national authorities for 10
years after the PPE has been placed on the market.

10. 
The manufacturer's authorised representative may
lodge the application referred to in point 3 and fulfil the obligations set out
in points 7 and 9, provided that they are specified in the mandate.

ANNEX VI

Conformity
to type based on internal production control

(Module
C)

1. 
Conformity to type based on internal production
control is the part of a conformity assessment procedure whereby the manufacturer
fulfils the obligations laid down in points 2 and 3, and ensures and declares
under his sole responsibility that the PPE concerned is in conformity with the
type described in the EU type-examination certificate and satisfies the
applicable essential health and safety requirements referred to in Article 5
and set out in Annex II.

2. 
Manufacturing

The manufacturer shall take all measures
necessary so that the manufacturing process and its monitoring ensure
conformity of the manufactured PPE with the type described in the EU
type-examination certificate and with the applicable essential health and
safety requirements.

For made-to-measure PPE the manufacturer shall
take all measures necessary so that the manufacturing process and its
monitoring ensure conformity of the manufactured made-to-measure PPE with the basic
model described in the EU type-examination certificate and with the applicable
essential health and safety requirements.

3. 
CE marking and EU declaration of conformity

3.1. 
The manufacturer shall affix the CE marking to
each individual PPE that is in conformity with the type described in the EU
type-examination certificate and satisfies the applicable essential health and
safety requirements.

3.2. 
The manufacturer shall draw up a written EU
declaration of conformity for a PPE model and keep it at the disposal of the
national authorities for 10 years after the PPE has been placed on the market.
The EU declaration of conformity shall identify the PPE for which it has been
drawn up.

A copy of the EU declaration of conformity or a
simplified EU declaration of conformity shall accompany every PPE.

4. 
Authorised representative

The manufacturer's obligations set out in point
3 may be fulfilled by his authorised representative, on his behalf and under
his responsibility, provided that they are specified in the mandate.

ANNEX VII

Conformity
to type based on product verification

(Module
F)

1. 
Conformity to type based on product verification
is the part of a conformity assessment procedure whereby the manufacturer
fulfils the obligations laid down in points 2, 3, 5.2 and 6, and ensures and
declares on his sole responsibility that the PPE, which has been subject to the
provisions of point 4, is in conformity with the type described in the EU
type-examination certificate and satisfies the applicable essential health and
safety requirements referred to in Article 5 and set out in Annex II.

2. 
Manufacturing

The manufacturer shall take all measures
necessary so that the manufacturing process and its monitoring ensure the
homogeneity of production and conformity of the manufactured PPE with the type
described in the EU type-examination certificate and with the applicable
essential health and safety requirements.

3. 
Application for product verification

Before placing PPE on the market, the manufacturer
shall lodge an application for product verification with a single notified body
of his choice.

The application shall include the following:

(a) 
the name and address of the manufacturer and, if
the application is lodged by the authorised representative, his name and
address;

(b) 
a written declaration that the same application
has not been lodged with any other notified body;

(c) 
the identification of the PPE concerned.

Where the chosen body is not the body that has
carried out the EU type-examination, the application shall also include the
following:

(a) 
the technical documentation described in Annex
III;

(b) 
a copy of the EU type-examination certificate.

4. 
Verification of conformity

4.1. 
The notified body shall carry out appropriate
examinations and tests in order to check the homogeneity of production and the
conformity of the PPE with the type described in the EU type-examination
certificate and with the applicable essential health and safety requirements.

4.2. 
The examinations and tests shall be carried out
at least once a year, at random intervals determined by the notified body. The
first examinations and tests shall be carried out no more than one year after
the date of issue of the EU type-examination certificate.

4.3. 
An adequate random sample of the manufactured
PPE shall be selected by the notified body at a place agreed between the body
and the manufacturer. All items of PPE of the sample shall be examined and
appropriate tests set out in the relevant harmonised standard(s) and/or
equivalent tests set out in other relevant technical specifications shall be
carried out in order to verify the conformity of the PPE with the type
described in the EU type-examination certificate and with the applicable
essential health and safety requirements.

4.4. 
Where the notified body referred to in point 3
is not the body that issued the relevant EU type-examination certificate, it
shall contact that body in the event of difficulties in connection with the
assessment of the conformity of the sample.

4.5. 
If the examination and testing reveal that the
production is not homogeneous or that the PPE does not comply with the type
described in the EU type-examination certificate or with the applicable
essential health and safety requirements, the notified body shall take measures
appropriate to the fault(s) recorded and inform the notifying authority
thereof.

5. 
Test report

5.1. 
The notified body shall provide the manufacturer
with a test report, and shall authorise the manufacturer to affix the notified
body's identification number to each individual PPE that is in conformity with
the type described in the EU type-examination certificate and satisfies the
applicable essential health and safety requirements.

5.2. 
The manufacturer shall keep the test report at
the disposal of the national authorities for 10 years after the PPE has been
placed on the market.

6. 
CE marking and EU declaration of conformity

6.1. 
The manufacturer shall affix the CE marking,
and, with the authorisation of the notified body referred to in point 3, the
latter's identification number to each individual PPE that is in conformity
with the type described in the EU type-examination certificate and satisfy the
applicable essential health and safety requirements.

6.2. 
The manufacturer shall draw up a written EU
declaration of conformity for each PPE model and keep it at the disposal of the
national authorities for 10 years after the PPE has been placed on the market.
The EU declaration of conformity shall identify the PPE model for which it has
been drawn up.

A copy of the EU declaration of conformity or a
simplified EU declaration of conformity shall accompany every PPE.

7. 
If the notified body referred to in point 3
agrees, the manufacturer may affix the notified body's identification number to
the PPE during the manufacturing process.

8. 
Authorised representative

The manufacturer's obligations may be fulfilled
by his authorised representative, on his behalf and under his responsibility,
provided that they are specified in the mandate. An authorised representative
may not fulfil the manufacturer's obligations set out in point 2.

ANNEX VIII

Conformity to type based on quality assurance of the production
process

(Module D)

1. 
Conformity to type based on quality assurance of
the production process is the part of a conformity assessment procedure whereby
the manufacturer fulfils the obligations laid down in points 2, 5 and 6, and
ensures and declares on his sole responsibility that the PPE concerned is in
conformity with the type described in the EU type-examination certificate and
satisfies the applicable essential health and safety requirements referred to
in Article 5 and set out in Annex II.

2. 
Manufacturing

The manufacturer shall operate an approved
quality system for production, final product inspection and testing of the PPE
concerned as specified in point 3, and shall be subject to surveillance as
specified in point 4.

3. 
Quality system

3.1. 
The manufacturer shall lodge an application for
assessment of his quality system with a single notified body of his choice.

The application shall include:

(a) 
the name and address of the manufacturer and, if
the application is lodged by the authorised representative, his name and
address;

(b) 
a written declaration that the same application
has not been lodged with any other notified body;

(c) 
the identification of the PPE concerned;

(d) 
the documentation concerning the quality system.

Where the chosen body is not the body that has
carried out the EU type-examination, the application shall also include the
following:

(a) 
the technical documentation of the PPE described
in Annex III;

(b) 
a copy of the EU type-examination certificate.

3.2. 
The quality system shall ensure that the PPE is
in conformity with the type described in the EU type-examination certificate
and fulfils the applicable essential health and safety requirements.

All the elements, requirements and provisions
adopted by the manufacturer shall be documented in a systematic and orderly
manner in the form of written policies, procedures and instructions. The
quality system documentation shall permit a consistent interpretation of the
quality programmes, plans, manuals and records.

It shall, in particular, contain an adequate
description of:

(a) 
the quality objectives and the organisational
structure, responsibilities and powers of the management with regard to product
quality;

(b) 
the corresponding manufacturing, quality control
and quality assurance techniques, processes and systematic actions that will be
used;

(c) 
the examinations and tests that will be carried
out before, during and after manufacture, and the frequency with which they
will be carried out;

(d) 
the quality records, such as inspection reports
and test data, calibration data, qualification reports on the personnel
concerned, etc., and

(e) 
the means of monitoring the achievement of the
required product quality and the effective operation of the quality system.

3.3. 
The notified body shall assess the quality
system to determine whether it satisfies the requirements referred to in point
3.2.

It shall presume conformity with those
requirements in respect of the elements of the quality system that comply with
the corresponding specifications of the relevant harmonised standards.

In addition to experience in quality management
systems, the auditing team shall have at least one member with experience of
evaluation in the field of PPE and technology concerned, and knowledge of the
applicable essential health and safety requirements. The audit shall include an
assessment visit to the manufacturer's premises. The auditing team shall review
the technical documentation of the PPE referred to in point 3.1 to verify the
manufacturer's ability to identify the applicable essential health and safety
requirements and to carry out the necessary examinations with a view to
ensuring conformity of the PPE with those requirements.

The result of that assessment shall be notified
to the manufacturer. The notification shall contain the conclusions of the
audit and the reasoned assessment decision.

3.4. 
The manufacturer shall undertake to fulfil the
obligations arising out of the quality system as approved and to maintain it so
that it remains adequate and efficient.

3.5. 
The manufacturer shall keep the notified body
that has approved the quality system informed of any intended change to the
quality system.

The notified body shall evaluate any proposed
changes and decide whether the modified quality system will continue to satisfy
the requirements referred to in point 3.2 or whether a reassessment is
necessary.

It shall notify the manufacturer of its
decision. The notification shall contain the conclusions of the examination and
the reasoned assessment decision.

3.6. 
The notified body shall authorise the
manufacturer to affix the notified body's identification number to each
individual PPE that is in conformity with the type described in the EU
type-examination certificate and satisfy the applicable essential health and
safety requirements.

4. 
Surveillance under the responsibility of the
notified body

4.1. 
The purpose of surveillance is to make sure that
the manufacturer duly fulfils the obligations arising out of the approved
quality system.

4.2. 
The manufacturer shall, for assessment purposes,
allow the notified body access to the manufacture, inspection, testing and
storage sites and shall provide it with all necessary information, in
particular:

(a) 
the quality system documentation;

(b) 
the quality records, such as inspection reports
and test data, calibration data, qualification reports on the personnel
concerned.

4.3. 
The notified body shall carry out periodic
audits, at least once a year, to make sure that the manufacturer maintains and
applies the quality system and shall provide the manufacturer with an audit
report.

4.4. 
In addition, the notified body may pay
unexpected visits to the manufacturer. During such visits the notified body
may, if necessary, carry out examinations or tests of the PPE, or have them
carried out, in order to verify that the quality system is functioning
correctly. The notified body shall provide the manufacturer with a visit report
and, if tests have been carried out, with a test report.

5. 
CE marking and EU declaration of conformity

5.1. 
The manufacturer shall affix the CE marking,
and, with the authorisation of the notified body referred to in point 3.1, the
latter's identification number to each individual PPE that is in conformity
with the type described in the EU type-examination certificate and satisfy the
applicable essential health and safety requirements.

5.2. 
The manufacturer shall draw up a written EU
declaration of conformity for each PPE model and keep it at the disposal of the
national authorities for 10 years after the product has been placed on the
market. The EU declaration of conformity shall identify the PPE model for which
it has been drawn up.

A copy of the EU declaration of conformity or a
simplified EU declaration of conformity shall accompany every PPE.

6. 
The manufacturer shall, for a period ending 10
years after the PPE has been placed on the market, keep at the disposal of the
national authorities:

(a) 
the documentation referred to in point 3.1;

(b) 
the information related to the change referred
to in point 3.5, as approved;

(c) 
the decisions and reports of the notified body
referred to in points 3.5, 4.3 and 4.4.

7. 
The notified body shall inform its notifying
authority of quality system approvals issued or withdrawn, and shall,
periodically or upon request, make available to its notifying authority the
list of such quality system approvals refused, suspended or otherwise
restricted.

The notified body shall inform the other
notified bodies of quality system approvals which it has refused, suspended,
withdrawn or otherwise restricted, and, upon request, of such quality system
approvals which it has issued.

8. 
If the notified body referred to in point 3.1
agrees, the manufacturer may affix the notified body’s identification number to
the PPE during the manufacturing process.

9. 
Authorised representative

The manufacturer's obligations set out in points
3.1, 3.5, 5 and 6 may be fulfilled by his authorised representative, on his
behalf and under his responsibility, provided that they are specified in the
mandate.

ANNEX IX

EU
declaration of conformity

1. 
PPE (product, batch, type or serial number):

2. 
Name and address of the manufacturer or his
authorised representative [The authorised representative must also give the
business name and address of the manufacturer]:

3. 
This declaration of conformity is issued under
the sole responsibility of the manufacturer:

4. 
Object of the declaration (identification of PPE
allowing traceability; it may, where necessary for the identification of the
PPE, include a colour image of sufficient clarity):

5. 
The object of the declaration described in point
4 is in conformity with the relevant Union harmonisation legislation:

6. 
References to the relevant harmonised standards,
including the date of the standard, or references to the other technical
specifications, including the date of the specification, in relation to which
conformity is declared:

7. 
Where applicable, the notified body ... (name,
number)... performed the EU type-examination (Module B) and issued the EU
type-examination certificate ... (reference to that certificate).

8. 
Where applicable, the PPE is subject to the conformity
assessment procedure ... (either (Conformity to type based on product
verification (Module F)) or (Conformity to type based on quality assurance of
the production process (Module D)) ... under surveillance of the notified body
... (name, number).

9. 
Additional Information:

Signed for and on behalf of:

(place and date of issue):

(name, function) (signature):

ANNEX X

Simplified
EU declaration of conformity

The simplified EU declaration of conformity
shall be provided as follows:

Hereby, [Name of manufacturer] declares that the PPE type [designation of type of PPE] is in compliance with the PPE Regulation (EU) No [XXXX/YYYY].

ANNEX XI

Correlation table

CORRELATION TABLE

Directive 89/686/EEC || This Regulation

||

Article 1(1) || Articles 1 and 2(1)

Article 1(2) and (3) || Article 3(1)

Article 1(4) || Article 2(2) and (3)

Article 2(1) || Article 4

Article 2(2) || Article 6

Article 2(3) || Article 7(2)

Article 3 || Article 5

Article 4(1) || Article 7(1)

Article 4(2) || ___

Article 5(1), (4), (5), (6) || ___

Article 5(2) || Article 14

Article 6 || Article 38

Article 7 || ___

Article 8(1) || Article 8(2) first subparagraph

Article 8(2) – (4) || Articles 17 and 18 and Annex I

Article 9 || Articles 19, 23(1), 24, and 29(1)

Article 10 || Annex V

Article 11(A) || Annex VII

Article 11(B) || Annex VIII

Article 12(1) || Article 15

Articles 12(2) and 13 || Article 16

Article 14 || ___

Article 15 || ___

Article 16 || ___

Annex I || Article 2(2)

Annex II || Annex II

Annex III || Annex III

Annex IV || Article 16

Annex V || Article 23(2) – (11)

Annex VI || Annex IX

[1]               Directive 2003/10/EC of the European Parliament and
of the Council of 6 February 2003 on the minimum health and safety requirements
regarding the exposure of workers to the risks arising from physical agents
(noise) (OJ L 42, 15.2.2003, p. 38).