EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, 27.3.2014  
COM(2014) 186 final 
2014/0108 (COD) 
  
Proposal for a 
REGULATION OF THE EUROPEAN PA RLIAMENT AND OF THE COUNCIL 
on personal protective equipment 
(Text with EEA relevance) 
{SWD(2014) 118 final} 
{SWD(2014) 119 final}   
EN 2   EN EXPLANATORY MEMORANDUM  
1. CONTEXT  OF THE  PROPOSAL 
General context, reasons for and objectives of this proposal  
Directive 89/686/EEC on pers onal protective equipment1 was adopted on 21 December 1989 
and became fully applicable as from 1 July 1995. 
Directive 89/686/EEC (PPE Directive) ensure s the free movement of personal protective 
equipment (PPE). It has contributed consider ably 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 Di rective. Manufacturers must al so affix the CE marking and 
provide users with instructions for storage,  use, cleaning, mainte nance, 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 harmonisati on 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 ag ainst one or more health and safety hazards” . 
It also covers “ interchangeable PPE components which ar e essential to it s satisfactory 
functioning and used exclusi vely 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 designe d 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 it s objectives in creating a single market and 
ensuring a high level of protection for users of  PPE, certain problems ha ve 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 wh ich is currently not 
covered by the PPE Directive. Furthermore so me provisions of the PPE Directive should be 
made clearer and simpler. 
This proposal intends to repl ace Directive 89/686/EEC on pers onal protective equipment by a 
Regulation, in line with the Comm ission’s simplification objectives. 
                                                
 
1 OJEU L 399, 30.12.1989, p.18.  
EN 3   EN The overall objectives of this initiative are to bett er protect the health and safety of PPE users, 
to ensure a level playing fiel d for PPE economic operators with in 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 exis ting Directive and aligns it with the provisions 
of Decision No 768/2008/EC2 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 privat e use providing protectio n against heat, damp 
and water. Experience with the implementation and enforcement of the PPE Directive showed 
that these exclusions were no l onger justified. In order to improve  the health and safety of the 
users, the requirements of the PPE Directive an d hence of this proposal should apply to these 
products. Clarifications were in troduced in order to reduce in terpretation, e. g. concerning 
provisions for made-to-measure a nd individually adapted PPE. Th e 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 cha nges 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 th e 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 th e Member States as regards th e evaluation and monitoring of 
notified bodies). A number of manufacturers ar e also faced with the problem of the legal 
framework being complex and sometimes incons istent. The alignment of the PPE Directive 
with the NLF responds to the political comm itment laid down in Article 2 of the NLF 
Decision. 
The NLF Decision sets out a common framewor k for EU product harmonisation legislation. 
This framework consists of the provision s 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 ef fectively in practice. New elements, such as 
obligations of importers, have been introduced, which are crucia l for improving the safety of 
products on the market.  
The Commission has already proposed the alignmen t of nine Directives to the NLF Decision 
within an NLF implementation package adopted on 21 November 2011. 
In view of ensuring consistency across Uni on harmonisation legislation for industrial 
products, in accordance with the political comm itment resulting from the adoption of the NLF 
Decision and the legal obliga tion 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 Eur opean 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 an d repealing Council Deci sion 87/95/EEC and 
Decision No 1673/2006/EC of the Europ ean Parliament and of the Council
3. 
                                                 
2 OJEU L 218, 13.8.2009, p.82. 
3 OJEU L 316, 14.11.2012, p.12.  
EN 4   EN The proposal also takes into account the proposal of the Co mmission of 13 February 2013 for 
a Regulation on market surveillance of products4, which intends to set out a single legal 
instrument on the market surveillance activi ties in the field of non-food goods, consumer or 
non-consumer products and produc ts covered or not by Union harmonisation legislation. The 
proposal merges the rules on ma rket surveillance of Direc tive 2001/95/EC on general product 
safety5, Regulation (EC) 765/2008 of the European Pa rliament and of the Council of 9 July 
2008 setting out the requirements for accreditati on and market surveillance relating to the 
marketing of products6 and of sector-specific harmonisation legislation in order to increase 
the effectiveness of market su rveillance activities within the Union. Th e proposed Regulation 
on market surveillance of products contains also the relevant provisions on market 
surveillance and safeguard clauses. Therefor e, provisions in existing sector specific 
harmonisation legislation that re late to market surveillance a nd safeguard clauses should be 
removed from that harmonisation legislati on. The overacting objective of the proposed 
Regulation is to simplify the Union market surv eillance framework fundamentally so that it 
works better for its main users: market surv eillance authorities and economic operators. The 
current PPE Directive provides for a safeguard cl ause procedure. In line with the framework 
intended to be established by the proposed Regul ation on market surveillance of products, this 
proposal for a Regulation on PPE does not incl ude the provisions on market surveillance and 
safeguard clause procedures for PPE provided fo r in the NLF Decision. However, in order to 
ensure legal clarity, it makes a reference to the proposed Regula tion on market surveillance of 
products. 
Consistency with other policies and objectives of the Union 
This initiative is in line with the Single Market Act7, 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 polic y on Better Regulation and simplification of 
the regulatory environment. 
This proposal does not change the re lationship to the Directive 89/656/EEC
8 of 
30 November 1989 on the minimum health and safe ty requirements for the use by workers of 
personal protective equipment at the workplace (thi rd individual directiv e 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 disc ussed with all stakehol ders, including Member 
States, manufacturers' federati ons, notified bodies and represen tatives from standardisation. 
                                                 
4 Proposal for a Regulation of the European Parlia ment 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.  
EN 5   EN The consultation included meetings for a select ed group of experts as well as consultation of 
the PPE Working Group as well as the PPE AdCo  Group of market surv eillance authorities. 
While the success of the Directiv e is generally recognised a br oad consensus exists among the 
Member States and other stakeholders that so me 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 survei llance. Most of the proposed 
improvements result from the day to day experi ence of Member States authorities and other 
stakeholders with the enforcement and implem entation 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, tr ade associations, individual citi zens), 2 from an EFTA country 
and 1 from overseas. The replie s provided the Commi ssion services with a broader view on 
the identified policy needs and as such  confirmed the envisaged approaches9. 
In general all stakeholders expressed support fo r 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 ali gn the PPE Directive to the NLF and thus to 
improve the existing general regulatory framew ork. 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 stake holders expressed their support for: 
– The extension of the product cove rage 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 tech nical 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 opti ons 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 asse ssment conducted in the framework of the NLF 
Implementation package of 21 November 2011
10. 
                                                 
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 Pa ckage (Implementation Goods Package), Commission 
Staff Working Paper – Impact Assessment accompanyi ng document to the 10  Proposals to Align 
Product Harmonisation Directives to Decision No 768/2008/EC (SEC(2011) 1376 final).  
EN 6   EN In particular, the modifications due to the a lignment 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 w ith regard to the PPE Directive. The Report 
contained also an analysis of the impacts re sulting 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 carri ed out. It focused on analysing the 
competitiveness impacts of the envisaged changes12. 
Based on the information collected, the imp act assessment carried out by the Commission 
examined and compared three options with rega rd to problems and issues relating to the PPE 
Directive. 
Option 1 – “Do nothing” - No chan ges 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 m odifying 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 th at the positive impacts w ould 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 th e market surveillance authorities and 
consequently reduces the non-compliant pr oducts 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 manufacturer s 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; 
                                                 
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/mechani cal/files/ppe/rev-study-competitiveness_en.pdf.   
EN 7   EN – 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 enla rged 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 existin g exclusions and clarifies that  it does not apply to PPE for 
head, face or eye protection, subj ect to the relevant UNECE Regul ation, 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 ma rket, free movement, obligatio ns of economic operators, 
CE marking 
The proposal contains the typical provision s for product-related  Union harmonisation 
legislation and sets out the obl igations of the relevant econo mic operators (manufacturers, 
authorised representatives, importers and dist ributors), 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 declara tion of conformity. 
3.3. Notified bodies 
Proper functioning of notified bodies is crucial fo r ensuring a high level of  health and safety 
protection and for the confiden ce 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 assessm ent bodies (notified bodi es). It leaves the 
ultimate responsibility for designating and mo nitoring 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 pr otect. The risks belonging to each category are 
set out in Annex I. Made-to-measur e 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 cut ting, bullet wounds or knife  stabs, and harmful noise  is listed under 
category III and subject to the most stri ngent conformity assessment procedure.  
EN 8   EN The proposal keeps the applicable conformity assessme nt 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 intr oduced concerning the 
minimum content and the length of validity of  the EU type-examination certificates. The 
module provides for a procedure fo r 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 thr ee 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 impractic able or that create confusion. 
3.6. Implementing acts 
The proposal empowers the Commission to adop t, where appropriate, implementing acts to 
ensure the uniform application of this Regulatio n in respect of notified bodies that do not meet 
or no longer meet the require ments for their notification. 
Those implementing acts will be adopted in acc ordance 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 ru les 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 acc ount the progress of tec hnical 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 St ates time to adapt to the new requirements. 
However, the designation of no tified 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 pr oposed Regulation, sufficient no tified 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 Direct ive 89/686/EEC so as to allow stoc ks 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, subs idiarity principle and legal form 
Legal basis 
The proposal is based on Article 114 of the Tr eaty on the Functioning of the European Union. 
Subsidiarity principle  
EN 9   EN The subsidiarity principle aris es in particular with regard  to the newly added provisions 
aiming at the improvement of effective enfo rcement of Directive 89/686/EEC, namely, the 
economic operators’ obligations, the traceabilit y provisions, the provisions on the assessment 
and notification of conformity assessment bodies.  
Experience with the enforcement of the legislat ion has shown that measures taken at national 
level have led to divergent ap proaches and to a different tr eatment 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 proportiona lity, the proposed modifications do not go 
beyond what is necessary to achieve the objectives set.  
The new or modified obligations do not impos e unnecessary burdens an d costs on industry - 
especially on small and medium sized enterpri ses - 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 respons e to the problems identified. A number of 
modifications concern the improvement of cl arity of the existing Directive without 
introducing new requirements th at 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 doe s 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 equi pment. 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 requirement s 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 pro cedures 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 Directiv e into their national la w and its content is in  many cases reproduced 
word for word in the nati onal 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 a nd distributors of PPE and for 
the notified bodies that carry out the conformity assessment  procedures. All of these 
provisions are clear and sufficien tly precise to be applied dire ctly by the actors concerned. 
The obligations set by the legislation for the Memb er 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 Me mber States by means of the necessary  
EN 10   EN 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 w ill not lead to any change in the regulatory 
approach. The characteristics of the New Appro ach 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 specif ications) and in the 
choice of the procedure used to demonstrate compliance from among the available conformity 
assessment procedures. The existing mechan isms supporting the implementation of the 
legislation (standardisation pr ocess, working groups, market surveillance, administrative 
cooperation (AdCo), and the development of gui dance documents…) will not be affected by 
the nature of the legal instrume nt and will continue to opera te 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 st akeholders, avoids the risk of ‘gold plating’. It also allows 
manufacturers to work directly with the Regul ation 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 mo st appropriate solution 
for all involved parties as it wi ll allow a more rapid and cohere nt application of the proposed 
legislation and will establish a clearer re gulatory 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.  
EN 11   EN 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 CO UNCIL 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 Eu ropean Economic and Social Committee, 
Acting in accordance with the or dinary 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 a nd to remove obstacles to trade in PPE 
between Member States. 
(2) Directive 89/686/EEC is based on the Ne w Approach principles, as set out in the 
Council Resolution on a new approach to technical harmonisation and standards14. 
Thus, it sets only the essential safety requi rements applying to PPE, whereas technical 
details are adopted by the European Comm ittee for Standardisation (CEN) and the 
European Committee for Electrotechnical Standardisation (CENELEC) in accordance 
with Regulation (EU) No 1025/2012 of the Eu ropean Parliament and of the Council15. 
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 requi rements of Directive 89/686/ EEC. Experience has shown 
that those basic principles ha ve worked well in this sect or 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 
                                                
 
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).  
EN 12   EN account of this experience and to provide cl arification in relation to the framework 
within which products covered by this Regulation may be ma rketed, certain aspects of 
Directive 89/686/EEC should be revised and enhanced.  
(4) Since the scope, the esse ntial health and safety re quirements 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 accreditati on of conformity assessment bodies and 
on the CE marking. 
(6) Decision No 768/2008/EC of the Eur opean Parliament and of the Council17 provides 
common principles and reference provisions for the purposes of legislation based on 
the New Approach principles. In order to ensure consistency w ith other sectoral 
product legislation, it is appr opriate to align certain provi sions of this Regulation to 
that Decision, in so far as sectoral speci ficities do not require a different solution. 
Therefore, certain definiti ons, the general obligations of economic operators, the 
presumption of conformity, EU declarati on of conformity, rules on CE marking, 
requirements for conformity assessment bodies and notification procedures, the 
conformity assessment procedures and the pr ovisions concerning procedures to deal 
with products presenting a risk shou ld be aligned to that Decision.  
(7) Regulation (EU) No 1025/ 2012 provides for a procedure for objections to harmonised 
standards where those standa rds do not entirely satisf y the requirements of this 
Regulation. 
(8) Regulation (EU) No xx/xxxx of the Eu ropean Parliament and of the Council 18 
provides detailed rules on market surveill ance and on controls of harmonised products, 
including PPE, entering the Union from third countries. In accordance with that Regulation, Member States ar e to organise and carry ou t market surveillance, to 
appoint market surveillance authorities, to specify their powers and duties, and to set 
up general and sector-specific market surv eillance programmes. That Regulation also 
sets out a safeguard clause procedure. 
(9) Some products on the mark et that provide a protective  function to the user are 
excluded from the scope of Directive 89/686/EE C. In order to ensure as high level of 
protection for the user of those pr oducts as for the PPE covered by 
Directive 89/686/EEC, the scope of this Re gulation should include PPE for private use 
against damp, water and heat (e.g. dish-w ashing gloves, oven gloves), in line with 
                                                
 
16 Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out 
the requirements for accreditation an d 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)].  
EN 13   EN similar PPE for professional use which is  already covered by  Directive 89/686/EEC. 
Artisanal products, such as handmade gl oves, 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 appropri ate 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 therefor e are excluded from the PPE Regulation. 
(10) In order to facilitate the understanding and uniform app lication 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 cond itions of their manufacture. 
(11) Economic operators should be responsibl e for the compliance of products, in relation 
to their respective roles in th e supply chain, so as to ensure a high level of protection 
of public interests, such as health and safety, and the protec tion of users and to 
guarantee fair competition on the Union market. 
(12) All economic operators in tervening in the supply and di stribution chain should take 
appropriate measures to ensure that PPE pr otects the health and safety of persons and 
that they make available on the market  only products which comply with this 
Regulation. This Regulation s hould provide a clear and pro portionate distribution of 
obligations which correspond to the role  of each operator in the supply and 
distribution chain. 
(13) The manufacturer, having detailed know ledge of the design and production process, is 
best placed to carry out the complete conf ormity assessment procedure. Conformity 
assessment should therefore remain the ob ligation of the manu facturer alone. 
(14) It is necessary to ensure that PPE entering the Union market complies with this 
Regulation and, in particular , that appropriate assessmen t 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 techni cal documentation draw n 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 shoul d act with due care to  ensure that their 
handling of the PPE does not adversel y 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 cont acted. 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 impor ter 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 car ried out by competent national authorities, and should be  
EN 14   EN prepared to participate act ively, providing those aut horities 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 requi rement to label PPE protecting against 
harmful noise with a comfort index should be  removed as experien ce has shown that it 
is not possible to measure and establish such an index. As regards mechanical 
vibrations, it is appropriate to remove th e 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, si nce the indication of the protection factor 
is more useful and is sufficient for the user. 
(21) It is necessary to clearly specify the re lationship and scope of th is Regulation with the 
entitlement of Member States to lay down requirements for the use of PPE at 
workplace, in particular pursuan t to Council Directive 89/656/EEC19, 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 in troduced into this 
Regulation. It should be possible to provide a simplified EU declaration of conformity 
in order to reduce the burden associated wi th this requirement without reduction of its 
effectiveness. Both possibilities should th erefore be provided for in this Regulation. 
(23) In order to increase the efficiency of ma rket surveillance it is necessary to extend the 
obligation to draw up a complete t echnical 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-exami nation 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 vi sible consequence of 
a whole process comprising conformity a ssessment in a broad sense. The general 
principles governing the CE marking ar e set out in Regulation (EC) No 765/2008. 
Rules governing the affixing of the CE mark ing on PPE should be laid down in this 
Regulation.  
(26) It is crucial to make clear to manufactur ers 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, ot her markings should be allowed as long 
                                                 
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 workpl ace (OJ L 393, 30.1 2.1989, p. 18).  
EN 15   EN 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 e ssential safety requirements, it is necessary to 
lay down appropriate confor mity assessment procedures to be followed by the 
manufacturer. Directive 89/686/ EEC classifies PPE into th ree categories that are 
subject to different conformity assessm ent procedures. In order to ensure a 
consistently high level of safe ty for all PPE, the list of pr oducts subject to one of the 
conformity assessment procedures relating to  the production phase should be enlarged. 
The conformity assessment procedures for eac h 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 performan ce of bodies performing 
conformity assessment of PPE throughout the Union, and all such bodies should 
perform their functions at the same leve l and under conditions of fair competition. 
Therefore obligatory requirements should be  set for conformity assessment bodies 
wishing to be notified in or der to provide conformity a ssessment 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, notificati on 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 accord ance 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 cons ultations during its preparatory work, 
including at expert level. The Commissi on, when preparing and drawing-up delegated 
acts, should ensure a simultaneous, timely an d appropriate transmission of relevant 
documents to the European Parliament and Council. 
(32) In order to ensure un iform conditions for the implementation of this Regulation , 
implementing powers should be conferre d 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 pe nalties applicable to infringements of the 
provisions of this Regulation and ensure th at they are implemented. Those penalties 
should be effective, prop ortionate and dissuasive. 
(34) In order to allow manufac turers 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 fo rce of this Regulation during which PPE 
which complies with Directive 89/686/EEC  may still be placed on the market. 
                                                
 
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).  
EN 16   EN (35) Since the objective of th is 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 a nd 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 effect s, be better achieved at Union level, the 
Union may adopt measures, in accordance with the principle of subs idiarity set out in 
Article 5 of the Treaty on European Uni on. 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 or der to ensure a uniform implementation 
throughout the Union, Directive 89/686/EEC should be repealed and replaced by a 
Regulation.  
EN 17   EN 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 pr otective 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 agai nst 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 appli cable in Member States; 
(e) for head, face or eye protection of users,  subject to the relevant Regulation of 
the United Nations Economic Commissi on for Europe (UNECE), of two- or 
three-wheeled motor vehicles.  
Article 3 
Definitions 
For the purposes of this Regulation, th e 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  
EN 18   EN device or structure, that are removabl e and not intended to be permanently 
fixed to a structure; 
2. 'individually adapted PPE' means PPE pr oduced 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 a ccording 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 co mmercial activity, whether in return for 
payment or free of charge; 
5. 'placing on the market' means the first ma king 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 mark ets 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 fr om a manufacturer to act on his behalf 
in relation to specified tasks; 
8. 'importer' means any natural or legal pe rson established within the Union who places 
PPE from a third country on the Union market; 
9. 'distributor' means any natural or legal pe rson in the supply chain, other than the 
manufacturer or the importer, who makes PPE available on the market; 
10. 'economic operators' means the manufactur er, the authorised representative, the 
importer and the distributor; 
11. ‘technical specification’ means a document th at prescribes techni cal requirements to 
be fulfilled by PPE; 
12. 'harmonised standard' means harmonised stan dard as defined in Article 2(1)(c) of 
Regulation (EU) No 1025/2012; 
13. 'accreditation' means accreditation as define d in Article 2(10) of Regulation (EC) No 
765/2008; 
14. 'national accreditation body' means na tional accreditation body as defined in 
Article 2(11) of Regulation (EC) No 765/2008; 
15. 'conformity assessment' means the pro cess demonstrating wh ether the essential 
health and safety requirements of this Regul ation relating to PPE have been fulfilled; 
16. 'conformity assessment body' means a body that performs conformity assessment 
activities including calib ration, testing, certification and inspection; 
17. 'recall' means any measure aimed at achievi ng 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;  
EN 19   EN 19. 'CE marking' means a marking by which the manufacturer indicates  that PPE is in 
conformity with the applicable requi rements set out in Union harmonisation 
legislation providing for its affixing; 
20. 'Union harmonisation legislation' mean s 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 us ed 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.  
EN 20   EN Article 7 
Free movement 
1. Member States shall not impede, for th e aspects covered by this Regulation, the 
making available of PPE which complies with this Regulation in their territory. 
2. At trade fairs, exhibitions, and demonstra tions, Member States shall not prevent the 
showing of PPE which does not comply with  this Regulation provided that a visible 
sign clearly indicates that th e PPE does not comply with this Regulation and is not 
available on the market until it ha s been brought into conformity. 
During demonstrations, adequate measures sh all be taken to ensu re the protection of 
persons. 
CHAPTER II 
OBLIGATIONS OF ECONOMIC OPERATORS 
Article 8 
Obligations of manufacturers 
1. When placing PPE on the market, manufact urers 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 technica l 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 sha ll carry out the conformity assessment 
procedure set out in Annex VI. 
Where compliance of PPE with the appl icable essential health and safety 
requirements has been demonstrated by th e appropriate procedure(s), manufacturers 
shall draw up an EU declaration of confor mity 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 procedur es are in place for series production to 
remain in conformity with this Regulati on. Changes in the design or characteristics 
of the PPE and changes in the harmoni sed 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 wh ich they place on the market bears a type, 
batch or serial number or other element allo wing its identification or, where the size  
EN 21   EN or nature of the PPE does not allow it, th at 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 whic h 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 re ferred 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 reas on to believe that PPE which they have 
placed on the market is not in conformity w ith this Regulation shall immediately take 
the necessary corrective measures to bring it into conformity, to withdraw it or to 
recall it, as appropriate. Furthermore, wh ere the PPE presents a risk, manufacturers 
shall immediately inform the market surveilla nce authorities of the Member States in 
which they made the PPE available on the mark et to that effect, giving details, in 
particular, of the non-conformity a nd of any corrective measures taken. 
10. Manufacturers shall, further to a reas oned 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, a ppoint an authorised representative. The 
obligations laid down in Article 8(1) a nd 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 pe rform the tasks specified in the mandate 
received from the manufacturer. The ma ndate shall allow the authorised 
representative to do at  least the following: 
(a) keep the EU declaration of  conformity and the tec hnical documentation at the 
disposal of the national market surveill ance authorities for at least 10 years 
after the PPE has been placed on the market;  
EN 22   EN (b) further to a reasoned request from a national market surveillance authority, 
provide that authority with all the in formation and documentation necessary to 
demonstrate the conformity of the PPE; 
(c) cooperate with the national market surv eillance 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, importe rs shall ensure that the appropriate 
conformity assessment procedure(s) referred to in Article 18 ha ve been carried out 
by the manufacturer. They shall ensure that the manufacturer has drawn up the 
technical documentation, that the PPE b ears the CE marking, is accompanied by the 
EU declaration of conformity  or a simplified EU declara tion of conformity, and that 
it is accompanied by the instructions referred to in Article 8(7) and that the manufacturer has complied with the require ments 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 sa fety 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 survei llance 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 th ey 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 unders tood by end-users and market surveillance 
authorities. 
4. Importers shall ensure that the PPE is acco mpanied 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, wher e 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 mark et to that effect, giving details, in 
particular, of the non-conformity a nd of any corrective measures taken. 
7. Importers shall, for at least 10 years af ter the PPE has been placed on the market, 
keep a copy of the EU declaration of c onformity at the disposal of the market 
surveillance authorities and ensure that the technical documentation can be made 
available to those authorities, upon request.  
EN 23   EN 8. Importers shall, further to a reasoned re quest 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 coopera te 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 requireme nts of this Regulation. 
2. Before making PPE available on the market, di stributors shall verify  that it bears the 
CE marking, is accompanied by the EU declar ation of conformity or a simplified EU 
declaration of conformity, a nd 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 sa fety 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 pres ents a risk, the distributor shall inform 
the manufacturer or the importer to that e ffect 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 conform ity with the requirements of this Regulation 
shall make sure that the necessary correct ive 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 pa rticular, 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 doc umentation 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 ta ken to eliminate the risks posed by PPE 
which they have made available on the market. 
Article 12 
Cases in which obligations of manufactu rers apply to importers and distributors  
EN 24   EN An importer or distributor shall be consider ed 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 na me or trademark or modifies PPE already 
placed on the market in such a way that the conf ormity with the applicable essential health 
and safety requirements set out in Annex II may be affected.  
EN 25   EN Article 13 
Identification of economic operators 
Economic operators shall, on re quest, identify the following to  the market surveillance 
authorities: 
(a) any economic operator who ha s 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 ha ve supplied the PPE. 
CHAPTER III 
CONFORMITY OF THE PPE 
Article 14 
Presumption of conformity 
PPE which is in conformity with harmonised st andards or parts thereo f 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 hea lth and safety requireme nts 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 st ate that the fulfilment of the applicable 
essential health and safety requirements se t 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 Stat e in which the PPE is made available on 
the market. The EU declaration of conf ormity accessible through internet address 
shall be available in the language or la nguages 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 declar ation of conformity shall be  drawn up in respect of all 
such Union acts. That declaration shall c ontain the identification of the Union acts 
concerned, including their publication references.  
EN 26   EN 5. By drawing up the EU declaration of conf ormity, 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 ge neral principles set out in Article 30 of 
Regulation (EC) No 765/2008. 
2. The CE marking shall be affixed visibly, le gibly and indelibly to the PPE. Where that 
is not possible or not warranted on account of the nature of th e 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 i ndicating 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 procedur e 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 cont rol (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;  
EN 27   EN (2) conformity to type based on quality assurance of the production process 
(module D) set out in Annex VIII. 
CHAPTER V 
NOTIFICATION OF CONFOR MITY ASSESSMENT BODIES 
Article 19 
Notification 
Member States shall notify the Commission and th e 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 designa te a notifying authority that  shall be responsible for 
setting up and carrying out the necessary procedures  for the assessment and 
notification of conformity assessment bodi es 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 nati onal 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 sh all comply mutatis 
mutandis with the requirements laid down in Article 21. In addition that body shall 
have arrangements to cover liabi lities arising out of its activities. 
4. The notifying authority shall take full re sponsibility 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 organise d 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 ac tivities that conformity 
assessment bodies perform or consultancy services on a commercial or competitive basis.  
EN 28   EN 5. A notifying authority shall safeguard the c onfidentiality of the information it obtains. 
6. A notifying authority shall have a suffici ent 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 a ssessment bodies and the monitori ng 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 c onformity assessment body shall meet the 
requirements laid down in paragraphs 2 to 11. 
2. A conformity assessment body shall be esta blished 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, manu facturing, 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 conform ity assessment tasks shall not be the 
designer, manufacturer, supplier,  purchaser, owner, user or maintainer of the PPE 
which they assess, nor the authorised repres entative of any of thos e 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 th e conformity assessment tasks shall not be directly or 
indirectly involved in  the design, manufacture, making av ailable, 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 fo r which they are notified. This shall in 
particular apply to consultancy services. 
Conformity assessment bodies shall ensure that  the activities of th eir subsidiaries or 
subcontractors do not affect the confidentia lity, objectivity or impartiality of their 
conformity assessment activities. 
5. Conformity assessment bodies and their pe rsonnel shall carry out the conformity 
assessment activities with the highest de gree of professional integrity and the 
requisite technical competence in the spec ific field and shall be free from all 
pressures and inducements, particularly financial, which might influence their  
EN 29   EN judgement or the results of their conform ity assessment activitie s, especially as 
regards persons or groups of persons with an interest in the results of those activities. 
6. A conformity assessment body shall be capab le 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 asse ssment 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 su fficient and appropriate experience 
to perform the conformity assessment tasks; 
(b) descriptions of procedures in accordan ce with which conformity assessment is 
carried out ensuring the transparency a nd 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 notifi ed body and other activities; 
(c) procedures for the performance of activi ties which take due a ccount of the size 
of an undertaking, the sector in which it operates, its structure, the degree of 
complexity of the PPE technology in ques tion and the mass or serial nature of 
the production process. 
A conformity assessment body shall have  the means necessary to perform the 
technical and administrativ e tasks connected with th e conformity assessment 
activities in an appropriate manner and sh all have access to all necessary equipment 
or facilities. 
7. The personnel responsible for carrying out  conformity assessm ent 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, r ecords and reports de monstrating that 
assessments have been carried out. 
8. The impartiality of the conformity asse ssment bodies, their management and of the 
personnel responsible for carrying out the conformity assessment tasks shall be 
guaranteed. 
The remuneration of the top level mana gement and personnel responsible for 
carrying out the conformity assessment task s of a conformity assessment body shall 
not depend on the number of assessments ca rried out or on the results of those 
assessments. 
9. Conformity assessment bodies shall take ou t liability insurance unless liability is 
assumed by the State in accordance with nati onal law, or the Member State itself is 
directly responsible for th e conformity assessment.  
EN 30   EN 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 a nd shall apply as general guidance the 
administrative decisions and documents produc ed 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 subcontrac ting by notified bodies 
1. Where a notified body subcontracts specif ic 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 res ponsibility for the tasks performed by 
subcontractors or subsidiaries wh erever these are established. 
3. Activities may be subcontracted or carr ied out by a subsid iary 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 qua lifications 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  
EN 31   EN attesting that the conform ity assessment body fulfils th e requirements laid down in 
Article 23. 
3. Where the conformity assessment body c oncerned cannot provide an accreditation 
certificate, it shall provide the notifying aut hority 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 conf ormity assessment bodies which have 
satisfied the requirements laid down in Article 23. 
2. They shall notify the Commission and the ot her Member States us ing 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 sh all provide the Commi ssion and the other 
Member States with documentary eviden ce 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 activ ities of a notified body only where no 
objections are raised by the Commission or  the other Member States within two 
weeks of a notification wher e an accreditation certificate is used or within two 
months of a notification wher e 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 Co mmission and the other Member States of 
any subsequent relevant ch anges to the notification. 
Article 28 
Identification numbers and lists of notified bodies 
1. The Commission shall assign an iden tification number to a notified body. 
It shall assign a single iden tification number even where the body is notified under 
several Union acts. 
2. The Commission shall make publicly avai lable the list of th e bodies notified under 
this Regulation, including the identification numbers that ha ve 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  
EN 32   EN 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 au thority shall restrict, suspe nd or withdraw notification 
as appropriate, depending on the seriou sness 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 notif ication, 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 ar e either processed by another 
notified body or kept available for the re sponsible 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 respon sibilities 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 sensi tive 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 notificati on, 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 conform ity assessments in accordance with the 
conformity assessment procedures provi ded 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 th e size of an undert aking, the sector in 
which it operates, its structure, the degr ee of complexity of the PPE technology in 
question and the mass or serial na ture of the production process. 
In so doing they shall nevertheless respec t the degree of rigour and the level of 
protection required for the compliance of the PPE with the requirements of this 
Regulation.  
EN 33   EN 3. Where a notified body finds that the a pplicable essential health and safety 
requirements set out in Annex II or the co rresponding harmonised standards or other 
technical specifications have  not been met by a manufactur er, it shall require the 
manufacturer to take appropriate corre ctive measures and shall not issue a 
conformity certificate. 
4. Where, in the course of the monitori ng 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 manufact urer to take appropriate 
corrective measures and shall suspend or  withdraw the certif icate if necessary. 
5. Where corrective measures are not taken or  do not have the required effect, the 
notified body shall restrict, su spend or withdraw the cer tificate, as appropriate. 
Article 32 
Appeal against decisions of notified bodies 
Member States shall ensure that  an appeal procedur e against decisions of  the notified bodies 
is available. 
Article 33 
Information obligation on notified bodies 
1. Notified bodies shall inform the no tifying 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 ha ve received from market surveillance 
authorities regarding confor mity assessment activities; 
(d) on request, conformity assessment activit ies performed within the scope of 
their notification and a ny other activity performed, including cross-border 
activities and subcontracting. 
2. Notified bodies shall provide the other bodi es notified under this Regulation carrying 
out similar conformity assessment activitie s 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  
EN 34   EN The Commission shall ensure that appropriate  coordination and coope ration 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 notif ied 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 eviden ce and by taking into account the conformity 
assessment procedure that need to be followe d 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 respec t of the delegation of power not later 
than nine months before the end of th e 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 extens ion not later than three months before 
the end of each period 
3. The delegation of powers referred to in Ar ticle 36 may be revoked at any time by the 
European Parliament or by the Council. A d ecision to revoke sha ll put an end to the 
delegation of the power spec ified 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 alr eady 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 pursu ant to Article 36 shall en ter into force only if no 
objection has been expressed either by th e European Parliament or the Council 
within a period of two months of notificati on 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 Commi ssion that they will not object. That 
period shall be extended by two months at th e initiative of the European Parliament 
or the Council.  
EN 35   EN 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 para graph, Article 4 of Re gulation (EU) 182/2011 
shall apply. 
CHAPTER VII 
FINAL AND TRANSITIONAL PROVISIONS 
Article 39 
Penalties 
Member States shall lay down the rules on pena lties 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, proporti onate 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 no tify it without delay of any 
subsequent amendment affecting them.  
EN 36   EN 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 cove red by Directive 89/686/EEC which are in 
conformity with that Directive and wh ich 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