COMMISSION STAFF WORKING DOCUMENT IMPACT ASSESSMENT Accompanying the document Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on personal protective equipment
Date: 2014-03-27
Institutions: European Commission
Subjects: EC conformity marking, European standard, free movement of goods, marketing standard, protective equipment, single market, technical standard













EUR-Lex - 52014SC0118 - EN











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52014SC0118

COMMISSION STAFF WORKING DOCUMENT IMPACT ASSESSMENT Accompanying the document Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on personal protective equipment /* SWD/2014/0118 final */









COMMISSION STAFF WORKING DOCUMENT
IMPACT ASSESSMENT
Accompanying the document
Proposal for a 
REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
on personal protective equipment
Commission
legislative proposal for a revision of
Directive
89/686/EEC on the approximation of the laws of the Member States relating to
personal protective equipment.
Disclaimer:
This report commits only the Commission's services involved in its preparation
and does not prejudge the final form of any decision to be taken by the
Commission.
TABLE OF CONTENTS
Executive Summary Sheet. 3
1............ Procedural issues and consultation of
interested parties. 5
1.1......... Identification. 5
1.2......... Organisation and timing. 5
1.3......... Consultation and expertise. 5
1.4......... Scrutiny by the Commission Impact
Assessment Board. 6
2............ Context 6
2.1......... PPE Directive. 6
2.2......... Overview of the PPE market 12
2.3......... Alignment to the New Legislative
Framework. 16
3............ Problem definition. 18
3.1......... Product coverage. 18
3.2......... Conformity assessment 20
3.3......... Requirements. 21
3.4......... EU right to act 24
4............ Objectives. 24
4.1......... General policy objectives. 24
4.2......... Specific and operational policy
objectives. 25
4.3......... Consistency with other policies and
objectives. 27
5............ Policy options. 27
5.1......... Product coverage. 27
5.2......... Conformity assessment 27
5.3......... Requirements. 28
6............ Analysis of impacts. 30
6.1......... General remark. 30
6.2......... Overview of the relevant impacts and the
methodology for their assessment 30
6.3......... Qualitative analysis. 31
6.4......... In depth analysis. 36
6.5......... Mitigation measures. 47
7............ Comparing the options. 47
8............ Monitoring and evaluation. 50
9............ Choice of the legal instrument 51
Annex 1: Article 11
of the PPE Directive. 53
Annex 2: Relevant
parts from the ANNEX II of the PPE Directive. 55
Annex 3: Definition
of PPE of category III (exclusive and exhaustive list of PPE covered by this
category) 57
 Executive Summary Sheet 
 Impact assessment on the revision of Directive 89/686/EEC on the approximation of the laws of the Member States relating to personal protective equipment (PPE Directive) 
 A. Need for action 
 Why? What is the problem being addressed? 
 All the identified deficiencies of the PPE Directive are of minor significance. Consequently, the Impact Assessment Report deals with the identified issues in a proportionate way. The areas of improvements called “problems” do not involve major changes; however, in light of the experience of the functioning of the Directive, the outcome of the Impact Assessment Study (2010) and the input to the Public Consultation (2011) the following issues will be addressed: -        the alignment of the PPE Directive with the New Legislative Framework (NLF) in line with the political commitment laid down in Article 2 of the NLF Decision No 768/2008/EC; -        the extension of the product coverage of the PPE Directive; -        the addition of some types of PPE to the list of products subject to the most stringent conformity assessment procedure; -        the change of three basic health and safety requirements; and -        the change of the requirements to the technical file, the validity and content of the EC type-examination certificate, and the EC Declaration of Conformity. 
 What is this initiative expected to achieve? 
 The overall objectives of this initiative are to (1) better protect the health and safety of PPE users, (2) create a level playing field for PPE economic operators and (3) simplify the European regulatory environment in that field. 
 What is the value added of action at the EU level? 
 The alignment with the NLF Decision No 768/2008/EC is the major step on simplification as it will ensure that harmonised solutions can be applied across the sectors subject to EU product harmonisation legislation. The PPE Directive harmonizes the rules for the placing on the internal market of PPE. The proper and effective functioning of the internal market requires common rules for the design and placing on the market of personal protective equipment in order to ensure both the free movement within the Union and the health protection and safety of user. If actions are taken at national level to address the problems, they may create obstacles to the free movements of PPE. Therefore, any changes to the scope, procedures or requirements must be carried out at EU level in order to avoid distortions on the EU market. 
 B. Solutions 
 What legislative and non-legislative policy options have been considered? Is there a preferred choice or not? Why? 
 Three alternative policy options have been considered for each of the discussed problems, i.e. 1) the “do nothing” as a baseline option; 2) the “soft law” option as non-legislative alternative consisting of issuing commonly agreed interpretation on the application of the PPE Directive; and 3) as “legislative” options the amendment of the legal text. Option No. 3) is the preferred choice since only it can appropriately respond to the “problems” identified. 
 Who supports which option? 
 In general all stakeholders expressed support for the initiative. Both authorities and industry support the need to simplify and clarify the PPE legislation. There is unanimity on the need to improve market surveillance and the system for assessing and monitoring notified bodies. The revision of the PPE Directive has been several times subject to discussion at the Member States PPE Working Group that is chaired by the Commission and the Notified Bodies group meetings which have suggested many of the modifications. The majority of the respondents to the Public Consultation (2011) confirmed the envisaged approaches using the legislative option. Alternative proposals for the areas covered were not put forward by interested parties. 
 C. Impacts of the preferred option 
 What are the benefits of the preferred option (if any, otherwise main ones)? 
 All described problems are of regulatory nature. Therefore only the legislative option will result in clarification and legal certainty. Despite the fact that the costs for the legislative option are higher compared to the soft law option, the legislative option results in higher benefits as well as in higher legal certainty. The proposed changes will bring about the following social benefits: the health and safety of the PPE users will increase because the level of protection provided by the PPE will increase and the number of products on the market that do not ensure an adequate level of protection will be reduced (expected percentage of reduction differs for affected PPE from 10% up to 50%). With the clarification also the work of the market surveillance authorities will be supported. Manufacturers will benefit from the higher legal certainty as well as from established level playing field. 
 What are the costs of the preferred option (if any, otherwise main ones)? 
 The costs of the preferred option differ for the affected manufacturers. The extension of the product coverage will entail costs for relevant manufactures in the order of a few hundred euros per product series and will thus have a low impact on costs per unit. The change in the conformity assessment procedures will not entail high costs for the manufacturers that have already quality control systems in place. The changes of the basic health and safety requirements will lower the costs for manufacturers and Notified Bodies. The costs of implementing the changes to the technical file and the EC Declaration of Conformity will be marginal. In case of the changes to the EC type-examination certificate no values for the costs were available. But the proposal will provide for a procedure in order to limit the additional burden of the manufacturers. 
 How will businesses, SMEs and micro-enterprises be affected? 
 The proposed changes will be applicable to all types of businesses. Exempting SMEs from the proposed changes in the Directive is not a viable option since a large percentage of PPE manufacturers are SMEs. An exemption would result in a much lower improvement of the health and safety of the users than intended by the revision. Since the PPE sector is part of the health and safety field such an outcome is undesirable. 
 Will there be significant impacts on national budgets and administrations? 
 The initiative will not have significant impacts on national budgets and administrations. 
 Will there be other significant impacts? 
 The changes to the PPE Directive improve its readability and clarity and are therefore not assumed to have any other significant impacts. 
 D. Follow up 
 When will the policy be reviewed? 
 No decision on the revision of the policy has been made. However it is a common practise to have an evaluation carried out five years after a revised legislation has become applicable. 
1.           Procedural
issues and consultation of interested parties
1.1.        Identification
Lead DG: DG ENTR
Other involved DGs: SG, SJ, DG EMPL, DG
SANCO
Agenda Planning/WP Reference: 2011/ENTR/015
1.2.        Organisation and timing
Work on the present
Impact Assessment (IA) report started in 2010 with the launch of an external
study. A steering group was created and met 3 times: on 15 March 2012, 30
August 2012 and 14 November 2012. Representatives of SG, SJ, DG EMPL and DG
SANCO were invited. SG and DG SANCO participated in the meetings. DG EMPL sent
written contributions.
1.3.        Consultation and expertise
Stakeholders, including Member States,
manufacturers' federations, notified bodies and representatives from standardisation,
have been involved in the IA process from its beginning. The consultation
included organising of meetings for a selected group of experts as well
as consultation of the Personal Protective Equipment (PPE) Working Group
members[1].
Among others, they were actively involved in the elaboration of the options.
Additionally a
public consultation was launched and ran between April and June 2011.It
collected views and opinions of relevant stakeholders and citizens on various
issues that the revision of the PPE Directive (89/686/EEC) might address, such
as the appropriateness of the scope of the Directive, the consistency of the
conformity assessment procedures, the requirements on the EC type-examination
certificate and technical documentation, the reasonability of the basic health
and safety requirements and the alignment of the PPE Directive with the New
Legislative Framework. Overall 77 responses were received, 74 from the 27
Member States (authorities, enterprises, notified bodies, trade associations,
individual citizens), 2 from an EFTA country and 1 from overseas. The replies
provided the Commission services with a broader view on the identified policy
needs and as such confirmed the envisaged approaches[2]. The
Commission's minimum consultation standards were fully met.
In general all
stakeholders expressed support for the initiative. Both authorities and
industry support the need to simplify and clarify the PPE legislation. There is
unanimity on the need to improve market surveillance and the system for
assessing and monitoring notified bodies.
The results of the consultation
complemented the findings of an external study launched and completed in
2010[3]. The study provides an
overview of the structure of the personal protective equipment market as well
as it assesses the impacts of the proposed measures. 
In 2012 another
complementary study was carried out. It focused on analysing the
competitiveness impacts of the envisaged changes[4].
1.4.        Scrutiny by the Commission
Impact Assessment Board
The Impact Assessment Board of the European
Commission assessed a draft version of the present impact assessment and issued
its opinion on 19/06/2013. The Impact Assessment Board made several
recommendations and, in the light of the
latter, the final impact assessment report:
Clarifies
-       
how the options under consideration are
meant to achieve the objective of simplification;
-       
that the different policy options
proposed are generally independent one from the others and that no alternative
proposals for the areas covered were suggested by interested parties;
-       
the measures to improve the monitoring
and evaluation arrangements.
Describes
-       
the lack of detailed quantitative data
while flagging the efforts undertaken to collect data;
-       
that the proposed improvements result
from the experience of Member States authorities and other stakeholder and are
not directly related to accidents.
The assessment of the problems and their
relevance is strengthened as well as the assessment of benefits and costs in
order to throw more light on the trade-offs between protection and costs.
2.           Context
2.1.        PPE Directive
This IA accompanies a proposal for a
revision of the Council Directive 89/686/EEC of 21 December 1989 on the
approximation of the laws of the Member States relating to personal protective
equipment (PPE Directive). The Directive permits the free movement of PPE in
Europe while ensuring a high level of protection for its users. It defines a
PPE as "any device or appliance designed to be worn or held by an
individual for protection against one or more health and safety hazards."[5]
This definition distinguishes this directive from most of the other product
directives (e.g. Machinery Directive 2006/42/EC[6]
or Low Voltage Directive 2006/95/EC[7]).
As the PPE sector is a safety sector, the most relevant feature of the products
falling under it is to protect their users against risks. Therefore, safety
requirements are not additional requirements. They are the purpose of the
product.
PPE covers equipment designed to protect
against all kinds of hazards (e.g. heat, flames, chemicals, flying particles,
mechanical) occurring in different environments – at home, at work
(occupational health and safety risks), at leisure (sports) etc.[8] There is PPE
for nearly every part of the human body: mostly for its outer parts but also
for the inner parts (e.g. respiratory protection).
Examples of PPE include: head/ears/eyes
protection (helmets, hearing protection, and glasses), respiratory protection
(gas masks, filter masks), body protection (protective clothing against
chemicals, motorcycle suits, and high visibility vests), arm/shoulder
protection, hand protection (gloves), leg and foot protection (safety shoes,
knee pads), and equipment to prevent drowning (life jackets) (see Figure 1).
Figure
1: Examples
of personal protective equipment
The Directive applies to each individual item
of PPE which is intended to be placed and/or put into service on the EU market for
the first time. It sets out the basic health and safety requirements and
establishes the conformity assessment procedure to be followed by manufacturers
before a specific PPE is placed on the market. The procedure depends on the
severity of the risk involved. There are three distinct groups of PPE and their
corresponding conformity assessment procedures: "Simple design",
commonly known as category I, "Complex design" (category III) and "neither
of these" (category II):
·                        
Category I ("simple design"): the PPE is
defined by the exhaustive list in Article 8(3) of the PPE Directive.
PPE of simple design is the one where the designer assumes the user can himself
assess the level of protection provided against the minimal risk concerned, the
effects of which can be safely identified by the user in good time.
The manufacturer declares conformity by means of an EC declaration of
conformity (see Fig. 2 below).
Examples: gardening gloves, sunglasses.
·                        
Category II ("neither simple nor complex"):
PPE not defined by Article 8(3) nor (4)(a) is subject to an EC type-examination
by a Notified Body[9]
after which an EC declaration of conformity is issued.
Examples: safety helmets, football shin-guards.
·                        
Category III ("complex design"): the
PPE is defined by the exhaustive list in Article 8(4)(a).
PPE of complex design is intended to protect against mortal danger or against
dangers that may seriously and irreversibly harm the health, the immediate
effects of which the designer assumes the user cannot identify in sufficient
time.
These PPE are subject both to EC type-examination and to two Quality Assurance
procedures as described in Articles 11A and 11B (see Annex 1). An EC
declaration of conformity is issued.
Examples: dust masks, fall arresters.
Figure
2: Certification procedures for PPE
The
CE marking for category III PPE shall be followed by the identification number
(in the figure shown as nnnn) of the Notified Body which is involved in the quality
assurance procedures.
The basic health and safety requirements
are described in ANNEX II of the Directive[10].
There are three main chapters: General Requirements applicable to all PPE,
Additional requirements common to several classes or types of PPE, Additional
requirements specific to particular risks.
Annex III of the Directive lists the
technical documentation that the manufacturer shall assemble before placing a
PPE on the market. This so-called technical file shall be submitted to the
competent authorities on request.
The PPE Directive is based on Article 114
of the Treaty on the functioning of the European Union and is a so-called
"New Approach[11]
Directive", i.e. the Directive is restricted to the definition of
mandatory essential requirements (including appropriate conformity assessment
procedures) necessary to protect the public goals of health and safety.
Technical specifications agreed by stakeholders and experts in the field,
usually harmonised European standards, support the Directive in
"translating" the essential requirements into detailed requirements
for certain types of products. The New Approach has recently been revised and
integrated into the New Legislative Framework (NLF)[12].
PPE Actors and stakeholders 
There are various actors and organisations
involved in the management of the PPE Directive (i.e. adopting, implementing,
applying and enforcing). There is the PPE Working group chaired by the
Commission and made up of Member States and European stakeholders. The market
surveillance representatives of the Member States are organised in the PPE AdCo
group (Administrative Cooperation). The CEN/CENELEC consultants are key
operators in the checking of harmonised European standards. There is also a
close connection to the Coordination group for the Notified Bodies in the field
of PPE. Figure 3 shows a scheme of the main actors in the management of the PPE
Directive.
Figure
3: Organisational scheme for the PPE 89/686/EEC Directive
The
evaluation of the PPE Directive 
The Directive has been in place since 1989.
Although it has never been a subject to any formal evaluation, a regular
feedback on its functioning is mainly received through the representatives of
Member States responsible for the implementation of the Directive and relevant
stakeholders who meet in the PPE Working Group.
The representatives of Member States in the
PPE Working Group as well as the representatives of stakeholders have
consistently over time expressed the opinion that the PPE Directive has
provided an efficient and effective improvement of the safety of the users.
The success of
the PPE Directive is recognised by all stakeholders. The implementation of the
Directive across the EU has led to the harmonisation of standards and
regulations on protective equipment, facilitating the development of a large
European market[13].
In particular, the harmonisation of standards has removed barriers to trade
related to the need to comply with the standards and regulations of different
jurisdictions. 
The harmonisation
of standards also means that suppliers are exposed to more direct competition
from producers across the EU, with the likelihood that prices and profit
margins are reduced for them. European as well as foreign manufacturers are
obliged to comply with quality standards, product liability, sizing, and
packaging requirements set down by the Directive. 
Thanks to the
standardisation in this field, the European PPE sector has gained a major
advance over all other regions of the world. Although voluntary, the harmonised
standards are used by almost all PPE manufacturers and their application
provides purchasers of PPE with objectively tested information on the level of
protection provided by the equipment as well as precise instructions for use.
Major 'success stories' for the PPE Directive include the European standards
for sunglasses, cycling helmets and high-visibility clothing.
A key benefit
generated by the Directive is the improvement of the safety of users
(workers and consumers). Thanks to the requirements ensuring high quality of
products with high level of protective function, the number of injuries and thus
of working days lost as a result of these injuries considerably decreased over
the last 10 years. The figures below provide some indications about trends on
accidents.  Although it must be noted that available data are not disaggregated
enough to be able to attribute trends in injuries directly to the PPE
Directive, all stakeholders believe that the PPE Directive did play a role to a
certain degree in improving the safety of users.
Per relevant sector, the total number of
annual absence at work caused by an injury also decreased (see Fig. 4).
Figure
4: Total number of annual days of absence by sector of economic activity,
EU-15, 1996-2005
*
EU-15 + Norway
(1)
270 days were used for the class "more than 6 months of absence or in
permanent incapacity"
Source:
Eurostat - ESAW
Between 1995 and 2005 both non-fatal and
fatal accidents at work have also fallen in different relevant sectors (see
Figures 5 and 6).
Figure
5: Incidence rate of non-fatal accidents at work, EU-15, 1995-2005
Figure
6: Incidence rates of fatal accidents at work, EU-15, 1995-2005
2.2.        Overview of the PPE market

The quantitative data available about PPE and the PPE market is not enough
accurate and detailed to provide a clear picture about the PPE market and about
the relationships between the different PPE products and the legislative
provisions. The European Commission services have commissioned two studies and
have gathered other information to provide quantitative information as complete
as possible.
2.2.1.     Volume
of the European PPE market 
The size of the European and global market
for PPE is difficult to assess. Data are scarce and estimations show
substantial differences. Matrix Insight for example, estimated the EU market
for PPE to be approximately €5.9 billion in 2007 (at end-user prices), while
the global market was estimated to be €19.2 billion[14]. Research by Ecorys in
2009 indicated that the size of the European PPE market might be over €10
billion[15],[16]. This estimate
is based on a previous calculation related to the Lead Market Initiative[17]. Of this total,
Euratex estimates that protective textiles represent 50-60% of total turnover,
while footwear (partly textile-based) adds another 20%. Six areas represent 80%
of the turnover, namely (i) foul weather clothing (mainly leisure and active
wear), (ii) fire resistant clothing, (iii) medical (non-woven) protection, (iv)
high-visibility, (v) ballistic & cut protection, and (vi) disposable
chemical protection[18].
Textiles Intelligence estimated in 2009 that
the global turnover for PPE is over €10 billion ($13 billion) per year.
This turnover refers to four PPE-categories: (i) above-the-neck-protection
(headwear, ear and eye protection), (ii) protective clothing, (iii) protective
gloves, (iv) footwear[19],[20]. Frost &
Sullivan (2005)[21]
indicated that the segments for protective clothing and gloves are the
‘predominant textile-based sectors’ of the PPE market in Western Europe.
According to their estimates the turnover of protective textiles and gloves
accounted for approximately 60% of the total PPE market in Western Europe.
An overview of the PPE industry and value
chain is provided in Figure 7 below.
Figure
7: Overview of the PPE industry and value chain
Source: Matrix Insight Ltd. (2010).
2.2.2.     Growth of the European PPE market 
In nominal terms, the EU-27 PPE market grew
by 2.1% annually (in terms of value) between 2003 and 2007 compared with GDP
growth of 4.73%. PPE market growth was projected to accelerate to 2.67%
annually between 2007 and 2015[22].
In terms of geographic distribution, growth
is higher in Eastern and Central European countries.
Smaller PPE segments (like fall protection
equipment and hearing protection equipment) had higher annual average growth
rates than larger sectors (like protective clothing and safety footwear) between
2003 and 2007 (4.05% compared with 2.10%). 
2.2.3.     Demand for PPE in Europe 
Consumers of PPE can be divided into
enterprises (professional users) and private individuals. Professional use
constitutes approximately 70% of the overall demand for PPE. The industry
sectors with the highest intensity of demand for PPE are manufacturing,
construction, mining and health care. Other sectors like agriculture and public
services have been increasing their consumption of PPE in the recent past. 
In terms of geographic distribution, the
demand for PPE is concentrated in large Member States (Germany, UK, France,
Italy and Spain). However, set against the number of workers, professional
users in Northern European countries tend to spend more in terms of PPE
equipment than in Central, Southern or Eastern European countries. 
2.2.4.     Production of PPE in Europe 
Data estimates from different sources for total
EU production of PPE show substantial differences. Production could be within a
range of €2 to €6 billion. Production of PPE appears to have been declined at
an annual average of 2 %. Production declines have been particularly
marked in the UK, Spain and the Netherlands. According to an available study[23] manufacturers in the
EU have partially re-located or subcontracted production to more labour
intensive countries.
In terms of geographic distribution,
production is concentrated in few Member States with Italy, Germany and the UK
as market leaders in the three largest segments of PPE (protective footwear,
protective gloves and protective clothing respectively). 
Together Italy, Germany, France and the UK are
responsible for more than the half of all PPE production in Europe. According
to the data available, Italy was the leading manufacturer of PPE in the EU, followed
by Germany and France.
As depicted in Fig. 7 the distribution
of PPE takes primarily three forms: 
·                        
direct sell from manufacturers to companies, on
a contract basis; 
·                        
wholesale and retail distribution; and 
·                        
vertical integration, with manufacturers acting
as importers to expand their product offering. 
Wholesalers and retailers play an
increasingly important role, because they can supply "top-to-toe" PPE
that has been characterised by high demand in the recent past. In contrast, most
manufacturers tend to focus on one PPE segment only, though they increasingly
also provide consultancy services to their clients. 
In addition to its economic significance,
the European PPE industry has a significant social and employment impact. It represents
0.43% of the total manufacturing workforce.
2.2.5.     Main players in Europe 
Approximately 4,000 companies in the EU are
involved in manufacturing PPE. Most of these companies produce protective
clothing and safety headgear; only very few companies are involved in the
production of fall protection equipment. 
A very large percentage of enterprises
involved in the manufacturing of PPE are SMEs. The percentage of SMEs in the
market is particularly high in the protective clothing industry. 
There are few key players in the European
PPE industry. Amongst these, Honeywell Safety Products is the global leader in
eye protection equipment (20% market share); 3M (due to acquisition of Aearo)
dominates the global market for hearing protection equipment (40% market share)
and continues leadership for respiratory protection equipment (30%). The other
PPE market segments are much less concentrated. Key players have managed to
extend their market share primarily through mergers and acquisitions.
2.2.6.     Competition and competitiveness 
The introduction of binding regulation on
safety in the workplace and on protective equipment, both in the EU and in the
rest of the developed world, has led to the development of a mature, well
established and very competitive PPE market. Whilst consumers are increasingly
attracted by factors such as comfort, fashion and branding, price continues to
play a crucial role on purchasing decisions[24].

Trade and exposure to competition from
cheap exporting regions have reduced the profitability of the European PPE
industry. In response, manufacturers have tried to expand their market share by
targeting new products through mergers and acquisitions and to reduce
production costs by relocating to countries with lower labour costs. 
2.2.7.     Research and innovation intensity 
It is difficult to estimate the research
and innovation intensity and performance accurately across the sector. In terms
of innovation, it is apparent that there is a growing focus on a number of key
areas with a view to countering the impact of cheap imports. The design and
development of new products that provide a greater level of comfort and/or
style have been a particular focus, as have products with increased lifetimes.
However, the recent economic crisis might also have led to a reduction in
innovation investments, which will slow down product innovation and lengthen
product cycles, especially in Western European countries. 
The research intensity can be considered in
terms of R&D expenditures. Expenditures across the different PPE segments
are relatively low if compared to the production value. The Safety footwear
segment exhibits the lowest rate of investment, while the Eye protection
segment exhibits the highest rates of investments across the PPE sector.
2.3.        Alignment to the New
Legislative Framework
The Alignment to the New Legislative
Framework is the major step on simplification of the current legislation. With
the Alignment, the obligations of economic operators become more clear and
identical to those involving other pieces of New Approach legislation.  At the
same time, modules for conformity assessment are harmonised with those to be
applied in other EU legislation.  Manufacturers and notified bodies have very
often to use different pieces of EU legislation to ensure compliance with legal
requirements.  The current proposal contributed to provide a more structured
and a more clear legal framework.
As mentioned above the whole area of
product legislation and in particular the "New Approach" has recently
undergone a horizontal review that resulted in the adoption of the New
Legislative Framework (NLF)[25].
The objective of the NLF is to remedy a number of shortcomings observed across
various sectors, including the PPE sector, namely a significant number of
products that do not ensure an adequate level of protection that reach the
market, the unsatisfactory performance of certain notified bodies[26]
and inconsistencies throughout the legislation making its application
unnecessarily complicated for manufacturers and authorities.
The NLF consists of two instruments.
Regulation (EC) No 765/2008 on accreditation and market surveillance[27] (NLF Regulation) has introduced rules on accreditation[28]
and requirements for the organisation and performance of market surveillance
and controls of products from third countries. It is complemented by Decision No 768/2008/EC establishing a common framework for the
marketing of products[29] (NLF Decision) which is conceived as a "toolbox"
for future legislation providing solutions that can work across all
sectors. It contains model provisions to be commonly used in EU
product legislation (e.g. definitions, obligations of economic operators,
notified bodies, safeguard mechanisms, etc.). The three EU institutions
involved in the legislative process, Council, Parliament and Commission have
committed themselves to use the NLF Decision’s provisions as much as possible
in future legislation in order to bring about the maximum of coherence in the
regulatory framework[30]. The NLF was accompanied by an impact assessment[31]. 
The problems identified by the NLF have
also been observed in the context of implementing the PPE directive, namely
with regard to equipment placed on the market that does not ensure an adequate
level of protection. 
PPE that does not ensure an adequate level
of protection can present serious risks to the health and safety of the user
who can no longer rely on its protective function when exposed to the risk.
This can cause injuries, burns, electric shocks, and sometimes can even lead to
fatalities. Recent examples discussed at EU level[32] are:
–                        
Defective safety footwear: which is supposed to ensure protection against mechanical
penetration. However it was observed that the metallic anti-penetration inserts
of the footwear could become fully oxidised in which case they no longer offer
protection against injuries.
–                        
Defective protecting clothing against liquid
chemicals: the protective
clothing prevented permeation by liquid chemicals only for a very short time
(only a few minutes instead of hours as claimed in the product description).
–                        
Defective PPE against falls from a height: the fall arrest system either failed to arrest the fall within the
required distance or failed to arrest the fall altogether when tested in a
"fall back" situation – which is a foreseeable condition of use.
There have been also problems with the
quality of the services delivered by some notified bodies. In its reports to
the PPE Working Group the notified body group frequently expressed regret that
many notified bodies do not participate in the coordination meetings and do not
apply the Recommendation for Use Sheets[33].
Furthermore the group frequently pointed out different practices in the MS as
regards the evaluation and monitoring of notified bodies, for example with
regard to sub-contracting testing to other notified bodies or laboratories.
A number of PPE manufacturers are also
faced with the problem of a complex and sometimes inconsistent legal framework:
Certain PPE also has to comply with other directives[34], e.g. the pressure
equipment directive (for breathing devices), the electromagnetic compatibility
directive and the Radio and telecommunication terminal equipment directive (for
PPE that incorporates electrical or telecommunication devices).
In order to address the problems described
above and in line with the political commitment laid down in Article 2 of the
NLF Decision[35]
to use the solutions offered by the Decision as consistently as possible, the
PPE Directive needs to be aligned to the NLF.
In addition to these horizontal problems a
number of other issues specific to the PPE sector have been identified that
will be described in chapter 3. Those PPE specific shortcomings were the reason
why the PPE Directive had not been included in the package of Directives which
underwent a pure alignment with the New Legislative Framework (NLF) Decision in
2011.
The Impact Assessment Report on the
Alignment Package[36]
has already examined in depth the different options to give effect to the NLF
Decision. These options are exactly the same for the PPE Directive. The report
also provided an analysis of the impacts resulting from the measures set out by
the NLF Decision. In view of the structural similarities of the sectors
examined in that report with the PPE sector and the horizontal nature of these
measures the impacts are expected to be the same in the PPE sector. For this
reason this report will not examine these aspects. It will focus on PPE
specific problems and the ways to address them. 
3.           Problem definition 
Despite a
successful functioning of the Directive (see chapter 2.1 "The evaluation
of the PPE Directive"), there is also a broad consensus that there is room
to achieve some improvements that can contribute to an even more effective
protection of the health of the users and to a more efficient functioning of
the PPE legislation. Most of the proposed improvements result from the
experience of Member States authorities and other stakeholders with the
enforcement and implementation of the PPE legislation and are not directly
related to accidents. With the transposition of the Directive into national law
and with the experience of daily work with that legislation the below described
problems and inconsistencies were identified. The identified issues are the
output of communication with Member States and stakeholders:

 product coverage
 the application of the conformity
     assessment procedures
 basic health and safety requirements
 market surveillance

As it will be
explained in more detail in chapters 3.1-3.3, these problems lead to
insufficient protection of EU citizens, uneven level playing field for the
economic operators and complex regulatory environment for PPE. The quantitative
data available are not enough detailed to enable to provide an order of
magnitude for the selected issues.
3.1.        Product coverage
3.1.1.     Problem
that requires action and its underlying drivers
There are
products on the market that provide for a protective function to the user and
fit the definition of personal protective equipment of the PPE Directive but
are not covered by this Directive. That means in particular that these products
are not subject to the established safety and health requirements and
conformity assessment procedures for PPE. As a result, the level of protection
offered by such products is not as high as for PPE which explicitly fall under
the Directive's requirements. Therefore, when wearing them, the user is
potentially more exposed to injuries than in the case of a PPE compliant
product. The consumer might believe that she/he is protected against a specific
risk when in fact she/he may not be. For example products protecting against
heat designed for private use (such as oven gloves) are explicitly
excluded from the Directive. So are the products against damp and water for
private use (e.g. dish-washing gloves). However, the same type of products when
they are intended for professional use is subject to the PPE Directive. The
majority of the replies to the public consultation pointed out that the risk in
the case of the oven gloves was the same in all kinds of environments (be it
professional or private). The members of the PPE Working Group mentioned at
several occasions that these products that are outside the scope raise safety
and health problems. Dish-washing gloves for instance could also be used by consumers
to protect against relatively mild cleaning materials used in a domestic
setting. While e.g. housekeeping gloves, intended to protect against the latter
risk, are covered by the Directive the dish-washing gloves themselves are not.
The current situation creates confusion between those different usages.
For products
intended for private use that are not covered by the PPE Directive the General
Product Safety Directive 2001/95/EC (GPSD)[37]
will be applied. This legislation is intended to ensure a product safety for
consumer products that are not covered by specific sector legislation. It
provides a generic definition of a safe product. Nevertheless it does not set
specific safety requirements for products. In order to comply with the GPSD and
to check whether a product is safe or not, manufacturers as well as public
authorities have to develop technical specifications of the product to ensure
safety. However, when personal protective equipment is involved, a specific
European legislation is available, namely the PPE Directive, which provides the
requirements needed for this kind of products, even if limited so far to
products for professional use. From a legal certainty point of view, it is more
appropriate to apply similar requirements to similar products. 
The situation described above cause problems,
for instance, for the market surveillance authorities. The product coverage of
the PPE Directive for some types of protective equipment depends on the
circumstances of the intended usage, i.e. whether it is used in work places or for
private activities. It has been argued that the distinction between
professional and private use should not be relevant for placing (identical)
products on the market. Market surveillance authorities regularly raise the
need to overcome this situation.
The problem described is of regulatory
nature. This failure has repercussions for the market, on the level of health
and safety protection of users and creates confusion for the market
surveillance authorities.
3.1.2.     Who is affected, in what ways and to what extent?
It is mainly the users of these products that
are affected as well as the market surveillance authorities. The users might
not get the optimum level of protection when using products with a protective
function. The market surveillance authorities have to assess identical products
according to their intended use.
3.1.3.     Evolution of the problem
As the source
of the problem stems from the legislation itself, it will persist. The
situation for market surveillance authorities and manufacturers will not change
either.
For some types
of protective equipment the applicable legislation will depend on the nature of
the intended use. If it is intended to be used at work places it is subject to
the PPE Directive, if it is intended to be used for private activities it is
subject to the GPSD.
In the case of
products that have a protective function but which remain outside of the scope
of the Directive there will be examples on the market of those with sufficient
level of protection but also of those with insufficient or no protection at
all. Oven gloves for private use are an illustrative example of such a risk: oven
gloves are supposed to provide protection even if intended for private use, but
oven gloves carrying solely fashionable properties are available on the market.

One Member
State has identified 150 000 cases of burn at home in the country per year. 
Half of these burns concern the hands.
Detailed data,
in particular data related to gloves that do not ensure an adequate level of
protection and associated accidents, are not available.  Just to provide a
broad indication to be interpreted with caution, we have used below statistics
about accidents at work.
Burns, scalds
and frostbites, i.e. the type of injuries which could be prevented by the use
of oven/dishwashing gloves, account on average for roughly 2% of the total
number of accidents at work.  The overall number of these types of injuries was
around 85 000 in 2011. A conservative estimate of the costs due to this type of
injuries (considering only the costs of slight injuries as those are deemed to
be the most often occurring) was  in the range of 1.5 billion Euros in 2011. It
means that in the period 2002-2011 this type of injuries could have cost
society around 14.4 billion Euros. 
3.2.        Conformity assessment
3.2.1.     Problem
that requires action and its underlying drivers
As described in chapter 2.1 PPE is
classified by the Directive into three categories that are subject to different
conformity assessment procedures (see Fig. 2). The definitions of
categories I and III are accompanied by lists that describe exclusively and
exhaustively the PPE covered by these categories.
The experience with the application of the
Directive has shown that the list of products subject to the most stringent
conformity assessment procedure[38]
(i.e. PPE of category III) misses products that fit the definition of category
III, i.e. PPE designed to protect against mortal danger or danger that may seriously
and irreversibly harm health. As a consequence there are no regular audits of
the production process for these types of PPE in contrast to the listed types.
Therefore in certain fields there is no check of the quality of the actual PPE produced
and, by implication, not the same level of safety is provided by those PPE.
For instance a life jacket is intended to
protect against drowning and that risk does indeed fit the above mentioned
definition of category III. There have been cases reported by the European
Parliament and Member States where accidents and fatalities happened due to
improper functioning of life jackets. Nevertheless PPE to prevent drowning is
not listed as category III. As category II PPE the conformity of life jackets
is currently tested by an independent body only once during the EC type-examination
before serial production starts. But there is no obligation for independent
tests of the quality of the life-jackets actual produced thereafter. So, there
is no guarantee of a constant quality and consequently of a constant level of
safety for these types of PPE.
Other involved products are bullet-resistant
and knife stab-resistant PPE and PPE for protection against cutting by
hand-held chain saws, for protection against high pressure cutting and for protection
against noise. For the last of these it may not be immediately obvious that it
fits the definition of category III but it is an established fact that damage to
hearing is irreversible. The actual damage may not be perceived as an
irreversible development because the effect of the damage will be perceptible
only in the medium or long term.
Again the described problem is a regulatory
failure because both the definition and the list are integral parts of the
Directive.
3.2.2.     Who is affected, in what ways and to what extent?
The users of those products intended to
protect against serious risks are affected. Because there is no obligation to
test the items actually produced, the PPE in use might not have the same level
of protection as the type-tested specimen. Due to variability in the production
process the quality of the product can be subject to fluctuations. Changes in
product design, that might have impacts on the safety level, will not be picked
up by the Notified Body in contrast to what would happen with regular audits.
Manufacturers using a quality management system for the production process on a
voluntary basis will experience commercial disadvantages.
3.2.3.     Evolution of the problem
Questions on categorisation of particular
types of PPE are often discussed by Member States and the stakeholders.
However, discussions need to follow what is prescribed in the current text of
the PPE Directive. Inconsistent categorisation will persist unless changes to
the exclusive and exhaustive lists in the Directive are made. Taking into
account that more and more manufacturers apply quality management in their
production process one can expect some progress in the future. Nevertheless
this process does not involve technical competent third bodies who will ensure
independent assessment of the quality of the production process. As long as a
stable high quality level of the products mentioned above over the entire
production process cannot be guaranteed, there will be repercussions on the health
and safety of the users of these critical kinds of PPE.
Statistically, the accidents which
theoretically can be prevented by life jackets (drowning) accounted for
around 2200 fatalities during the period 2002-2011 and represented a total
societal loss of 570 million Euros. The potential benefit of a -0.5% decline in
these types of injuries for the period 2012-25 would bring about a social
benefit of around 2.9 million Euros. Taking into account the same reduction,
the estimated cost for society for the period 2012-25 would be of 630 million Euros.

3.3.        Requirements
3.3.1.     Problem
that requires action and its underlying drivers
Technical file[39]
Market surveillance authorities claim that
their work is hindered in some cases due to unclear or insufficiently detailed
requirements in the Directive for the technical file. Authorities report that
manufacturers of category I PPE are reluctant to work together with the authorities
when they are required to hand over documents on internal production control,
saying this information in the technical file is not required for category I
PPE. On the other hand stakeholders do not have a clear understanding of their
responsibilities with respect to the content of the technical file due to the
current structure of the requirement for the technical file. The quality and
the completeness of the technical file are indisputably crucial for the
assessment of the compliance of the product by the authorities.
Validity and content of EC
type-examination certificate
Regularly manufacturers, as well as market
surveillance authorities, report on problems with the EC type-examination certificate.
Due to the possibly unlimited validity of the certificate products that were EC
type-examined in the past on the basis of versions of harmonised standards that
have been subsequently withdrawn may be placed on the market. Such products
have to be considered as potentially not in conformity with the Directive. In
addition, this situation has a negative impact on competition and on
competitiveness. In fact, the manufacturers who have adapted their products to
the requirements of the more recent, and legally in force, harmonised standard
have to support the compliance costs while those manufacturers who have not do
escape those costs. The Notified Bodies have set up a voluntary agreement to
limit the validity of certificates to five years. However not all of the
Notified Bodies are observing that agreement. Discussions with representatives
of the Member States and of stakeholders have shown that the clarification of
this situation is widely supported.
Additionally the work of the market
surveillance authorities is hindered by the fact that the certificates issued
by various bodies differ in layout and content. There is no requirement in the Directive
to harmonise the certificate. In particular the authorities have problems due
to different languages and difficulties in identifying products.
EC Declaration of conformity (DoC)
The EC Declaration of Conformity is a legal
statement by the manufacturer attesting that the product concerned complies
with all relevant provisions of the Directive. It contains a description and
identification of the product that enables both the user and the market
surveillance authorities to identify the product covered by the declaration
without ambiguity. The DoC is a crucial document for the market surveillance
authorities to check the compliance of the product. However, market
surveillance authorities report that it is hard to obtain the DoC from the
manufacturer, especially if the manufacturer is located outside Europe. The PPE
Directive does not require that every product is accompanied by a DoC as is the
case for other single market directives.
Basic Health and Safety Requirements
(BHSR)
Experiences in dealing with the BHSR have
shown that there are three requirements that include impracticable or confusing
elements.
For protection against mechanical vibration
the Directive requires that the PPE does not transmit vibrations to the user
that exceed the established limit values recommended in the light of the
maximum foreseeable daily exposure. Such a general requirement applicable for
any PPE of this type is not practicable: At different workplaces, using
different working tools, the worker is exposed to different levels of vibration.
A better solution would be to have the choice between different classes of PPE
providing different attenuation levels of vibration. The worker would be able
to select a PPE providing him an optimum for both protection and usability for the
actual working situation.
For hearing protectors the Directive requires
the product to be labelled with a value of the "comfort index"
provided by the PPE. This index should include aspects such as the pressure of
the protector against the head, the weight, and the type of material. In the
light of discussions on this “comfort index” it was concluded that it is not
possible to measure and establish such an index. Comfort is seen and felt very
differently by individual persons as it could be described for all persons
using a universal index. The manufacturer is not able to fulfil the related
requirement. 
For protection against non-ionizing
radiation the manufacturer is obliged to include the transmission curve[40] of the used filters in
the instructions. This should make it possible to select the most appropriate
PPE. Nevertheless, the selection on the basis of the transmission curve cannot
be done straightforward; it requires additional calculation involving expert
knowledge. The selection using the transmission curve has proven to be a source
of confusion to the user who at the end does not take advantage of such
information. There is other information available, like the transmission factor
that could serve much better the same aim of the user selecting the appropriate
PPE.
The described problems above are regulatory
in nature because the requirements are an integral part of the Directive.
3.3.2.     Who is affected, in what ways and to what extent?
Market surveillance authorities, manufacturers
and users are affected. The authorities have to deal with the insufficient
results of the requirements resulting in some cases in an ineffective work. The
manufacturers of certain types of PPE are faced with trying to fulfil
requirements that are known to be impracticable. The users of PPE are affected to
the extent that the information they receive connected with the product is partial
and, on that basis, may be irrelevant and may be a potential source of confusion.
3.3.3.     Evolution of the problem
The identified problems will persist unless
changes to the requirements are made. Without sufficient and appropriate information
provided by the manufacturer the compliance of a product with the applicable
requirements is difficult or impossible to assess. Further to potential
negative effects on the protection of users, the work of the Member States
market surveillance authorities cannot be satisfactorily performed. There is a
need to clearly state the obligation of manufacturers to assemble the necessary
technical documentation.
With respect to the validity of EC
type-examination certificates, the voluntary agreement of the Notified
Bodies to limit this validity to 5 years may reduce the intensity of this
problem. Nevertheless the agreement being voluntary and thus not applied by all
Notified Bodies, the problem is not likely to disappear in the foreseeable
future. In addition, it is not likely that the current confusion caused by the
different layouts of the certificates will disappear either.
The difficulties raised by the
impracticable or unclear provisions on protection against mechanical vibration,
hearing protectors and protection against non-ionizing radiation will remain.
3.4.        EU right to act
This initiative concerns the proper
functioning of the internal market for products in the field of PPE. EU action
in this area is based on Article 114 of the TFEU. The aspects addressed in this
context are already regulated by the PPE Directive 89/686/EEC. This legislation
does not however address the identified problems as effectively as desirable.
If actions are taken at national level to address the problems, they may create
obstacles to the free movement of the PPE goods. Therefore, any changes to the
scope, procedures or requirements must be carried out at EU level in order to
avoid distortions in the EU market.
4.           Objectives 
4.1.        General
policy objectives
The overall objectives of this initiative
are to (1) better protect the health and safety of PPE users, (2) create a level
playing field for PPE economic operators and (3) simplify the European regulatory
environment in the field of Personal Protective Equipment (PPE). For the
problem tree see Figure 8.
4.2.        Specific
and operational policy objectives
 GENERAL || SPECIFIC || OPERATIONAL 
 Better protect the health and safety of PPE users || Ensure high quality of products protecting against high risks including a high quality of their production process Ensure the reliability and high quality of conformity assessment activities carried out by notified bodies Ensure traceability of products || Remove inconsistencies in the list of products subject to the most stringent conformity assessment procedure   Specify common criteria for the assessment, monitoring and control of NBs to be applied equally throughout the EU 
 Create a level playing field for PPE economic operators || Ensure consistency of conformity assessment services carried out by notified bodies Improve market surveillance mechanisms and tools || Clarify the requirements for EC type-examination certificates Simplify and clarify the requirements for the technical file Require the EC Declaration of conformity to accompany every product 
 Simplify the European regulatory environment in the field of PPE || Ensure consistent application of the legislation     Ensure the requirements are practicable || Clarify the scope of the Directive Simplify the applicable conformity assessment procedures Clarify the requirements set out in ANNEX II 
Figure
8: Problem tree depicting the links between problems, their drivers and the
objectives.
4.3.        Consistency
with other policies and objectives
This initiative is in line with the Council
Directive on the minimum health and safety requirements for the use by workers
of personal protective equipment at the workplace[41] as well as with the
Commission’s policy on the Single Market (Single Market Act)[42] and Better Regulation
policy.
5.           Policy options 
The policy options proposed are generally
independent one from the others.  They proposed taking into account the
contributions of representatives of Member States and of stakeholders as well
as the results of the studies commissioned by the Commission services.
Alternative proposals for the areas covered were not put forward by interested
parties.
5.1.        Product coverage

 Do nothing.

Option 1 is to
leave the existing situation unchanged. The product coverage of the Directive
would not be changed. Products that are covered have to fulfil the
requirements, products that are not covered do not have to fulfil the
requirements. The described problems will persist.

 Further clarify the product coverage in
     the Guidelines (Soft law).

Option 2 is a
soft law option. The Directive is not changed but the Guidelines on the
application of the PPE Directive are used to explain, in a more detailed way than
currently, the product coverage of the Directive. This would follow in a
clarification of the situation on the product coverage for some types of PPE.
Clarification could be added that products have to be assessed for every kind
of protection provided, even if it is not the intended use. 

 Amend the exhaustive list of PPE not
     covered by the Directive.

Option 3 uses
legislative measures, i.e. the PPE Directive will be changed. Annex I with its
exhaustive list of PPE classes not covered by the Directive will be changed in order
to solve the described problems. The exclusions of PPE designed and
manufactured for private use against damp and water and against heat will be deleted.
5.2.        Conformity assessment

 Do nothing.

Option 1 is to
leave the existing situation unchanged. The exclusive and exhaustive list for
category III[43]
products will not be changed. Consequently those types of PPE described in
section 3.2.1 (life jackets, bullet-resistant vests etc.) will not be subject
to the most stringent conformity assessment procedure even if they fit the
definition of category III. There will not be an obligation to let the
production process be monitored by an independent third body.

 Voluntary agreement on application of
     production control (Soft law).

Option 2
consists of non-regulatory instruments that encourage the voluntary application
of the third body control of the production process for the described types of
PPE. The manufacturers should agree to apply the most stringent conformity
assessment procedure even if the PPE is not listed as category III. The
agreement should also include the (fee-based) involvement of Notified Bodies.

 Modify the list of products subject to
     the most stringent conformity assessment procedure.

Option 3 uses
legislative measures. The exclusive and exhaustive list for category III
products will be changed. Some types of PPE will be added. The intended consequence
will be the obligation that the production of this PPE shall be subject to a
procedure to monitor the production process involving an independent third
body.
5.3.        Requirements
Technical file

 Do nothing.

Option 1 is to
leave the existing situation unchanged. The current structure of the requirements
for the technical file will remain and the requirements for products of
category I will continue not to be as detailed as for products of the other
categories. This affects in particular the description of the product and
details on the means used by the manufacturer to ensure the compliance of the
product with the applicable basic requirements.

 Further clarify the issue in the PPE
     guidelines (Soft law).

Option 2 is a
soft law option. The Directive is not changed but the Guidelines on the
application of the PPE Directive are used to explain the content of the
technical file and its importance for both the manufacturer and the
authorities. The manufacturer of category I products can be encouraged to draw
up voluntarily a detailed technical file as is explicitly required for the
other categories.

 Modify the requirements on the technical
     file.

Option 3 uses
legislative measures. Annex III of the Directive will be changed. The
requirements will be applied to all categories of PPE. Additionally the
structure and the wording will be simplified in order to provide more clarity.
Validity and content of the EC
type-examination certificate

 Do nothing.

Option 1 is to
leave the existing situation unchanged. The validity of the EC type-examination
certificate will continue not to be limited by legislative means. In addition the
requirements in respect of its content are insufficient in particular to
clearly identify the product.

 Notified Bodies to agree on limited
     validity and minimum content of certificates (Soft law).

Option 2
consists of non-regulatory instruments that encourage a voluntary agreement of
the Notified Bodies to limit the life-time of the certificates as well as on a
minimum content.

 Time limit the validity of certificates
     and improve the requirements for the content of certificates.

Option 3 uses
legislative measures. The validity of the EC type-examination certificate will
be limited. The existing requirements for the content of the certificate will
be redrafted to ensure that all necessary information is provided such that a
clear identification of the product is ensured.
EC Declaration of conformity (DoC)

 Do nothing.

Option 1 is to
leave the existing situation unchanged. The manufacturer is obliged to draw up
a DoC that should be made available to market surveillance authorities
immediately on demand.

 Further clarify in the Guidelines the
     need for detailed information on conformity of the product and about the
     manufacturer (Soft law).

Option 2 is a
soft law option. The Directive is not changed but the Guidelines on the
application of the PPE Directive are used to explain the importance of both detailed
information on the product and the possibility that this information is
available for the authorities. The detailed information must sufficiently
describe the compliance of the product with the Directive.

 Create a requirement for the DoC to be supplied
     with every product.

Option 3 will
introduce a requirement into the legislative text that every single product
placed on the market shall be accompanied by the DoC.
Basic Health and Safety Requirements
(BHSR)

 Do nothing.

Option 1 is to
leave the existing situation unchanged. The described problems will persist. In
particular, concerning the requirement to label PPE protecting against the
harmful effects of noise with a "comfort index", the manufacturers
have to deal with an obligation that cannot be fulfilled.

 Further clarify the application of BHSR
     in the Guidelines (Soft law).

Option 2 is a soft
law option. The Directive is not changed but the Guidelines on the application
of the PPE Directive are used to further clarify the application of the BHSR.
In particular they can be used to explain how, in practice, the problematic
requirements described in 3.3.1 can be addressed.

 Delete requirements from the BHSR on:

·              
Mechanical vibrations (BHSR 3.1.3).
–              
Delete in BHSH 3.1.3 the requirement that under
no circumstances must the effective value of the accelerations transmitted to
the user by those vibrations exceed the limit values recommended in the light
of the maximum foreseeable daily exposure of the part of the body at risk.
·              
Protection against harmful effects of noise
(BHSR 3.5).
–              
Delete in BHSR 3.5 the requirement to label the
PPE with the value of the comfort index provided by the PPE.
·              
Protection against radiation, non-ionising
radiation (BHSR 3.9.1).
–              
Delete in BHSR 3.9.1 the requirement that the
instructions for use supplied by the manufacturer must indicate the
transmission curves.
6.           Analysis of impacts 
6.1.        General remark
The analysis of impacts will be presented
in two steps. First all the policy options will be assessed qualitatively and
preferred options (chapter 6.3) will be selected. Then an in-depth analysis of
these options will follow (chapter 6.4). Following its outcome, mitigating
measures for the most affected parties will be considered (chapter 6.5). 
6.2.        Overview of the relevant
impacts and the methodology for their assessment
The following impacts are deemed the most
relevant and therefore have been considered:
Social impact: The social impact consists mainly of benefits to the health and
safety of the users of PPE. The proposed changes are
designed to reduce the number of illnesses and injuries through the following
three mechanisms
·                        
Proportion of products on the market that
do not ensure an adequate level of protection: the proposed changes are likely to decrease the number of such
products on the market and thus reduce the probability that the use of such a
product results in an injury.
·                        
Usage of PPE: some amendments would improve and extend the usage of PPE. An
increased usage of PPE might reduce the number of injuries especially in those
sectors where usage of PPE is more common.
·                        
Safety level prescribed by proposed policy
changes: some
amendments (e.g. reclassifying products from category II to category III) would
result in an increased level of safety associated with the use of PPE and thus
reduce the likelihood of accidents/injuries.
Economic impacts: Implementation of the proposed changes will entail costs to both manufacturers
and market surveillance authorities. Firstly, extended coverage and stricter
requirements will cause additional work for market surveillance authorities. In
addition, manufacturers will incur the following compliance costs:
·                        
Fixed costs: Manufacturers of PPE that was previously excluded from the Directive
will need to invest in product design, testing and document generation to
ensure conformity. Manufacturers of PPE that is moved from Category II to
Category III PPE, or classified as Category II PPE when previously excluded
from the Directive, will need to invest in testing and document generation,
production controls and monitoring systems, as well as paying higher fees to
notified bodies for monitoring the quality of products.
·                        
Variable costs: Manufacturers of PPE that is moved from Category II to Category III
PPE, or classified as Category II PPE when previously excluded from the
Directive, will need to invest in annual quality assurance by notified bodies. Requirement
changes will entail manufacturers having to invest in the production of the declaration
of conformity.
The assessment of each proposed change is
based on its costs and benefits, where the latter includes health benefits, as
well as improvements in legal certainty. Interviews with representatives of manufacturers,
notified bodies, and market surveillance bodies were used[44]. An estimate of the degree
of certainty of the health effects of the amendments was derived from the
number of interviews undertaken and the degree of consistency across responses.
Where quantitative estimates were not possible, a qualitative assessment of the
likely effect was made based on the interviews.
The first step of the options appraisal was
to compare the cost of the changes to manufacturers against the perceived likelihood
of their generating improvements in health. It is important to note that health
effects were not monetised to facilitate comparison with costs, when:
- a review of the existing evidence
revealed insufficient robust data on the improvements in health being generated
by the evidence; and
- the output from the interviews was
certainty about the existence of a health effect, rather than the degree of that
effect.
Thus, researcher judgement was used to
compare the certainty of the health effect against the impact on manufacturer
costs, with greater certainty of that effect being given more weight. It was
not always possible to conclude about the value of the intervention based on
health effects and costs alone. The impact of the amendments on legal certainty
was also considered in the following situations:
- Where health effects and costs were
considered marginal.
- Where health effects and costs were
considered similar.
- Where there was insufficient data to
determine the health effects and/or costs.
6.3.        Qualitative analysis
6.3.1.     Product
coverage

 Do nothing.

No impact. For
the baseline scenario see the description in chapter 3.1.3.

 Further clarify the product coverage in
     the Guidelines (Soft law).

With a further
explanation of the product coverage of the Directive in the Guidelines only a
slight reduction of the products that do not ensure an adequate level of
protection can be expected. Some manufacturers who already have products for
professional use in their portfolio (dish-washing or oven gloves) will follow
the Guidelines and will also fulfil the Directive's requirements for the gloves
for private use. Nevertheless, due to the fact that it is a voluntary measure,
it is expected that not all manufacturers will follow this explanation. The
manufacturers who currently have no knowledge about the PPE Directive because
they only produce products for private use that are currently excluded from the
Directive will hardly be reached by this option. This option will not lead to a
clear legal situation because the exclusions in the Directive will remain. Those
manufacturers who will apply the changes will incur higher costs due to the
process of making the products compliant to the Directive, which may result in
a cost disadvantage with respect to those not complying.

 Amend exhaustive list of PPE not covered
     by the Directive.

With a change of
the legislation a clear legal situation will be established. All manufacturers
of the relevant product will be reached. Consequently, the possible reduction
of products that do not ensure an adequate level of protection will be
maximised. For all manufacturers there will be costs due to the process of
making the products compliant to the legislation.  The legislative option will
provide for an effective compliance with higher safety requirements for those
products that today do not ensure an adequate level of protection.  A more
effective protection of consumers will be ensured and a contribution for the
reduction of accidents is therefore to be expected.
   || Effectiveness || Efficiency Costs                Benefits || Coherence 
 Do nothing || 0 || 0 || 0 || 0 
 Soft law || +/- || - || + || + 
 Legislative measure || ++ || -- || ++ || ++ 
6.3.2.     Conformity assessment

 Do nothing.

No impact. For
the baseline scenario see the description in chapter 3.2.3.

 Voluntary agreement on application of
     production control (Soft law).

Using this
option some reduction of products that do not ensure an adequate level of
protection can be expected, as it can be expected that some manufacturers would
adhere to stricter production control provisions. In order to have the maximum
effect all involved manufacturers should agree. However, the research carried
out suggests that this prospect is not realistic.

 Modify the list of products subject to
     the most stringent conformity assessment procedure.

Modification along
these lines will lead to greater legal certainty. All manufacturers of the
relevant PPE must apply the most stringent conformity assessment procedure. It
is expected that this will lead to a higher general quality of the products,
i.e. to a reduction of the products on the market that do not ensure an
adequate level of protection because the quality of the production process is regularly
monitored. Overall costs for this option will be higher than for option 2
because all manufacturers are obliged to apply the changes.  However, an
effective, consistent and reliable high quality of conformity assessment
activities will be ensured.
   || Effectiveness || Efficiency Costs                Benefits || Coherence 
 Do nothing || 0 || 0 || 0 || 0 
 Soft law || + || - || + || + 
 Legislative measure || ++ || -- || ++ || ++ 
6.3.3.     Requirements
Technical file

 Do nothing.

No impact. For
the baseline scenario see the description in chapter 3.3.3.

 Further clarify the issue in the PPE
     guidelines (Soft law).

The efficiency
of the market surveillance authorities will be increased in the case where manufacturers
follow the Guidelines and draw up a full technical file for category I
products. The reduction of products that do not ensure an adequate level of
protection that can be reached will depend on the percentage of manufacturers voluntarily
following the Guidelines. The authorities will have the same problems as of now
if the manufacturer does not provide a full technical file. Costs will arise
for those manufacturers who will voluntarily draw up a full technical file.

 Modify requirements on the technical
     file.

This will be the
best solution in terms of clarity. The market surveillance authorities will be
able to demand the technical file from all manufacturers because it will be a
legal requirement. This option will increase the efficiency of the work of the
authorities to the greatest degree. It is also reasonable to expect that the
number of products that do not ensure an adequate level of protection will subsequently
be reduced. Overall costs for this option will be higher than for option 2
because all manufacturers are obliged to draw up a full technical file.  On the
other hand, manufacturers would have a clearer legal framework in this
respect.  However, the legislative option will ensure that market surveillance
authorities can effectively verify whether or not compliance with essential requirements
is effectively achieved.
   || Effectiveness || Efficiency Costs                Benefits || Coherence 
 Do nothing || 0 || 0 || 0 || 0 
 Soft law || +/- || - || + || + 
 Legislative measure || ++ || -- || ++ || ++ 
Validity and content of the EC
type-examination certificate

 Do nothing.

No impact. For
the baseline scenario see description in chapter 3.3.3.

 Notified Bodies to agree on limited
     validity and minimum content of certificates (Soft law).

In order to
reach the best possible effect all Notified Bodies should follow such an
agreement. As described in chapter 3.3.1 experiences have shown that not all
Notified Bodies take part in the coordination group nor do they apply all
agreed procedures. So the expected reduction of products on the market that do
not ensure an adequate level of protection due to this change will be limited.
The market surveillance authorities, who will be assisted to a degree by this
proposal, will still be confronted with unclear certificates that, in addition,
might be based on obsolete standards.

 Time limit the validity of certificates
     and improve the requirements for the content of certificates.

This option will
deliver the maximum effect. The legal requirement of a time-limitation of
certificates will lead to a regular assessment of the compliance of the product
with the legislation. All manufacturers and Notified Bodies will be bound by
this. A reduction of the products on the market that do not ensure an adequate
level of protection is to be expected. Because this option will be mandatory to
all manufacturers the costs will be higher compared with option 2.
   || Effectiveness || Efficiency Costs                Benefits || Coherence 
 Do nothing || 0 || 0 || 0 || 0 
 Soft law || +/- || - || + || + 
 Legislative measure || ++ || -- || ++ || ++ 
EC Declaration of conformity (DoC)

 Do nothing.

No impact. For
the baseline scenario see description in chapter 3.3.3.

 Further clarify in the Guidelines the
     need for detailed information on conformity of the product and about the
     manufacturer (Soft law).

The change is
proposed in order to support the work of the market surveillance authorities.
It can be expected that some manufacturers will follow the recommendation of
the Guidelines and voluntarily accompany their products with a DoC. This will
lead to a more efficient work of the authorities and subsequently to a
reduction of the percentage of the products on the market that do not ensure an
adequate level of protection. However, this option does not oblige the
manufacturers to supply the DoC with the product. The market surveillance authorities
will still be faced with the problem of only partial information being
available.

 Create requirement for the DoC to be
     supplied with every product.

This option will
lead to a clear legal situation. Market surveillance authorities will benefit
from the DoC now being supplied with every product. Their work will be more
efficient than it has been previously been. Consequently the number of products
that do not ensure an adequate level of protection will decrease. All
manufacturers will be faced with the costs of printing the DoC for each item of
PPE sold.
   || Effectiveness || Efficiency Costs                Benefits || Coherence 
 Do nothing || 0 || 0 || 0 || 0 
 Soft law || + || - || + || + 
 Legislative measure || ++ || -- || ++ || ++ 
Basic Health and Safety Requirements
(BHSR)

 Do nothing.

No impact. For
the baseline scenario see description in chapter 3.3.3.

 Further clarify the application of BHSR
     in the Guidelines (Soft law).

This option will
lead to a better understanding of the requirements by the manufacturers. Nevertheless
the unclear legal situation will remain as there will be requirements in the
legislation that either cannot be fulfilled in principle (comfort index in BHSR
3.5) or will lead to confusion of the user (transmission curve in BHSR 3.9.1).
There are no additional costs expected with this proposed change.

 Delete requirements from the basic
     requirements on:

·              
Mechanical vibrations (BHSR 3.1.3).
·              
Protection against harmful effects of noise
(BHSR 3.5).
·              
Protection against radiation, non-ionising
radiation (BHSR 3.9.1).
This option will
solve practical problems for the manufacturers. In the case of BHSR 3.5 the
manufacturer is in principle not able to present the comfort index with the
product as described in chapter 3.3.1. The proposed changes will lead to a
clarification and simplification of the legal situation without any effects,
which could reasonably be expected, on the safety level of the products. No
additional costs are expected.
   || Effectiveness || Efficiency Costs                Benefits || Coherence 
 Do nothing || 0 || 0 || 0 || 0 
 Soft law || +/- || 0 || 0 || + 
 Legislative measure || ++ || 0 || 0 || ++ 
6.4.        In
depth analysis
6.4.1.     Product
coverage
6.4.1.1.  General
remarks
The amendment proposes to include in the
Directive products designed to protect against damp, water and heat and
manufactured for private use (e.g. dish-washing and oven gloves). One of the
reasons behind is that gloves for professional use are already included in the PPE
Directive. Confusion in the market will be reduced and a more level playing
field created by including gloves for private use as well. The amendment will
have a positive impact on the fairness of competition, because
self-certification will become mandatory. The public consultation showed support
for this amendment as two third of the respondents agreed with it; the expected
impact on costs was considered to be minimal.
6.4.1.2.  Social
impact
In interviews with the European Safety
Federation[45],
with one manufacturer and with representatives of Notified Bodies, some further
reasons were offered. One advantage of the amendment is that the product
labelling and user information will result in more clarity on the purpose of
use of the gloves and the content of materials used. Inclusion in the PPE legislation
will improve the general level and standard of information provided, including
information for users on potentially allergenic materials used in rubber and
coloured textile gloves. Consumers will thus be able to make a more informed
choice when purchasing a given type of glove.  
Manufacturers and market surveillance
authorities agree that the inclusion of dish-washing gloves in the PPE legislation
will have a positive effect on the proportion of products that do not ensure an
adequate level of protection. Manufacturers expect a strong reduction of such
products of 50% or more, whereas market surveillance authorities see room for a
more modest reduction of 10-20%. Little data was available on the effect of
updating the products included as PPE insofar as it would affect the
probability that people will use such products. No data was available to assess
the impact of including oven gloves as PPE. 
As already stated, one Member State has
identified 150 000 cases of burn at home in the country per year.  Half of
these burns concern the hands.
6.4.1.3.  Economic
impact

Impact on cost competitiveness

The effect of the amendment in terms of
compliance and administrative costs per product is small. Self-certification
implies that some technical documentation is needed on product composition and
fulfilment of the basic requirements. These costs can be estimated to be in the
order of a few hundred euros per product series and will thus have a low impact
on costs per unit. The costs of labelling and of compiling and inserting user information
are small as well, particularly in the case of firms that already produce
certified oven gloves for professional use. However, according to one of the
companies interviewed, consistent compliance with the basic requirements would
entail a more costly production process (e.g. washing of latex and leather
gloves so that they meet the requirements on protein and chromium,
respectively). Bringing production standards to the highest level in terms of the
basic protection of health and safety can entail 10 % to 20% higher production
costs for some of the segments of the overall glove market. This cost increase
would mostly affect those manufacturers that do not meet the basic requirements
at the moment. Because the gloves are not yet covered by the PPE Directive,
information for tracing the manufacturer is not yet required. Therefore,
products that do not ensure an adequate level of protection can currently reach
the market without a clear indication of their quality, and the level playing
field is thereby impaired. The amendment implies that such information should
be traceable in the future. Provided market surveillance is effective, this
will improve the conditions for fair and transparent competition.

Impact on SMEs

Awareness among SME about the basic
requirements for protective gloves may be at a lower level, if they do not
produce PPE gloves. If production processes need to be upgraded to ensure
compliance, the cost impact could be relatively large. The extent to which
EU-based SMEs would fail to comply with the basic requirements is unclear, but
information from the trade association ESF, one of the Notified Bodies and also
from the consultation report does not suggest many difficulties in this
respect. Compared to dishwashing gloves, the market for oven gloves features
quite a number of small operators that produce in the EU. The overall size of
the market is relatively small. Branding and design of textile gloves for small
retailers is a substantial niche market, where smaller volumes are produced.
The fixed costs related to this amendment will affect these SME producers more.
Previous awareness of the PPE Directive is also smaller among these types of
firms, because they are typically not involved in the production of PPE
products. The initial up-front costs will be higher as a consequence. Even so,
as the requirements for Category I PPE are not especially demanding, additional
costs are likely to remain relatively low. On the other hand manufacturers will
benefit from increased competitiveness because self-certification to the basic
PPE requirements improves transparency and helps to tackle import of products that
do not ensure an adequate level of protection by more effective market
surveillance and more awareness of the requirements by distributors that sell
for example private labels. 
6.4.2.     Conformity assessment
6.4.2.1.  General
remarks
The proposal is to move certain types of
PPE from category II to category III products. The proposed change has the
consequence that these products will be subjected to the most stringent
conformity assessment procedure (Article 11 of the PPE Directive[46]). It requires that the
production process is subject to an additional quality control procedure on
manufactured goods. The manufacturer has the option to choose between (i) an EC
quality control system for final products (Article 11 A), or (ii) a system
for ensuring EC quality of production by means of monitoring (Article 11 B).
In both cases a Notified Body carries out the check on the final product or monitors
the production process at least once a year.
The assessment is done separately for the
different types of PPE.
              PPE
to protect against drowning (life jackets)
A prospective amendment to move life
jackets into category III received support in several interviews on the grounds
that they protect against a danger of fatality. The public consultation showed
support for this reclassification, too.
6.4.2.2.  Social impact
Interviews with the EU-based manufacturers
revealed that such an amendment could help to improve compliance by introducing
annual monitoring. With such an amendment product quality would be checked more
consistently. The proportion of life jackets with inadequate level of
protection will be reduced although there was disagreement as to the extent of
the effect. Whereas market surveillance authorities would not expect to see a
perceptible effect here, manufacturers envisage a small reduction and Notified
Bodies expect reductions of products that do not ensure an adequate level of
protection in the order of 10 %.
6.4.2.3.  Economic impact

Impact on cost competitiveness

The public consultation indicates that
about half of the respondents expect either very modest compliance and
administrative costs or none at all. Even so a quarter would expect higher
costs. The main impact of the amendment would be the need for annual monitoring
of the production process under Article 11 of the PPE Directive. According to one
Notified Body, some adjustment may be needed to an existing general quality
assurance system to focus the system on the specific (families of) products
that are produced (under the choice for monitoring according to Article 11 B).
If a quality control system equivalent to
ISO 9001 has already been implemented but does not have a product-specific
implementation, the costs of adjusting the system for PPE category III audits
would be a one-off. It may involve one or two consultant audits (each in the
order of a few thousand Euros), and the internal costs of setting up detailed
quality assurance manuals. 
Most firms based in the EU already have an
ISO 9001 quality assurance system, or equivalent, in place. Those that
produce under the SOLAS[47]
regulation are also audited annually in respect of quality assurance. For these
manufacturers, additional costs would be low to negligible. In addition annual
recurring audit costs are low for these manufacturers. A Notified Body
indicated that quality assurance audit reports under SOLAS can be used as a
basis for PPE audits as well. For firms that have to implement a quality
control system from scratch, costs are highest. 

Impact on the capacity to innovate

The sector has shown rapid innovation in
characteristics such as in the operation of life jackets, and in their wearing
comfort and weight over the past 20 years. An important driver has been the
development of European and international product standards, most recently EN ISO 12402.
These standards are the benchmark for EC-type certification, and also require
quality control and the use of certified materials. The amendment therefore can
be expected to have limited effects on innovation by EU manufacturers.
Innovation and product quality are already seen as drivers of their competitive
strategies. The amendment will not affect their choice and use of materials and
their internal testing, because this is already part of the relevant EN ISO
product standards. For manufacturers based outside of the EU, the lower end
manufacturers will have to focus more on product quality, because annual
monitoring will require consistent quality levels that meet the industry
standards. 
It was also pointed out by stakeholders
that additional costs related to the annual checks by Notified Bodies could
come at the expense of research budgets. Moreover, EC-type certification of new
or changed products may cause delay in product development. This could reduce
the capacity to innovate. However the rules of EC type certification also
require examination under Category II. The extra impact of Category III is very
limited or even absent with regard to EC type-examination. Annual production
process audits can easily include additional products at limited costs.

Impact on international competitiveness

The impact on international competitiveness
of EU-based manufacturers is seen as mostly positive. Most of the larger
manufacturers do not produce in the EU. Some production by small to medium
sized manufacturers takes place in Europe. Most of these manufacturers adhere
to international standards and have quality control systems. Offshoring of
production will probably not increase as a consequence of the amendment, as
annual monitoring makes quality assurance even more important than before.
Costs of site visits outside of the EU are likely to be higher, and without
large scale production, it would be difficult to finance resources to assuring the
quality of products and monitoring systems across various production sites, and
even more so if they are offshore facilities. Some manufacturers deliberately
choose to produce in the EU to better guarantee the quality of production.
The amendment is likely to improve the competitiveness
of EU industry as a whole. This improvement of the competitive position of
EU-based firms in both domestic and international markets would reflect their
pre-existing focus on standards and quality assurance. Manufacturers outside
the EU that want to sell into the EU market will have to install quality
control systems that meet the EU standards, and invest in the proper
documentation for annual monitoring. Compliance in the market will increase due
to annual monitoring. This would help to prevent any forms of price competition
that were simply at the expense of maintaining quality standards. EU-based
manufacturers already commit themselves to EN ISO standards and related
quality control. Ultimately, products that do not ensure an adequate level of
protection may still reach the market, depending on the effectiveness of the market
surveillance function and the policies of distributors, but this phenomenon is
likely to decrease. 

Impact on SMEs

Annual monitoring creates costs that are
more difficult to bear at a lower scale of production. Budgets for research may
compete with fixed annual costs of monitoring, although the costs per product series
probably will not exceed a few thousand Euros annually once the quality
assurance mechanism has been implemented. Most SMEs in Europe have already
endorsed ISO standards and additional costs per product of annual monitoring
are still relatively limited, when compared to the volume of lifejackets sold.
              Hearing
protection (ear plugs, ear muffs)
The move of hearing protection equipment
from category II to category III is not endorsed unanimously by stakeholders.
Opinions differ as to its justification on the basis of protection against
serious irreversible harm. Others are not aware of user health and safety
problems that are related to malfunctioning of certified products. The
interviews carried out confirm the mixed opinions. The public consultation
shows that about twice as many stakeholders disagreed with the amendment; those
in agreement state that the impact in terms of compliance and administrative
burdens would be minimal.
The prevalence of products on the market that
do not ensure an adequate level of protection is often considered to be an
especially acute problem for ear muffs and ear plugs manufacturers. Even if
they have been certified in the past, current production may not comply with
the PPE certified model products. The change to category III would provide
extra safeguards for product quality. Annual testing better ensures product and
production homogeneity and compliance to basic PPE requirements and relevant
product standards. Another advantage of re-categorization would be quality
differentiation with respect to products that do not ensure an adequate level
of protection.
6.4.2.4.  Social impact
The proposed move to category III would
have a medium cost for manufacturers but also result in a medium reduction in
the proportion of products on the market that do not ensure an adequate level
of protection. Manufacturers expect a small reduction whereas Notified Bodies
expect a significant reduction of such products in the order of 25-50 %.
6.4.2.5.  Economic impact

Impact on cost competiveness 

Basic ear plugs and basic ear muffs are
homogeneous products. Production is typically in large volumes, and part of the
production has been offshored to the Far East. Often quality control systems
are in place. A move to category III would therefore not entail high costs. The
annual product or production process control costs would have to be borne. The
costs of EC type-examination (for new products) and annual product testing by
Notified Bodies could be relatively low for ear plugs and basic ear muffs as
these products are not so complex to test (a few thousand Euros per product
series). Moreover, the costs can be split over a large volume of production,
such that per unit costs would not increase much. Whilst the additional costs
per product series may be in the order of a few hundred to a few thousand euros
annually at maximum for manufacturers with established quality control systems,
the costs of starting from zero in terms of setting up quality control systems
could be a factor of ten higher.
Complex ear muffs or plugs are integrated solutions
for combinations of head, breathing, and hearing protection. In addition
electronic communication devices are often integrated. These products involve
more complex technology and are typically produced in smaller quantities, or can
even be customized to a considerable degree. The market for such products is
developing relatively fast. The cost structure is different for these products,
as it is driven more by innovation and high-skilled labour costs. Although the production
scale of individual items is smaller most firms in this segment of the market are
still large manufacturers. The extra costs of annual audits would be small
relative to the production value. Quality control systems in large firms can be
expected to be in place, especially if basic ear muffs are also produced.
Price increases to compensate for the cost
effect of the amendment are not expected, at least not in the short run. For
large EU manufacturers, the cost increase per unit is expected to be (very)
small. Smaller firms may face relatively higher initial costs to set up quality
control systems. Price setting by the dominant firms in the market determines
pricing of the smaller players. The amendment may result in cost increases due
to annual conformity assessment for these products, which would, in turn,
reduce the variations in product quality and prices.

Impact on the capacity to innovate

The impact on innovation differs somewhat
across the market segments of hearing protection products that are affected.
Ear plugs are less complex products than ear muffs, and involve less
innovation. No substantial impact on innovation is expected for ear plugs, ear
plug technology has not changed much over time. The large volumes of production
imply that additional costs of category III type approval and quality assurance
for new products only result in a small expected unit cost increase for any new
or improved products.
The development of product quality
standards has been a spur to innovation in the EU in various sectors of PPE. In
ear muffs, a more consistent monitoring of quality under Category III can
create a further focus on innovation. Innovation is a key to competitiveness
for this segment. Production monitoring by the Notified Body via annual
production site visits does not pose additional annual costs for new products.

Impact on international competitiveness

The impact on international competitiveness
entails some positive and some negative aspects. Positive effects include the
incentive to attain consistent levels of product quality and homogeneity in the
production process, for which EU manufacturers are better positioned. Annual
checks by Notified Bodies already help to increase compliance. The cost and
possibly price increases resulting from the change in PPE category imply,
however, that the need to keep products that do not ensure an adequate level of
protection off the market becomes even more important to ensure fair
competition. 
Most of the production of ear plugs and
basic ear muffs has been offshored to the Far East (e.g. China). The main
reasons for offshoring are labour costs and materials costs. EC type-examination
and annual monitoring are in general more expensive if production sites are
located outside the EU, due to travel costs and the availability of testing
houses. If anything, the consequence would be that offshoring becomes somewhat
less attractive. As long as products are relatively basic, and large volumes of
production are needed, quality of production can be sufficiently assured in
offshore production sites. The larger firms have centralized testing facilities
to check product quality across production sites. The more complex and
customized products are still manufactured in Europe, and, relatively more
often, by smaller companies that serve a more local market. It involves more
high-skilled labour inputs per unit produced. For all of these reasons offshoring
has not been such an attractive option so far in this segment.
A shift to category III would imply more
costs for manufacturers that do not have an EU-base where superior levels of
knowledge of the procedures and requirements of annual sample testing or
monitoring of production might reasonably be anticipated. 

Impact on SMEs

Where quality control systems are not in
place, their establishments involve fixed costs. The studies available do not
provide data about the share of SMEs having created or not quality control
systems. The impact on total costs and unit costs of creating such systems can
be more substantial for this group of companies. SMEs are more common in the
segment of complex, integrated hearing protection products, especially for
highly specialized communication muffs. More complex products will be more
likely to follow product standards that have a focus on product quality
aspects. However, this does not necessarily mean that all or a majority of SMEs
have created already quality control systems.
              Bullet-resistant
and knife stab-resistant PPE
Overall for these products the results of
consultations indicate that the move from category II to category III is seen
as a good, logical and important step. Related to this the European Safety
Federation for example stated in its position paper that it agreed that these
types of PPE should be classified as category III as these clearly provide protection
against the risk of fatalities. This was backed up by the interviews carried
out.
6.4.2.6.  Social impact
The move to category III will have only a
minor effect on the proportion of products on the market that do not ensure an
adequate level of protection. The main reason for this is the already existing high
quality of these products on the market. Nevertheless Notified Bodies expect a
reduction of products that do not ensure an adequate level of protection in the
order of 10 %.
6.4.2.7.  Economic impact

Impact on cost competiveness 

The amendment is expected to have a limited
impact on the cost competitiveness of the EU companies. The cost structure of
the vests is not entirely clear, but the high-tech fibres and fabrics and the
specialised garment making form the main inputs for these capital intensive
products. Furthermore most of the manufacturers of these vests already have a
system in place which fulfils the category III requirements or they can fulfil
the requirements with limited extra efforts. The most important clients
(50%-60% of market sales) are the defence industry and public servants involved
in the maintenance of law and order. These clients often work with tender
procedures where quality is an important element. Although PPE designed and
manufactured specifically for use by the armed forces or in the maintenance of
law and order are not covered by the PPE Directive, these products have to
satisfy very strict product quality and safety norms. Many producers,
therefore, have quality assurance procedures in place or are certified for
specific standards (e.g. ISO 9001) which then become the starting point for
the annual quality assurance monitoring by Notified Bodies for those products that
are subject to the PPE Directive. Their products and production processes
satisfy category III-equivalent levels of requirements (i.e. the basic
infrastructure and knowledge is already there). As a result, it is expected
that the effect on the costs (including compliance costs) and prices of the
products is very limited. Exceptions to this general assessment are those (usually
small) enterprises which do not have a proper quality system in place yet. 

Impact on the capacity to innovate  

The proposed move to category III has a
very limited effect on the capacity to innovate for companies in this segment.
For these types of PPE, the innovation mainly results from investments in
research and development (R&D), public procurement procedures (with
specific requirements) and existing standards. The additional quality control
process will not hinder and/or encourage these innovation processes (e.g. in
terms of market launch delay, lack of incentives, etc.). In very many of public
procurement procedures these kinds of quality control processes are already
required (and, indeed, already in place). 

Impact on international competitiveness

The expected impact of the amendment on international
competitiveness is considered neutral and/or limited. The amendment is expected
to have practically no impact on the EU as a production base or on the relocation
of production. This type of PPE requires high-tech inputs and a capital
intensive production process (fibres, fabrics, garments). Production is mainly
based in the EU and is expected to remain there. High quality fibres, fabrics
and garments are essential for the level of protection and to maintain the
trust of the main clients. Assembling work (e.g. stitching) is already done in
Romania, Bulgaria or outside the EU (North-Africa, Turkey, etc.). This
situation will not be influenced by the prospective amendments to the PPE
legislation. 
The amendment is expected to have a limited
effect on the competitiveness of EU companies in international or domestic
markets. The biggest markets, the US and EU, are already distinctly separate in
nature and it is often difficult to access alternative markets, either for
regulatory (lack of harmonised standards, specific US Army regulations) or for
practical reasons (e.g. scattered presence of end-users, the place of the zip,
etc.). The move from category II to category III will not influence this
situation.

Impact on SMEs

As indicated above the amendment will have
limited impact on manufacturers which already have a quality control system in
place. Within this segment the leading manufacturers are often medium sized
enterprises. Micro sized (< 10 employees) or small sized enterprises (<
50 employees) will tend, especially, to be confronted with additional costs as
they are not always already (e.g. ISO 9001) certified. It is unclear how
many (small sized) enterprises will be affected by this but stakeholders expect
that it is only a limited number.
              Protection
against cutting by hand-held chain saws
The overall opinion of the stakeholders
indicates that the move from category II to category III for this type of PPE
is seen as a logical step. It is established beyond doubt that this type of PPE
provides protection against irreversible harm to the health of the user or
worse. The proposed move to category III was backed by a large majority in the public
consultation (49 replies in favour against 5 not in favour).
6.4.2.8.  Social impact
Manufacturers and Notified Bodies estimate that
between 5 % and 20 % of the products on the market do not ensure an
adequate level of protection. Whereas manufacturers would not expect a change in
this proportion, Notified Bodies expect a large reduction of such products in
the order of 50 %. Taking an average of these it can be said that the move
to category III will have a small effect on the proportion of products on the
market that do not ensure an adequate level of protection. 
6.4.2.9.  Economic impact
The interviews point towards a low impact
on manufacturer costs from a reclassification of equipment to protect against
cutting by hand-held chain saws. A majority of those who responded to the
public consultation thought that very modest or no additional costs would occur
with the proposed modification.
              Protection
against high pressure cutting
There also seems to be a logical case for
moving PPE protecting against high pressure cutting into category III. As with PPE
protecting against cutting by hand held chain saws this PPE protects against
irreversible harm to the health of the user. Consequently a majority of replies
to the public consultation agreed with the proposed modification (31 replies in
favour with 10 against).
6.4.2.10.          Social impact
The Notified Bodies expect a significant reduction
(in the order of 25-50 %) of products on the market that do not ensure an
adequate level of protection. On the other hand market surveillance authorities
as well as manufacturers, do not expect a perceptible effect. Taking an average
of these it can be said that the move to category III will have a small effect.

6.4.2.11.          Economic impact
The public consultation indicated a large
majority estimating either very modest or no additional costs at all for the
manufacturers from the proposed modification. This estimate was confirmed
through the interviews that also foresaw only marginal additional costs for the
manufacturers.
6.4.3.     Requirements
The results of the interviews and
consultations suggest that the proposed requirement changes will lead to
marginal incremental costs for producers. These costs are offset by a variety
of effects on health (either through reduced likelihood that a product does not
ensure an adequate level of protection or through greater use of the product). Table
1 summarises the costs and benefits of the proposed changes.
Table
1: Summary of costs and
benefits of the proposed changes to the requirements of the PPE legislation
 Requirement change || Cost to current manufacturers || Certainty of health impact 
 Technical file || Marginal || Insufficient data 
 Validity of EC type-examination certificate || Insufficient data || Medium 
 EC Declaration of conformity || Marginal || Medium 
In all interviews the importance of
efficient market surveillance was stressed. The following proposed changes that
are being assessed support the work of the market surveillance authorities and
are seen by the stakeholders as an important tool to increase their efficiency.
              Technical file
6.4.3.1.  Social impact
In particular the market surveillance
authorities see an advantage with the proposed change to require the technical
file for category I PPE. This will facilitate the first assessment of these
products and will increase the efficiency of the work of the authorities. The
public consultation supports this option. A majority of 37 respondents agreed
that the proposed change would facilitate market surveillance whereas only 10
respondents disagreed. The interviewees could not offer firm figures but the
public consultation envisages, as a consequence, a reduction of the proportion
of products on the market that do not ensure an adequate level of protection in
the order of 1-10 %. Apart from this the proposed change will help to improve
legal certainty.
6.4.3.2.  Economic impact
The interviews suggest that the cost of
implementing this change will be marginal as manufacturers already have
internal production control in place and could easily provide this technical
documentation. This is supported by the result of the public consultation that expects
either very modest or no additional costs and/or administrative burdens for the
manufacturers.
              Validity and content of the
EC type-examination certificate
6.4.3.3.  Social impact
There was support from all types of
interviewees, as well as from the majority of the responders of the public
consultation, for the proposed time-limitation of the validity of the
certificate to five years. That would reduce the number of products that do not
ensure an adequate level of protection by ensuring that older products were
assessed more regularly. The market surveillance authorities as well as the
Notified Bodies expect a reduction in the order of 10-25 %.
The proposed change to introduce
requirements for a minimum content of the EC type-examination certificates will
support market surveillance authorities in identifying and acting upon the
relevant information in the certificate. The results of the public consultation
support this change with a huge majority (71 in favour, 2 against). Direct benefits
to health and safety are probably more marginal and limited to an increase in the
efficiency and effectiveness of the market surveillance function.
This proposed change on the EC type-examination
certificate would indisputably enhance legal certainty.
6.4.3.4.  Economic impact
The interviews did not give values for the
cost connected to any time-limitation of the certificates. In order to limit
the additional burden of the manufacturers for re-certification of their product
after the expiry of the certificate the proposal will provide for a
"light" procedure. Thus, where neither the product nor the relevant
harmonised standard has undergone a substantial change the applied procedure to
gaining a new certificate will be reduced compared to a new request for EC
type-examination.
The cost of a mandatory minimum content
will be negligible as the Notified Bodies, although having to use a different
format for their examination certificates, should be dealing with roughly the
same content. Provided that the change is only enacted for new certificates,
the costs would mainly be concentrated on the drafting process of the common
format
              EC Declaration of Conformity
(DoC)
6.4.3.5.  Social impact
The proposed requirement to supply the
Declaration of Conformity with the PPE has the aim to support the work of the market
surveillance authorities. With easier access to the data of the manufacturer
their work will be more efficient. The resulted reduction of products on the
market that do not ensure an adequate level of protection is expected to be in
the order of 10-25 % by the authorities and in the order of 25-50 %
by the Notified Bodies. The public consultation saw precisely as many replies
in favour as against this proposal. A majority of those respondents who were in
favour expected a reduction in the order of 5-15 %.
6.4.3.6.  Economic impact
Both the interviews and the public
consultation point towards very modest or no additional costs and
administrative burdens for the manufacturers as the result of the proposed
change. One manufacturer of PPE to protect against high pressure cutting felt
that the mandatory supply of the Declaration of conformity would actually save
money as his clients often require this document to be sent to them. Some
manufacturers have raised objections against this change. In their opinion this
will lead to extra costs for the manufacturers and extra burden for the
environment. But they welcomed the Commission proposal
to provide for a simplified Declaration of Conformity. A simplified DoC
consists only of one sentence in the printed user information supplied with the
PPE, which declares the compliance with the PPE legislation. It shall be
immediately followed by the exact internet or E-mail address where the full EC Declaration
of Conformity can be obtained. This solution will reach both aims to support
the authorities and to minimise the additional burden of the manufacturers.
              Basic Health and Safety
Requirements (BHSR)
The objective of all three changes to the
BHSR is to remove aspects from the Directive that do not contribute to health
and safety. Either:
–                        
the requirement is not deemed to be reasonable[48] (BHSR 3.1.3, limit
values in case of mechanical vibration) or 
–                        
the manufacturer in principle cannot fulfil the
requirement (BHSR 3.5, comfort index that is not established and consequently
cannot be measured) or
–                        
the consequences of the requirement are deemed
to be confusing for the user of the PPE (BHSR 3.9.1, indicating a transmission
curve in case of PPE against non-ionizing radiation).
Overall the impact of all the above changes
should be positive as no negative health and safety impacts can be expected
given that non-compliance with these requirements cannot be proven at present
and, in addition, their removal will lower the costs of producers and Notified
Bodies who have hitherto been required to prove that they fulfil them. Those who
responded to the public consultation confirm all three proposals with a large
majority and in particular do not expect any substantial increase in prices of
PPE due to the replacing of the requirement for information on the "transmission
curve" with that on the "protection factor" in case of BHSR
3.9.1.
6.5.        Mitigation measures
The in depth analysis has revealed that
costs related to the annual monitoring of the production process will result in
an additional burden especially for SMEs. In order to alleviate those,
different mitigating measures have been analysed. 
Exempting SMEs from the proposed changes in
the PPE legislation is not a viable option for the following reasons. As
mentioned in chapter 2.2.5 a large percentage of PPE manufacturers are SMEs. An
exemption would result in a much lower improvement of the health and safety of
the users than intended by the revision of the legislation. Only limited number
of products placed on the market by larger companies would be improved. Since
the PPE sector is part of the health and safety field such an outcome is
undesirable. Furthermore it is likely that an exemption for SMEs could create a
boomerang effect: the products placed on the market by SMEs would have a lower
level of safety compared to the products sold by large manufactures. This being
known to the consumers could have impact on their purchase choices and
preference for products providing higher level of protection, i.e. those sold
by large manufacturers.
However, as most of the burdens to SMEs
will originate from enhanced conformity assessment procedures, these burdens
can be reduced to a reasonable dimension. The revised legislation could provide
for mitigating measures for SMEs when making use of the service of a Notified
Bodies. There could be obligations for Notified Bodies to carry out the
conformity assessment in a proportionate manner. The NBs have to adapt their
activities to the size and structure of the manufacturer in order to reduce
unnecessary burdens.
7.           Comparing the options 
On the basis of the qualitative and in
depth assessment done in chapter 6 the following conclusions are made for comparing
the options (see Table 2). The magnitude of each impact is assessed according
to the following scale:
++        significant positive impact
+          minor positive impact
0          no impact / baseline
-           minor negative impact
--          significant negative impact
The preferred options for each proposed
change are highlighted in grey colour.
Table
2:
Comparing the options for the proposed change, the preferred options are
highlighted in grey colour
   || Effectiveness || Efficiency Costs                    Benefits || Coherence 
 Product coverage 
 Do nothing || 0 || 0 || 0 || 0 
 Soft law || +/- Specific objectives partly met (health and safety improved so to some extent; but unclear legal situation remains) || - costs for making products compliant (assuming that not 100% of manufacturers will comply if they do not need to do so) || + Slight reduction of non-compliant products (not all manufacturers will be reached) || + Will partly contribute to better regulation and Single Market Act; but unclear legal situation 
 Legislative measure || ++ Specific objectives fully met (improvement of health and safety; clear legal situation).  The legislative option will allow that products that today do not ensure an adequate level of protection will need to comply with higher safety requirements and therefore become reliable to consumers and contribute to reduce the number of accidents.  A more effective consumer protection will be ensured. || -- costs for making products compliant (all manufacturers obliged to comply) || ++ The highest reduction of non-compliant products (all manufacturers will be obliged to comply) || ++ Will optimally contribute to better regulation and Single Market Act; clear legal situation 
 Conformity assessment 
 Do nothing || 0 || 0 || 0 || 0 
 Soft law || + Specific objectives partly met (consistency of conformity assessment procedures not fully reached; some improvement of the quality of the relevant products) || - costs for establishing production control (assuming that not 100% of manufacturers will comply if they do not need to do so) || + Some reduction of non-compliant products (only voluntary measure) || + Will contribute to better regulation and Single Market Act; but unclear legal situation 
 Legislative measure || ++ Specific objectives fully met (consistency of conformity assessment procedures; most increment of the quality of the relevant products; clear legal situation).  The legislative option is the one that can ensure a consistent high quality of conformity assessment activities and the resulting reliability. || -- costs for establishing production control (all manufacturers obliged to comply) || ++ The highest reduction of non-compliant products (all manufacturers will be obliged) || ++ Will optimally contribute to better regulation and Single Market Act; clear legal situation 
 Technical file 
 Do nothing || 0 || 0 || 0 || 0 
 Soft law || +/- Specific objectives partly met (partial improvement of market surveillance work; but unclear legal situation) || - costs related to drawing up the technical file (for those applying voluntary schemes) || + Some reduction of non-compliant products (only voluntary) || + Will contribute to better regulation; but unclear legal situation 
 Legislative measure || ++ Specific objectives fully met (best improvement of market surveillance work; clear legal situation).  The effectiveness of ensuring compliance with legal requirements will be enhanced. || -- costs drawing up the technical file (for all) || ++ The highest reduction of non-compliant products (all manufacturers will be obliged) || ++ Will optimally contribute to better regulation; clear legal situation 
 Validity and content of EC type-examination certificate 
 Do nothing || 0 || 0 || 0 || 0 
 Soft law || +/- Specific objectives partly met (consistency of conformity assessment procedures not fully reached; partial improvement of market surveillance work; but unclear legal situation) || - costs for re-certification (for those applying voluntary schemes) || + Some reduction of non-compliant products (only voluntary) || + Will contribute to better regulation; but unclear legal situation 
 Legislative measure || ++ Specific objectives fully met (consistency of conformity assessment procedures; best improvement of market surveillance work; clear legal situation) || -- costs for re-certification (for all) || ++ The highest reduction of non-compliant products (all manufacturers will be obliged) || ++ Will optimally contribute to better regulation; requirement is coherent to other New Approach directives; clear legal situation 
 EC Declaration of Conformity (DoC) 
 Do nothing || 0 || 0 || 0 || 0 
 Soft law || + Specific objectives partly met (partial improvement of market surveillance work; but unclear legal situation) || - costs for printing the DoC for each item sold (for those applying voluntary schemes) || + Some reduction of non-compliant products (only voluntary) || + Will contribute to better regulation; but unclear legal situation 
 Legislative measure || ++ Specific objectives fully met (best improvement of market surveillance work; clear legal situation) || -- costs for printing the DoC for each item sold (for all) || ++ The highest reduction of non-compliant products (all manufacturers will be obliged) || ++ Will optimally contribute to better regulation; requirement is coherent to other New Approach directives; clear legal situation 
 Basic Health and Safety Requirements (BHSR) 
 Do nothing || 0 || 0 || 0 || 0 
 Soft law || +/- Specific objectives partly met (simplification only through Guidance; unclear legal situation) || 0 no costs due to the deletion of parts of the BHSR || 0 No effective change of the health and safety level due to the deletion of parts of the BHSR || + Will contribute to simplification of regulation; but unclear legal situation 
 Legislative measure || ++ Specific objectives fully met (simplification of the legislation; practicable Directive's requirements; clear legal situation) || 0 no costs due to the deletion of parts of the BHSR || 0 No effective change of the health and safety level due to the deletion of parts of the BHSR || ++ Will optimally contribute to simplification of regulation; clear legal situation 
8.           Monitoring and evaluation 
In order to improve
the basis for monitoring and evaluation of the effectiveness of the PPE
legislation, a systematic reporting on accidents with PPE involved will be
required within the various cooperation mechanisms already established. Those
involve in particular the following established groups:
–                        
PPE  Working group;
–                        
PPE Administrative Cooperation group (AdCo);
–                        
Horizontal Coordination of the Notified Bodies
in the field of PPE.
In all of these groups a standing agenda
item will be established for reporting on products that do not ensure an
adequate level of protection and related accidents and Member States, Notified
Bodies as well as other stakeholder will be asked to report.
Additional feedback will be obtained from
the new or expanded cooperation and information exchange mechanisms provided
for by NLF Regulation 765/2008.
The monitoring of the reduction of products
that do not ensure an adequate level of protection will be possible via the
following indicators:
–                        
Number of products checked;
–                        
Number of products that do not ensure an
adequate level of protection among those checked;
–                        
Type of problems found.
These enforcement indicators will be based
on information provided by the market surveillance authorities via
–                        
the RAPEX[49] system;
–                        
a general database established under Article 23
of the NLF Regulation 765/2008 for the exchange of information among the Member
States on market surveillance activities and products that do not ensure an
adequate level of protection (ICSMS);
–                        
the safeguard clause notification procedures.
Non-compliance will also be detectable through
complaints addressed to the Commission. 
In line with its "Smart
regulation" policy[50]
the Commission will evaluate the effectiveness of the revised PPE legislation
within a period of five up to a maximum of 10 years after the date of
application of the revised legislation, basing itself on the feedback obtained
from the mechanisms set out above. Should specific circumstance so require, the
Commission will ask for an external evaluation.
9.           Choice
of the legal instrument
In line with the Commission policy to
simplify the regulatory environment, it is proposed to change the Directive
into a Regulation.
The use of a Regulation does not conflict
with the subsidiarity principle. As outlined in chapter 3.4, this legislation
is based on Article 114 TFEU with the objective of ensuring the proper
functioning of the internal market for personal protective equipment. To
achieve this objective, the PPE directive is a total harmonisation directive.
Member States are not allowed to impose more stringent or additional
requirements in their national legislation for the placing on the market of
PPE. In particular, the mandatory essential health and safety requirements for
products and the conformity assessment procedures to be followed by
manufacturers must be identical in all of the Member States. Given this level
of harmonisation, which is necessary to avoid obstacles to the free movement of
PPE, Member States have almost no flexibility in transposing the Directive into
their national law and its content is in many cases reproduced word for word in
the national transposition legislation.
The same applies to the new provisions that
will be integrated into the text following the alignment to the NLF Decision No
768/2008/EC. These provisions lay down requirements, obligations and procedures
for the manufacturers, importers and distributors of PPE and for the notified
bodies that carry out the conformity assessment procedures. All of these
provisions are clear and sufficiently precise to be applied directly by the
actors concerned.
The obligations set by the legislation for
the Member States, such as the obligation to assess, appoint and notify the
conformity assessment bodies are, in any case, not transposed as such into
national law but implemented by the Member States by means of the necessary
regulatory and administrative arrangements. This will not change when the
obligations concerned are set out in a Regulation. 
The change from a Directive to a Regulation
will not lead to any change in the regulatory approach. The characteristics of
the New Approach will be fully preserved, in particular the flexibility given
to manufacturers in the choice of the means employed to comply with the
essential requirements (harmonised standards or other technical specifications)
and in the choice of the procedure used to demonstrate compliance from among
the available conformity assessment procedures. The existing mechanisms
supporting the implementation of the legislation (standardisation process,
working groups, market surveillance, administrative cooperation (ADCO), the
development of guidance documents…) will not be affected by the nature of the
legal instrument and will continue to operate in the same manner under the
Regulation as they currently do under the Directive.
Stakeholder views:
On a general level, industry associations[51] have expressed their preference
for using Regulations in the area of internal market legislation, for two
reasons: first, the risk of ‘gold plating’ is avoided and second, it allows
manufacturers to work directly with the Regulation text instead of needing to
identify and examine 28 transposition laws. 
There is no uniform position of Member
States on this issue. While some see benefits in terms of saving transposition
costs, other point out that, despite the direct applicability of a Regulation,
certain national implementation measures (e.g. relating to enforcement) and
modifications of existing national legislation are necessary.
Summing up, it is considered that the use
of a Regulation will be beneficial for the sector. It will avoid the costs for
the Member States associated with the transposition of a Directive. It will
allow for a more rapid application of the new legislation and will help
economic operators to conduct their business as they will have to deal with a
single regulatory instrument rather than with 28 national laws transposing a
Directive.
              Annex 1: Article 11 of the PPE Directive
Article 11
A.        ‘EC’ quality control system
for the final product
1. A manufacturer shall take all steps
necessary to ensure that the manufacturing process, including the final
inspection of PPE and tests, ensures the homogeneity of production and the
conformity of PPE with the type described in the EC type-approval certificate
and with the relevant basic requirements of this Directive.
2.         A body of which notification has
been given, chosen by a manufacturer, shall carry out the necessary checks.
Those checks shall be carried out at random, normally at intervals of at least
one year.
3.         An adequate sample of PPE taken
by the body of which notification has been given shall be examined and
appropriate tests defined in the harmonized standards or necessary to show
conformity to the basic requirements of this Directive shall be carried out to
check the conformity of PPE.
4.         Where a body is not the body
that issued the relevant EC type-approval certificate it shall contact the body
of which notification has been given in the event of difficulties in connection
with the assessment of the conformity of samples.
5.         The body of which notification
has been given shall provide the manufacturer with a test report. If the report
concludes that production is not homogeneous or that the PPE examined do not
conform to the type described in the EC type-approval certificate or the
relevant basic requirements, the body shall take measures appropriate to the
nature of the fault or faults recorded and inform the Member State which gave
notification thereof accordingly.
6.         The manufacturer must be able to
present, on request, the report of the body of which notification has been
given.
B.        System for ensuring EC quality
of production by means of monitoring
1.         The system
(a)                   
Under this procedure the manufacturer submits an
application for the approval of his quality-control system to a body of which
notification has been given, of his choice.
That application shall include:
–              
all the information relating to the category of
PPE concerned, including, where appropriate, documentation relating to the
model approved,
–              
documentation on the quality-control system,
–              
the undertaking to maintain the obligations
arising from the quality-control system and to maintain its adequacy and
efficiency.
(b)                   
Under the quality-control system, each PPE shall
be examined and the appropriate tests referred to in Section A paragraph 3 shall
be carried out to check their conformity to the relevant basic requirements of
this Directive.
The documentation on the quality-control system shall in particular include an
adequate description of:
–              
the quality objectives, the organization chart,
the responsibilities of executives and their powers in respect of product
quality,
–              
the checks and tests which must be carried out
after manufacture,
–              
the means to be employed to check the efficient
operation of the quality-control system.
(c)                   
The body shall assess the quality-control system
to determine whether it satisfies the provisions referred to in paragraph 1
(b). It shall assume that quality-control systems applying the relevant
harmonized standard satisfy those provisions.
The body carrying out audits shall make all necessary objective evaluations of
the components of the quality-control system and shall check in particular
whether the system ensures conformity of PPE manufactured with the approved
model.
The decision shall be communicated to the manufacturer. It shall include the
conclusions of the check and the reasoned assessment decision.
(d)                  
The manufacturer shall inform the body which
approved the quality-control system of any plan to alter the quality-control
system.
The body shall examine the proposed changes and decide whether the altered
quality-control system satisfies the relevant provisions. It shall communicate
its decision to the manufacturer. The communication shall include the
conclusions of the check and the reasoned assessment decision.
2.         Supervision
(e)                   
The purpose of supervision is to ensure that a
manufacturer correctly fulfils the obligations arising from the approved
quality-control system.
(f)                    
The manufacturer shall authorize the body to
have access, for purposes of inspection, to PPE inspection, testing and storage
sites and shall provide the body with all requisite information, in particular:
–              
documentation on the quality-control system,
–              
technical documentation,
–              
quality control manuals.
(g)                   
The body shall periodically carry out audits to
ensure that the manufacturer is maintaining and applying the approved
quality-control system and shall provide the manufacturer with a copy of the
audit report.
(h)                   
In addition, the body may make unannounced
visits to the manufacturer. In the course of such visits the body shall provide
the manufacturer with a report of the visit and, if appropriate, with an audit
report.
The manufacturer must be able to present,
on request, the report of the body of which notification has been given.
              Annex 2: Relevant parts from the ANNEX II of the PPE
Directive
ANNEX
II (of 89/686/EEC)
BASIC
HEALTH AND SAFETY REQUIREMENTS
1.         GENERAL REQUIREMENTS APPLICABLE
TO ALL PPE
PPE must provide adequate protection
against all risks encountered.
…
1.4.      Information supplied by the
manufacturer
In addition to the name and address of the
manufacturer and/or his authorized representative established in the Community,
the notes that must be drawn up by the former and supplied when PPE is placed
on the market must contain all relevant information on:
(i)                     
storage, use, cleaning, maintenance, servicing
and disinfection. Cleaning, maintenance or disinfectant products recommended by
manufacturers must have no adverse effect on PPE or users when applied in
accordance with the relevant instructions;
(j)                     
performance as recorded during technical tests
to check the levels or classes of protection provided by the PPE in question;
(k)                   
suitable PPE accessories and the characteristics
of appropriate spare parts;
(l)                     
the classes of protection appropriate to
different levels of risk and the corresponding limits of use;
(m)                 
the obsolescence deadline or period of
obsolescence of PPE or certain of its components;
(n)                   
the type of packaging suitable for transport;
(o)                   
the significance of any markings (see 2.12).
(p)                   
where appropriate, the references of the Directives
applied in accordance with Article 5 (6) (b);
(q)                   
the name, address and identification number of
the notified body involved in the design stage of the PPE.
These notes, which must be precise and
comprehensible, must be provided at least in the official language(s) of the
Member State of destination.
…
3.         ADDITIONAL REQUIREMENTS SPECIFIC
TO PARTICULAR RISKS
3.1.      Protection against mechanical
impact
…
3.1.3.   Mechanical vibration
PPE designed to prevent the effects of
mechanical vibrations must be capable of ensuring adequate attenuation of
harmful vibration components for the part of the body at risk.
Under no circumstances must the effective
value of the accelerations transmitted to the user by those vibrations exceed
the limit values recommended in the light of the maximum foreseeable daily
exposure of the part of the body at risk.
…
3.5.      Protection against the harmful
effects of noise
PPE designed to prevent the harmful effects
of noise must be capable of attenuating the latter to such an extent that the
equivalent sound levels perceived by the user do not under any circumstances
exceed the daily limit values laid down by Council Directive 86/188/EEC of 12
May 1986 on the protection of workers from the risks related to exposure to
noise at work (OJ No L 137, 24.5.1986, p. 28).
All PPE must bear labelling indicating the
noise attenuation level and the value of the comfort index provided by the PPE;
should this not be possible, the labelling must be fixed to the packaging.
…
3.9.      Radiation protection
3.9.1.   Non-ionizing radiation
PPE designed to prevent acute or chronic
eye-damage from sources of non-ionizing radiation must be capable of absorbing
or reflecting the majority of the energy radiated in the harmful wavelengths
without unduly affecting the transmission of the innocuous part of the visible
spectrum, the perception of contrasts and the ability to distinguish colours
where required by the foreseeable conditions of use.
To this end, protective glasses must be so
designed and manufactured as to possess, for each harmful wave, a spectral
transmission factor such that the radiant-energy illumination density capable
of reaching the user's eye through the filter is minimized and, under no
circumstances, exceeds the maximum permissible exposure value.
Furthermore, the glasses must not
deteriorate or lose their properties as a result of the effects of radiation
emitted under the foreseeable conditions of use and all marketed specimens must
bear the protection-factor number corresponding to the spectral distribution
curve of their transmission factor.
Glasses suitable for radiation sources of
the same type must be classified in the ascending order of their protection
factors and the manufacturer's notes must indicate, in particular, the
transmission curves which make it possible to select the most appropriate PPE
bearing in mind such inherent factors of the effective conditions of use as
distance to source and the spectral distribution of the energy radiated at that
distance.
The
relevant protection-factor number must be marked on all specimens of filtering
glasses by the manufacturer.
              Annex
3: Definition of PPE of category III (exclusive and exhaustive list of PPE
covered by this category)
Article 8 
…
4. Production of PPE shall be subject: 
(a) according to the manufacturer's choice,
to one of the two procedures referred to in Article 11 in the case of PPE of
complex design intended to protect against mortal danger or against dangers
that may seriously and irreversibly harm the health, the immediate effects of which
the designer assumes the user cannot identify in sufficient time. This category
shall cover exclusively: 
–                        
filtering respiratory devices for protection
against solid and liquid aerosols or irritant, dangerous, toxic or radiotoxic
gases, 
–                        
respiratory protection devices providing full
insulation from the atmosphere, including those for use in diving, 
–                        
PPE providing only limited protection against
chemical attack or against ionizing radiation, 
–                        
emergency equipment for use in high-temperature
environments the effects of which are comparable to those of an air temperature
of 100 °C or more and which may or may not be characterized by the presence of
infra-red radiation, flames or the projection of large amounts of molten
material, 
–                        
emergency equipment for use in low-temperature
environments the effects of which are comparable to those of an air temperature
of -50 °C or less, 
–                        
PPE to protect against falls from a height, 
–                        
PPE against electrical risks and dangerous
voltages or that used as insulation in high-tension work,
[1]               The PPE Working group is chaired by the Commission
with the participation of the Member States and European stakeholders
(industrial associations, standardisation, Notified Bodies).
[2]               A
report on the results is available at http://ec.europa.eu/enterprise/sectors/mechanical/files/ppe/pc-report_en.pdf
[3]               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)
[4]               See http://ec.europa.eu/enterprise/sectors/mechanical/files/ppe/rev-study-competitiveness_en.pdf
[5]               For guidelines on the application of Directive
including explanations on the definition look at http://ec.europa.eu/enterprise/sectors/mechanical/files/ppe/ppe-guidelines_en.pdf
[6]               See http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2006:157:0024:0086:EN:PDF
[7]               See http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2006:374:0010:0019:EN:PDF
[8]               Mäkinen, ‘Protective clothing- nowadays and vision’,
article for the 3rd European Conference on Protective Clothing (ECPC) and
NOKOBETEF 8, may 2006.
[9]               These bodies are conformity assessment bodies, which
test, inspect and certify products. They are called "notified bodies"
because they are notified by the Member States to the Commission.
[10]             See Annex 2 of this document for the parts of ANNEX II
of the PPE Directive that are relevant for this impact assessment.
[11]             New Approach, see http://ec.europa.eu/enterprise/policies/single-market-goods/regulatory-policies-common-rules-for-products/new-approach/index_en.htm
[12]             New Legislative Framework for marketing of products:
see http://ec.europa.eu/enterprise/policies/single-market-goods/regulatory-policies-common-rules-for-products/new-legislative-framework/index_en.htm
[13]             BizAcumen Inc. (2009), report “Personal protective
equipment, A world market analysis”, November 2009
[14]             Matrix Insight Ltd, ‘Amendment of the PPE Directive –
study to support the European Commission’s impact assessment; Part 1’, December
2010, p. 13. This estimation is based on data from BizAcumen Inc., report ‘Personal
protective Equipment, a world market analysis’, November 2009. 
[15]             Ecorys, ‘Competitiveness of the European security
industry’ (including PPE), study for the European Commission, November 2009.
[16]             Ecroys, Interview with Euratex and European Safety
Federation (ESF) in autumn 2009.
[17]             In the report of the ‘Taskforce on protective
textiles’, composed in preparation of the Lead Market Communication, the size
of the total European market for PPE (in relation to textiles) was estimated at
€ 8 billion, of which 85% is covered by the EU15. The Report uses a definition
of PPE that covers ‘clothing and other often textile-based systems and accessories
whose main function it is to protect the user’. This definition is broader than
the legal definition given in Article 1 of Directive 89/686/EEC. Euratex
indicated to the study team that, for example, medical clothing and clean room
textiles were included in the report, while these do not fall under the
PPE-Directive. Further the Taskforce Report estimated (based on Euratex and
Eurostat data) that in 2006 the EU-25 market for textile industrial
applications was approximately € 39.4 billion, of which protective textiles was
one of the largest segments (20%). The Report also estimated that 200,000 jobs
are directly or indirectly linked to the PPE industry. The service operations
related to PPE (work wear and healthcare segments) account for € 1.5 – 2
billion turnover and 35.000- 40.000 employees.
[18]             European Commission, Report of the Taskforce on
Protective Textiles: ‘Accelerating the development of the protective textiles
market in Europe’, composed in preparation with COM (2007) 860 on 'A Lead
Market Initiative for Europe'.
[19]             Textiles Intelligence, Editorial: Europe’s Research
Roadmap for new PPE, May 2009.
[20]             Ecorys, ‘Competitiveness Proofing – Personal Protective
Equipment (PPE) Industry, study for the European Commission, August 2012:
Initial and partial assessment made by the study team would suggest that this
figure underestimates the size of the sector.
[21]             Frost & Sullivan, ‘Personal Protective Equipment in
Western Europe provides Growth opportunities for technical textiles’, press
release June 2005.
[22]             Source: International Monetary Fund 2010
[23]             See chapter 4.3 of http://ec.europa.eu/enterprise/sectors/mechanical/files/ppe/rev-study-assess-part1_en.pdf

[24]             BizAcumen Inc. (2009), report “Personal protective
equipment, A world market analysis”, November 2009
[25]             http://ec.europa.eu/enterprise/policies/single-market-goods/documents/new-legislative-framework/index_en.htm
[26]             Laboratories and certification or inspection bodies delivering
certificates which are notified to the Commission by Member States.
[27]             Regulation (EC) No 765/2008 of the
European Parliament and of the Council of 9 July 2008 setting out the
requirements for accreditation and market surveillance relating to the
marketing of products and repealing Regulation (EEC) No 339/93, OJ L 218, 13.8.2008, p. 30;
See http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2008:218:0030:0047:EN:PDF
[28]             Accreditation is a tool for the control of the
competence of laboratories and certification/inspection bodies delivering
certificates in the EU
[29]             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 L218,
13.8.2008, p.82.
See http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2008:218:0082:0128:EN:PDF
[30]             Article 2 of Decision 768/2008 reads: "Subject
matter and scope: This Decision sets out the common framework of
general principles and reference provisions for the drawing up of Community
legislation harmonising the conditions for the marketing of products
("Community harmonisation legislation"). Community harmonisation
legislation shall have recourse to the general principles set out in this
Decision and to the relevant reference provisions of Annexes I, II
and III. However, Community legislation may depart from those general
principles and reference provisions if that is appropriate on account of the
specificities of the sector concerned, especially if comprehensive legal
systems are already in place". 
[31]             See SEC 2007(173)
http://ec.europa.eu/governance/impact/ia_carried_out/docs/ia_2007/sec_2007_0173_en.pdf
[32]             These products have either been subject of safeguard
clause notifications from Member States to the Commission or formal objections
against harmonised standards.
[33]             These "Technical sheets for coordination"
report the common position of the Notified Bodies. The topics range from the
interpretation of provisions of the Directive to practical problems as
encountered by NB. It is expected that all NBs stick to the common positions as
published.
[34]             See Guide to application of the
directive 89/686/EEC on Personal Protective Equipment, Chapter I, point 1.1.5
available at http://ec.europa.eu/enterprise/sectors/mechanical/documents/guidance/personal-protective-equipment/chapter1/index_en.htm
[35]             See footnote 30
[36]             See SEC 2007(173) http://ec.europa.eu/governance/impact/ia_carried_out/docs/ia_2007/sec_2007_0173_en.pdf
[37]             GPSD, see
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2002:011:0004:0017:EN:PDF
[38]             See Annex 3 for the relevant text of the current PPE
Directive.
[39]             The technical file must comprise all relevant data on
the means used by the manufacturer to ensure that a PPE complies with the basic
requirements relating to it.
[40]             The transmission curve is the mathematical function or
graph that describes the transmission fraction of an optical or electronic
filter as a function of frequency or wavelength. It is a figure for the
properties of the used filter.
[41]             See http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:1989:393:0018:0028:EN:PDF
[42]             See http://ec.europa.eu/internal_market/strategy/index_en.htm
[43]             See Annex 3 for the relevant text of the current PPE
Directive.
[44]             See chapter 2.4.2 on p.18 of http://ec.europa.eu/enterprise/sectors/mechanical/files/ppe/rev-study-assess-part2_en.pdf
and chapter 1.2 on p.12 of http://ec.europa.eu/enterprise/sectors/mechanical/files/ppe/rev-study-competitiveness_en.pdf
[45]             ESF – an European association of manufacturers in the
field of PPE
[46]             See Annex 1.
[47]             SOLAS is the International Convention for the Safety
of Life at Sea, an international maritime safety
treaty. Life jackets intended to be used on sea-going vessels are excluded from
the PPE Directive. Nevertheless there can be manufacturers that have life
jackets for the use on sea-going vessels and for use as PPE in their portfolio.
[48]             See explanation to BHSR in chapter 3.3.1.
[49]             RAPEX is the EU rapid alert system for all dangerous
consumer and non-consumer harmonised products (see http://ec.europa.eu/consumers/dyna/rapex/rapex_archives_en.cfm).
[50]             http://ec.europa.eu/enterprise/policies/smart-regulation/index_en.htm
[51] E.g. ORGALIME Position paper on the reform of the internal market for
goods , 16 April 2013, http://www.orgalime.org/sites/default/files/position-papers/PP_Internal_Market_for_Industrial_Products_April13.pdf