COMMISSION STAFF WORKING DOCUMENT EXECUTIVE SUMMARY OF THE 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: health care, market supervision, marketing standard, personal effects, product safety, protective equipment, safety standard













EUR-Lex - 52014SC0119 - EN











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52014SC0119

COMMISSION STAFF WORKING DOCUMENT EXECUTIVE SUMMARY OF THE IMPACT ASSESSMENT Accompanying the document Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on personal protective equipment /* SWD/2014/0119 final */









COMMISSION STAFF WORKING DOCUMENT
EXECUTIVE SUMMARY OF THE IMPACT ASSESSMENT
Accompanying the document
Proposal for a 
REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
on personal protective equipment
Disclaimer: This executive summary 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.
1.           Problem Definition
Despite the successful functioning of PPE Directive
89/686/EEC, a broad consensus exists among the Member States and other
stakeholders that it needs some improvements. This does not involve major
changes; however, in light of the experience of the functioning of the
Directive, the input to the Public Consultation (2011) and the outcome of the Impact
Assessment Study (2010), the following issues will need to be addressed:
–                        
The alignment of the PPE Directive with the New
Legislative Framework (NLF);
–                        
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.
Problem 1: Alignment of the PPE
Directive with the NLF
Many of the general problems identified by
the NLF have also been observed in the context of implementing the PPE
Directive (PPE placed on the market that does not ensure an adequate level of
protection, problems with the quality of the services delivered by some
notified bodies, different practices in the Member States as regards the
evaluation and monitoring of notified bodies). A number of manufacturers are
also faced with the problem of the legal framework being complex and sometimes
inconsistent.
The alignment of the PPE Directive with the
NLF responds to the political commitment laid down in Article 2 of the NLF
Decision No. 768/2008.
The Impact Assessment Report on the
Alignment Package has already examined the different options to give effect to
the NLF Decision. Since the options are exactly the same for the PPE Directive,
this Impact Assessment Report will not examine these aspects.
Problem 2: The extension of the product
coverage of the PPE Directive
There are
products on the market that provide for a protective function to the user and
fit the definition of the PPE Directive but are not covered by this Directive. Consequently
these products are not subject to the safety and health requirements for PPE
and, as a result, the level of protection offered by such products is not as
high as for PPE. The consumer might believe that she/he is protected against a
specific risk when in fact she/he is not. Products protecting against heat,
damp and water designed for private use are explicitly excluded from the
Directive. However these types of products intended for professional use
are covered. Products that are outside the scope raise safety and health
problems. One Member State has identified 150 000 cases of burn at
home in the country per year. Half of these burns concern the hands.
The situation also
causes problems for the market surveillance authorities. 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.
Problem 3: The addition of some types of
PPE to the list of products subject to the most stringent conformity assessment
procedure
PPE is classified by the Directive into
three categories that are subject to different conformity assessment
procedures. The definitions of categories I and III are accompanied by lists
that describe the PPE covered by these categories.
The experience has shown that the list of PPE
subject to the most stringent conformity assessment procedure (i.e. PPE of
category III) misses PPE that fits the definition of category III, i.e. PPE
designed to protect against serious risks. As a consequence there are no
regular audits of the production process for this PPE. 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 this PPE.
The affected types of PPE are: life jackets,
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.
Problem 4: The change of three 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:
BHSR 3.1.3:   for protection against
mechanical vibration;
BHSR 3.5:      for protection against the
harmful effects of noise;
BHSR 3.9.1:   for protection against non-ionizing
radiation.
For these points the Directive sets out
requirements that are either not practicable or confusing for the user or it
was shown that it is not possible to fulfil. The manufacturers are faced
requirements that are known to be impracticable. The users are affected because
the information connected with the PPE is partial, may be irrelevant and may be
a potential source of confusion.
Problem 5: 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
The market surveillance authorities have to
deal with insufficient results of the requirements concerning the above mentioned
documents. Their work is hindered due to unclear or ineffective requirements in
the Directive for those documents even if their quality and completeness are
crucial for the assessment of the compliance of the PPE. Also the manufacturers
do not have a clear understanding of their responsibilities. Some requirements
for the documents do not reflect the change of the harmonised standards with
time and can follow to a potentially non-conformity of the PPE with the
Directive. Furthermore the authorities claim that there are problems to collect
documents necessary to assess the PPE.
Necessity for public intervention
The 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. This legislation does not however address the identified
problems effectively. The study carried out and the conclusions on the options
examined have shown that the problems will remain if the Directive is not
revised.
2.           Analysis of subsidiarity
The proper and effective functioning of the
internal market requires common rules for the design and placing on the market of
PPE in order to ensure both the free movement and the health protection and
safety of the user.
Actions taken at national level to address
the problems may create obstacles to the free movement of PPE. Any changes to
the scope, procedures or requirements must be carried out at EU level in order
to avoid distortions on the EU market.
In view of the increasing
internationalisation of trade, the number of cross-border cases is constantly
rising. Coordinated action at EU level can much better achieve the objectives
set, and will in particular render market surveillance more effective. Hence it
is more appropriate to take action at EU level.
3.           Objectives
The overall objectives of this initiative
are to better protect the health and safety of PPE users, create a fair level playing
field for PPE economic operators and simplify the European regulatory
environment in the field of PPE.
The more specific and operational policy
objectives are presented in Table 1 below.
Table 1: 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 
4.           Policy Options
Three alternative policy options have been considered
for each respective problem, i.e. 
–                        
the “do nothing” as baseline option; 
–                        
the “soft law” option as non-legislative
alternative consisting of issuing commonly agreed interpretation on the
application of the PPE Directive; and 
–                        
the “legislative” option included the change of
the legal text. 
The analysis of impacts of the above policy
options was separately carried out for each of the identified areas of
improvement.
5.           Assessment of Impacts
The qualitative analysis demonstrated that
for all the problem areas the legislative option is the preferred one. As all the
described problems are of regulatory nature 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 quantitative data available about PPE
and the PPE market is not enough accurate and detailed to provide a clear
picture about the market and about the relationship between the different PPE
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.
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. In the following section the outcome of the in-depth
analysis of the legislative option for each problem is presented.
Product coverage
The amendment will have a positive impact on the fairness of
competition, because self-certification will become mandatory.
Social impact: 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 PPE and the content of materials used. The general level
of information provided will be improved. Manufacturers as well as market
surveillance authorities expect a reduction of products that do not ensure an
adequate level of protection between 20% and 50%. No data was available to
assess the impact of including oven gloves as PPE. One Member State has identified 150 000 cases of burn at home in the country per
year. Half of these burns concern the hands.
Economic impact: The effect in terms of compliance and
administrative costs per product is small. These costs can be estimated to be
in the order of a few hundred euros per PPE series and will thus have a low
impact on costs per unit. 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. 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. With the amendment
such information should be traceable in the future which will improve the
conditions for fair and transparent competition. 
Conformity assessment
Social impact: The amendment could help to improve compliance of the above
mentioned types of PPE by introducing annual monitoring. It provides for extra
safeguards for product quality. Annual testing better ensures product and production
homogeneity and compliance to basic PPE requirements and relevant product
standards. The proportion of PPE with inadequate level of protection will be reduced.
The proportion of the reduction depends on the type of PPE and differs from
10 % up to 50 %.
Economic impact: A majority of respondents to the public consultation expect either very
modest compliance and administrative costs or none at all. Some respondents
expect higher costs. The main impact would be the need for annual monitoring of
the production process. If a quality control system has already been
implemented, the costs of adjusting the system for PPE category III audits
would be a one-off. Moreover, for most of the affected
PPE the costs can be split over a large volume of production, such that per
unit costs would not increase much. Positive effects on international
competitiveness include the incentive to attain consistent levels of product
quality and homogeneity in the production process, for which EU manufacturers
are better positioned.
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. Overall the impact of these 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.
Technical file, EC type-examination
certificate, EC Declaration of Conformity
Social impact: The stakeholders see an advantage with the proposed change as it
will either facilitate the assessment of this PPE and will increase the
effectiveness of their work or reduce the number of PPE that does not ensure an
adequate level of protection by ensuring that older PPE was assessed more
regularly. Depending on the type of PPE the stakeholders envisage a reduction
of products that do not ensure an adequate level of protection in the order of 1-25 %.
The proposed change will improve legal certainty.
Economic impact: The cost of implementing the changes will be marginal for the
technical file as manufacturers already have internal production control in
place and could easily provide this document. The same applies for the change
concerning the Declaration of Conformity. For the time-limitation of the
certificates the interviews did not give values for the connected costs. In
order to limit the additional burden of the manufacturers for re-certification
of their PPE the proposal will provide for a "light" procedure. The
cost of a mandatory minimum content of the certificate will be negligible as
the Notified Bodies should be dealing with roughly the same content.
6.           Comparison of Options
The comparison of the options based on the
outcome of the assessment of the options lead to the result that for all
problems the legislative measure delivers the most positive impact. For the
legislative option the specific objectives are fully met in providing for
improvement of the health and safety, legal certainty, consistency in the
requirements and the best improvement of the market surveillance work.
7.           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. In all
of the groups on PPE with Commission participation a standing agenda item will
be established for reporting on PPE 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.
Non-compliance will also be detectable
through complaints addressed to the Commission. 
8.           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. This legislation is based on Article 114 TFEU
with the objective of ensuring the proper functioning of the internal market
for PPE. To achieve this objective, the PPE Directive 89/686/EEC is a total
harmonisation directive. Member States are not allowed to impose more stringent
or additional requirements in their national legislation for the placing on the
market of PPE.
The use of Regulations in the area of
internal market legislation, allows, in accordance also with the preference
expressed by stakeholders, to avoid the risk of ‘gold plating’. It also allows
manufacturers to work directly with the Regulation text instead of needing to
identify and examine 28 transposition laws.
On this basis, it is considered that the
choice of a Regulation is the most appropriate solution for all involved
parties as it will allow a more rapid and coherent application of the proposed
legislation and will establish a clearer regulatory environment for economic
operators.