Commission staff working document accompanying the proposal for a Directive of the European Parliament and of the Council on the repeal of 8 metrology directives - Impact Assessment {COM(2008) 801 final} {SEC(2008)2909} {SEC(2008)2968}
Date: 2008-12-03
Institutions: European Commission
Subjects: approximation of laws, carrying capacity, cereals, marketing, measuring equipment, precision instrument, tanker, water supply, weights and measures

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COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 3.12.2008 
SEC(2008) 2910 

COMMISSION STAFF WORKING DOCUMENT 

Accompanying the  

Proposal for a Directive of the European Parliament and of the Council 

on the repeal of 8 metrology directives 

Impact Assessment 

{COM(2008) 801 final} 

{SEC(2008)2909} 

{SEC(2008)2968} 

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Lead DG: Enterprise and Industry 

Other involved services:  

Agenda  planning  or  WP  reference:  CWLP  2008/ENTR/015  -  measuring  instruments: 
Extension  of  the  scope  of  Directive  2004/22/EC  on  measuring  instruments  and  repeal  of  8 
"old approach" metrology Directives 

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.  Extension  of 
Directive 2004/22/EC and repeal of 8 Directives 

1. 

EXECUTIVE SUMMARY 

In the key issues document the Commission services presented three options: 

1. 

2. 

3. 

“Old approach” Directives exist next to national rules (current situation) 

Repeal of directives, no harmonisation, national rules continue to exist 

Harmonisation via the Measuring Instruments Directive and repeal of directives. 

From  the  public  consultation  and  an  external  study  it  appears  that  there  are  no  obstacles  to 
trade  in  the  6  sectors  covered  by  the  8  old  approach  directives.  It  is  also  apparent  that  the 
directives are less and less used and have not hampered technological advance. Where there is 
additional national legislation it apparently fully takes into account mutual recognition.  

Based on the assessment of impacts there is no option that stands out. As there are no barriers 
to trade, harmonisation does not have any benefit that cannot be achieved either by the market 
in an unregulated context or by national regulation based on international standards taking the 
concept  of  mutual  recognition  fully  into  account.  What  is  more,  a  substantial  number  of 
Member  States  have  indicated  that  they  will  opt-out  of  harmonisation  which  effectively 
compromises the very aim of harmonisation.  

For  reasons  of  simplification  and  subsidiarity,  therefore,  the  option  of  repeal  without 
reregulation could be deemed the most appropriate.  

2. 

PROCEDURAL ISSUES AND CONSULTATION OF INTERESTED PARTIES 

2.1. 

Organisation and timing 

This  impact  assessment  accompanies  a  proposal  to  repeal  8  "Old  Approach"  metrology 
Directives (CLWP 2008/ENTR/015). The work on this impact assessment has started in April 
2007 by means of a meeting with national experts. No inter-service steering group has been 
set  up  since  no  cross-cutting  impacts  were  expected  to  materialise  and  no  comments  were 
received from other DGs in the ISC on the key issues document in May 2008 (AGRI, ENV, 
MARKT, SANCO, TAXUD, TRADE and TREN). 

2.2. 

Context 

This impact assessment concerns 8 metrology directives in the following sectors:  
- Cold Water Meters for Non-Clean Water  (Directive 75/33/EEC) 
- Alcohol Meters and Alcohol Tables (Directive 75/765/EEC and 75/766/EEC) 
-  Medium  and  Above-Medium  Accuracy  Weights  (Directive  71/317/EEC  and  74/148/EEC) 
- Tyre Pressure Gauges for Motor Vehicles  (Directive 86/217/EEC) 
- Standard Mass of Grain (Directive 74/347/EEC)   
- Calibration of Ship Tanks (Directive 71/349/EEC) 

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All but directive 75/766/EC are of the so-called optional type. The instruments described in 
each  directive  must  be  accepted  by  Member  States  and  this  was  useful  in  the  1970’s  when 
there  were  trade  barriers  due  to  differing  Member  State  regulation.  Next  to  applying  the 
directives,  Member  States  are  allowed  to  keep  their  own  national  laws  containing  technical 
specifications.  These  national  laws  have  often  been  further  developed  to  keep  pace  with 
technological  progress  and  are  based  on  international  or  European  standards  and  contain 
mutual  recognition  clauses  giving  the  requirement  that  instruments  with  similar  level  of 
performance are accepted as well. It should also be noted that both international and European 
standards are voluntary and do not require national law or harmonised directives in order to be 
applied by manufacturers. 

2.3. 

Consultation and expertise 

2.3.1.  Public consultation 21 May -15 July 2008 

Commission services have published a key issues document for public consultation until 15 
July  2008.  Next  to  repeal,  the  option  of  reregulation  is  outlined,  namely  to  include  one  or 
more of these sectors in the Measuring Instruments Directive (Directive 2004/22/EC). In the 
key issues document the concern was expressed that currently the old directives are not easily 
adaptable  to  technological  progress  and  therefore  risk  hindering  innovation.  The  key  issues 
document was subject to an inter-service consultation involving 10 Directorates-General. 

Publicity  about  the  start  of  the  public  consultation  was  sent  to  28.000  subscribers  of 
Enterprise e-news, by means of ‘Your voice in Europe’ website to the general public and by 
e-mail  to  the  national  experts  as  well  as  to  the  consultant  for  mention  in  his  contacts  with 
stakeholders. Nonetheless, only 14 reactions were received in the public consultation during 
the  8-week  period  up  to  15  July  2008.  From  the  reactions  it  did  not  emerge  that  there  are 
barriers to trade that would require harmonisation under Article 95 of the Treaty. Nor was any 
other consideration of an overriding policy need brought up. 

2.3.2.  External study by RPA Ltd. – 26 March till 16 July 2008 

The consultant RPA Ltd. was commissioned for a study among stakeholders. The study was 
kicked off on 26 March 2008 and the final report delivered to the Commission services on 28 
July 2008. The study contains comprehensive outlines of each of the sectors.  

The main findings of the RPA study are: 
- The 6 sectors covered by the 8 directives are small, with annual output amounting to €120 
million, mostly in tyre pressure gauges and weights. 
- There is no mention by stakeholders of any barriers to trade. 
- Apparently only a minority of Member States require legal metrological control based on the 
used. 
directives 
- There is widespread use of alternative technical specifications (European, international and 
industry standards), notably in ship tanks, alcohol production and cereals.  
- Technological progress is being taken into account by means of voluntary international and 
European standardisation. 
- EU regulations for alcoholic drinks and cereals reference these standards, not the directives. 

instruments  which 

practice 

less 

less 

and 

are 

by 

in 

2.3.3.  Meetings with national experts  

The Commission services have discussed with national experts in meetings on 18 April 2007 
and  24  July  2008.  Member  States,  expressed  varying  views  the  essence  of  which  will  be 
described in the following. Some Member States have chosen to be transparent by expressing 
their  views  in  the  public  consultation  and  these  contributions  have  been  published  in  their 

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entirety  on  the  Commission  website.  The  conclusion  was  that  in  most  cases  either  half  the 
Member States or a majority are in favour of repeal. 

The  directives  contain  technical  descriptions  for  non-electronic  instruments.  Conformity 
assessment  under  the  directives  is  the  responsibility  of  the  national  authorities.  The  same 
conformity  assessment  system  will  sometimes  be  used  for  instruments  under  national  law 
which  are  technically  more  progressed,  i.e.  electronic  and  digital,  as  long  as  there  is  a  non-
electronic  part  which  is  covered  by  the  directive.  Such  conformity  assessment  documents 
allow  authorities  an  easy  way  of  checking  who  has  been  responsible  for  conformity 
assessment.  

For  tasks  where  Member  States  require  legal  metrological  control  there  is  often  also  a 
requirement  for  periodic  verification  of  the  instruments  that  are  in-service  This  is  always  a 
national responsibility even where there has been harmonisation under the New Approach, i.e. 
for  non-automatic  weighing  instruments  (Dir  90/384/EEC)  and  measuring  instruments  (Dir 
2004/22/EC).  National  experts  say  that  they  need  full  knowledge  about  the  certification 
history of an instrument in order to perform the appropriate periodic verification in metrology. 

It  was,  however,  pointed  out  that  this  rather  specific  issue  of  the  certification  history  of  an 
instrument  relevant  for  periodic  verification, mentioned  above,  is  already  fully  addressed  in 
the  WELMEC  Type  Approval  Agreement,  which  concerns  the  non-harmonised  area,  i.e. 
technologically more advanced instruments outside of the directives. In 1993, the cooperation 
of  national  authorities  WELMEC  (The  Western  European  Legal  Metrology  Cooperation) 
decided  to  seek  to  reduce  barriers  to  trade  in  measuring  instruments  by  an  agreement  which 
would  remove  the  need  for  multiple  type  approval  testing  against  various  national  legal 
requirements, i.e. the non-harmonised field. This agreement consists of a declaration on the part 
of  the  signatories  (the  members  of  WELMEC,  i.e.  authorities  of  all  EU  Member  States  and 
Norway,  Iceland  and  Switzerland)  of  their  intention  to  accept  conformity  with  an  OIML 
Recommendation as the basis for a national type approval with little or no further examination 
where the instrument has already been granted approval in another signatory country1. 

On the one hand, some experts indicated that transposing the directives had been imposed as a 
condition  for  EU  membership  and  that  there  was  no  choice  for  new  Member  States  but  to 
have  these  directives  in  national  law.  On  the  other  hand,  other  experts  indicated  that  New 
Approach  harmonisation  would  allow  a  wider  number  of  routes  to  conformity  assessment 
than currently allowed in national laws (although they agree that Member States do not need 
EU  regulation  to  allow  more  sophisticated  forms  of  conformity  assessment  in  national 
regulation.)  

2.3.4.  Conclusion from consultation and expertise 

The public consultation and external study have informed the impact assessment. Both point 
to an apparent lack of trade barriers, the limited use of the directives and the availability of 
voluntary alternative standards which are widely used. The current situation does not seem to 
pose  any  problem  and  the  repeal  of  the  directives  would  not  affect  the  market  place. 
Voluntary  standardisation  and  mutual  recognition  already  cover  market  needs  also  those 
related to technological innovation. 

The key issues document, report on the public consultation and all contributions to it as well 
the  Europa  website:
as 

by  RPA 

available 

report 

study 

the 

are 

on 

http://ec.europa.eu/enterprise/prepack/ms_inst/mi_directives.htm 

1 
http://www.welmec.org/publications/5thIssue_Introduction.pdf 

WELMEC European cooperation in legal metrology – An Introduction, p.9 

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Main conclusions per sector are outlined in the Annex to the document.  

3. 

PROBLEM DEFINITION 

3.1.  What is the issue or problem that may require action? 

The Old Approach directives had the aim of allowing harmonised goods to penetrate the trade 
barriers existing under differing national regulations in the pre-Cassis de Dijon era. Operators 
could be sure that the technical specifications in the directives would be accepted. 

Since  then  national  regulations  encompassing  technological  progress  have  been  based  on 
international standards due to obligations of  membership laid down by international (treaty) 
organisations like ISO and OIML2 as well as of European Standardisation Organisations and 
eventually  also  by  the  WTO-TBT  agreement.  Since  1983  mutual  recognition  clauses 
concerning  instruments  and  conformity  assessment  procedures  have  been  entered  into 
national  rules,  also  in  the  context  of  the  notification  procedure  of  Directive  98/34/EC.  In 
addition since 1993 the WELMEC type approval agreement has given a framework for inter-
governmental  cooperation  regarding  the  mutual  recognition  of  conformity  assessment 
specifically of non-harmonised measuring instruments based on international standards. 

As  there  exist  international  standards,  also  for  the  outdated  technologies,  it  would  seem 
reasonable to expect that Member States, who as a consequence of subsidiarity choose to re-
regulate in case the Directives were repealed, would by so-doing not resurrect new barriers to 
trade. The expectation is that there would be no change compared to the current situation.  

It should be noted that Article 2 of the Measuring Instruments Directive (2004/22/EC) allows 
an opt-out to Member States in the sense that for tasks where they require legal metrological 
control it may only be by means of instruments complying with the directive, whilst in other 
cases  they  may  not  have  any  requirements.  Given  the  expressed  preferences  of  national 
experts, it is to be expected that a substantial number of Member States will apply the opt-out 
in each of the sectors.  

3.2.  What are the underlying drivers of the problem? 

The underlying driver of the problem common to all sectors is that there no longer is a need 
for  EU  legislation  to  create  an  internal  market  for  these  instruments  and  that  the  existing 
directives are less and less used. Due to technological development the existing directives are 
less and less applied. In some cases they may still have practical value, e.g. weights, where 
there  is  no  technological  development  for  the  weights  although  there  is  a  trend  away  from 
manual weighing. In  all  cases  (except the very diverse non-clean water  meters)  the  existing 
directives  are  covered  fully  by  existing  international  standards,  as  indicated  in  the  third 
column  of  Table  1.  The  Member  States  arguing  in  favour  of  regulation  motivate  this  by 
pointing out that they would need to regulate nationally. However, if a Member State should 
decide to regulate it is obliged to base its laws on international standards under the conditions 
of WTO/TBT agreement of 1995, the outcome of such national regulation would be identical 
to the current one based on the directives. 

Table 1: EU legislation and standards applied in the sectors 

Sector  

Current 
Directive 

Related 
Standard  

Other EU 
regulation 

Related 
Standard  

2 

Organisation  Internationale  pour  la  Métrologie  Légale  of  which  all  Member  States  are  member  and 
which is recognaised under the TBT agreement as an international standards setting body. 

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Non-clean 
meters 

water 

75/33/EEC  None 

none 

none 

Alcohol meters 

76/765/EEC  OIML 

R44/1985 

Regl.2676/1990 
Regl.2870/2000 

ISO 4801:1979 
ISO 4805:1982 
ISO 3507: 

Alcohol tables 

76/766/EEC  OIML 

R22/1975 

Regl.2676/1990 
Regl.2870/2000 

Weights 

71/317/EEC 
74/148/EEC 

OIML 
R111/2004 

Tyre gauges 

86/217/EEC  OIML 

R23/1975 

Mass of grain 

74/347/EEC  OIML 

Regl.824/2000 

R15/1970 

Ship tanks 

71/349/EEC  OIML 

R95/1990 

ISO 
7971/2:1995 

ISO 4269:2001 
ISO 4512:2000 
ISO 5024:1999 
Phoenix API/EI 

(Source: Study for the Commission of July 2008 by RPA Ltd.) 

Under the conditions of WTO/TBT agreement of 1995 Member States that choose to regulate 
are  obliged  to  base  their  laws  on  international  standards.    National  laws  will  therefore  be 
based  on  international  standards,  which  often  have  also  been  transposed  into  European 
standards. On top of this the ‘Cassis de Dijon’ jurisprudence by the European Court of Justice 
prohibits  disproportionate  national  requirements  and  obliges  mutual  recognition  of  products 
legally marketed in other Member States. 

When  barriers  to  trade  exist  or  there  is  a  large  risk  of  them  appearing,  harmonisation  is 
justified  on  the  basis  of  Art  95  of  the  Treaty.  In  the  case  of  a  harmonising  directive,  the 
obligation  to  base  the  law  on  international  standards  is  assumed  by  the  EU.  Under  New 
Approach  harmonisation,  any  technical  specification  that  complies  with  the  essential 
requirements in the Directive is allowed. Therefore innovation can occur without any need to 
change  the  law.  Under  Dir  2004/22/EC  European  standards  and  international  standards  are 
always  voluntary  but  give  presumption  of  conformity,  which  for  manufacturers  can  be  an 
efficient option of complying with the essential requirements of the directive. The so-called 
blue guide3 gives a comprehensive explanation of the New Approach harmonisation. 

1.1.1. 

3  The Guide to the Implementation of Directives Based on New Approach and Global Approach is 
on: 
available 
http://ec.europa.eu/enterprise/newapproach/legislation/guide/index.htm 

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3.3.  Who is affected, in what ways, and to what extent? 

Even though the sectors are small in turnover, the instruments and measures are used to give 
indications on many products. For example, tyre pressure gauges are needed to inflate the 1 
billion tyres on EU roads.  

There  do  not  seem  to  be  any  parties  that  would  be  affected  by  a  repeal  as  identified  in  the 
problem definition. The existing directives are virtually not applied and have been superseded 
by  national  laws  based  on  international  standards  which  take  into  account  technological 
progress and these national laws are subject to mutual recognition. Where needed, consumer 
protection  is  thereby  assured,  whilst  mutual  recognition  relieves  manufacturers  of  multiple 
conformity assessment. It should be noted that the mutual recognition principle (concerning 
non-harmonised  goods,  i.e.  products  subject  to  national  laws  not  based  on  harmonising  EU 
directives) has recently been further clarified when the European Parliament and the Council 
adopted Regulation (EC) No 764/2008, which will apply from 13 May 2009.  

Repeal  of  the  directives  would  not  affect  the  producers  of  technologically  more  advanced 
products because their products are either currently subject to national law or not regulated at 
all, depending on the Member State. Manufacturers do not report barriers to trade that would 
justify additional harmonisation through EU regulation. Consumers and buyers of instruments 
would not be affected by the repeal because either there are national laws in place or there is 
currently  no  protection.  Consumers  did  not  report  lack  of  protection.  National  authorities 
would  not  be  affected  because  most  of  the  directives  are  less  and  less  used.  Authorities 
currently  can  use  the  WELMEC  type  approval  agreement  in  order  to  exchange  information 
for  purposes  of  market  surveillance  in  the  non-harmonised  field  and  periodic  in-service 
controls  and  this  would,  of  course,  also  be  the  case  if  the  directives  were  repealed  without 
new harmonisation.  

3.4. 

How would the problem evolve, all things being equal? 

Mutual recognition is already the rule for these sectors and this is not expected to change. 

Without any new EU action, the old Directives would still exist until technical progress has 
completely  overtaken  the  technological  specifications..  The  old  directives  concern  mostly 
outdated  (non  electrical)  technology.  According  to  the  RPA  study,  it  is  expected  that  the 
market will evolve quickly to products more technologically advanced no longer covered by 
the old directives.  

3.5. 

Does  the  EU  have  the  right  to  act  –  Treaty  base,  ‘necessity  test’  (subsidiarity) 
and fundamental rights limits? 

Given the apparent lack of constraints and trade barriers, it would appear that there is no need 
to replace current outdated harmonisation by new Community law. 

There  are  no  apparent  barriers  to  trade  that  would  require  harmonisation  on  the  basis  of 
Article 95 of the Treaty.  

Only  the  Community  can  repeal  existing  Directives,  therefore  action  at  Community  level  is 
necessary and fully in line with the subsidiarity principle. 

4. 

OBJECTIVES  

In  line  with  the  Commission’s  approach  to  simplification  (COM(2005)535)  the  general 
objective  is  to  simplify  the  acquis  of  European  law  by  repealing  obsolete  legislative  acts, 
which have little or no practical impact and therefore have become irrelevant.  

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The specific objective is to simplify the EU acquis in the areas covered by eight old approach 
metrology Directives while maintaining the free circulation  of  the  measuring instruments in 
the internal market and not hindering technological progress.  

These  objectives  are  fully  in  line  with  the  Community  policy  of  better  regulation  and 
simplification,  and  are  in  line  with  the  Lisbon  strategy.  The  objectives  aim  to  continue  free 
circulation  of  goods  and  services  on  the  Internal  Market  consistent  with  international 
standards. In line with better regulation and simplification, changes are kept to the minimum 
and where needed continuity of enforcement is best ensured. The objectives are to maintain 
conditions that have proven to be conducive to competitiveness of European enterprises.  

5. 

POLICY OPTIONS 

5.1.  What  are  the  possible  options  for  meeting  the  objectives  and  tackling  the 

problem?  

The options under consideration have been set out in the Key Issues Document (for the public 
consultation) as follows: 

Option 1: Maintain the current regulatory framework unchanged. This option will act as the 
baseline for assessing the impacts of adopting either Option 2 or 3.  
Option 2: Repeal the eight existing Directives without proposing any new Community 
legislative instrument to replace them. Under this option the free movement of measuring 
instruments within the Internal Market would implicitly rely on the Mutual Recognition 
Principle and horizontal legislation framing its correct functioning. Rather than national 
regulation Member States could rely on the voluntary application of European standards. For 
the updating and development of such standards the Commission could, if needed, give a 
mandate to the European Standardisation Organisations. Member States wanting to keep 
national regulation would need to base their laws on international standards. For most 
instruments international standards exist. Under WTO/TBT obligations, international 
standards would be the basis for national regulation as well as for European standards. Option 
2 is the repeal of the Old Approach directives without any change to the MI Directive 
2004/22/EC. 
Option 3: Replace the current Directives by new harmonising legislation added into the 
Measuring Instruments Directive 2004/22/EC, the latter already providing a legal framework 
for certain measuring instruments under the New Approach. This option implies the inclusion 
of these new sectors into this New Approach Directive. It does not allow any national rules, 
although Member States remain free to choose the tasks for which they want to prescribe legal 
metrological control. For these tasks they may only allow instruments conformity assessed on 
the essential requirements in the directive to be used on their territory. New Approach 
harmonisation prescribes essential requirements and allows any technological specification 
that complies with these requirements. Option 3 is to add new annexes for each instrument to 
the MI Directive 2004/22/EC. 

Which options have been discarded at an early stage and why?  

No option has in principle been excluded beforehand. 

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6. 

ANALYSIS OF IMPACTS 

6.1.  What are the likely economic, social and environmental impacts of each of the 

short-listed options? 

It  was  originally  hoped  that  sufficient  data  would  be  obtained  by  the  study  consultant  or 
otherwise  to  enable  robust  estimates  to  be  made  of  the  administrative  costs  associated  with 
each  of  the  options  (outlined  above).  Although  this  has  not  proved  to  be  possible,  attempts 
have  been  made  to  suggest  (qualitatively  at  least)  whether  administrative  costs  are  likely  to 
increase  or  decrease  (with  respect  to  the  existing  regulatory  framework)  for  each  of  the 
sectors  under  each  of  the  options.  It  should  be  noted  that  given  the  nature  of  the  initiative 
(simplification)  and  the  very  limited  or  even  non-existing  impacts  as  indicated  by  the 
consultation and the study, the analysis of impacts is carried out in line with the principle of 
proportionate analysis. 

6.1.1. 

Impacts of option 1 (No action) 

Option 1 is used as the baseline case and represents the current situation 

Scenario 1A is a limitative interpretation that only the old approach directive applies and so 
no  new  technology  may  be  sold  on  the  market.  It  would  probably  be  at  odds  with  mutual 
recognition in the non-harmonised sector. As there were no complaints about such a situation, 
scenario 1A probably does not exist anywhere.  

Scenario  1B  is  the  case  where  national  rules  exist  parallel  to  the  old  approach  directive  in 
order  to  cover  technological  advances.  Such  national  rules  can  be  based  on  international 
standards  (required  since  1995  by  WTO  /TBT)  (scenario  1B)  and  offer  a  high  level  of 
protection  but  at  the  cost  of  national  conformity  assessment.  Mutual  recognition  allows 
uninhibited  entry  into  other  Member  States,  due  also  to  the  WELMEC  type  approval 
agreement. 

Scenario  1C  would  be  the  case  of  national  specifications  diverging  from  international 
standards  which  could  lead  to  a  barrier  to  trade.  As  no  information  was  received  from 
stakeholders  about  barriers  to  trade  it  would  seem  that  scenario  1C  probably  does  not  exist 
anywhere either.  

Scenario 1D is the case of no national rules. In this case the Old Approach directive is on the 
national rule book but it is nowhere required and is therefore completely voluntary. It is left 
up to consumers to decide what they need. It means that there are no administrative costs but 
there may be sub-standard instruments on the market, which would be difficult to take off the 
market, failing a law. This problem has only been mentioned by a UK authority in the public 
consultation in the case of tyre pressure gauges. Such abuse would normally be a reason for a 
Member  State  to  propose  national  legislation,  but  only  half  of  Member  States  wanting  to 
regulate these sectors.  

Summarising, it would seem that only scenarios 1B and 1D are actually encountered and these 
two are the baseline relative to which impacts are analysed. Both of these scenarios are fully 
in line with the principle of mutual recognition. They will allow products to freely circulate, 
whereby the WELMEC type approval agreement will provide information about conformity 
assessment needed for appropriate market surveillance.  

According to a UK local authority in the public consultation most firms are relatively small 
and already operating in various markets. It would seem that both scenarios IB and 1D would 
be  equally  conducive  to  cross  border  expansion  by  small  and  medium  sized  businesses, 
notably due to the lack of barriers to trade afforded by mutual recognition.  

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6.1.2. 

Impacts of option 2 (Repeal the directives)  

Option 2 would continue to allow regulation by Member States as is already the case now.  

If a Member State would choose to regulate based on international standards, there would be 
minimal  costs,  given  that  mutual  recognition  of  conformity  assessment  and  WELMEC  type 
approval agreement would normally allow one conformity assessment to be accepted all over 
the EU (Scenario 2A). In its effects Scenario 2A is the same as Scenario 1B. 

The  only  case  which  could  involve  significant  costs  is  where  a  Member  State  would  try  to 
impose a technology differing from international standards. This case, however, looks highly 
improbable  in  the  light  of  WTO/TBT  and  the  obligations  of  Member  States  under  the 
principle  of  mutual  recognition.  (Scenario  2B).  Scenario  2B  is  comparable  to  the  situation 
under scenario 1C, which is currently not encountered, so it will be discarded 

If a state chooses not to regulate (Scenario 2C) there would be no costs or protection. Scenario 
2C is equal to Scenario 1D. 

Foreign  producers  would  not  be  unduly  influenced  by  the  repeal.  Just  like  now  they  can 
continue  to  benefit  from  mutual  recognition  on  the  EU  single  market  based  on  a  national 
conformity assessment certificate. 

6.1.3. 

Impacts  of  option  3  (repeal  directives  and  inclusion  in  Measuring  Instruments 
Directive) 

Option  3  would  be  to  introduce  the  sectors  into  the  New  Approach  directive  for  measuring 
instruments.  The  directive  allows  all  instruments  which  comply  with  the  essential 
requirements  facilitating  such  compliance  by  recognising  international  standards  which  can 
easily be updated, i.e. without adapting the directive. The directive allows a Member State to 
prescribe legal metrological control as it thinks fit (opt-in that recognises subsidiarity) but on 
the condition that only instruments conforming to the directive may be used. This is the case 
of scenario 3A. As there are currently not barriers to trade, the impacts of scenario 3A would 
conceivably be equal to scenario 1B. 

However,  Article  2  of  the  same  directive  allows  for  optionality,  so  a  Member  State  may 
choose not to introduce any legal metrological control. This is the case of Scenario 3B which 
in its impacts is equal to Scenario 1D. 

Foreign  producers  would  not  be  unduly  influenced.  European  conformity  assessment  would 
replace  national  conformity  assessment  certificate  without  any  difference  from  the  current 
situation.  

6.2. 

Specify uncertainties and how impact may be affected by changes in parameters 
(uncertainty and sensitivity analysis). 

Notwithstanding  that  the  simplification  exercise  was  kicked  off  nearly  one  and  a  half  years 
ago by means of a meeting with national experts in April 2007, there is still some uncertainty 
about  the  existing  situation  in  Member  States.  Authorities  have  until  now  not  very  clearly 
expressed  themselves.  According  to  the  consultant's  study,  however,  in  general  the  market 
place does not seem to be overly hindered by regulation at the moment, which would dovetail 
with  the  apparent  lack  of  complaints  about  barriers  to  trade  being  brought  forward  in  the 
consultation. Nevertheless, sensitivity analysis will be provided below (Impacts of dynamics) 
of different possible responses of Member States to a change of their regulatory framework. 

If the option of repeal would be chosen, it does not seem probable that Member States would 
suddenly increase national regulation, given that Member States could in the past already do 

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so and so there is no ground to assume that they will suddenly start legislating when obsolete 
directives are repealed. 

As the current directives are virtually not used, there do not seem to be substantial economic, 
environmental  or  social  impacts.  In  no  way  will  repeal  reduce  the  current  possibilities  of 
Member  States  to  address  the  issue  of  measurement  in  these  sectors.  National  rules  may 
continue  to  exist  and  new  rules  may  be  formulated  based  on  international  standards  with 
mutual  recognition  requiring  Member  States  to  give  uninhibited  access  to  their  market  of 
products giving similar protection and levels of performance. 

6.3.  What are the potential obstacles to compliance? 

There do not seem to be obstacles to compliance in the case of repeal (option 2). In the case of 
inclusion under MID (option 3), there could be substantial opting out by a substantial number 
of Member States. 

7. 

COMPARING THE OPTIONS 

As monetisation of impacts is difficult, the analysis is of a qualitative nature. 

7.1. 

Impacts of options 

The options are the two possible outcomes of the simplification objective: repeal (option 2) or 
re-regulation  (option  3).  Both  options  would  achieve  the  objective  of  simplification  and 
therefore other criteria are added to compare them. Only where the criteria differ per option 
have they been made explicit.  

It  would  appear  that  in  this  case  where  there  are  no  reported  barriers  to  trade  and  no  other 
overriding  policy  needs,  there  only  remain  the  issues  of  a  high  level  of  protection  versus 
administrative costs which are the distinguishing impacts between options. 

High  level  of  protection  is  ensured  either  by  national  law  based  on  international  standards 
(scenario 1B and 2A) or by harmonisation (scenario 3A). When there are no laws, there is no 
guaranteed protection (scenarios ID, 2C and 3B) 

All costs are of an equal magnitude across the options, i.e. the low to medium administrative 
costs  of  scenario  1B  are  equal  to  those  of  2A  and  3B.  Where  there  are  no  laws  no 
administrative costs need be made (scenarios ID, 2C and 3B). 

Competitiveness is equally ensured under all scenarios given that there are no barriers to trade 
and that this is not going to change under any of the scenarios. 

Table 2: Impacts per option (scenario) (+ = benefit, - = cost) 

Scenario 

1B 

1D 

2A 

2C 

3A 

3B 

High level protection 

Administrative costs 

Total 

+ 

- 

0 

0 

0 

0 

+ 

- 

0 

0 

0 

0 

+ 

- 

0 

0 

0 

0 

In the case of regulation (scenarios 1B, 2A and 3A) administration costs to manufacturers pay 
for  the  benefit  of  a  high  level  of  protection.  Where  there  is  no  law  there  are  no  costs.  No 
negative impacts on trade are expected in either case. 

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The  trade-off  between  protection  benefits  and  administrative  costs  may  exist  for  weights  as 
concerns honesty of transaction and tyre pressure gauges as concerns performance, although 
harmonisation is nowhere required in the light of an overriding policy need and national rules 
can be expected to be equally effective in ensuring such protection where needed 

7.2. 

Present results of the weighing 

As these administration costs concern the conformity assessment, which already exists in all 
Member States with additional national rules covering technological progress under scenario 
1B,  it  would  seem  that  these  costs  are  discounted  in  the  EU  market.  Also  the  benefits  of  a 
high  level  of  protection  are  already  being  enjoyed  under  scenario  1B  and  these  costs  and 
benefits will not change either under repeal (option 2) or reregulation (option 3). 

It  is  most  likely  that  Member  States  will  not  wish  to  change  from  their  current  situation, 
whatever  the  outcome  may  be,  e.g.  a  Member  State  now  in  scenario  1B  will  keep  national 
rules  unchanged  under  repeal  (scenario  2A)  and  will  opt-in  under  harmonisation  (scenario 
3A). 

Comparison in Table 3 below of the options to the baseline shows zero impacts everywhere! 
Whatever change is made it is “impact free” and no negative impacts on trade are expected.  

Table 3: Impacts of options compared to the baseline option 1 (likely choice by Member 
States) 

Scenario 

2A vs 1B 

2C vs 1D 

3A vs 1B 

3B vs 1D 

High level protection  0 

Administrative costs 

Total 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

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7.3. 

Impacts of dynamics (uncertainty)  

There may be reasons for Member States to cross-over either to deregulate by getting rid of 
current national rules or to increase protection by new rules, be they national or harmonised. It 
may seem less likely but should not be discarded in this analysis.  

Introducing  rules  where  there  were  none  would  give  more  protection  at  the  price  of  an 
increase in administration costs (columns 2 and 4 of the Table 4 below). Deregulating would 
mean  less  guaranteed  protection  with  a  gain  of  no  longer  requiring  administration  costs 
(columns 3 and 5 of the Table 4 below). 

Table 4: Effects of crossing over compared to baseline option 1 (less likely choice by of 
Member States) 

Scenario 

2A vs 1D 

2C vs 1B 

3A vs 1D 

3B vs 1B 

High level protection  + 

Administrative costs 

Total 

- 

0 

- 

+ 

0 

+ 

- 

0 

- 

+ 

0 

Only  in  the  case  of  shifts  to  more  regulation  will  there  be  low  to  medium  sized  costs  for 
conformity  assessment  compared  to  the  case  of  no  regulation  (shift  from  1D  to  2A  or  3A). 
Such  shifts  are  under  both  options  2  and  3  a  choice  by  each  Member  State  in  line  with  the 
principle of subsidiarity. It seems, however, quite unlikely that a Member State will decide to 
substantially  change  its  current  stance  on  regulations,  because  it  can  already  do  so  in  the 
current  situation.  In  the  case  of  option  2  there  is  no  obligation  to  change  from  the  current 
situation. Under Option 3 there could be minor ‘moral’ pressure because Member States must 
indicate in writing what the reasons are for their opt-out (Art. 2 of MI Dir 2004/22/EC) 

7.4. 

Indicate if the analysis confirms whether EU action would have an added value. 

The analysis confirms that mutual recognition based on international and industry standards is 
common  in  all  sectors  and  repeal of the current directives (option 2) would  have zero costs 
over the current situation (option 1). EU action consisting of repeal of the directives has added 
value in the context of the overall policy aim of simplification and better regulation. 

As regards, the option of regulation under MID, value added of EU action is less evident due 
to  the  absence  of  any  reported  barriers  to  trade,  which  would  point  to  a  failure  of  mutual 
recognition.  Next  to  that  there  could  be  associated policy benefits, but there is no reason to 
assume that these cannot be achieved just as well by national rules under mutual recognition. 
It is also to be expected that half or more of Member States would opt-out which would add 
an uncertainty that would compromise the aim of the re-regulation. 

The  simplification  benefit  is  evident  in  the  case  of  repeal  (option  2)  but  less  evident  in  the 
case of re-regulation under the MID, due to the apparent lack of barriers to trade. 

7.5. 

If possible and appropriate, set out a preferred option. 

On the basis of impact assessment as such, there is no preferred option. This is due to the lack 
of trade barriers and due to the Old Approach directives being less and less used.  

The  justification  to  repeal  all  8  metrology  directives  (option  2)  would  be  in  line  with  the 
Commission’s  approach  in  COM(2005)535  to  simplify  the  acquis  of  European  law  by 

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repealing obsolete legislative acts, which have little or no practical impact and therefore have 
become irrelevant, It would also be fully in accordance with the principle of subsidiarity.  

Option  3  does  not  appear  to  reach  beyond  the  current  situation  of  mutual  recognition.  This 
also  given  that  a  substantial  number  of  Member  States  are  expected  to  opt-out  of 
harmonisation, as is possible under Art. 2 of the MID.  

8. 

MONITORING AND EVALUATION 

8.1.  What 

is 
arrangements? 

the  broad  outline 

for  possible  monitoring  and  evaluation 

Stakeholders  could  bring  up  new  evidence  which  could  lead  the  Commission  services  to 
consider, in the light of developments whether new policy needs would require harmonisation 
in  the  future.  Such  new  evidence,  together  with  the  option  of  expanding  the  scope  of  the 
directive  by  means  of  additional  MI-annexes,  could  be  considered  in  the  report  by  the 
Commission on the Measuring Instruments Directive which is foreseen before 30 April 2011 
by Article 25 of Directive 2004/22/EC. 

8.2. 

How  has  the  opinion  of  the  IA  board  of  24  September  2008  been  taken  into 
account 

The  opinion  of  the  IA  board  has  been  taken  into  account  in  this  version  of  the  report.  The 
following changes have been made:.  

(1) “Improve the presentation of the underlying framework”: Section 3.2 about the underlying 
drivers of the problem has been extended from the first sentence only to a full page as well 
and also have been added the last two sentences in the description of Option 3 in section 3.6. 
Table 1, which initially was in the annex, has been moved forward to section 3.2. 

(2) “Clarify the current role of the directives”: This has been taken into account in section 3.2, 
notably the second and third sentences of the first paragraph as well as changes to section 3.4. 

 (3) “Clarify the impact on administrative burden”: In section 7.1 the first paragraph has been 
added,  paragraphs  4  and  5  reworded  and  the  last  paragraph  added  whilst  in  section  7.3  the 
penultimate paragraph and in section 7.4 the last paragraph have been added. The comment 
on  competitiveness  has  led  to  rephrasing  the  penultimate  paragraph  of  section  7.1  and  the 
third paragraph of section 7.2 as well as adaption of Tables 2, 3 and 4. 

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ANNEX: Analysis of Sectors  

MARKET SIZE AND REGULATION 

In its study RPA has estimated the size of the market currently covered by the directives and 
the  additional  sales  of  technologically  more  advanced  alternatives.  The  largest  sector  under 
the  current  directives  is  weights  at  €30m,  wh ilst,  if  technological  progress  is  taken  into 
account, additional sales for tyre pressure gauges amount to €70m. Most sectors are small, if 
not minute, compared to these two, already not large, sectors. Manufacturers have confirmed 
to  the  Commission  services  that  annual  turnover  of  the  third  largest  sector,  alcohol  meters, 
amounts to only €8m, see table 1. 

Table 1: Estimates of the annual turnover per sector on the EU market, currently under 
a directive and additional due to technological innovation (million €) 

Sector  

Annual turnover on the EU market including imports and excluding 
exports (million €) 

Only 
directive  

existing 

Additional 
technical innovation 

due 

to 

Total:  existing  + 
new  

Non-clean 
meters 

water 

Alcohol meters 

Weights 

Tyre gauges 

Mass of grain 

Calibration ship tanks 

Total 

4

2

30

3

0.6

0.75

40

0 

6 

0 

70 

4 

0 

80 

4

8

30

73

4.6

0.75

120

(Source: Study for the Commission of July 2008 by RPA Ltd.) 

The study shows fairly exhaustive coverage by international standards, whereby technological 
progress  is  taken  into  account  for  alcohol  and  mass  of  grain  by  means  of  references  in  EU 
regulations. There are also alternative standards for ship tanks, see Table 1 in the main text.. 

ISSUES PER SECTOR 

Non-clean  water.  In  non-clean  water  there  are  many  uses,  e.g.  measuring  waste  water, 
irrigation  water  use  as  well  as  metering  of  large  scale  sales  among  utilities  of  clean  water. 
However these fields are highly diverse and all outside of the current scope of the MID. EC 
harmonisation would appear to be technically complex, while there do not seem to be drivers 
in  the  area  of  EU  environmental  policy  requiring  such  harmonisation.  In  its  reaction  to  the 
public consultation, the EU water manufacturing industry has asked for the existing directive 
to be repealed and it does not require harmonised legislation for non-clean water meters. 

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Alcohol  meters  In  their  reactions  to  the  public  consultation  two  manufacturers  of 
alcoholmeters and Scotch whiskey producers indicate that harmonisation  should  incorporate 
and not inhibit technological innovation. They do not mention any trade barriers. The use of 
alcohol  meters  that  could  be  different  and  more  technological  advanced  than  those  in  the 
directive is already prescribed in the EU regulations on wine and spirits drinks (Regl. 2676/90 
and 2870/2000). It would appear that these regulations go much further than OIML and the 
directive.  The  regulations  are  directly  applicable  and  do  not  contain  any  conformity 
assessment  criteria  for  the  instruments  used.  It  is  unclear  on  which  grounds  a  proposal  for 
harmonisation  could  be  justified  for  instruments,  the  use  of  which  is  currently  already 
harmonised  for  all  intents  and  purposes  by  means  of  these  regulations  for  wine  and  spirit 
drinks. For beer on the other hand, there are no EU regulations. 

Alcohol  tables  are  covered  by  international  OIML  and  ISO  standards  and  are  already 
harmonised in national law of all Member States, due to the fact that the current directive is 
mandatory.  The  above  mentioned  regulations  for wine and  spirit drinks also contain similar 
tables, but only for the alcohol ranges concerning wine and spirits. There does not seem any 
reason  to  change  such  laws.  If  there  were  no  longer  an  EU  directive,  there  would  remain  a 
legal base in the regulations. Lower percentage alcohol tables would need to remain covered 
by national law based on international standards. Alcohol tables do not concern a measuring 
instrument,  but  rather  the  way  measurements  by  alcohol  meters  should  be  read  in  order  to 
obtain a percentage, so it would not be possible to include them in the Measuring Instruments 
Directive. 

Medium and Above-Medium Accuracy Weights: The two optional Directives have a link 
to  the  Directive  on  Non-automatic  Weighing  instruments  (Directive  90/384/EEC)  which  is 
mandatory and includes manual weighing with weights. Experts of 17 Member States indicate 
that  manual  weighing  still  exists  in  shops  and  on  markets  and  for  precision  weighing  in 
pharmaceutics. Practical use may be expected to decline but there may nonetheless remain a 
back-up  function  of  material  weighing.  Given  that  there  is  no  technological  advance, 
international standards duplicate fully the directive. 

Tyre  Pressure  Gauges  for  Motor  Vehicles,  Road  safety  and  energy  efficiency  could  be 
deemed  policy  needs  to  harmonise  tyre  pressure  gauges.  It  could  complement  current 
Commission  initiatives  to  improve  road  safety  and  energy  efficiency  by  means  of  more 
accurate  tyre  pressure  monitoring  systems  (TPMS)  in  new  cars  (COM(2008)316).  The 
proposal  is  to  let  new  cars  be  equipped  with  a  system  for  continuous  monitoring  of  tyre 
pressure.  A  driver  would  be  warned  about  less  than  optimal  tyre  pressure.  In  the 
accompanying  impact  assessment,  it  is  estimated  that  energy  efficiency  of  cars  can  be 
improved  by  2.5%  if  tyres  are  correctly  inflated.  At  this  stage,  it  is  not  evident  that 
harmonisation  of  tyre  pressure  gauges  is  required  as  a  precondition  to  obtain  the  benefits 
outlined due to TPMS. Directive 2004/22/EC on measuring instruments also allows Member 
States an opt-out, so possibly only half of Member States will apply it. 

Mass of grain is only one of the elements used to determine the payments for grain under EU 
intervention (next to density, humidity) and therefore more advanced instruments than those 
in  the  directive  are already  prescribed  by  the  AGRI  regulation  on  cereals  (Regl.  824/2000). 
This regulation references international/European ISO/EN standards, not those of OIML and 
the  directive.  The  regulations  are  directly  applicable  and  do  not  contain  any  conformity 
assessment  criteria  for  the  instruments  used.  It  is  unclear  on  which  grounds  a  proposal  for 
harmonisation  could  be  justified  for  instruments,  the  use  of  which  is  currently  already 
harmonised for all intents and purposes by means of the EU agricultural regulation. 

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Calibration  of  ships  tanks  is  about  marking  the  contents  of  tanks  on  inland  and  coastal 
shipping.  The  procedure  is  to  fill  them  and  place  marks.  The  indications  on  the  tanks  are 
rarely  the  only  ones  used  in  transactions,  because  generally  the  transaction  is  based  on  the 
measurement when the cargo has been unloaded. It is not an element in the inland shipping 
safety  directive  (Dir  2006/87/EC).  For  petroleum  transport  there  exist  ISO  standards  and  a 
widely  used  industry  API/EI/ISO  standard  under  the  Phoenix  agreement.  As  few  Member 
States  currently  require  legal  metrological  control  there  do  not  seem  to  be  overriding  EU 
policies that would require intensifying such control. 

Due to these developments there are no apparent trade barriers in any of the sectors, neither 
for  the  instruments  under  the  existing  directive  nor  for  more  technologically  advanced 
instruments and there is widespread use of alternatives to the directives, many of which are 
based on international standards. 

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