EN    EN EN 
 
EN    EN  COMMISSION OF THE E UROPEAN 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} 
 
EN 2   EN 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 servi ces involved in its pr eparation and does not 
prejudge the final form of any d ecision 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 Commi ssion services presented three options: 
1. “Old approach” Directives  exist next to national rules (current situation) 
2. Repeal of directives, no harmonisati on, national rules co ntinue to exist 
3. Harmonisation via the Measuring Instrument s 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 regula tion based on internationa l standards taking the 
concept of mutual recognition fully into acco unt. What is more, a substantial number of 
Member States have indicated that they wi ll opt-out of harmonisation which effectively 
compromises the very aim of harmonisation.  
For reasons of simplification and subsidiarit y, therefore, the optio n 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 st eering group has been 
set up since no cross-cutting impacts were exp ected 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 Al cohol Tables (Directive 75/765/EEC and 75/766/EEC)  
- Medium and Above-Medium Accuracy We ights (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 Ta nks (Directive 71/349/EEC) 
 
EN 3   EN All but directive 75/766/EC are of  the so-called optional type. The instruments described in 
each directive must be accepted by Member Stat es and this was useful in the 1970’s when 
there were trade barriers due to differing Me mber 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 ar e based on international or Eu ropean standards and contain 
mutual recognition clauses giving the requiremen t 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 i ssues document for public consultation until 15 
July 2008. Next to repeal, the option of reregu lation is outlined, namely to include one or 
more of these sectors in the Measuring Inst ruments 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 pr ogress and therefore risk hinde ring innovation. The key issues 
document was subject to an inter-service consultation invol ving 10 Directorates-General. 
Publicity about the start of the public cons ultation was sent to 28.000 subscribers of 
Enterprise e-news, by means of ‘Your voice in Europe’ website to th e general public and by 
e-mail to the national experts as well as to th e consultant for mention in his contacts with 
stakeholders. Nonetheless, only 14 reactions we re received in the public consultation during 
the 8-week period up to 15 July 2008. From the reactions it di d 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 stake holders. 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 stakeholde rs of any barrier s to trade.  
- Apparently only a minor ity of Member States require legal metrological  control based on the 
directives by instruments which in practice are less and less used. - There is widespread use of a lternative technical specificati ons (European, international and 
industry standards), notably in ship tanks, alcohol production and cereals.  
- Technological progress is being taken into  account by means of volunt ary international and 
European standardisation.  - EU regulations for alcoholic dr inks and cereals reference these standards, not the directives. 
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 va rying views the essence of which will be 
described in the following. Some Member States have chosen to be tr ansparent by expressing 
their views in the public consul tation and these contributions have been published in their 
 
EN 4   EN entirety on the Commission website. The conclusi on was that in most cases either half the 
Member States or a majority  are in favour of repeal. 
The directives contain techni cal descriptions for non-electro nic instruments. Conformity 
assessment under the directives is the responsib ility of the national au thorities. The same 
conformity assessment system will sometimes be used for instruments under national law 
which are technically more progre ssed, i.e. electronic and digital, as long as there is a non-
electronic part which is covere d by the directive. Such conformity assessment documents 
allow authorities an easy way of checking who has been responsib le for conformity 
assessment.  
For tasks where Member States  require legal metrological c ontrol there is often also a 
requirement for periodic verification of the inst ruments that are in-service This is always a 
national responsibility even where there has b een 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, whic h concerns the non-harmonised area, i.e. 
technologically more advanced instruments outsi de of the directives. In 1993, the cooperation 
of national authorities WELM EC (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 mu ltiple 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 member s of WELMEC, i.e. authorities of all EU Member States and 
Norway, Iceland and Switzerland) of their inte ntion to accept confor mity with an OIML 
Recommendation as the basis for a national type approval with little or no further examination 
where the instrument has already been gran ted approval in anot her signatory country
1. 
On the one hand, some experts indi cated that transposing the dire ctives had been imposed as a 
condition for EU membership a nd that there was no choice fo r new Member States but to 
have these directives in nati onal law. On the other hand, othe r experts indicated that New 
Approach harmonisation would allow a wider nu mber of routes to conformity assessment 
than currently allowed in natio nal laws (although they agree th at 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 wh ich are widely used. The current  situation does not seem to 
pose any problem and the repeal of the dir ectives 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 cons ultation and all contribu tions to it as well 
as the study report by RPA are available on the Europa website:
 http://ec.europa.eu/enterprise/pre pack/ms_inst/mi_directives.htm 
                                                
 
1 WELMEC European cooperation in legal metrology – An Introduction, p.9 
http://www.welmec.org/publicati ons/5thIssue_Introduction.pdf  
 
EN 5   EN Main conclusions per sect or are outlined in the Annex to the document.  
3. PROBLEM DEFINITION  
3.1. What is the issue or proble m that may require action? 
The Old Approach directives had the aim of a llowing harmonised goods to penetrate the trade 
barriers existing under differing nati onal regulations in the pre-Ca ssis de Dijon era. Operators 
could be sure that the technical specificat ions in the directiv es 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 Sta ndardisation Organisations and 
eventually also by the WTO-TBT agreemen t. Since 1983 mutual  recognition clauses 
concerning instruments and conformity assess ment procedures have been entered into 
national rules, also in the c ontext of the notification proce dure of Directiv e 98/34/EC. In 
addition since 1993 the WELMEC type approval agreement has given a framework for inter-
governmental cooperation regarding the mutu al recognition of conformity assessment 
specifically of non-harmonised measuring inst ruments 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 repeale d, would by so-doing not re surrect new barriers to 
trade. The expectation is that there would be no change compar ed to the current situation.  
It should be noted that Arti cle 2 of the Measuring Instrume nts 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 substantia l 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 probl em common to all sectors is th at there no longer is a need 
for EU legislation to create an internal mark et for these instruments and that the existing 
directives are less and less used. Due to techno logical development the existing directives are 
less and less applied. In some cases they may s till 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 argu ing in favour of regula tion motivate this by 
pointing out that they would n eed to regulate nationally. Howeve r, 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 regulatio n would be identical 
to the current one based on the directives. 
Table 1: EU legislation and st andards applied in the sectors 
Sector  Current 
Directive Related 
Standard  Other EU 
regulation Related 
Standard  
                                                 
2 Organisation Internationale pour la Métrologie Lé gale of which all Member States are member and 
which is recognaised under the TBT agreement as an international standards setting body. 
 
EN 6   EN Non-clean water 
meters 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 
R15/1970 Regl.824/2000 ISO 
7971/2:1995 
Ship tanks 71/349/EEC OIML 
R95/1990  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 requirement s and obliges mutual recognition of products 
legally marketed in other Member States. 
When barriers to trade exist or there is a la rge 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 specif ication that complies with the essential 
requirements in the Directive is allowed. Ther efore 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 c onformity, which for manufacturers can be an 
efficient option of complying wi th the essential requirements of the directive. The so-called 
blue guide
3 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 
available on: 
http://ec.europa.eu/enterprise/newapproach/legislation/guide/index.htm 
 
 
EN 7   EN 3.3. Who is affected, in what ways, and to what extent? 
Even though the sectors are small in turnover, the instruments a nd 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 vi rtually not applied and have been superseded 
by national laws based on intern ational standards which take  into account technological 
progress and these national laws are subject to mutual recogn ition. Where needed, consumer 
protection is thereby assured, whilst mutual recognition relieves manufacturers of multiple conformity assessment. It should be noted th at the mutual recogniti on principle (concerning 
non-harmonised goods, i.e. products subject to  national laws not based on harmonising EU 
directives) has recently been further clarifie d when the European Parliament and the Council 
adopted Regulation (EC) No 764/2008, wh ich 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 currentl y subject to national la w or not regulated at 
all, depending on the Member State. Manufacturer s do not report barriers to trade that would 
justify additional harmonisation through EU regulation. Consumer s and buyers of instruments 
would not be affected by the repeal because either  there are national laws in place or there is 
currently no protect ion. Consumers did not report lack of protection. Nati onal authorities 
would not be affected because most of the directives are less and less used. Authorities 
currently can use the WELMEC type approval ag reement 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 th e 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 no t expected to change. 
Without any new EU action, the old Directives would still ex ist until technical progress has 
completely overtaken the technological specif ications.. The old directives concern mostly 
outdated (non electrical) technol ogy. According to the RPA study, it is expected that the 
market will evolve quickly to  products more technologically a dvanced no longer covered by 
the old directives.  
3.5. Does the EU have the right to act – T reaty base, ‘necessity test’ (subsidiarity) 
and fundamental rights limits? 
Given the apparent lack of constr aints 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 Direct ives, therefore action at Community level is 
necessary and fully in line with the subsidiarity principle. 
4. O
BJECTIVES  
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.  
 
EN 8   EN The specific objective is to simplify the EU acqui s in the areas covered by eight old approach 
metrology Directives while maintaining the free circulation of the meas uring instruments in 
the internal market and not hinde ring technological progress.  
These objectives are fully in line with th e 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 servi ces on the Internal Market consistent with international 
standards. In line with better regulation and simplification, cha nges 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 meet ing the objectives and tackling the 
problem?  
The options under consideration have been set ou t in the Key Issues Do cument (for the public 
consultation) as follows: 
Option 1: Maintain the current regulatory framewor k 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. Unde r this option the free movement of measuring 
instruments within the Internal Market w ould implicitly rely on the Mutual Recognition 
Principle and horizontal legislation framing its  correct functioning. Rather than national 
regulation Member States could rely on the volunt ary application of European standards. For 
the updating and development of such standa rds the Commission could, if needed, give a 
mandate to the European Standardisation Orga nisations. Member Stat es 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 directiv es without any change to the MI Directive 
2004/22/EC. Option 3: Replace the current Directives by new ha rmonising legislation added into the 
Measuring Instruments Directive 2004/22/EC, the latter already providi ng a legal framework 
for certain measuring instruments under the New Approach. This option implies the inclusion 
of these new sectors into this New Approach Di rective. It does not al low 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 requirement s 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. 
 
EN 9   EN 6. ANALYSIS OF IMPACTS  
6.1. What are the likely economic, social a nd environmental impacts of each of the 
short-listed options? 
It was originally hoped that sufficient data would be obtain ed by the study consultant or 
otherwise to enable robust estimates to be ma de of the administrative costs associated with 
each of the options (outlined above). Although th is has not proved to be possible, attempts 
have been made to suggest (qua litatively 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 not ed 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 impact s 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 ex ist parallel to the old approach directive in 
order to cover technological a dvances. 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 cas e 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 scenar io 1C probably does not exist 
anywhere either.  
Scenario 1D is the case of no national rules. In this case the Old Approa ch 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 mark et, which would be difficult to take off the 
market, failing a law. This problem has only be en 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, bu t 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 ar e analysed. Both of these scenarios are fully 
in line with the principle of mutual recogniti on. They will allow products to freely circulate, 
whereby the WELMEC type appr oval agreement will provide information about conformity 
assessment needed for appropriate market surveillance.  
According to a UK local authority in the public  consultation most firm s 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 expans ion by small and medium sized businesses, 
notably due to the lack of barriers to trade afforded by mutual recognition.  
 
EN 10   EN 6.1.2.  Impacts of option 2 (Repeal the directives)  
Option 2 would continue to allow regulation by Me mber States as is already the case now.  
If a Member State would choose to regulate base d on international standards, there would be 
minimal costs, given that mutual recognition of conformity assessment and WELMEC type 
approval agreement would normally allow one c onformity 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 invo lve significant costs is where a Member State would try to 
impose a technology differing from international st andards. This case, however, looks highly 
improbable in the light of WT O/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 influe nced 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 inst ruments which comply with the essential 
requirements facilitating such compliance by re cognising international standards which can 
easily be updated, i.e. without adapting the direct ive. The directive allo ws a Member State to 
prescribe legal metrological cont rol as it thinks fit (opt-in th at 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 barrie rs to trade, the impacts of scenario 3A would 
conceivably be equal to scenario 1B. 
However, Article 2 of the same directive a llows 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 influen ced. European conformity assessment would 
replace national conformity assessment certifi cate 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, ther e is still some uncertainty 
about the existing situation in Member States . Authorities have until now not very clearly 
expressed themselves. According to the consu ltant's study, however, in  general the market 
place does not seem to be overly hindered by re gulation at the moment, which would dovetail 
with the apparent lack of complaints about ba rriers to trade being brought forward in the 
consultation. Nevertheless, sensitivity analysis will be provided below (Impacts of dynamics) of different possible responses of Member Stat es to a change of their regulatory framework. 
If the option of repeal would be chosen, it doe s not seem probable that Member States would 
suddenly increase national regulatio n, given that Member States could in the past already do 
 
EN 11   EN 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 vi rtually 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 meas urement in these sectors. National rules may 
continue to exist and new rules may be form ulated based on interna tional 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 opti ng out by a subs tantial number 
of Member States. 
7. C
OMPARING 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 obj ective: repeal (option 2) or 
re-regulation (option 3). Both options woul d achieve the objective of simplification and 
therefore other criteria are adde d to compare them. Only where the criteria differ per option 
have they been made explicit.  
It would appear that in this case where ther e are no reported barriers  to trade and no other 
overriding policy needs, there only remain the i ssues 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 in ternational standards 
(scenario 1B and 2A) or by harmonisation (scenar io 3A). When there are no laws, there is no 
guaranteed protection (scen arios ID, 2C and 3B) 
All costs are of an equal magnitude across the op tions, i.e. the low to medium administrative 
costs of scenario 1B are e qual 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 ch ange under any of the scenarios. 
Table 2: Impacts per option (scenario) (+ = benefit, - = cost) 
Scenario 1B 1D 2A 2C 3A 3B 
High level protection + 0 + 0 + 0 
Administrative costs - 0 - 0 - 0 
Total 0 0 0 0 0 0 
In the case of regulation (scenarios 1B, 2A an d 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. 
 
EN 12   EN The trade-off between protection benefits and administrative costs may exist for weights as 
concerns honesty of transaction and tyre pre ssure gauges as concerns performance, although 
harmonisation is nowhere required in the light of an overriding policy ne ed 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 discounte d in the EU market. Al so the benefits of a 
high level of protection are al ready being enjoyed under scenar io 1B and these costs and 
benefits will not change eith er 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) an d will opt-in under ha rmonisation (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 th e baseline option 1 (l ikely choice by Member 
States) 
Scenario 2A vs 1B 2C vs 1D 3A vs 1B 3B vs 1D 
High level protection 0 0 0 0 
Administrative costs 0 0 0 0 
Total 0 0 0 0 
 
EN 13   EN 7.3. Impacts of dynamics (uncertainty)  
There may be reasons for Member States to cro ss-over either to deregu late 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 a nd 4 of the Table 4 belo w). Deregulating would 
mean less guaranteed protection with a gain of no longer re quiring 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 regulati on 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 c hoice by each Member State in line with the 
principle of subsidiarity. It seems, however, qui te 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 ‘m oral’ 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 wheth er 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 (op tion 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 trad e, which would point to a failure of mutual 
recognition. Next to that there could be associ ated 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 Stat es would opt-out which would add 
an uncertainty that would compromi se 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 Appro ach directives being less and less used.  
The justification to repeal al l 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 
 
EN 14   EN 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 cu rrent situation of mutual recognition. This 
also given that a substantia l number of Member States are expected to opt-out of 
harmonisation, as is possible und er Art. 2 of the MID.  
8. MONITORING AND EVALUATION  
8.1. What is the broad outline for po ssible monitoring and evaluation 
arrangements? 
Stakeholders could bring up new evidence wh ich could lead the Commission services to 
consider, in the light of developments whet her new policy needs woul d require harmonisation 
in the future. Such new evidence, together with the option of expa nding the scope of the 
directive by means of additi onal MI-annexes, could be cons idered in the report by the 
Commission on the Measuring Inst ruments 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 in to account in this vers ion 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 senten ce only to a full page as well 
and also have been added the la st two sentences in the description of Op tion 3 in section 3.6. 
Table 1, which initially was in the anne x, has been moved forward to section 3.2. 
(2) “Clarify the current role of the directives”: This has be en taken into acc ount in section 3.2, 
notably the second and third sent ences of the first paragraph as  well as changes to section 3.4. 
 (3) “Clarify the impact on admi nistrative burden”: In section 7.1 the first paragraph has been 
added, paragraphs 4 and 5 rewo rded and the last paragraph added whilst in section 7.3 the 
penultimate paragraph and in section 7.4 the la st paragraph have b een 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. 
 
EN 15   EN ANNEX: Analysis of Sectors  
MARKET SIZE AND REGULATION  
In its study RPA has estimated the size of the ma rket currently covered by the directives and 
the additional sales of technologi cally more advanced alterna tives. 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 p er sector on the EU market, currently under 
a directive and additional due to t echnological innovation (million €) 
Sector  Annual turnover on the EU ma rket including imports and excluding 
exports (million €) 
 Only existing 
directive  Additional due to 
technical innovation Total: existing + 
new  
Non-clean water meters 40  4
Alcohol meters 2 6 8
Weights 30 0 30
Tyre gauges 3 70 73
Mass of grain 0.6 4 4.6
Calibration ship tanks 0.75 0 0.75
Total 40 80 120
(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 altern ative 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 la rge 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 environmenta l policy requiring such harmoni sation. In its reaction to the 
public consultation, the EU wate r manufacturing industry has as ked for the existing directive 
to be repealed and it does not require harm onised legislation for non-clean water meters. 
 
EN 16   EN Alcohol meters In their reactions to the public consultation two manufacturers of 
alcoholmeters and Scotch whiskey producers in dicate that harmonisation should incorporate 
and not inhibit technological i nnovation. They do not mention any trade barriers. The use of 
alcohol meters that could be different and mo re technological advan ced than those in the 
directive is already prescribed in the EU regul ations on wine and spirits drinks (Regl. 2676/90 
and 2870/2000). It would appear that these regul ations go much further than OIML and the 
directive. The regulations are directly ap plicable 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 instrument s, the use of which is currently already 
harmonised for all intents and purposes by mean s of these regulations for wine and spirit 
drinks. For beer on the other ha nd, there are no EU regulations. 
Alcohol tables  are covered by interna tional 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 concerni ng 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. Lo wer percentage alcohol tables would need to remain covered 
by national law based on interna tional standards. Alcohol tabl es 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 wei ghts. Experts of 17 Member States indicate 
that manual weighing still exis ts in shops and on markets a nd 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 dup licate 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 mon itoring systems (TPMS) in new cars (COM(2008)316). The 
proposal is to let new cars be equipped with a system for c ontinuous 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 inflate d. At this stage, it is not evident that 
harmonisation of tyre pressure gauges is requ ired 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 pos sibly 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 ther efore more advanced in struments than those 
in the directive are already prescribed by the AGRI regulation on cereals (Regl. 824/2000). 
This regulation references international/Europea n 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 instrument s, the use of which is currently already 
harmonised for all intents and purposes by means of the EU agricultural regulation. 
 
EN 17   EN 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, be cause 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 petrol eum 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 co ntrol 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 directiv e nor for more techno logically advanced 
instruments and there is widespread use of alternatives to the directives, many of which are based on international standards.