COMMISSION STAFF WORKING DOCUMENT REFIT- Evaluation of the pre-packaging legal framework Directives 75/107/EEC, 76/211/EEC and 2007/45/EC Accompanying the document REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL AND THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE on the application of the pre-packaging legal framework Directives 75/107/EEC, 76/211/EEC and 2007/45/EC
Date: 2016-07-04
Institutions: Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs, European Commission
Subjects: approximation of laws, consumer information, free movement of goods, intra-EU trade, market approval, marketing standard, measuring equipment, metrology, preparation for market, weights and measures

EN 

   EN 

   EUROPEAN COMMISSION  Brussels, 4.7.2016  SWD(2016) 219 final   COMMISSION STAFF WORKING DOCUMENT REFIT- Evaluation of the pre-packaging legal framework Directives 75/107/EEC, 76/211/EEC and 2007/45/EC Accompanying the document REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL AND THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE  on the application of the pre-packaging legal framework Directives 75/107/EEC, 76/211/EEC and 2007/45/EC  {COM(2016) 438 final}  
 
 
Table of Contents 

1 

INTRODUCTION ............................................................................................................................... 3 

1.1 

1.2 

Purpose of evaluation ............................................................................................................. 3 

Scope of the evaluation ........................................................................................................... 3 

2 

BACKGROUND ON THE DIRECTIVES ................................................................................................ 4 

2.1 

2.2 

Description of the directives and their objectives .................................................................. 4 

Baseline ................................................................................................................................... 8 

3 

EVALUATION QUESTIONS ................................................................................................................ 8 

4  METHODOLOGY ............................................................................................................................... 8 

4.1 

4.2 

Data collection and representativeness .................................................................................. 8 

Limitations – robustness of findings ........................................................................................ 9 

5 

STATE OF PLAY OF THE IMPLEMENTATION (RESULTS) ................................................................. 11 

5.1 

5.2 

5.3 

Implementation ..................................................................................................................... 11 

State of play ........................................................................................................................... 11 

Unexpected results in other areas ........................................................................................ 12 

6 

ANSWERS TO THE EVALUATION QUESTIONS ................................................................................ 13 

6.1 

Effectiveness .......................................................................................................................... 13 

6.1.1 
To what extent have the objectives been achieved? Which main factors have 
contributed or stood in the way of achieving those objectives? .................................................. 13 

6.1.2 

More internal market promoting growth and competitiveness ................................... 13 

6.1.3 

Better consumer welfare by more choice of sizes ........................................................ 14 

6.1.4 

Level playing field by means of market surveillance ..................................................... 15 

Are there any aspects/means/actors that render certain aspects of the Directives 

6.1.5 
more or less effective than others, and - if there are - what lessons can be drawn from this? ... 16 

6.1.6  What are, if any, the consequences or effects (either positive or negative) that were 
not originally planned? .................................................................................................................. 16 

6.2 

Efficiency ............................................................................................................................... 16 

6.2.1  What are the costs associated with the compliance with the directives and how do 
they compare to the benefits? Are the benefits achieved at reasonable costs (with focus on 
SMEs)?  16 

Taking into account the objectives and benefits of the directives, is there evidence 

6.2.2 
that the legislative requirements have caused unnecessary burden (e.g. administrative and 
reporting burden), especially for SMEs? ....................................................................................... 17 

6.3 

Coherence ............................................................................................................................. 18 

2 

 
 
 
To what extent are there overlaps/ complementarities between the Directives and any 
6.3.1 
other Union or Member State action in the relevant areas? To what extent are they coherent?18 

6.4 

Relevance .............................................................................................................................. 19 

To what extent are the objectives of the Directives still relevant in relation to the 

6.4.1 
stakeholders needs and overarching political objectives? What is the level of support of 
stakeholders for them? ................................................................................................................. 19 

6.4.2 

How well do the (original) objectives (still) correspond to the needs within the EU? . 19 

6.4.3 

How well adapted is the Directive to technical/international progress? ..................... 20 

6.5 

EU Added value ..................................................................................................................... 20 

6.5.1  What is the added value of the Directives for stakeholders? ....................................... 21 

To what extent do the issues addressed by the directives continue to require action at 

6.5.2 
EU level? 21 

7 

CONCLUSIONS ............................................................................................................................... 22 

ANNEXES ................................................................................................................................................ 23 

ANNEX 1: PROCEDURAL INFORMATION concerning the process to prepare the evaluation ........... 23 

ANNEX 2: STAKEHOLDER CONSULTATION – SYNOPSIS REPORT ....................................................... 26 

1.  Data Collection ...................................................................................................................... 26 

2. 

Findings .................................................................................................................................. 27 

The majority of consumers and consumer organisations think that the current packaging law 
satisfies their expectations. This is particularly the case for respondents who have noticed the 3-
mark (58% satisfied). For the e-mark the share of satisfied consumers is 48%. This compares 
favourably with the 14.86% and 16.67% respectively who are not satisfied. ................................... 28 

3. 

Information about any diverging views between or within stakeholder groups .................. 38 

ANNEX 3: EVALUATION QUESTIONS ................................................................................................. 39 

ANNEX 4: SUGGESTIONS BY AUTHORITIES ON TECHNICAL ISSUES .................................................. 40 

ANNEX 5: PRODUCT SPECIFIC DIRECTIVES ........................................................................................ 42 

ANNEX 6: UNION LEGISLATION PROTECTING CONSUMERS ............................................................. 44 

ANNEX 7: SUGGESTIONS FOR TECHNICAL/INTERNATIONAL PROGRESS .......................................... 45 

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1  INTRODUCTION 

1.1  Purpose of evaluation 

The  purpose  of  this  evaluation  is  to assess the  performance  of  the  legal  framework  for  pre-
packaging that is governed by three Directives:  Directive 2007/45/EC on nominal quantities 
for pre-packed products, Directive 75/107/EEC on bottles used as measuring containers and 
Directive 76/211/EEC on the making-up pre-packaged products (by weight or volume). This 
exercise aims at judging whether the Directives in their current form are fit for purpose and 
meet  their  objectives  (effectiveness)  at  acceptable  costs  (efficiency),  whether  they  are  still 
relevant  in  relation  to  stakeholders  needs  and  relevant  to  achieve  the  overarching  political 
objectives, i.e. promoting the internal market and regulatory simplification with the least red-
tape for SMEs, coherence with other EU policies and having EU added value. 

Article  9(1)  of  the  Pack  sizes  Directive  2007/45/EC1,  stipulates  that  the  Commission  has  to 
provide a report on application and effects of the Directive by 2015. Directive 76/211/EC was 
evaluated  in  20052  while  Directive  75/107/EEC  has  never  been  evaluated.  Since  the  three 
Directives  are  closely  related,  it  was  decided  to  take  this  opportunity  to  evaluate  the 
functioning of those three Directives in a consistent evaluative package and to link it to the 
Regulatory Fitness and Performance Programme (REFIT) of the Commission in 20143. 

1.2  Scope of the evaluation 

The  subject  area  of  the  evaluation  concerns  the  pre-packaging  directives  dealing  with  the 
measurement of quantities contained in pre-packaged goods and with their sizes.  

  Directive  75/107/EEC4  on  bottles  used  as  measuring  containers  provides  for  the  free 
circulation  of  3-marked  bottles.  Its  application  is  voluntary,  meaning  that  operators  can 
choose to apply EU law or not, but once they do so, the provisions of the Directive have to 
be  followed.  It  also  provides  for  market  surveillance  authorities  a  statistical  test  for  the 
content of the bottles; 

  Directive  76/211/EEC5  on  making-up  pre-packaged  products  (by  weight  or  volume) 
concerns the  quantity  indicated  on pre-packed  products.  It guarantees  free  circulation  of  
e-marked  pre-packages.  It  also  provides  a  statistical  test  for  the  market  surveillance 
authorities  of  the  quantity  in  the  pre-packages.  Just  as  Directive  75/107/EEC,  this 

1Directive  2007/45/EC of  the  European  Parliament  and  of  the  Council  of  5 September 2007  laying  down  rules  on  nominal 
quantities  for  pre-packed  products,  repealing  Council  Directives 75/106/EEC  and  80/232/EEC,  and  amending  Council 
Directive 76/211/EEC. 
2 Report on  packaging consultation
3COM(2014)368 and SWD(2014)192.  
4Council  Directive  75/107/EEC  of  19  December  1974  on  the  approximation  of  the  laws  of  the  Member  States  relating  to 
bottles used as measuring containers 
5Council Directive 76/211/EEC of 20 January 1976 on the approximation of the laws of the Member States relating to the 
making-up by weight or by volume of certain prepackaged products. 

, ENTERPRISE AND INDUSTRY DIRECTORATE-GENERAL, 24 August 2005 

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directive also falls under optional harmonization as it is the choice of the packer/importer 
to apply it; 

  Directive  2007/45/EC  on  nominal  quantities  of  pre-packed  products  introduced  total 
harmonization by prohibiting Member States to regulate on pack/bottle sizes up to 10L/kg 
whilst prescribing mandatory EU sizes wines and spirit drinks. It applies to all pre-packed 
products. 

The  geographical  coverage  is  the  European  Economic  Area;  the  evaluation  covers  a  5-year 
period starting on 1 January 2009 (2009 – 2013). 

The  evaluation  covers  the  part  of  the  production  chain  concerned  with  filling  and  labelling 
that are regulated by the directives. It concerns only the metrological aspect, not other aspects 
such  as  product  description,  nutritional  content,  ingredient  listing,  health  claims,  packaging 
materials, commercial practices and advertisement, and price labelling, which are subject to 
other pieces of Union legislation.  

2  BACKGROUND ON THE DIRECTIVES 

2.1  Description of the directives and their objectives 
In the 1960s, national laws and specifications concerning bottles used as measuring containers 
differed, notably as regards markings, and presented barriers to trade in the internal market. 
This  was  due  to  national  habits  and  these  obstacles  were  recognised  when  the  European 
Commission decided to harmonize the different national rules on nominal quantities, leaving 
the  choice  to  companies  operating  mainly  or  exclusively  in  their  home  markets  to  continue 
their practices based on national law without any need to change. The result of this effort was 
the  introduction  of  Directive  75/107/EEC  on  bottles  as  measuring  containers  and  Directive 
76/211/EEC on quantities in pre-packages.  

In  2000,  the  European  Court  of  Justice6  ruled  that  Member  States  are  precluded  from 
prohibiting the marketing of a pre-package having a nominal volume not included in the (non-
mandatory)  Community  range7,  which  is  lawfully  manufactured  and  marketed  in  another 
Member  State,  unless  such  a  prohibition  is  designed  to  meet  an  overriding  requirement 
relating to consumer protection, applies without distinction to national and imported products 
alike,  is  necessary  in  order  to  meet  the  requirement  in  question  and  is  proportionate  to  the 
objective  pursued,  and  that  objective  cannot  be  achieved  by  measures  which  are  less 
restrictive of intra-Community trade. As its point  of reference the Court  considered that  the 
“average consumer is reasonably well informed and reasonably observant and circumspect”. 

Therefore, in the context of the SLIM exercise for simpler legislation8, liberalisation of pack 
sizes (except for EU sizes for wines and spirits) was introduced in 2007. Based on an impact 
assessment9,  including  a  wide  consultation  of  all  interested  stakeholders,  it  aimed  in  many 

6European Court of Justice, Case C-3/99. Judgement of the Court (Sixth Chamber) of 12 October 2000. Cidrerie. 
Ruwet SA v. Cidre Stassen SA and HP Bulmer Ltd. 
7Non-mandatory sizes were laid down for many products by Directive 75/106/EEC and 80/232/EEC, next to mandatory sizes 
for wine and spirits. 
8Simpler legislation: SLIM-IV (COM (2000) 56 final-pp 9-11 & 21, 22 of 4 February 2000. 
9 SEC(2004) 1298, 25.10.2004 related to proposal COM(2004)708 final 

5 

 
 
 
 
                                                            
sectors, by means of free nominal quantities to increase the freedom of producers to provide 
goods according to consumer tastes and enhance competition as regards quality and price on 
the  internal  market.  In  wine  and  spirits,  however,  it  was  deemed  more  appropriate,  in  the 
interests  of  consumers  and  business,  to  retain  mandatory  nominal  quantities  for  the  time 
being. Consumer protection was considered already to be facilitated by the full application of 
then existing legislation, notably by the Directive on unit pricing10.  

The  three  Directives  are  closely  related  to  one  another.  Bottles  complying  with  Directive 
75/107/EEC  are  3-marked  and  can  be  used  as  measuring  containers  (but  need  not  be)  to 
comply with Directive 76/211/EEC allowing affixing the e-mark next to the nominal quantity 
indication. Both  these  Directives  are  optional  for  the  packer,  but  must  be  implemented  and 
market surveillance undertaken by Member States. The alternative to using the Directives is 
national  law  which  may  be  the  same  or  different  from  the  two  Directives.  However,  the 
possibility to affix the 3- or e-mark is not provided under alternative national law. The pack 
sizes Directive 2007/45/EC is mandatory for all prepacked products (and not only those 3- or 
e-marked)  –  it  prohibits  Member  States  to  regulate  sizes,  it  lays  down  fixed  EU  sizes  for 
wines and spirit drinks and it waives aerosols volumes from also being labelled by weight. 

Directive 75/107/EEC concerns bottles used as measuring containers, i.e. bottles that contain 
a  certain  quantity  of  liquid  depending  on  the  level  to  which  they  are  filled.  The  Directive 
requires the manufacturer to register himself ex-ante with the authorities and has obligations 
for precision and markings  whilst it provides a check by the  market surveillance authorities 
for statistically testing the quantity of the bottles. The Directive guarantees free circulation of 
the  bottles  marked  with  the  reverse  epsilon  mark,  3-mark,  which  is  defined  by  Directive 
2009/34/EC11. 

The Directive is optional in the sense that it is the choice of the manufacturer to apply it. His 
alternative is to apply national specifications and his products are then subject to the Articles 
of the Treaty concerning mutual recognition (Article 34-36 TFEU).  

The Directive dates from the 1970s when effectively national laws presented barriers to most 
trade  on  the  internal  market.  National  specifications  concerning  bottles  used  as  measuring 
containers  differed,  notably  as  regards  markings,  and  this  caused  barriers  to  trade.  The 
Directive led to a level playing field and was quickly adopted by industry as best practice. The 
statistical  test  provided  by  the  Directive  allows  for  regular  market  surveillance  and  gives  a 
legal basis for mutual trust by national authorities. 

There exist no international standards upon which the Directive is based. 

Directive  76/211/EEC  concerns  the  quantity  contained  in  pre-packed  products,  i.e.  the 
indicated  quantity  in  pre-packages  that  are  filled  without  the  consumer  being  present.  The 
Directive  contains  the  legal  requirements  for  precision  (so-called  tolerance)  and  markings 
whilst it provides a statistical test for the market surveillance authorities by which to check the 

10Directive  98/6/EC  of  the  European  Parliament  and  of  the  Council  of  16  February  1998  on  consumer  protection  in  the 
indication of the prices of products offered to consumers. 
11 Directive 2009/34/EC of the European Parliament and of the Council of 23 April 2009 relating to common provisions for 
both measuring instruments and methods of metrological control (recast of Directive 71/316/EEC). 

6 

 
 
                                                            
 
quantity of pre-packs during one hour of production. The Directive guarantees free circulation 
of  the  pre-packages  marked  with  the  lower  case  e-mark,  which  is  defined  by  Directive 
2009/34/EC, recast of Directive 71/316/EEC. The Directive is optional in the sense that it is 
the choice of the packer/importer to apply it. 

Should  a  packer  not  wish  to  apply  the  directive,  his  alternative  is  to  apply  national 
specifications  and  his  products  are  then  subject  to  the  Articles  of  the  Treaty  concerning 
mutual recognition (Article 34-36 TFEU). These national specifications may differ as regards 
the tolerances (more or less than in the Directive12) and markings (often no marking). 

The Directive dates from the 1970s when effectively national laws presented barriers to trade 
in prepacks on the internal market. The Directive led to a level playing field and was quickly 
absorbed into best practice. 

The  Directive  is  based  upon  international  standards,  i.e.  the  recommendations  of  the 
International  Organisation  for  Legal  Metrology:  OIML  R7913  and  OIML  R8714  prescribing 
the average system15, meaning that the quantity of one hour production of pre-packages must 
on average be equal to what is indicated. Laws of the EUs trading partners are also based on 
these  international  standards,  thus  giving  EU  exports  of  pre-packed  products  access  to  all 
world markets. 

Market surveillance consists of (quality) assessing pre-packaging procedures and, as defined 
by  the  Directive,  the  competent  authority  may  undertake  a  statistical  sampling  check  of  a 
batch of one-hour production, which takes place at the premises of the packer or importer. 

Directive  2007/45/EC  on  rules  on  nominal  quantities  for  pre-packed  products  (pack  sizes) 
extended  the  scope  of  Directive  76/211/EEC  to  include  all  liquids  and  repealed  two 
Directives.16 It freed all pack/bottle sizes up to 10L/kg whilst maintaining a reduced number 
of mandatory EU sizes for certain sizes of wines and spirit drinks. A phasing-out period for 
national sizes in certain other products was allowed until 2012/2013, in Member States that 
previously  had  such  laws.  Moreover,  it  waives  labelling  by  weight  for  aerosols  already 
labelled by volume17. 

The Directive is not based on international standards.  It is, however, based on the notion of 
"the  average  consumer  (being)  reasonably  well  informed  and  reasonably  observant  and 
circumspect" that the European Court of Justice takes as the point of reference in the area of 
pre-packaging and advertisement to consumers18.  

12Tolerances reduce depending on pack size: from  9% for up to a 50g pack to 1.5% for a kilo/litre pack and over (Directive 
76/211/EC, Annex 1, table 2.4). 
13 http://www.oiml.org/en/files/pdf_r/r079-e97.pdf. 
14http://www.oiml.org/en/files/pdf_r/r087-e04.pdf. 
15The  alternative  to  the  average  system  is  the  minimum  system  which  means  that  every  pack  is  filled  at  least  with  the 
indicated quantity. This system however is not the international standard and would mean filling 3-18% more, depending on 
the size of the pack. 
16Directives 75/106/EEC and  80/232/EEC. 
17Aerosol Dispensers Directive 75/324/EEC. 
18Case  C-3/99  Ruwet  v.  Cidre  Stassen/H.P.Bulmer  [2000]  ECR  I-08749,  paragraph  53,  Case  C-220/98  Estée  Lauder 
Cosmetics v. Lancaster Group [2000] ECR I-117, paragraph 27, Case C-210/96 Gut Springenheide and Tusky [1998] ECR I-
4657, paragraph 31. 

7 

 
 
                                                            
The  Directive  should  therefore  be  understood  as  being  complementary  to  other  harmonised 
EU law that directly or indirectly protects consumers: 
 Consumers are able to compare prices per litre or kilo (so-called unit prices), shown on the 
shelf directly next to the product as is required by the unit prices Directive19. In the case of 
downsizing  the  quantity,  the  price  per  kilo/litre  of  the  product  will  increase  relative  to 
competitors and this will be apparent from the unit price indication. 
 Consumers are protected from deception due to excessive packaging of products under the 
terms of the Packaging and packaging waste Directive20foreseeing that: "Packaging shall be 
so manufactured that the packaging volume and weight be limited to the minimum adequate 
amount  to  maintain  the  necessary  level  of  safety,  hygiene  and  acceptance  for  the  packed 
product and for the consumer." 
  Specific  rules  apply  to  pre-packed  foodstuffs,  for  example  concerning  the  additional 
indication  of  drained  weight  and  not  including  in  the  nominal  quantity  the  ice  (glaze) 
contained in frozen products21. 

Summarising, the objectives of the three directives are to enable free circulation (promoting 
internal  market  –  the  level  playing  field)  of  pre-packed  products,  contributing  in  turn  to 
market  growth  and  the  competitiveness  of  EU  industry.  By  means  of  coordinated  market 
surveillance,  consumers  are  guaranteed  the  quantities  that  are  indicated  on  the  packages 
contributing  to  consumer  welfare  whilst  deregulation  of  sizes  has  improved  consumer 
choice. In the case of wine and spirit drinks, the fixed pack sizes shield small business from 
demands  for  other  bottle  sizes  by  supermarkets  and  distributors,  thereby  improving 
competition. 

The intervention logic diagram makes these causalities explicit: 

Legal instrument 

Inputs 

Mechanisms 

Results 

Impacts 

19Directive 98/6/EC 
20Directive 94/62/EC Annex II, point 1(1). 
21Regulation (EC)  No 1169/2011 on the provision of food information to consumers. 

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2.2   Baseline  

Back  in  the  1960s  and  1970s,  barriers  to  trade  caused  by  discriminatory  national  rules 
nurtured home market champions. Under these conditions, mutual recognition under the EC 
Treaty  was  in  effect  blunted  to  virtual  non-existence.  The  jurisprudence  by  the  European 
Court of Justice at the end 1970s, sometimes referred to as Cassis de Dijon case-law, led to a 
clarification of the concept of mutual recognition of Treaty Articles 34-36 (TFEU) based on 
proportionality  of  national  law.  Steps  to  improve  the  implementation  of  the  Mutual 
Recognition  principle  have  been  taken  (e.g.  Regulation  (EC)  N°2008/764).  However,  the 
functioning  of  the  principle  is  not  optimal  yet22.  It  is  observed  that  producers  relying  on 
mutual  recognition  may  still  face  numerous  challenges  in  terms  of  managing  to  access  the 
internal  market.  Harmonisation  of  pre-packaging  offers  a  credible  alternative  to  avoid  such 
issues.  It  aimed  at  breaching  national  defences,  by  defining  packs  that  were  produced 
voluntarily (i.e. at the choice of the manufacturer) according to common EU law (e-mark, 3-
mark) in common mandatory (metric) units of measurement  and in common sizes allowing 
free  circulation  in  all  Member  States.  The  common  sizes  for  wines  and  spirits  became 
mandatory towards the end of the 1980s and early 1990s, meaning that any different national 
sizes were no longer allowed.  

3  EVALUATION QUESTIONS 

The  evaluation  assesses  the  effectiveness,  efficiency,  coherence,  relevance  and  EU  added 
value of the 3 Directives. To this end, a set of questions was defined to guide the analysis of 
the performance of the three legislative acts (see Annex 3) and are answered in section 6. 

4  METHODOLOGY 

The  evaluation  builds  on  a  report  by  an  external  consultant  conducted  during  one  year  and 
ending on 29 July 2015 [add web link to the published version]. 

4.1  Data collection and representativeness 

Data were collected by the external consultant by means of: 
- desk research: qualitative and quantitative analysis of existing documents and reporting;  
- qualitative interviews with EU officials;  
-  qualitative  interviews  with  officials  from  23  national  administrations  (all  EU  except  for 
France, Italy, Lithuania, Latvia and Malta);  
- qualitative interviews with 25 selected representatives from industry (15 European industry 
associations, 10 companies);  
-  online  surveys  targeting  consumer  organisations,  individual  firms,  industry  associations, 
national authorities; 

22 Evaluation of the Application of the mutual recognition principle in the field of goods,  June 2015 (see third 
last link on: http://ec.europa.eu/growth/single-market/goods/free-movement-sectors/mutual-
recognition/index_en.htm) 

9 

 
 
 
 
 
 
                                                            
- market analysis. 

- online open public consultation (EU survey via Your Voice) has been held from 13 January 
till 7 April 2015 in 22 languages. 

Main stakeholders are: 

1.  Consumers, Consumer organisations and NGOs 

2.  Producers of glass bottles and Bottle fillers  

3.  Packers (other than bottles) 

4.  Importers 

5.  Retailers (supermarket, shop, do-it-yourself store (DIY) often arranging for packing to 

be done 

6.  Wholesalers/distributors of pre-packaged products 

7.  Other legal persons arranging for the packing to be done 

8.  Industry federations in food and non-food and of SMEs 

9.  Competent departments (authorities) 

10. Market-surveillance authorities 

The  representativeness  of  the  on-line  survey  and  open  public  consultation  was  satisfactory. 
The online survey for industry received a total of 248 completed responses, 85% of which are 
companies situated in the EU. Approximately half of these respondents are SMEs. The great 
majority  (77%)  of  industry  survey  respondents  fall  under  one  of  the  three  following 
categories:  bottle  filler,  packer,  or  producer  of  pre-packaged  goods.  The  online  open  public 
consultation  received  109  industry  stakeholder  responses,  with  83  responses  coming  from 
SMEs. The responses were equally divided over all size categories of firms (micro to large). 
As  for  the  online  survey  for  consumer  associations,  the  response  rate  was  quite  low  (only 
twelve completed responses). However, the low response rate to the survey was compensated 
by the participation of consumers, consumer associations and NGOs in the online open public 
consultation  (150  responses).  While  35  responses  to  the  consumer  part  of  the  online  open 
public consultation came  from pre-packaging  “experts”, rather than consumers per se,  these 
do  not  differ  significantly  from  consumer  responses  and  they  have  all  been  included  in  the 
findings presented in the consultant report.  

4.2  Limitations – robustness of findings 
The  data  collection  presented  several  challenges.  These  are  summarised  below  and  more 
details are provided in Annex 1.  

Firstly, there are no systematically collected market data on the pre-packaging sector or on the 
number  or  share  of  companies  applying  the  Directives.  Pre-packaging  is  an  activity  which 
often  takes  place  within  larger  companies  that  produce  pre-packaged  products  (e.g.  food 
products). However, pre-packaging itself is only a very small subset of the activities of these 
companies. Furthermore, no secondary data exist on the application of the e-mark or 3-mark, 
either  in  commercial  or  public  databases.  The  consultant  collected  this  information  from 
primary  data  sources  (surveys  and  interviews  with  industry  associations  and  national 
authorities). Therefore, estimates of market size, market share of the marking Directives and 

10 

 
 
 
 
 
related  compliance  costs  need  to  be  interpreted  with  care  and  they  should  be  seen  as 
indications of an order of magnitude rather than as precise point estimates. Furthermore, no 
information was available from primary sources on the use of the markings among imports. 

Secondly, given the large geographic, sector and size coverage of the evaluation, there were 
significant  challenges  because  of  the  limited  number  of  company  interviews  that  could  be 
carried out and the consultant took measures to try to ensure representativeness. 

Thirdly, a major challenge lay in the relative lack of stakeholder engagement and difficulty in 
identifying individuals who would be prepared and sufficiently knowledgeable to contribute. 
Indeed, as the results clearly indicate, the majority of stakeholders are relatively satisfied with 
the status quo and they do not see the need for a major revision of the Directives or the current 
pre-packaging regime. Similarly the number of importers who contributed is relatively small. 
This may lead to an over-estimation of the perceived « problems » with the Directive which 
needs to be kept in mind when drawing conclusions and formulating recommendations.  

Summarizing, the consultant interviews would seem representative in the case of industry and 
industry  associations  as  well  as  23  authorities23.  The  consultant  survey  of  consumer 
organisations did not have a full response, even though all national and European consumer 
organisations known to the Commission were invited to respond.  

Given that it was extremely difficult to capture the impacts of the 3 directives on the internal 
market, competitiveness and improved competition, the benefits are described in a qualitative 
way.  

23 France, Italy, Lithuania, Latvia and Malta did not respond 

11 

 
 
 
 
 
 
                                                            
5  STATE OF PLAY OF THE IMPLEMENTATION (RESULTS) 

5.1  Implementation 

All  Member  States  have  transposed  and  implemented  the  Directives.  Authorities  and 
stakeholders  in  WELMEC24  have  inventoried  differences  between  Member  States  in  their 
Guide  6.10  which  is  published  on  the  public  web25,  with  the  aim  to  focus  attention  of 
authorities when deciding on which guidance to make. 

WELMEC guide 6.10 and consultant report findings show that: 

 

in many Member States national laws are not different from the optional directives, so 
that many 3- and e-marked products are in fact the same as non-marked products; 

  some  countries  require  down-payment  fee  when  first  assessing  a  packer  or  importer, 
although  industry  considers  these  amounts  not  to  be  excessive,  they  might  deter  some 
firms; 
in some countries controls of 3- and e-marked products are more frequent, but the survey 
showed that at least 70% of packers are controlled once every one or two years; 

 

  Consultant  analysis  showed  there  are  differences  in  the  way  directive  76/211/EC  is 
implemented in national legislation. In some countries26, its rules and requirements are 
implemented directly in the national legislation meaning that in practice, all companies 
have  to  comply  with  it  in  these  countries,  whether  or  not  they  use  the  e-mark.  The 
analysis showed also that in some countries, companies have to apply or pay for the e-
mark, leading to some differences in market surveillance controls27. 

These  differences  in  national  implementation  concern  administrative  and  production  control 
processes  and  do  not  lead  to  differences  in  outcomes  as  regards  the  harmonised  products 
placed on the market.  

As  regards  the  temporary  allowance  to  maintain  existing  national  sizes  in  certain  sectors 
(milk,  butter,  dried  pasta,  coffee  until  2012  and  white  sugar  until  2013)  only  one  authority 
mentioned  the  extension,  namely  for  dried  pasta.  The  reason  mentioned  was  to  protect 
consumers who were used to very specific types of packages, but when the exemption ended 
the size of these products did not change, in fact. 

5.2  State of play 

As  regards  market  surveillance  under  Directive  76/211/EEC  there  are  various  approaches. 
Findings based on WELMEC Guide 6.10 and from interviews by the consultant show that 

24WELMEC is the European Cooperation on Legal Metrology and consists of authorities of all EU Member States, EEA 
states and enlargement countries. All are also member of the International organization of Legal Metrology (OIML). Non-
authority stakeholders also participate in the working groups of WELMEC, of which working group 6 concerns itself with 
prepackaging for which it has written comprehensive guidance. 
25http://www.welmec.org/fileadmin/user_files/publications/WELMEC_06.10_Controls_on_Prepacked_Products_wp6-
10_issue. 
26 E.g. Austria, Belgium, Estonia, Spain, Croatia, Poland, Portugal, Romania, Slovakia, UK 
27 Details on specific situations in some Member States can be found in Chapter 7.2 of the Consultant report. 

12 

 
 
                                                            
  Eight Member States base their market surveillance on risk of non-compliance based 
on past assessment28, which leads to more frequent checks for companies performing 
less well in terms of quality assurance.  

  Most  do  a  system  quality  check  as  well  as  the  reference  test  described  in  Directive 

76/211/EEC. 

  Next  to  the  8  who  do  risk-based  checks,  9  do  annual  checks,  4  do  a  check  every  2 

years and 3 a longer interval. (4 Member States are missing) 

  Some countries check non-e-mark packers with the same frequency others less often.  
 
Importers are mentioned by some as being difficult to find, for example because they 
are not registered as such or they change products and sources regularly. 

  Budget cuts have led to fewer checks, but keeping better records of past visits has led 

to authorities becoming 'smarter'. 

Use of the directives based on survey results is as follows: 

  3-marked bottles are used by 60% of large firms and by 40% of SMEs. 
  Two thirds of glass bottle manufacturers produce 3-marked bottles. 
  E-mark filling is used by 80-90% of large firms and by 70% of SMEs 
  Estimated  number  of  enterprises  using  the  3-  and  e-markings  is  92  glass 
manufacturers,  3,300  bottle  fillers  and  96,000  packers,  giving  640.000  full  time 
employed (0.3% of EU employment). 

Drivers for usage of the 3- and e-marked Directives:  

  As best practice, directives have become part of routine production process design 
  Directives  facilitate  trade  (one  third)  and  transparency  of  compliance  with  market 

surveillance (one third) 

  Not using the directives is mainly because it is allowed to use the national alternative 

and because of concentration on the home market. 

5.3  Unexpected results in other areas 

Stakeholders did not identify any significant negative unintended consequences. One positive 
effect  identified  by  national  authorities  is  the  recognition  of  the  e-mark  system  (Directive 
76/211/EEC) in countries outside the EU. 

As a positive spill-over effect the industry points out that there are unexpected environmental 
benefits  associated  with  all  three  Directives.  Greater  efficiency  in  logistics  (associated  with 
the  scale  effect  due  to  fixed  sizes  in  the  2007  Directive)  has  led  to  lower  emissions  from 
transport  whereas  the  harmonisation  afforded  by  e-  and  3-marking  of  bottles  provides  an 
incentive  for  producers  to  use  lightweight  glass  to  reduce  costs  of  transport  which  is 
beneficial  to  the  environment.  In  the  absence  of the  markings,  there  may  not  have  been  the 
incentive  for  producers  to  develop  light  glass,  thus  not  decreasing  packaging  relative  to  the 
volume of product sold.  

28 This "risk of non-compliance" is different from the "serious risk to the health of) users" referred to in Regl (EC) 
N°765/2008 on market surveillance 

13 

 
 
 
                                                            
A  second  effect  is  that  industry  considers  the  e-mark  to  be  a  favourable  marketing  aspect 
because consumers know the mark and like it. 

6  ANSWERS TO THE EVALUATION QUESTIONS 

6.1  Effectiveness 

6.1.1  To what extent have the objectives been achieved? Which main factors have 

contributed or stood in the way of achieving those objectives?   

The three Directives meet the objectives that they aimed to reach i.e. by means of contributing 
to enhancing the internal market, facilitating trade within the Union, increasing market growth 
and  competitiveness  and  boosting  consumer  welfare  by  means  of  offering  more  choice  of 
sizes of products and protection of consumers by means of appropriate market surveillance.  

6.1.2  More internal market promoting growth and competitiveness 

The  main  driver  for  industry  behind  the  use  of  both  markings,  based  on  the  consultation 
process, is to ensure that their products can be sold anywhere in the EU. The Directives have 
harmonised how companies market their products and they are now a standard part of product 
labelling. Furthermore, industry does not identify any major barriers to the implementation of 
any of the three Directives that would negatively impact the internal market.  

As  it  proved  difficult  to  link  directly  the effects  of  the  directives  to  the  trade  flow,  because 
trade figures do not reflect whether the Directives or national law have been applied, survey 
results could serve as a proxy. An indication of growth in an efficient internal market is that 
turnover since 2009 was up in 40% of companies answering the industry survey and online 
open  public  consultation  (against  down  in  10%  and  50%  no  change)29  whilst  employment 
went up in 20% of companies (against down in 10% and 70% no change)30. 

Also  there  are  some  indications  that  the  mandatory  pack  size  Directive  has  promoted  more 
diverse sized prepacked products in the EU. According to the industry survey and online open 
public  consultation,  approximately  half  of  producers  and  packers  introduced  different  pack 
sizes  over  the  last  five  years  (larger,  smaller,  and  both  larger  and  smaller).  This  result 
illustrates the existing interest on behalf of industry to produce and sell pre-packaged goods in 
wider diversity of sizes. Interestingly, survey and consultation results also show that in fixed 
sizes  sectors  (wines  and  spirits),  a  number  of  respondents  (27%)  also  indicated  having 
introduced a wider range of packs or bottle sizes over the last five years31. 

In terms of social and competitiveness impacts and benefits:  from a social point of view, the 
pre-packaging  sector  provides  for  an  estimated  640,000  full  time  employment  –  though  not 
solely attributable to the Directives – which is significant.  
In terms of competitiveness, three types of impacts can be distinguished:  

29Consultant report, Annex 6, graph Q6, p.139. 
30Consultant report, Annex 6, graph Q9, p.142. 
31Consultant report, 8.1.2, p.68. 

14 

 
 
 
 
                                                            
o 

o  Cost  competitiveness  is  not  negatively  affected  by  the  marking  Directives 
because  they  are  a)  optional  and  b)  do  not  impose  significant  costs  on 
companies.  In  addition,  many  imported  goods  that  are  sold  throughout  the 
Single Market also use the Directives;  
International competitiveness is improved because the two marking Directives 
have facilitated trade across the Single Market and (in some cases) beyond the 
EU and 
Innovation  competitiveness  is  improved  by  the  liberalisation  of  pack  sizes 
(except for wines and spirits) which has brought a greater variety of pack sizes 
and bottles to the market.  

o 

6.1.3  Better consumer welfare by more choice of sizes 

As regards pack sizes consumers are broadly supportive of the current situation. Two thirds of 
consumers think wine and spirits sizes should remain fixed by law and more than half want 
sizes outside wines and spirits to remain free. These findings should be considered in the light 
of  the  approximately  half  of  producers  and  packers  having  introduced  different  pack  sizes 
over  the  last  five  years  (larger,  smaller,  and  both  larger  and  smaller).  There  would  clearly 
seem  to  be  an  increase  in  the  variety  of  consumer  choice  which  is  valued  as  such  by 
consumers.  The  reported  relatively  high  percentage  of  firms  controlled  by  authorities  (see 
next chapter) and compliance rate seems to confirm that indeed, protection of consumers in 
relation to the quantities they are providing is ensured. 

About  half  of  consumers  have  never  noticed  the  3-mark  which  is  not  surprising  since  this 
marking  is  not  meant  directly  for  end-consumers  but  for  businesses  that  use  bottles  as 
measuring  containers  and  for  authorities  for  market  surveillance  purposes.  About  55%  of 
consumers  are  not  familiar  with  the  e-marking  (either  because  they  have  never  seen  it  or 
because they do not know what it means). In this case there is a lack of awareness in the sense 
that the consumer is assured that the (EU) law has been applied. Industry considers the e-mark 
to be a favourable marketing aspect because consumers know the mark and like it.  

Two thirds of consumers who responded to the online open public consultation rarely or never 
doubt  the  content  of  the  pre-packaged  products  that  they  purchase  (Annex  2,  Figure  6). 
National  authorities  consider  that,  as  a  result  of  the  e-mark,  consumers  are  informed  more 
consistently across the EU about nominal quantity than would otherwise be the case. 

Consumer concerns relate primarily to the risk of being misled by deceptive packaging (e.g. 
air in pack, bag in box, extra packaging material in the pack, dark and non-transparent glass, 
oval  shaped  (cosmetics)  bottles  to  increase  the  area  in  the  consumer  vision)  and  drained 
weight/desiccating products. Authorities point out that liberalisation of pack sizes (other than 
wines  and  spirits)  is  not  an  obstacle  to  consumer  protection  because  mandatory  unit  prices 
(Directive  98/6/EC)  allow  consumers  to  compare  prices  of  products  in  a  simple  and 
transparent way.  

15 

 
 
 
 
Regarding  the  exception  for  wines  and  spirits  in  Directive  2007/45/EC,  six  Member  States 
suggest removing the exception since unit prices address the issue from a consumer protection 
point  of  view  but  five  Member  States  say  that  the  exception  should  be  kept  to  protect 
consumers  and  the  remaining  ten  Member  States  think  that  there  are  both  advantages  and 
disadvantages  to  either  option  and,  in  the  absence  of  complaints,  the  status  quo  should  be 
maintained.  

The  development  in  prices  of  alcoholic  beverages  broadly  tracked  that  of  food  and  non-
alcoholic beverages with year-on-year increases averaging 2.6% in the 2005-2009 period and 
2.3% thereafter32. There appears to be no upward shift in the price trend after 2009 coinciding 
with the freeing of pack sizes. 

6.1.4  Level playing field by means of market surveillance 

The main contribution of the e- and 3-marking Directives is that they have increased trust and 
understanding among market surveillance authorities and thereby facilitated the operation of 
the Single Market. This is particularly relevant given the results of a recent evaluation of the 
principle  of  mutual  recognition  which  finds  that  lack  of  trust  in  the  authorities  of  other 
Member  States  is  a  key  barrier  to  the  free  movement  of  goods.  As  a  result,  the  Directives 
enjoy broad support from national authorities.  

Survey results show that 70% of companies are inspected on compliance at least once every 2 
years. National authorities indicate that limited resources, the low priority of pre-packaging as 
a result of there not being many issues in relation to consumer complaints, and the adoption of 
smarter (risk based) controls means controls specific to pre-packaging are not more frequent.  

Smart  (risk  based)  controls  seem  to  be  extremely  effective  where  the  packaging  process  is 
quality  assured,  which  is  nowadays  generally  the  case  in  fully  automated  batch  packaging 
installations.  Market  surveillance  then  is  about  checking  the  reporting  mechanism  which 
allows  retroactively  controlling  the  compliance  of  each  batch  in  the  case  of  a  complaint.  It 
would seem that the percentage of inspections is adequate in relation to consumer protection. 

However  the  perception  of  market  operators  (packers,  bottle  fillers,  distributors  and 
importers) that there are differences between the approaches in various jurisdictions indicate 
that there is apparently a need to further reinforce cooperation by competent departments and 
to better hone best practice and adaptation to technological innovation within the remits of the 
legislation. In line with the emphasis on improving market surveillance in the context of the 
follow-up  to  the  Single  Market  Strategy  more  regular  and  more  representative  meetings  of 
authorities could be envisaged. 

32Eurostat "Harmonised index of consumer prices", Consultant report, figure 8 on p.34. 

16 

 
 
 
 
 
                                                            
6.1.5  Are there any aspects/means/actors that render certain aspects of the Directives 
more or less effective than others, and - if there are - what lessons can be drawn 
from this? 

Industry  does  not  identify  any  major  barriers  to  the  implementation  of  any  of  the  three 
Directives.  For  instance,  for  the  coffee  industry,  potential  barriers  to  free  movement  relate 
mainly to other labelling requirements and languages used on labels (which are not the subject 
of the 3 Directives).  

In the light of the perception that national approaches in applying EU law may differ, it would 
seem that a more coherent approach on an EU-wide scale could help realise the full potential 
of the level playing field on the internal market.  

Some  national  authorities  pointed  to  issues  relating  to  Directive  76/211/EEC,  that  they 
consider to be relatively small, but that would represent in their views possible opportunities 
to  further  harmonise  the  EU  market33,  see  Annex  4  for  more  details.  Those  issues  concern 
viscose  products  in  mass  or  volume,  wrappings  with  pre-packages,  the  control  of  activities 
carried out by importers. 

6.1.6  What are, if any, the consequences or effects (either positive or negative) that 

were not originally planned? 

From an environmental point of view industry reports that the 3 directives have facilitated the 
development  of  light  glass  and  improved  logistics  which  in  turn  leads  to  lower  transport 
emissions (see §5.3 above).  

6.2  Efficiency  

6.2.1  What are the costs associated with the compliance with the directives and how do 
they compare to the benefits? Are the benefits achieved at reasonable costs (with 
focus on SMEs)? 

On  the  whole,  the  costs  associated  with  the  use  of  optional  markings  are  low  and  deemed 
affordable  by  stakeholders  considering  the  benefits  the  three  directives  bring.  Furthermore, 
there  are  no  significant  one-off  or  recurring  costs  to  the  pack  size  Directive  (2007/45/EC) 
which simply liberalises pack sizes for most sectors. 

The  different  types  of  costs  to  be  considered  are  the  one-off  costs  related  to  investment  in 
equipment and the recurring costs of complying with the Directives (including administrative 
burden). 

It is estimated that the total one-off cost of the marking Directives across the EU 28 at EUR 
440  million34  (=1.3%  of  annual  value  added).  The  majority  of  these  costs  would,  however, 
also  be  incurred  in  the  absence  of  the  optional  marking  Directives  since  the  requirement  to 

33Industry interviewees did not raise any barriers when asked this question. 
34Consultant report, p.74:. 

17 

 
 
 
 
 
 
                                                            
indicate nominal  quantity would remain. Most of these  costs were incurred a long time ago 
but given the relatively low cost of weighing equipment, new market entrants are unlikely to 
perceive costs as an obstacle to taking up the markings. Some Member States impose fees on 
companies using the markings but where data were available the level of these fees was rather 
low and they are unlikely to act as a significant disincentive for companies (including SMEs) 
wanting to use the markings.  

Depending on the way in which they are implemented at national level, recurring costs mainly 
relate to the recognition of the procedures by the competent authorities at national level. They 
can include  

  costs associated with receiving or producing evidence of nominal quantity,  

  costs associated with sampling pre-packages;  

  costs  associated  with  inspection  (time  and  any  fees  levied  by  the  national  authority 

where applicable);  

  costs associated with the application and use of the 3- and e-mark (where applicable).  

It should be noted that all of these costs (except for the last one) would be incurred in whole 
or  in  part  irrespective  of  the  use  of  the  marking  as  part  of  general  market  surveillance  and 
control of nominal quantity. The annual costs imposed by the Directives were reported in the 
surveys to in the order of 1% and they were not mentioned as being a disadvantage by SMEs 
or as being significant by industry interviewees in general. 

The rather limited costs are proportionate to much more extensive (albeit difficult to quantify) 
benefits  of  the  Directives  which  include  improved  free  movement  of  goods,  enhanced 
consumer  protection,  greater  harmonisation  of  packaging  practices,  recognition  of  high 
quality  procedures  between  companies,  consumers  and  authorities,  consensus  and  trust 
between  Member  States  and  a  clear  definition  of  tasks  and  responsibilities  of  products 
including a legal framework for enforcement. 

6.2.2  Taking into account the objectives and benefits of the directives, is there evidence 

that the legislative requirements have caused unnecessary burden (e.g. 
administrative and reporting burden), especially for SMEs? 

In support of the above conclusion, cost issues were not mentioned by industry interviewees 
as particularly significant and there is a widespread perception that costs of the Directive are 
proportionate  to  the  benefits  (i.e.  facilitation  of  the  Single  Market  and  market  surveillance, 
building consumer trust). Administrative burdens are seen as minimal35:  

  Administrative  burdens  are  seen  as  negligible  with  industry  generally  unable  to 

 

provide any evidence of unnecessary administrative burdens;  
the spirits industry argues that there is little administrative burden associated with the 
Directives.  

35Consultant report, pp. 73, 75, 77 and 93. 

18 

 
 
 
                                                            
  The  key  benefit  is  that  by  using  the  marking  Directives,  administrative  burdens  are 
seen as minimal as compared to what might be required under mutual recognition in 
case market access would be denied by the Member State of destination.  

  On the whole, the costs associated with the use of optional markings appear to be low; 
  This  includes  one-off  costs,  fees  (applicable  in  some  countries)  and  administrative 

burdens, none of which were raised as important by industry. 

However, while the overall burden remains very low, the cost burden on SMEs linked to the 
use of the marks does appear to be slightly higher than for large companies36: among 3- and e-
mark users, 70% of SME respondents indicate the cost of the marking is less than 1% of their 
annual turnover, compared to 77% for large companies. 

Finally,  enforcement  costs  vary  substantially  between  Member  States.  These  differences 
relate to the size of the country, the number of companies using the markings, and not least, 
the  way  in  which  enforcement  of  the  Directives  is  organised  at  national  level.  In  some 
countries  enforcement  is  the  responsibility  of  local  governments,  while  most  have  central 
government  departments.  In  some  countries  costs  are  partly  offset  by,  companies  have  to 
apply and pay for a certificate in order to use the e-mark. Elsewhere national authorities carry 
the full burden of inspections themselves. However, this can happen where subsidiarity comes 
into play as is the case with Directives. 

None  of  the  national  authorities  criticise  any  of  the  Directives’  provisions  regarding  market 
surveillance and they consider that the benefits of the Directives outweigh the costs and that 
the  additional  costs  are  not  very  high  given  that  inspections  would  continue  even  in  the 
absence of the Directives on e- and 3-markings. 

6.3  Coherence 

6.3.1  To what extent are there overlaps/ complementarities between the Directives and 

any other Union or Member State action in the relevant areas? To what extent 
are they coherent? 

None  of  the  stakeholder  groups  identified  any  significant  overlaps  or  complementarities 
between the Directives and other EU or national action.  

According to the external consultant, some national authorities mentioned limited overlaps of 
some  product-specific Directives  and  Directive  76/211/EEC,  without being  too  specific,  see 
Annex  5  for  a  detailed  list  of  reported  legislation  (e.g.  legislation  on  cosmetics,  detergents, 
fertilizers,  food  information  regulation  conflicting  with  Directive  76/211/EEC  and  the 
aerosols  directive  conflicting  with  Directive  2007/45/EC.).  In  all  these  cases  concerning 
Directive  76/211/EEC,  there  is  no  contradiction  but  complementarity  instead  between  the 
mentioned  EU  laws  in  the  sense  that  they  give  the  requirements  to  be  fulfilled  when  the 
optional directives are not followed. The choice for e-marking is voluntary and, if chosen, it 
leads to additional requirements that are particular to Directive 76/211/EEC.  

36Consultant report p. 75:. 

19 

 
 
 
 
 
                                                            
A perceived conflict of Directive 2007/45/EC (equal to its predecessor Directive 80/232/EEC 
in this respect) with the Aerosols Directive is not a real conflict because every Member State 
implements Directive 2007/45/EC by giving an exemption to all aerosols (since 1982). How 
such should best be legally formulated can be taken account of in the current evaluation of the 
Aerosols Directive37. 

Several pieces of Union legislation are in place to protect consumers which are relevant for 
pre-packaging as indicated in Annex 6 (e.g. directives on packaging and packaging waste, on 
business practices deceiving consumers, on unit price indications and on food labelling) but 
no overlaps or inconsistencies were noted.   

6.4  Relevance 

6.4.1  To what extent are the objectives of the Directives still relevant in relation to the 

stakeholders needs and overarching political objectives? What is the level of 
support of stakeholders for them? 

Overall,  all  three  Directives  are  still  seen  as  highly  relevant  to  consumer,  industry  and 
authorities' needs for correctly filled pre-packs.  

The e- and 3-marking Directives are widely used by industry though coverage is somewhat 
higher among larger companies than among SMEs. Indeed, smaller companies are more likely 
to take advantage of the voluntary nature of the e- and 3-markings and they use national law 
because they mainly produce for the national market.  

The  main  reasons  for  companies  to  use  the  e-marking  and  3-marking  Directives  are  in  line 
with their political objectives. Of those who apply the 3-mark 84% do so either to facilitate 
trade or to facilitate compliance with market surveillance. For the e-mark, the main driver of 
usage is more evenly split between facilitation of trade (37%), market surveillance (30%) and 
customer requests / market demand (30%).  

Regarding the pack size Directive (2007/45/EC), the majority of respondents to the industry 
survey and online open public consultation - including more than 70% of bottle fillers - agree 
or strongly agree that for wine and spirit drinks, bottle sizes should continue to be fixed by 
law.  In  addition  to  bottle  fillers,  support  is  particularly  strong  among  retailers,  wholesalers 
and distributors of pre-packaged goods. At the same time, for non-wine and spirits products, 
most respondents agree that producers should remain free to choose pack sizes (e.g. 60% of 
packers  (other  than  bottles),  50%  of  bottle  fillers)).  Finally,  approximately  half  of  all 
producers have introduced different pack sizes since the 2007 Directive came into force. 

The widespread support by consumers and authorities is discussed in the next paragraphs.  

6.4.2  How well do the (original) objectives (still) correspond to the needs within the 

EU? 

Industry and consumers are very supportive of all 3 Directives because they consider current 
EU  law  fits  their  needs  and  they  do  not  see  a  need  for  fundamental  change  in  the  current 
regime.  

37 Evaluation of the Aerosol Dispensers Directive: 
http://ec.europa.eu/smart-regulation/roadmaps/docs/2017_grow_001_evaluation_aerosol_en.pdf 

20 

 
 
 
                                                            
1.  Levels of dissatisfaction with the e- and 3-marks among consumers are low at 15-17% and 
national  authorities  confirm  that  there  have  been  very  few  complaints  from  consumers 
regarding  the  Directives.38  Similarly,  for  Directive  2007/45/EC,  only  17-18%  of 
consumers disagree with the status quo in terms of regulation of pack / bottle sizes. Like 
the  total  of  consumers,  among  those  who  disagree  with  the  current  regulatory  regime, 
there are no clearly discernible patterns regarding desired changes with some arguing for 
less regulation and others for stricter rules,  

2.  Only  20%  of  industry  respondents  to  the  survey  and  consultation  indicate  that  they  are 
dissatisfied with the law on pre-packaging and where there is dissatisfaction this is mainly 
due to the perception of strict national application and a certain tolerance towards imports 
from outside the EU. Interviews with industry associations are even more supportive and 
there  support  from  the  sector  representations  to  the  Directives  as  they  consider  that  the 
current pre-packaging regime works well, at reasonable costs and suits their needs.  

3.  Corroborating  these  results,  all  22  interviewed  national  authorities  also  feel  that  the 
objectives  of  the  Directives  are  indeed  still  relevant  today.  Nearly  all  authorities 
emphasise  the  importance  of  removing  any  barriers  to  trade  and  correctly  informing 
consumers about the nominal weight or volume contained in pre-packages.39 

6.4.3  How well adapted is the Directive to technical/international progress? 
Several authorities point to the fact that there have only been a few adaptations to Directive 
76/211/EEC and Directive 75/107/EEC over time. Interviewees noted that the Directives are 
designed  in  such  a  way  that  they  allow  for  technological  progress  without  losing  their 
relevance  or  applicability.  Also  Directive  2007/45/EC  is  considered  to  be  up-to-date  and  in 
line with today’s consumer preferences. 

While industry and authorities are generally satisfied with the applicability of the Directives 
to  current  operations  within  firms  and  with  their  “fitness  for  purpose”,  some  raised  issues 
about  expanding  the  scope  of  Directive  76/211/EEC,  see  Annex  7.  These  issues  relate  to: 
products sold by length, area or number (few products and already covered by national law); 
drained weight (no international standard), larger weight/volume of pre-packs (few products 
and  already  covered  by  national  law),  speed  of  production  and  samples  of  pre-package 
batches. As these issues relate to technical and/or international progress  they are and should 
remain subject of prospective research by stakeholders as is currently the case in WELMEC. 

6.5  EU Added value 

38This  figure  needs  to  be  interpreted  with  care  since  a  large  share  of  consumers  indicate  not  knowing  the  marking  or  its 
significance. In addition, consultation results also show that, when prompted, less than one third of consumers “sometimes” 
doubt the quantity of prepackages. However, these doubts do not translate into actual consumer complaints that are picked up 
by national authorities. 
39Only  one  authority  questioned  the  relevance  of  one  of  the  Directives,  namely  Directive  75/107/EEC  on  bottles  used  as 
measuring containers. The authority argues that given the fact that Directive 76/211/EEC has to be complied with anyway in 
order to be able to use the e-mark, the relevance of the 3-mark Directive is limited (and only exists for those companies bying 
the bottles from producers). 

21 

 
 
 
                                                            
6.5.1  What is the added value of the Directives for stakeholders? 
There is  a general  consensus among all  stakeholders that the Directives generate significant 
added value.  

Consumers  are  broadly  supportive  of  the  current  situation,  irrespective  of  whether  they  are 
aware  of  the  markings  or  not.  Two  thirds  of  consumers  think  wine  and  spirits  sizes  should 
remain fixed by law and more than half want sizes outside wines and spirits to remain free for 
producers to choose. 

For industry, the added value lies mainly in creating trust and credibility among buyers of pre-
packaged products (consumers and retailers), marketing benefits, and cost savings as a result 
of a lower variety of bottle sizes as well as facilitation of market surveillance controls.  

In the view of national authorities, the impacts of the Directives would have been unlikely to 
be achieved by Member States individually or by other initiatives. There is significant value 
added  over  mutual  recognition  through  harmonisation  of  packaging  practices,  high  quality 
labelling  procedures,  consensus  between  Member  States  and  a  clear  definition  of  tasks  and 
responsibilities. 

6.5.2  To what extent do the issues addressed by the directives continue to require 

action at EU level? 

Free circulation of pre-packed products and consumer choice are the issues addressed by the 
three directives in the context of EU law. A barrier free internal market has been achieved and 
will continue to be achieved by the legislation. Free sizes increase choice of consumers whilst 
rules on correct quantity filling and containers in conjunction with regular market surveillance 
guarantee consumer protection in relation with the amount they are provided with.  Important 
is  also  that  the  law  gives  appropriate  means  to  authorities  to  check  compliance  and  the 
framework  as  a  whole  offers  a  basis  for  mutual  trust  amongst  authorities.  Based  on  the 
consultation, there is continued tacit support by consumers and widespread expressed support 
by industry and national authorities for maintaining the functioning current acquis, either with 
improvements or, at least, in the state as currently is. 

The alternative to EU law of mutual recognition would involve large uncertainty to industry 
about potential disproportional administrative burdens imposed by national legislation and the 
lack of administrative cooperation between authorities. 

22 

 
 
 
 
 
7  CONCLUSIONS 

The Commission concurs with the consultant conclusions that all three Directives continue to 
be  relevant,  that  they  are  generally  considered  efficient  and  effective  with  significant  value 
added  for  all  stakeholder  groups.  None  of  the  three  Directives  impose  significant 
administrative  or  compliance  costs.  At  the  same  time,  they  are  perceived  as  beneficial  in 
terms  of  contributing  to  consumer  protection,  fostering  competitiveness  and  facilitating  the 
Single Market. The Directives are also coherent with and complementary to other legislation 
at EU and national level. As a result of this, there is widespread support from all stakeholder 
groups (industry, consumers and national authorities) for all three Directives. On the basis of 
his  analysis,  the  consultant  concluded  that  the  Directives  are  “fit  for  purpose”  and  do  not 
require fundamental reform. 

The  consultant  report  highlights  a  number  of  issues,  in  order  of  importance  and  provides 
recommendations on how to tackle them: 

1.  Different structures and interpretations across countries on how the Directives should 
be  applied  are  leading  to  variations  in  national  implementation:  the  contractor  has 
proposed  to  engage  discussions  with  Member  States  on  difference  in  national 
implementation with the view to exchange "good practices".  

2.  In  relation  with  market  surveillance,  weakness  in  systematic  information  exchange 
between  national  authorities  leading  to  unclarity,  lack  of  coherent  approach  towards 
imports and lack of trust in the market surveillance system across the EU were noted. 
The  consultant  suggested  developing  a  systematic  information  exchange  system 
between national authorities.  

3.  In relation with unclarities related to minor or technical aspects for specific industries 
such  as  products  sold  by  length,  area  or  number,  drained  weight,  larger  batch 
definitions,  provisions  on  the  speed of  production  and  sampling,  viscose  products  in 
mass  or  volume,  wrappings  with  pre-packages,  it  recommended  clarification  to  be 
made via expert discussion in WELMEC WG6.  

4.  In relation with the fact that many consumers do not understand the meaning of the e-
mark  or  are  not  aware  of  it  -  whereas  consumer  protection  is  one  of  the  primary 
objectives  of  the  legislation  –  it  recommended  more  explanation  to  be  made  on  the 
Commission website.  

The  issues  reported  by  the  consultant  and  its  recommendations  for  improvement  seem 
supported by the evidence provided in this report. The Commission will consider them in its 
follow-up  work  with  competent  experts  and  stakeholders,  with  the  view  to  improve  the 
application of the directives. 

23 

 
 
 
 
 
ANNEXES 

ANNEX 1: PROCEDURAL INFORMATION concerning the process to prepare 

the evaluation  

  Lead DG:  

DG GROW 

  Agenda planning/Work Programme references:  

2015/GROW/045 

  Organisation  and  timing:  The  inter-service  Steering  Group  consisted  of  SG,  AGRI,  MARE, 
SANTE,  JUST  and  GROW.  After  kick-off  on  2/6/14  it  met  4  times  in  2014  and  5  times  in 
2015. 

  Consultation of the Regulatory Scrutiny Board (if relevant). Not relevant. 

  External expertise: the evaluation work was outsourced to a consultant. 

  Methodology - Robustness 

The data collection presented several challenges. These are summarised below.  

Firstly, there are no systematically collected market data on the pre-packaging sector or on the 
number  or  share  of  companies  applying  the  Directives.  Pre-packaging  is  an  activity  which 
often  takes  place  within  larger  companies  that  produce  pre-packaged  products  (e.g.  food 
products). However, pre-packaging itself is only a very small subset of the activities of these 
companies. Furthermore, no secondary data exist on the application of the e-mark or 3-mark, 
either in commercial or public databases.  

As  a  result,  this  information  needed  to  be  collected  from  primary  data  sources,  namely 
surveys and interviews with industry associations and national authorities. The robustness of 
these data depends on the survey and interview response rates. The following steps were used 
to  estimate  the  size  of  the  pre-packaging  market  and  the  share  of  companies  applying  the 
Directives:  
1. First, absolute numbers of companies applying the Directives were requested from national 
authorities.  
2.  Where  these  were  not  available,  figures  obtained  in  the  industry  survey  were  used  to 
calculate the proportion of companies applying the Directives.  
3. Where gaps remained, estimates were produced based on data from other Member States 
and Eurostat structural business statistics. 
4.  Compliance  cost  data  collected  through  primary  sources  was  very  limited.  Where 
quantified  estimates  were  provided  by  stakeholders,  these  were  taken  into  account  and 
complemented  with  secondary  information  from  other  published  evaluations  of  related 
legislation  (e.g.  automatic  weighing  instruments  in  Measuring  Instruments  Directive 
2004/22/EC)  

As a result of the above data challenges, estimates of market size, market share of the marking 
Directives and related compliance costs need to be interpreted with care and they should be 
seen  as  indications  of  an  order  of  magnitude  rather  than  as  precise  point  estimates. 
Furthermore, no information was available from primary sources on the use of the markings 
among imports. 

24 

 
 
 
 
 
 
 
 
 
 
Secondly, given the large geographic, sector and size coverage of the evaluation, there were 
significant  challenges  because  of  the  limited  number  of  company  interviews  that  could  be 
carried out. 

The following steps were used to ensure representativeness:  

1. The industry interview programme focused on EU level industry associations in sectors that 
involve pre-packaging. A list of interviewees is presented in Annex 5 of the consultant report. 
By focusing on organisations that speak on behalf of all companies in their sector, it has been 
possible  to  gather  a  more  representative  industry  input,  than  it  would  have  been  possible  if 
only individual companies were interviewed. Consumer input was gathered through the online 
open public consultation (EU survey) and from the online survey for consumer organisations, 
to which 12 organisations responded, all but 2 anonymously as well as the online open public 
consultation, to which 6 organisations responded, one of which identified itself.  

2. The survey and online open public consultation questionnaires focused on gathering input 
from individual companies, consumer associations, consumers and other stakeholders whose 
input could not be covered in interviews. The survey and online open public consultation were 
based on the same questionnaire and run concurrently, the latter in all official languages thus 
giving stakeholders the possibility to provide input in as user-friendly a way as possible. The 
consultant  report  presents  in  Annex  6  the  results  of  the  industry  and  consumer  association 
surveys  the  results  of  the  online  open  public  consultation  (implemented  by  the  European 
Commission) have been integrated into the main body of the consultant report.  

3. Follow-up interviews were carried out with 10 companies which had agreed to be contacted 
in the survey / online open public consultation (consultant report, Annex 5). These interviews 
served mostly to cross-check results and fill data gaps. There were no significant differences 
in the opinions of the companies interviewed and their sector representations at EU level.  

4. At national level, all competent authorities were contacted for interview to ensure as wide a 
geographic coverage as possible. A list of the 23 Member State authorities interviewed is in 
Annex 5 of the consultant report.  

5.  By  triangulating  data  from  survey,  interviews  and  online  open  public  consultation,  it  has 
been  possible  to  identify  whether  there  were  any  major  divergences  between  data  collected 
through these different tools. Where differences were noted, these are highlighted in the main 
report and they should be kept in mind when interpreting the findings.  

Third, a major challenge lay in the relative lack of stakeholder engagement and difficulty in 
identifying individuals who would be prepared and sufficiently knowledgeable to contribute. 
Indeed, as the results clearly indicate, the majority of stakeholders are relatively satisfied with 
the status quo and they do not see the need for a major revision of the Directives or the current 
pre-packaging regime.  

The consultant spent a significant amount of resource and effort on convincing stakeholders 
(authorities as well as companies and industry associations) of the rationale for the research 
and  the  need  to  gather  their  input.  However,  the  absence  of  a  significant  motivation  (i.e.  a 
desire  for  regulatory  change)  made  many  stakeholders  reluctant  to  respond.  Where 
stakeholders repeatedly declined to participate, alternative contacts were sought for interview.  

25 

 
 
 
 
 
 
 
 
 
In  interpreting  the  findings,  it  is  therefore  important  to  note  that  the  evaluation  is  based  on 
data  collected  among  stakeholders  who  agreed  to  contribute.    Amongst  national  authorities, 
for  instance,  this  means  that  France,  Italy,  Lithuania,  Latvia  and  Malta  are  not  included 
because  the  research  team  did  not  receive  any  input  from  these  authorities.  Similarly  the 
number of importers who contributed is relatively small. This may lead to an over-estimation 
of  the  perceived  «  problems  »  with  the  Directive  which  needs  to  be  kept  in  mind  when 
drawing conclusions and formulating recommendations.  

Finally,  no  full  analysis  of  each  Directive  and  its  implementation  at  national  level  was 
conducted. National differences in implementation were therefore investigated on the basis of 
interviews with a selection of Member State authorities (Consultant report Annex 5) as well 
as consultations with industry and consumers (Consultant report Annex 6). 

Summarizing, the consultant interviews would seem representative in the case of industry and 
industry  associations  as  well  as  23  authorities.  The  consultant  survey  of  consumer 
organisations did not have a full response, even though all national and European consumer 
organisations known to the Commission were invited to respond.  

Given that it was extremely difficult to capture the impacts of the 3 directives on the internal 
market, competitiveness and improved competition, the benefits are described in a qualitative 
way.  

26 

 
 
 
 
ANNEX 2: STAKEHOLDER CONSULTATION – SYNOPSIS REPORT 

1.  Data Collection 

In the scope of this evaluation, the following groups of stakeholders were consulted:  

  Consumers (individuals)  
  Consumer organisations 
  Private companies in the EU28  
  EU and national industry associations  
  Market surveillance authorities  

The  following  data  collection  techniques  were  used:  (face-to-face  or  telephone)  interviews 
(private  companies,  industry  associations  and  market  surveillance  authorities)  and  two 
targeted online surveys (companies and consumer organisations). In parallel to the consultant, 
the  European  Commission  ran  an  online  open  public  consultation.  All  stakeholders  were 
consulted  through  targeted  and  online  open  public  consultations,  with  the  exception  of 
consumers (individuals), whose views were gathered only through the EC online open public 
consultation. The results of the online open public consultation were used for informing the 
evaluation and drawing final conclusions and recommendations.  

All  market  surveillance  authorities  in  the  EU28  were  contacted  to  participate  in  the 
evaluation. A total of 23 market surveillance authorities in 22 EU Member States accepted 
to participate and were consulted via telephone interviews (Consultant report, Annex 5).  
In  addition,  in-depth  interviews  informing  all  evaluation  questions  were  conducted  with  14 
EU industry associations and 1 national industry association. 10 private companies were 
also consulted via telephone in-depth interviews (Consultant report, Annex 5).  

Two on-line surveys were conducted in order to collect information on the level of use and 
effects of the pre-packaging directives on two types of stakeholders:  industry stakeholders 
(industry  survey)  and  consumer  organisations.  In  order  to  enhance  the  robustness  of  the 
survey,  the  results  obtained  were  merged  with  the  results  of  the  online  open  public 
consultation carried out by the European Commission.  

All Commission minimum standards for public consultations were met. 

The main objectives of the industry survey were as follows:  

  Collect market data in relation to market coverage of the Directives;  
  Gather  the  perceptions  of  industry  stakeholders  in  relation  to  whether  the  Directives 

are ‘fit-for-purpose’; and  

  Achieve broad coverage of relevant sectors covered by the Directives across all EU-28 

countries.  

Firstly,  the  industry  survey  questionnaire  was  distributed  through  European  industry 
associations  (Consultant  report,  Figure  62).  Secondly,  it  was  also  distributed  to  a  list  of 
selected  EU28  companies  obtained  from  the  commercial  database  ORBIS  (developed  by 
Bureau  Van  Dijk).  A  total  of  57,568  EU28  companies  were  contacted  (Consultant  report, 
figure 63). Thirdly, in order to boost the response rates and to ensure responses from each of 

27 

 
 
 
the  EU  Member  States,  national  authorities  provided  the  evaluation  team  with  a  list  of 
nominated  companies  for  their  respective  Member  States  following  an  official  request  from 
the  European  Commission.  National  authorities  from  20  EU28  countries  provided  a  list  of 
representative  stakeholders  on  their  territory  to  the  consultant.  This  corresponded  to  372 
contacts,  including  346  companies,  13  competent  authorities,  2  consumer  organisations  and 
11  industry  associations  (Consultant  report,  Figure  64).  The  (online)  industry  survey  was 
launched  on  20  November  2014  and  was  opened  for  three  months  (closed  on  20  February 
2015). A total of 248 full responses were received to the industry survey. The results obtained 
were merged and jointly analysed with 109 additional responses from industrial stakeholders 
to the online open public consultation. 

The  consumer  organisations  survey  was  designed  with  the  intention  of  collecting  primary 
data for consumer organisations across EU-28 countries. It covered the following points:  

  Size and location of the organisation  
  Level of awareness of the directives and respective markings  
  Perception of the impact of the directives & markings on consumer protection  
  Relevance of the free and fixed sizes directives  

The  consumer  organisations  survey  was  distributed  via  consumer  organisations,  using  the 
addresses  of  the  consumer  organisation  network  published  by  DG  SANCO.  This  network 
provided  access  to  two  European  consumer  organisations,  which  are  federations  of  national 
consumer  organisations  from  across  the  EU:  ANEC  and  BEUC.  In  addition,  the  consultant 
contacted  additional  national  level  organisations  to  ensure  full  geographic  and  sectorial 
coverage (Consultant report, Figure 65). A total of 12 answers were received from consumer 
organisations (Consultant report, Figure 67).  

Finally, the European Commission online open public consultation ran between 13 January 
and 7 April 2015. It was available in 22 official EU languages and was publicised to SMEs by 
the  DG  GROW  Enterprise  Europe  Network.  There  were  294  respondents.  A  total  of  118 
consumers  and  6  consumer  organisations  responded  to  the consultation.  From  industry,  109 
EU companies and 14 industry federations provided inputs. There was an equal distribution of 
micro,  small,  medium  and  large  enterprises  over  a  wide  range  of  sectors.  12  Competent 
Authorities from 7 Member States also expressed their views.  

2.  Findings 

The  evaluation  assesses  the  effectiveness,  efficiency,  coherence,  relevance  and  EU  added 
value  of  the  3  Directives.  The  latter  two  have  drawn  upon  the  answers  mentioned  below 
under the first  three headings. For the first three criteria, the following questions  have been 
answered. (NB. Page numbers in the text refer to the pages of consultant report) 

28 

 
 
 
 
  Relevance 

The majority of consumers and consumer organisations think that the current packaging law 
satisfies their expectations. This is particularly the case for respondents who have noticed the 
3-mark  (58%  satisfied).  For  the  e-mark  the  share  of  satisfied  consumers  is  48%.  This 
compares favourably with the 14.86% and 16.67% respectively who are not satisfied. 

Figure 1  

Does EU law satisfy your expectations? 

Yes 

No 

No opinion  No response 

Source 

Consumer  
Noticed 3-mark  58% 
Noticed e-mark  48% 
Consumer 
organisation 
3 mark* 
e-mark* 
free sizes* 
Industrial firm 

1 
5 
2 
52% 

15% 
17% 

27% 
35% 

2 on 148 
2 on 148 

Fig 29, p63 
Fig 29, p63 

0 
2 
5 
20% 

10 
4 
5 
28% 

1 on 11 
1 on 11 
0 on 12 
96 on 261 

Q8, p168 
Q7, p168 
Q9, p168 
Q17b, p157 

* Does the law for 3-mark, e-mark, and free sizes protect consumers? 

Figure 2  

Should free / fixed sizes continue to be law? 

Consumer  
free sizes 
Fixed sizes 
Consumer 
organisation 
free sizes 
Fixed sizes 
Industrial firm 
free sizes 
Fixed sizes 
Authority 
free sizes 
Fixed sizes 

Yes 

No 

No opinion  No response 

Source 

52% 
67% 

31% 
15% 

17% 
18% 

1 on 149 
0 on 150 

Fig 41, p84 
Fig 41, p84 

4 
6 

4 
1 

56% 
67% 

25% 
16% 

24 
5(+10) 

0 
6 

3 
4 

18% 
18% 

0 
(10) 

1 on 11 
1 on 11 

Q13, p169 
Q12, p169 

116 on 241 
106 on 251 

Q21b, p166 
Q21b, p166 

0 on 24 
0 on 24 

p85 
P85 

  Efficiency 

Cost  issues  were  not  mentioned  by  industry  interviewees  as  particularly  significant.  This 
includes one-off costs, fees (applicable in some countries) and administrative burdens, none 
of which were raised as important by industry. There is a widespread perception that costs of 

29 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
the  Directive  are  low  and  therefore  considered  a  fair  price  to  pay  for  the  benefits  (i.e. 
facilitation  of  market  surveillance,  trade  in  the  Single  Market  and  building  consumer  trust). 
Administrative  burdens  are  seen  as  negligible  with  industry  usually  unable  to  provide  any 
evidence  of  administrative  burdens.  Furthermore  no  complaints  about  the  cost  of  the 
Directives  were  identified,  despite  the  fact  that  there  are  fees  for  the  use  of  the  e-mark 
imposed by authorities in some countries.  

The electronic survey and online open public consultation results show that the great majority 
of users of the markings (72% for the 3-mark and 77% for the e-mark) indicate that the cost of 
marking nominal quantity, as a percentage of their annual production costs is less than 1%40. 
Less  than  20%  of  respondents  using  the  markings  indicate  that  costs  represent  between  1% 
and 5% of their annual production costs. Only 7% of respondents using the 3-mark indicate 
the cost of marking the nominal quantity exceeds 5%, while this is only the case of 3% of e-
mark users. Most of these respondents are SMEs (7 out of a total of 9 respondents). 

While the overall burden is very low, the cost burden on SMEs linked to the use of the marks 
does appear to be slightly higher, compared to large companies. For example, among 3-mark 
users,  70%  of  SME  respondents  indicate  the  cost  of  the  marking  is  less  than  1%  of  their 
annual  turnover,  compared  to  77%  for  large  companies.  The  share  of  large  e-mark  users 
indicating the cost is less than 1% of annual turnover is also higher than for SMEs. 

Figure 3 
annual production costs (SME vs non- SME; 3-mark users), (p76) 

 Estimate  of  the  cost  of  marking  nominal  quantity,  as  a  percentage  of 

Number of responses: 75. Source: electronic survey and online open public consultation. 

Figure  4  Estimate  of  the  cost  of  marking  nominal  quantity,  as  a  percentage  of  annual 
production costs (SME vs non- SME, e-mark users), (p76) 

40  Indeed,  a  recurring  market  surveillance  cost  of  EUR  3,500  (as  in  Sweden)  represents  only  0.35  percent  of  the  annual 
turnover of a small company with EUR 1m in turnover  

30 

 
 
 
 
                                                            
Number  of  responses:  141.  Source:  electronic  survey  and  online  open  public 
consultation. 

Comments from EU level industry associations on the cost of the Directives (p77)  

  The beer industry suggested that the burden of the Directives had been incurred mostly 
on introduction with initial investments in equipment but with little recurring cost. The 
association could not indicate cost but suggested that this was not very significant in any 
case  and  the  sector  reiterated  that  burdens  would  lie  mostly  in  any  change  to  the 
Directives  which  should  therefore  be  left  as  they  are.  This  opinion  is  shared  by  other 
sectors that were interviewed. For instance, the spirits industry argues that there is little 
administrative  burden  associated  with  the  Directives  and  no  differential  impact  on 
SMEs.  In  addition  none  of  the  survey  respondents  mentioned  costs  as  a  particular 
obstacle  in  open  text  answers  (2  respondents  who  provided  open  text  comments 
suggested simplification/elimination of the Directives. 

  For the wine industry the impact of the 2007 Directive on SMEs is positive because 
SMEs struggle more with large numbers of Stock Keeping Units (SKUs). There is also 
no  evidence  of  problems  and  other  costs  associated  with  market  surveillance  or 
application of the Directives as a whole.  

  Aerosols also suggested that investments had been made a long time ago and that the 
2007 Directive did not represent a major change for the sector and no further costs were 
incurred.  

 

In the coffee sector, the EU association noted that the pack size Directive has not been a 
cost  factor.  Although  the  e-mark  requires  some  administrative  work,  there  is  no 
evidence of substantial costs for this association. 

  Similarly, the glass container industry suggested that the main cost driver for them is the 
number  of  moulds  and  that  pack  size  restrictions  under  the  2007  Directive  reduce  the 
number of moulds required and thus this Directive represents a cost saving. Further the 
industry suggested that there was no additional cost to the e- and 3-marking since initial 

31 

 
 
 
investments had been made a long time ago (and these investments were quote limited in 
any case). 

  Effectiveness 

  Consumers 

About  half  of  consumers  had  never  noticed  the  3-mark  which  is  not  surprising  since  this 
marking is not actually meant directly for end-consumers but for businesses that use bottles as 
measuring containers. In comparison, only 21% of consumers had never noticed the e-mark. 
44%  of  consumers  had  seen  the  mark  and  knew  what  it  means  whereas  34%  did  not  know 
what  it  means.  Put  differently,  about  55%  of  consumers  are  not  familiar  with  the  marking 
(either because they have never seen it or because they don’t know what it means).  

Figure 5 Consumer awareness of either e- or 3-markings on packaging (p.83) 

I have noticed the mark on
packaginig and know what it means

I have noticed the mark on
packaginig, but do not know what it
means

I have never noticed the mark

33,56 

44,22 

16,78 

34,69 

49,66 

21,09 

0

10

20

30

40

50

60

3-mark

E-mark

Number of responses: 147. Non response 3. Source: Online open public consultation. 

At  the  same  time,  about  35%  of  consumers  who  responded  to  the  online  open  public 
consultation  sometimes  or  often  doubt  the  content  of  the  pre-packaged  products  that  they 
purchase.  Where  consumers  did  express  doubts  regarding  net  quantity  this  is  related  to  the 
feeling of being misled by deceptive packaging (e.g. air in pack, bag in box, extra packaging 
material  in  the  pack,  dark  and  non-transparent  glass,  oval  shaped  (cosmetics)  bottles  to 
increase  the  area  in  the  consumer  vision)  which  was  raised  in  the  online  open  public 
consultation.  The  most  effective  remedy  against  such  deceptive  packaging  remains  unit 
pricing.41  The  figure  below  shows  the  breakdown  of  responses  to  the  online  open  public 
consultation by frequency of doubt of the quantity contained in pre-packages.  

41  At  this  point,  the  centrality  of  the  concept  of  the  average  consumer  in  EU  law  should  be  underlined.  The  fairness  or 
unfairness  of  a  commercial  practice  is  assessed  against  the  "average  consumer"  benchmark.  The  average  consumer,  as 
interpreted  by  the  European  Court  of  Justice,  is "reasonably  well-informed  and  reasonably  observant  and  circumspect", 
taking  into  account  social,  cultural  and  linguistic  factors.  If  a  commercial  practice  is  directed  at  a particular  group  of 
consumers (such as vulnerable categories of consumers, then an average member of that group is the benchmark. 

32 

 
 
 
 
 
 
 
                                                            
Figure 6 Consumer doubt on quantity contained in a bottle or in packaging (p.84)  

Source: Online open public consultation, 118 answers, 0 non-response  

As  regards  pack  sizes,  consumers  were  broadly  supportive  of  the  status  quo.  Two  thirds  of 
consumers  thought  wine  and  spirits  sizes  should  remain  fixed  by  law  and  more  than  half 
wanted  sizes  outside  wines  and  spirits  to  remain  free  for  producers  to  choose  (see  Table 
below).  

Figure 7 Opinion of consumers on packaging sizes (p.84)   

Opinion  

Agree 
Disagree 
No opinion 
Total 
Source: 
consultation. 

Online 

open 

public 

Statement 
For  wine  and  spirits, 
bottles  sizes  should 
continue  to  be  fixed 
by law  
Freq.  Percent 
100 
23 
27 
150 

66.67 
15.33 
18 
100 

Outside of wine and spirits, 
sizes  should  continue  to 
remain  free  by  law    for 
producers to choose 
Freq. 
78 
46 
25 
149 

Percent 
52.35 
30.87 
16.78 
100 

  Industry 

Overall,  the  survey  and  consultation  found  that  approximately  55%  of  bottle  fillers  indicate 
using 3-marked bottles as measuring containers (see Figure below). Breaking this result down 
by company size indicates that 60% of large bottle fillers use 3-marked bottles as measuring 
containers, compared with 48% of SME bottle fillers. 

In addition, interviews confirm that the 3-mark is very pervasive among bottle manufacturers 
(almost all manufacturers use it according to FEVE, the sector representation at EU level).42 

42 The number of glass bottle producers responding to the survey is too low to make any broad assessment on the basis of 
the survey only. However it is worth highlighting that six out of eight glass bottle producer respondents indicate using the 
3-mark. 

33 

 
 
 
 
 
  
  
  
  
 
                                                            
Based  on  electronic  survey  results  only,  it  appears  that  the  share  of  bottle  fillers  using  3-
marked bottles as measuring containers is higher among those working with wines and spirits, 
compared with non-wine and spirits fillers. 

Figure 8 Use of 3-mark by type of respondent, (p.53)  

Number of responses: 162. Source: electronic survey and online open public consultation. 

Furthermore,  industry  survey  and  online  open  public  consultation  results  show  that  glass 
bottles, spirit drinks, and wine sectors make the most intensive use of the 3-mark (64%, 58% 
and 51% respectively).43 The share of users in non-alcoholic drinks (34%) appears to be lower 
than in the alcoholic drinks sectors. 

Figure  9  Use  of  e-mark  by  type  of  respondent:  SME  vs  non-SME  (packers  &  bottle 
fillers*), (p.58) 

43 These figures only include sectors with more than 10 responses. 

34 

72%69%79%91%0%10%20%30%40%50%60%70%80%90%100%Packer(cid:9)(other(cid:9)than(cid:9)bottles)Bottle(cid:9)fillerNON(cid:9)SME's(cid:9)using(cid:9)the(cid:9)e-markSMEs(cid:9)using(cid:9)the(cid:9)e-mark38401827 
 
 
 
                                                            
Number of responses: 123. Source: electronic survey and online open public consultation.  

*These  were  the  only  two  categories  of  respondents  recording  more  than  15  responses,  for 
which data on company size and turnover was provided. 

Additional information on usage of the Directives by EU industry associations, (p.58) 

  The European  container glass federation estimates that all companies  in  their sector 
use 3-marking. Companies in this sector only produce the glass containers, they do not 
fill them, and they do not know what share of production eventually leaves the EU as 
filled  bottles.  Hence  all  bottles  tend  to  have  the  3  symbol  and  the  markings  are 
probably also recognised outside the EU. In addition, the sector association suggests 
that, by observation, their clients who fill the 3-marked bottles also tend to use the e-
marking on the 3-marked bottle. 

  The  spirits  industry  stated  that  all  companies  are  very  well  informed  about  the 
Directives. In the case of the 2007 Directive, the industry has to comply with rules on 
nominal quantities and directors of production will also know about e and 3-marking, 
although  they  might  not  be  aware  of  the  European  Directive  at  the  origin  of  the 
markings.  The  e-marking  is  used  by  almost  all  producers  with  a  few  specific 
exceptions  that  are  explained  by  the  nature  of  the  product  (e.g.  a  spirits  product  in 
Poland that is filled into bottles at very low temperature and then dilates in the bottle) 
or  by  the  specific  destination  market  (e.g.  a  lot  of  Cognac  is  produced  directly  for 
export and these bottles will not appear on the EU market and may therefore not be e-
marked). 

  The beer industry suggested that there is widespread awareness of the 3 and e-marks 
and sufficient practical knowledge to be able to comply with the requirements of the 
Directives. In addition, almost all beer producers (90%) and certainly all of the large 
producers  use  the  e-marking.  The  only  exceptions  to  e-marking  are  some  micro-
breweries  which  might  not  see  the  need  to  use  the  Directives  because  they  are  less 
likely  to  trade  across  borders.  For  these  stakeholders  the  fact  that  the  Directives  are 
optional is helpful because it gives smaller microbreweries the possibility not to apply 
them. There is also strong support from the beer industry for the 2007 Directive in the 
sense that it exempts beer from the mandatory pack sizes.   

 

Interviewees in the wine sector estimated that the level of uptake of e-marking is high 
because the filling machines that are used in the sector often have relevant tolerances 
built-in by default. 

  The  aerosol  industry  suggests  that  all  companies  use  the  e-mark  and  sector 
representatives are not aware of any companies not using it. The main reason for this 
is  that  the  markings  are  well-recognised  and  they  have  become  integrated  into  the 
production  process  as  a  matter  of  routine.  At  the  same  time  and  due  to  the 
pervasiveness of the mark, there would be a credibility issue for any products that are 

35 

 
 
 
not  e-marked  and  this  would  be  seen  negatively.  According  to  the  industry 
representation, no companies ever question the use of the e-mark.   

  The  coffee  industry  suggested  that  major  retailers  require  the  e-marking  and  thus 
coffee producers have to comply to be able to get their products onto the market. Since 
large  roasters  supplying  supermarkets  will  use  e-marking,  it  is  estimated  that  this 
accounts  for  approximately  80%  of  the  market.  At  the  same  time,  equipment 
manufacturers,  where  MS  so  require  or  if  the  manufacturer  so  chooses,  provide 
catchweighers  conforming  to  MID44  that  delivers  the  level  of  accuracy  required  for 
coffee producers to be able to comply with the Directive which facilitates widespread 
adoption of the e-marking. 

  Representatives  of  the  salt  industry  estimated  that  75-80%  of  the  market  would  be 
covered by e-marking although they found it difficult to estimate compliance by small 
companies. 

When  asked  to  choose  the  main  reason  for  their  use  of  the  3-marking,  fully  73%  of 
industry  survey  and  consultation  respondents  stated  that  they  apply  the  mark  either  to 
facilitate  trade  or  to  facilitate  compliance  with  market  surveillance  (37%  and  36% 
respectively). As national authorities explained these two answers are very inter-linked in 
that  using  the  markings  could  reduce  the  chances  of  being  controlled  by  the  national 
authorities  in  the  destination  country.45  This  compares  with  only  24%  who  apply  the 
marking in response to customer requests or market demand and a mere 2% who use the 
marking for another reason. 

Figure 10 Main reasons for using the 3 mark, (p.61) 

Number  of  responses:  94  by  65  respondents.    Source:  electronic  survey  and  online  open 
public consultation.  

44 Automatic catchweighers as defined in Class X in chap II, point 2.1 of Annex MI-006 of Directive 2004/22/EC may be 
used to comply with Directive 76/211/EEC anccording to its Annex I point 4.2 
45 It should be noted that the importance of this argument depends on the chances of being controlled by authorities (see 
also section 7.2). In addition, controls must be on site (the average system can hardly be meaningfully controlled without 
taking random sample from a batch as produced) so chances of control in the country of destination are virtually zero. 
This further underlines the importance of cooperation by national authorities. 

36 

37%36%24%2%To(cid:9)ensure(cid:9)that(cid:9)my(cid:9)product(cid:9)can(cid:9)be(cid:9)sold(cid:9)anywhere(cid:9)in(cid:9)the(cid:9)EUTo(cid:9)make(cid:9)it(cid:9)easier(cid:9)to(cid:9)comply(cid:9)with(cid:9)market(cid:9)surveillanceIn(cid:9)response(cid:9)to(cid:9)customers'(cid:9)requests(cid:9)and/or(cid:9)market(cid:9)demandOther 
 
 
                                                            
For the e-mark (Figure below), survey and consultation results show that the main driver of 
usage  is  also  facilitation  of  trade  (38%).  Market  surveillance  comes  in  second  with  31%  of 
responses, and responding to customer requests / market demand comes in third with 27%.  

In  relation  to  market  surveillance,  national  authority  interviews  provide  an  insight  into  the 
way in which the use of the markings can be cost-effective. For instance, the e-mark allows 
companies to use the ‘average-system’ rather than the ‘minimum system’46. This is beneficial 
for companies because it allows them to ensure that products are filled with the right amount 
on average (with certain margins  of error) rather than having to  overfill packages to  ensure 
that all packs contain a certain minimum.  

In relation to customer requests / market demand, it is important to note that, for producers, 
packers  and  fillers,  this  of  course  includes  not  just  end-consumers  but  also  retailers  and 
distributors.  Indeed,  a  few  national  authorities  suggested  in  interviews  that  companies  were 
sometimes forced to use the e-mark by large retail chains in Europe. Like for the 3-mark, only 
3% of respondents indicated that there were other reasons for the use of the markings.  

Figure 11 Main reasons for using the e-mark, (p.62) 

Number  of  responses:  253  by  165  respondents.    Source:  electronic  survey  and  online  open 
public consultation.  

For another perspective on the drivers of use of the markings, companies that are not using the 
markings were also asked why this was the case. For both markings, a majority (48% in the 
case of 3-mark and 44% in the case of the e-mark) stated that this was because the Directives 
were only optional. This compares with about 14% who were simply not aware of the 3-mark 

46 Annex 1(1) of Directive 76/211/EEC states that « Prepackages covered by this Directive shall be made up in such a way 
that the completed packages satisfy the following requirements: 1.1 . the actual contents shall not be less, on average, than the 
nominal  quantity;  1.2.  the  proportion  of  prepackages  having  a  negative  error  greater  than  the  tolerable  negative  error  laid 
down in 2.4 shall be sufficiently small for batches of prepackages to satisfy the requirements of the tests specified in Annex 
II; 1.3 . no prepackage having a negative error greater than twice the tolerable negative error given in the table in 2.4 may 
bear the EEC sign provided for in 3.3 »  

37 

38%31%27%4%To(cid:9)ensure(cid:9)that(cid:9)my(cid:9)product(cid:9)can(cid:9)be(cid:9)sold(cid:9)anywhere(cid:9)in(cid:9)the(cid:9)EUTo(cid:9)make(cid:9)it(cid:9)easier(cid:9)to(cid:9)comply(cid:9)with(cid:9)market(cid:9)surveillanceIn(cid:9)response(cid:9)to(cid:9)customers'(cid:9)requests(cid:9)and/or(cid:9)market(cid:9)demandOther 
 
 
                                                            
(11% for the e-mark), and between 19% (3-mark) and 26% (e-mark) who indicated that they 
didn’t use the markings because they only produce for their domestic market.  

The  reasons  for  not  using  the  markings  differ  based  on  company  size (SME  vs.  non  SME). 
For example, when it comes to the 3-mark, SMEs are generally less aware about the marking 
compared  to  large  companies  (24%  vs  14%  respectively),  leading  to  a  lower  use  of  the 
marking. On the other hand, mainly producing for domestic markets appears to be less of a 
barrier to the use of the 3-mark for SMEs than for non-SMEs (16% vs. 24% respectively). In 
addition,  the  fact  that  the  marking  is  not  required  has  a  lesser  influence  on  the  level  of  use 
among SMEs (35%) than among non-SMEs (48%). 

In  terms  of the e-mark, not  knowing about the marking  is also a more important barrier for 
SMEs  than  for  non-SMEs  (14%  vs  8%  respectively).  The  non-mandatory  nature  of  the 
markings seems to influence the uptake of the marking among both groups equally (43% and 
47%  respectively),  while  mainly  producing  for  the  domestic  market  is  clearly  a  more 
significant barrier for large companies than for SMEs (36% vs 19%).  

Figure 12 Main reasons for not using the markings, (p.63) 

3-mark 

SM
E  % 

NonS
ME 

% 

All  % 

9 

24% 

4 

14%  13 

13 

35% 

14 

48%  28 

6 

16% 

7 

24%  13 

Answer 

I  don’t  know 
the 
about 
marking 

The  marking 
is 
not 
required 

produce 
I 
mainly 
for 
the  domestic 
market 

Not  relevant 
to my work 

5 

14% 

2 

7% 

9 

Other 

4 

11% 

2 

7% 

7 

e-mark 

SM
E 

6 

18 

8 

6 

4 

% 

14
% 

43
% 

19
% 

14
% 

10
% 

19
% 

40
% 

19
% 

13
% 

10
% 

17 

13 

1 

2 

TOTAL 

37 

100%  29 

100%  70 

100
% 

42 

100
% 

36 

NonS
ME 

% 

All 

% 

3 

9 

8% 

11% 

47
% 

36
% 

44% 

36 

21  26% 

3%  9 

11% 

6%  7 

9% 

100
% 

82 

100
% 

38 

 
 
 
 
3.  Information about any diverging views between or within stakeholder 

groups 

Diverging views between stakeholders are:  

  consumer concerns relate primarily to the risk of being misled by deceptive packaging 
(e.g.  air  in  pack,  bag  in  box,  extra  packaging  material  in  the  pack,  dark  and  non-
transparent  glass,  oval  shaped  (cosmetics)  bottles  to  increase  the  area  in  the  consumer 
vision) and drained weight/desiccating products, 

  some in industry concerning the perceived complexity of the marking Directives, 
 

regarding  the  exception  for  wines  and  spirits  in  Directive  2007/45/EC,  a  minority  of 
Member States suggest removing the exception,  

  some  national  authorities  mentioned  limited  overlaps  between  some  product-specific 

Directives and Directive 76/211/EEC.  

39 

 
 
 
 
ANNEX 3: EVALUATION QUESTIONS 

The  evaluation  assesses  the  effectiveness,  efficiency,  coherence,  relevance  and  EU  added 
value of the 3 Directives. To this end, the following questions are answered in section 6: 

  Effectiveness 

1.  To  what  extent  have  the  objectives  been  achieved?  Which  main  factors  have 

contributed or stood in the way of achieving those objectives?   

2.  Are there any aspects/means/actors that render certain aspects of the Directives more 
or less effective than others, and - if there are - what lessons can be drawn from this? 

3.  What are, if any, the consequences or effects (either positive or negative) that were not 

originally planned? 

  Efficiency 

4.  What are the costs associated with the compliance with the directives and how do they 
compare to the benefits? Are the benefits achieved at reasonable costs (with focus on 
SMEs)?  

5.  Taking into account the objectives and benefits of the directives, is there evidence that 
the legislative requirements have caused unnecessary burden (e.g. administrative and 
reporting burden), especially for SMEs?  

  Coherence 

6.  To what extent are there overlaps/ complementarities between the Directives and any 
other  Union  or  Member  State  action  in  the  relevant  areas?  To  what  extent  are  they 
coherent? 

  Relevance 

7.  To  what  extent  are  the  objectives  of  the  Directives  still  relevant  in  relation  to  the 
stakeholders needs and overarching political objectives? What is the level of support 
of stakeholders for them? 

8.  How well do the (original) objectives (still) correspond to the needs within the EU? 

9.  How well adapted is the Directive to technical/international progress? 

  EU added value 

10.  What is the added value of the Directives for stakeholders? 

11.  To what extent do the issues addressed by the directives continue to require action at 

EU level? 

40 

 
 
 
 
 
 
ANNEX 4: SUGGESTIONS BY AUTHORITIES ON TECHNICAL ISSUES 

(ad  §  6.2.5)  Issues  related  to  Directive  76/211/EEC,  to  render  aspects  of  the  Directives 
more or less effective: 

  Viscose  products  in  mass  or  volume:  there  were  still  some  fundamental  differences 
between  Member  States  and  within  international  standardisation  agencies  (Codex 
Alimentarius,  OIML).  Examples  of  such  products  included  all  sorts  of  pastes,  ice-
cream,  yoghurt,  mustard,  paint,  and  hair  gel.    Nominal  quantity  is  expressed  in 
kilograms  in  some  Member  States,  litres  in  others.47  The  lack  of  consistency  has 
implications  for  the  unit  pricing  of  products  (Directive  98/6/EC),  complicating  the 
calculation of the unit prices. In the case of an e-marked quantity both in weight and in 
volume, both need to be exact according to the Directive. The issue exists already for 
many  years  and  Directive  76/211/EEC  by  its  article  4  allows  for  differing  trade 
practices  even  at  regional  and  sector  level.  As  long  as  there  is  no  international 
agreement  (between  Member  States  and  within  Codex  Alimentarius),  there  is  no 
common basis for EU law. WELMEC is inventorying products and national rules. 

  Wrappings  within  pre-packages:  Two  national  authorities  complained  that  they  still 
disagree  with  the  outcome  of  the  2005  evaluation  of  Directive  76/211/EEC48,  which 
concluded to apply the internationally recognised OIML R87 the definition of nominal 
quantity, namely by excluding the weight of the individual wrappings (of sweets for 
example).  OIML  R87  (point  2.9)  provides  a  clear  definition  of  ‘packing  material’ 
namely “everything of the pre-package that is intended to be left over after use of the 
product,  except  for  items  naturally  in  the  product.  Use  includes  consumption  or 
subjecting to a treatment.” However, the interviewees explained that they think issue 
was not resolved in a legally binding way i.e. by an explicit prohibition by the EU. As 
a  consequence,  these  two  complaining  Member  States  have  not  yet  fulfilled  their 
WTO/TBT commitment and applied the changed international standard as a basis for 
their  national  law  (i.e.  the  transposition  of  Directive  76/211/EEC)  and  thus  have 
continued to allow the weight of the wrappings to be included in the overall nominal 
weight  whereas  all  other  Member  States  apply  the  changed  international  standard. 
They suggested that a legally binding resolution to this issue would be beneficial but a 
proposal  could  conceivably  go  against  international  standardisation;  allowing 
packaging  material  to  be  included  as  content  would  imply  micro-legislation  on  the 
weight of such packaging material. 

  Despite the fact that importers using the e-mark need to fulfil the same requirements 
as  packers  in  Europe  using  the  e-mark,  it  is  much  harder  to  control  these  importers 
because  it is  more  difficult  to  trace  them.  In  practice,  this  leads  to  a  situation  where 

47This point is also related to the provisions of Article 23 of the FIC Regulation and the possibility to adopt delegated acts in 
the future for the expression of net quantity for certain specified foods. 
48 Report on the 2005 Packaging consultation, (p6): "There is widespread agreement to follow international definitions of 
content excluding the packaging  not to be consumed. Respondents mentioned the following points: 
- the quantity indicated should exclude wrapping of sweets, detergent tablets and wax on cheeses 
- a non-dissociable dissolvable film on detergent liquitabs should be included as product." 
http://ec.europa.eu/growth/single-market/goods/building-blocks/legal-metrology/pre-packaging/index_en.htm 

41 

 
 
 
                                                            
packers are controlled more often than importers, which means that there is a risk of 
importers  putting  products  with  e-marks  on  the  European market  without  complying 
with the conditions laid down in the Directive. This problem is hard to address, as it is 
hard to trace importers and they often does not have the premises to conduct controls. 
One  longer-term  possibility  would  be  to  move  towards  a  global  certificate-system. 
There are some  developments in  OIML going in this direction, but this is  out  of the 
scope of this report. In the meantime, WELMEC is improving its guidance on imports, 
which arguably has not been easy, thereby enhancing administrative cooperation and 
development of best practice. 

42 

 
 
 
 
ANNEX 5: PRODUCT SPECIFIC DIRECTIVES 

(ad § 6.3.1)  

1.  Possible overlaps / complementarities with Directive 76/211/EEC: 

  Cosmetics: Regulation (EC) No 1223/2009, although Article 19 on labelling does not 

seem to contradict Directive 76/211/EEC49. 

  Detergents: Regulation (EC) No 648/2004, although Article 11 on labelling does not 

seem contradict Directive 76/211/EEC50 

  Fertilizers: Regulation (EC) No 2003/2003, although Article 9 on labelling and Article 

13 on nutrient tolerances do not seem to contradict Directive 76/211/EEC 51 

  HACCP52:  Regulation  (EC)  No  852/2004  on  the  hygiene  of  foodstuffs,  although  it 
does not mention "batch" so there is no  apparent contradiction with the definition of 
batch as an hour production in Directive 76/211/EEC.  

  Size of quantity indication   The Food Information Regulation requires53 that the net 
quantity of  foods “shall be printed on the package   in  such  a way as  to  ensure clear 
legibility, using  a font size  equal to or  greater than 1.2  mm”, with  an exception  for 
small  packages54.      Where  the  pre-packed  food  is  not  e-marked  the  above  is  the 
minimum  height,  but  the  printing  has  to  ensure  “clear  legibility”.  For  e-marked  pre-
packages the minimum heights referred to in Directive 76/211/EEC55 are:  

49Regulation  (EC)  No  1223/2009,  Article  19  Labelling  1.  Without  prejudice  to  other  provisions  in  this  Article,  cosmetic 
products  shall  be  made  available  on  the  market  only  where  the  container  and  packaging  of  cosmetic  products  bear  the 
following information in indelible, easily legible and visible lettering:(a) the name or registered name and the address of the 
responsible  person.  Such  information  may  be  abbreviated  in  so  far  as  the  abbreviation  makes  it  possible  to  identify  that 
person and his address. If several addresses are indicated, the one where the responsible person makes readily available the 
product information file shall be highlighted. The country of origin shall be specified for imported cosmetic products;(b) the 
nominal content at the time of packaging, given by weight or by volume, except in the case of packaging containing less than 
five grams or five millilitres, free samples and single-application packs; for pre-packages normally sold as a number of items, 
for which details of weight or volume are not significant, the content need not be given provided the number of items appears 
on the packaging. This information need not be given if the number of items is easy to see from the outside or if the product 
is normally only sold individually. 
50Regulation  (EC)  No  648/2004,  Article  11  Labelling  2.  The  following  information  must  appear  in  legible,  visible  and 
indelible  characters  on  the  packaging  in  which  the  detergents  are  put  up  for  sale  to  the  consumer:  (a)  the  name  and  trade 
name of the product; (b) the name or trade name or trademark and full address and telephone number of the party responsible 
for placing the product on the market; (c) the address, email address, where available, and telephone number from which the 
datasheet  referred  to  in  Article  9(3)  can  be  obtained.  The  same  information  must  appear  on  all  documents  accompanying 
detergents transported in bulk. 3. The packaging of detergents shall indicate the content, in accordance with the specifications 
provided for in Annex VII A. It shall also indicate instructions for use and special precautions, if required. 4. Additionally, 
the  packaging  of  consumer  laundry  detergents  and  consumer  automatic  dishwasher  detergents  shall  bear  the  information 
provided for in section B of Annex VII.  
51Regulation (EC) No 2003/2003, Article 9 Markings 1. Without prejudice to other Community rules, the packages, labels 
and accompanying documents, referred to in Article 7 shall bear the following markings: (a) Compulsory identification - Net 
or gross mass and, optionally, volume for fluid fertilisers. If the gross mass is given, the tare mass must be indicated beside it; 
- The name or trade name and the address of the manufacturer.  
52Hazard  Analysis  and  Critical  Control  Points:  a  preventative  food  safety  system  in  which  every  step  in  the  manufacture, 
storage and distribution of a food product is scientifically analyzed for microbiological, physical and chemical hazards 
53 Regulation (EU) No 1169/2011, Article 13.2. 
54 Regulation (EU) No 1169/2011, Article 13.3. 
55 Directive 76/211/EEC, Annex I, section 3.1. 

43 

 
 
 
 
 
                                                            
Nominal quantity and unit of measurement 

Exceeding 1L or 1 kg  

height 

Minimum 
indication (actual height in brackets) 
6 mm (6 mm) 

of 

quantity 

Exceeding 200g/20cl but not exceeding 1 kg / 1L 

4 mm (4 mm) 

Exceeding 50 g/5cl but not exceeding 200 g/20cl 

3 mm (3 mm) 

Not exceeding 50 g/5cl 

Food Information Regulation 

2 mm (2 mm) 

1.2 mm (1.2 mm) 

The  choice  for  e-marking  is  voluntary  and  if  chosen,  the  larger  size  requirement  must  be 
followed when the e-marking is affixed. Materially a large pack allows more room for a larger 
indication, so there does not seem to be a major issue there.  

2.  Possible overlaps / complementarities with Directive 2007/45/EC: 
  Aerosols Dispensers: Directive 2007/45/EC waives the weight indication required by 
the Aerosols Dispensers Directive 75/324/EEC Article 8 1(e)56 - this exemption exists 
legally since 1980 (Directive 80/232/EEC) and is supported by European industry57. 

56Directive 75/324/EEC Article 8 1. Without prejudice to Regulation (EC) No 1272/2008 of the European Parliament and of 
the  Council  (  1  ),  each  aerosol  dispenser  or,  where  particulars  cannot  be  put  on  the  aerosol  dispenser  due  to  its  small 
dimensions  (maximum  capacity  of  150  ml  or  less)  a  label  attached  thereto  must  bear  the  following  particulars  in  visible, 
legible and indelible characters: (a) the name and address or trade mark of the person responsible for marketing the aerosol 
dispenser,  (b)  the  symbol  ‘3’  (inverted  epsilon)  certifying  conformity  with  the  requirements  of  this  Directive,  (c)  code 
markings enabling the filling batch to be identified, (d) the details referred to in point 2.2 of the Annex, (e) the net contents by 
weight and by volume. 
57FEA  favours  a  mandatory  labelling  of  the  nominal  quantities  in  volume  (ml),  which has  been an  established  rule  since 
1980: http://www.aerosol.org/regulatory-policy-affairs/legal-metrology. 

44 

 
 
 
 
 
 
                                                            
ANNEX 6: UNION LEGISLATION PROTECTING CONSUMERS 

(ad § 6.3.1):  

  Directive 94/62/EC58  prohibits 

the  use  of  excess  packaging  materials  and 
Directive 2005/29/EC59, which applies to business-to-consumer transactions, requires 
traders  to  provide  consumers  with  information  they  need  to  take  informed  decisions 
and prohibits business practices that are likely to deceive consumers.  

  Directive  98/6/EC60  requires  the  selling  price  and  the  unit  price  (price  per  unit  of 
measurement) to be indicated for products offered by traders to consumers, in order to 
improve consumer information and to facilitate comparison of prices. 

  Regulation (EU) No 1169/201161 requires the net quantity of the food and, in the case 
of food presented in a liquid medium also the drained net weight, to be indicated on 
the label. 

58 OJ L 365, 31.12.1994 
59 OJ L 149, 11.6.2005 
60 OJ L 80, 18.3.1998 
61 OJ L 304, 22.11.2011 

45 

 
 
 
 
 
                                                            
ANNEX 7: SUGGESTIONS FOR TECHNICAL/INTERNATIONAL PROGRESS 

(ad  §  6.4.3)  Suggestions  on 
technical/international progress:  

the  scope  of  Directive  76/211/EEC  regarding 

  Products  sold  by  length,  area,  or  number:  Five  authorities  mention  that,  unlike  the 
international  standard  OIML  R8762,  Directive  76/211/EEC  does  not  cover  products 
that are sold by length, area, or number63. Examples here are fabric (sometimes sold 
by  metres)  or  screws  and  nails  (sold  by  number).  Some  authorities  feel  that  the 
Directive needs to be updated in line with these recommendations, in order to simplify 
and to harmonise rules in all countries (by making the recommendations obligatory for 
all  Member  States).  A  few  others,  however,  are  of  the  opinion  that  this  is  not 
necessary  as  all  EU  Member  States  must  follow  the  OIML  recommendation  in  their 
national law already64.  

  Drained weight: A couple of authorities mention that the Directive does not concern 
drained weight (e.g. product in liquid and frozen products). The interviewees explain 
that it is difficult to establish drained weight at the point of time when the product is 
measured. Due to the lack of harmonised procedures in this respect, the issue is still 
dealt  with  differently  across  Member  States  even  though  all  products  are  in  practice 
benefiting from free circulation. In the absence of an internationally accepted standard, 
guide  6.8  developed  by  WELMEC  is  considered  an  important  step  forward  in 
increasing  harmonisation  in  this  respect  –  although  as  guidance  it  is  not  legally 
binding.65  

  Maximum  weight/volume  of  pre-packs  covered  by  the  Directive:  Six  out  of  22 
authorities mention that Article 1 of Directive 76/211/EEC stipulates that the Directive 
applies to pre-packages of “not less than 5 g or 5 ml and not more than 10 kg or 10 l”. 
A number of interviewees argue that while these limits may have been appropriate at 
the time the Directive was developed, consumers today buy prepacks containing much 
larger  (but  sometimes  also  smaller)  quantities.  Examples  of  products  that  regularly 
exceed the weight/volume limits of the Directive include cat litter, paint, and cement 
(more  than  10kg/l)  and  saffron  (less  than  5g/ml).  Although  a  limited  number  of 
products, expanding the coverage of the Directive would reflect this reality. However, 
national  law  can  and  does  already  take  account  of  larger  sizes,  whereby  the  OIML 
recommendation serves as basis. 

62 OIML R87(2004), point 1: http://www.oiml.org/en/files/pdf_r/r087-p-e04.pdf 
63 The fact that other authorities did not mention these issues when asked about the how up to date the Directives are, should 
not be interpreted to mean that they disagree with the finding. 
64Tthe  FIC Regulation  (EU)  No 1169/2011  also addresses  some  of  these  points.  In  particular:  Article  23.2  referring  to  the 
delegated acts that may be adoted by the Commission which may establish for certain categories of foods a different manner 
of expression of net quantity other than the units of mass or volume and Article 42 referring to national measures concerning 
the  expression  of  net  quantity  for  specified  foods  in  a  different  manner  which  MS  may  maintain  in  the  absence  of  Union 
rules. in the absence of Union rulest quantity for specified foods in a different manner  
By 13 December 2014, the Commission had been informed by the following MS: UK, SE, IE, NL, DE, PL. 
65WELMEC 6.8 - European Cooperation in Legal Metrology Drained Weight: “Guide on the Verification of Drained Weight, 
Drained Washed Weight and Deglazed Weight”, May 2013. 

46 

 
 
 
                                                            
  Speed  of  production:  Two  out  of  22  authorities  and  the  association  of  beer  brewers 
mention  that  the  Directives  are  based  on  outdated  production  speeds.  In  the  1970s 
when the Directive was drafted filling or packing 10,000 containers or packs an hour 
was  considered  a  lot.  Nowadays,  however,  multinationals  sometimes  produce  up  to 
120,000 an hour (which means 10,000 only represents 5 minutes of production time). 
Therefore,  they  believe  that  this  maximum  batch  of  10,000  should  be  adapted  (for 
example to “an hourly production”).  

  Sample of pre-package batches: Paragraph 2.1.4 of Annex II of Directive 76/211/EEC 
stipulates  that  in  order  to  pick  the  sample  of  pre-packages  to  be  tested  “[…]  the 
necessary  sample  shall  be  drawn  at  random  from  the  first  sample  and  marked.  This 
marking operation shall be completed before the start of the measuring operations.” 
Two  interviewees  note  that  nowadays,  random  sampling  can  be  done  with  software 
programmes66. Thus, there is no need to mark prepacks manually anymore. However, 
in one follow-up interview, the interviewee notes that if software programmes are used 
then  there  needs  to  be  a  proper  validation  process  to  ensure  the  calculations  are 
correct.  In  practice,  there  have  been  instances  where  software  systems  at  packers’ 
premises led to systematic over- or under filling due to programming mistakes.67 

66See WELMEC guide 6.4 on use of software: http://www.welmec.org/fileadmin/user_files/publications/6-4.pdf 
67If the maximum batch is increased, then the sample size needs to be increased accordingly to ensure it is still statistically 
representative of the batch that is being controlled. 

47