COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL Alignment of ten technical harmonisation directives to Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of products
Date: 2011-11-21
Institutions: European Commission
Subjects: free movement of goods, harmonisation of standards, market supervision, marketing, product safety, single market

EUROPEAN COMMISSION 

Brussels, 21.11.2011 
COM(2011) 763 final 

NEW LEGISLATIVE FRAMEWORK (NLF) ALIGNMENT PACKAGE 
(Implementation of the Goods Package) 

COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN 
PARLIAMENT AND THE COUNCIL 

Alignment of ten technical harmonisation directives to Decision No 768/2008/EC of the 
European Parliament and of the Council of 9 July 2008 on a common framework for the 
marketing of products 

(Text with EEA relevance) 

{SEC(2011) 1375 final} 
{SEC(2011) 1376 final} 

 
 
 
 
  
 
1. 

POLITICAL CONTEXT 

Europe needs a strategy to help it emerge stronger from the economic crisis and turn the EU 
into  a  smart,  sustainable  and  inclusive  economy  delivering  high  levels  of  employment, 
productivity  and  social  cohesion.  Europe  2020  sets  out  a  vision  of  Europe's  social  market 
economy for the 21st century. 

Although  the  single  market  is  not  itself  one  of  the  seven  flagship  policies  identified  as 
essential to achieve the headline targets of the EU 2020 strategy, the Communication on EU 
2020 states that EU-level instruments, notably the single market, financial levers and external 
policy tools, will be fully mobilised to tackle bottlenecks and deliver the Europe 2020 goals. 
Operational proposals to ensure the full contribution of these instruments to the strategy are 
an integral part of the Europe 2020. 

The Communication goes on to assert that a stronger, deeper, extended single market is vital 
for  growth  and  job  creation.  With  a  view  to  re-launching  the  single  market,  in  late  2009 
President Barroso invited Prof. Mario Monti to prepare a report setting out recommendations 
and  solutions.  Prof  Monti  presented  his  report  in  2010,  observing  that  the  single  market  is 
instrumental in several other areas of EU policy making which attract great political interest 
and risk not delivering what they are intended to deliver, if they cannot fully stand on a robust 
single market. 

In  relation  to  goods  in  particular,  Prof.  Monti  stated  that  maintaining  a  dynamic  and 
expanding single market for goods required building on the full implementation of the goods 
package,  approved  in  2008,  particularly  with  regard  to  the  mutual  recognition  principle  and 
market surveillance. 

The present initiative is an important step in the implementation of the legislative framework 
adopted  as  part  of  the  “goods  package”  on  9  July  2008.  The  objective  of  the  2008  package 
was to boost the free movement of safe goods by reinforcing the effectiveness of EU product 
safety  legislation,  strengthening  consumer  protection  and  levelling  the  playing  field  for 
economic operators.  

In  the  presence  of  the  world  economic  crisis,  this  remains  particularly  important  today 
because  an  effectively  functioning  internal  market  is  crucial  to  fostering  competitiveness, 
growth and  employment in the European Union –  major  political  priorities  of  the  European 
Commission, as demonstrated in the proposal for a Single Market Act1. 

2. 

THE GOODS PACKAGE AND ITS CONTRIBUTION TO THE INTERNAL MARKET 

The free movement of goods is a major foundation stone of the internal market, as enshrined 
in the Treaty, and is at the very heart of the development of the European Union. 

Since  the  1970s,  a  large  variety  of  goods  have  come  to  be  regulated  by  EU  legislation 
designed  to  ensure  the  protection  of  the  consumer,  the  worker  in  the  workplace,  the 

1 

COM(2011) 206 final of 13.4.2011. 

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environment,  energy  resources  and  so  on  in  a  uniform  manner,  thereby  ensuring  free 
movement throughout the Union. 

The  adoption  of  the  New  Approach  legislative  technique  in  1985,  restricting  legislative 
requirements to those that are essential and addressing detailed technical issues in harmonised 
European  Standards,  has  contributed  to  the  acceleration  of  the  harmonisation  process, 
enabling whole industrial sectors to benefit from free movement. 

Technical harmonisation legislation has proved a success. The internal market for goods is a 
reality and has simultaneously ensured a high degree of safety of goods and facilitated their 
free movement throughout the European Union.  

However,  the  implementation  and  enforcement  of  this  legislation  has  revealed  a  number  of 
weaknesses that undermine its effectiveness, illustrated by continued presence on the market 
of  non-compliant  and  potentially  dangerous  goods.  This  damages  confidence  in  the  whole 
system  and  creates  an  uneven  playing  field  for  economic  operators.  It  is  due  partly  to  the 
unsatisfactory  performance  of  certain  notified  bodies  and  inconsistencies  throughout  the 
legislation  making 
its  application  unnecessarily  complicated  for  manufacturers  and 
authorities. 

Non-compliance  can  be  potentially  harmful  to  users  of  goods.  It  also  reduces  the 
competitiveness  of  compliant  firms  as  non-compliant  rivals  take  unfair  advantage  (e.g.  by 
avoiding costly conformity assessment procedures). 

One major difficulty for national market surveillance authorities is that non-compliant goods 
and the operators who supplied them are very often not traceable, particularly when the goods 
originate  in  third  countries.  Moreover,  market  surveillance  is  not  always  carried  out  in  the 
Member  States  as  consistently  or  rigorously  as  it  should  be,  allowing  potentially  dangerous 
goods to circulate. As market surveillance is primarily carried out at national level, there is an 
urgent  need  for  better monitoring,  coordination  and  exchange  of  information  at  EU  level  in 
order to ensure a more uniform level of safety throughout the EU. 

Legislative  requirements  for  goods  have  become  increasingly  complicated  for  economic 
operators.  Modern  goods  have  become  technologically  more  complex  and  present  more 
diverse risks than before to both the health and safety of persons and the environment. This 
has meant that manufacturers and other economic operators now have to contend with a large 
and growing number of different pieces of legislation which apply simultaneously to a single 
product.  In  addition,  inconsistencies  have  gradually  arisen  in  product  legislation  -  different 
terminology  is  used  to  describe  concepts  that  are  in  fact  common  to  all  harmonising 
legislation (e.g. conformity assessment procedures and safeguard clauses). This last problem 
is more important than at first appears. 

Even  minor  divergences  can  make  it  difficult  for  economic  operators  to  understand  how  to 
comply with EU legislative requirements. This can lead honest operators to invest heavily in 
areas  which  are  in  fact  unnecessary,  in  the  belief  that  this  will  make  absolutely  sure  of 
compliance.  At 
inconsistencies  and  ambiguities  provide 
unscrupulous operators with ways to circumvent public authority controls. Often, it is unclear 
to  national  authorities  what  checks  must  be  done,  or  how.  This  leads  to  Member  States  (or 
even  regions  within  those  States)  adopting  different  approaches,  with  the  result  that  market 
surveillance is not performed with uniform regularity, operating criteria and rigour across the 

legislative 

the  same 

time, 

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EU. This in turn allows an uneven playing field to develop for economic operators, be they 
manufacturers or importers. 

On the basis of these considerations, in 2003 the Commission presented a Communication to 
the  Parliament  and  the  Council  on  the  implementation  of  the  New  Approach,  adopted  in 
19852.  This  concluded  that  the  New  Approach  legislative  technique  needed  to  be  reviewed 
and complemented by legislative requirements for the accreditation of conformity assessment 
bodies and a general policy on market surveillance for goods.  

3. 

THE NEW LEGISLATIVE FRAMEWORK AND ITS IMPLEMENTATION 

In response to this review process, the Commission presented a collection of measures which 
came to be known  as the  “Goods package”. The New Legislative  Framework (NLF) texts - 
Regulation  (EC)  No  765/2008  and  Decision  No  768/2008/EC  -  were  adopted  as  part  of  the 
package  (which  also  included  a  Communication  on  car  registration  and  a  proposal  for  a 
regulation  on  mutual  recognition).  These  texts  go  far  beyond  a  mere  review  of  the  New 
Approach and in fact set up a new legislative environment for the harmonised area.  

The two NLF texts constitute a major political breakthrough for the functioning of the internal 
market  for  goods,  in  that  they  not  only  establish  an  overarching  and  coherent  approach  to 
technical  harmonisation  policy  in  relation  to  product  safety  but  also  open  the  door  to  a  real 
and  effective  market  surveillance  policy  for  all  goods  placed  on  the  market,  whether  they 
originate in the EU or in third countries.  

The objective of the NLF texts is to reinforce the effectiveness of legislation protecting health 
and safety (and other public interests) by: 

– 

– 

– 

filling  in  the  missing  elements  of  EU  policy,  e.g.  accreditation  and  market 
surveillance including the control of goods from third countries; 

addressing the shortcomings of the existing situation in the light of twenty years of 
implementation of the New Approach alongside more traditional legislation; 

bringing coherence to legislation which now cuts across more and more sectors. 

The  two  texts  contribute  in  their  different  ways  to  answering  these  needs  and  complete  the 
legislative quality chain: (essential) requirements relating to health and safety and other public 
interest protection, quality requirements for manufacturers and conformity assessment bodies, 
an  accreditation  system  to  ensure  the  quality  of  conformity  assessment  bodies,  transparent 
conformity  assessment  procedures,  strong  market  surveillance  and  controls  of  goods  from 
third  countries.  A  weak  or  missing  link  in  this  chain  can  allow  unsafe  goods  to  reach  the 
market and the end user, whether private or professional. The NLF texts are complementary 
documents,  inextricably  linked  the  one  to  the  other,  and  both  relate  very  closely  to  sectoral 
legislation, which they support and complement. 

2 

Communication  from  the  Commission  to  the  European  Parliament  and  the  Council:  Enhancing  the 
Implementation of the New Approach Directives, COM(2003) 240 final of 7.5.2003. 

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The  Regulation  introduces  principles,  rules,  rights  and  obligations.  Its  provisions  have  been 
directly applicable since 1st January 2010 and are being implemented by national authorities, 
with the Commission helping to ensure a coordinated approach.  

The  Decision  contains  model  provisions  based  on  those  in  many  existing  pieces  of  Union 
harmonisation legislation but does not itself have any legal effect. As a sui generis decision, it 
constitutes  a  commitment  on  the  part  of  the  EU  legislator  to  apply  its  contents  as 
systematically  as  possible  to  all  product  legislation,  past,  present  and  future,  and  hence 
facilitate implementation by all involved. 

The  full  effects  of  the  Regulation  depend  to  some  extent  on  the  process  of  integrating  the 
provisions of the Decision into the sectoral legislation. 

The  NLF  texts  apply  in  conjunction  with  Union  harmonisation  legislation  in  the  following 
manner:  

– 

– 

sectoral  legislation  sets  levels  of  health  and  safety  and  other  public  interest 
protection,  imposes  requirements  on  economic  operators  and  national  authorities, 
chooses  the  appropriate  conformity  assessment  procedures  and  includes  safeguard 
mechanisms; 

Regulation  (EC)  No  765/2008  sets  out  rules  for  the  accreditation  of  conformity 
assessment  bodies  which  provide  conformity  assessment  services  under  sectoral 
legislation and imposes obligations on market surveillance authorities relating to the 
enforcement of obligations set out in sectoral legislation and to the control of goods 
from third countries. 

Through  the  alignment  process,  the  provisions  of  Decision  No  768/2008/EC  on  definitions, 
obligations  of  economic  operators,  traceability  requirements,  consolidated  criteria  and 
procedures for the notification of conformity assessment bodies and consolidated conformity 
assessment  procedures  are  all  integrated  into  sectoral  legislation,  thus  allowing  the  market 
surveillance provisions set out in Regulation (EC) No 765/2008 to have full effect. 

4. 

THE ALIGNMENT PROCESS AND THE PRESENT PACKAGE 

For  future  legislation,  the  Commission  will  systematically  examine  whether  it  is  feasible  to 
integrate the provisions of the Decision into sectoral legislation, aligning as often and as fully 
as possible. Where it decides not to align, the unsuitability of the provisions of the Decision 
must  be  fully  explained.  This  process  will  take  place  as  and  when  sectoral  legislation  is 
modified. 

Since  the  adoption  of  the  Decision,  a  number  of  pieces  of  legislation  have  come  up  for 
review. The toys directive was revised by directive 2009/48/EC of 18 June 20093, and is the 
first directive to be fully aligned with Decision No 768/2008/EC. Others are in the pipeline. 

The  question  is  what  to  do  where  no  review/revision  of  legislation  is  envisaged  in  the  near 
future.  Clearly,  the  more  coherent  product  legislation  is,  the  easier  it  is  to  comprehend  and 

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OJ L 170, 30.6.2009, p. 1. 

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therefore  to  comply  with  and  to  enforce.  Horizontal,  non-sectoral  harmonised  solutions 
certainly contribute to better coherence, as in the cases of conformity assessment procedures, 
rules for notified bodies, etc. 

There is therefore a real need to review a number of directives which would not ordinarily be 
revised  in  the  near  future,  in  order  to  enable  market  surveillance-related  provisions  to  be 
quickly put into operation in the sectors concerned. 

Therefore it is proposed to align with the Decision a package of directives which were not due 
for revision but in relation to which provisions on market surveillance and other cross-sectoral 
issues would be beneficial, without calling into question purely sectoral considerations. 

The  objective  of  this  package  is  therefore  to  amend  selected  directives  solely  to  integrate 
horizontal  provisions  of  the  Decision  in  a  one-off,  simplified  process  without  reviewing 
sectoral matters, in order to produce the immediate benefits of the NLF in as many sectors as 
possible.  

In  order  to  maximise  legal  clarity,  the  Commission  has  opted  for  the  recast  legislative 
technique.  This  and  the  Interinstitutional  Agreement  between  the  European  Parliament,  the 
Council and the Commission should help focus discussion in the co-decision procedure on the 
horizontal  alignment  of  the  texts  with  Decision  No  768/2008/EC  and  avoid  reopening 
discussions on sector-specific aspects. 

The  directives  should  also  be  aligned  with  the  terminology  and  provisions  of  the  Lisbon 
Treaty. In particular the new provisions on comitology must be introduced as a number of the 
directives concerned established committees. 

5. 

THE SELECTION OF THE DIRECTIVES CONCERNED 

Following  adoption  of  the  NLF  in  July  2008,  the  Commission  services  screened  product 
legislation to identify instruments due to be revised within the next 3-5 years (i.e. up to 2013) 
for sector-specific reasons (e.g. to clarify or expand their scope, to update safety requirements 
etc.).  Most  existing  legislation  required  updating  for  sector-specific  reasons  and  these 
individual revisions appear in the Commission Work Programme. Alignment will take place 
in the context of these revisions. 

The Commission also looked for legislation which largely shared the structure and approach 
of the provisions of Decision No 768/2008/EC to form part of an exercise devoted solely to 
alignment  with  the  Decision.  This  automatically  limited  the  choice  of  directives  to  those 
adopted  under  the  New  Approach  technique,  as  other  legislation  (in  particular  old  or 
traditional  approach  directives)  would  require  more  in  depth  adaptation  going  beyond  mere 
“alignment”. 

This  process  led  the  Commission  to  identify  the  following  ten  new  approach  directives  for 
inclusion in this alignment package: 

• 

Civil  Explosives  Directive:  Directive  93/15/EEC  on  the  harmonisation  of  the 
provisions  relating  to  the  placing  on  the  market  and  supervision  of  explosives  for 
civil use;  

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• 

• 

• 

• 

• 

• 

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• 

• 

Directive  on  equipment  for  use  in  explosive  atmospheres  (ATEX):  Directive 
94/9/EC  on  the  approximation  of  the  laws  of  the  Member  States  concerning 
equipment  and  protective  systems  intended  for  use  in  potentially  explosive 
atmospheres;  

Lifts Directive: Directive 95/16/EC on the approximation of the laws of the Member 
States relating to lifts;  

Pressure  Equipment  Directive:  Directive  97/23/EC  on  the  approximation  of  the 
laws of the Member States concerning pressure equipment;  

Measuring 
instruments;  

Instruments  Directive:  Directive  2004/22/EC  on  measuring 

Electromagnetic  Compatibility  Directive  (EMC):  Directive  2004/108/EC  on  the 
approximation  of  the  laws  of  the  Member  States  relating  to  electromagnetic 
compatibility;  

Low  Voltage  Directive  (LVD):  Directive  2006/95/EC  on  the  harmonisation  of  the 
laws  of  Member  States  relating  to  electrical  equipment  designed  for  use  within 
certain voltage limits; 

Pyrotechnic Articles Directive: Directive 2007/23/EC on the placing on the market 
of pyrotechnic articles;  

Non-automatic  Weighing  Instruments  Directive:  Directive  2009/23/EC  on  non-
automatic weighing instruments;  

Simple  Pressure  Vessels  Directive:  Directive  2009/105/EC  relating  to  simple 
pressure vessels. 

The  major  common  characteristic  of  these  directives  is  that  they  have  a  similar  structure: 
definitions,  essential  health  and  safety  requirements,  references  to  harmonised  European 
traceability  requirements  and  conformity 
standards,  requirements  for  manufacturers, 
assessment  requirements  (all  have  conformity  assessment  procedures,  eight  require  the 
intervention of notified bodies) and safeguard mechanisms. 

Some  of  the  directives  have  cross  sectoral  relevance  (in  particular,  low  voltage,  EMC, 
measuring instruments, equipment for use in explosive atmospheres and pressure equipment) 
thus  reinforcing  the  expected  benefits  of  alignment  for  economic  operators  and  national 
authorities responsible for the surveillance of these markets. 

The  sectors  concerned  are  very  important  industrial  sectors  which  are  faced  with  severe 
international competition and will therefore benefit from simplification and the guarantee of a 
level playing field in the EU market.  

Basic data for some of these sectors can be summarised as follows: 

The low voltage and EMC directives cover in general all domestic and professional electrical 
appliances  which  answer  to  an  output  of  some  €  235.59  billion  for  equipment  covered  by 
LVD  and  €  200.12  billion  for  equipment  covered  by  EMC.  The  trade  balance  is  negative 

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of exports. The internal consumption is 
(LVD: € 103.93 billion of imports and € 83.09 billion 
estimated at € 256.42 billion. EMC: € 100.78 billion  of imports and € 76.07 billion of exports. 
The internal consumption is estimated at € 224.83 billion). 

The  ATEX  equipment  directive  covers  any  product  likely  to  be  used  in  an  explosive 
atmosphere,  whether  electrical,  mechanical  or  pressure  driven  (mines,  petrochemical  plants, 
mills,  filling  stations.  etc).  The  output  is  to  the  order  of  some  €  2.2  billion,  and  its  trade 
balance is positive: imports amount to € 400 million, whereas internal consumption estimated 
at € 1.9 billion, 86% of internal production. 

The sector  of  measuring instruments (including  non-automatic weighing instruments) which 
covers all measuring meters for water, gas, electricity, petrol and all other liquids and includes 
all  weighing  instruments  in  retail  commerce  has  an  output  of  some  €  5.75  billion.  Most 
instruments  are  manufactured  in  the  EU,  imports  representing  less  than  a  quarter  of  EU 
production. 

Pyrotechnics, which cover not only fireworks but also the technology for automobile air-bags, 
has an output of € 4.2 billion (€ 2.8 billion for ai
rbags). The fact that 95% of fireworks are 
produced outside the EU underlines the need for strong traceability requirements. 

Pressure  equipment  (including  simple  pressure  vessels)  may  fall  under  several  different 
sectors as it is mostly used as a component in a larger end product. Goods including pressure 
equipment  range  from  consumer  goods  (e.g.  pressure  cookers,  domestic  air  conditioning 
systems,  fire  extinguishers,  etc.)  to  industrial  goods  (e.g.  pressure  vessels  and  piping  in 
chemical plants, various types of machinery, etc.). 

This  clearly  shows  the  importance  of  the  sectors  concerned  and  underlines  that  enhancing 
legislative  coherence  and  enabling  effective  market  surveillance,  in  particular  in  relation  to 
goods originating in third countries, will have very positive effects. 

6. 

THE CONTENTS OF THE PROPOSALS 

The  proposals  covered  by  this  initiative  are  strictly  limited  in  content  to  alignment  with 
Decision No 768/2008/EC and the new terminology of the Lisbon Treaty (including the new 
provisions  on  comitology).  More  specifically,  they  will  align  definitions,  traceability 
requirements, obligations of economic operators, criteria and procedures for the selection of 
conformity assessment bodies (notified bodies) and conformity assessment requirements.  

The language used in the provisions of the Decision has been retained as far as possible, but 
in certain circumstances it has been adapted to enable correct and meaningful integration into 
the  directives.  Thus,  terminology  may  differ  from  one  directive  to  another  but  the  meaning 
and legal obligations will be the same. 

The substance of the alignment of the ten directives can be summarised as follows: 

(1) 

Measures intended to address the problem of non-compliance: 

• 

Obligations  of  importers  and  distributors  to  check  that  goods  bear  the  CE 
marking,  are  accompanied  by  the  required  documents  and  carry  traceability 
information. Additional obligations are imposed on importers. 

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• 

• 

• 

Obligations of manufacturers to provide instructions and safety information in 
a  language  easily  understood  by  consumers  and  end-users,  and  to  carry  out 
sample testing and product monitoring. 

requirements 

the  whole  distribution  chain: 
Traceability 
manufacturers and importers must put their names and addresses on products; 
every economic operator must be able to inform the authorities from whom he 
purchased a product and to whom he supplied it.  

throughout 

Reorganisation of safeguard clause procedure (market surveillance) to clarify 
how the relevant enforcement authorities are informed about dangerous goods 
and  ensure  that  the  same  action  is  taken  in  relation  to  that  product  in  all 
Member States. 

(2) 

Measures intended to ensure the quality of work done by notified bodies:  

• 

• 

• 

• 

Reinforcement  of  the  notification  requirements  for  notified  bodies  (including 
subcontractors  and  subsidiaries)  such  as  impartiality,  competence  in  carrying 
out  their  activity  and  the  application  of  guidance  developed  by  coordination 
groups.  

Revised  notification  process:  Member  States  notifying  a  body  must  include 
information on the evaluation of the competence of that body. Other Member 
States can object to the notification within a certain period.  

Requirements for notifying authorities (i.e. the national authorities responsible 
for  the  assessment,  notification  and  monitoring  of  notified  bodies)  such  as 
objectivity and impartiality in carrying out their activity. 

Information  obligations:  Notified  bodies  must  inform  notifying  authorities  of 
refusals, restrictions, suspensions and withdrawals of certificates.  

(3) 

Measures intended to ensure greater consistency among directives: 

• 

• 

Alignment of commonly used definitions and terminology. 

Alignment of the texts of the conformity assessment procedures.  

It  should  be  underlined  that  issues  relating  to  the  implementation  of  EU  standardisation 
policy,  which  could  have  knock-on  effects  on  the  implementation  of  the  directives  covered 
here, are being dealt with in a separate initiative (the standardisation package). 

7. 

CONCLUSIONS 

The  Commission  attaches  great  importance  to  these  proposals,  which  make  an  important 
contribution  to  the  political  goal  of  a  properly  functioning  internal  market  for  consumers, 
professionals and economic operators in general. The aligned directives will help strengthen 
the competitiveness of European enterprises, guaranteeing a level playing field for all where 
law-abiding operators will be protected against those less scrupulous. 

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This initiative is also very much in line with the Commission’s objective of Better Regulation 
and  Simplification,  as  it  brings  coherence  and  legislative  uniformity  across  many  different 
industrial sectors, helping to make EU legislation easier to understand, implement, obey and 
enforce.  

The  Commission  has  selected  instruments  for  this  package  on  the  basis  that  the  only 
amendments made to them relate to alignment with the provisions of the NLF. No changes are 
made  to  the  substantive  technical  aspects  of  the  particular  sectoral  legislation  involved4. 
Accordingly,  the  Commission  calls  upon  the  European  Parliament  and  Council  to  treat  the 
package as such in order to ensure the overall coherence implicit in the recast technique and 
to avoid splitting up debates into a collection of sectoral discussions. 

4 

An  exception  is  made  for  the  pyrotechnic  articles  directive.  The  Commission  proposes  a  small 
correction  to  Annex  I  point  (4)  in  order  to  avoid  an  unintended  ban  of  airbags  and  certain  other 
pyrotechnic articles after 4 July 2013. The amendment is relatively minor in terms of changes made to 
the existing text. Hence it is considered more appropriate and efficient to keep the directive inside the 
package instead of carrying out an independent revision process. 

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