EUROPEAN COMMISSION 
21.11.2011 
SEC(2011) 1375 final 
  
NEW LEGISLATIVE FRAMEWORK (NLF) ALIGNMENT PACKAGE 
(Implementation of Goods Package) 
COMMISSION STAFF WORKING PAPER 
Accompanying document to 
 
10 PROPOSALS TO ALIGN PRODUCT HARMONISATION DIRECTIVES TO 
DECISION No 768/2008/EC 
 
EXECUTIVE SUMMARY OF THE IMPACT ASSESSMENT 
{COM(2011) 763 final} 
{SEC(2011) 1376 final}  
 
EN 1   EN 1. PROBLEM DEFINITION  
General problems with product harmonisation directives … Over a period of more than 30 years the EU has set up requirements in its “technical 
harmonisation” directives for a vast range of products such as machinery, automobiles, toys, electrical products, lifts , etc. This legislation has two objectives: 
On the one hand it ensures that products  available in Europe safeguard public 
interests like health and safety, consumer protection or environmental protection at a 
high level. On the other hand it ensures th e free movement of products by replacing 
national rules with a single harmonised set of conditions for the marketing of the products concerned that appl y in all EU Member States
1.  
A stocktaking exercise on experience gain ed with existing legislation in the 
harmonised area, and in part icular with the New Appr oach was launched in 2004. 
The overall conclusion of this stocktaki ng was that the legislation has largely 
succeeded in liberalising trade in goods and in setting robust requirements ensuring 
the safety of products. However, it also re vealed a number of shortcomings, namely a 
significant number of  non-compliant products  still reaching the market, the 
unsatisfactory performance of certain  notified bodies2, and inconsistencies  
throughout the legislation making its app lication unnecessarily complicated for 
manufacturers and authorities.  
… and general solu tion identified 
To remedy these shortcomings, the “N ew Legislative Framework” (NLF) was 
adopted as part of the goods package. It consists of two comple mentary instruments: 
• Regulation (EC) No 765/2008 on accredita tion and market surveillance (NLF 
Regulation)3  
• Decision No 768/2008/EC establishing a comm on framework for the marketing of 
products (NLF Decision)4.  
Both instruments strengthen and complete  the existing rules and improve the way 
they are applied and enforced in pr actice by business and authorities.  
                                                 
1 The evolution of the EU’s policy on technical harmonisation is outlined in detail in the impact 
assessment that accompanied the New Le gislative Framewor k. SEC(2007) 173, 
http://ec.europa.eu/governance/impact/ia_carried_out/docs/ia_2007/sec_2007_0173_en.pdf   
2 Laboratories and certification or inspection bodies  delivering certificates wh ich are notified to the 
Commission by Member States. 
3 Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out 
the requirements for accreditation and market surveillance relating to the marketing of products and 
repealing Regulation (EEC) No 339/93, OJ L218 of 13.08.2008. 
4 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, and repealing Council Decision 93/465/EEC, OJ L218 of 
13.08.2008. 
 
EN 2   EN The Regulation introduced rules on accreditation and requirements for the 
organisation and performance of market su rveillance and controls of products from 
third countries. The Regulation b ecame applicable on 1 January 2010. 
The Decision contains model text  that is meant to reinforce various provisions 
commonly used in EU product legislation (for example concerning definitions, 
obligations of economic operators, notified bodies, safeguard mechanisms, etc) so 
that the legislation works more effectively in  practice. It also introduces new aspects, 
such as obligations of importers, which are crucial to improving the safety of 
products on the market.  
However, unlike the Regulation, the Decision does not have immediate legal effects 
on economic operators, individuals or Me mber States. It is conceived as a “toolbox”  
for future legislation . By adopting the Decision, the Parliament, the Council and the 
Commission have committed themselves to using its provisions as much as possible 
in future product legislation in order to maximise the coherence of the regulatory 
framework5. To give practical effect  to the provisions of th e Decision, they need to 
be integrated into existing and new product legislation.  
A specific set of harmonisation directives 
Against this background, the Commission ha s identified a specific set of product 
harmonisation directives for which alignmen t with the NLF Decision could be dealt 
with as a 'package' (i.e. as opposed to individual alignments carried out at the same time as broader revisions
6). The ten directives concerned are the following:  
– Civil Explosives Directive:  Directive 93/15/EEC on the harmonisation of the 
provisions relating to the plac ing on the market and supe rvision of explosives for 
civil use  
– ATEX Directive:  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 of 29 June 1995 on the approximation of the 
laws of the Member States relating to lifts 
– Pressure Equipment Directive (PED):  Directive 97/23/EC on the approximation 
of the laws of the Member States concerning pressure equipment  
                                                
 
5 Article 2 (Subject matter and scope) of Decision No 768/2008/EC reads: "This Decision sets out the 
common framework of general principles and reference provisions for the drawing up of Community 
legislation harmonising the conditions for the marketing of products (Community harmonisation legislation. Community harmonisation legislation shall ha ve recourse to the general principles set out in 
this Decision and to the relevant reference provisions of Annexes I, II and III. However, Community 
legislation may depart from those general principles and reference provisions if that is appropriate on 
account of the specificities of the sector concerned, especially  if comprehensive legal systems are 
already in place." 
6 Examples of individual alignments that are being carried out together with the revision of sector-
specific elements (e.g. product requirements or tes ting methods) are the Recr eational Craft Directive, 
the Directive on Personal Protective Equipment or the R&TTE Directive. 
 
EN 3   EN – Measuring Instruments Directive (MID):  Directive 2004/22/EC on measuring 
instruments  
– Electromagnetic Compatib ility Directive (EMC):  Directive 2004/108/EC on 
the approximation of the laws of the Me mber States relating to electromagnetic 
compatibility and repealing Directive 89/336/EEC 
– Low Voltage Directive (LVD):  Directive 2006/95/EEC on the harmonisation of 
the laws of Member States relating to el ectrical 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 (NAWI):  Directive 
2009/23/EC on non-automatic weighing instruments 
– Simple Pressure Vessels Directive (SPVD) : Directive 2009/105/EC relating to 
simple pressure vessels 
The directives concerned by this initiative set out requirements which ensure that 
products are designed and manufactured in such  a way that they do not pose a risk to 
the health and safety of c onsumers or other users, th at they produce accurate 
measuring results (measuring instruments) or  that they do not cause electromagnetic 
disturbances (electromagnetic compatibility directive).  
The economic sectors to which the directiv es apply are electric and electronic goods 
(LVD and/or EMC), equipment for use in potentially expl osive atmospheres 
(ATEX), pressure equipment (SPVD or PED), measuring instruments (MID or 
NAWI), civil explosives, lifts  and pyrotechnic articles. 
General problems also affect this specific set of directives  
This impact assessment examines to what extent the general problems identified with 
product harmonisation legislati on also affect these 10 dire ctives and whether their 
alignment with the new framework esta blished by the NLF Decision would be 
beneficial for the sectors concerned.  
The problem of non-compliance  with the requirements of directives is generally 
perceived throughout all sectors concerne d, whereas certain sectors (and product 
categories) are more affected than ot hers. Overall 92% of economic operators 
answering the public consultation consider that their sector is affected by non 
compliance.  
Non-compliance can be potentially harmful for product users, although the risks vary 
according to the nature of the product. For instance defective electronic products 
falling under the scope of the LVD can present a risk of electric shock or burns. 
Electrical equipment that does not comply with the essential requirements of the EMC could produce electromagnetic disturbanc es that affect the correct functioning 
of other apparatus (TVs, radio and teleco mmunications networks) and may not work 
as intended. The explosion of industrial pr essure equipment such as a boiler or a 
reactor vessel in a chemical plant is likely to lead to serious injuries and may cause 
 
EN 4   EN significant damage to surrounding infrastr uctures. Non compliance of measuring 
instruments can lead to wrong measuring results linked with economic damage for 
end-users. 
In addition, non-compliance hampers the comp etitiveness of compliant firms. Non-
compliant economic operators can gain sign ificant cost advantages (e.g. by avoiding 
costly conformity assessment procedures ) by comparison with those who follow the 
rules7. In sectors where there is tough competition from imported low-price products, 
European industry is disadvantaged. 87% of economic operators responding to the 
public consultation consider that they su ffer from unfair competition due to this 
situation.  
A major reason for non compliance is that  market surveillance does not operate 
effectively in the EU. This  perception is widely shar ed amongst stakeholders. A 
specific difficulty for the authorities is th e traceability of non-compliant products and 
the operators who supplied them , in particular when the products originate in third 
countries.  
A further reason is that existing obligat ions in product directives focus on 
manufacturers, while importe rs and distributors do not car ry out the necessary checks 
to ensure that they are not supplying non- compliant products. They rely on the fact 
that it is the task of  the manufacturer to ensure th e compliance of the product and do 
not check whether the manufacturer has act ually carried out this task properly. To 
remedy this, Member States have in troduced obligations on importers and 
distributors in their national laws, which how ever differ from country to country and 
lead to different approaches when dealing with non-compliant products. 
Eight of the ten directives concerned require the certification of products by 
“notified bodies ”8 before they can be placed on the market9. Notified bodies hence 
play an important role in ensuring the safety and compliance of products on the 
market. However there have been problems with the quality of services  delivered by 
some of them. This assessment was shar ed by 68% of notified bodies, 84% of 
economic operators using notified bodies and 53% of public authorities that 
participated in th e public consultation. 
One reason is that certain notified bodies la ck the necessary competence to carry out 
conformity assessments properly. Another r eason is that, in order to issue their 
certificates at significantly lower rates, certa in bodies do not put th e required level of 
effort into their assessment or into the application of procedures. For example, the 
elimination or reduction of on site controls or relaxed requirements regarding the frequency of periodic audits/inspections can reduce the costs of assessments quite 
considerably. 
                                                
 
7 Quote from questionnaire reply: “Expert estimations say that fulfilling the safety and administrative 
provisions required by our regulations can add up to a fifth of total manufacturing costs. In the absence 
of efficient enforcement mechanis ms some manufacturers might be tempted to "take the easy way" and 
to market non-compliant products.” 
8 These bodies are conformity assessment bodies, which test, inspect and certify products. They are 
called “notified bodies”, because they are notif ied by the Member States to the Commission. 
9 In the electro-technical sector th e role of notified bodies is different. For instance under EMC Directive 
recourse to notified bodies in the conf ormity assessment procedure is voluntary.  
 
EN 5   EN The third problem to be tackled is the inc onsistency gradually bu ilt up in the existing 
product legislation due to the fact that the directives have evolved over time. For 
example different terminology is used for c oncepts that are common to all of them 
(conformity assessment procedures, defini tions or safeguard clauses). Sometimes 
definitions or legal provisions leave room for divergent interpretations and this leads to legal uncertainty and conf usion, in particular when two or more directives apply 
simultaneously. For example, a considerable  number of measuri ng instruments also 
have to comply with the EMC. Certain pyrotechnic articles also have to comply with the LVD or EMC. 
2. A
NALYSIS OF SUBSIDIARITY  
This initiative concerns the proper functi oning of the internal market in goods. EU 
action in this area is based on Article 114 of  the TFEU. The aspect s addressed in this 
context are already regulate d by the ten directives conc erned, although they do not 
effectively address the weaknesses identified  or, as regards inc onsistency, may even 
be the source of the problem. Action taken at national level to address these problems 
has led to divergent national approaches in  the treatment of economic operators and 
risks creating obstacles to the free moveme nt of goods. Hence it is appropriate to 
take action at EU level. 
3. OBJECTIVES  
This initiative has 3 main objectives. The fi rst is to ensure that products on the EU 
market are safe and fulfil all the requirem ents ensuring a high level of protection of 
public interests (health and safety, electromagnetic compatibility, correct measurements). The main specific goal is to reduce the number of non-compliant 
products on the market by providing authorities with more effective tools to carry out 
market surveillance controls and to m onitor the activities of notified bodies. 
The second objective is to improve the f unctioning of the internal market, by 
ensuring that non-compliant products and ec onomic operators are equally treated and 
that notified bodies are equally a ssessed throughout the EU market. 
Finally, this initiative aims to simplif y the regulatory environment for products. 
4. P
OLICY OPTIONS  
Due to the specific context of this initiative  as explained in section 1, this impact 
assessment explores a limited set of options. The objective is  to ascertain whether the 
directives concerned should make use of th e measures of the NL F Decision and, if 
so, to assess whether alignment with the Deci sion should be carried out by legislative 
or non legislative means. The resulting options are: 
– Option 1: No policy change . This option consists of not introducing any changes 
to the existing situation. 
– Option 2: Alignment with the NLF Decision  by non legislative measures . 
Option 2 consists of a set of non-regul atory instruments that encourage the 
 
EN 6   EN voluntary application of all or part of th e solutions contained in the NLF Decision. 
The latter could also be presented as “best practice” in guidance documents and 
the parties concerned would be encouraged to apply them. In pr actice, this option 
would be a “voluntary” alignment with the NLF Decision. 
– Option 3: Alignment with the NLF Decision by legislative measures . Option 3 
consists of the modification of the direct ives concerned that would then make use 
of the measures set out  in the NLF Decision. 
Under option 2 and option 3 the measures  provided by the NLF Decision can be 
summarised as follow:  
(1) Measures intended to address th e problem of non-compliance: 
• Obligations for importers and distributors  to check that products bear the CE 
marking, are accompanied by the require d documents and carry traceability 
information. Additional obligati ons are imposed on importers. 
• Manufacturer obligations  to provide instructions and safety information in a 
language easily understood by consumers and end-users, to carry out sample 
testing and product monitoring. 
• Traceability requirements  throughout the whole distribution chain: 
manufacturers and importers must put their name and address on the product; 
every economic operator must be able to inform the authorities from whom he 
purchased a product and to whom he supplied it.  
• Reorganisation of safeguard clause procedure (market surveillance)  to clarify 
how the relevant enforcement author ities are informed about dangerous 
products and ensure that equivalent acti on is taken against that product in all 
Member States. 
(2) Measures intended to ensure the quality of notified bodies' work:  
• Reinforcement of the no tification requirements  for notified bodies (including 
subcontractors and subsidiaries) such as impartiality and competence in 
carrying out their activ ity and application of guidance developed by 
coordination groups.  
• Revised notification process : Member States notifying a body must include 
information on the evaluation of the co mpetence of that body. Other Member 
States can object to the notific ation within a certain period.  
• Requirements for notifying authorities  (i.e. the national authorities in charge of 
the assessment, notifica tion 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 more  consistency among the directives: 
 
EN 7   EN • Alignment of commonly used definitions and terminology. 
• Alignment of the texts of the conformity assessment procedures.  
5. ASSESSMENT OF IMPACTS  
The impact assessment report examines the economic impacts of the options in terms 
of internal market, compet itiveness, costs and admini strative burdens for economic 
operators or notified bodies and th e impacts on public authorities and 
consumers/users. The report also looks at  the social impact on public health and 
safety and on the simplification of the regulatory environment.  
Although no additional policy initiative is  taken, the no policy change option is 
expected to have some positive impact in the sectors concerned already, due to the 
progressive implementation of the NLF Re gulation, which strengthens the powers of 
market surveillance authorities. This plays a positive role in relation to the goal of 
reducing non-compliance and delivers benefits both to compliant-firms (competitiveness) and users (economic and safety impact). The NLF Regulation also facilitates the task of public authorities in  their activities relating to the notification 
and monitoring of some conformity assessment bodies (i.e. those using accreditation). However, the option has no real impact on the internal market or on the simplification of the regulatory environment.  
The option of alignment with  the NLF Decision by non-legi slative measures has the 
potential for positive impacts on all stak eholders. For instance, clarifying the 
responsibilities of importer s and distributors and intr oducing specific traceability 
requirements would facilitate the equal treat ment of the parties involved (positive 
impact on internal market); it would also  provide authorities with more effective 
tools to address non-compliance and so reduce the scope for unfair competition (competitiveness) and risks taken by users (economic and safety impact). However, under option 2 the provisions of the NL F Decision would only be non binding 'best 
practice' and so their implementation would entirely de pend on the voluntary 
commitment of the different stakeholders . This casts serious doubt on whether the 
positive impacts identified will actually materialise and provide real added value with respect to the no- change option
10. 
Under the option of alignment with the NL F Decision by legisl ative measures the 
provisions of the NLF Decision would be part  of applicable sector legislation. The 
provisions of the NLF Deci sion would be binding oblig ations enforceable by 
Commission and by national authorities. This  would give a stronger guarantee that 
the positive impacts of the ali gnment would actually occur.  
This analysis of positive impacts is largely supported by stakeholders. For instance 
73-76% of general economic operators and small and medi um enterprises 
                                                 
10 It this respect, it is important to note that existing guidance contained in the so-called "Blue Guide" 
(Guide  to the implementation of directives based on the New Approach and the Global Approach , 
European Commission, September 1999), already points to the responsibilities of the economic 
operators that are then clarified by Decision No 768/2008/EC. However as the Blue Guide is not 
binding, it has not been sufficient to address the issues identified. 
 
EN 8   EN participating in the public consultation believe that clarification of obligations 
relating to them and market surveilla nce procedures will help defend the 
competiveness of EU businesses. Similarly most stakeholders11 agree that this policy 
action will help protect p ublic health and safety. 
Alignment by legislative measures is not e xpected to have a significant impact on the 
costs of firms and notified bodies. Most  obligations of economic operators 
complement existing obligations or codify what would be normal practice for a responsible/compliant firm according to the spirit of existing legislation. Similarly, 
the requirements for notified bodies are fu lly in line with st andards defining the 
relevant benchmark for the assessment of conformity assessment bodies
12. Overall an 
impact on costs is possible, in relation to  obligations of importers/distributors and 
traceability, but is considered moderate. Indeed 55% of genera l economic operators 
and 30-33% of small and medium enterprises having participated in  the consultations 
believe that the alignment of these oblig ations will bring about moderate cost 
increases, while a further 12% and 27% respectively consider that there will be no or no significant cost increases. Due to the large variety of products concerned by this 
exercise, it is not possible to provide quantitative estimates.  
At the end of the impact assessment there was no indication that the selected option 
might result in a disproportionate burden for SME. 
Some implementation costs for public authoriti es have been identified, in particular 
as regards the need to re-notify conform ity assessment bodies in accordance with the 
requirements in the NLF Decision. However,  the number of re-notifications to be 
handled by each competent authority is very limited (with the exception of the 
authorities dealing with non-automatic weighi ng instruments, in only 2 countries). In 
any case, the Commission will introduce a specific transitional provision that allows time for re-notifications before the general date of applicability of the directives. 
6. C
OMPARISON OF OPTIONS  
The no policy change option is only partly e ffective in relation to the objectives of 
this policy intervention. Furthermore, it is  not coherent with the policy commitment 
underpinning  the NLF  Decision. 
The option of aligning by non-legislative m easures might be more effective than 
option 1 as, in principle, it addresses all the objectives, except simplification. However, it does not guarantee positive impacts due to its poor enforceability. In terms of efficiency the non-legislative meas ure is the option with the lowest score 
since, on the one hand it does not guarant ee significant benefits by comparison with 
                                                
 
11 58-78% of economic operators, 72-78% of notifie d bodies 58-62% of authorities and about 72-79% of 
users participating in the consultation (excluding the measuring instrument sector). 
12 These are 1) EN 45011:1998, General requirements  for bodies operating product certification systems; 
2) EN ISO/IEC 17020:2004, General criteria for the operation of various types of bodies performing 
inspection; 3) EN ISO/IEC 17021:2006, Conformity assessment – Requirements for bodies providing 
audit and certification of management systems; 4) EN ISO/IEC 17024:2003, Conformity assessment – General requirements for bodies operating certification of persons; 5) EN ISO/IEC 17025:2005, 
Conformity assessment – General requirements for the competence of testing and calibration 
laboratories. 
 
EN 9   EN the no policy change scenario, and on the ot her hand it brings a bout some (moderate) 
increase in compliance costs for economic operators and notified bodies that voluntarily commit to the be st practice proposed.  
The option of aligning by legi slative measures addresses all the objectives and is 
more effective than both option 1 and option 2. This option will bring about 
moderate costs that are more than offset by its positive impacts. This option is then considered efficient. Furthermore, this option is fully consistent with the policy commitment underpinning the NLF Decision. 
In the light of its effectiveness, efficiency  and coherence, option 3 stands out as the 
preferred option. 
Table 1: Comparison of the listed options  
 Effectiveness Efficiency  Coherence  
Option 1: No 
change Neutral  
[It addresses to some 
extent the objectives of 
reducing the number of 
non-compliant products 
and scope for unfair 
competition. 
It addresses the objective 
of increasing reliability of 
NB, but only when 
accredited.  
It does not meet the 
objectives of equal 
treatment of EO and of 
consistency of legislation / 
simplification of product 
regulatory framework] Neutral   
[No additional resources 
needed, however objectives 
only partially met.]  Neutral  
[Incoherent with other 
NLF instrument and policy 
commitment underpinning 
NLF Decision] 
Option 2: Non-
legislative 
measures Low 
does not provide tangible 
improvement with respect 
to Option 1 due to poor 
enforceability. It will 
increase the compliance 
gap between responsible 
and unscrupulous EO/NB. 
It does not address 
simplification. Low 
less efficient than Option 1, 
same effectiveness vs 
higher costs for responsible 
stakeholders Neutral  
[Incoherent with other 
NLF instrument and policy 
commitment underpinning 
NLF Decision] 
Option 3: 
Alignment High  
addresses all objectives. 
More effective than option 
1 and option 2 in relation 
to the objectives of 
reducing the number of High  
important benefits for all 
stakeholders vs small or 
moderate additional costs Coherent 
with other NLF instrument 
and policy commitment 
underpinning NLF 
Decision   
 
EN 10   EN non-compliant products 
and scope for unfair 
competition. Effective as to 
simplification.  
7. MONITORING AND EVALUATION  
The evaluation of the effectiveness of the legislation will be based on the feedback 
received through the various cooperation mechanisms al ready established under the 
directives themselves to facilitate their implementation (experts groups, 
administrative cooperation groups (ADCOs), notified body groups).  
In 2018 the Commission will produce a comp rehensive report on the functioning of 
market surveillance,13 which will also allow conclu sions to be drawn for the 
evaluation of this initiative. 
Indicators allowing to m onitor the reduction of non-co mpliant products on the 
market and the improvement of the quali ty of conformity assessment services 
delivered by notified bodies will be base d on information obtained via the RAPEX 
system, the market surveillance database established under Article 23 of the NLF Regulation, data provided by authorities responsible for the controls at external 
borders, the National Market Surveillance Programmes established under Article 18 
of the NLF Regulation, the market surveillance and safeguard clause notification procedures established unde r every directive and the NANDO
14 database. 
                                                 
13 See Article 40 of Regulation (EC) No 765/2008. 
14 http://ec.europa.eu/enterprise/newapproach/nando/