Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on consumer product safety and repealing Council Directive 87/357/EEC and Directive 2001/95/EC
Date: 2013-02-13
Institutions: European Commission
Subjects: Community certification, customs inspection, distributor, exchange of information, market supervision, marketing standard, product safety, quality control of industrial products, single market

EUROPEAN 
COMMISSION 

Brussels, 13.2.2013  
COM(2013) 78 final 

2013/0049 (COD) 

PRODUCT SAFETY AND MARKET SURVEILLANCE PACKAGE 

Proposal for a 

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

on consumer product safety and repealing Council Directive 87/357/EEC and Directive 
2001/95/EC  

(Text with EEA relevance) 

{SWD(2013) 33 final} 
{SWD(2013) 34 final} 

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EXPLANATORY MEMORANDUM 

1. 

CONTEXT OF THE PROPOSAL 

The  free  movement  of  safe  consumer  products  is  one  of  the  cornerstones  of  the 
European Union. It is an important pillar of the single market and gives consumers 
confidence when purchasing products. 

This  proposal  for  a  Regulation  on  consumer  product  safety,  which  will  replace 
Directive  2001/95/EC  of  the  European  Parliament  and  of  the  Council  on  general 
product safety1 (the "General Product Safety Directive" or simply GPSD), concerns 
manufactured  non-food  consumer  products.  Like  the  GPSD  also  the  proposed 
Regulation  requires  that  consumer  products  must  be  "safe",  sets  certain  obligations 
on economic operators and contains provisions for the development of standards in 
support of the general safety requirement. 

However, the operation of the proposed Regulation and its interface with other Union 
legislation will be significantly streamlined and simplified whilst maintaining a high 
level of protection of the health and safety of consumers.  

Overlaps  of  market  surveillance  rules  and  obligations  of  economic  operators  laid 
down  in  various  pieces  of  Union  legislation  (the  GPSD,  the  Regulation  (EC)  No 
765/2008  setting  out  the  requirements  for  accreditation  and  market  surveillance 
relating  to  the  marketing  of  products2  and  sector-specific  Union  harmonisation 
legislation  that  also  covers  consumer  products)  has  led  to  confusion  on  the  part  of 
both  economic  operators  and  national  authorities  and  has  seriously  hampered  the 
effectiveness of market surveillance activity in the Union. 

This  proposal  aims  at  clarifying  the  regulatory  framework  for  consumer  products 
taking  into  account  legislative  developments  in  recent  years  such  as  the  New 
Legislative  Framework  on  the  Marketing  of  Products  adopted  in  20083,  the 
alignment of sector-specific Union harmonisation legislation to that new framework4 
and the entry into application on 1 January 2013 of a new Regulation on European 
standardisation5.  

The proposal is part of the "Product Safety and Market Surveillance Package" which 
also  includes  a  proposal  for  a  single  market  surveillance  regulation  and  a  multi-
annual  action  plan  for  market  surveillance  covering  the  period  2013-2015.  The 
Single Market Act (2011)6 identified the revision of the GPSD and the drawing up of 
a market surveillance plan as initiatives that will contribute to boosting growth and 
creating  jobs.  The  Single  Market  Act  II7,  adopted  in  2012,  confirms  the  "Product 
Safety and Market Surveillance Package" as a key action "to improve the safety of 

1 
2 
3 

4 

5 

6 
7 

OJ L 11, 15.1.2002, p. 4. 
OJ L 218, 13.8.2008, p. 30. 
Consisting of Regulation (EC) No 765/2008 and 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, OJ L 218, 
13.8.2008, p. 82. 
Adopted  by  the  Commission  on  21  November  2011,  http://ec.europa.eu/enterprise/policies/single-
market-goods/internal-market-for-products/new-legislative-framework/index_en.htm. 
Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012, OJ 
L 316, 14.11.2012, p. 12. 
COM(2011)206 final. 
COM(2012)573 final. 

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products circulating in the EU through better coherence and enforcement of product 
safety and market surveillance rules". 

2. 

RESULTS OF CONSULTATIONS WITH THE INTERESTED PARTIES AND 
IMPACT ASSESSMENTS 

From  2009  to  2011,  the  Commission  held  extensive  public  consultations  on  the 
revision of the GPSD concerning the scope of the impact assessment. Following the 
definition of the scope of the impact assessment, the Commission proceeded to the 
second  round  of  public  consultation  which  concentrated  on  four  main  substantive 
areas for improvement in the EU product safety regime: (i) procedures for mandating 
standards under the GPSD for non-harmonised products, (ii) harmonisation of safety 
evaluations,  (iii)  market  surveillance  cooperation  and  coordination,  including  the 
functioning of the EU Rapid Information System (RAPEX) and on-line distribution 
channels, and (iv) alignment with the Free Movement of Goods Package. 

The  second  round  of  public  consultation  on  problems  identified  and  the  solutions 
proposed by the Commission took place between May and December 2010. Between 
18  May  and  20  August  2010,  the  Commission  held  an  internet  public  consultation 
focussing  on  those  four  areas.  The  Commission  sought  feedback  through  four 
consultation  papers  and  nine  online  questionnaires  targeting  various  groups  of 
stakeholders.  55  national  authorities  responded,  from  all  EU  Member  States  except 
one  and  from  Norway,  Iceland  and  Switzerland.  Various  other  stakeholders, 
including more than thirty business associations, seventeen consumer organisations, 
and over fifty individual economic operators (including several SMEs) contributed to 
the consultation. In total, 305 replies were received to the nine online questionnaires. 
In addition, thirteen business and consumer organisations provided separate position 
papers. A number of presentations and direct exchanges with stakeholders (with both 
business and consumer organisations) were also held during the consultation period. 

The  second  round  of  public  consultation  ended  with  an  international  stakeholder 
conference on the "Revision of the General Product Safety Directive" on 1 December 
2010 during which the Commission received feedback from the stakeholders on key 
conclusions of the public internet consultation. 

The third round of public consultation took place between January and March 2011. 
It took the form of targeted stakeholder meetings with the participation of experts in 
the  relevant  areas.  These  meetings  covered  structural  topics,  including  the 
organisation of market surveillance coordination, the impact of the new definitions of 
obligations of economic operators (in particular traceability obligations), procedures 
for establishing mandates leading to the establishment of European standards under 
the  GPSD  and  ways  to  establish  a  clear  and  understandable  structure  for  non-food 
product safety rules. 

One  of  the  outcomes  of  the  public  consultation  process  and  the  dialogue  with 
interested  parties  was  to  transfer  the  market  surveillance  rules  from  the  current 
GPSD  into  a  new  stand-alone  Market  Surveillance  Regulation  to  be  developed  and 
adopted hand in hand with the present proposal for the revision of the GPSD. 

The  impact  assessment  prepared  by  the  Commission  thus  covers  aspects  related  to 
both this proposal and the proposal for a new Market Surveillance Regulation. The 
Commission's  Impact  Assessment  Board  delivered  a  favourable  opinion  in 
September 2012. 

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3. 

• 

LEGAL ELEMENTS OF THE PROPOSAL 

Scope and definitions 

The  proposed  Regulation  clearly  delimits  its  scope  of  application  compared  to 
sectoral  Union  harmonisation  legislation.  Whilst  the  general  principle  that  all  non-
food  consumer  products  must  be  safe  applies  across  the  board,  the  more  detailed 
obligations on economic operators only apply to those operators that are not subject 
to corresponding obligations laid down in harmonising legislation covering a specific 
product  sector.  The  Commission  envisages  drawing  up  guidance  which  will  help 
businesses,  in  particular  small  and  medium-size  enterprises,  to  identify  which 
legislation applies to the consumer products they manufacture or distribute. 

The definitions section has been updated and, where applicable aligned with the New 
Legislative Framework for the Marketing of Products8. 

• 

General safety requirement and obligations of economic operators 

The  requirement  that  all  consumer  products  must  be  safe  when  placed  or  made 
available on the Union market is a fundamental pillar of EU legislation in the field of 
product  safety.  This  general  product  safety  requirement,  laid  down  already  in  the 
GPSD,  has  been  kept.  However,  its  operation  in  practice  will  be  significantly 
simplified due to the introduction of a clear link with sector-specific legislation and a 
simplification of the rules on standards.  

Consumer products that comply with sector-specific Union harmonisation legislation 
that aims  at ensuring the  health and  safety of persons shall be presumed to be safe 
also  under  this  proposed  Regulation.  If  they  do  not  comply  with  the  applicable 
harmonisation  legislation,  they  would  not  benefit  from  the  safety  presumption  but 
correction  of  such  situation  would  be  governed  by  the  sector-specific  legislation  in 
conjunction with the future single market surveillance regulation.  

Moreover, the proposal lays down the elementary obligations of economic operators 
(manufacturers,  importers,  distributors)  involved  in  the  supply  chain  of  consumer 
products insofar as they are not subject to corresponding requirements under sector-
specific Union harmonisation legislation. The obligations are based on the reference 
provisions  set  out  in  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 products9 
and  address,  among  others,  issues  related  to  labelling,  product  identification, 
corrective  actions  to  be  taken  in  case  of  unsafe  products  and  information  of  the 
competent  authorities.  Proportionate  to  the  potential  risks  of  their  products, 
manufacturers will be obliged to establish a technical documentation regarding their 
products which shall contain the necessary information to prove that their product is 
safe. 

Equally  based  on  Decision  No  768/2008/EC,  the  proposal  requires  economic 
operators to be able to identify the operators who supplied them with the product and 
to whom they supplied it. Where justified due to the risks inherent to specific types 
of  products,  the  Commission  should  be  empowered  to  adopt  measures  requiring 
economic operators to establish or adhere to an electronic traceability system. 

Use of European standards 

See footnote 3. 
OJ L 218, 13.8.2008, p. 82. 

• 

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Like the GPSD, also the proposal for the new Regulation favours the use of standards 
in  support  of  the  implementation  of  the  general  safety  requirement.  However,  the 
process  to  identify  existing  European  standards  or  to  ask  for  the  development  of 
European standards that would give rise to presume that a product is safe has been 
significantly simplified and aligned to Regulation (EU) No 1025/2012 that sets a new 
overarching  framework  for  European  standardisation10.  This  underlines 
the 
importance the Commission gives to an approach of co-regulation and will enhance 
the use of European standards in support of the proposed Regulation.  

• 

Transfer  of  rules  on  market  surveillance  and  RAPEX  to  a  new  Market 
Surveillance Regulation 

In  line  with  the  objective  to  strengthen  and  streamline  market  surveillance  for  all 
products,  whether  harmonised  or  not  and  whether  intended  for  consumers  or  for 
professionals,  the  provisions  regarding  market  surveillance  and  RAPEX  that  are 
currently  contained  in  the  GPSD  have  been  transferred  to  the  proposal  for  a  new 
single  Market Surveillance Regulation. That new Regulation would produce a  one-
tier  system  in  which  all  market  surveillance  rules  are  brought  together  in  a  single 
instrument and in which RAPEX will be the single alert system regarding products 
presenting  a  risk.  Further  information  is  given  in  the  proposal  for  a  Regulation  on 
market surveillance of products. 

• 

Union competence, subsidiarity, proportionality and legal form 

The  proposal  is  based  on  Article  114  of  the  Treaty  on  the  Functioning  of  the 
European  Union  (TFEU)  which  provides  for  the  same  legal  base  for  the 
establishment and functioning of the internal market on which the current GPSD was 
adopted. In regulating product safety, the Union is exercising its shared powers under 
Article 4(2) of the TFEU. 

Within the internal market where products can circulate freely, the rules on product 
safety  can effectively be  adopted only at Union  level. This is necessary in order to 
guarantee a high level of consumer protection (in line with Article 169 TFEU) and 
also  to  prevent  Member  States  from  adopting  diverging  product  regulations  which 
would result in fragmentation of the single market. In accordance with the principles 
of proportionality and subsidiarity, as set out in Article 5 of the Treaty on European 
Union, this proposal does not go beyond what is necessary in order to achieve those 
objectives. 

The proposal takes the form of a Regulation. This is the appropriate legal instrument 
as  it  imposes  clear  and  detailed  rules  which  will  become  applicable  in  a  uniform 
manner  and  at  the  same  time  throughout  the  Union.  It  will  avoid  diverging 
transposition  by  Member  States  which  is  liable  to  lead  to  different  levels  of  health 
and  safety  protection  and  to  create  obstacles  to  the  internal  market.  Replacing  the 
national transposition measures also has a strong simplification effect since it allows 
economic  operators  to  conduct  their  business  on  the  basis  of  a  single  regulatory 
framework, rather than a 'patchwork' of Member States' national laws. 

• 

Fundamental rights  

In  line  with  the  Charter  of  Fundamental  Rights  of  the  EU,  this  proposal  seeks  to 
ensure  a  high  level  of  human  health  protection  (Article  35  of  the  Charter)  and 
consumer  protection  (Article  38)  by  assuring  a  high  level  of  safety  of  consumer 

10 

See footnote 5. 

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products  made  available  on  the  Union  market.  The  proposal  affects  the  freedom  of 
economic operators to conduct business (Article 16) but the obligations imposed on 
manufacturers,  importers  and  distributors  of  consumer  products  are  necessary  to 
guarantee a high level of safety of those products. 

4. 

BUDGETARY IMPLICATION 

The  proposal  does  not  have  other  budgetary  implications  than  those  related  to  the 
proper management of the Regulation which, in form of the GPSD, is already part of 
the Union law acquis. The budgetary implications are already foreseen in the existing 
or  proposed  programmes  and  respect  the  Commission  proposal  for  the  new 
multiannual  financial  framework.  The  details  are  set  out  in  the  financial  statement 
attached to this proposal. 

5. 

SIMPLIFICATION AND SMART REGULATION 

This proposal contributes to the simplification  of EU legislation  and  adheres to the 
principles  of  smart  regulation.  When  preparing  this  proposal  the  Commission  has 
taken stock of the important advancement of sector-specific legislation that aims at 
ensuring  the  safety  of  products  and  which  usually  does  not  make  a  distinction 
whether  the  products  covered  are  intended  for  consumers  or  professional  users. 
Contrary to the situation 10 or 15 years ago, it is not necessary any more to apply a 
second  layer  of  obligations  to  economic  operators  who  are  already  appropriately 
regulated  by  sector-specific  legislation.  At  the  same  time,  the  obligations  for  those 
who produce, import or distribute consumer products that are not covered by specific 
legislation are to a large extent aligned with those applicable to harmonised products.  

This  approach  will  reduce  administrative  burdens  and  compliance  costs  for 
businesses, in particular for small and medium-sized enterprises. In the future, they 
can easily identify the set of rules applicable to their commercial activity so that they 
will save on costs caused by legal uncertainty. 

Due  to  the  subject-matter  and  objective  of  the  proposed  Regulation,  micro-
enterprises  as  defined  in  Commission  Recommendation  2003/361/EC11  cannot  be 
exempted  from  its  requirements  because  rules  aiming  at  protecting  the  health  and 
safety  of  persons  must  apply  regardless  of  the  size  of  the  economic  operator.  But 
micro-enterprises are likely to benefit most from the simplification that the new piece 
of  legislation  will  bring  about  which  is  fit  for  purpose  and  replaces  two  directives 
that  have  become  out  of  date.  The  Commission  is  committed  to  providing  further 
guidance  to  businesses,  in  particular  to  small  and  medium-sized  enterprises,  and 
consumers to help them to easily identify their respective rights and obligations.  

11 

OJ L 124, 20.5.2003, p. 36. 

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2013/0049 (COD) 

Proposal for a 

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

on consumer product safety and repealing Council Directive 87/357/EEC and Directive 
2001/95/EC  

(Text with EEA relevance) 

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, 

Having  regard  to  the  Treaty  on  the  Functioning  of  the  European  Union,  and  in  particular 
Article 114 thereof, 

Having regard to the proposal from the European Commission, 

After transmission of the draft legislative act to the national Parliaments, 
Having regard to the opinion of the European Economic and Social Committee12,  

Acting in accordance with the ordinary legislative procedure, 

Whereas: 

(1) 

(2) 

(3) 

Directive 2001/95/EC of the European Parliament and of the Council of 3 December 
2001  on  general  product  safety13  lays  down  the  requirement  that  consumer  products 
must be safe and that Member States' market surveillance authorities must take action 
against dangerous products as well as exchange information to that effect through the 
Community rapid information exchange system RAPEX. Directive 2001/95/EC needs 
to be fundamentally revised to improve its functioning and to ensure consistency with 
developments  in  Union  legislation  as  regards  market  surveillance,  obligations  of 
economic  operators  and  standardisation.  In  the  interest  of  clarity,  Directive 
2001/95/EC should be repealed and replaced by this Regulation. 

A Regulation is the appropriate legal instrument as it imposes clear and detailed rules 
which do not give room for divergent transposition by Member States. A Regulation 
ensures that legal requirements are applicable at the same time throughout the Union. 

This  Regulation  must  contribute  to  the  attainment  of  the  objectives  referred  to  in 
Article 169 of the TFEU. In particular it should aim at ensuring the functioning of the 
internal  market  as  regards  products  intended  for  consumers  by  laying  down  uniform 
rules  regarding  a  general  safety  requirement,  assessment  criteria  and  obligations  of 
economic  operators.  Given  that  rules  on  market  surveillance,  including  rules  on 
RAPEX,  are  laid  down  in  Regulation  (EU)  No  […/…]  [on  market  surveillance  of 
products]14  which  applies  also  to  products  covered  by  this  Regulation,  no  further 
provisions on market surveillance or RAPEX are needed in this Regulation. 

12 
13 
14 

OJ C , , p. . 
OL L 11, 15.1.2002, p. 4. 
OJ L , , p. . 

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(4) 

Union legislation on food, feed and related areas sets up a specific regime ensuring the 
safety  of  the  products  covered  by  it.  This  Regulation  should  therefore  not  apply  to 
those  products  with  the  exception  of  materials  and  articles  intended  to  come  into 
contact  with  food  insofar  as  risks  are  concerned  that  are  not  covered  by  Regulation 
(EC)  No  1935/2004  of  the  European  Parliament  and  of  the  Council  of  27  October 
2004  on  materials  and  articles  to  come  into  contact  with  food15  or  by  other  food 
specific legislation which only covers chemical and biological food related risks. 

(5)  Medicinal products are subject to a pre-market assessment that includes a specific risk-
benefit analysis. They should therefore be excluded from the scope of this Regulation. 

(6) 

(7) 

(8) 

(9) 

This Regulation should not cover services. However, in order to secure the attainment 
of the protection of health and safety of consumers, it should apply to products that are 
supplied  or  made  available  to  consumers  in  the  context  of  the  provision  of  services, 
including  products  to  which  consumers  are  directly  exposed  during  a  service 
provision.  Equipment  on  which  consumers  ride  or  travel  which  is  operated  by  a 
service provider should be excluded from the scope of this Regulation since it has to 
be dealt with in conjunction with the safety of the service provided.  

Despite  the  development  of  sector-specific  Union  harmonisation  legislation  that 
addresses safety aspects of specific products or categories of products, it is practically 
impossible to adopt Union legislation for all consumer products that exist or may be 
developed.  There  is  therefore  still  a  need  for  a  legislative  framework  of  a  horizontal 
nature to fill gaps and ensure consumer protection not otherwise ensured, in particular 
with a view to achieving a high level of protection of safety and health of consumers, 
as required by Article 114 and Article 169 of the TFEU. 

In respect of the consumer products subject to this Regulation the scope of application 
of  the  different  parts  of  it  should  be  clearly  delimited  from  sector-specific  Union 
harmonisation  legislation.  Whilst  the  general  product  safety  requirement  and  related 
provisions should be applicable to all consumer products, the obligations of economic 
operators should not apply where Union harmonisation legislation includes equivalent 
obligations,  such  as  Union  legislation  on  cosmetics,  toys,  electrical  appliances  or 
construction products. 

In  order  to  ensure  consistency  between  this  Regulation  and  sector-specific  Union 
harmonisation  legislation  with  regard  to  specific  obligations  of  economic  operators, 
the  provisions  concerning  manufacturers,  authorised  representatives,  importers  and 
distributors  should  be  based  on  the  reference  provisions  included  in  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 products16. 

(10)  The  scope  of  this  Regulation  should  not  be  limited  to  any  selling  technique  of 

consumer products, and thus also cover distance selling.  

(11)  This Regulation should apply to second hand products that re-enter the supply chain in 
the course of a commercial activity, except for those second-hand products for which 
the consumer cannot reasonably expect that they fulfil state-of-the art safety standards, 
such as antiques. 

(12)  This  Regulation  should  also  apply  to  consumer  products  which,  although  not 
foodstuff, resemble foodstuff and are likely to be confused with foodstuff in a way that 

15 
16 

OJ L 338, 13.11.2004, p. 4. 
OJ L 218, 13.8.2008, p. 82. 

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consumers, especially children, may place them in their mouths, suck or ingest them, 
which might cause, for example, suffocation, poisoning, the perforation or obstruction 
of  the  digestive  tract.  Those  food-imitating  products  have  so  far  been  regulated  by 
Council  Directive  87/357/EEC  of  25  June 1987 on  the approximation of  the  laws of 
the  Member  States  concerning  products  which,  appearing  to  be  other  than  they  are, 
endanger the health or safety of consumers17 which should be repealed. 

(13)  The safety of products should be assessed taking into account all the relevant aspects, 
in  particular  their  characteristics  and  presentation  as  well  as  the  categories  of 
consumers who are likely to use the products taking into account their vulnerability, in 
particular children, the elderly and the disabled. 

(14)  To avoid overlapping safety requirements and conflicts with other Union legislation, a 
product  which  conforms  to  sector-specific  Union  harmonisation  legislation  that  aims 
at the protection of health and safety of persons should be presumed to be safe under 
this Regulation. 

(15)  Economic operators should be responsible for the compliance of products, in relation 
to their respective roles in the supply chain, so as to ensure a high level of protection 
of the health and safety of consumers. 

(16)  All  economic  operators  intervening  in  the  supply  and  distribution  chain  should  take 
appropriate measures to ensure that they only make available on the market products 
which are safe and in conformity with this Regulation. It is necessary to provide for a 
clear and proportionate distribution of obligations which correspond to the role of each 
operator in the supply and distribution process. 

(17) 

Importers bear the responsibility that products from third countries that they place on 
the  Union  market  comply  with  the  requirements  of  this  Regulation.  The  specific 
obligations of importers should therefore be included in this Regulation. 

(18)  Distributors make products available on the market after they have been placed on the 
market by the manufacturer or the importer and should act with due care to ensure that 
their handling of the product does not adversely affect the compliance of the product 
with this Regulation. 

(19)  Any economic operator that either places a product on the market under his own name 
or  trademark  or  modifies  a  product  in  such  a  way  that  compliance  with  the 
requirements  of  this  Regulation  may  be  affected  should  be  considered  to  be  the 
manufacturer and should assume the obligations of the manufacturer. 

(20)  Ensuring  product  identification  and  the  traceability  of  products  throughout  the  entire 
supply  chain  helps  to  identify  economic  operators  and  to  take  effective  corrective 
measures against unsafe products, such as targeted recalls. Product identification and 
traceability  thus  ensure  that  consumers  and  economic  operators  obtain  accurate 
information  regarding  unsafe  products  which  enhances  confidence  in  the  market  and 
avoids  unnecessary  disruption  of  trade.  Products  should  therefore  bear  information 
allowing  their  identification  and  the  identification  of  the  manufacturer  and,  if 
applicable,  of 
technical 
documentations  regarding  their  products  for  which  they  may  choose  the  most 
appropriate and cost-efficient way such as by electronic means. Moreover, economic 
operators should be required to identify the operators who supplied them and to whom 
they  supplied  a  product.  Directive  95/46/EC  of  the  European  Parliament  and  of  the 

importer.  Manufacturers  should  also  establish 

the 

17 

OJ L 192, 11.7.1987, p. 42. 

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Council  of  24  October  1995  on  the  protection  of  individuals  with  regard  to  the 
processing of personal data and on the free movement of such data18 is applicable to 
the processing of personal data for the purposes of this Regulation. 

(21)  The  indication  of  origin  supplements  the  basic  traceability  requirements  concerning 
the name and address of the manufacturer. In particular, the indication of the country 
of origin helps to identify the actual place of manufacture in all those cases where the 
manufacturer cannot be contacted or its given address is different from the actual place 
of  manufacture.  Such  information  can  facilitate  the  task  of  market  surveillance 
authorities in tracing the product back to the actual place of  manufacture and enable 
contacts with the authorities of the countries of origin in the framework of bilateral or 
multilateral cooperation on consumer product safety for appropriate follow up actions. 

(22) 

In  order  to  facilitate  the  effective  and  consistent  application  of  the  general  safety 
requirement  set  out  in  this  Regulation,  it  is  important  to  make  use  of  European 
standards  covering  certain  products  and  risks  in  such  a  way  that  a  product  which 
conforms  to  such  a  European  standard,  the  reference  of  which  is  published  in  the 
Official Journal of the European Union, is to be presumed to be in compliance with 
that requirement.  

(23)  Where the Commission identifies a need for a European standard ensuring compliance 
of certain products with the general safety requirement under this Regulation, it should 
apply  the  relevant  provisions  of  Regulation  (EU)  No  1025/2012  of  the  European 
Parliament  and  of  the  Council  of  25  October  2012  on  European  standardisation19  to 
request one or several European standardisation organisations to either draft or identify 
a standard which is suitable to ensure that products which conform to it are presumed 
to  be  safe.  The  references  of  such  European  standards  should  be  published  in  the 
Official Journal of the European Union. 

(24)  The  procedures  to  request  European  standards  in  support  of  this  Regulation,  and  on 
formal objections against them, should be laid down in this Regulation and be aligned 
with  Regulation  (EU)  No  1025/2012.  To  ensure  overall  consistency  in  European 
standardisation  issues,  requests  for  European  standards,  or  objections  to  a  European 
standard, should therefore be brought before the committee set up by that Regulation, 
after appropriate consultation of experts of the Member States in the field of consumer 
product safety.  

(25)  European standards, the references of which have been published in accordance with 
Directive 2001/95/EC, should continue providing presumption of conformity with the 
general  safety  requirement.  Standardisation  mandates  issued  by  the  Commission  in 
accordance  with  Directive  2001/95/EC  should  be  deemed  standardisation  requests 
issued in accordance with this Regulation.  

(26)  Where no relevant European standards or other recognised means to assess the safety 
of  products  exist,  the  assessment  of  product  safety  should  take  into  account 
Commission  recommendations  adopted  for  this  purpose  pursuant  to  Article  292 
TFEU. 

(27) 

In  order  to  ensure  uniform  conditions  for  the  implementation  of  this  Regulation, 
implementing  powers  should  be  conferred  on  the  Commission  as  regards  the 
exemption  to  the  obligation  to  inform  market  surveillance  authorities  about  products 
presenting a risk, as regards the type of data carrier and its placement on the product 

18 
19 

OJ L 281, 23.11.1995, p. 31. 
OJ L 316, 14.11.2012, p. 12. 

EN 

10 

   EN 

                                                 
for  the  purposes  of  the  traceability  system,  as  regards  standardisation  requests  to 
European standardisation organisations and as regards decisions on formal objections 
to  European  standards.  Those  powers  should  be  exercised  in  accordance  with 
Regulation  (EU)  No  182/2011  of  the  European  Parliament  and  of  the  Council  of  16 
February  2011  laying  down  the  rules  and  general  principles  concerning  mechanisms 
for  control  by  the  Member  States  of  the  Commission's  exercise  of  implementing 
powers20. 

(28)  The  advisory  procedure  should  be  used  for  the  adoption  of  implementing  acts  with 
respect  to  the  objections  to  European  standards  and  where  the  references  to  the 
European  standard  concerned  have  not  yet  been  published  in  the  Official  Journal  of 
the  European  Union,  given  that  the  relevant  standard  has  not  yet  led  to  the 
presumption  of  conformity  with  the  general  safety  requirement  laid  down  in  this 
Regulation. 

(29) 

In order to maintain a high level of health and safety of consumers, the power to adopt 
acts in accordance with Article 290 TFEU should be delegated to the Commission in 
respect  of  products  for  which  the  name  and  address  of  the  manufacturer  and  of  the 
importer does not need to be indicated on the product itself due to the low level of risk 
related  to  such  products,  and  in  respect  of  the  identification  and  traceability  of 
products  bearing  a  potential  serious  risk  to  health  and  safety.  It  is  of  particular 
importance  that  the  Commission  carry  out  appropriate  consultations  during  its 
preparatory  work,  including  at  expert  level.  The  Commission,  when  preparing  and 
drawing  up  delegated  acts,  should  ensure  a  simultaneous,  timely  and  appropriate 
transmission of relevant documents to the European Parliament and to the Council. 

(30)  Member States should lay down rules on penalties applicable to infringements of this 
Regulation and ensure that they are implemented.  Those  penalties must  be effective, 
proportionate and dissuasive. 

(31)  To  allow  economic  operators,  Member  States  and  the  Commission  to  adapt  to  the 
changes  introduced  by  this  Regulation,  it  is  appropriate  to  provide  for  a  sufficient 
transitional period until the requirements of this Regulation are applicable. 

(32)  Since the objective of this Regulation, namely to ensure the functioning of the internal 
market as regards products intended for consumers while guaranteeing a high level of 
health  and  safety  protection  of  consumers,  cannot  be  sufficiently  achieved  by  the 
Member  States  and  can  therefore,  by  reason  of  the  scale  of  the  measure,  be  better 
achieved  at  Union  level,  the  Union  may  adopt  measures,  in  accordance  with  the 
principle  of  subsidiarity  as  set  out  in  Article  5  of  the  Treaty  on  European  Union.  In 
accordance  with  the  principle  of  proportionality,  as  set  out  in  that  Article,  this 
Regulation does not go beyond what is necessary in order to achieve that objective. 

(33)  This Regulation respects the fundamental rights and observes the principles recognised 
in  particular  by  the  Charter  of  Fundamental  Rights  of  the  European  Union.  In 
particular  this  Regulation  seeks  to  ensure  full  respect  for  the  obligation  to  ensure  a 
high level of human health protection and consumer protection as well as the freedom 
to conduct business. 

20 

OJ L 55, 28.2.2011, p. 13. 

EN 

11 

   EN 

                                                 
HAVE ADOPTED THIS REGULATION: 

CHAPTER I 

General provisions 

Article 1 

Subject matter 

This Regulation lays down rules on the safety of consumer products placed or made available 
on the Union market. 

Article 2 

Scope 

1. 

2. 

3. 

This  Regulation  shall  apply  to  products  obtained  through  a  manufacturing  process 
placed  or  made  available  on  the  market,  whether  new,  used  or  reconditioned,  and 
which comply with any of the following criteria:  

(a)  which are intended for consumers;  

(b)  which  are  likely,  under  reasonably  foreseeable  conditions,  to  be  used  by 

consumers even if not intended for them; 

(c) 

to which consumers are exposed in the context of a service provided to them. 

This Regulation shall not apply to products to be repaired or reconditioned prior to 
being used where those products are made available on the market as such.  

This Regulation shall not apply to the following: 

(a)  medicinal products for human or veterinary use; 

(b) 

food; 

(c)  materials and articles intended to come into contact with food insofar as risks 
related  to  those  products  are  covered  by  Regulation  (EC)  No  1935/2004  or 
other Union legislation applicable to food;  

(d) 

feed;  

(e) 

living  plants  and  animals,  genetically  modified  organisms  and  genetically 
modified  microorganisms  in  contained  use,  as  well  as  products  of  plants  and 
animals relating directly to their future reproduction;  

(f) 

animal by-products and derived products; 

(g)  plant protection products; 

(h) 

equipment  on  which  consumers  ride  or  travel  which  is  operated  by  a  service 
provider within the context of a service provided to consumers; 

(i) 

antiques. 

4. 

Chapters  II  to  IV  of  this  Regulation  shall  not  apply  to  products  subject  to 
requirements  designed  to  protect  human  health  and  safety  laid  down  in  Union 
harmonisation legislation or pursuant to it. 

EN 

12 

   EN 

For the purposes of this Regulation the following definitions shall apply: 

Article 3 

Definitions 

(1) 

(2) 

(3) 

(4) 

(5) 

(6) 

(7) 

(8) 

(9) 

(10) 

(11) 

(12) 

(13) 

(14) 

(15) 

(16) 

‘safe  product’  means  any  product  which,  under  normal  or  reasonably  foreseeable 
conditions of use of the product concerned, including the duration of use and, where 
applicable,  its  putting  into  service,  installation  and  maintenance  requirements,  does 
not  present  any  risk  or  only  the  minimum  risks  compatible  with  the  product's  use, 
considered  acceptable  and  consistent  with  a  high  level  of  protection  of  health  and 
safety of persons; 

‘making  available  on  the  market’  means  any  supply  of  a  product  for  distribution, 
consumption  or  use  on  the  Union  market  in  the  course  of  a  commercial  activity, 
whether in return for payment or free of charge; 

‘placing on the market’ means the first making available of a product on the Union 
market; 

‘manufacturer’ means any natural or legal person who manufactures a product or has 
a  product  designed  or  manufactured  and  markets  that  product  under  his  name  or 
trademark; 

‘authorised representative’ means any natural or legal person established within the 
Union who has received a written mandate from a manufacturer to act on his behalf 
in relation to specified tasks; 

‘importer’  means  any  natural  or  legal  person  established  within  the  Union  who 
places a product from a third country on the Union market; 

‘distributor’  means  any  natural  or  legal  person  in  the  supply  chain,  other  than  the 
manufacturer or the importer, who makes a product available on the market; 

‘economic  operators’  means  the  manufacturer,  the  authorised  representative,  the 
importer and the distributor; 

‘European  standard’  means  a  European  standard  as  defined  in  Article  2(1)(b)  of 
Regulation (EU) No 1025/2012; 

‘international standard’ means an international standard as defined in Article 2(1)(a) 
of Regulation (EU) No 1025/2012; 

‘national  standard’  means  a  national  standard  as  defined  in  Article  2(1)(d)  of 
Regulation (EU) No 1025/2012; 

‘European  standardisation  organisation’  means  a  European  standardisation 
organisation as defined in Article 2(8) of Regulation (EU) No 1025/2012; 

‘market  surveillance  authority’  means  a  market  surveillance  authority  as  defined  in 
Article [3(12] of Regulation (EU) No […/…] [on market surveillance of products]; 

‘recall’  means  any  measure  aimed  at  achieving  the  return  of  a  product  that  has 
already been made available to the end user; 

‘withdrawal’ means any measure aimed at preventing a product in the supply chain 
from being further made available on the market; 

‘Union  harmonisation  legislation’  means  any  Union  legislation  harmonising  the 
conditions for the marketing of products; 

EN 

13 

   EN 

(17) 

‘serious  risk’  means  a  risk  requiring  rapid  intervention  and  follow-up,  including 
cases where the effects may not be immediate. 

Article 4 

General safety requirement  

Economic operators shall place or make available on the Union market only safe products. 

Article 5 

Presumption of safety  

For the purpose of this Regulation, a product shall be presumed to be in compliance with the 
general safety requirement laid down in Article 4 in the following cases: 

(a) 

(b) 

(c) 

1. 

as  regards  the  risks  covered  by  requirements  designed  to  protect  human  health  and 
safety laid down in or pursuant to Union harmonisation legislation, if it conforms to 
those requirements; 

in  the  absence  of  requirements  laid  down  in  or  pursuant  to  Union  harmonisation 
legislation  referred  to  in  point  (a),  as  regards  the  risks  covered  by  European 
standards,  if  it  conforms  to  relevant  European  standards  or  parts  thereof,  the 
references  of  which  have  been  published  in  the  Official  Journal  of  the  European 
Union in accordance with Articles 16 and 17; 

in  the  absence  of  requirements  laid  down  in  or  pursuant  to  Union  harmonisation 
legislation referred to in point (a) and European standards referred to in point (b), as 
regards the risks covered by health and safety requirements laid down in the law of 
the Member State where the product is made available on the market, if it conforms 
to such national requirements. 

Article 6 

Aspects for assessing the safety of products 

In the absence of Union harmonisation legislation, European standards or health and 
safety requirements laid down in the law of the Member State where the product is 
made available on the market as referred to in points (a), (b) and (c) of Article 5, the 
following  aspects  shall  be  taken  into  account  when  assessing  whether  a  product  is 
safe, in particular: 

(a) 

(b) 

(c) 

(d) 

(e) 

the  characteristics  of  the  product,  including  its  composition,  packaging, 
instructions  for  assembly  and,  where  applicable,  for 
installation  and 
maintenance; 

the effect on other products, where it is reasonably foreseeable that it will be 
used with other products; 

the presentation of the product, the labelling, any warnings and instructions for 
its  use  and  disposal  and  any  other  indication  or  information  regarding  the 
product; 

the  categories  of  consumers  at  risk  when  using  the  product,  in  particular 
vulnerable consumers; 

the appearance of the product and in particular where a product, although not 
foodstuff, resembles foodstuff and is likely to be confused with foodstuff due 

EN 

14 

   EN 

to  its  form,  odour,  colour,  appearance,  packaging,  labelling,  volume,  size  or 
other characteristics. 

The  feasibility  of  obtaining  higher  levels  of  safety  or  the  availability  of  other 
products  presenting  a  lesser  degree  of  risk  shall  not  constitute  grounds  for 
considering a product not to be safe. 

2. 

For  the  purpose  of  paragraph  1,  when  assessing  whether  a  product  is  safe,  the 
following aspects, when available, shall be taken into account, in particular: 

(a) 

the state of the art and technology; 

(b)  European  standards  other  than  those  the  references  of  which  have  been 
published  in  the  Official  Journal  of  the  European  Union  in  accordance  with 
Articles 16 and 17; 

(c) 

(d) 

international standards; 

international agreements; 

(e)  Commission recommendations or guidelines on product safety assessment; 

(f) 

national standards drawn up in the Member State in which the product is made 
available; 

(g)  product safety codes of good practice in force in the sector concerned; 

(h) 

reasonable consumer expectations concerning safety. 

Article 7 

Indication of the origin 

1. 

2. 

3. 

Manufacturers  and  importers  shall  ensure  that  products  bear  an  indication  of  the 
country of origin of the product or, where the size or nature of the product does not 
allow  it,  that  indication  is  to  be  provided  on  the  packaging  or  in  a  document 
accompanying the product. 

For  the  purpose  of  determination  of  the  country  of  origin  within  the  meaning  of 
paragraph  1,  non-preferential  origin  rules  set  out  in  Articles  23  to  25  of  Council 
Regulation  (EEC)  No  2913/92  establishing  a  Community  Customs  Code21  shall 
apply. 

Where the country of origin determined in accordance with paragraph 2 is a Member 
State  of  the  Union,  manufacturers  and  importers  may  refer  to  the  Union  or  to  a 
particular Member State. 

CHAPTER II 

Obligations of economic operators 

Article 8 

Obligations of manufacturers 

21 

OJ L 302, 19.10.1992, p. 1. 

EN 

15 

   EN 

                                                 
1. 

2. 

3. 

4. 

5. 

6. 

7. 

8. 

When placing their products on the market, manufacturers shall ensure that they have 
been designed and manufactured in accordance with the general safety requirement 
laid down in Article 4.  

Manufacturers  shall  ensure  that  procedures  are  in  place  for  series  production  to 
remain in conformity with the general safety requirement laid down in Article 4. 

Proportionate  to  the  possible  risks  of  a  product,  manufacturers  shall,  to  protect  the 
health and safety of consumers, carry out sample testing of products made available 
on  the  market,  investigate  complaints  and  keep  a  register  of  complaints,  non-
conforming products and product recalls, and shall keep distributors informed of any 
such monitoring. 

Proportionate  to  the  possible  risks  of  a  product,  manufacturers  shall  draw  up  a 
technical documentation.The technical documentation shall contain, as appropriate: 

(a) 

(b) 

a  general  description  of  the  product  and  its  essential  properties  relevant  for 
assessing the product's safety;  

an analysis of the possible risks related to the product and the solutions adopted 
to  eliminate  or  mitigate  such  risks,  including  the  outcome  of  any  tests 
conducted by the manufacturer or by another party on his behalf; 

(c)  where  applicable,  a  list  of  the  European  standards  referred  to  in  point  (b)  of 
Article 5 or health and safety requirements laid down in the law of the Member 
State where the product is made available on the market referred to in point (c) 
of  Article  5,  or  other  aspects  referred  to  in  Article  6(2),  applied  to  meet  the 
general safety requirement laid down in Article 4. 

Where  any  of  the  European  standards,  health  and  safety  requirements  or  other 
aspects  referred  to  in  point  (c)  of  the  first  subparagraph  have  been  only  partly 
applied, the parts which have been applied shall be identified. 

Manufacturers shall keep, for a period of ten years after the product has been placed 
on  the  market,  the  technical  documentation  and  make  it  available  to  the  market 
surveillance authorities, upon request.  

Manufacturers shall ensure that their products bear a type, batch or serial number or 
other  element  allowing  the  identification  of  the  product  which  is  easily  visible  and 
legible for consumers, or, where the size or nature of the product does not allow it, 
that  the  required  information  is  provided  on  the  packaging  or  in  a  document 
accompanying the product. 

Manufacturers  shall  indicate  their  name,  registered  trade  name  or  registered  trade 
mark and the address at which they can be contacted on the product or, where that is 
not  possible,  on  its  packaging  or  in  a  document  accompanying  the  product.  The 
address must indicate a single point at which the manufacturer can be contacted. 

Manufacturers  shall  ensure  that  their  product  is  accompanied  by  instructions  and 
safety  information  in  a  language  which  can  be  easily  understood  by  consumers,  as 
determined  by  the  Member  State  in  which  the  product  is  made  available,  except 
where  the  product  can  be  used  safely  and  as  intended  by  the  manufacturer  without 
such instructions and safety information.  

Member States shall inform the Commission about any provisions adopted by them 
determining the required language(s). 

EN 

16 

   EN 

9. 

Manufacturers who consider or have reason to believe that a product which they have 
placed  on  the  market  is  not  safe  or  is  otherwise  not  in  conformity  with  this 
Regulation  shall  immediately  take  the  corrective  action  necessary  to  bring  that 
product  into  conformity,  to  withdraw  it  or  recall  it,  if  appropriate.  Furthermore, 
where  the  product  is  not  safe,  manufacturers  shall  immediately  inform  the  market 
surveillance  authorities  of  the  Member  States  in  which  they  made  the  product 
available  to  that  effect,  giving  details,  in  particular,  of  the  risk  to  health  and  safety 
and of any corrective action taken. 

Article 9 

Authorised representatives 

1. 

A manufacturer may, by a written mandate, appoint an authorised representative. 

The obligations laid down in Article 8(1) and (4) shall not form part of the authorised 
representative's mandate. 

2. 

An  authorised  representative  shall  perform  the  tasks  specified  in  the  mandate 
received  from 
the  authorised 
the  manufacturer.  The  mandate  shall  allow 
representative to do at least the following: 

(a) 

further to a request from a market surveillance authority, provide that authority 
with  all  the  information  and  documentation  necessary  to  demonstrate  the 
conformity of a product; 

(b) 

cooperate  with  the  market  surveillance  authorities,  at  their  request,  on  any 
action taken to eliminate the risks posed by products covered by their mandate. 

Article 10 

Obligations of importers 

1. 

2. 

3. 

4. 

Before  placing  a  product  on  the  market  importers  shall  ensure  that  the  product  is 
compliant  with  the  general  safety  requirement  laid  down  in  Article  4  and  that  the 
manufacturer has complied with the requirements set out in Article 8(4), (6) and (7). 

Where  an  importer  considers  or  has  reason  to  believe  that  a  product  is  not  in 
conformity with this Regulation, he shall not place the product on the market until it 
has  been  brought  into  conformity.  Furthermore,  where  the  product  is  not  safe,  the 
importer shall inform the manufacturer and the market surveillance authorities of the 
Member State in which he is established to that effect. 

Importers  shall  indicate  their  name,  registered  trade  name  or  registered  trade  mark 
and the address at which they can be contacted on the product or, where that is not 
possible,  on  its  packaging  or  in  a  document  accompanying  the  product.  They  shall 
ensure  that  any  additional  label  does  not  obscure  any  information  on  the  label 
provided by the manufacturer. 

Importers  shall  ensure  that  the  product  is  accompanied  by  instructions  and  safety 
information  in  a  language  which  can  be  easily  understood  by  consumers,  as 
determined  by  the  Member  State  in  which  the  product  is  made  available,  except 
where  the  product  can  be  used  safely  and  as  intended  by  the  manufacturer  without 
such instructions and safety information.  

Member States shall inform the Commission about any provisions adopted by them 
determining the required language(s). 

EN 

17 

   EN 

5. 

6. 

7. 

8. 

1. 

2. 

3. 

4. 

5. 

Importers shall  ensure that, while a product is under their responsibility,  storage or 
transport  conditions  do  not  jeopardise  its  compliance  with  the  general  safety 
requirement laid down in Article 4 and its conformity with Article 8(6). 

Proportionate to the possible risks presented by a product, importers shall, to protect 
the  health  and  safety  of  persons,  carry  out  sample  testing  of  marketed  products, 
investigate  complaints,  and  keep  a  register  of  complaints,  of  non-conforming 
products  and  of  product  recalls,  and  shall  keep  the  manufacturer  and  distributors 
informed of such monitoring. 

Importers  who  consider  or  have  reason  to  believe  that  a  product  which  they  have 
placed  on  the  market  is  not  safe  or  is  otherwise  not  in  conformity  with  this 
Regulation  shall  immediately  take  the  corrective  action  necessary  to  bring  that 
product  into  conformity,  to  withdraw  it  or  recall  it,  if  appropriate.  Furthermore, 
where  the  product  is  not  safe,  importers  shall  immediately  inform  the  market 
surveillance  authorities  of  the  Member  States  in  which  they  made  the  product 
available  to  that  effect,  giving  details,  in  particular,  of  the  risk  to  health  and  safety 
and of any corrective action taken. 

Importers shall keep, for a period of ten years after the product has been placed on 
the  market,  the  technical  documentation  and  make  it  available  to  the  market 
surveillance authorities, upon request.  

Article 11 

Obligations of distributors 

When making a product available on the market, a distributor shall act with due care 
in relation to the requirements of this Regulation. 

Before  making  a  product  available  on  the  market  distributors  shall  verify  that  the 
manufacturer and the importer have complied with the requirements set out in Article 
8(6), (7) and (8) and Article 10(3) and (4), as applicable.  

Where  a  distributor  considers  or  has  a  reason  to  believe  that  a  product  is  not  in 
conformity  with  this  Regulation,  he  shall  not  make  the  product  available  on  the 
market until it has been brought into conformity. Furthermore, where the product is 
not safe, the distributor shall inform the manufacturer or the importer, as applicable, 
to  that  effect  as  well  as  the  market  surveillance  authority  of  the  Member  State  in 
which the distributor is established. 

Distributors shall ensure that, while a product is under their responsibility, storage or 
transport  conditions  do  not  jeopardise  its  compliance  with  the  general  safety 
requirement laid down in Article 4 and its conformity with Article 8(6), (7) and (8) 
and Article 10(3) and (4), as applicable. 

Distributors who consider or have reason to believe that a product which they have 
made available on the market is not safe or is not in conformity with Article 8(6), (7) 
and (8) and Article 10(3) and (4), as applicable, shall make sure that the corrective 
action  necessary  to  bring  that  product  into  conformity  is  taken,  to  withdraw  it  or 
recall it, if appropriate. Furthermore, where the product is not safe, distributors shall 
immediately  inform  the  manufacturer  or  importer,  as  applicable  as  well  as  market 
surveillance  authorities  of  the  Member  States  in  which  they  made  the  product 
available  to  that  effect,  giving  details,  in  particular,  of  the  risk  to  health  and  safety 
and of any corrective action taken. 

EN 

18 

   EN 

Article 12 

Cases in which obligations of manufacturers apply to importers and distributors 

An  importer  or  distributor  shall  be  considered  a  manufacturer  for  the  purposes  of  this 
Regulation and shall be subject to the obligations of the manufacturer under Article 8, where 
he places a product on the market under his name or trademark or modifies a product already 
placed on the market in such a way that compliance with the requirements of this Regulation 
may be affected. 

1. 

2. 

3. 

1. 

2. 

1. 

Exemption from certain obligations of manufacturers, importers and distributors  

Article 13 

Obligation  to  inform  the  market  surveillance  authorities  in  accordance  with  Article 
8(9),  Article  10(2)  and  (7)  and  Article  11(3)  and  (5)  shall  not  apply  where  the 
following conditions are fulfilled: 

(a)  only a limited number of well-identified products are not safe;  

(b) 

(c) 

the manufacturer, importer or distributor can demonstrate that the risk has been 
fully controlled and cannot any more endanger the health and safety of persons;  

the  cause  of  the  risk  of  the  product  is  such  that  knowledge  of  it  does  not 
represent useful information for the authorities or the public. 

The Commission may by means of implementing acts determine the situations which 
meet  the  conditions  of  paragraph  1.  Those  implementing  acts  shall  be  adopted  in 
accordance with the examination procedure referred to in Article 19(3).  

The  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  with 
Article 20 determining the products, categories or groups of products for which, due 
to their low level of risk, the information referred to in Article 8(7) and Article 10(3) 
does not need to be indicated on the product itself. 

Article 14 

Identification of economic operators 

Economic  operators  shall,  on  request,  identify  the  following  to  the  market 
surveillance authorities: 

(a) 

(b) 

any economic operator who has supplied them with the product; 

any economic operator to whom they have supplied the product. 

Economic  operators  shall  be  able  to  present  the  information  referred  to  in  the  first 
paragraph for a period of 10 years after they have been supplied with the product and 
for a period of 10 years after they have supplied the product. 

Article 15 

Traceability of products 

For  certain  products,  categories  or  groups  of  products  which,  due  to  their  specific 
characteristics  or  specific  conditions  of  distribution  or  usage,  susceptible  to  bear  a 
serious risk to health and safety of persons, the Commission may require economic 
operators who place and make available those products on the market to establish or 
adhere to a system of traceability.  

EN 

19 

   EN 

2. 

3. 

4. 

5. 

1. 

2. 

3. 

4. 

The  system  of  traceability  shall  consist  of  the  collection  and  storage  of  data  by 
electronic  means  enabling  the  identification  of  the  product  and  of  the  economic 
operators involved in its supply chain as well as of the placement of a data carrier on 
the product, its packaging or accompanying documents enabling access to that data. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  with 
Article 20: 

(a)  determining the products, categories or groups of products susceptible to bear a 
serious risk to health and safety of persons as referred to in paragraph 1; 

(b) 

specifying the data which economic operators shall collect and store by means 
of the traceability system referred to in paragraph 2. 

The  Commission  may  by  means  of  implementing  acts  determine  the  type  of  data 
carrier and its placement as referred to in paragraph 2. Those implementing acts shall 
be adopted in accordance with the examination procedure referred to in Article 19(3). 

When adopting the measures referred to in paragraphs 3 and 4, the Commission shall 
take into account the following: 

(a) 

the cost-effectiveness of the measures, including their impact on businesses in 
particular small and medium-sized enterprises; 

(b) 

the compatibility with traceability systems available at international level. 

CHAPTER III 

European standards providing presumption of conformity 

Article 16 

Standardisation requests to European standardisation organisations 

The Commission may request one or several European standardisation organisations 
to  draft  or  identify  a  European  standard,  which  aims  at  ensuring  that  products  that 
conform to such standard or parts thereof comply with the general safety requirement 
laid down in Article 4. The Commission shall determine the requirements as to the 
content to be met by the requested European standard and a deadline for its adoption. 

The Commission shall adopt the request referred to in the first subparagraph by an 
implementing decision. Those implementing acts shall be adopted in accordance with 
the examination procedure referred to in Article 19(3). 

The relevant European standardisation organisation shall indicate, within one month 
following receipt of the request referred to in paragraph 1, if it accepts it. 

Where  a  request  for  funding  is  made,  the  Commission  shall  inform  the  relevant 
European standardisation  organisations, within two months following the receipt  of 
the acceptance referred to in paragraph 2, about the award of a grant for drafting a 
European standard. 

The European  standardisation organisations  shall inform the  Commission about the 
activities  undertaken  for  the  development  of  the  European  standard  referred  to  in 
paragraph  1.  The  Commission 
the  European  standardisation 
organisations  shall  assess  the  compliance  of  the  European  standards  drafted  or 
identified by the European standardisation organisations with its initial request. 

together  with 

EN 

20 

   EN 

5. 

1. 

2. 

3. 

4. 

5. 

1. 

2. 

Where  the  European  standard  satisfies  the  requirements  it  aims  to  cover  and  the 
general  safety  requirement  laid  down  in  Article  4,  the  Commission  shall  publish  a 
reference  to  such  European  standard  without  delay  in  the  Official  Journal  of  the 
European Union. 

Article 17 

Formal objections to European standards 

When  a  Member  State  or  the  European  Parliament  considers  that  a  European 
standard referred to in Article 16 does not entirely satisfy the requirements it aims to 
cover and the general safety requirement laid down in Article 4, it shall inform the 
Commission thereof with a detailed explanation and the Commission shall decide: 

(a) 

(b) 

to  publish,  not  to  publish  or  to  publish  with  restriction  the  references  to  the 
European standard concerned in the Official Journal of the European Union; 

to  maintain,  to  maintain  with  restriction  or  to  withdraw  the  references  to  the 
European  standard  concerned  in  or  from  the  Official  Journal  of  the 
European Union. 

The Commission shall publish information on its website on the European standards 
that have been subject to a decision referred to in paragraph 1. 

The  Commission  shall  inform  the  European  standardisation  organisation  concerned 
of the decision referred to in paragraph 1 and, if necessary, request the revision of the 
European standard concerned. 

The decision referred to in point (a) of paragraph 1 of this Article shall be adopted in 
accordance with the advisory procedure referred to in Article 19(2). 

The decision referred to in point (b) of paragraph 1 of this Article shall be adopted in 
accordance with the examination procedure referred to in Article 19(3). 

CHAPTER IV 

Final provisions 
Article 18 

Penalties 

The Member States shall lay down the rules on penalties applicable to infringements 
of the provisions of this Regulation and shall take all measures necessary to ensure 
that  they  are  implemented.  The  penalties  provided  for  must  be  effective, 
proportionate  and  dissuasive.  Member  States  shall  notify  those  provisions  to  the 
Commission  by  [insert  date  -  3  months  prior  to  the  date  of  application  of  this 
Regulation] and shall notify it without delay of any subsequent amendment affecting 
them. 

The  penalties  referred  to  in  paragraph  1  shall  have  regard  to  the  size  of  the 
undertakings and in particular to the situation of small and medium-sized enterprises. 
The  penalties  may  be  increased  if  the  relevant  economic  operator  has  previously 
committed  a  similar  infringement  and  may  include  criminal  sanctions  for  serious 
infringements.  

EN 

21 

   EN 

Article 19 

Committee procedure 

1. 

The  Commission  shall  be  assisted  by  a  Committee.  That  Committee  shall  be  a 
committee within the meaning of Regulation (EU) No 182/2011. 

2. 

3. 

4. 

1. 

2. 

3. 

4. 

5. 

However, for the purposes of Articles 16 and 17 of this Regulation the Commission 
shall  be  assisted  by  the  Committee  established  by  Regulation  (EU)  No  1025/2012. 
That  Committee  shall  be  a  committee  within  the  meaning  of  Regulation  (EU)  No 
182/2011. 

Where  reference  is  made  to  this  paragraph,  Article  4  of  Regulation  (EU)  No 
182/2011 shall apply. 

Where  reference  is  made  to  this  paragraph,  Article  5  of  Regulation  (EU)  No 
182/2011 shall apply. 

Where  the  opinion  of  the  Committee  referred  to  in  the  second  subparagraph  of 
paragraph  1  is  to  be  obtained  by  written  procedure,  that  procedure  shall  be 
terminated without result when, within the time-limit for delivery of the opinion, the 
chair  of  the  committee  so  decides  or  a  simple  majority  of  committee  members  so 
request. 

Article 20 

Exercise of the delegation 

The power to adopt the delegated acts is conferred on the Commission subject to the 
conditions laid down in this Article.  

The  power  to  adopt  delegated  acts  referred  to  in  Articles  13(3)  and  15(3)  shall  be 
conferred on the Commission for an indeterminate period of time from [insert date - 
the date of entry into force of this Regulation]. 

The  delegation  of  power  referred  to  in  Articles  13(3)  and  15(3)  may  be  revoked  at 
any  time  by  the  European  Parliament  or  by  the  Council.  A  decision  of  revocation 
shall put an end to the delegation of the power specified in that decision. It shall take 
effect the day following its publication in the Official Journal of the European Union 
or at a later date specified therein. It shall not affect the validity of any delegated acts 
already in force. 

As soon as it adopts a delegated act, the Commission shall notify it simultaneously to 
the European Parliament and to the Council.  

A  delegated  act  adopted  pursuant  to  Articles  13(3)  and  15(3)  shall  enter  into  force 
only if no objection has been expressed either by the European Parliament or by the 
Council  within  a  period  of  two  months  of  notification  of  that  act  to  the  European 
Parliament  and  the  Council  or  if,  before  the  expiry  of  that  period,  the  European 
Parliament  and  the  Council  have  both  informed  the  Commission  that  they  will  not 
object. That period may be extended by two months at the initiative of the European 
Parliament or of the Council. 

EN 

Article 21 

Evaluation 

22 

   EN 

No  later  than  [five]  years  after  the  date  of  application,  the  Commission  shall  assess  the 
application  of  this  Regulation  and  transmit  an  evaluation  report  to  the  European  Parliament 
and  the  Council.  This  report  shall  assess  if  this  Regulation  achieved  its  objectives,  in 
particular  with  regard  to  enhancing  the  protection  of  consumers  against  unsafe  products, 
taking  into  account  its  impact  on  business  and  in  particular  on  small  and  medium-sized 
enterprises. 

Article 22 

Repeal 

1. 

2. 

3. 

1. 

2. 

3. 

1. 

2. 

Directive 2001/95/EC is repealed with effect from [insert date - day of application of 
this Regulation].  

Directive 87/357/EEC is repealed with effect from [insert date - day of application of 
this Regulation]. 

References to Directive 2001/95/EC and Directive 87/357/EEC shall be construed as 
references  to  this  Regulation  and  shall  be  read  in  accordance  with  the  correlation 
table in the Annex. 

Article 23 

Transitional provisions 

Member  States  shall  not  impede  the  making  available  on  the  market  of  products 
covered  by  Directive  2001/95/EC  which  are  in  conformity  with  that  Directive  and 
which  were  placed  on  the  market  before  [insert  date  -  day  of  application  of  this 
Regulation]. 

European standards the reference of which is published in the Official Journal of the 
European  Union  in  accordance  with  Directive  2001/95/EC  shall  be  deemed  to  be 
European standards referred to in point (b) of Article 5 of this Regulation. 

Mandates  given  by  the  Commission  to  a  European  standardisation  organisation  in 
accordance  with  Directive  2001/95/EC  shall  be  deemed  standardisation  requests 
referred to in Article 15(1) of this Regulation. 

Article 24 

This  Regulation  shall  enter  into  force  on  [insert  date  -  the  same  day  as  entry  into 
force of Regulation (EU) No […/…][on market surveillance of products]. 

It  shall  apply  from  [insert  date  -  the  same  day  as  date  of  application  of  Regulation 
(EU) No […/…][on market surveillance of products]. 

This Regulation shall be binding in its entirety and directly applicable in all Member States. 

Done at Brussels,  

For the European Parliament 
The President 

For the Council 
The President 

EN 

23 

   EN 

Annex 

Correlation table 

Directive 2001/95/EC 

Directive 87/357/EEC 

This Regulation 

Article 1(1) 

Article 1(2), 1st subparagraph  

Article 1(2), 2nd subparagraph 

Article 2 

Article 2(b)(i)-(iv) 

Article 3(1) 

Article 3(2) 

Article 3(3) 

Article 3(4) 

Article 4 

Article 5(1), 1st subparagraph 

Article 5(1), 2nd subparagraph 

Article 5(1), 3rd subparagraph 

Article 1 

Article 2(1) 

Article 2(4) 

Article 3 

Article 6(1) 

Article 4 

Article 5 

Article 6(2) 

-  

Articles 16 and 17 

Article 8(8) 

- 

Article 8(9) 

Article 5(1), 4th subparagraph 

Article 8(3), (6) and (7)  

Article 5(1), 5th subparagraph 

Article 5(2) 

- 

Article 11 

Article 5(3), 1st subparagraph 

Article 8(9) and Article 11(5) 

Article 5(3), 2nd subparagraph 

Article 5(4) 

Article 6(1) 

Article 6(2) and (3) 

Article 7 

Article 8(1)(a) 

Article 8(1)(b) – (f) 

-  

- 

-  

-  

Article 18 

- 

- 

EN 

24 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Article 8(2), 1st subparagraph 

Article 8(2), 2nd subparagraph 

Article 8(2), 3rd subparagraph 

Article 8(3) 

Article 8(4) 

Article 9(1) 

Article 9(2) 

Article 10 

Article 11 

Article 12 

Article 13 

Article 14 

Article 15 

Article 16 

Article 17 

Article 18(1) 

Article 18(2) 

Article 18(3) 

Article 19(1) 

Article 19(2) 

Article 20 

Article 21 

Article 22 

Article 23 

- 

- 

-  

- 

- 

- 

- 

-  

- 

-  

- 

- 

Article 19 

- 

- 

-  

-  

- 

- 

Article 21 

- 

- 

Article 22 

Article 24 

Annex I, section 1 

Article 8(9) and Article 11(5) 

Annex 
sentence 

I, 

section  2, 

first 

-  

EN 

25 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Annex  I,  section  2,  second 
sentence 

Annex I, section 3 

Annex II 

Annex III 

Annex IV 

Article 13(1) and (2) 

-  

- 

- 

Annex 

Article 1 

Article 6(1)(e) 

Articles 2 to 7 

- 

EN 

26 

   EN 

 
 
 
 
 
 
 
LEGISLATIVE FINANCIAL STATEMENT 

1. 

FRAMEWORK OF THE PROPOSAL/INITIATIVE  

1.1.  Title of the proposal/initiative  

1.2.  Policy area(s) concerned in the ABM/ABB structure 

1.3.  Nature of the proposal/initiative  

1.4.  Objective(s)  

1.5.  Grounds for the proposal/initiative  

1.6.  Duration and financial impact  

1.7.  Management method(s) envisaged  

2. 

MANAGEMENT MEASURES  

2.1.  Monitoring and reporting rules  

2.2.  Management and control system  

2.3.  Measures to prevent fraud and irregularities  

3. 

ESTIMATED FINANCIAL IMPACT OF THE PROPOSAL/INITIATIVE  

3.1.  Heading(s)  of  the  multiannual  financial  framework  and  expenditure  budget 
line(s) affected  

3.2.  Estimated impact on expenditure  

3.2.1. Summary of estimated impact on expenditure  

3.2.2. Estimated impact on operational appropriations  

3.2.3. Estimated impact on appropriations of an administrative nature 

3.2.4. Compatibility with the current multiannual financial framework 

3.2.5. Third-party participation in financing  

3.3.  Estimated impact on revenue 

EN 

27 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
LEGISLATIVE FINANCIAL STATEMENT 

1. 

FRAMEWORK OF THE PROPOSAL/INITIATIVE  

1.1. 

Title of the proposal/initiative  

Proposal  for  a  Regulation  of  the  European  Parliament  and  of  the  Council  on 
consumer product safety 
Policy area(s) concerned in the ABM/ABB structure22  

1.2. 

Title 17 – Health and consumer protection – Chapter 17 02: Consumer policy 

1.3. 

Nature of the proposal/initiative  

(cid:133) The proposal/initiative relates to a new action  

(cid:133)  The  proposal/initiative  relates  to  a  new  action  following  a  pilot  project/preparatory 
action23  

X The proposal/initiative relates to the extension of an existing action  

(cid:133) The proposal/initiative relates to an action redirected towards a new action  

1.4. 

Objectives 

1.4.1.  The  Commission's  multiannual 

strategic  objective(s) 

targeted  by 

the 

proposal/initiative  

The proposal contributes to the European Union’s ten-year growth strategy "Europe 
2020"  by  enhancing  consumer  confidence  in  the  safety  of  products  and  improving 
the functioning of the single market. 

1.4.2. 

Specific objective(s) and ABM/ABB activity(ies) concerned  

SANCO  specific  objective:  To  consolidate  and  enhance  product  safety  through 
effective market surveillance throughout the Union 

22 
23 

ABM: Activity-Based Management – ABB: Activity-Based Budgeting. 
As referred to in Article 49(6)(a) or (b) of the Financial Regulation. 

EN 

28 

   EN 

                                                 
1.4.3.  Expected result(s) and impact 

Specify the effects which the proposal/initiative should have on the beneficiaries/groups targeted. 

On consumers: Reinforced confidence that consumer products made available on the 
single market are safe. 

On economic operators: Clearer rules as regards the respective obligation incumbent 
on manufacturers, importers and distributors.  

On  authorities:  Clear  legal  framework  to  enforce  general  safety  requirement  and 
obligations on economic operators and better identification of (dangerous) consumer 
products. 

1.4.4. 

Indicators of results and impact  

Specify the indicators for monitoring implementation of the proposal/initiative. 

Ratio  of  traceable/non-traceable  consumer  products  covered  by  this  Regulation 
notified under RAPEX. 

Number  of  mandates  to  European  standardisation  organisations  and  number  of 
European standards referenced in the OJ pursuant to the new Regulation. 

1.5. 

Grounds for the proposal/initiative  

1.5.1.  Requirement(s) to be met in the short or long term  

The objective is to build a consistent regulatory framework for safe products in the 
single  market.  This  shall  overcome  the  fragmentation  of  market  surveillance  rules 
and  obligations  of  economic  operators  among  various  pieces  of  Union  legislation 
(Directive  2001/95/EC,  Regulation  (EC)  No  765/2008  and  sector-specific  Union 
harmonisation legislation) which has led to confusion on the part of both economic 
operators  and  national  authorities  and  has  seriously  hampered  the  effectiveness  of 
market surveillance activity in the Union. 

Along  with  a  series  of  other  actions,  the  Single  Market  Act  I  and  II  identified  the 
revision of the General Product Safety Directive as part of the Product Safety Market 
Surveillance  Package  as  important  initiatives  to  contribute  to  boosting  growth  and 
creating jobs. 

1.5.2.  Added value of EU involvement 

The  proposed  revision  of  Directive  2001/95/EC,  which  will 
the 
modifications  of  the  Lisbon  Treaty,  can  only  be  achieved  at  Union  level.  The 
proposal is based on Article 114 Treaty on the Functioning of the  European Union 
(TFEU),  to  which  also  Article  169  TFEU  refers,  in  order  to  ensure  a  high  level  of 
protection of health and safety of all  European consumers and establish an internal 
market for consumer goods.  

integrate 

In  accordance  with  the  principles  of  proportionality  and  subsidiarity,  as  set  out  in 
Article 5 of the Treaty on European Union, this proposal does not go beyond what is 
necessary to achieve those objectives. 

1.5.3.  Lessons learned from similar experiences in the past 

The  use  of  European  standards  in  support  of  Directive  2001/95/EC  is  cumbersome 
and resource-intensive. The proposal aims at simplifying the procedures. 

EN 

29 

   EN 

The application of Directive 2001/95/EC in terms of market surveillance measures to 
consumer  products  covered  also  by  sector-specific  legislation  was  not  always  clear 
which will be clarified. 

1.5.4.  Coherence and possible synergy with other relevant instruments 

This proposal is part of the Product Safety and Market Surveillance Package and thus 
fully coherent with the proposal for a Regulation of the European parliament and of 
the Council on market surveillance of products. 

This  proposal  aligns  definitions  and  economic  operators'  obligations  with  the  New 
Legislative Framework adopted in 2008. It is therefore coherent with the "Alignment 
Package"  of  sectoral  Union  harmonisation  legislation  currently  negotiated  in  the 
European Parliament and in the Council. 

The  provisions  on  European  standards  are  coherent  with  the  recently  adopted 
Regulation (EU) No 1025/2012 on European standardisation. 

EN 

30 

   EN 

1.6. 

Duration and financial impact  

(cid:133) Proposal/initiative of limited duration  

–  (cid:133)  Proposal/initiative in effect from [DD/MM]YYYY to [DD/MM]YYYY  

–  (cid:133)  Financial impact from YYYY to YYYY  

X Proposal/initiative of unlimited duration 

–  Implementation with a start-up period from YYYY to YYYY, 

–  followed by full-scale operation. 
1.7.  Management mode(s) envisaged24  

X Centralised direct management by the Commission  

X  Centralised  indirect  management  with  the  delegation  of  implementation  tasks 
to: 

–  x  executive agencies  
–  (cid:133)  bodies set up by the Communities25  

–  (cid:133)  national public-sector bodies/bodies with public-service mission  

–  (cid:133)  persons entrusted with the implementation of specific actions pursuant to Title 
V of the Treaty on European Union and identified in the relevant basic act within 
the meaning of Article 49 of the Financial Regulation  

(cid:133) Shared management with the Member States  

(cid:133) Decentralised management with third countries  

(cid:133) Joint management with international organisations (to be specified) 

If more than one management mode is indicated, please provide details in the "Comments" section. 

Comments:  

Implementation  of  the  proposed  Regulation  should  be  ensured  through  centralised 
direct management by the Commission.  

The management of the proposed Regulation may be complemented by actions with 
the involvement of the Executive Agency on Health and Consumers (EAHC) that, in 
accordance with Council Regulation (EC) No 58/2003 of 19 December 200226, can 
be entrusted with certain tasks in the management of Community programmes. The 
Commission  has  entrusted27  the  Executive  Agency  for  Health  and  Consumers  with 
implementation tasks for the management of the Programme of Community Action 
in  the  field  of  Consumer  policy  for  2007-2013.  The  Commission  may  therefore 
decide  to  entrust  the  Executive  Agency  for  Health  and  Consumers  also  with 
implementation tasks for the management of the Consumers Programme 2014-2020, 
which, once adopted, should be the legal basis for procurement and grants in the field 
of product safety. 

24 

25 
26 
27 

Details  of  management  modes  and  references  to  the  Financial  Regulation  may  be  found  on  the 
BudgWeb site: http://www.cc.cec/budg/man/budgmanag/budgmanag_en.html 
As referred to in Article 185 of the Financial Regulation. 
OJ L 11, 16.1.2003, p. 1. 
Commission Decision C(2008)4943 of 9 September 2008. 

EN 

31 

   EN 

                                                 
The  envisaged  programme  delegation  will  be  the  extension  of  tasks  already 
externalised to the Executive Agency for Health and Consumers (EAHC). 

EN 

32 

   EN 

2. 

MANAGEMENT MEASURES  

2.1.  Monitoring and reporting rules  

Specify frequency and conditions. 

The  GPSD  committee  (which  the  proposed  Regulation  will  transform  into  a 
committee within the meaning of Regulation (EU) No 182/2011) and existing expert 
groups and/or the European Market Surveillance Forum foreseen in the proposal for 
a  single  market  surveillance  regulation  will  provide  a  regular  platform  to  discuss 
issues related to the implementation of the new Regulation. 

The  proposal  suggests  that  the  Commission  should  review  its  implementation  and 
submit a report theron to the European parliamnet and to the Council. 

2.2.  Management and control system  

2.2.1.  Risk(s) identified  

The  two  proposals  (on  general  product  safety  and  on  market  surveillance)  forming 
part of the Package are separated from each other during the legislative negotiations 
and do not progress in parallel. 

2.2.2.  Control method(s) envisaged  

The provisions on entry into force are interlinked in both proposals. 

2.3.  Measures to prevent fraud and irregularities  

Specify existing or envisaged prevention and protection measures. 

In addition to the application of all regulatory control mechanisms, DG SANCO will 
devise  an  anti-fraud  strategy  in  line  with  the  Commission's  new  anti-fraud  strategy 
(CAFS; adopted on 24 June 2011) in order to ensure inter alia that its internal anti-
fraud  related  controls  are  fully  aligned  with  the  CASF  and  that  its  fraud  risk 
management approach is geared to identify fraud risk areas and adequate responses. 
Where  necessary,  networking  groups  and  adequate  IT  tools  dedicated  to  analysing 
fraud cases related to the Consumer Programme will be set up. In particular a series 
of measures will be put in place such as: 

-  decisions,  agreements  and  contracts  resulting  from  the  implementation  of  the 
Consumer Programme will expressly entitle the Commission, including OLAF, and 
the Court of Auditors to conduct audits, on-the-spot checks and inspections; 

-  during  the  evaluation  phase  of  a  call  for  proposals/tender,  the  proposers  and 
tenderers are checked against the published exclusion criteria based on declarations 
and the Early Warning System (EWS); 

- the rules governing the eligibility of costs will be simplified in accordance with the 
provisions of the Financial Regulation. 

-  regular  training  on  issues  related  to  fraud  and  irregularities  is  given  to  all  staff 
involved  in  contract  management  as  well  as  to  auditors  and  controllers  who  verify 
the beneficiaries' declarations on the spot. 

EN 

33 

   EN 

3. 

3.1. 

ESTIMATED FINANCIAL IMPACT OF THE PROPOSAL/INITIATIVE  

Heading(s)  of  the  multiannual  financial  framework  and  expenditure  budget 
line(s) affected  

•  Existing expenditure budget lines  

In order of multiannual financial framework headings and budget lines. 

Budget line 

Type of  
expenditure

Contribution  

Number  
[Description………………………...……….] 

Diff./non-
diff. 
(28) 

from 
EFTA29 
countries 

from 
candidate 
countries30 

from third 
countries 

within the 
meaning of Article 
18(1)(aa) of the 
Financial 
Regulation  

17.01.04.01 

Administrative  expenditure  in  support  of  the 
Consumer Programme 2014 - 2020 

Non-
diff. 

YES 

NO 

NO 

NO 

•  New budget lines requested 

In order of multiannual financial framework headings and budget lines. 

Budget line 

Type of 
expenditure

Contribution  

Number  
[Heading……………………………………..] 

Diff./non-
diff. 

from 
EFTA 
countries 

from 
candidate 
countries 

from third 
countries 

within the 
meaning of Article 
18(1)(aa) of the 
Financial 
Regulation  

Heading of 
multiannual 
financial 
framework 

N° 3: 
Security and 
citizenship 

Heading of 
multiannual 
financial 
framework 

N° 3: 
Security and 
citizenship 

17 02 01 
Consumer Programme 2014 - 2020 

Diff. 

YES 

YES 

NO 

NO 

28 
29 
30 

Diff. = Differentiated appropriations / Non-diff. = Non-Differentiated Appropriations 
EFTA: European Free Trade Association.  
Candidate countries and, where applicable, potential candidate countries from the Western Balkans. 

EN 

34 

   EN 

                                                 
3.2. 

3.2.1. 

Estimated impact on expenditure  
Summary of estimated impact on expenditure31  

Heading of multiannual financial 
framework:  

3 

Security and citizenship 

EUR million in current prices (to 3 decimal places) 

2015 

2016 

2017 

2018 

2019 

2020 

TOTAL 

DG: SANCO 

(cid:121) Operational appropriations  

Number of budget line 17.02.01 

Appropriations 
administrative 
 from the envelope for specific programmes32  

an 

of 

Number of budget line: 17.01.04.01 

Commitments 

Payments 

(1) 

(2) 

nature 

financed 

Commitments 

Payments 

(1a) 

(2a) 

1,107 

1,189 

1,272 

1,356 

1,443 

1,530 

0,554 

1,148 

1,230 

1,314 

1,400 

2,251 

0,094 

0,094 

0,094 

0,094 

0,094 

0,094 

0,094 

0,094 

0,094 

0,094 

0,094 

0,094 

TOTAL appropriations 
for DG SANCO 

Commitments 

=1+1a 

1,201 

1,283 

1,366 

1,450 

1,537 

1,624 

Payments 

=2+2a 

0,648 

1,242 

1,324 

1,408 

1,494 

2,345 

7,897 

7,897 

0,564 

0,564 

8,461 

8,461 

(cid:121) TOTAL operational appropriations  

Commitments 

(3) 

1,107 

1,189 

1,272 

1,356 

1,443 

1,530 

7,897 

31 
32 

EN 

Amounts subject to the outcome of the legislative process based on the Commission proposal for the new Multiannual Financial Framework 2014-2020. 
Technical and/or administrative assistance and expenditure in support of the implementation of EU programmes and/or actions (former "BA" lines), indirect research, 
direct research. 

35 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
  
  
  
  
  
 
 
 
 
 
 
 
 
 
 
 
                                                 
(cid:121)TOTAL appropriations of an administrative nature financed 
from the envelope for specific programmes  

Payments 

(4) 

(5) 

0,554 

1,148 

1,230 

1,314 

1,400 

2,251 

7,897 

0,094 

0,094 

0,094 

0,094 

0,094 

0,094 

0,564 

TOTAL appropriations  
under HEADING 3 
of the multiannual financial framework 

Commitments 

=3+ 5 

1,201 

1,283 

1,366 

1,450 

1,537 

1,624 

Payments 

=4+ 5 

0,648 

1,242 

1,324 

1,408 

1,494 

2,345 

8,461 

8,461 

EN 

36 

EN 

 
  
 
Heading of multiannual financial 
framework:  

5 

" Administrative expenditure " 

2015 

2016 

2017 

2018 

2019 

2020 

TOTAL 

EUR million in current prices (to 3 decimal places) 

(cid:121) Human resources  

0,524 

0,524 

0,524 

0,524 

0,524 

(cid:121) Other administrative expenditure (missions, meetings) 

0,069 

0,069 

0,069 

0,069 

0,069 

0,524 

0,069 

TOTAL 

Appropriations  

0,593 

0,593 

0,593 

0,593 

0,593 

0,593 

3,144 

0,414 

3,558 

TOTAL appropriations 
under HEADING 5 
of the multiannual financial framework  

(Total 
= Total payments) 

commitments 

0,593 

0,593 

0,593 

0,593 

0,593 

0,593 

3,558 

2015 

2016 

2017 

2018 

2019 

2020 

TOTAL 

EUR million in current prices (to 3 decimal places) 

TOTAL appropriations  
under HEADINGS 1 to 5 

Commitments 

1,794 

1,876 

1,959 

2,043 

2,130 

2,217 

of the multiannual financial framework  Payments 

1,241 

1,835 

1,917 

2,001 

2,087 

2,938 

12,019 

12,019 

EN 

37 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
3.2.2.  Estimated impact on operational appropriations  

–  The proposal/initiative requires the use of operational appropriations, as explained below: 

2015 

2016 

2017 

2018 

2019 

2020 

TOTAL 

Commitment appropriations in EUR million in current prices (to 3 decimal places) 

Indicate objectives 
and outputs  

f
o

3
3

(cid:216)  

e
p
y
T

t
u
p
t
u
o

e
g
a
r
e
v
A

t
s
o
c

e
h
t

f
o

t
u
p
t
u
o

r
e
b
m
u
N

s
t
u
p
t
u
o

f
o

t
s
o
C

r
e
b
m
u
N

s
t
u
p
t
u
o

f
o

t
s
o
C

r
e
b
m
u
N

s
t
u
p
t
u
o

f
o

t
s
o
C

r
e
b
m
u
N

s
t
u
p
t
u
o

f
o

t
s
o
C

r
e
b
m
u
N

s
t
u
p
t
u
o

f
o

t
s
o
C

r
e
b
m
u
N

s
t
u
p
t
u
o

f
o

t
s
o
C

l
a
t
o
T

f
o

r
e
b
m
u
n

s
t
u
p
t
u
o

l
a
t
o
T

t
s
o
c

SPECIFIC OBJECTIVE: 
To consolidate and enhance product 
safety through effective market 
surveillance throughout the Union 

1,316 

4

1,107

4

1,189

4

1,272

4 

1,356

4

1,443

4 

1,530 

24 

7,897 

- Output 

Product safety: 
scientific advice, 
international 
cooperation, 
monitoring and 
assessing of the 
safety of products, 
knowledge base 

Sub-total for specific objective: To 
consolidate and enhance product safety 
through effective market surveillance 
throughout the Union  

4

1,107

4

1,189

4

1,272

4 

1,356

4

1,443

4 

1,530 

24 

7,897 

33 

EN 

The output consists in ensuring a high level of consumer product safety. It would be difficult to further break it down in quantitative outputs because, due to lack of 
reliable data, it is not possible to indicate in absolute or relative terms a target number for fewer unsafe products on the market. The number of RAPEX notifications 
does not necessarily reflect the number of unsafe products on the market. An increased number of RAPEX notifications can mean more effective market surveillance 
but less unsafe products and vice versa. 

38 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
TOTAL COST 

4

1,107

4

1,189

4

1,272

4 

1,356

4

1,443

4 

1,530 

24 

7,897 

EN 

39 

EN 

 
  
3.2.3.  Estimated impact on appropriations of an administrative nature 

3.2.3.1.  Summary  

–  The  proposal/initiative  requires  the  use  of  administrative  appropriations,  as 

explained below: 

EUR million in current prices (to 3 decimal places) 

2015 

2016 

2017 

2018 

2019 

2020 

TOTAL 

HEADING 5 
of the multiannual financial 
framework 

Human resources 

0,524 

0,524 

0,524 

0,524 

0,524 

0,524 

3,144 

0,069 

0,069 

0,069 

0,069 

0,069 

0,069 

0,414 

0,593 

0,593 

0,593 

0,593 

0,593 

0,593 

3,558 

Other administrative 
expenditure 

Subtotal HEADING 5 
of the multiannual financial 
framework  

Outside HEADING 534 
of the multiannual financial 
framework  

Human resources  

0 

0 

0 

0 

0 

0 

Other expenditure  
of an administrative nature 

Subtotal  
outside HEADING 5 
of the multiannual financial 
framework  

0,094 

0,094 

0,094 

0,094 

0,094 

0,094 

0,564 

0,094 

0,094 

0,094 

0,094 

0,094 

0,094 

0,564 

TOTAL 

0,687 

0,687 

0,687 

0,687 

0,687 

0,687 

4,122 

34 

Technical  and/or  administrative  assistance  and  expenditure  in  support  of  the  implementation  of  EU 
programmes and/or actions (former "BA" lines), indirect research, direct research. 

EN 

40 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
3.2.3.2.   Estimated requirements of human resources  

–  The proposal/initiative requires the use of human resources, as explained below: 

17 01 01 01 (Headquarters and Commission’s 
Representation Offices)  

XX 01 01 02 (Delegations) 

XX 01 05 01 (Indirect research) 

10 01 05 01 (Direct research) 

XX 01 02 01 (CA, INT, SNE from the "global 
envelope") 

XX 01 02 02 (CA, INT, JED, LA and SNE in 
the delegations) 

XX 01 04 yy 35 

- at Headquarters36 

- in delegations  

XX 01 05 02 (CA, INT, SNE - Indirect 
research) 

10 01 05 02 (CA, INT, SNE - Direct research) 

Other budget lines (specify) 

TOTAL 

EUR million in current prices (to 3 decimal places) 

2015 

2016 

2017 

2018 

2019 

2020 

TOTAL 

0,524 

0,524 

0,524 

0,524 

0,524 

0,524 

3,144 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0,524 

0,524 

0,524 

0,524 

0,524 

0,524 

3,144 

XX is the policy area or budget title concerned. 

The human resources required will be met by staff from the DG who are already assigned to 
management of the action and/or have been redeployed within the DG, together if necessary 
with any additional allocation which may be granted to the managing DG under the annual 
allocation  procedure  and  in  the  light  of  budgetary  constraints.  The  resources  required  are 
indicated  without  taking  account  of  the  tasks  which  will  be  implemented  by  an  executive 
agency. The proposal does not lead to an increase of the resources already involved in the 
executive agency. 

Description of tasks to be carried out: 

Officials and temporary agents 

Administrators: 

•  Ensure, monitor and report on the proper implementation and 
application of EU policies in the area of product safety. 
•  Follow policy developments in the area of product safety and 

information exchange between Member States. 

•  Participate and represent the Commission in comitology meetings and 

• 

expert groups linked to product safety. 
Identify and prepare initiatives within the framework of the Consumer 
Product Safety Regulation to ensure a consistent and high level of 
consumer product safety, in particular standardisation mandates and 
assessment of standards and specifications to support the application 
of the Regulation.  

35 
36 

Under the ceiling for external personnel from operational appropriations (former "BA" lines). 
Essentially  for  Structural  Funds,  European  Agricultural  Fund  for  Rural  Development  (EAFRD)  and 
European Fisheries Fund (EFF). 

EN 

41 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
Assistants: 

•  Ensure the administrative support with the operation of the comitology 

committee and expert groups. 

•  Carry out various tasks related to the interface with internal and 

external correspondents and stakeholders in the area of product safety. 
•  Assist in launching, managing and monitoring calls for tenders and the 

implementation of contracts. 

EN 

42 

   EN 

 
3.2.4.  Compatibility with the current multiannual financial framework  

–  X  Proposal/initiative is compatible with the new multiannual financial framework 

2014-2020 as proposed by the Commission. 

–  (cid:133)  Proposal/initiative  will  entail  reprogramming  of  the  relevant  heading  in  the 

multiannual financial framework. 

Explain what reprogramming is required, specifying the budget lines concerned and the corresponding 
amounts. NA 

–  (cid:133)  Proposal/initiative requires application of the flexibility instrument or revision 

of the multiannual financial framework37. 

Explain what is required, specifying the headings and budget lines concerned and the corresponding 
amounts. NA 

3.2.5.  Third-party contributions  

–  The proposal does not provide for co-financing by third parties  

3.3. 

Estimated impact on revenue  

–  X  The proposal has no financial impact on revenue.  

37 

See points 19 and 24 of the Interinstitutional Agreement. 

EN 

43 

   EN