EN    EN  
 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}  
Ref. Ares(2013)325780 - 12/03/2013EN 2   EN EXPLANATORY MEMORANDUM  
1. CONTEXT  OF THE  PROPOSAL 
The free movement of safe consumer produc ts 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 th e European Parliament a nd of the Council on general 
product safety1 (the "General Product Safety Direc tive" or simply GPSD), concerns 
manufactured non-food consumer products . Like the GPSD also the proposed 
Regulation requires that consum er 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 Regul ation 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 an d 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 ac creditation and market surveillance 
relating to the marketing of products2 and sector-specifi c Union harmonisation 
legislation that also covers consumer pr oducts) has led to confusion on the part of 
both economic operators and national authorities and ha s seriously hampered the 
effectiveness of market surv eillance activity in the Union. 
This proposal aims at clarifying the regu latory framework fo r consumer products 
taking into account legislative developmen ts in recent years such as the New 
Legislative Framework on the Mark eting of Products adopted in 20083, the 
alignment of sector-specifi c Union harmonisation legislat ion to that new framework4 
and the entry into application on 1 Janua ry 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 survei llance 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 OJ L 11, 15.1.2002, p. 4. 
2 OJ L 218, 13.8.2008, p. 30. 
3 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. 
4 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. 
5 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. 
6 COM(2011)206 final. 
7 COM(2012)573 final. EN 3   EN products circulating in the EU through better coherenc e 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 c oncentrated on four  main substantive 
areas for improvement in the EU product sa fety 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 th e Free Movement of Goods Package. 
The second round of public consultation on problems identified and the solutions 
proposed by the Commission took place be tween May and December 2010. Between 
18 May and 20 August 2010, the Commission he ld an internet public consultation 
focussing on those four areas. The Co mmission sought feedback through four 
consultation papers and nine online ques tionnaires targeting various groups of 
stakeholders. 55 national authorities res ponded, from all EU Member States except 
one and from Norway, Iceland and Sw itzerland. Various other stakeholders, 
including more than thirty business associ ations, seventeen consumer organisations, 
and over fifty individual economic operators (including several SM Es) contributed to 
the consultation. In total, 305 replies were received to th e nine online questionnaires. 
In addition, thirteen business and consumer organisations provided separate position 
papers. A number of presentations and dire ct exchanges with stakeholders (with both 
business and consumer organisations) were also held during the consultation period.
 
The second round of public consultation e nded with an international stakeholder 
conference on the "Revision of the General Pr oduct Safety Directive" on 1 December 
2010 during which the Commission received f eedback from the stakeholders on key 
conclusions of the public  internet consultation. 
The third round of public c onsultation took place between  January and March 2011. 
It took the form of targeted stakeholder mee tings with the particip ation of experts in 
the relevant areas. These meetings c overed structural topics, including the 
organisation of market surveillance coordinatio n, the impact of the new definitions of 
obligations of economic operato rs (in particular traceabilit y obligations), procedures 
for establishing mandates lead ing to the estab lishment of European standards under 
the GPSD and ways to esta blish a clear and understand able structure for non-food 
product safety rules. 
One of the outcomes of the public cons ultation process and the dialogue with 
interested parties was to transfer the ma rket surveillance rules from the current 
GPSD into a new stand-alone Market Surv eillance 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 Co mmission thus covers aspects related to 
both this proposal and the proposal for a new Market Surveillance Regulation. The 
Commission's Impact Assessment Boar d delivered a favourable opinion in 
September 2012. EN 4   EN 3. LEGAL  ELEMENTS  OF THE  PROPOSAL 
• Scope and definitions 
The proposed Regulation clearly delimits it s scope of application compared to 
sectoral Union harmonisation legislation. Whilst the general principle that all non-
food consumer products must be safe appl ies across the board, the more detailed 
obligations on economic operators only apply to those operators that are not subject 
to corresponding obligations la id down in harmonising legislation covering a specific 
product sector. The Commission envisages drawing up guidance which will help 
businesses, in particular small and medi um-size enterprises, to identify which 
legislation applies to the consumer pr oducts they manufacture or distribute. 
The definitions section has been updated a nd, where applicable aligned with the New 
Legislative Framework for the Marketing of Products8. 
• General safety requirement and ob ligations 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 ope ration in practice will be significantly 
simplified due to the introduction of a clear link with sector-speci fic legislation and a 
simplification of the rules on standards.  
Consumer products that comply with sect or-specific Union harmonisation legislation 
that aims at ensuring the health and safety of persons shall be presumed to be safe also under this proposed Re gulation. If they do not co mply with the applicable 
harmonisation legislation, they would not be nefit from the safety presumption but 
correction of such situation would be govern ed by the sector-specific legislation in 
conjunction with the future single  market surveillance regulation.  
Moreover, the proposal lays down the elemen tary obligations of economic operators 
(manufacturers, importers, distributors) i nvolved in the supply chain of consumer 
products insofar as they ar e not subject to corresponding requirements under sector-
specific Union harmonisation legislation. The obligations are base d 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 fr amework for the marketing of products
9 
and address, among others, issues rela ted to labelling, pr oduct identification, 
corrective actions to be taken in case of  unsafe products and information of the 
competent authorities. Proportionate to th e potential risks of  their products, 
manufacturers will be obliged to establis h a technical documentation regarding their 
products which shall contain th e 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 id entify the operators who supplie d 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 em powered to adopt measures requiring 
economic operators to establish or adhe re to an electronic traceability system. 
• Use of European standards 
                                                 
8 See footnote 3. 
9 OJ L 218, 13.8.2008, p. 82. EN 5   EN Like the GPSD, also the proposal for the new Regulation favours the use of standards 
in support of the implementation of the ge neral safety requirement. However, the 
process to identify existing European sta ndards or to ask for the development of 
European standards that woul d give rise to presume that  a product is safe has been 
significantly simplified and aligned to Re gulation (EU) No 1025/2012 that sets a new 
overarching framework for European standardisation10. This underlines the 
importance the Commission gives to an appr oach of co-regulation and will enhance 
the use of European standards in support of the proposed Regulation.  
• Transfer of rules on market survei llance 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 wh ether intended for consumers or for 
professionals, the provisions regarding ma rket surveillance and RAPEX that are 
currently contained in the GPSD have b een transferred to th e proposal for a new 
single Market Surveillance Regulation. Th at new Regulation would produce a one-
tier system in which all market surveillan ce 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 Un ion 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 Un ion level. This is necessary in order to 
guarantee a high level of consumer protec tion (in line with Ar ticle 169 TFEU) and 
also to prevent Member States from a dopting diverging product regulations which 
would result in fragmentation of the single market. In accordance with the principles 
of proportionality and subsidia rity, 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 appropria te legal instrument 
as it imposes clear and detailed rules wh ich 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 liabl e to lead to different  levels of health 
and safety protection and to create obstacl es to the internal market. Replacing the 
national transposition measures  also has a strong simplification effect since it allows 
economic operators to conduct their busines s 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 prot ection (Article 35 of the Charter) and 
consumer protection (Article 38) by assu ring a high level of safety of consumer 
                                                
 
10 See footnote 5. EN 6   EN products made available on the Union mark et. 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 sa fety 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 al ready 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 simplifica tion of EU legislation and adheres to the 
principles of smart regulation. When pr eparing this proposal the Commission has 
taken stock of the important advancement of sector-specific legislation that aims at 
ensuring the safety of pr oducts and which usually doe s not make a distinction 
whether the products covere d are intended for consumer s or professional users. 
Contrary to the situation 10 or 15 years a go, 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 exte nt aligned with those appli cable to harmonised products.  
This approach will reduce administrative burdens and compliance costs for 
businesses, in particular for small and medi um-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 object ive of the proposed Regulation, micro-
enterprises as defined in Co mmission Recommendation 2003/361/EC11 cannot be 
exempted from its requirements because ru les 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 f it 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. EN 7   EN 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 CO UNCIL 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 Eu ropean Economic and Social Committee
12,  
Acting in accordance with the or dinary legislative procedure, 
Whereas: (1) Directive 2001/95/EC of the European Pa rliament and of the Council of 3 December 
2001 on general product safety
13 lays down the requirement that consumer products 
must be safe and that Member States' mark et surveillance authorities must take action 
against dangerous products as well as exchan ge information to that effect through the 
Community rapid information exchange sy stem 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 a nd replaced by this Regulation. 
(2) A Regulation is the appropriate legal instrument as it imposes clear and detailed rules 
which do not give room for divergent tr ansposition by Member States. A Regulation 
ensures that legal requirements are appli cable at the same time throughout the Union. 
(3) This Regulation must contribute to the attainment of the object ives referred to in 
Article 169 of the TFEU. In pa rticular it should aim at en suring the functioning of the 
internal market as regards products inte nded for consumers by laying down uniform 
rules regarding a general safety requirement , assessment criteria and obligations of 
economic operators. Given that  rules on market survei llance, including rules on 
RAPEX, are laid down in Regulation (EU) No […/…] [ on market surveillance of 
products ]
14 which applies also to products c overed by this Regul ation, no further 
provisions on market surveillance or RAPEX are needed in this Regulation. 
                                                 
12 OJ C , , p. . 
13 OL L 11, 15.1.2002, p. 4. 
14 OJ L , , p. . EN 8   EN (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 excepti on of materials and articles intended to come into 
contact with food inso far 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 food
15 or by other food 
specific legislation which only covers chem ical and biological food related risks. 
(5) Medicinal products are subject to a pre-ma rket assessment that includes a specific risk-
benefit analysis. They should therefore be ex cluded from the scope of this Regulation. 
(6) This Regulation should not cover services. However, in or der to secure the attainment 
of the protection of health and safety of c onsumers, it should apply to products that are 
supplied or made available to consumers in the context of the pr ovision of services, 
including products to which consumers are directly exposed  during a service 
provision. Equipment on which consumers ri de or travel which is operated by a 
service provider should be excluded from th e scope of this Regulation since it has to 
be dealt with in conjunction with th e safety of the service provided.  
(7) Despite the development of sector-speci fic Union harmonisation legislation that 
addresses safety aspects of specific products or categories of products, it is practically 
impossible to adopt Union legislation for al l consumer products that exist or may be 
developed. There is therefore still a need for a legislative fram ework of a horizontal 
nature to fill gaps and ensure consumer pr otection not otherwise ensured, in particular 
with a view to achieving a high level of prot ection of safety and health of consumers, 
as required by Article 114 a nd Article 169 of the TFEU. 
(8) In respect of the consumer products subjec t to this Regulation th e scope of application 
of the different parts of it should be cl early delimited from sector-specific Union 
harmonisation legislation. Whils t the general product safety  requirement and related 
provisions should be ap plicable to all consumer produc ts, the obligations of economic 
operators should not apply where Union harm onisation legislation includes equivalent 
obligations, such as Union legislation on co smetics, toys, electrical appliances or 
construction products. 
(9) In order to ensure consistency between  this Regulation and sector-specific Union 
harmonisation legislation with regard to sp ecific obligations of economic operators, 
the provisions concerning ma nufacturers, authorised repr esentatives, importers and 
distributors should be base d on the reference provision s 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 al so cover distance selling.  
(11) This Regulation should appl y to second hand products that re-enter the supply chain in 
the course of a commercial activity, excep t 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 OJ L 338, 13.11.2004, p. 4. 
16 OJ L 218, 13.8.2008, p. 82. EN 9   EN consumers, especially children, may place them in their  mouths, suck or ingest them, 
which might cause, for example, suffocation, poisoning, the perforat ion 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 whic h, appearing to be ot her than they are, 
endanger the health or safety of consumers17 which should be repealed. 
(13) The safety of products should be assessed ta king into account all the relevant aspects, 
in particular their characteristics and pr esentation as well as the categories of 
consumers who are likely to use the products taking into account th eir vulnerability, in 
particular children, the el derly 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 responsibl e for the compliance of products, in relation 
to their respective roles in th e supply chain, so as to ensure a high level of protection 
of the health and safety of consumers. 
(16) All economic operators in tervening in the supply and di stribution 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 obliga tions which correspond to the role of each 
operator in the supply an d distribution process. 
(17) Importers bear the respons ibility that products from thir d countries that they place on 
the Union market comply with the require ments of this Regulation. The specific 
obligations of importers should theref ore be included in this Regulation. 
(18) Distributors make product s available on the market after they have been placed on the 
market by the manufacturer or the importer a nd should act with due care to ensure that 
their handling of the product does not advers ely 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 a ffected should be considered to be the 
manufacturer and should assume the obligations of the manufacturer. 
(20) Ensuring product identification and the tr aceability of products throughout the entire 
supply chain helps to identify economic opera tors and to take effective corrective 
measures against unsafe products, such as ta rgeted recalls. Product identification and 
traceability thus ensure that consumer s and economic operators obtain accurate 
information regarding unsafe products whic h enhances confidence in the market and 
avoids unnecessary disruption of trade. Pr oducts should therefore bear information 
allowing their identification and the iden tification of the ma nufacturer and, if 
applicable, of the importer. Manufactur ers should also establish 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 w ho supplied them and to whom 
they supplied a product. Directive 95/46/EC of the European Parliament and of the 
                                                
 
17 OJ L 192, 11.7.1987, p. 42. EN 10   EN 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 fo r the purposes of this Regulation. 
(21) The indication of origin supplements th e basic traceability re quirements concerning 
the name and address of the manufacturer. In  particular, the indi cation 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 give n address is different from the actual place 
of manufacture. Such information can faci litate the task of market surveillance 
authorities in tracing the pr oduct back to the actual pla ce of manufacture and enable 
contacts with the authorities of the countries of origin in the fram ework of bilateral or 
multilateral cooperation on consumer product sa fety 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 ri sks in such a way that a product which 
conforms to such a European standard, th e 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 fo r a European standard ensuring compliance 
of certain products w ith the general safety requiremen t under this Regulation, it should 
apply the relevant provisions of Regul ation (EU) No 1025/2012 of the European 
Parliament and of the Council of 25 Oc tober 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 confor m to it are presumed 
to be safe. The references of such Eur opean standards should be published in the 
Official Journal of the European Union . 
(24) The procedures to request European st andards 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 ensu re overall consistency in European 
standardisation issues, requests for European  standards, or objections to a European 
standard, should therefore be brought befo re the committee set up by that Regulation, 
after appropriate consultation of experts of th e 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 co ntinue providing presumpti on of conformity with the 
general safety requirement. Standardisat ion 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 un iform conditions for the implem entation of this Regulation, 
implementing powers should be conferre d on the Commission as regards the 
exemption to the obligation to  inform market surveillanc e authorities about products 
presenting a risk, as regards the type of data carrier and its placement on the product 
                                                
 
18 OJ L 281, 23.11.1995, p. 31. 
19 OJ L 316, 14.11.2012, p. 12. EN 11   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 ge neral principles concerning mechanisms 
for control by the Member States of th e 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 st andards 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 genera l 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 s hould be delegated to the Commission in 
respect of products for which the name an d 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 se rious risk to health and sa fety. It is of particular 
importance that the Commission carry out  appropriate consultations during its 
preparatory work, including at expert level. The Comm ission, when preparing and 
drawing up delegated acts, should ensure  a simultaneous, timely and appropriate 
transmission of relevant documents to th e European Parliament and to the Council. 
(30) Member States should lay down rules on pena lties applicable to infringements of this 
Regulation and ensure that they are implem ented. Those penalties must be effective, 
proportionate and dissuasive. 
(31) To allow economic operators, Member St ates and the Commission to adapt to the 
changes introduced by this Regulation, it is appropriate to provi de 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 c onsumers while guarante eing a high level of 
health and safety protection of consumer s, 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 proportional ity, 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 observe s the principles recognised 
in particular by the Charter of Fundament al 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 c onsumer protection as well as the freedom 
to conduct business. 
                                                
 
20 OJ L 55, 28.2.2011, p. 13. EN 12   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. 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 fore seeable 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. 
2. This Regulation shall not apply to products to be repaired or reconditioned prior to 
being used where those pr oducts are made available on the market as such.  
3. This Regulation shall no t 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 h ealth and safety laid down in Union 
harmonisation legislation or pursuant to it. EN 13   EN Article 3 
Definitions 
For the purposes of this Regulation th e following definitions shall apply: 
(1) ‘safe product’ means any product which, under normal or reasonably foreseeable 
conditions of use of the product concerne d, including the duration of use and, where 
applicable, its putting into service, installation and ma intenance 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; 
(2) ‘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; 
(3) ‘placing on the market’ means the first ma king available of a product on the Union 
market; 
(4) ‘manufacturer’ means any natural or legal person who manufactures a product or has 
a product designed or manuf actured and markets that product under his name or 
trademark; 
(5) ‘authorised representative’ means any natural or legal person established within the 
Union who has received a written mandate fr om a manufacturer to act on his behalf 
in relation to specified tasks; 
(6) ‘importer’ means any natural or legal pe rson established within the Union who 
places a product from a third country on the Union market; 
(7) ‘distributor’ means any natural or legal pe rson in the supply chain, other than the 
manufacturer or the importer, who ma kes a product available on the market; 
(8) ‘economic operators’ means the manufactur er, the authorised representative, the 
importer and the distributor; 
(9) ‘European standard’ means a European stan dard as defined in Article 2(1)(b) of 
Regulation (EU) No 1025/2012; 
(10) ‘international standard’ means an international standard as defined in Article 2(1)(a) 
of Regulation (EU) No 1025/2012; 
(11) ‘national standard’ means a national stan dard as defined in Article 2(1)(d) of 
Regulation (EU) No 1025/2012; 
(12) ‘European standardisation organisation’  means a European standardisation 
organisation as defined in Article 2(8) of Regulation (EU) No 1025/2012; 
(13) ‘market surveillance authority’ means a mark et surveillance authority as defined in 
Article [ 3(12] of Regulation (EU) No […/…] [on market surveillance of products ]; 
(14) ‘recall’ means any measure aimed at achie ving the return of  a product that has 
already been made available to the end user; 
(15) ‘withdrawal’ means any measure aimed at preventing a product in the supply chain 
from being further made available on the market; 
(16) ‘Union harmonisation legislation’ means any Union legislation harmonising the 
conditions for the marketing of products; EN 14   EN (17) ‘serious risk’ means a risk requiring ra pid intervention and follow-up, including 
cases where the effects may not be immediate. 
Article 4 
General safety requirement  
Economic operators shall place or make availa ble on the Union market only safe products. 
Article 5 
Presumption of safety  
For the purpose of this Regulati on, a product shall be presumed to be in compliance with the 
general safety requirement laid down in Article 4 in the following cases: 
(a) 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; 
(b) in the absence of requirements laid dow n 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 Eu ropean 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; 
(c) in the absence of requirements laid dow n 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 safe ty 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 
1. In the absence of Union harmonisation legi slation, 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 acc ount when assessing whether a product is 
safe, in particular: 
(a) the characteristics of the product, including its composition, packaging, 
instructions for assembly and, wher e applicable, for installation and 
maintenance; 
(b) the effect on other products, where it is reasonably foreseeable that it will be 
used with other products; 
(c) the presentation of the product, the labell ing, any warnings and instructions for 
its use and disposal and any other indi cation or information regarding the 
product; 
(d) the categories of consumers at risk wh en using the product, in particular 
vulnerable consumers; 
(e) the appearance of the product and in par ticular where a pro duct, although not 
foodstuff, resembles foodstuff and is likel y to be confused with foodstuff due EN 15   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 ri sk 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) international standards; 
(d) international agreements; 
(e) Commission recommendations or guide lines 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 expect ations concerning safety. 
Article 7 
Indication of the origin 
1. 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 provi ded on the packaging or in a document 
accompanying the product. 
2. For the purpose of determination of the c ountry of origin with in the meaning of 
paragraph 1, non-preferential or igin rules set out in Arti cles 23 to 25 of Council 
Regulation (EEC) No 2913/92 estab lishing a Community Customs Code21 shall 
apply. 
3. Where the country of origin determined in accordance with paragraph 2 is a Member 
State of the Union, manufacturers and impor ters 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 16   EN 1. When placing their products on the market, ma nufacturers shall ensure that they have 
been designed and manufactured in accordan ce with the general safety requirement 
laid down in Article 4.  
2. Manufacturers shall ensure that procedur es are in place for series production to 
remain in conformity with the general safety requirement laid down in Article 4. 
3. Proportionate to the possible risks of a product, manufacturers sh all, to pr otect the 
health and safety of consumers, carry out sample testing of products made available on the market, investigate complaints a nd keep a register of complaints, non-
conforming products and product recalls, and sh all keep distributors informed of any 
such monitoring. 
4. Proportionate to the possible risks of a product, manufacturers shall draw up a 
technical documentation.The technical doc umentation shall cont ain, as appropriate: 
(a) a general description of the product and its essential properties relevant for 
assessing the product's safety;  
(b) an analysis of the possibl e risks related to the produc t 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. 
5. Manufacturers shall keep, for a period of ten years after the pr oduct has been placed 
on the market, the technical documentation and make it available to the market 
surveillance author ities, upon request.  
6. 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 provide d on the packaging or in a document 
accompanying the product. 
7. Manufacturers shall indicate their name, regi stered trade name or registered trade 
mark and the address at whic h 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 wh ich the manufacturer can be contacted. 
8. Manufacturers shall ensure that their pr oduct is accompanied by instructions and 
safety information in a language which ca n be easily understood  by consumers, as 
determined by the Member State in whic h the product is made available, except 
where the product can be used safely a nd as intended by the manufacturer without 
such instructions and safety information.  
Member States shall inform the Commissi on about any provisions adopted by them 
determining the requ ired language(s). EN 17   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 co rrective action necessa ry to bring that 
product into conformity, to withdraw it or  recall it, if appropr iate. Furthermore, 
where the product is not safe, manufacturer s 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 th e 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) a nd (4) shall not form pa rt of the authorised 
representative's mandate. 
2. An authorised representative shall pe rform the tasks specified in the mandate 
received from the manufacturer. The ma ndate shall allow the authorised 
representative to do at  least the following: 
(a) further to a request from a market surv eillance authority, provide that authority 
with all the information and documen tation 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. Before placing a product on the market impor ters 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 requireme nts set out in Article 8(4), (6) and (7). 
2. Where an importer considers or has reas on 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. Furtherm ore, where the product is not safe, the 
importer shall inform the manufacturer and th e market surveillance authorities of the 
Member State in which he is established to that effect. 
3. Importers shall indicate their name, regist ered 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. 
4. Importers shall ensure that the product is  accompanied by inst ructions and safety 
information in a language which can be easily understood by consumers, as 
determined by the Member State in whic h the product is made available, except 
where the product can be used safely a nd as intended by the manufacturer without 
such instructions and safety information.  
Member States shall inform the Commissi on about any provisions adopted by them 
determining the requ ired language(s). EN 18   EN 5. Importers shall ensure that, while a produc t is under their respons ibility, storage or 
transport conditions do not jeopardise its compliance with the general safety requirement laid down in Article 4 an d its conformity with Article 8(6). 
6. Proportionate to the possible risks presente d 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 regi ster of complaints, of non-conforming 
products and of product recalls, and shall keep the manufactur er and distributors 
informed of such monitoring. 
7. 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 co rrective action necessa ry to bring that 
product into conformity, to withdraw it or  recall it, if appropr iate. Furthermore, 
where the product is not sa fe, importers shall immedi ately inform the market 
surveillance authorities of the Member States in which they made the product 
available to that effect, giving details, in particular, of th e risk to health and safety 
and of any corrective action taken. 
8. Importers shall keep, for a period of ten ye ars after the product has been placed on 
the market, the technical documentation and make it available to the market surveillance author ities, upon request.  
Article 11 
Obligations of distributors 
1. When making a product available on  the market, a distributor shall  act with due care 
in relation to the requirements of this Regulation. 
2. Before making a product available on the mark et 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.  
3. Where a distributor considers or has a reason to believe that a product is not in 
conformity with this Regulation, he sh all not make the product available on the 
market until it has been br ought into conformity. Furthe rmore, where the product is 
not safe, the distributor shal l inform the manufacturer or the importer, as applicable, 
to that effect as well as the market su rveillance authority of the Member State in 
which the distributor is established. 
4. Distributors shall ensure that, while a pr oduct 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. 
5. Distributors who consider or have reason to believe th at a product which they have 
made available on the market is  not safe or is not in conf ormity 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 appropria te. Furthermore, where the product is not safe, distributors shall 
immediately inform the manufacturer or impor ter, 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 th e risk to health and safety 
and of any corrective action taken. EN 19   EN Article 12 
Cases in which obligations of manufactu rers apply to importers and distributors 
An importer or distributor shall be consider ed a manufacturer for the purposes of this 
Regulation and shall be subject to the obligatio ns 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 comp liance with the requireme nts of this Regulation 
may be affected. 
Article 13 
Exemption from certain obligations of manufacturers, importers and distributors  
1. Obligation to inform the market surveilla nce 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-iden tified products are not safe;  
(b) the manufacturer, importer or distributor can demonstrate that the risk has been 
fully controlled and cannot any more enda nger the health and safety of persons;  
(c) the cause of the risk of the product is such that knowledge of it does not 
represent useful information fo r the authorities or the public. 
2. The Commission may by means of implementing acts determine the situations which 
meet the conditions of para graph 1. Those implementing acts shall be adopted in 
accordance with the examination proce dure referred to in Article 19(3).  
3. The Commission shall be empowered to a dopt delegated acts in  accordance with 
Article 20 determining the products, categor ies or groups of products for which, due 
to their low level of risk, the information re ferred to in Article 8(7) and Article 10(3) 
does not need to be indi cated on the product itself. 
Article 14 
Identification of economic operators 
1. Economic operators shall, on request, identify the following to the market 
surveillance authorities: 
(a) any economic operator who has s upplied them with the product; 
(b) any economic operator to whom they have supplied the product. 
2. Economic operators shall be able to presen t 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 
1. For certain products, categories or groups of products which, due to their specific 
characteristics or specific conditions of di stribution or usage, susceptible to bear a 
serious risk to health an d safety of persons, the Co mmission may require economic 
operators who place and make available thos e products on the market to establish or 
adhere to a system of traceability.  EN 20   EN 2. The system of traceability shall consist of  the collection and storage of data by 
electronic means enabling th e identification of the product and of the economic 
operators involved in it s 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. 
3. The Commission shall be empowered to a dopt delegated acts in  accordance with 
Article 20: 
(a) determining the products, categories or gr oups of products susceptible to bear a 
serious risk to health an d safety of persons as re ferred to in paragraph 1; 
(b) specifying the data which economic operato rs shall collect and store by means 
of the traceability system referred to in paragraph 2. 
4. 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 examina tion procedure referred to in Article 19(3). 
5. 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 impa ct on businesses in 
particular small and medium-sized enterprises; 
(b) the compatibility with traceability system s available at international level. 
CHAPTER III 
European standards providing presumption of conformity 
Article 16 
Standardisation requests to European standardisation organisations 
1. The Commission may request one or severa l European standardisation organisations 
to draft or identify a European standard, which aims at ensuri ng 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 dead line for its adoption. 
The Commission shall adopt the request refe rred to in the first subparagraph by an 
implementing decision. Those implementing act s shall be adopted in accordance with 
the examination procedure referred to in Article 19(3). 
2. The relevant European standardisation or ganisation shall indicat e, within one month 
following receipt of the request referred to in paragraph 1, if it accepts it. 
3. Where a request for funding is made, th e Commission shall inform the relevant 
European standardisation organisations, w ithin two months follo wing the receipt of 
the acceptance referred to in paragraph 2, about the award of a grant for drafting a European standard. 
4. The European standardisation organisati ons shall inform the Commission about the 
activities undertaken for the development of the European standard referred to in paragraph 1. The Commission together with the European standardisation 
organisations shall assess the compliance of the European standards drafted or 
identified by the European standardisati on organisations with its initial request. EN 21   EN 5. Where the European standard satisfies th e requirements it aims to cover and the 
general safety requirement laid down in Article 4, the Commission shall publish a reference to such European st andard without delay in the Official Journal of the 
European Union . 
Article 17 
Formal objections to European standards 
1. When a Member State or the European Parliament considers that a European 
standard referred to in Article 16 does not en tirely satisfy the requirements it aims to 
cover and the general safety requirement la id down in Article 4, it shall inform the 
Commission thereof with a detailed explan ation and the Commission shall decide: 
(a) to publish, not to publish or to publish w ith restriction the references to the 
European standard concerned in the Official Journal of the European Union ; 
(b) to maintain, to maintain with restricti on or to withdraw the references to the 
European standard concerned in or from the Official Journal of the 
European Union . 
2. The Commission shall publish information on its website on the European standards 
that have been subject to a deci sion referred to in paragraph 1. 
3. The Commission shall inform the European  standardisation organisation concerned 
of the decision referred to in paragraph 1 a nd, if necessary, request the revision of the 
European standard concerned. 
4. The decision referred to in point (a) of para graph 1 of this Article shall be adopted in 
accordance with the advisory procedur e referred to in Article 19(2). 
5. The decision referred to in point (b) of para graph 1 of this Article shall be adopted in 
accordance with the examination proce dure referred to in Article 19(3). 
CHAPTER IV 
Final provisions 
Article 18 
Penalties 
1. The Member States shall lay down the rule s on penalties applicable to infringements 
of the provisions of this Regulation and sha ll take all measures necessary to ensure 
that they are implemented. The penal ties provided for must be effective, 
proportionate and dissuasive. Member Stat es shall notify thos e 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. 
2. The penalties referred to in paragraph 1 shall have regard to the size of the 
undertakings and in particular to the situation of small a nd medium-sized enterprises. 
The penalties may be increased if the re levant economic operator has previously 
committed a similar infringement and may include criminal sanctions for serious infringements.  EN 22   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. 
However, for the purposes of Articles 16 and 17 of this Regula tion the Commission 
shall be assisted by the Committee esta blished by Regulation (EU) No 1025/2012. 
That Committee shall be a committee within  the meaning of Regulation (EU) No 
182/2011. 
2. Where reference is made to this para graph, Article 4 of Regulation (EU) No 
182/2011 shall apply. 
3. Where reference is made to this para graph, Article 5 of Regulation (EU) No 
182/2011 shall apply. 
4. Where the opinion of the Committee refe rred to in the second subparagraph of 
paragraph 1 is to be obtained by written procedure, that procedure shall be 
terminated without result when, within th e time-limit for delivery of the opinion, the 
chair of the committee so decides or a si mple majority of committee members so 
request. 
Article 20 
Exercise of the delegation 
1. The power to adopt the delegated acts is  conferred on the Comm ission subject to the 
conditions laid down in  this Article.  
2. The power to adopt delegated acts referre d 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 fo rce of this Regulation]. 
3. 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. 
4. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to 
the European Parliament and to the Council.  
5. A delegated act adopted pursu ant to Article s 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 mo nths at the initiative of the European 
Parliament or of the Council. 
Article 21 
Evaluation EN 23   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 pr otection 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. Directive 2001/95/EC is repe aled with effect from [ insert date - day of application of 
this Regulation ].  
2. Directive 87/357/EEC is rep ealed with effect from [ insert date - day of application of 
this Regulation ]. 
3. 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 
1. Member States shall not impede the ma king 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 ]. 
2. European standards the reference of which is  published in the Offi cial Journal of the 
European Union in accordance with Dire ctive 2001/95/EC shall be deemed to be 
European standards referred to in point (b) of Article 5 of this Regulation. 
3. Mandates given by the Commission to a Eu ropean 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 
1. 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]. 
2. It shall apply from [insert date - the same  day as date of app lication 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 For the Council 
The President The President EN 24   EN Annex  
Correlation table 
Directive 2001/95/EC Directive 87/357/EEC This Regulation 
Article 1(1)  Article 1 
Article 1(2), 1st subparagraph   Article 2(1) 
Article 1(2), 2nd subparagraph  Article 2(4) 
Article 2  Article 3 
Article 2(b)(i)-(iv)  Article 6(1) 
Article 3(1)  Article 4 
Article 3(2)  Article 5 
Article 3(3)  Article 6(2) 
Article 3(4)  -  
Article 4  Articles 16 and 17 
Article 5(1), 1st subparagraph  Article 8(8) 
Article 5(1), 2nd subparagraph  - 
Article 5(1), 3rd subpara graph  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 18 
Article 8(1)(a)  - 
Article 8(1)(b) – (f)  - EN 25   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 19 
Article 16  - 
Article 17  - 
Article 18(1)  -  
Article 18(2)  -  
Article 18(3)  - 
Article 19(1)  - 
Article 19(2)  Article 21 
Article 20  - 
Article 21  - 
Article 22  Article 22 
Article 23  Article 24 
Annex I, section 1  Article  8(9) and Article 11(5) 
Annex I, section 2, first 
sentence  -  EN 26   EN Annex I, section 2, second 
sentence  Article 13(1) and (2) 
Annex I, section 3  -  
Annex II  - 
Annex III  - 
Annex IV  Annex 
 Article 1 Article 6(1)(e) 
 Articles 2 to 7 - EN 27   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 fina ncial 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 ope rational appropriations  
 3.2.3. Estimated impact on appropriati ons 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 28   EN LEGISLATIVE FINANCIAL STATEMENT  
1. FRAMEWORK  OF THE  PROPOSAL/INITIATIVE   
1.1. Title of the proposal/initiative  
Proposal for a Regulation of  the European Parliame nt and of the Council on 
consumer product safety 
1.2. Policy area(s) concerned in the ABM/ABB structure22  
Title 17 – Health and consumer protection – Chapter 17 02: Consumer policy 
1.3. Nature of the proposal/initiative  
 The proposal/initiative relates to  a new action   
 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   
 The proposal/initiative relates to an action redirected towards a new action   
1.4. Objectives 1.4.1. The Commission's multiannual strategi c 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 consolid ate and enhance product safety through 
effective market surveill ance throughout the Union 
                                                 
22 ABM: Activity-Based Management – ABB: Activity-Based Budgeting. 
23 As referred to in Article 49(6)(a) or (b) of the Financial Regulation. EN 29   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 ob ligation 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 (d angerous) consumer 
products. 
1.4.4. Indicators of results and impact  
Specify the indicators for monitoring implementation of the proposal/initiative. 
Ratio of traceable/non-traceab le consumer products covered by this Regulation 
notified under RAPEX. 
Number of mandates to European standa rdisation organisati ons and number of 
European standards referenced in th e 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 regul atory framework for safe products in the 
single market. This shall overcome the frag mentation of market surveillance rules 
and obligations of economic operators am ong 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 author ities and has seriously hamp ered 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 Direct ive as part of the Product Safety Market 
Surveillance Package as important initia tives 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 integrate 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 refe rs, in order to ensure a high level of 
protection of health and safety of all Eur opean consumers and establish an internal 
market for consumer goods.  
In accordance with the principles of proportio nality and subsidiarity, as set out in 
Article 5 of the Treaty on European Uni on, this proposal does not go beyond what is 
necessary to achieve those objectives. 
1.5.3. Lessons learned from sim ilar 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 30   EN The application of Directive 2001/95/EC in te rms of market survei llance measures to 
consumer products covered also by sector-s pecific legislation was not always clear 
which will be clarified. 
1.5.4. Coherence and possible synergy wi th other relevant instruments 
This proposal is part of th e Product Safety and Market Su rveillance Package and thus 
fully coherent with the proposal for a Regul ation of the European parliament and of 
the Council on market su rveillance of products. 
This proposal aligns definitions and econom ic 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 ar e coherent with the recently adopted 
Regulation (EU) No 1025/2012 on European standardisation. EN 31   EN 1.6. Duration and financial impact  
 Proposal/initiative of limited duration  
–  Proposal/initiative in effect fr om [DD/MM]YYYY to [DD/MM]YYYY  
–  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  
–  bodies set up by the Communities25  
–  national public-sector bodies/bodies with public-service mission  
–  persons entrusted with the implementation of specific actions pursuant to Title 
V of the Treaty on European Union and iden tified in the relevant basic act within 
the meaning of Article 49 of  the Financial Regulation  
 Shared management with the Member States  
 Decentralised management with third countries   
 Joint management with international organisations (to be specified) 
If more than one management mode is indicated, pl ease 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 Regulati on 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 manageme nt of the Consumers Programme 2014-2020, 
which, once adopted, should be the legal basi s for procurement and grants in the field 
of product safety. 
                                                 
24 Details of management modes and references to the Financial Regulation may be found on the 
BudgWeb site: http://www.cc.cec/budg/man/b udgmanag/budgmanag_en.html  
25 As referred to in Article 185 of the Financial Regulation. 
26 OJ L 11, 16.1.2003, p. 1. 
27 Commission Decision C(2008)4943 of 9 September 2008. EN 32   EN The envisaged programme delegation will be the extension of tasks already 
externalised to the Executive Agency  for Health and Consumers (EAHC). EN 33   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 Regulati on (EU) No 182/2011) and existing expert 
groups and/or the European Market Surveill ance Forum foreseen in the proposal for 
a single market surveillance regulation will provide a re gular platform to discuss 
issues related to the implem entation 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 re gulatory 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 th at its internal anti-
fraud related controls are fully aligned with the CASF and that its fraud risk 
management approach is geared to identif y fraud risk areas a nd adequate responses. 
Where necessary, networking groups and adeq uate IT tools dedicated to analysing 
fraud cases related to the Consumer Program me will be set up. In particular a series 
of measures will be put in place such as: 
- decisions, agreements and contracts re sulting from the implementation of the 
Consumer Programme will expressly enti tle the Commission, including OLAF, and 
the Court of Auditors to conduct aud its, on-the-spot check s and inspections; 
- during the evaluation phase of a call for proposals/tender, the proposers and 
tenderers are checked against the published exclusion criteria base d on declarations 
and the Early Warning System (EWS); 
- the rules governing the eligibility of cost s 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 c ontrollers who verify 
the beneficiaries' declarations on the spot. EN 34   EN 3. ESTIMATED  FINANCIAL  IMPACT  OF THE  PROPOSAL/INITIATIVE   
3.1. Heading(s) of the multiannual financ ial framework and expenditure budget 
line(s) affected  
• Existing expenditure budget lines  
In order  of multiannual financial framewor k headings and budget lines. 
Budget line  Type of  
expenditureContribution  
Heading of 
multiannual 
financial 
framework 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  
N° 3: 
Security and 
citizenship 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 
expenditureContribution  
Heading of 
multiannual 
financial 
framewor k 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  
N° 3: 
Security and 
citizenship 17 02 01 
Consumer Programme 2014 - 2020  Diff. YES YES  NO  NO 
                                                 
28 Diff. = Differentiated appropriations / Non- diff. = Non-Differentiated Appropriations 
29 EFTA: European Free Trade Association.  
30 Candidate countries and, where applicable, poten tial candidate countries from the Western Balkans.  
EN 35   EN 3.2. Estimated impact on expenditure  
3.2.1. Summary of estimated impact on expenditure31  
EUR million in current prices (to 3 decimal places)  
Heading of multiannual financial 
framework:  3 Security and citizenship 
 
DG: SANCO   2015 2016 2017 2018 2019 2020 TOTAL 
y Operational appropriations         
Commitments (1) 1,107 1,189 1,272 1,356 1,443 1,530 7,897 
Number of budget line 17.02.01  
Payments (2) 0,554 1,148 1,230 1,314 1,400 2,251 7,897 
Appropriations of an administrative nature financed 
 from the envelope for specific programmes32              
Commitments (1a) 0,094 0,094 0,094 0,094 0,094 0,094 0,564 
Number of budget line: 17.01.04.01  
Payments (2a) 0,094 0,094 0,094 0,094 0,094 0,094 0,564 
          
Commitments =1+1a 1,201 1,283 1,366 1,450 1,537 1,624 8,461 TOTAL appropriations 
for DG SANCO  Payments =2+2a 0,648 1,242 1,324 1,408 1,494 2,345 8,461 
 
y TOTAL operational appropriations  Commitments (3) 1,107 1,189 1,272 1,356 1,443 1,530 7,897 
                                                 
31 Amounts subject to the outcome of the le gislative process based on the Commission pr oposal for the new Multiannual Financial F ramework 2014-2020. 
32 Technical and/or administrative assistance and expenditure in support of the implementation of EU programmes and/or actions (f ormer "BA" lines), indirect research, 
direct research.  
EN 36   EN Payments (4) 0,554 1,148 1,230 1,314 1,400 2,251 7,897 
yTOTAL appropriations of an administrative nature financed 
from the envelope fo r specific programmes  (5) 0,094 0,094 0,094 0,094 0,094 0,094 0,564 
Commitments =3+ 5 1,201 1,283 1,366 1,450 1,537 1,624 8,461 TOTAL appropriations  
under HEADING 3 
of the multiannual financial framework  Payments =4+ 5 0,648 1,242 1,324 1,408 1,494 2,345 8,461 
  
EN 37   EN  
Heading of multiannual financial 
framework:  5 " Administrative expenditure "  
EUR million in current prices (to 3 decimal places) 
   2015 2016 2017 2018 2019 2020 TOTAL 
        
y Human resources  0,524 0,524 0,524 0,524 0,524 0,524 3,144 
y Other administrative expenditure (missions, meetings)  0,069 0,069 0,069 0,069 0,069 0,069 0,414 
TOTAL  Appropriations  0,593 0,593 0,593 0,593 0,593 0,593 3,558 
 
TOTAL appropriations 
under HEADING 5 
of the multiannual financial framework   (Total commitments 
= Total payments) 0,593 0,593 0,593 0,593 0,593 0,593 3,558 
EUR million in current prices (to 3 decimal places) 
   2015 2016 2017 2018 2019 2020 TOTAL 
Commitments  1,794 1,876 1,959 2,043 2,130 2,217 12,019  TOTAL appropriations  
under HEADINGS 1 to 5 
of the multiannual financial framework Payments  1,241 1,835 1,917 2,001 2,087 2,938 12,019   
EN 38   EN 3.2.2. Estimated impact on opera tional appropriations  
– The proposal/initiative requires the use of opera tional appropriations, as explained below: 
Commitment appropriations in EUR million in current prices (to 3 decimal places) 
  2015 2016 2017 2018 2019 2020 TOTAL 
 Indicate objectives 
and outputs  
 
Ø  
Type of 
output33 
Average 
cost  
of the 
output
Number 
of outputs 
Cost 
Number 
of outputs 
Cost 
Number 
of outputs 
Cost 
Number 
of outputs 
Cost 
Number 
of outputs 
Cost 
Number 
of outputs 
Cost 
Total 
number of 
outputs 
Total  
cost 
SPECIFIC OBJECTIVE: 
To consolidate and enhance product 
safety through effective market 
surveillance throughout the Union               
- Output                 
Product safety: 
scientific advice, 
international 
cooperation, 
monitoring and 
assessing of the 
safety of products, 
knowledge base  1,316 4 1,107 4 1,189 4 1,272 4 1,356 4 1,443 4 1,530 24 7,897 
Sub-total for specific objective: To 
consolidate and enhance product safety 
through effective mark et 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 The output consists in ensuring a high level of consumer product safety. It would be difficult to further break it down in qua ntitative 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 ma rket. The number of RAPEX notifications 
does not necessarily reflect the number of un safe products on the market. An increased number of RAPEX notifications can mean m ore effective market surveillance 
but less unsafe products and vice versa.  
EN 39   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 40   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 
Other administrative 
expenditure 0,069 0,069  0,069  0,069  0,069  0,069  0,414 
Subtotal HEADING 5 
of the multiannual financial 
framework  0,593 0,593  0,593  0,593  0,593  0,593  3,558 
 
Outside HEADING 534 
of the multiannual financial 
framework        
 
Human resources  0 0 0 0 0  0 
Other expenditure  
of an administrative nature 0,094 0,094  0,094 0,094 0,094 0,094 0,564 
Subtotal  
outside HEADING 5 
of the multiannual financial 
framework  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" li nes), indirect research, direct research.  
EN 41   EN 3.2.3.2.  Estimated requirements of human resources  
– The proposal/initiative requires the use of human resources, as explained below: 
EUR million in current prices (to 3 decimal places) 
 2015 2016 2017 2018 2019 2020 TOTAL 
17 01 01 01 (Headquarters and Commission’s 
Representation Offices)  0,524 0,524 0,524 0,524 0,524 0,524 3,144  
XX 01 01 02 (Delegations) 0 0 0 0 0   
XX 01 05 01 (Indirect research) 0 0 0 0 0   
10 01 05 01 (Direct research) 0 0 0 0 0   
XX 01 02 01 (CA, INT, SNE from the "global 
envelope")  0 0 0 0 0   
XX 01 02 02 (CA, INT, JED, LA and SNE in 
the delegations) 0 0 0 0 0   
- at Headquarters36 0 0 0 0 0   
XX 01 04 yy 35 
- in delegations  0 0 0 0 0   
XX 01 05 02 (CA, INT, SNE - Indirect 
research) 0 0 0 0 0   
10 01 05 02 (CA, INT, SNE - Direct research) 0 0 0 0 0   
Other budget lines (specify) 0 0 0 0 0   
TOTAL 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 budgeta ry 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 incr ease 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 partic ular standardisation mandates and 
assessment of standards and specifica tions to support the application 
of the Regulation.  
                                                 
35 Under the ceiling for external personnel from op erational appropriations (former "BA" lines). 
36 Essentially for Structural Funds , European Agricultural Fund for Rural Development (EAFRD) and 
European Fisheries Fund (EFF).  
EN 42   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 m onitoring calls for tenders and the 
implementation of contracts.   
EN 43   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. 
–  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  
–  Proposal/initiative requires application of  the flexibility inst rument 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.