COMMISSION STAFF WORKING DOCUMENT Accompanying the report from the Commission to the European Parliament, the Council and the European economic and social Committee on the implementation of Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 Organisation of market surveillance in the Member States
Date: 2013-02-13
Institutions: European Commission
Subjects: Community certification, EU Member State, administrative check, application of EU law, customs inspection, exchange of information, intergovernmental cooperation (EU), market supervision, marketing standard, product safety, quality control of industrial products, single market

EUROPEAN 
COMMISSION 

Brussels, 13.2.2013  
SWD(2013) 36 final 

PRODUCT SAFETY AND MARKET SURVEILLANCE PACKAGE 

COMMISSION STAFF WORKING DOCUMENT 
Accompanying  

the report from the Commission to the European Parliament, the Council and the 
European economic and social Committee 

on the implementation of Regulation (EC) No 765/2008 of the European Parliament and 
of the Council of 9 July 2008 setting out the requirements for for accreditation and 
market surveillance relating to the marketing of products and repealing  
Regulation (EEC) No 339/93 

Organisation of market surveillance in the Member States 

{COM(2013) 77 final} 
{SWD(2013) 35 final} 

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TABLE OF CONTENTS 

1. 

2. 

2.1. 

2.2. 

INTRODUCTION ....................................................................................................... 4 

RESPONSES ............................................................................................................... 4 

FRANCE ...................................................................................................................... 4 

UNITED KINGDOM .................................................................................................. 4 

2.2.1.  Market Surveillance ..................................................................................................... 4 

2.2.2.  Customs........................................................................................................................ 5 

2.3. 

CZECH REPUBLIC .................................................................................................... 6 

2.3.1.  Market Surveillance ..................................................................................................... 6 

2.3.2.  Customs........................................................................................................................ 7 

2.4. 

FINLAND .................................................................................................................... 8 

2.4.1.  Market surveillance...................................................................................................... 8 

2.4.2.  Customs........................................................................................................................ 8 

2.5. 

IRELAND .................................................................................................................... 8 

2.5.1.  Market surveillance...................................................................................................... 8 

2.5.2.  Customs...................................................................................................................... 11 

2.6. 

POLAND ................................................................................................................... 11 

2.6.1.  Market surveillance.................................................................................................... 11 

2.6.2.  Customs...................................................................................................................... 11 

2.7. 

THE NETHERLANDS.............................................................................................. 13 

2.7.1.  Market surveillance.................................................................................................... 13 

2.7.2.  Customs...................................................................................................................... 13 

2.8. 

SLOVENIA................................................................................................................ 14 

2.8.1.  Market surveillance.................................................................................................... 14 

2.8.2.  Customs...................................................................................................................... 14 

2.9. 

SWEDEN ................................................................................................................... 15 

2.9.1.  Market surveillance.................................................................................................... 15 

2.9.2.  Customs...................................................................................................................... 16 

2.10. 

SLOVAKIA ............................................................................................................... 16 

2.10.1.  Market surveillance.................................................................................................... 16 

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2.10.2.  Customs...................................................................................................................... 18 

2.11.  GERMANY ............................................................................................................... 19 

2.11.1.  Market surveillance.................................................................................................... 19 

2.11.2.  Customs...................................................................................................................... 21 

2.12.  BULGARIA ............................................................................................................... 21 

2.12.1.  Market surveillance.................................................................................................... 21 

2.13.  DENMARK ............................................................................................................... 22 

2.13.1.  Market surveillance.................................................................................................... 22 

2.13.2.  Customs...................................................................................................................... 22 

2.14. 

ITALY........................................................................................................................ 22 

2.14.1.  Market surveillance.................................................................................................... 22 

2.14.2.  Customs...................................................................................................................... 28 

2.15. 

LITHUANIA.............................................................................................................. 30 

2.15.1.  Market surveillance.................................................................................................... 30 

2.15.2.  Customs...................................................................................................................... 31 

2.16. 

LUXEMBOURG ....................................................................................................... 31 

2.16.1.  Market Surveillance ................................................................................................... 31 

2.16.2.  Customs...................................................................................................................... 32 

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COMMISSION STAFF WORKING DOCUMENT 
Accompanying  

the report from the Commission to the European Parliament, the Council and the 
European economic and social Committee 

on the implementation of Regulation (EC) No 765/2008 of the European Parliament and 
of the Council of 9 July 2008 setting out the requirements for for accreditation and 
market surveillance relating to the marketing of products and repealing  
Regulation (EEC) No 339/93 

Organisation of market surveillance in the Member States 

1. 

INTRODUCTION 

Regulation (EC) No 765/2008 establishes specific requirements for the organisation 
of  market  surveillance  by  Member  States.  Most  of  them  have  then  fine-tuned  their 
administrative structures and put in place specific solutions to ensure the fulfilment 
of those requirements.  

In view of the preparation of the accompanying report on the implementation of the 
Regulation  (EC)  No  765/2008,  the  Commission  requested  from  Member  States  a 
contribution regarding the implementation of the Regulation at national level.  

This  Commission  Staff  Working  Document  gives  an  overview  of  the  replies  of 
sixteen Member States. The other Member States did not reply. 

2. 

RESPONSES 

2.1. 

FRANCE 

France has not communicated any shortcomings in the market surveillance area. The 
coordination  between  market  surveillance  authorities  is  done  by  the  Directorate-
General for Competitiveness and Services (DGCIS), which also centralizes data from 
different  French  authorities  monitoring  the  market  to  develop  the  national  market 
surveillance.  It  also  organizes  several  annual  meetings  to  exchange  views  on  the 
implementation of Regulation (EC) 765/2008 by different authorities. 

2.2. 

UNITED KINGDOM 

2.2.1.  Market Surveillance 

Before  the  Regulation  (EC)  765/2008  came  into  force,  Market  Surveillance 
Authorities in UK have already existed and been indicated for each EU legislation. 
UK  Market  Surveillance  Co-ordination  Committee  was  established  which  includes 
all  UK  market  surveillance  authorities  (and  also  business  interaction).  The 
implementation of ICSMS in all market surveillance authorities is required. 

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The  Regulation  has  not  directly  led  to  any  adjustments  to  procedures  to  follow-up 
complaints, because the UK has had effective systems in place for many years. These 
systems are reviewed and amended on a regular basis to ensure that they are fit for 
purpose  e.g.  consumer  complaints  via  Consumer  Direct  are  now  made  through  the 
Citizens Advice Bureau which has stronger brand recognition amongst consumers.  

No adjustments have been made to the existing systems on procedures to follow-up 
complaints, to monitor accidents and harm to health. The UK also continues to feed 
into  the  EU’s  Injuries  Database.  UK  believes  that  a  system  for  the  collection  of 
comprehensive  accident  data  is  needed  and  should  be  based  on  the  existing  EU’s 
Injuries Database and that policy decisions to strengthen this (particularly the causal 
linkages between accidents and products) and over increased levels of participation 
needs to be taken at the Union level. 

No changes were considered necessary to strengthen market surveillance authorities' 
powers,  because  existing  UK  enforcement  powers  are  considered  to  be  broadly 
compatible to those required by the Regulation. 

No  major  adjustments  to  the  UK’s  market  surveillance  system  were  considered 
necessary  to  strengthen  market  surveillance  authorities'  financial  and  human 
resources  as  a  direct  result  of  Regulation  (EC)  No  765/2008.  Measures  to  avoid 
multiple  inspections  and  to  maintain  competencies  of  the  market  surveillance 
officials will deliver greater effectiveness and efficiency. Given the current economic 
climate, public authority budgets will remain a challenge. 

Penalties  for  economic  operators  have  remained  unchanged  because  UK 
implementing legislation already meets the relevant requirements of 765/2008. 

2.2.2.  Customs 

A  sub-group  of  the  Market  Surveillance  Co-ordination  Committee  has  been 
established  involving  representatives  from  the  customs  authorities  and  the  market 
surveillance  authorities.  This  has  established  a  protocol  for  the  exchange  of 
information and developed policy for how border controls will be carried out in the 
UK. 

The  UK  has  also  worked  collaboratively  with  NED  (co-operation  project  on  best 
practices  with  the  Netherlands  (VWA)  at  their  largest  ports  (Felixstowe  in  the  UK 
and Rotterdam in the Netherlands) to develop best practices. 

A  new  law  has  also  been  made  to  protect  customs  information  from  misuse  when 
disclosed for the purposes of 765/2008 (SI 2012/1848). The ongoing work is required 
to  ensure  that  the  border  controls  work  is  broadened  to  cover  more  points  of  entry 
beyond the major container ports. In addition, the identification of priorities and the 
management  of  risk  based  profiles  is  a  continuous  work  in  progress  to  ensure  that 
border  controls  are  properly  targeted  and  that  trade  facilitation  is  not  adversely 
affected.  The  main  challenges  that  remain  are  operational  rather  than  issues 
revolving around co-operation. 

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2.3. 

CZECH REPUBLIC 

2.3.1.  Market Surveillance 

The responsibility and identity of the CTI (Czech Trade Inspection) was set out by 
the Act No. 64/1996 Coll., on the Czech Trade Inspection,  as amended and further 
responsibilities  were  identified  by  the  Act  No.  634/1992  Coll.,  on  consumer 
protection,  as  amended,  Act  No.  22/1997  Coll.,  on  technical  requirements  of 
products,  as  amended,  Act  No.  102/2001  Coll.,  on  general  product  safety,  as 
amended and by related government regulations. Act No. 22/1997 Coll. and Act No. 
102/2001 Coll. was amended, namely in relation to the protective measures extension 
and  producers,  importers  and  distributors  obligations.  The  form  of  national 
communication and co-ordination responsibility setting needs to be introduced. 

The attribution of responsibilities and the identity of State Energy Inspection (SEI) 
authorities were achieved in Act on business Conditions and Public Administration 
in  the  Energy  Sector  No.  458/2000  Sb.  and  in  Act  on  Energy  Management  No. 
406/2000 Sb. in valid version at the time of entry into force of Regulation 765/2008. 
SEI was, on the basis of these two acts, authorized to perform market surveillance on 
Energy  using  Products  (EuP).  Since  2009  SEI  is  responsible  also  for  market 
surveillance  on  Energy  related  Products  (ErP),  in  the  field  of  implementation 
Directive  2010/30/EU  on  the  indication  by  labelling  and  standard  product 
information  of  the  consumption  of  energy  and  other  resources  by  energy-related 
products  and  Directive  2009/125/EC  establishing  a  framework  for  the  setting  of 
ecodesign requirements for energy-related products. 

The attribution of responsibilities and the identity of Czech Proof House for Arms 
and Ammunition authorities were achieved in Act on business Conditions and Public 
Administration  in  the  Energy  Sector  No.  458/2000  Sb.  and  in  Act  on  Energy 
Management  No.  406/2000  Sb.  in  valid  version  at  the  time  of  entry  into  force  of 
Regulation 765/2008. 

Communication and coordination between CTI authorities and between Czech Proof 
House  for  Arms  and  Ammunition  authorities  is  based  on  optional  mutual 
agreements  only.  The  communication  and  coordination  mechanisms  between  CMA 
(Czech Mining Authority) market surveillance authorities were modified by Act No. 
490/2009 Coll. 

Follow-up complaints procedure is set out sufficiently within the CTI. Accidents and 
harm  to  health  monitoring  procedure  has  not  been  set  out  in  Czech  Republic  yet. 
There  is  a  negotiation  between  MTI  (Ministry  of  Trade  and  Industry)  and  CTI  on 
harm and health accidents monitoring procedure, therefore an appropriate procedure 
on accidents and harm to health needs to be established. 

In  SEI  the  establishment  of  procedure  to  follow-up  complaints  was  solved  in 
accordance with provision of the Act on State Inspection No. 552/1991 Sb. and No. 
458/2000 Sb. The complaints are properly checked and if necessary the fines are put 
on  the  account  of  legal  persons  according  to  Administrative  Procedure  Code  No. 
500/2004  Sb.  SEI  is  not  authorized  to  inspect  and  monitor  accidents  and  harm  to 
health caused by products. Accidents and harm to health monitoring procedure is not 
set  out  yet  for  Czech  Proof  House  for  Arms  and  Ammunition.  The  obligation 

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regarding  the  procedure  to  monitor  accidents  and  harm  to  health  has  been  already 
established in CMA. 

In CTI the financial and human sources as a whole were reduced due to the budget 
cut, thus the reorganization ensured current capacities of human resources. Their goal 
is to acquire additional human and financial resources. 

Strengthening  SEI  market  surveillance  powers  is  currently  enlarged  on  the  base  of 
ongoing implementation of Directive 2009/125/EC and Directive 2010/30/EU on the 
different ErP according to issued Commission Regulations. 

Strengthening  market  surveillance  authorities'  financial  and  human  resources 
properly  depended  and  depends  on  SEI  budget.  The  ongoing  provisions  on  state 
budget savings invoke very strict behaviour for market surveillance activities. Market 
surveillance goals are ensured with existing human and financial resources. 

In CMA, strengthening market surveillance authorities' powers was adjusted by Act 
No.  490/009  Coll,  competency  ultra  vires  Act  No.  61/1988  Coll  and  Act  No. 
552/1991  Coll.  In  CMA  due  to  the  state  budget  cut  there  was  no  strengthening  of 
market surveillance authorities' financial and human resources. 

Effective  and  dissuasive  penalties  for  economic  operators  were  established 
sufficiently  for  the  CTI  by  relevant  national  legislation  Act  No.  22/1997  Coll.  was 
amended  in  relation  to  the  serious  and  non-serious  violation  sanctions.  SEI  is 
authorized to put and administrate the penalties during the process of ErP pursuant to 
listed  act.  In  CMA,  penalties  for  economic  operators  were  modified  by  Act  No. 
490/2009 Coll – partial extension in comparison with Act No. 61/1988 Coll. 

2.3.2.  Customs 

Cooperation between customs and CTI was set-out by the Act No. 64/1996 Coll. The 
CTI is represented in the Working Group on import controls in the area of product 
safety  and  compliance,  organised  by  the  Directorate-general  Taxation  and  Customs 
Union  (DG  TAXUD)  and  coordinates  the  horizontal  cooperation  on  the  national 
level  simultaneously.  A  number  of  agreements  between  Customs  and  CTI 
directorates have been signed.  

The  cooperation  between  SEI  and  customs  in  the  scope  of  ErP  has  not  been 
established yet. 

Cooperation  between  CMAs  and  customs  has  been  already  set  up  by  common 
cooperation (Act No. 500/2004 Coll). 

2.4. 

FINLAND 

2.4.1.  Market surveillance 

Communication  and  coordination  mechanisms  between  market  surveillance 
authorities in Finland were adapted by: 

• 

setting up a working group (NLF-national working group); 

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• 

• 

the act on the Information Exchange in Market Surveillance (1197/2009); 

modifications to the Market Surveillance Information Exchange Network. 

Finish  authorities  are  still  in  preparation  of  the  general  market  surveillance 
programme  and  in  the  future  they  will  set  up  an  official  body  to  carry  out 
coordination tasks. 

Strengthening of the market surveillance authorities' powers was adjusted by Section 
36 of the Consumer Safety Act (920/2011) regarding non-compliance related to CE 
marking. 

Penalties  for  economic  operators  were  modified  by  the  Act  on  CE  marking 
Infringement (187/2010) and by the Consumer safety Act (920/2011), Section 52. 

2.4.2.  Customs 

Discussions  and  information  exchange  are  still  ongoing  regarding  cooperation 
between market surveillance authorities and customs. 

2.5. 

IRELAND 

2.5.1.  Market surveillance 

In Ireland responsibilities for sectoral market surveillance had already been assigned 
to  various  market  surveillance  authorities  through  transposition  of  Directives  into 
national  law.  Since  the  Regulation  765/2008  came  into  force,  the  Irish  Medicines 
Board (IMB) was nominated as Competent Authority for cosmetics in October 2010. 
The  role  of  Market  Surveillance  Authority  for  cosmetics  was  transferred  from  the 
Department  of  Health  to  the  IMB  in  October  2010.  A  new  section  on  Recreational 
Craft is being added to the Marine Survey Office (MSO), section of the Department 
of Transport, Tourism and Sports’ (DTTAS) website and updated by the MSO. The 
IMB  is  seeking  clarification  on  need  to  implement  national  legislation  to  formalise 
its  nomination  as  the  market  Surveillance  Authority  for  cosmetics  and  medical 
devices. 

The system for communication with other market surveillance authorities is in place 
which continues to be developed and enhanced. The IMB has actively participated in 
the  EU  working  group  PEMSAC  (Platform  of  European  Market  Surveillance 
Authorities  for  cosmetics)  since  becoming  the  Competent  Authority  for  cosmetic 
products.  This  group  continues  to  include  improvements  on  increasing  cooperation 
between market surveillance authorities within its work programme. 

Training  for  GRAS-RAPEX  was  organised  for  Market  Surveillance  Authorities 
(MSAs)  by  the  National  Consumer  Agency  (NCA),  which  is  the  national  contact 
point  for  IT  system  GRAS-RAPEX1.Training  for  ICSMS  was  organised  for  MSAs 
by the Health & Safety Authority (HSA), the national contact point for ICSMS. 

1 

General  Rapid  Alert  System  used  for  the  Member  states  to  submit  RAPEX  notifications.  GRAS-
RAPEX replaced the old IT system RAPEX-REIS and extended the scope of RAPEX to professional 
products and to other risks than health and safety.  

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A Market Surveillance Forum (comprised of MSAs and Customs) meets quarterly to 
exchange  information  and  to  keep  abreast  of  developments.  It  is  chaired  by  the 
Department  of  Jobs,  Enterprise  and  Innovation.  More  specifically,  the  IMB  has 
established a National Cosmetics Surveillance Forum consisting of representatives of 
IMB  and  Health  Service  Executive  (HSE)  involved  in  the  operational  aspects  of 
cosmetic  product  market  surveillance.  The  IMB  also  participates  in  the  European 
PEMSAC  working  group  establishing  a  national  work  programme  on  a  two-yearly 
basis.  In  the  medical  devices  sector,  the  IMB  is  an  active  participant  at  the 
Compliance  and  Enforcement  Working  Group  (COEN)  and  currently  holds  the 
position of co-chair of the Group. 

Irish  authorities  still  need  to  ensure  that  all  projects  and  activities  agreed  through 
the 
SOGS-MSG  are  communicated 
Commission  for  each  sector.(e.g.  projects  undertaken  by  DG  TAXUD  to  be 
communicated  and  agreed  with  DG  SANCO  for  inclusion  into  specific  annual 
programme  of  work  for  PEMSAC  (cosmetics  market  surveillance  authorities)). 
Likewise,  at  the  COEN  Group,  similar  challenges  exist  to  ensure  that  relevant 
projects are communicated at a cross-sectoral level. 

the  relevant  directorates-general  of 

to 

Procedures for collection of national accident data in relation to persons at work were 
already  in  place.  Compliance  checks  undertaken  have  been  based  on  alerts, 
complaints,  inspections  and  accident  reports.  More  specifically,  the  Recreational 
Craft  Directive  ADCO  Group  use  agreed  ADM  forms  (RCDADM)  to  request 
information  or  action  from  other  market  surveillance  authorities.  Marine  Casualty 
Investigation  Board  (MCIB)  carries  out  investigations  into  marine  casualties  that 
take place in Irish waters or involve Irish registered vessels. Reports are produced on 
accidents investigated by the MCIB which include recommendations for appropriate 
action  to  be  taken  by  relevant  parties.  The  IMB  manages  the  medical  device 
vigilance system for Ireland managing all incidents that occur in Ireland, monitoring 
all  field  safety  actions  in  Ireland  and  taking  the  lead  role  in  a  European  vigilance 
cases as appropriate. This is all completed in line with Meddev 2.12-1 Guidelines on 
a medical device Vigilance System. The scope, management and guidance in the area 
of medical device vigilance is continuously being expanded and improved. 

A new section on Recreational Craft will be added to the MSO section of the DTTAS 
website and updated by the MSO – this will include information on recent relevant 
RAPEX  alerts  and  follow-up. Marine  Notices  are issued where considered relevant 
on  the  DTTAS  website.  Marine  Notices  are  information  notices  that  are  issued  to 
publicise  important  safety,  regulatory  and  other  relevant  information  relating  to 
maritime  affairs  in  Ireland.  They  are  circulated  to  a  wide  range  of  individuals  and 
organisations, ranging from State agencies and the fishing industry, to international 
shipping and water-based recreational interests. The IMB has established a cosmeto-
vigilance system for reporting by healthcare professionals and consumers. With the 
implementation of Regulation 1223/2009 in July 2013, which introduces mandatory 
vigilance  reporting  requirements  for  cosmetics,  a  more  formal  process  will  be 
adopted. IMB is currently monitoring undesirable effects associated with the use of 
cosmetic products. 

There has been still lack of existing infrastructure and resources to monitor consumer 
accidents and harm to health. The medical devices legislation is currently undergoing 
a substantial revision in Europe. It is anticipated that vigilance data will be collated 

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and  trend  analysis  conducted  to  detect  safety  signals  sooner.  Current  cosmetics 
legislation  does  not  provide  for  mandatory  reporting  requirements  (Cosmetics 
Directive 76/768/EEC). However with the implementation of Regulation 1223/2009 
mandatory reporting requirements are introduced. 

While Regulation 765/2008 clarifies the powers for market surveillance authorities, 
many  enforcement  powers  were  already  in  place  under  extant  legislation.  With  the 
implementation of Regulation 1223/2009 the Competent Authority will have powers 
to recall and withdraw products posing a risk to consumers. In the interim solution, 
the  market  surveillance  authority  only  has  powers  to  recall  products  in  case  of  a 
serious risk.  

Irish  authorities  would  like  to  have  in  the  future  the  ability  to  request  those,  who 
place  substances,  mixtures  or  articles,  to  undertake  a  product  recall.  The  medical 
devices  legislation  is  currently  undergoing  revision  and  it  is  anticipated  that 
proposals  will  place  greater  responsibility  on  the  economic  operators  within  the 
supply chain.  

Since  2001  there  has  been  a  consistent  increasing  trend  of  market  surveillance 
reports  being  received,  and  is  increasing  year  by  year.  With  the  implementation  of 
the new cosmetics legislation in July 2013 (Regulation 1223/2009) there will be an 
increase  in  the  scope  for  Competent  Authorities  in  terms  of  monitoring  vigilance 
activities including increased communication and reporting requirements. 

Both  human  and  financial  resources  were  assigned  to  the  extent  possible  given 
restrictions  and  cut-backs  in  public  sector  numbers.  Where  staff  numbers  had 
increased to deal with the work load, the volume of reports currently being received 
continues  to  make  this  a  challenge  to  achieve.  A  risk  based  approach  is  currently 
adopted by the IMB medical devices section to deal with this challenge. 

In  many  cases,  an  increase  in  financial  and  human  resources  is  not  planned  due  to 
financial  constraints. However, financial  resources  are  being assigned to cover cost 
of product testing in respect of chemical related issues. 

Increased  economic  pressures  have  an  impact  on  the  funding  available  for  market 
surveillance activities within Ireland. Irish authorities will continue to secure funding 
for  purchase,  transport  and  testing,  especially  of  complex  articles.  The  IMB  is 
currently  investigating  the  funding  structure  for  medical  devices  both  at  a  national 
and  European  level.  Optimising  funding  and  resourcing  of  market  surveillance 
authorities  for  medical  devices  remains  a  key  challenge.  A  robust  funding  model 
based  on  periodic  fees  for  surveillance  activity  may  be  the  best  means  to  secure 
funding  and  allow  appropriate  development  of  robust  medical  device  market 
surveillance at each national level. 

In  most  cases,  penalties  already  existed  under  extant  legislation.  In  cosmetics 
legislation, with the implementation of Regulation 1223/2009, national implementing 
provisions will be applied to address penalties for economic operators. The medical 
devices legislation is currently undergoing substantial revision in Europe. This may 
have an impact on penalties. 

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2.5.2.  Customs 

Customs  and  many  market  surveillance  authorities  have  signed  Data  Exchange 
Agreements  and/or  Memoranda  of  Understanding  (MOU).  A  Market  Surveillance 
Forum (comprised of MSAs and Customs) meets quarterly to exchange information 
and  to  keep  abreast  of  developments.  It  is  chaired  by  the  Department  of  Jobs, 
Enterprise and Innovation.  

The  process  on  signing  of  MOUs  and/or  Data  Exchange  Agreements  between 
Customs and remaining MSAs is on-going. Training and development of procedures 
and the use of check lists is also in progress. 

In  the  future  Irish  authorities  would  like  to  concentrate  on  co-operation  with  other 
market  surveillance  authorities  where  products  originate  in  another  EU  Member 
State. Resource challenges are in terms of inspection including at ports. 

2.6. 

POLAND 

2.6.1.  Market surveillance 

In Poland all minor adjustments were implemented by the Act of 15 April 2011 on 
amendments  of  the  conformity  assessment  system  act  and  some  other  acts  (OJL  of 
2011 No. 102, item 586). 

2.6.2.  Customs 

Under articles 27-29 of Regulation 765/2008, customs authorities have the powers to 
stop  import  of  dangerous/non-compliant  goods  and  consult  relevant  competent 
authorities if import of such goods is in breach of the legislation on general product 
safety or conformity of goods. Accordingly, in Poland: 

• 

• 

• 

• 

customs  authorities  contact  national  competent  authorities  in  various  sectoral 
fields  when  they  find  out  that  there  is  a  reason  to  believe  that  goods  that  are 
placed  under  customs  procedure  of  release  for  free  circulation  do  not  fulfill 
requirements of the relevant legislation; 

national market surveillance authorities are obliged to advise customs whether 
goods  mee  tthe  relevant  requirements  if  their  release  for  free  circulation  has 
been  suspended  and  they  should  provide  their  opinion  within  three  working 
days; 

lack  of  such  an  opinion  means  that  the  goods  may  be  released  for  free 
circulation on condition that they fulfill other relevant import requirements; 

in  the  case  of  non-compliance,  indicated  by  market  surveillance  authorities, 
customs authorities, if possible, seek voluntary compliance from an economic 
operator when a product is found  not to comply with the relevant legislation. 
However,  once  a  market  surveillance  authority  (MSA)  indicates  that  it  is  not 
possible to apply corrective measures, customs authorities ban release for free 
circulation of such products; 

EN 

11 

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• 

• 

customs  authorities  are  obliged  by  national  law  to  inform  the  Office  of 
Competition  and  Consumer  Protection,  the  authority  monitoring  the  market 
surveillance  system,  on  actions  undertaken  with  regard  to  products  which  do 
not  meet  requirements,  i.e.  customs  authorities  inform  on  the  customs 
procedure  that  was  assigned  to  the  products,  which  most  often  involve  re-
export  or  customs  warehouse  procedure  (if  there  is  a  possibility  to  apply 
corrective measures with regard to the product, e.g. labeling, attaching the CE 
marking); 

the Polish customs authorities take a risk based approach in the area of market 
surveillance  checks.  Customs  officials  have  unique  access 
the 
documentation  relating  to  imports  from  third  countries,  consequently,  the 
information contained in customs declarations and the supporting documents is 
profiled in order to target products that are likely to present a risk to users. Risk 
analysis involves a combination of central and local intelligence. Risk analysis 
is assisted by electronic customs systems and RAPEX. 

to 

Customs authorities co-operate with MSAs, particularly in the cases of: 

• 

• 

• 

specific actions, such as joint actions with other Member States and/or market 
surveillance authorities (e.g. the PROSAFE projects on lighters or toys), or 

a  need  to  implement  uniform  and/or  stricter  measures  for  a  given  period  of 
time, or 

an implementation of a new checklist. 

In  all  of  the  regional  customs  offices  (16  Customs  Chambers),  there  have  been 
designated  so  called  ”co-ordinators  for  product  safety  issues”.  These  are  customs 
officials  who  are  responsible  for  providing  assistance  to  customs  officers  who 
perform customs controls, maintaining contacts with the central authority (Ministry 
of Finance), carrying out or assisting in risk analysis, helping to harmonize customs 
actions, and training customs officers. A systematic increase in the number of actions 
undertaken by customs authorities has been noticed and high efficiency of customs 
actions, which is confirmed by a significant number of negative opinions issued by 
MSAs.  

2.7. 

THE NETHERLANDS 

2.7.1.  Market surveillance 

Dutch  authorities  created  a  national  coordination  platform  where  all  market 
surveillance authorities (MSAs) in the field of EU non-food legislation and Customs 
participate  (Alliance  group  market  surveillance  and  border  controls  EU  legislation 
non-foods). Amongst others the task of this group is to discuss and adopt the Dutch 
position  in  the  SOGS-MSG  group  and  in  general  to  improve  the  information  flow, 
share strategies, tactics and knowledge (for instance on e-commerce, risk assessment 
and  relations  with  Asia)  and  concrete  cooperation  between  the  MSA’s  and  with 
customs. 

In certain domains (e.g. the equipment for professional use) the current procedure to 
follow up complaints was improved by appointing sections/units where a complaint 

EN 

12 

   EN 

 
can  be  filed  and  investigated  by  the  inspectorate.  For  professional  products  the 
current  procedure  to  monitor  accidents  will  be  further  developed  in  order  to 
investigate them more systematically.  

Priorities  were  re-organized  and  resources  in  some  domains  have  or  are  being 
strengthened. In the future it will be important to find more financial resources (e.g. 
by introducing fees for certain inspections and controls). 

Penalties  for  economic  operators  have  been  already  established  prior  to  Regulation 
765/2008, but in future perspectives penalties should be increased which will have a 
more deterrent effect. There is also a need for more uniformity of penalties. 

2.7.2.  Customs 

Several  MSAs  have  established  written  agreements  with  customs  to  strengthen 
cooperation  in  the  field  of  border  controls.  These  agreements,  including  roles  and 
responsibilities,  differ  depending  on  the  domain  in  question.  Other  MSAs  are 
working on improving co-operation with customs. 

The  future  challenge  is  to  enlarge  the  number  of  concrete  market  surveillance  and 
border controls projects in which a large number  of  MSAs  and  customs  authorities 
participate.  There  is  a  need  for  improving  information  sharing  between  market 
surveillance  and  customs  authorities  as  well  as  for  intensifying  cooperation  with 
MSAs of third countries. Another challenging task for the future is also functioning 
of the ICSMS system. 

2.8. 

SLOVENIA 

2.8.1.  Market surveillance 

In March 2011 Slovenia adopted new “Act regulating the technical requirements for 
products  and  the  conformity  assessment”  for  designation  of  the  competent  market 
surveillance authorities.  

The  communication  and  coordination  mechanisms  between  market  surveillance 
authorities were intensified and strengthened through existing channels. Ministry of 
the  economic  development  and  technology,  as  responsible  ministry  for  the 
implementation  of  the  Regulation  765/2008,  chairs  a  “765  Coordinative  working 
group”  composed  of  all  market  inspectorates  and  customs  authorities.  The  work  of 
this group was adjusted to the requirements of the Article 18 of Regulation 765/2008.  

There  were  no  changes  in  the  existing  Slovenian  system  concerning  complaints. 
Slovenia  is  a  member  of  Injury  Data  Base  (IDB)  since  2006,  which  includes  the 
injury  registries  in  hospitals.  There  is  no  other  systematic  monitoring  of  accidents 
and harm caused by products. 

Powers of Slovenian market surveillance authorities were strengthened through more 
precise  legal  base  for  market  surveillance  measures.  In  March  2011  Slovenian 
Parliament adopted new “Act regulating the technical requirements for products and 
the  conformity  assessment”.  Act  for  the  purpose  of  implementing  Regulation 
765/2008  designates  the  competent  market  surveillance  authorities  and  penal 
provisions.  

EN 

13 

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The  entry  into  force  of  the  Regulation  765/2008  requires  strengthening  of  market 
surveillance  authorities'  financial  and  human  resources.  Due  to  crisis  in  Slovenia 
MSAs are not able to earmark more financial and human resources for more effective 
implementation.  They  oriented  all  powers  for  optimisation  of  the  work  in  the 
competent market surveillance authority. 

Establishment  of  effective  and  dissuasive  penalties  for  economic  operators  were 
necessary. This was done through the new “Act regulating the technical requirements 
for products and the conformity assessment”, where chapter IV (Penalties provisions) 
precisely defines the level of fine for the offences.  

2.8.2.  Customs 

Slovenia  reports  effective  cooperation  between  Slovenian  Market  Surveillance 
Inspectorate  and  Slovenian  Customs  Office.  This  cooperation  is  based  on  the 
bilateral  agreement  between  the  Slovenian  Market  Surveillance  Inspectorate  and 
Slovenian Customs Office (signed in 2003). Since Regulation 765/2008 entered into 
force, special agreements for cooperation between market surveillance and customs 
authorities are not necessary. Horizontal exchange of information is done through the 
“765  Coordinative  working  group”  chaired  by  the  Ministry  of  the  economic 
development and technology. Sector specific issues are discussed on a bilateral level 
between  customs  authority  and  different  inspectorates.  The  future  challenge  is  to 
strengthen  the  cooperation  between  customs  authority  and  other  inspectorate  while 
following the good practice in the case of cooperation between Customs Office and 
Market Inspectorate 

2.9. 

SWEDEN 

2.9.1.  Market surveillance 

Responsibilities and identity of authorities were adapted to Regulation 765/2008 by 
Law  and  Regulation  on  Accreditation  and  CE-marking  (SFS  2011:791  and  SFS 
2011:811).  Market  surveillance  provisions  adjusting  Swedish  law  to  Regulation 
765/2008 have been adopted in some sectors by: 

• 

Law  and  Regulation  on  explosive  products  (SFS  2010:1011)  and  (SFS 
2010:1075). 

• 

Law and Regulation on safety of toys (SFS 2011:579) and (SFS 2011:703). 

to 

Sweden  is  in  a  phase  of  adjusting  national  regulations  concerning  market 
surveillance 
the  Regulation  765/2008.  Most  Swedish  rules  concerning 
responsibilities for market surveillance are found in national regulations transposing 
harmonisation  directives  (or  complementing  EU-regulations).  Some  aspects  of 
market  surveillance  are  covered  by  a  horizontal  regulation  (SFS  2005:893), 
concerning  e.g.  cooperation  and  reporting  obligations,  which  is  currently  being 
updated. 

The  future  task  of  Swedish  MSA  is  to  update  all  Swedish  regulations  to  avoid 
duplications  or  even  conflicts  between  national  rules  and  Regulation  765/2008.  In 
many cases legislation will be updated to nine directives in the Alignment package. 

EN 

14 

   EN 

 
Sweden has had a coordination body for market surveillance since 2005, designated 
as the Market Surveillance Council. Its duties and responsibilities are regulated (e.g. 
to establish a national action plan for market surveillance and a yearly report to the 
government).  The  council  meets  four  to  five  times  a  year  and  represents  fifteen 
MSAs and the Customs. Brand and consumer organisations are invited on a regular 
basis and working groups have been established for different issues, e.g. guidelines 
for publication of information on dangerous products, guidelines on how to plan and 
form  the  sector  specific  action  plans.  In  addition,  an  external  website  and  an 
exchange  and  information  system  were  set  up  in  2010  (www.marknadskontroll.se). 
The Swedish Agency for Accreditation and Conformity Assessment (Swedac) holds 
the secretariat and chairmanship of the Council. 

The  procedure  to  follow-up  complaints,  monitor  accidents  and  harm  to  health  was 
adapted  by  Law  and  Regulation  on  explosive  products  (SFS  2010:1011)  and  (SFS 
2010:1075),  Law  and  Regulation  on  safety  of  toys  (SFS  2011:579)  and  (SFS 
2011:703).  There  is  a  room  for  improvements  by  using  more  statistics  in  order  to 
monitor accidents and a more systematic approach might be also needed. 

Powers of market surveillance authorities are complemented with national legislation 
which is being updated. Financial resources for market surveillance are handled as a 
part of the ordinary Swedish budgetary process for public authorities. 

Penalties for economic operators were adapted to Regulation 765/2008 by: 

• 

• 

• 

Law  and  Regulation  on  explosive  products  (SFS  2010:1011)  and  (SFS 
2010:1075);  

Law  and  Regulation  on  explosive  products  (SFS  2010:1011)  and  (SFS 
2010:1075). 

Law and Regulation on safety of toys (SFS 2011:579) and (SFS 2011:703). 

The legal support for the duties of MSA (e.g. penalties/sanctions) varies from sector 
to sector. All MSAs should have the same possibilities which will be taken care of 
when updating national legislation.  

2.9.2.  Customs 

In 2008 a national cooperation model/flowchart was set up between the Customs and 
all  MSAs.  The  aim  was  to  clarify  the  distribution  of  responsibilities  between 
Customs and MSAs. Routines for contact were made between MSAs and Customs. 
The  model  was  updated  to  adapt  to  Regulation  765/2008.  The  model  is  a  “living” 
document  and  will  be  updated  as  a  result  of  the  new  DG  TAXUD  guidelines.  In 
addition, a working group was established within the Market Surveillance Council in 
2011 for all customs related issues. 

EN 

15 

   EN 

 
2.10. 

SLOVAKIA 

2.10.1.  Market surveillance 

Responsibilities and identity of authorities in Slovakia are governed by the horizontal 
law2 that refers to the specific regulations governing the procedures for the respective 
NMSA  (supervisory  authorities).  Responsibilities  of  STI3  result  from  the  Act 
No.128/2002  Coll.  on  State  control  of  the  internal  market  in  consumer  protection 
matters,  and  amending  certain  laws  as  amended.  Responsibilities  of  SMA4  result 
from the Act No. 51/1988 Coll. on mining activity, as amended. Responsibilities of 
PHA5  result  from  the  Act  No.  355/2007  Coll.  on  the  protection,  promotion  and 
development  of  public  health  and  amending  certain  laws,  as  amended,  and 
Government Regulation No. 658/2005 Coll. laying down requirements for cosmetic 
products,  as  amended.  Responsibilities  of  SIDC6  result  from  the  Act  No.  362/2011 
Coll.  on  drugs  and  medical  devices,  as  amended.  Responsibilities  of  SMI7  result 
from  the  Act  No.  142/2000  Coll.  on  metrology,  as  amended.  Responsibilities  of 
RTRA8  result  from  the  Act  No.  513/2009  Coll.  on  railways,  as  amended. 
Responsibilities  of  TO  SR9  concerning  products  covered  by  the  R&TTE  and  EMC 
Directive  result  from  the  Act  No.  351/2011  Coll.  on  Electronic  Communications 
(especially article 38, article 36 paragraph 1, article 39 paragraph 2 and article 73), 
by which the previous Act No. 610/2003 Coll. was canceled and Act No. 264/1999 
Coll. (article 30 and related articles) on Technical Requirements for Products and on 
Conformity Assessment, as amended. Responsibilities of LI10 concerning determined 
products11 result from the Act No. 125/2006 Coll. on Labour Inspection, as amended 
(amendment  of  the  law  with  effect  from  1.7.2012  in  the  context  of  Regulation 
765/2008) and Act No. 264/1999 Coll. (article 30 and related articles) on Technical 
Requirements for Products and on Conformity Assessment, as amended. There is a 
new text of horizontal law on technical requirements for products and on conformity 
assessment which should replace the Act. No. 264/1999 Coll.12 

Communication  and  coordination  mechanisms  between  market  surveillance 
authorities  were  created  from  January  2009  through  inter-departmental  Working 
group (WG), coordinated by SOSMT13, as the leader of the implementation of NLF 
in  Slovakia.  WG  consists  of  representatives  of  the  Slovak  market  surveillance 
authorities,  relevant  ministries  and  the  Custom  Department  of  the  Financial 
Directorate SR. PHI Cooperation Agreement is signed between the PHI SVFA and 

2 

3 
4 
5 
6 
7 
8 
9 
10 
11 
12 

13 

Act  No.  264/1999  Coll.  on  technical  requirements  for  products  and  on  conformity  assessment  as 
amended 
STI - Slovak Trade Inspection 
SMA - State Mining Authority 
PHA - Public Health Authority of SR 
SIDC - State Institute for Drugs Control 
SMI - Slovak Metrology Inspection 
RTRA - Railways Transport Regulation Authority 
TO SR - Telecommunication Office SR 
LI - Labour Inspectorates 
Determined products are such products that represent higher risk of jeopardy to justified concern 
Act  No.  264/1999  Coll.  on  technical  requirements  for  products  and  on  conformity  assessment  as 
amended 
SOSMT - Slovak Office of Standards, Metrology and Testing 

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16 

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STI in the field of control of food and cosmetic products. PHA made amendment to 
the Act 355/2007 Coll.14

There  were  no  major  adjustments  made  concerning  procedure  to  follow-up 
complaints.  Among  other  provisions  of  sectoral  regulations  or  the  horizontal  act, 
there  is  an  Act  No.  9/2010  on  complaints  which  refers  to  follow-up  process  of 
complaints  in  general.  This  Act  regulates  the  procedure  for  applying,  accepting, 
recording, investigation and written notification of the result of the investigation of a 
complaint  or  its  checkup.  No  major  adjustments  were  performed  to  procedure  to 
monitor accidents and harm to health. In LI complaints are regulated by the Act No. 
125/2006  Coll.  on  Labour  Inspection,  as  amended  and  Act.  No.  124/2006  Coll.  on 
Occupational Safety and Health. In STI info system ECHO was introduced in 2008. 

The procedure to follow-up complaints, to monitor accidents and harm to health of 
RTRA is set out in article 19 of the Act No. 513/2009 Coll. on Railways: the operator 
of  the  determined  technical  equipment15  (DTE)  is  obliged  to  report  to  RTRA 
(Security  Authority)  the  emergence  of  incident  in  operation.  In  PHI  -  under 
"enforcement  of  preventive  measures  in  the  field  of  cosmetic  products  with  a 
particular focus on consumer education" the procedure for electronic notification of 
serious  adverse  effects  of  cosmetic  products  on  public  health  will  be  developed  by 
the end of 2013. 

No  major  adjustments  were  made  regarding  strengthening  of  market  surveillance 
authorities'  powers  apart  from  Safety  of  toys  Directive  (2009/48/EC).  STI  issued  a 
new  Act  No.  78/2012  Coll.  on  Safety  of  toys  and  on  amending  of  the  Act  No. 
128/2002  Coll.  on  State  control  of  the  internal  market  in  consumer  protection 
matters. PHA amended the Act. No. 355/2007 Coll.16
 (Addition of competence in the 
field  of  state  health  supervision  in  the  field  of  cosmetic  products:  impose  an 
obligation  for  natural  or  legal  person  to  take  corrective  action  if  product  does  not 
comply  with  the  specific  regulation,  including  withdrawal  or  recall,  impose 
withdrawal of the product from the consumer, if product presents a serious risk.).  

No  major  adjustments  were  executed  to  strengthen  market  surveillance  authorities' 
financial  and  human  resources.  It  is  necessary  to  strengthen  market  surveillance 
authorities' financial and human resources. LI believes that it is necessary to provide 
funds to verify the safe condition of the determined product17, or clearly define who 
is required to pay for the costs related to physical and laboratory tests (under § 7 of 
the Act No. 125/2006 Coll. on Labour Inspection, as amended). According to RTRA 
strengthening  of  market  surveillance  authorities'  financial  and  human  resources  is 
required only in case of an extension beyond the activities carried out so far. 

No  major  adjustments  were  done  on  penalties  for  economic  operators.  Act  No. 
264/1999  Coll.  (article  32)  on  Technical  Requirements  for  Products  and  on 
Conformity Assessment, as amended. In RTTA penalties are regulated according to 

14 

15 

16 

17 

Act. 355/2007 Coll. on protection, promotion and development of public health and amending certain 
laws under preparation 
Determined  technical  equipment  is  such  equipment  that  represent  higher  risk  of  jeopardy  to  justified 
concern (Act. No. 264/1999 Coll.) 
Act  No.  355/2007  Coll.  on  protection,  promotion  and  development  of  public  health  and  amending 
certain laws under preparation 
Determined product is such product that represent higher risk of jeopardy to justified concern (Act No. 
264/1999 Coll.)  

EN 

17 

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articles  103  and  109  of  the  Act  No.  513/2009  Coll.  on  Railways,  as  amended.  In 
PHA  penalties  are  regulated  in  amended  Act  No.  355/2007  Coll.  (Change  of 
penalties for natural or legal person depending on the deficiencies found in the field 
of cosmetic products.). 

2.10.2.  Customs 

Customs Administration SR and NMSA cooperate on a base of bilateral agreements 
following  the  Articles  27-29  of  the  Regulation  765/2008.  Until  now  cooperation 
agreements have been concluded between the Customs Directorate of SR and:  

• 

• 

• 

• 

Central Inspectorate of the Slovak Trade Inspection, 

State Institute for Drugs Control, 

Department of State Control of Veterinary Biological Products and Drugs, 

State Veterinary and Food Administration of SR. 

In STI cooperation Agreements were concluded with the Public Health Authority SR 
(control  of  health  safety  of  toys,  childcare  products  and  products  containing  the 
detected  volume  of  chemicals)  and  the  State  Veterinary  and  Food  Administration 
(control of general food sales requirements). 

Other  cooperation  is  organised  on  the  basis  of  oral  agreements  and  it  is  applied  to 
case-by-case issues. 

According  to  Regulation  765/2008  (articles  27–29),  STI  extended  "Exchange  of 
information and cooperation within Working group", coordinated by SOSMT18. 

Negotiations for the conclusion of other cooperation agreements have already started. 
PHA made an amendment to the Act 355/2007 Coll.19

There is also an addition of competencies - cooperation of public health authorities 
with the Customs in the area of inspection of products imported from third countries. 

The  cooperation  between  different  NMSA  and  the  cooperation  with  customs  still 
need to be improved. There are two ongoing projects: the preparation of the opening 
of the ICSMS system in Slovakia and training of NMSA in 2013. 

2.11.  GERMANY 

2.11.1.  Market surveillance 

The measures described below refer in the first line only to market surveillance 
in the area of the German Product Safety Act and specified market surveillance 
activities  do  not  apply  to  all  sectors.  This  legal  act  transposes  the  General 
Product  Safety  Directive  and  the  following  twelve  New  Approach  Directives 
into German national law: 

18 
19 

SOSMT - Slovak Office of Standards, Metrology and Testing 
Act  No.  355/2007  Coll.  on  protection,  promotion  and  development  of  public  health  and  amending 
certain laws 

EN 

18 

   EN 

 
  
                                                 
• 

• 

• 

• 

• 

• 

• 

• 

• 

General Product Safety (2001/95/EC), 

Aerosol dispensers (75/324/EEC), 

Simple pressure vessels (2009/105/EC), 

Personal protective equipment (89/686/EEC), 

Appliances burning gaseous fuels (90/396/EEC), 

Equipment  and  protective  systems  intended  for  use  in  potentially 
explosive atmospheres (94/9/EC), 

Recreational craft (94/25/EC), 

Lifts (95/16/EC), 

Pressure equipment (97/23/EC), 

•  Machinery (2006/42/EC), 

• 

• 

• 

• 

Low voltage (2006/95/EC), 

Toys (2009/48/EC), 

Noise  emission  in  the  environment  by  equipment  for  use  outdoors 
(2000/14/EC). 

in 

The  entry  into  force  of  the  Regulation  765/2008  did  not  require 
changes/adjustments 
structure  of  market 
the  administrative 
surveillance in the area of the German Product Safety Act. However, as 
one  result  of  the  MATTEL  case  (toys  recall  in  2007)  the  Federal 
Government  together  with  the  German  Länder  (German  Federal  States) 
established  a  programme  for  the  enhancement  of  market  surveillance 
(Common  Strategy  of  the  Federal  and  State  Governments  to  strengthen 
market surveillance in the area of the Equipment and Product Safety Act 
- 
http://www.baua.de/de/Produktsicherheit/Marktueberwachung/pdf/Eckpu
nkte.pdf?__blob=publicationFile&v=1).  One  important  step  in  this 
programme  is  the  attribution  of  certain enforcement responsibilities  and 
coordination tasks to the Zentralstelle der Länder für Sicherheitstechnik –
ZLS (Central Authority of the German Federal States for Safety). 

In  special  cases  (e.g.  two  or  more  local  market  surveillance  authorities  involved  – 
diverging  risk  assessment  and  therefore  diverging  measures)  the  enforcement 
competence will pass to the ZLS. The ZLS could also take over a case by order of 
the majority of the German Länder. Changes/adjustments were partially necessary in 
the  area  of  Energy  Efficiency.  The  pressure  to  streamline  responsibilities  results  in 
the area of energy labelling, however, rather from the increasing number of covered 
products and the increasing workload. 

EN 

19 

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As regards communication and coordination, special tasks were assigned to the ZLS. 
Changes/adjustments  were  partially  necessary  in  the  area  of  Energy  Efficiency.  In 
this  field  a  committee  on  market  surveillance  for  the  coordination  between  the 
national level and the level of the Federal States was established in June 2012. The 
committee  covers  market  surveillance  in  the  areas  of  energy  labelling  (Directive 
2010/30/E) and ecodesign (Directive 2009/125/EC). 

No  special  measures  were  created  to  the  procedure  to  follow-up  complaints  in  the 
area of the German Product Safety Act. In the area of Energy Efficiency there was a 
need  to  establish  a  procedure  on  how  to  react  on  notices  on  non-compliance  with 
energy labelling rules. It was not necessary to establish a new procedure in terms of 
administrative  law  since  existing  administrative  law  covers  also  administrative 
decision in terms of market surveillance activities. 

No  special  measures  were  created  for  the  procedure  to  follow-up  complaints,  to 
monitor accidents and harm to health in the area of the German Product Safety Act 
and also not in the area of Energy Efficiency, because energy labelling has no effects 
on product safety and human health. 

Since  the  revision  of  the  Product  Safety  Act  (entry  into  force  in  December  2011), 
there  are  provisions  for  higher  fines.  Besides  this  authorities  have  to  charge 
economic operators for their testing and enforcement activities when they find non-
compliant  products.  In  the  area  of  Energy  Efficiency,  new  competences  of  market 
surveillance  authorities  were  introduced,  when  adapting  national  energy  labelling 
law to the Regulation 765/2008. 

Due to the important role of market surveillance in the area of the German Product 
Safety Act for both, businesses and consumers, there is no further staff reduction in 
this area. In the area of Energy Efficiency it can only be remarked that financial and 
human resources of market surveillance authorities are within the competence of the 
Länder, not within the competence at the national level. 

In  the  area  of  Energy  Efficiency,  resulting  from  the  additional  competences  on 
market  surveillance,  there  are  additional  possibilities  for  penalties.  Administrative 
offences  and  administrative  fines  are,  however,  no  new  instruments  in  the  area  of 
energy labelling. 

2.11.2.  Customs 

The  ZLS  will  become  in  2013  the  “contact  point”  for  the  German  customs. 
Nevertheless the cooperation according to articles 27 to 29 of Regulation 765/2008 
will still exist at a local level. 

The guidelines for cooperation between customs and market surveillance authorities 
are  currently  being  revised  and  updated  in  the  area  of  the  German  Product  Safety 
Act. 

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20 

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2.12.  BULGARIA 

2.12.1.  Market surveillance 

Communication  and  coordination  mechanisms  between  market  surveillance 
authorities  were  adjusted  by  Amendments  of  a  Decree  No.  180  of  the  Council  of 
Ministers  from  1  August  2005  for  the  establishment  of  a  Council  for  coordination 
and exchange of information between market surveillance authorities. The main aims 
of  the  amendments  are  to  clarify  the  functions,  tasks  and  the  composition  of  the 
Council  and  to  move  the  secretariat  of  the  Council  into  the  Ministry  of  Economy, 
Energy and Tourism. 

The procedure to follow-up complaints is being updated. There is a need to develop а 
procedure/national system to follow-up complaints, to monitor accidents and harm to 
health caused by products. 

2.13.  DENMARK 

2.13.1.  Market surveillance 

There  are  no  major  adjustments  in  responsibilities  and  identity  of  authorities, 
strengthening of market surveillance authorities' powers and strengthening of market 
surveillance authorities' financial and human resources. 

Regarding  communication  and  coordination  mechanisms  between  market 
surveillance authorities, a market surveillance committee has been set up to facilitate 
coordination.  Several 
initiatives  on  coordination  are  ongoing:  exchange  of 
experiences  on  enforcement,  including  alternative  enforcement  mechanisms  and 
formal exchange of officials between authorities. A main challenge will be to avoid a 
‘one size fits all’ approach but to encompass all authorities in activities in the market 
surveillance committee. 

Denmark improved procedure to follow-up complaints, monitor accidents and harm 
to  health  following  implementation  of  Regulation  765/2008.  A  couple  of  Danish 
Authorities  already  has  completed  a  procedure  to  follow-up  complaints,  several 
authorities  have  already  set  up  procedures  to  monitor  accidents  and  are  in  the 
progress  of  setting  up  procedures  to  monitor  harm  to  health.  But  there  are  still  a 
couple of authorities which have not fully implemented a procedure for monitoring 
accident, while others do not deem it relevant. 

Penalties for economic operators were partly adjusted to Regulation 765/2008 and as 
an ongoing process - one authority is currently changing its penalties. 

2.13.2.  Customs 

Some  authorities  are  still  in  process  of  drafting  formal  cooperation  agreements 
between market surveillance authorities and customs. Formal cooperation agreement 
with tax authorities are being drafted for other authorities. 

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2.14. 

ITALY 

2.14.1.  Market surveillance 

Following authorities in Italy contributed to the reply:  

•  Ministry  of  Health,  Department  of  Public  Health  and 

Innovation,  

Directorate General for Prevention, REACH Office; 

•  Ministry of Infrastructure and Transport, Port General Command; 

• 

• 

Department for Transport, Navigation and Information Systems and Statistics, 
Directorate General for Rail Transport; 

Directorate General for Maritime and Inland Waterways; 

•  Ministry  of  Economy  and  Finance,  Independent  Administration  of  State 

Monopolies (AAMS); 

• 

Customs agency, Central Directorate for Verifications and Controls, Office for 
methodology and control of trade in the field of customs and taxation; 

•  Ministry  of  Interior,  Department  of  Public  Safety,  Office  of  the  General 
Administration, Affairs Office of the Social and Administrative Policy; 

• 

Fire  Department  of  Public  Assistance  and  Civil  Defense,  Central  Directorate 
for Prevention and Technical Safety, Area II - Standardization notification and 
control; 

•  Ministry  of  Economic  Development,  Department  of  Communications  and  the 
Regional  Inspectorates,  Directorate  General  for  Planning  and  spectrum 
management; 

• 

• 

Department  for  Enterprise  Internationalization,  Directorate  General  for 
industrial policy and competitiveness; 

Directorate  General  for  the  Market,  Competition,  Consumer,  Supervisory 
Board  and  the  Technical  Regulations,  Security  and  Compliance  of  Products 
Division; 

• 

National Union Chamber of Commerce. 

1)  Responsibility  and  identity  of  authorities:  Articles  20  and  50  of  the  National 
Decree  of  31  March  1998  -  attributed  to  the  Chambers  of  Commerce,  Industry, 
Crafts  and  Agriculture  the  functions  performed  by  the  Metric  Offices  and  the 
provincial  offices  for  industry,  trade  and  craft  (UPICA).  This  Decree  transferred  to 
the Chamber  skills inspections competences, the  control of conformity of  products, 
measurement  tools  and  skills  to  any  sanctions.  The  aim  was  to  enhance  the  role  of 
the chamber as well as to point out the reference for the business system subject to 
market  regulation,  consumer  protection  and  public  confidence.  The  national 
legislation of 15 February 2010 re-defined the institutional and organizational skills 
of the Chamber of Commerce and the chamber system as a whole by strengthening 

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the function of supervision and control. The competent chamber offices comply with 
the rules of the industry for:  

• 

• 

• 

• 

• 

• 

• 

• 

• 

• 

• 

• 

• 

Legal metrology; 

Electrical low voltage;  

Products subject to electromagnetic compatibility;  

Toys; 

Personal protective equipment of the first category (eg, sunglasses, ski goggles, 
etc.);  

Labeling of footwear;  

Labeling of textile products; and in the following aspects: 

Safety aspects of products (pursuant to legislative decree of 6 September 2005, 
No. 206, Part IV, Title I - articles 102 to 113);  

Fuel  consumption  and  emissions  of  carbon  dioxide  (CO2)  of  the  various 
models of new cars;  

Domestic  consumption  of  products  related  to  the  use  of  energy.  Control 
activities  include  the  operation  of  inspections  and  sanctions  according  to  the 
competency of the following:  

Control of visual products: these are undertaken by all operators in the industry 
and are designed to verify compliance with formal regulations. 

Controls  type  of  document  on  technical  dossiers  relating  to  food  or  metric 
tools:  these  checks  are  intended  to  ensure  compliance  of  the  products  with 
respect  to  the  technical  requirements  laid  down  by  the  legislation  which  is 
binding and voluntary. 

Laboratory  tests:  these  controls  are  designed  to  ensure  the  physical  and 
chemical characteristics of the products complying with the operation of testing 
laboratories.  

The  investigative  powers  of  the  Chambers  of  Commerce  are  governed  not  only  by 
the national transposition of EU directives, but also by national legislation No. 689 of 
1981.  

Ministry  of  Health:  the  authorities'  control  is  subject  to  the  enforcement  forum  of 
ECHA ( The European Chemical Agency Helsinki).  

Ministry of Health, Directorate General for Prevention: responsibility and identity 
of  authorities  is  in  accordance  with  Legislative  Decree  No.  54/2011,  Article  29, 
paragraph 5. 

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23 

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Supervisory Authority, General Command of the body of the Harbor - 6th Ward is 
responsible  for  Council  Directive  96/98/EC  by  performing  a  reacting  monitoring 
(complaints,  specific  incidents  on  board,  inspections'  national  units  which  issue 
certification  of  ship  safety).  They  check  product  certification  on-board,  perform 
operational testing on-board and laboratory tests on the product. They also establish 
the  plan  for  the  activities,  cooperate  with  competent  authorities  and  have  available 
resources for proactive surveillance. 

The  Ministry  of  Economic  Development,  Department  for  Enterprise  and 
Internationalization,  Directorate  General  for  Market,  Competition,  Consumer, 
Supervision  and  Technical  Regulations,  Security  and  Compliance  Division:  article 
14 of Legislative Decree 58 of 4 April 2010 implementing Directive 2007/23/EC on 
the placing on the market of pyrotechnic products provides supervision to ensure that 
these items are safe, properly stored and used for purposes which they are intended 
for.  

Ministry  of  infrastructure  and  transport,  Department  for  transport  navigation, 
information  systems  and  statistics,  Directorate-General  for  maritime  transport  and 
inland  waterways:  the  Directive  94/25/EC  was  amended  by  Directive  2003/44/EC, 
which is implemented by the Legislative Decree No. 171 of 18 July 2005. Article 11, 
Paragraph  1  of  the  Legislative  Decree  No.  171  provides  that  the  supervisory 
activities  on  recreational  craft  are  carried  out  in  coordination  with  the  Ministry  of 
Economic Development and the Ministry of Infrastructure and Transport and within 
their respective competences. In the legislative context described above, it should be 
noted that, with regard to the responsibility of the Department of Infrastructure and 
Transport, DG Maritime transport and inland waterways, the market surveillance of 
recreational  craft  is  one  of  the  duties  of  the  Division  5.  The  performance  of  office 
tasks consists of the verification of conformity of recreational craft and components 
to  the  requirements  of  the  aforementioned  Decree,  through  specific  checks  and 
targeted  checks  on  the  market,  even  with  sampling  basis  (Article  11,  paragraph  3) 
and  of  the  control  of  the  technical  documentation  referred  to  in  Annex  IX  of  the 
Decree,  that  the  manufacturer  or  his  authorized  representative,  established  in  the 
territory, are required to keep for ten years (Article 11, paragraph 5). This Office is 
working  with  the  relevant  sectoral  group  created  in  the  RCD  ADCO  for  the 
preparation of a document "Risk Assessment". 

Circulation tobacco, Directorate for Excise: Following the correspondence with the 
Ministry  of  Economic  Development,  this  directorate was identified as the authority 
responsible  for  the  supervision  on  fire  protection  requirements  of  the  cigarettes 
referred to the Commission Decision No. 264 of 25 March 2008. 

2)  Communication  and  coordination  mechanisms  between  market  surveillance 
authorities:  In  order  to  support  the  supervisory  activities  of  the  Chambers  of 
Commerce  for  the  Inspection  Campaign  National  Memorandum  of  Understanding 
MED/Unioncamere 2009, the Information System VIMER was created. VIMER is a 
database that allows to record all data of Chambers of Commerce and to report on the 
inspections  carried  out  on  the  field.  The  data  collection  and  consultation  by 
Chambers and MED allows monitoring in real time the control activities which are 
carried  out  by  the  authorities  in  order  to  better  coordinate  the  activities  throughout 
the  country  in  accordance  with  national  surveillance  programs  and  to  avoid 
duplication  in  controls.  The  system  also  provides  reporting  for  any  notifications  in 

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the RAPEX system. In the VIMER system information is collected and managed on 
the control activities carried out by the Chambers of Commerce relating to: Safety of 
products (toys, electrical products, personal protective equipment), labeling products 
(shoes, textiles) and MID surveillance tools.  

Ministry  of  Health:  communication  and  coordination  mechanisms  between  market 
surveillance authorities are proceeded through websites and via e-mail. 

National  Administration  Ministry  of  Health,  Directorate  General  for  Prevention 
created  a  network  of  territorial  and  central  units  of  NAS  (Police  Unit  for  the 
Protection  of  health  and  safety  of  products)  with  the  Ministry  of  Health.  The 
Communication is provided by electronic mail and paper mail PEC. 

Circulation  tobacco,  Directorate  for  Excise:  Participation  in  the  seminars  for  the 
management of RAPEX and ICSMS platforms. 

3)  Procedure  to  follow-up  complaints,  to  monitor  accidents  and  harm  to  health: 
Chambers  of  Commerce  -  Information  System  VIMER  collects,  among  others, 
information  regarding  non-conforming  products  and  when  data  are  available,  it 
collects also information on incidents, risk categories and measures taken as a result 
of the inspection.  

Ministry  of  Health:  Procedure  to  follow-up  complaints,  to  monitor  accidents  and 
harm to health exists in Legislative Decree of 9 April 2008 No. 81 on Law safety at 
workplace. 

National  Administration  Ministry  of  Health,  Directorate  General  for  Prevention 
established a network between the Emergency Hospital, the Authorities of territorial 
control, the headquarters of Police Unit for the Protection of Health and the Ministry 
of Health. 

Responsible  national  administration  for  Directive  1999/5/EC  (Radio  and 
Telecommunications  Terminal  Equipment)  enhance  communication  with  other 
supervisory  authorities  (Department  of  Business  and  Internationalization  MISE) 
through  representation  in  the  National  Advisory  Committee  which  meets  twice  per 
month. Territorial Inspectorates are involved for products that are potentially harmful 
to health and results are submitted to Competent Authority to input data in RAPEX 
system. 

4) Strengthen market surveillance authorities' powers:  

Ministry of Health: not necessary. 

National  Administration  Ministry  of  Health,  Directorate  General  for  Prevention: 
An  agreement  signed  with  the  Region  Piemonte:  monitoring  and  evaluation  of  the 
toxicity of cosmetic products and those used in tattoo parlors, the amount allocated 
40,000  EUR.  An  agreement  signed  with  the  Institute  ISS:  Identification  of  volatile 
organic  compounds  produced  by  the  combustion  of  incense  on  a  scientific  basis  to 
promote evaluation and limitations of use, the amount allocated 55,141,34 EUR. An 
agreement  signed  with  the  National  Institute  of  Health:  Support  Action  for 
interventions  of  Rapid  Alert  System  (RAPEX)  and  Remediation  of  Soils  and 
groundwater which are contaminated, the amount allocated 250,000 EUR. 

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25 

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5)  Strengthen  market  surveillance  authorities'  financial  and  human  resources:  in 
order  to  strengthen  the  supervisory  activities  of  the  market  surveillance  authorities 
and  to  adapt  to  Regulation  765/2008,  the  Ministry  of  Economic  Development  and 
Union Chamber signed in June 2009 a Memorandum of Understanding that provides 
the  allocation  of  resources  for  strengthening  of  monitoring  on  the  field  by  the 
Chambers of Commerce. The initial term of this protocol has been extended until 31 
December  2012.  The  signature  of  the  new  Memorandum  of  Understanding  for  the 
rest of the activities is an ongoing project. The Protocol provides means to create a 
network  of  services,  integrated  and  in  connection  with  the  MED  and  a  tool  that 
contributes  to  the  creation  of  a  harmonized  surveillance  system  in  the  European 
single  market  for  the  benefit  of  the  health  and  safety  of  consumers  and  the  public 
interests. This plan involved eighty three chambers of commerce across Italy. Under 
the Protocol there are also following activities carried out:  

• 

• 

• 

• 

Technology  Platform  for  the  national  information  system  that  manages 
controls:  an  information  system  has  been  set  up  to  collect  information  on 
security  controls  and  labeling.  The  information  system  is  used  to  track  and 
manage the control plan at national and local level and to avoid duplication of 
controls in this area.  

Operating  procedures  for  the  conduct  of  audits:  operating  procedures  and 
related forms are defined for each supervision and monitoring arrangement in 
order  to  define  a  common  reference  framework  for  the  conduct  of  audits  and 
facilitate the role of officials in the chamber and ensure uniformity of behavior 
in the country.  

Training  of  personnel  involved  in  the  activities  of  the  Chamber  of  Control: 
general education and studies on supervisory activities. The training provided 
useful  insights  for  the  Chamber  personnel  to  carry  out  the  checks  in  various 
areas.  

Communication  plan  dedicated  to  consumers  and  businesses:  the  project 
specific support for managing information programs directed to the consumer 
and  information/training  directed  to  economic  operators  who  are  potential 
recipients of control activities. 

Ministry of Health: There are currently 220 inspectors on the field for REACH and 
CLP. The central surveillance will have about 40 inspectors. 

The  Ministry  of  Economic  Development,  Department  for  Enterprise  and 
Internationalization,  Directorate  General  for  Market,  Competition,  Consumer, 
Supervision  and  Technical  Regulations,  Security  and  Compliance  Division:  There 
are currently 220 inspectors available in the domain of the REACH Regulation and 
CLP  Regulation  (classification,  labeling,  packaging).  In  the  current  situation  of 
economic difficulty, it is necessary to implement the resources which have not been 
adequately sufficient, in order to prepare and ensure that the audit work is efficient 
and effective. 

Circulation  tobacco,  Directorate  for  Excise:  They  have  implemented  tools  and 
professional  resources  of  the  laboratory  of  analysis  for  the  implementation  of 

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controls,  according  to  ISO  standards,  of  the  fire-prevention  requirements  of 
cigarettes. 

The  Ministry  of  Economic  Development,  Department  for  Enterprise  and 
Internationalization,  Directorate-General  for  Market,  Competition,  Consumer, 
Supervision  and  Technical  Regulations,  Security  and  Compliance  Division:  In  this 
situation  of  economic  difficulty,  it  is  necessary  to  implement  the  resources  which 
have  not  been  adequately  sufficient,  in  order  to  prepare  and  ensure  that  the  audit 
work is efficient and effective. 

6)  Penalties  for  economic  operators:  each  Chamber  of  Commerce  established  an 
Office  for  Penalties  for  the  adoption  of  sanctions  as  a  result  of  the  administrative 
offenses.  These  offices  shall  examine  the  fines  ticket  provided  by  control  bodies 
(Municipal Police, State Police, Finance etc.) for the violation of standards in various 
sectors, including security and products' compliances.  

Ministry  of  Health:  Penalties  for  economic  operator  are  regulated  by:  Legislative 
Decree  No.  133/2009  laying  down  "Sanctioning  discipline  for  violation  of  the 
provisions  of  Regulation  1907/2006,  which  establishes  principles  and  requirements 
for registration, evaluation, authorisation and restriction of chemical substances"; by 
Legislative  Decree  186/2011  laying  down  "Discipline  penalties  for  violation  of  the 
provisions of Regulation 1272/2008 on the classification, labeling and packaging of 
substances  and  mixtures,  amending  and  repealing  Directives  67/548/EEC  and 
1999/45/EC, and amending Regulation 1907/2006 "; by Legislative Decree 200/2011 
laying  down  "Discipline  penalties  for  violation  of  the  provisions  of  Regulation 
689/2008  on  the  export  and  import  of  dangerous  chemicals"  and  by  Legislative 
Decree 266/2006 laying down "Discipline penalties for violation of the provisions of 
Regulation 648/2004 on detergents". 

National  Administration  Ministry  of  Health,  Directorate  General  for  Prevention: 
Penalties  for  economic  operator  are  regulated  by:  Legislative  Decree  No.  14  of  13 
September  2009  (article  16)  in  relation  to  violations  of  Article  67  of  REACH 
Regulation  1907/2006  as  amended  by  the  Regulation  552/2009;  by  Legislative 
Decree No. 54 of 11 April 2011 implementing Directive 2009/48/EC on the safety of 
toys (article 31) and by Consumer Code of 6 September 2005 (article 206).  

The  Ministry  of  Economic  Development,  Department  for  Enterprise  and 
Internationalization,  Directorate  General  for  Market,  Competition,  Consumer, 
Supervision  and  Technical  Regulations,  Security  and  Compliance  Division:  The 
rules on penalties are regulated by article 17 of national legislation No. 58/2010.  

2.14.2.  Customs 

Ministry of Health created a monitoring network with all customs ports and airports 
by signing the Memorandum of Understanding between the Customs Agency and the 
Ministry of Health on 23 March 2007. 

Control  activities  are  in  accordance  with  articles  27,  28  and  29  of  Regulation 
765/2008 and the Code of Consumption: 

• 

Joint  projects  carried  out:  "Safe  Christmas"  2007,  "STOP,  Only  Safe  Toys 
Please" 2008-2009,  Conventions "For a safer market" 2010-2013, "Safe Toy" 

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2011-2102  on  the  strengthening  of  the  audit  -  when  imported  -  of  the 
compliance  of  toys  and  electrical  products  suspected  not  to  satisfy  the 
requirements  laid  down  in  Union  legislation  on  "Updating  the  procedural 
manual  for  customs  inspections  in  the  field  of  product  safety"  -  December 
2009.  

Joint participation on the preparation of "Guidelines for import controls in the 
area of product safety and compliance",  

Joint training activities on Directive 2009/48/EC (Toys Safety Directive) and in 
cooperation  with  Assogiocattoli  and,  in  security  and  counterfeiting,  with 
National Federation of Electrotechnical and Electronics (ANIE).  

Exchange  of  information  for  monitoring  of  market  control  activities  in  the 
product safety area.  

Participation in events organized by national associations. Periodic meetings of 
coordination on emerging issues. 

Convention "Secure Toy 2012" on the strengthening of the audit - import - the 
compliance  of  toys  and  electrical  products  suspected  of  not  satisfying  the 
requirements laid down in Union legislation. 

Joint  actions  for  the  strengthening  of  the  surveillance  of  imports  of  products 
that may be harmful to the health and safety of consumers.  

Joint training activities and seminars.  

Revision  of  the  procedural  manual  for  customs  inspections  in  the  field  of  the 
product safety. 

• 

• 

• 

• 

• 

• 

• 

• 

The  Ministry  of  Economic  Development,  Department  for  Enterprise  and 
Internationalization,  Directorate  General  for  Market,  Competition,  Consumer, 
Supervision  and  Technical  Regulations,  Security  and  Compliance  of  Products 
Division carried out a procedural work for the realization of the provisions in Tables 
A and B of the Prime Minister's Decree No. 242/2010, implementing article 4 of Law 
350/2003 on the establishment of a single customs. 

National  administration  responsible  for  Directive  1999/5/EC  on  Radio  and 
Telecommunication  Equipment  was  engaged  in  a  direct  exchange  with  some 
customs  offices  to  receive  news  on  non-conforming  products  and  requiring  the 
destination  of  the  product  in  order  to  proceed  with  further  checks  involving  the 
competent Territorial Inspectorates. 

Ministry  of  Economic  Development  Department  for 
the  Enterprise  and 
Internationalization  signed  the  Convention  MISE  with  Customs  Agency  ISS-IMQ 
for  Toy  Fair  2012  and  in  September  2012  they  signed  the  Convention  MISE  with 
Customs Agency ISS-IMQ for Toy Fair 2013-2014. 

Chambers  of  Commerce  cooperates  through  specific  agreements  with  other 
supervisory authorities (Customs Agency, the Financial Supervision), committed in 
the area of the same interests. 

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2.15.  LITHUANIA 

2.15.1.  Market surveillance 

1) Responsibilities and identity of authorities: There were no major adjustments in all 
identity  of 
Lithuanian  market  surveillance  authorities.  Responsibilities  and 
authorities are set out in the following legal acts:  

• 

• 

• 

• 

• 

• 

Law on the State Labour Inspectorate (Official Gazette, 2008, No. 137-5385). 

Law on the Weaponry Fund of the Republic of Lithuania under the Ministry of 
Interior  of  the  Republic  of  Lithuania  (Official  Gazette,  1996,  No.  71-1717; 
2005, No. 67-2396, 2010 and No. 13-612). 

Regulation on the State Non Food Products Inspectorate under the Ministry of 
Economy (Official Gazette, 2000, No. 53-1558, 2006 and No.14-485). 

Regulation  of  the  Communications  Regulatory  Authority  (Official  Gazette, 
2004, No.131-4734). 

Regulation of the State Health Care Accreditation Agency under the Ministry 
of Health (Official Gazette, 2011, No. 112-5279). 

Regulation  of  the  Lithuanian  Metrology  Inspectorate  (Official  Gazette,  2011; 
No.  69-3308).  Regulation  of  the  Lithuanian  Maritime  Safety  Administration 
(Official Gazette, 2010, 77-3982). 

2)  Communication  and  coordination  mechanisms  between  market  surveillance 
authorities:  In  2002  the  State  Labour  Inspectorate  and  the  State  Non  Food 
Inspectorate  signed  a  cooperation  agreement.  In  2003  the  Communications 
Regulatory Authority and State Non Food Products Inspectorate signed a cooperation 
agreement. 

3)  Procedure  to  follow-up  complaints,  monitor  accidents  and  harm  to  health: 
Lithuanian  market  surveillance  authorities  have  internal  data  bases.  The  State  Non 
Food  Inspectorate  and  the  State  Labour  Inspectorate  use  the  RAPEX  system  for 
registration  and  announcement  of  dangerous  consumer  goods.  The  Lithuanian 
Maritime Safety Administration participates in the GRAS-RAPEX system.  

4) Strengthen market surveillance authorities' powers: The powers, which are granted 
to Lithuanian market surveillance authorities, are sufficient to fulfill their functions 
and tasks described in the legal acts mentioned in point 1. The provisions regarding 
strengthening  of  institution‘s  powers  will  be  foreseen  in  the  Draft  of  Law  on  State 
Labour Inspectorate. 

5)  Strengthen  market  surveillance  authorities'  financial  and  human  resources:  The 
seminar on CE marking was held on 15 December 2011. The training on the use of 
ICSMS  took  place  on  18-20  September  2012.  The  annual  budget  of  the  State  Non 
Food  Inspectorate  in  2010  was  8.515.000  LTL  and  118  people  were  employed.  In 
2012  number  of  personnel  was  reduced  to  100  and  the  budget  was  reduced  to 
5.228.000 LTL. 

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The  annual  budget  of  the  Lithuanian  Metrology  Inspectorate  was  reduced  from 
3.713.000 LTL in 2008 to 2.236.000 LTL in 2012 (number of personnel was reduced 
from  58  to  43).  The  reform  of  institutions  supervising  economic  entities  has  been 
implemented  in  Lithuania  since  2009.  The  main  purpose  of  the  reform  is  the 
effectiveness of supervisory institutions. 

6)  Penalties  for  economic  operators:  The  penalty  exemption  is  foreseen  in  the 
Administrative Code (Art. 30(2) of Official Gazette, 1992, No. 21-610, 2010 and No. 
142-7257).  

2.15.2.  Customs 

The  Agreement  on  Cooperation  between  the  State  Non  Food  Products  Inspectorate 
and  the  Customs  was  signed  in  2002.  The  Agreement  on  Cooperation  between  the 
Communications  Regulatory  Authority  and  the  Customs  was  signed  in  2003.  The 
Agreement on Exchange of Data between the State Non Food Products Inspectorate 
and the Customs was signed in 2004. 

The  Lithuanian  Metrology  Inspectorate  provides  the  Customs  with  the  relevant 
information. 

The  Agreement  on  Cooperation  between 
Administration and the Customs is under the consideration. 

the  Lithuanian  Maritime  Safety 

The Agreement on Cooperation between the State Health Care Accreditation Agency 
under the Ministry of Health and Customs is under the consideration. 

2.16.  LUXEMBOURG 

2.16.1.  Market Surveillance 

The  authorities  in  Luxembourg  are  clearly  identified  and  their  responsibilities  are 
defined. However a new law on the restructuring of ILNAS20 foresees some changes 
in  the  responsibilities  and  identity  of  these  authorities.  The  State  Council  has 
expressed its advice and the Ministry of Economy and Foreign trade is now waiting 
that the Parliament will start to work on the document. 

The law of 20 May 2008 on the creation of ILNAS puts in place a communication 
and  coordination  structure.  A  national  committee  was  created  under 
the 
responsibility of ILNAS. 

The new law on the restructuring of ILNAS clearly covers the procedure to follow-
up, to monitor accidents and harm to health. 

The  ILNAS  law  of  20  May  2008  covers  the  obligation  on  strengthening  of  market 
surveillance authorities' powers. The new legislation on the restructuring of ILNAS 
is also strengthening the authorities’ power. 

At  the  moment  a  new  legislation  is  on  the  way  regarding  strengthening  of  market 
surveillance  authorities'  financial  and  human  resources.  It  will  reinforce  ILNAS’ 

20 

Institut 
de 
qualité des produits et services. 

luxembourgeois 

la 

normalisation, 

de 

l'accréditation, 

de 

la 

sécurité 

et  

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human  resources.  Personnel  and  financial  reinforcement  of  the  market  surveillance 
department is an ongoing challenge. 

The  ILNAS  law  of  20  May  2008  covers  the  penalties  for  economic  operators.  The 
new legislation on the restructuring of ILNAS will strengthen this obligation, after its 
adoption. 

2.16.2.  Customs 

A cooperation  agreement, signed between market surveillance authorities, has been 
in place since 1998. To be in line with the Regulation 765/2008, the agreement was 
amended in 2011. 

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