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 accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93
Date: 2017-12-19
Institutions: Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs, European Commission
Subjects: EC conformity marking, EFTA countries, EU Member State, Türkiye, harmonisation of standards, international cooperation, market supervision, product safety, quality control of industrial products, single market

EN 

  EN 

   EUROPEAN COMMISSION  Brussels, 19.12.2017  COM(2017) 789 final  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 accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93  
 
 
1. 

SUMMARY 

Product safety is our common concern. When we buy a product, we want to be sure 
that  it  is  safe  and  fulfils  all  legal  requirements.  Therefore,  manufacturers  often  ask 
independent  bodies,  the  so-called  ‘conformity  assessment  bodies,  to  verify  if  their 
products  meet  certain  standards  before  they  are  sold.  This  is  why  we  need  reliable 
and  competent  conformity  assessment  bodies  that  do  their  work  correctly.  This  is 
also  the  reason  why  the  EU  has  put  in  place  a  system  of  accreditation  of  these 
conformity  assessment  bodies.  National  accreditation  bodies  check  the  competence 
and  impartiality  and  independency  of  the  conformity  assessment  bodies  in  their 
country. 

This report gives an overview of how the accreditation provisions of Regulation (EC) 
No  765/2008  (‘the  Regulation’)  and  CE  marking  were  implemented  between  2013 
and 2017. The report on the implementation of rules on market surveillance and the 
control  of  products  entering  the  EU  market  is  included  in  the  evaluation 
accompanying the enforcement proposal, which is also part of the "Goods Package".  

This  report  confirms  that  the  European  accreditation  infrastructure  created  by  the 
Regulation  has  provided  added  value,  not  only  for  the  single  market  but  also  for 
international trade.  Accreditation  has  wide support  from  European  industry and  the 
conformity  assessment  community  for  ensuring  that  products  meet  the  applicable 
requirements,  removing  barriers  for  conformity  assessment  bodies  and  helping 
entrepreneurial  activities  to  flourish  in  Europe.  The  Regulation  established  a 
trustworthy and  stable  accreditation system  in  all  Member  States,  as  well  as  EFTA 
countries and Turkey. However, it faces the challenge of maintaining its solidity; i.e. 
keeping  the  whole  accreditation  system  in  line  with  the  latest  state  of  the  art  and 
ensuring  that  it  is  applied  with  the  same  stringency.  This  report  also  confirms  that 
businesses are also better aware of the important role of CE marking on products in 
the single market. 

This  report  was  prepared  in  cooperation  with  the  Member  States  through  the 
accreditation sub-group of the ‘Internal market for products’ experts group. 

2. 

ACCREDITATION 

2.1.  

Policy considerations 

The single market for industrial products is one of Europe’s real success stories and 
its  best  asset  in  times  of  increasing  globalisation.  It  is  an  engine  for  building  a 
stronger  and  fairer  EU  economy.  For  over  80 %  of  industrial  products,  regulatory 
obstacles  have  been  removed  through  the  adoption  of  common  European  rules, 
creating  a  seamless  market  of  over  500  million  consumers.  This  has  boosted 
competitiveness  and  innovation  while  at  the  same  time  Europe’s  consumers  are 
offered  an  ever  wider  choice  of  safe  products  that  comply  with  high  standards  for 
public interests such as safety, environment and health. 

In  order to address the priority set by the Juncker Commission  relating to  a deeper 
and  fairer  internal  market1,  and  as  proposed  in  the  Commission’s  Single  Market 
Strategy2,  it  is  important  to  strengthen  product  compliance  with  the  applicable 

1  
2  

https://ec.europa.eu/commission/priorities_en  
COM(2015) 550 final, Upgrading the Single Market: more opportunities for people and business. 

1 

 
 
                                                            
legislative requirements.  Deepening the single market also means strengthening the 
conformity assessment system. 

Conformity  assessment  bodies  (laboratories,  certification  bodies,  inspection  bodies, 
environmental  verification  bodies  etc.)  are  involved  in  assessing  the  conformity  of 
products against the relevant legislative requirements, where the sectoral legislation 
calls for third party assessment, such as in the case of machinery, pressure vessels, 
medical devices, lifts, measuring instruments. Conformity assessment bodies are also 
used  voluntarily  by  businesses  to  demonstrate  compliance  with  standards  or 
regulation even where it is not a legislation requirement. Accreditation ensures and 
confirms  that  these  bodies  have  the  technical  capacity  to  perform  their  duties 
properly. 

2.2  

The impact of accreditation and functioning of the accreditation system 

Accreditation is the confirmation by a national accreditation body that a conformity 
assessment  body  meets  the  requirements  set  by  harmonised  standards  and  where 
applicable  any  additional  requirements,  including  those  set  out  in  relevant  sectoral 
schemes. 

The  Regulation  plays  a  key  part  in  facilitating  the  free  movement  of  goods  in  the 
internal  market  and  international  trade.  Under  its  provisions,  the  Member  States 
appoint  a  single  National  Accreditation  Body  that  provides  accreditation  of 
conformity  assessment  bodies.  The  reliance  on  EU-wide  harmonised  standards  is 
intended  to  create  the  necessary  level  of  transparency  and  confidence  in  the 
competence  of  conformity  assessment  bodies,  and  to  ensure  that  the  European 
accreditation system is compatible with the international accreditation system. 

While  manufacturers  remain  responsible  for  their  product’s  compliance  with  the 
applicable  legislative  requirements,  a  high  technical  capacity  of  conformity 
assessment bodies ensures that checks are precise and reliable. This contributes to the 
protection of public interests such as health and safety in the internal market. 

The  Regulation  provides  for  a  uniformly  rigorous  approach  to  accreditation  in  all 
Member  States  —  so  that  ultimately  one  accreditation  certificate  is  enough  to 
demonstrate  the  technical  capacity  of  a  conformity  assessment  body  throughout 
Europe.  Therefore,  the  benefit  of  accreditation  in  the  EU  is  that  once  a  conformity 
assessment  body  has  been  successfully  accredited  according  to  the  Regulation, 
Member States' authorities are obliged to recognise the accreditation certificate. This 
eliminates the unnecessary overhead of being accredited separately in every Member 
State  and  having  the  products  checked  by  different  conformity  assessment  bodies. 
This  creates  an  environment  favourable  for  developing  businesses  in  the  European 
market. 

By the end of 2016, more than 34450 accreditations were delivered3 (in regulated and 
non-harmonised areas) covering a wide range of activities and distributed as follows: 

Type of accreditation 

Calibration4  
Testing5 

Number of accreditations for 2016 
3245 
18625 

3  

4  
5  

EA  MLA  report  2016,  http://www.european-accreditation.org/information/ea-multilateral-agreement-
report-2016-is-now-released . 
Calibration is mainly technical configuration of measuring devices. 
Testing is the determination of technical characteristics of a product without examining its conformity. 

2 

 
 
                                                            
Type of accreditation 

Medical examinations 
Product certification6 
Management systems certification 
Persons certification  
Inspection7 
Proficiency testing providers (PTP) 
Reference materials producers (RMP) 
Verification 14065 (greenhouse gases)8  
Eco-management and Audit Scheme (EMAS) 
Total 

Number of accreditations for 2016 
3407 
1752 
1355 
480 
5158 
176 
44 
133 
79 
34454 

The process of restructuring and adapting to the Regulation is now completed9. All 
Member  States  as  well  as  EFTA  countries  and  Turkey  have  set  up  national 
accreditation bodies10.  

2.3. 

European accreditation infrastructure 

As set out in the Regulation, the Commission recognised the European Cooperation 
for Accreditation (EA) as the European accreditation infrastructure11. It concluded an 
agreement  in  2009  that  specifies  the  detailed  tasks  of  the  EA  and  the  principles  of 
cooperation. 

The EA has the fundamental function of determining the competence of the national 
accreditation  bodies  by  means  of  peer  evaluation12.  Following  the  successful  peer 
evaluation,  national  accreditation  bodies  became  signatories  to  the  EA  Multilateral 
Agreement  (MLA)13  for  the  mutual  recognition  of  accreditation  certificates.  A 
successful  peer  evaluation  is  the  prerequisite  for  the  mutual  recognition  of 
accreditation  certificates.  The  peer  evaluation  system  has  demonstrated  its  strength 
by ensuring that national accreditation bodies have a high level of competence. 

In  addition,  the  EA  has  been  working  with  interested  stakeholders  through  its 
Advisory Board  and  participated in the  international  accreditation organisations the 
ILAC and the IAF14. 

The cooperation with the EA has been very fruitful on the whole. The importance of 
accreditation of conformity assessment bodies has substantially increased over recent 
years. Due to the work of the EA and its members it is recognised that accreditation 
—  as  the  last  level  of  control  in  the  European  conformity  assessment  system  —  is 

6  

7  

8  
9 
10 

11 
12  
13  

14   

Certification is the demonstration over multiple checks that specific requirements (legislative or not) are 
fulfilled. Certification may encompass several inspections (see footnote 8 for ‘inspection’) and includes 
continuous monitoring. 
Inspection  is  the  examination  of  conformity  with  specific  requirements  (legislative  or  not)  in  a  once-
only check. 
Requirements for bodies measuring/verifying emissions of greenhouse gases. 
See Articles 4, 6 and 8 of the Regulation. 
Their  contact  details  are  available  on 
http://ec.europa.eu/growth/tools-databases/nando/  
See Article 14 of the Regulation. 
See Articles 10, 11 and 13 of the Regulation. 
The  EA  Multilateral  Agreement  (EA  MLA)  is  a  signed  agreement  whereby  the  signatories  recognise 
and accept the equivalence of the accreditation systems operated by the signing members, and also the 
reliability of the conformity assessment results provided by conformity assessment bodies accredited by 
the signing members. 
International Laboratory Accreditation Cooperation / International Accreditation Forum. 

the  Commission  website  at 

the  following  address: 

3 

 
 
                                                            
essential for the correct functioning of a transparent and quality-oriented market and 
to safeguard a high level of protection of public interests such as health, safety and 
the environment. 

2.4. 

Commission funding of European accreditation  

In June 2014, the Commission and the EA signed the second framework partnership 
agreement  for  a  four-year  period  (until  June  2018).  This  framework  partnership 
agreement allows financial support for the EA in fulfilling its tasks as laid down by 
the  Regulation  and  meeting  the  objectives  detailed  in  the  guidelines.  The  EA 
activities eligible for EU funding include: 

  carrying out technical work linked to the peer evaluation system; 
  providing 

interested  parties  and  participation 

information  of 

in 

the 

international organisations in the field of accreditation; 

  drawing  up  and  updating  of  contributions 

to  guidelines  related 

to 

accreditation; 

  giving assistance to third countries15. 

The framework partnership agreement stipulates that the EA and its secretariat could 
receive an annual operational grant for its ongoing work. At the time of writing this 
report, four annual operational grants amounting to EUR 600 000 and approximately 
40 % of the overall EA budget have been disbursed. 

Part of the grant has supported work related to the operation and management of the 
peer evaluation system which in 2013-2017 included16: 

Year 

2013 

2014 

2015 

2016 

Evaluations performed17 
11 

13 

10 

19 

Total man-days of evaluation work 

673 

807 

583 

1138 

The number of evaluators for 2016 by scope of activity is the following: 

15 
16  

17  

See Article 32 of the Regulation. 
EA  MLA  report  2016,  http://www.european-accreditation.org/information/ea-multilateral-agreement-
report-2016-is-now-released. 
Evaluations, initials, re-evaluations with or without scope extensions and extraordinary evaluations. 

4 

 
 
                                                            
Number of evaluators by scope (2016) 

Proficiency

"Green House Gases" Verification

Certification of persons

Products certification

Management systems certification

Inspection

Medical examinations

Testing

Calibration

23 

20 

35 

45 

29 

37 

57 

62 

88 

0

10

20

30

40

50

60

70

80

90

In 2016, the peer evaluation teams reported a total of 135 findings where corrective 
action was required by national accreditation bodies. The EA is monitoring how the 
corrective  action  is  being  implemented.  In  July  2014  one  Accreditation  Body  has 
been  suspended.  Following  the  successful  implementation  of  the  corrective  actions 
required by EA, the suspension has been lifted end 2014 following the results of an 
extraordinary evaluation by EA. 

Regarding  peer  evaluation  the  EA’s  activities  also  include  the  continuous 
improvement  of  the  peer  evaluation  system  and  the  launch  of  peer  evaluations  for 
new conformity assessment activities. 

The grant has also supported the EA’s work on (i) harmonising accreditation criteria, 
(ii)  developing,  consolidating  and  implementing  accreditation  in  the  EU,  and  (iii) 
cooperating  with  accreditation  organisations  outside 
international 
organisations and private stakeholders. 

the  EU, 

Besides the annual operational grant, the framework partnership agreement with the 
EA also stipulates the possibility of action grants for specific projects. In this respect 
the EA participated in the following projects: 

 

 

 

In  2013  the  EA  signed  a  specific  agreement  with  DG  CLIMA  on  a  grant  for 
action regarding the implementation of accreditation in the context of Regulation 
(EU)  No  600/201218.  The  work  related  to  this  specific  agreement  was 
successfully concluded in February 2015. 

In 2012 the EA signed a service contract with EuropeAid for the ‘Approximation 
of  the  EU  and  Russian  Federation  Accreditation  Systems’.  The  work  was 
successfully concluded in December 2015. 

In  2014  the  EA  signed  a  service  contract  with  the  JRC  for  ‘Support  services 
regarding  the  accreditation  aspects  of  the  project  on  a  European  voluntary 
Quality  Assurance  scheme  for  Breast  Cancer  Services  underpinned  by 
Accreditation  and  high-quality  Guidelines’.  The  project  is  still  ongoing  at  the 
time of writing this report. 

18  

Regulation  (EU)  No  600/2012  on  the  verification  of  greenhouse  gas  emission  reports  and  tonne-
kilometre reports and the accreditation of verifiers pursuant to Directive 2003/87/EC. 

5 

 
 
 
                                                            
The  Commission  and  the  EA  are  currently  discussing  the  third  framework 
partnership agreement. 

2.5. 

Accreditation in support of notification 

Notification  is  the  act  of  a  Member  State  informing  the  Commission  and  the  other 
Member  States  that  it  has  designated  a  conformity  assessment  body  under  an  EU 
harmonisation act, and that the body fulfils the relevant requirements set out in that 
act. Member States take the final responsibility for the competence of their notified 
bodies concerning the other Member States and the EU institutions. 

Although  accreditation  is  the  favoured  instrument  for  verifying  the  competence  of 
conformity assessment bodies, other ways to evaluate the competence of conformity 
assessment bodies are allowed as well. In such cases, evidence must be given to the 
Commission and other Member States that the evaluated body complies with all the 
applicable  regulatory  requirements19.  Furthermore,  the  notified  body  must  undergo 
regular  surveillance  similar  to  the  practice  established  by  the  accreditation 
organisations. 

The proportion of notifications of accredited conformity assessment bodies increased 
by 34 percentage points between end 2009 and November 2017. At the end of 2009, 
before  the  entry  into  force  of  the  Regulation,  out  of  2249  notifications  1089 
concerned  accredited  conformity  assessment  bodies  and  1118  concerned 
unaccredited bodies; i.e. 48.4 % of all notifications across all sectors were accredited. 
By  November  2017,  there  were  2708  notifications  of  which  472  concerned 
unaccredited conformity assessment bodies while 2236 concerned accredited bodies; 
i.e. 82.6 % of all notifications were for accredited bodies. 

Meanwhile, the EA developed the ‘Accreditation for Notification’ (AfN) package. It 
includes  guidance  documents  and  good  practices  and  aims  for  more  harmonisation 
throughout  Europe  when  assessing  notified  bodies.  The  project  was  successfully 
concluded in 2016 and the EA and its members are implementing the results. 

The  following  table  shows  the  breakdown  of  notifications  per  Member  State  and 
piece of legislation20. 

19  
20  

Article 5(2) of Regulation (EC) No 765/2008. 
State of play is 3 November 2017 

6 

 
 
 
 
 
                                                            
United Kingdom
Turkey
Sweden
Spain
Slovenia
Slovakia
Romania
Portugal
Poland
Norway
Netherlands
Malta
Luxembourg
Lithuania
Liechtenstein
Latvia
Italy
Ireland
Iceland
Hungary
Greece
Germany
France
Finland
Estonia
Denmark
Czech Republic
Cyprus
Croatia
Bulgaria
Belgium
Austria

Notifications per country (accredited vs non-accredited) 

82 

63 

5 

66 

4 

7 

4 
80 

35 

41 
36 

35 

1 
128 

2 

136 

2 

4 

0 
0 

11 

0 
21 

1 

2 
0 

4 

4 
1 
0 

8 

49 

0 

52 

92 

3 

116 

46 
0 

23 

277 

10 

30 

61 

262 

103 

Accredited

Non-accredited

0 

236 
5 

102 

72 

1 

100 

5 

8 

2 

13 

48 

1 

53 

64 

84 

2 

5 

0

50

100

150

200

250

300

350

7 

 
 
 
 
Notifications per legislation (accredited vs non-accredited) 

Accredited

Non-accredited

Regulation (EU) No 305/2011 - Construction products
Regulation (EU) 2016/426 Appliances burning gaseous fuels
Regulation (EU) 2016/425 Personal protective equipment
Regulation (EU) 2016/424 Cableway installations
Regulation (EC) No 552/2004 - Interoperability of the European Air Traffic Management network

0 

Decision 2009/750/EC (implementing Directive 2004/52/EC) - Interoperability of Electronic…

98/79/EC In vitro diagnostic medical devices
94/25/EC Recreational craft
93/42/EEC Medical devices
92/42/EEC Hot-water boilers
90/385/EEC Active implantable medical devices
89/686/EEC Personal protective equipment
2014/90/EU Marine equipment
2014/68/EU Pressure equipment
2014/53/EU Radio equipment

2014/34/EU Equipment and protective systems intended for use in potentially explosive…

2014/33/EU Lifts and safety components for lifts
2014/32/EU Measuring Instruments Directive
2014/31/EU Non-automatic weighing instruments
2014/30/EU Electromagnetic compatibility
2014/29/EU Simple pressure vessels
2014/28/EU Explosives for civil uses
2013/53/EU Recreational craft and personal watercraft
2013/29/EU Pyrotechnic articles
2010/35/EU Transportable pressure equipment
2009/48/EC Safety of toys
2009/142/EC (ex-90/396/EEC) Appliances burning gaseous fuels
2008/57/EC Interoperability of the rail system within the Community (Recast)
2006/42/EC Machinery
2000/9/EC Cableway installations designed to carry persons
2000/14/EC Noise emission in the environment by equipment for use outdoors

545 
6 

136 
2 

27 

6 

14 

7 

31 

36 

65 

41 

7 

22 

34 
1 
1 
4 

43 

100 

267 

63 
216 

80 

65 

12 

162 

50 

47 

48 

16 

170 

51 

1 

0 

0 

3 

11 

17 

5 
15 

8 

2 

15 

13 

28 

8 

55 

58 

5 

10 

17 

7 

15 

7 

2 

9 

0 

2 

13 

7 

8 

 
 
 
2.6. 

International cooperation — Agreement with Canada 

Upon  the  provisional  entry  into  force  of  the  EU-Canada  Comprehensive  Economic 
and Trade Agreement21 on 21 September 201722, the CETA Protocol on the Mutual 
Acceptance  of  the  Results  of  Conformity  Assessment  has  replaced  the  previous 
Mutual  Recognition  Agreement  with  Canada  of  1998.  The  Protocol  expands  its 
scope and substantially simplifies procedures for designating conformity assessment 
bodies to perform tasks for the purpose of meeting regulatory/legal requirements of 
both the EU and Canada. 

Under the CETA Protocol, once designated, a conformity assessment body in the EU 
can  test  products  for  export  to  Canada  according  to  Canadian  rules  and  vice  versa. 
This is particularly helpful to smaller companies as they don’t pay twice for the same 
test, and the time to market is shortened as products are not tested and certified in the 
country of destination. 

The  Protocol  relies  on  accreditation,  which  thus  becomes  an  even  more  important 
pillar for international cooperation with third countries. 

It  is  expected  that  EU  and  Canadian  accreditation  bodies  will  be  eventually 
recognised  as  being  able  to  perform  accreditation  that  complies  with  the  Canadian 
and EU regulatory/legal requirements respectively. For this purpose, the EA and the 
Canadian  accreditation  body,  the  Standards  Council  of  Canada  (SCC)  concluded  a 
cooperation  agreement  on  10  June  2016.  Its  purpose,  among  other  things,  is  to 
exchange  information  and  experts  for  on-site  assessments  to  increase  mutual 
confidence in the respective EU and Canadian accreditation processes. 

Furthermore,  following  the  CETA  Protocol  close  cooperation  between  the  EA  and 
the  SCC  has  been  established  to  ensure  consistency  in  assessing  conformity 
assessment bodies against European and Canadian product legislations. 

The sectors covered by the CETA protocol are: 

  electrical  and  electronic  equipment,  including  electrical  installations  and 

appliances, and related components; 

radio and telecommunications terminal equipment; 

toys; 

 

 

  construction products; 

  machinery,  including  parts,  components  —  including  safety  components, 

interchangeable equipment, and assemblies of machines; 

  measuring instruments; 

  hot-water boilers, including related appliances; 

  equipment,  machines,  apparatus,  devices,  control  components,  protection 
systems,  safety  devices,  controlling  devices  and  regulating  devices,  and  related 

21  
22  

OJ L 11, 14.1.2017. 
Notice  concerning  the  provisional  application of  the  Comprehensive  Economic  and Trade  Agreement 
(CETA) between Canada, of the one part, and the European Union and its Member States, of the other 
part, OJ L 238, 16.9.2017. 

9 

 
 
                                                            
instrumentation  and  prevention  and  detection  systems  for  use  in  potentially 
explosive atmospheres (ATEX equipment); 

  equipment for outdoor use as it relates to noise emission in the environment; 

 

recreational craft and their components. 

2.7. 

Commission’s  measures  for  enforcing  the  accreditation  provisions  of  the 
Regulation 

The  Regulation  specifies  that  the  Member  States  shall  appoint  a  single  National 
Accreditation  Body.  Yet,  a  few  private  entities  claim  that  they  are  also  performing 
accreditation.  Therefore,  the  Commission  opened  infringement  cases  and  requested 
that two Member States take measures to prevent ‘non-national bodies’ — self-styled 
‘accreditation  bodies’  that  are  not  the  officially  appointed  national  accreditation 
bodies  —  operating  in  their  territories  from  carrying  out  tasks  that  contradict  the 
Regulation  and  to  correct  the  description  of  their  activities.  The  cases  are  still  on-
going. 

Furthermore, as the Regulation allows operators to appeal/object against decisions of 
the  national  accreditation  bodies  and  obliges  each  Member  State  to  recognise  the 
equivalence  of  accreditation  certificates  of  other  Member  States’  national 
accreditation  bodies,  the  Commission  questioned  the  relevant  parts  of  a  new 
accreditation law adopted by a Member State in 2015. Following the Commission’s 
action, this Member State fully addressed the Commission’s concerns by amending 
the law on accreditation to comply with the Regulation. 

2.8. 

Legal developments related to accreditation in specific sectors 

2.8.1 Data protection 

Article  43(1)  of  the  new  General  Data  Protection  Regulation23  (GDPR)  obliges 
Member  States  to  offer  both  possible  accreditation  methods  to  certification  bodies, 
i.e.  by  the  national  data  protection  supervisory  authority  established  in  accordance 
with  data  protection  legislation  and/or  by  the  national  accreditation  body.  These 
accreditation  methods  concern  certification  mechanisms  falling  within  the  scope  of 
Article 42 of the GDPR. 

By  giving  specific  powers  to  independent  supervisory  authorities,  the  EU 
acknowledges the special features of personal data protection as a fundamental right 
enshrined  in  Article  8  of  the  Charter  of  Fundamental  Rights  and  thus  the  need  for 
special review and monitoring of the decisions of certification bodies. 

The  Commission  encourages  the  sharing  of  experiences  between  the  EA  and  the 
supervisory  authorities  of  the  GDPR.  In  this  respect  the  EA’s  infrastructure  and 
know-how  will  be  an  asset  to  ensure  that  all  channels  of  accreditation  under  the 
GDPR are consistent. 

23  

Regulation  (EU)  2016/679  of  the  European  Parliament  and  the  Council  of  27  April  2016  on  the 
protection of natural persons with regard to the processing of personal data and on the free movement of 
such data. 

10 

 
 
 
 
 
                                                            
2.8.2 Food and feed 

The  new  food  and  feed  Regulation24  introduces  accreditation  and  states  that  ‘the 
accreditation  should  be  delivered  by  a  national  accreditation  body  operating  in 
accordance with Regulation (EC) No 765/2008’. In this respect the Commission will 
monitor  the  EA’s  deployment  of  the  accreditation  infrastructure  into  the  food  and 
feed sector. 

2.8.3 Cybersecurity 

The  Proposal  for  a  Regulation  on  Cybersecurity25  introduces  accreditation  and 
stipulates that ‘the conformity assessment bodies shall be accredited by the national 
accreditation body named pursuant to Regulation (EC) No 765/2008 only when they 
meet  the  requirements  set  out  in  the  Annex  to  this  Regulation’.  Furthermore,  the 
Proposal lays downs that ‘in duly justified cases’ a European cybersecurity certificate 
can  only  be  issued  by  a  public  (conformity  assessment)  body;  the  latter  may  be, 
among others, a national certification supervisory authority. 

As a national certification supervisory authority must also supervise the compliance 
of the certificates issued by other conformity assessment bodies with the legislative 
requirements, the Commission  in  cooperation with  the Member States will monitor 
the implementation of the Cybersecurity Regulation (once adopted), and ensure that 
the  compliance  of  the  certificates  is  supervised  in  an  impartial  and  transparent 
manner. 

2.9. 

Challenges 

The Regulation has set a solid legal framework for accreditation. The main challenge 
now is to keep the whole accreditation system in line with the latest state of the art 
and ensure that it is applied with the same stringency. 

Furthermore due to the wider use of accreditation, some national accreditation bodies 
may  face  more  requests  for  accreditation  in  the  future  which  may  impact  on  their 
financial and human resources. 

Another challenge is creating a better level playing field when accreditation is used 
for notification. A lot of work has already been done by EA with the "Accreditation 
for  Notification"  (AfN)  package.  The  correct implementation  of  this  project  should 
be monitored. In this respect Member States in their role as notifying authorities have 
a major role to play.  

Accreditation  is  increasingly  being  used  in  new  policy  areas.  The  wider  use  of 
accreditation and the general trust in accreditation is an important  responsibility for 
the  EA  and  the  national  accreditation  bodies.  Therefore,  it  is  essential  that  the  EA 
continues  to  receive  EU  support  to  help  it  implement  its  tasks.  Furthermore  it  is 
important  to  maintain  a  high  level  of  awareness  and  understanding  of  the 
accreditation  system  among  its  stakeholders  in  order  to  ensure  its  correct 

24  

25  

Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 on official 
controls and other official activities performed to ensure the application of food and feed law, rules on 
animal health and welfare, plant health and plant protection products. 
Proposal  for  a  Regulation  of  the  European  Parliament  and  of  the  Council  on  ENISA  (EU  agency  for 
Network  and  Information  Security),  the  ‘EU  Cybersecurity  Agency’,  and  repealing  Regulation  (EU) 
526/2013,  and  on  Information  and  Communication  Technology  cybersecurity  certification  — 
‘‘Cybersecurity Act’’, COM(2017) 477 final. 

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implementation especially in the new policy areas. The Commission will continue to 
promote the use of accreditation in accordance with Regulation 765/2008 in any new 
proposals requiring conformity assessment. 

3. 

CE MARKING 

Regulation (EC) No 765/2008 lays down the general requirements and principles of 
the CE marking. Most new EU legislation on non-food products adopted since 2010 
specifically  requires  products  to  carry  the  CE  marking,  and  that  the  CE  marking  is 
subject to the general principles set out in Regulation (EC) No 765/2008. 

In  2014  the  Commission  examined  whether  the  current  regime  of  CE  marking  is 
satisfactory. The results of the assessment show an overall satisfaction  with the CE 
marking which is considered appropriate and effective. The assessment also showed 
that there is no need for any fundamental change in CE marking, although there is a 
need for greater consistency and to avoid having different requirements for different 
pieces of legislation and address the issue of products with multiple parts26.  

The Commission webpage dedicated to the CE marking serves as a one-stop shop for 
information  on  CE  marking  in  all  EU/EFTA  languages27  and  is  regularly  updated. 
The number of visits to the CE marking web pages28 demonstrates the importance of 
this information being made available to stakeholders. 

At the same time, the number of written questions to the European Commission on 
CE  marking  has  substantially  decreased  over  the  last  four  years  (less  than  100 
questions per year compared to almost 400 four years ago). 

The comprehensive information of the dedicated website increased the stakeholders’ 
familiarity with  the CE  marking  and their awareness of their  rights  and obligations 
stemming  from  EU  harmonised  legislation.  Furthermore,  the  questions  themselves 
are now more complex, detailed and refined, demonstrating good knowledge of the 
CE marking requirements. 

26  

27  
28  

Commission staff working document SWD(2014)23 on the evaluation of the internal market legislation 
for  industrial  products,  accompanying  Communication  COM(2014)25  on  a  vision  for  the  internal 
market for industrial products.  
https://ec.europa.eu/growth/single-market/ce-marking_en 
616 489 visits in the period from 11 July 2016 until 27 September 2017. 

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